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WHO MEDICINES STRATEGY 2004-2007 |x

WHO MEDICINES STRATEGY 2004-2007 |xiACRONYMSACTADRAPIARVAFROAMROASEANATCCADREACCAMCMSCPACSODDDDOTSDTCECEDMEMEAEMROEUGACPGCPGDPGMPGTDPHAIICHINNINRUDIPCMDGMSFArtemisinin combination therapyAdverse Drug ReactionActive Pharmaceutical IngredientAntiretroviralWHO African Regional OfficeWHO Americas Regional OfficeAssociation of Southeast Asian NationsAnatomic Therapeutic ChemicalAgreement of Drug Regulatory Authorities inEuropean Union Associated CountriesComplementary and Alternative MedicineCentral Medical StoresConfederation of Pharmaceutical AssociationsCivil Society OrganizationDefined Daily DoseDirectly Observed Treatment Short-CourseDrug and Therapeutics CommitteeEuropean CommissionEssential Drugs and Medicines PolicyEuropean Medicines Evaluation AgencyWHO Eastern Mediterranean Regional OfficeEuropean UnionGood Agricultural and Collection PracticesGood Clinical PracticeGross Domestic ProductGood Manufacturing PracticesGood Trade and Distribution PracticesHealth Action InternationalInternational Conference on Harmonization oftechnical Requirements for registration of Pharmaceuticals for Human UseInternational Nonproprietary NameInternational Network for Rational Use of DrugsInternational Pharmaceutical CoordinationMillennium Development GoalMédecins Sans Frontières

WHO MEDICINES STRATEGY 2004-2007 |xiiMSHNGONISNMPNPOOAPIPAHOQCSADCSMACSSEAROTDRTBTMTRIPSUNAIDSUNCTADUNDCPUNDPUNFPAWHAWIPOWPROWTOManagement Sciences for HealthNon-governmental OrganizationNewly Independent StatesNational Medicines PolicyNational Professional OfficerOrganisation Africaine de la Propriété IntellectuellePan American Health OrganizationQuality ControlSouthern African Development CommunityPharmaceutical Starting Materials Certification SchemeWHO South-East Asian Regional OfficeUNDP/World Bank/WHO Special Programme forResearch and Training in Tropical DiseasesTuberculosisTraditional MedicineAgreement on Trade-Related Aspects of Intellectual Property RightsJoint United Nations Programme on HIV/AIDSUnited Nations Conference on Trade and DevelopmentUnited Nations Drug Control ProgrammeUnited Nations Development ProgrammeUnited Nations Population FundWorld Health AssemblyWorld Intellectual Property OrganizationWHO Western Pacific Regional OfficeWorld Trade Organization

HIGHLIGHTS

WHO MEDICINES STRATEGY 2004-2007 | 2

HIGHLIGHTS | 3OUR VISIONOur vision is that people everywhere haveaccess to the essential medicines they need; thatthe medicines are safe, effective, and of goodquality; and that the medicines are prescribedand used rationally.EXPANDING ACCESS TO ESSENTIAL MEDICINESScaling up access to essential medicines —especially for HIV/AIDS, tuberculosis (TB), andmalaria — is critical to global efforts by WHO toprevent millions of deaths a year, reduce suffering,and help reduce the economic burden of illnesson the poorest families.WHO estimates that over 10.5 million lives ayear could be saved by 2015 — also boostingeconomic growth and social development — byexpanding access to existing interventions forinfectious diseases, maternal and child health,and noncommunicable diseases.Most of these interventions depend on essentialmedicines. Yet today, almost 2 billion people —one-third of the global population — do not haveregular access to essential medicines. In some ofthe lowest-income countries in Africa and Asia,more than half of the population have no regularaccess to essential medicines.In developing countries, where an estimated40 million people are infected with HIV/AIDS,life-saving antiretroviral medicines (ARVs) areavailable to only 300 000 of the 5-6 millionpeople currently in need of treatment — a crisisthat WHO has declared to be a global healthemergency.Average per capita spending on pharmaceuticalsin high-income countries is 100 times higherthan in low-income countries — about US$ 400compared with US$ 4. WHO estimates that 15%of the world’s population consumes over 90% ofthe world’s production of pharmaceuticals (byvalue).Access to health care is a fundamental humanright, enshrined in international treaties andrecognized by governments throughout the world.However, without equitable access to essentialmedicines for priority diseases the fundamentalright to health cannot be fulfilled. Access toessential medicines is also one of the UN’sMillennium Development Goals (MDGs).Note:Numbered references (sources) are listed at the end (pages147-149). References indicated by a letter in the text areexplained in Endnotes (page 150).

MEDICINESAND PUBLIC HEALTH

MEDICINES AND PUBLIC HEALTH | 13Essential medicines save lives, reducesuffering, and improve health. But onlyif they are of good quality and safe,available, affordable, and rationallyused. The concept of essential medicinesencourages health systems to focus onaccess to those medicines that representthe best balance of quality, safety, efficacyand cost to meet priority health needswithin any given health care setting. Overthe last 25 years the concept has provento be a global necessity for countries fromthe poorest to the wealthiest.CURRENT CHALLENGES IN A CHANGING WORLDIn 2002, there were almost 6 million deaths fromHIV/AIDS, TB, and malaria. Of the over 1 millionwho died from malaria, most were children inAfrica. In addition, WHO estimates that in 2002over 2 million children in developing countriesdied from perinatal conditions and 4 million diedfrom just three diseases — pneumonia, measles,and diarrhoea. Meanwhile heart disease, stroke,cancer, and other chronic diseases are a majorcause of death in high- and middle-incomecountries, and an increasing problem in lowincomecountries. Yet for nearly all of these majorhealth problems, medicines exist that can extendlife and reduce disability.In 2001, the Commission on Macroeconomicsand Health estimated that 10.5 million lives peryear could be saved by the year 2015 — alsoboosting economic growth and development— by scaling up access to existing healthinterventions to prevent or treat infectiousdiseases, maternal and perinatal conditions,childhood diseases, and noncommunicablediseases. Most of these interventions depend onessential medicines.Figure 1: 10.5 million lives per year could besaved by ensuring access to existing medicines,vaccines, and prevention strategiesNo. of deaths in millionsABCDEA B C D EInfectious diseasesMaternal & perinatalRespiratory infectionsCancersCardiovascular diseases1998 Baseline2015 without Scaling-up2015 with Scaling-upSource: Commission on Macroeconomics andHealth, WHO, 2001

WHO MEDICINES STRATEGY 2004-2007 | 14Figure 2: Estimated global share ofpharmaceutical consumption (by value) in low-,middle-, and high-income countriesEssential medicines also have a huge economicimpact on countries and on households. Indeveloping countries today, because of highprices, medicines account for 25%-70% oftotal health care expenditures, compared toless than 15% in most high-income countries.For governments and NGOs providing primaryhealth care, medicines are the largest expenseafter personnel costs. For households in lowincomecountries, medicines represent 50%-90%of out-of-pocket spending on health. Yet in somecountries, less than half of people living in poorhouseholds receive all the medicines they needfor acute illness – and one-third receive none ofthe medicines they need. Source: World Medicines Situation,WHO (forthcoming).Despite considerable progress in access toessential medicines over the last 25 years, anestimated 1.7 billion people today still have noregular access to quality essential medicines.While this is a smaller percentage of the globalpopulation than in 1977, when the first WHOModel List of essential medicines was published,gross inequity in access to medicines remains theoverriding feature of the world pharmaceuticalsituation.From 1985 to 1999, the global share ofpharmaceuticals production and consumption

MEDICINES AND PUBLIC HEALTH | 15(by value) increased in high-income countries,but fell in low-income countries — despitean increase in population. As a result, WHOestimates that 15% of the world’s populationconsumes 91% of the world’s production ofpharmaceuticals (by value).Compared to 1985, many more countries todayhave national medicines policies. However, inlow-income countries, all too often these policieslack implementation plans and supportingstrategies such as price control, generic promotionor the effective regulation of quality. Theserealities are a continuing challenge for WHO inpromoting the concept of essential medicines.Over the past 15 years, there have also beenchanges in the global context in which nationalmedicines policies are being implemented. Theglobal burden of disease has undergone a majorshift as both the scale and impact of HIV/AIDShave become fully apparent. In 1988, therewere an estimated 6.3 million HIV/AIDS casesworldwide. By the end of 2003 an estimated 40million people were living with HIV/AIDS. Ofthose, about 30% live in southern Africa — hometo just 2% of the world’s population — and anestimated 2.5 million are children under the ageof 15. During 2003, WHO estimates that about 5million people were newly infected with HIV andthere were about 3 million AIDS deaths.The global response to the HIV/AIDS pandemichas brought into focus a number of key issuesin medicines policy. One of these is the criticalimportance of innovation. The research anddevelopment of new, safe, and effective medicinesis critical to saving lives and reducing sufferingfrom a new disease on an epidemic scale.However, many of these new medicines havebeen at the centre of continuing controversiesabout prices and the legal limits to competitionthrough intellectual property rights in the form ofpatents. In a global trading situation, intellectualproperty rights occupy an important place andmedicines have held centre stage in discussionsin and around the World Trade Organization(WTO) about whether, and at what speed,implementation of a single set of internationaltrade rules should occur.

WHO MEDICINES STRATEGY 2004-2007 | 1625 YEARS OF EXPERIENCEWITH THE ESSENTIAL MEDICINES CONCEPTThe essential medicines concept arose from thegrowing recognition that medicines bring dangersas well as great promise, and the realization thatdeveloping countries were spending up to 40% oftheir health expenditure on medicines. Originallyknown as “essential drugs”, the concept emergedin the 1970s with a definition of essential drugsin 1975 and the publication of the first WHOModel List of Essential Drugs in 1977 followed bythe 1978 Declaration of Alma Ata that identified“provision of essential drugs” as one of the eightelements of primary health care.Revalidation of the concept is taking place in the21 st century with inclusion of access to essentialmedicines in the UN’s Millennium DevelopmentGoals (MDGs), and with WHO modernizing themethods for selection and publishing the firstWHO Model Formulary.This has led to a complete overhaul and renewalof the whole essential medicines concept.The 1980s saw the operationalization of theessential drugs concept with the establishmentof the Action Programme for Essential Drugs inGeneva and national essential drugs programmesin five countries. A number of non-governmentalorganizations (NGOs) such as Health ActionInternational (HAI) and the International Networkfor Rational Use of Drugs ( INRUD) were formedto support the implementation of the concept.Consolidation and expansion during the 1990swas carried out in an environment that waschanging politically, pharmaceutically, andepidemiologically.

MEDICINES AND PUBLIC HEALTH | 17HOPE AND PROMISE FOR THE FUTURESignificant progress has been made in:strengthening national pharmaceuticalprogrammes, with notable achievements incountries in each of the six WHO regions;developing effective medicines regulation;maximizing the impact of WHO clinicalguidelines; helping countries respond to theimpact of trade on their pharmaceutical sector;promoting safe and effective use of traditionalmedicine; and monitoring WHO’s work inessential drugs and medicines policy.WHO’s current priority in medicines is to expandaccess to essential medicines, particularly forlow-income and disadvantaged populations andfor the priority diseases of HIV/AIDS, TB, andmalaria. Considerable progress is being madeon drug selection and drug pricing. Greaterfocus is being put on financing, supply systems,and quality assurance, areas in which effectivework with countries and partnerships withother international organizations, aid agencies,and NGOs are crucial for achieving sound,sustainable results.

WHO MEDICINES STRATEGY 2004-2007 | 18OUR GOALOur vision is that peopleeverywhere have access to theessential medicines they need;that the medicines are safe,effective, and of good quality;and that the medicines areprescribed and used rationally.WHO’s goal in medicines is to help save lives andimprove health by ensuring the quality, efficacy,safety and rational use of medicines, includingtraditional medicines, particularly for the poorand disadvantaged.The challenge for WHO in 2004-2007 is tocontinue to interpret the concept of essentialmedicines via a strategy and activities that reflectboth the ongoing issues and the current highprofile issues around access to, financing, andquality of medicines.This document sets out the WHO MedicinesStrategy for the years 2004-2007. The title ofthe document acknowledges the fact that all theactivities should benefit countries, which remainat the core of our work. Countries at the coreexpresses the current wider vision of WHO aswell as acknowledging the fact that over the past25 years the activities of the Essential Drugs andMedicine Policy (EDM) department have beenfocused on countries.The WHO Medicines Strategy 2000-2003 (WMS2000-2003) was anchored in WHO’s constitutionand the numerous resolutions adopted by theWorld Health Assembly (WHA) which haveguided WHO’s work in the medicines area for

MEDICINES AND PUBLIC HEALTH | 19many years. In May 2001 the WHA endorsedthe WMS 2000-2003 (Resolution WHA54.11).Progress in the implementation of WMS 2000-2003 has been measured by a set of 26 indicators.For most of these, indicator status as of 1999 wasincluded, against which targets for 2003 were set.Table 5 in chapter 4 sets out the new indicatorsfor the latest Strategy, together with the status asof 1999 and 2003, where available, and the newtargets for 2007.the work of Member States “in formulatingnational policies and regulations on traditionalmedicine and complementary and alternativemedicine.”The WHO Medicines Strategy 2004-2007 (WMS2004-2007) is an update of WMS 2000-2003. It isthe result of a global WHO consultation exerciseinvolving WHO headquarters, regional offices,and country offices. It takes into account morerecent WHA resolutions (WHA 55.14, May 2002,WHA 56.27, WHA 56.31, both May 2003) whichconsider the evolving international context. WHA56.27 “Intellectual property rights, innovationand public health” requests WHO’s Director-General to support Member States in efforts toimprove access to medicines “in the exchangeand transfer of technology and research findings…in the context of paragraph 7 of the DohaDeclaration” and to “monitor and analyse thepharmaceutical and public health implications ofrelevant international agreements…” WHA 56.31Traditional Medicine, requests WHO to facilitate

WHO MEDICINES STRATEGY 2004-2007 | 20PROGRESS IN 2000-2003The WHO Medicines Strategy 2000-2003 wasbased on four core objectives: (1) promoting theformulation, implementation, and monitoring ofnational drug policies as guides to coordinationof action by all stakeholders, (2) expanding accessto essential medicines through improvementsin financing and supply systems, (3) improvingthe quality and safety of medicines throughstrengthening of norms and standards and throughsupport for effective regulation and informationexchange, and (4) promoting rational use ofmedicines by health professionals and consumersin the public and private sectors.Progress in 2002-2003 has been tracked througha set of country progress indicators, which aredetailed below in Table 3. Specific country,regional, and global achievements are describedin the annual reports for Essential Drugs andMedicines Policy 1 , Essential Drugs in Brief, 2 andthe reports to the World Health Assembly 3 . Someexamples of these achievements include:> Country support in essential medicines,tailored to the priorities of each country,provided to over 120 countries, with intensivesupport to over 20 countries, and documentedimprovements in access, quality, and rationaluse of medicines.> Implementation of a global system formonitoring country progress and launch of atargeted assessment package for monitoringaccess to medicines, used in over 20countries, which includes household surveyson access to and use of medicines.> Launch of the WHO Traditional MedicinesStrategy to support safe and informed use oftraditional and complementary medicine andprotect traditional knowledge.> Provision of systematic guidance onthe impact of trade liberalization andglobalization on access to medicines, focusingon bilateral, regional, and international tradeagreements, in particular the WTO Agreementon Trade-Related Aspects of IntellectualProperty Rights (TRIPS).

MEDICINES AND PUBLIC HEALTH | 21> Intensive work on access to medicines forHIV/AIDS, TB, malaria, and other prioritydiseases, with a focus on selection, regulation,quality assessment, prices, and monitoring oftrade agreements.> Expansion of information on comparativemedicine prices worldwide and developmentof a new price survey methodology to helphealth systems and consumers become moreinformed buyers of quality medicines.> Launch of the first global training programmeon GMP to improve the quality of medicinesproduction worldwide.> Creation of a programme for qualityassessment for priority products(prequalification) which now covers HIV/AIDS, TB, and malaria.> Expansion of the WHO InternationalProgramme for Monitoring Drug Safety, whichalso marked its 25 th year and now extends to72 countries.OBJECTIVES AND EXPECTEDOUTCOMES FOR 2004-2007The WMS 2004-2007 retains the same fourobjectives as the previous strategy, but dividesexpected outcomes into seven components.These objectives and components reflect whatis needed in countries to achieve the essentialmedicines vision. WHO’s work for the nextfour years is then defined in terms of support forcountries to achieve these aims.> Revision of the essential medicines selectionprocess to ensure a more evidence-based,independent, and transparent process.Reasons for selection are published on theWHO Medicines Library website, togetherwith comparative information on prices andthe WHO Model Formulary.> Development of comprehensive trainingprogrammes on rational use of medicines,including programmes on problembasedtherapy, rational use in communityprescribing, pharmacoeconomics, and drugsand therapeutics committees.> Launch of a campaign to raise awarenessabout the dangers of counterfeit andsubstandard medicines.

WHO MEDICINES STRATEGY 2004-2007 | 22WHO MEDICINES STRATEGY 2004-2007SUMMARY TABLE OF PLANNING ELEMENTSOBJECTIVES COMPONENTS EXPECTED OUTCOMES IN COUNTRIESPOLICY1.1 Medicines policies developed, updated and implementedCommitment among1taking into consideration health, development, and intersectoralImplementation and monitoring of policiesall stakeholders tomedicines policies1.2 Implementation of medicines policy regularly monitored andmedicines policiesAdvocate and support theevaluatedbased on the essential implementation and monitoring of1.3 Public health aspects protected in the negotiation andmedicines concept, medicines policies based on theimplementation of international, regional, and bilateral tradeand to coordinated concept of essential medicines.agreementsimplementation, Monitor the impact of trademonitoring and agreements on access to quality1.4 Human resources capacity increased in the pharmaceuticalsectorevaluation of policies. essential medicines. Build capacityin the pharmaceutical sector. 1.5 Promotion of innovation based on public health needs,especially for neglected diseasesACCESSEquitable financing,affordability anddelivery of essentialmedicines in linewith MillenniumDevelopment Goals,Target 17.2Traditional medicine andcomplementary and alternativemedicineAdequate support provided tocountries to promote the safety,efficacy, quality, and sounduse of traditional medicine andcomplementary and alternativemedicine.3Fair financing mechanisms andaffordability of essential medicinesGuidance provided on financingthe supply and increasing theaffordability of essential medicinesin both the public and privatesectors.4Medicines supply systemsEfficient and secure systems formedicines supply promoted forboth the public and private sectors,in order to ensure continuousavailability of essential medicines.1.6 Gender perspectives introduced in the implementation ofmedicines policies1.7 Access to essential medicines recognized as a human right1.8 Ethical practices promoted and anti-corruption measuresidentified and implemented in the pharmaceutical sector2.1 TM/CAM integrated into national health care systems whereappropriate2.2 Safety, efficacy, and quality of TM/CAM enhanced2.3 Availability and affordability of TM/CAM enhanced2.4 Rational use of TM/CAM by providers and consumers promoted3.1 Access to essential medicines improved, including medicinesfor HIV/AIDS, malaria , TB, childhood illnesses andnoncommunicable diseases3.2 Increased public funding of medicines promoted along withcost containment mechanisms3.3 Increased access to medicines through development assistance,including the Global Fund3.4 Medicines benefits promoted within social health insurance andpre-payment schemes3.5 Medicine pricing policies and exchange of price informationpromoted3.6 Competition and generic policies implemented4.1 Supply systems assessed and successful strategies promoted4.2 Medicines supply management improved4.3 Local production assessed and strengthened, as appropriate andfeasible4.4 Good procurement practices and purchasing efficiencyimproved4.5 Public-interest NGOs included in national medicine supplystrategies, where appropriate

MEDICINES AND PUBLIC HEALTH | 23OBJECTIVES COMPONENTS EXPECTED OUTCOMES IN COUNTRIESQUALITY5ANDNorms and standards forSAFETYpharmaceuticalsGlobal norms, standard, and 5.3 Pharmaceutical specifications and reference materialsThe quality, safetydeveloped and maintainedguidelines for the quality, safety,and efficacy of alland efficacy of medicinesmedicines assured strengthened and promoted.by strengthening andputting into practiceregulatory and qualityassurance standardsRATIONALUSETherapeutically soundand cost-effective useof medicines by healthprofessionals andconsumers6Medicines regulation and qualityassurance systemsInstruments for effective drugregulation and quality assurancesystems promoted in order tostrengthen national drug regulatoryauthorities.7Rational use by health professionalsand consumersAwareness raising and guidance oncost-effective and rational use ofmedicines promoted, with a view toimproving medicines use by healthprofessionals and consumers.5.1 Pharmaceutical norms, standards, and guidelines developed orupdated5.2 Medicines nomenclatures and classification efforts continued5.4 Balance between abuse prevention and appropriate access topsychoactive substances achieved6.1 Medicines regulation effectively implemented and monitored6.2 Information management and exchange systems promoted6.3 Good practices in medicine regulation and quality assurancesystems promoted6.4 Post-marketing surveillance of medicine safety maintained andstrengthened6.5 Use of substandard and counterfeit medicines reduced6.6 Prequalification of products and manufacturers of medicinesfor priority diseases and quality control laboratories, asappropriate, through procedures and guidelines appropriate forthis activity6.7 Safety of new priority and neglected medicines enhanced6.8 Regulatory harmonization monitored and promoted, asappropriate, and networking initiatives developed7.1 Rational use of medicines by health professionals andconsumers advocated7.2 Essential medicines list, clinical guidelines, and formularyprocess developed and promoted7.3 Independent and reliable medicines information identifieddisseminated and promoted7.4 Responsible ethical medicines promotion for healthprofessionals and consumers encouraged7.5 Consumer education enhanced7.6 Drug and therapeutics committees promoted at institutional anddistrict/national levels7.7 Training in good prescribing and dispensing practices promoted7.8 Practical approaches to contain antimicrobial resistancedeveloped based on the WHO Global Strategy to containAntimicrobial Resistance7.9 Identification and promotion of cost-effective strategies topromote rational use of medicines

WHO MEDICINES STRATEGY 2004-2007 | 24Figure 3:Ensuring access to essential medicines requires acoordinated set of actionsPRIORITIES FOR 2004-2007The central priority for 2004-2007 remains thatof expanding access to essential medicines,one of the health-related MDGs to which theinternational community is committed. Toachieve this goal, WHO will emphasize access toall essential medicines, including those for HIV/AIDS, TB, malaria, and childhood illness.Ensuring access to essential medicines dependson success in putting in place the four key piecesof the access puzzle: rational selection, affordableprices, sustainable financing, and reliable healthsupply systems (Figure 3). Work in this areawill include analysis of effective drug supplystrategies, including supply services operated byfaith-based organizations.Within the overall objective of access, WHO willgive the greatest attention to scaling up access toARVs to meet the WHO target of ensuring that3 million people in developing countries haveaccess to treatment for HIV/AIDS by 2005.New and continued priorities in the area ofnational medicines policies include:> implementation of the WHO TraditionalMedicine Strategy> promotion and monitoring of access toessential medicines as a human right> greater attention to innovation to ensure thedevelopment of new medicines for neglecteddiseases and other priority needs> ensuring a public health-oriented approach tonational implementation of trade agreements> promoting a stronger ethical dimension in thepharmaceutical sector, including the use ofanti-corruption measures.Finally, during 2004-2007 increased attention willbe given to medicines safety through expandedsafety monitoring and continued strengthening ofquality assurance.

COMPONENTSOF THE STRATEGY

WHO MEDICINES STRATEGY 2004-2007 | 26COMPONENT 1NATIONAL POLICIES ON MEDICINES

COMPONENTS OF THE STRATEGY | 27A NATIONAL MEDICINESPOLICY:National medicines policies (NMPs) arecommitments to goals and guides for action. Theyprovide frameworks within which priorities areset, the activities of the pharmaceutical sectorcan be coordinated, and legislation developedto support public health needs. They cover boththe public and the private sectors and involveall the main actors in the pharmaceutical field.While recognizing that each country’s situationis unique, WHO proposes 4 that the generalobjectives of medicines policies should be toensure:> Access: equitable availability and affordabilityof essential medicines> Quality: quality, safety, and efficacy of allmedicines> Rational use: therapeutically sound andcost-effective use of medicines by healthprofessionals and consumers.> presents a formal record ofvalues, aspirations, aims,decisions, and mediumtolong-term governmentcommitments> defines the national goalsand objectives for thepharmaceutical sector, and setspriorities> identifies the strategies neededto meet those objectives, andthe various actors responsiblefor implementing the maincomponents of the policy> creates a forum for nationaldiscussions on these issues.

WHO MEDICINES STRATEGY 2004-2007 | 28>>>The policy process is just as important as thepolicy document. A systematic approachto the policy process includes assessmentof the pharmaceutical situation, planning astrategy based on the results of this assessment,implementation of the strategy, and ongoingmonitoring. Assessment and monitoring of thepharmaceutical situation are vital in order toidentify strengths and weaknesses, determinepriority health needs, track progress, coordinatedonor support, and raise funds. Data gatheredduring assessments should be used to informpolicy plans. The planning process should involveall key stakeholders. Working together to defineobjectives, set priorities, and develop strategieshelps ensure joint ownership of plans and thecommitment of key stakeholders — a criticalneed in view of the national effort necessary forimplementation.Although many countries have adopted andrevised NMPs, not all of them have succeededin systematically implementing these policiesand monitoring them effectively or ensuring thatthey are tailored to national health priorities.New challenges are also arising. For instance, theimpact of international, regional, and bilateraltrade agreements on access to medicines needsto be carefully monitored to safeguard publichealth. Other challenges include increasing thehuman resource capacity in the pharmaceuticalsector, promoting innovation of medicallyneeded new medicines for neglected diseasesand other public health priorities, addressinggender differences in access and rational use ofmedicines, promoting the recognition of accessto medicines as a human right, and promotingethical practices and anti-corruption measures inthe pharmaceutical sector.In defining the expectedoutcomes for WHO MedicinesStrategy 2004-2007, WHO willadvocate for and support theimplementation and monitoring ofmedicines policies based on theconcept of essential medicines;will monitor the impact of tradeagreements on access to qualityessential medicines; and will buildcapacity in the pharmaceuticalsector.

COMPONENTS OF THE STRATEGY | 29EO 1.1Medicines policies developed,updated, and implemented,taking into consideration health,development, and intersectoralpolicies to achieve maximum impactRationaleExperience in many countries has shown thatissues relating to medicines are best addressedwithin a common policy framework. EffectiveNMPs improve access and rational use ofquality essential medicines. WHO recommendsthat all countries formulate and implementcomprehensive NMPs, within the framework ofa particular health care system, a national healthpolicy and, where appropriate, a programme ofhealth sector reform. The goals of NMPs shouldbe consistent with broader health objectives andtheir implementation should help attain thoseobjectives.ProgressIn 2001, WHO revised and updated itspublication on How to develop a nationaldrug policy. Over the past two years, over120 countries have been supported in thedevelopment, updating, and implementationof NMPs. In response to WHO’s Questionnaireon Structures and Processes of CountryPharmaceutical Situations, 98 out of 131countries reported having a NMP 5 .The Essential Drugs Monitor, which has reportedon the findings of numerous country case studieson different aspects of the development andimplementation of NMPs, continues to provide aninvaluable resource for Member States.Whilst the number of countries with NMPs isimpressive, many of these were developed, ofnecessity, as ‘stand alone’ policies. There is nowa need to update these NMPs, in consultationwith key stakeholders, to take account ofchanging health, development and intersectoralpolicies. Meanwhile, in some countries, NMPsexist on paper but have not been disseminated,implemented or monitored in a systematicmanner.Meeting the challenges in 2004-2007Over the next four years WHO will:> advocate for and support the development ofNMPs and associated implementation plans,including plans for ongoing monitoring.> support countries in their efforts to reviewtheir NMPs and to integrate them intowider health and intersectoral policies andprogrammes.> encourage strengthened collaborationbetween ministries of health and other keystakeholders in the development and reviewof NMPs, through ensuring ownership andcommitment to NMPs and implementationstrategies.> Commission articles for the Essential DrugsMonitor outlining country experiences in thedevelopment and implementation of NMPs asa means of sharing global knowledge.OUTCOME INDICATORS1999 2003 2007ChallengesNo. of countries with an official national medicines policydocument – new or updated within the last 10 yearsNo. of countries with a national medicines policyimplementation plan – new or updated within the last 5years#REPORTING % TARGET#REPORTING % TARGET67/152 44% 55% 62/123 50% 59%41/106 39% 43% 49/103 48% 61%

WHO MEDICINES STRATEGY 2004-2007 | 30EO 1.2Implementation of medicines policyregularly monitored and evaluated,providing data that can be used inadjusting policy and interventionsto improve access to medicinesRationaleAs an integral part of a NMP, a system formonitoring and evaluation is a constructivemanagement tool that enables ongoingassessment of progress, and contributes tothe necessary management decisions, policydevelopment or reform. Standards can be setand comparison made between countries, areas,and facilities, as well as over time — providingevidence-based information on progress.There is also a need to measure household accessto medicines. While indicators measured atfacility/provider level have proved to be useful,the household survey is an important tool toobtain accurate information on how a populationgroup is accessing and using the medicines itneeds.ProgressA WHO survey package has been developedfor monitoring and assessing pharmaceuticalsituations through the use of measurableindicators. Until recently, efforts by countriesto monitor their pharmaceutical situation werehampered by the lack of time and resourcesneeded to carry out training, gather data inthe field, and analyse the results. The newtool, together with a detailed guide on how tocarry out technical preparation, training andfield surveys, has been used in 22 countries— resulting in savings in both time and cost. Thesystem and process has evolved into a practicaltool that can be used in countries. The surveyshave provided a wealth of information on issuessuch as access, rational use, and medicinessupply systems.Results from Bulgaria and the Philippines haveshown the value of repeating monitoring andassessment at diferent points in time. In the AfricaRegion, active involvement of health ministrypersonnel in the data collection teams has beenan impetus to review country pharmaceuticalaction plans and to direct activities to priorityareas identified in the survey. In Nepal, thesurvey package, including the household survey,

COMPONENTS OF THE STRATEGY | 31is to be adapted as a regular monitoring tool. Inaddition, several countries in the Americas Regionincluded in the European Commission (EC)-WHOjoint programme will undertake baseline countrysurveys.WHO is also developing a quantitative householdsurvey package that covers health-seekingbehaviour and the affordability, availability,source, and appropriate use of medicines.Household surveys have been carried out inseveral African countries and in Nepal.ChallengesOne of the key challenges is to persuade countriesand donors to recognize that investment of timeand finances in monitoring and evaluation isworthwhile. It is important that all countriescarrying out monitoring and assessment do so byusing or adapting the current survey tool. The useof a fixed set of key indicators is vital to ensurethat repeated and comparable monitoring canbe carried out. While qualitative and descriptiveassessment can be useful, it should not replacethe need to qualitatively measure actual impact.Another challenge is to find ways of movingbeyond data analysis to discussion, presentationof results to different groups in the country asevidence for use in planning, and identificationand prioritization of strategies. Clear presentationof data and information has proved to bevaluable in generating debate and in-depthdiscussion to identify what action is needed.A third challenge is the need to balance availableresources and local capacity to undertake thesurvey, including adequate training in gatheringsurvey data. Conducting surveys at the householdlevel is a complex task. Quantitative andqualitative questionnaires need to be carefullystructured in order to obtain reliable informationfrom respondents. There is also a need to ensureappropriate and manageable sampling.Meeting the challenges 2004-2007Over the next four years WHO will:> further refine and promote the monitoring anddata collection tools to develop an evidencebasedapproach to policy development.> provide support, where requested, to promotethe process of monitoring and evaluation andassist governments in developing a regularmonitoring process appropriate to countryneeds and available human and financialresources.> promote innovative methods for trainingcountry staff or other concerned groups whocan assist the government in efforts to gatherdata from health facilities and households.OUTCOME INDICATORS1999 2003 2007No. of countries having conducted a national assessmentof their pharmaceutical situation in the last 4 years#REPORTING % TARGET#REPORTING % TARGETna na na 47/90 52% 58%

WHO MEDICINES STRATEGY 2004-2007 | 32EO 1.3Public health aspects protectedin the negotiation andimplementation of international,regional, and bilateral tradeagreements through inter-countrycollaboration and legislative stepsto safeguard access to essentialmedicinesRationaleWHO supports the use of measures to protectpublic health and promote access to medicines,consistent with the provisions of the TRIPSAgreement and the Doha Declaration on theTRIPS Agreement and Public Health. The DohaDeclaration (paragraph 4) affirmed that the TRIPSAgreement “can and should be interpreted andimplemented in a manner supportive of WTOMembers’ right to protect public health, and inparticular, to promote access to medicines for all”.The Doha Declaration was agreed after intensedebate about the implications of intellectualproperty rights on public health and access tomedicines.Mindful of such concerns about the currentpatent system, especially as regards access tomedicines in developing countries, the 56 th WorldHealth Assembly (WHA) urged Member Statesto consider adapting national legislation in orderto use to the full the flexibilities contained in theTRIPS Agreement. The WHA further noted that inorder to tackle new public health problems withinternational impact — such as the emergenceof severe acute respiratory syndrome (SARS)— access to new medicines with potentiallytherapeutic effect, and to health innovationsand discoveries should be universally availablewithout discrimination.ProgressThe Network for Monitoring the Impact ofGlobalization and TRIPS on Access to Medicinesis coordinated by four WHO CollaboratingCentres, with additional input from appropriateexperts. The Network has developed indicatorsand an assessment tool published in 2004 on thebasis of field tests. To date, assessments have beencompleted in 11 countries in East Asia, EasternEurope, and Latin America 7 8 .WHO PERSPECTIVES ON ACCESS TO MEDICINES 6Access to quality essential medicines is a human rightAffordability of essential medicines is a public health priorityEssential medicines are not simply another commodity; TRIPS safeguards are crucialPatent protection has been an effective incentive for research and development of new medicinesPatents should be managed in an impartial way, protecting the interests of the patent holder, as well assafeguarding public health principlesCountries should assess the public health impacts of the TRIPS Agreement before introducing requirementsmore stringent than the TRIPS requirements (“TRIPS-plus”) in national legislation or as a part of regional orbilateral trade agreements or extending TRIPS requirements to non-WTO members

COMPONENTS OF THE STRATEGY | 33Figure 4:WHO policy and technical support onTRIPS to over 70 countriesMeeting on TRIPS in OAPI countries (Yaoundé, May 2002)Meetings on globalization, TRIPS & access to medicines(Jakarta, May 2000 and May 2003Briefing on TRIPS (SADC) South Africa, June 2000)Workshop on TRIPS (Harare, August 2001)Participants of both South Africa and Harare meetings• •* ••• ••• ••**•••••••••••***• • •*•**Inter-country meeting on the TRIPS Agreement (Warsaw, September 2001)*•Country support: guidance on cost containment measures, advice on national medicines legislation, and training and briefingson TRIPS safeguardsIntensified country support: 26 countries with WHO medicines advisors, based in-country to facilitate collaboration betweenWHO and national implementing agencies in planning, implementation and monitoring of medicines and related policiesChallenges remainingIn many countries, especially low-incomecountries, there is insufficient awareness,implementation, and assessment of the provisionsin international, regional, and bilateral tradeagreements that can be used to safeguard accessto essential medicines.Meeting the challenges in 2004-2007Over the next four years WHO will:> Support countries in their efforts to improveaccess to medicines, including through directcountry support and technical assistance onthe use of flexibilities and safeguards in theirnational legislation in accordance with theDoha Declaration.> Cooperate with countries to ensure effectiveimplementation of the August 30 Decision, ofthe WTO General Council a and to promotea permanent solution that is simple andworkable, to help WTO members withinsufficient or no manufacturing capacity inthe pharmaceutical sector to make effectiveuse of compulsory licensing under the TRIPSAgreement.> Monitor and provide independent data andanalysis on the pharmaceutical and publichealth implications of relevant internationalagreements, including WTO and other tradeagreements, in order to assist countries inthe effective assessment and developmentof pharmaceutical and health policies andregulatory measures that maximize thepositive and mitigate the negative impact ofsuch agreements.OUTCOME INDICATORS1999 2003 2007No. of countries integrating TRIPS Agreement flexibilitiesinto national legislation to protect public health#REPORTING % TARGET#REPORTING % TARGETna na na 32/105 30% 45%

WHO MEDICINES STRATEGY 2004-2007 | 34EO 1.4Human resources capacity increasedin the pharmaceutical sectorthrough education and trainingprogrammes to develop capacityand to motivate and retainpersonnel in sufficient numberswithin a clearly defined andorganized structureRationaleEffective medicines policy implementation canonly be achieved when appropriate numbers ofwell-trained and motivated pharmaceutical staffare employed and functioning in an efficientway. Motivation arises as a result of an effectivepolicy, a clear understanding of the rationale andobjectives of the policy, adequate remunerationfor work, well-defined roles and responsibilities,and clear standards for performance.ProgressIn 2002 alone, WHO support to countriesincluded the training of nearly 900 healthprofessionals in: medicines regulation, qualityassurance, and anti-counterfeit activities; rationaluse of medicines by health professionals; publicsector medicines supply; national medicinespolicy development and monitoring; the impactof trade agreements on access to medicines;medicines financing and pricing; improvingmedicines use by consumers; and establishmentof pharmaceutical norms and standards 9 . Thesetraining programmes were held in all six WHOregions, in English, French, and Spanish.Challenges remainingIn many countries, policy implementation isconstrained by the lack of sufficient numbers ofadequately trained and motivated pharmaceuticalstaff and difficulties in retaining trained staff. Insome sub-Saharan countries there are less than10 pharmacists in the public service. In addition,other health professionals are not adequatelyeducated about the essential medicinesconcept, which is central to understandingand implementing a national medicines policy.Although WHO offers a number of trainingcourses, the challenge is to ensure that coursesare integrated into larger strategies to build humancapacity in pharmaceuticals, that appropriateparticipants are identified and selected, and thatthey receive follow-up support.Meeting the challenges 2004-2007Over the next four years WHO will:> provide technical assistance to governmentswith severe staff shortages to help themaddress key policy issues (including supportin the development of strategies to train andretain pharmaceutical staff and to improve theknowledge of all health professionals in theconcept of essential medicines).> work with universities to ensure theintegration of the essential medicines conceptin curricula for health professionals.> maximize the impact of WHO trainingcourses through: ensuring that courses fit intobroader strategies to increase human resourcecapacity in pharmaceuticals; courses arefocused on relevant topics, regularly updated,and available in the appropriate languages;participants are carefully selected and receivefollow-up support.

COMPONENTS OF THE STRATEGY | 35Figure 5: Medicines training for health professionals in 20014443412525522513551215555212345Access to essential medicines – medicines policy issues, pharmacoeconomics, drug managementMedicines quality – good manufacturing practices, TB drug quality, combating counterfeit drugs,good laboratory practices, managing the analytic laboratory, thin layer chromatographyMedicines regulation – basic training, computer-assisted registration, good clinical practiceMonitoring medicines safety and use – pharmacovigilance, the study of adverse reactions,anatomical therapeutic chemical classification system/defined daily dosesRational use of medicines – promoting rational drug use, teaching rational pharmacotherapy,promoting rational drug use in the community, drugs and therapeutics committees, data analysis forrational use researchOUTCOME INDICATORS1999 2003 2007No. of countries that provide both basic and continuingeducation programmes for pharmacists#REPORTING % TARGET#REPORTING % TARGET54/85 64% na 34/110 31% 35%

WHO MEDICINES STRATEGY 2004-2007 | 36EO 1.5Promotion of innovation based onpublic health needs, especially forneglected diseases through policiesand actions creating a favourableenvironment for innovation ofmedically needed new medicinesRationaleMost medicines development is carried out bythe R&D-based pharmaceutical industry and theselection of products is driven largely by marketdemand. As a result, medicines for some diseasesand health conditions are neglected because noviable market currently exists for these products.WHO estimates that over 95% of globalinvestments in drug development today aretargeted to the medical needs of the richest 20%of the world’s population. By contrast, only 1%of the drugs developed over the last 25 yearswere for tropical diseases, and TB, diseases thattogether account for over 11% of global diseaseburden.The lack of investment in medicines R&D fordiseases of public health importance has a majorimpact on health, especially in low-incomecountries. For example, there is a shortage ofeffective, safe, and affordable health technologiesthat can be used to reduce the burden ofparasitic and infectious diseases in low- andmiddle-income countries. New medicinesare also needed to replace toxic treatmentsfor trypanosomiasis (sleeping sickness) andleishmaniasis, to combat drug-resistant malariaand TB, and to treat some diseases that are as yetuntreatable. 10 These neglected diseases causehigh mortality and morbidity, mainly amongthe poor, who have little purchasing power.Moreover, the few medicines, diagnostics, andvaccines that do exist for neglected diseasesare often too complicated to use in ruralenvironments.Other ‘pharmacological gaps’ with considerablepublic health impact include: the lack of safe andeffective medicines for some high-burden diseases(Alzheimer’s disease and some forms of cancer)for which scientific approaches are lacking; lackof investment in R&D for low-prevalence diseases(e.g. cystic fibrosis) or for mainly low-incomemarkets (e.g. TB and malaria); lack of safety andefficacy R&D on the use of medicines amongspecific groups (e.g. pregnant women); and lackof user-friendly and appropriate formulations ofdrugs for specific groups (e.g. children and theelderly), which cause difficulties in dosing andadministration.There is a need for public funding for R&D toaddress these pharmacological gaps which havea considerable public health impact. This calls forcareful and transparent prioritization of treatmentneeds, on the basis of sound epidemiologicalinformation, clear public health criteria, and wideconsultation.ProgressWHO has initiated work on developing amethodology to prioritize research basedon disease burden and an assessment of thepharmaceutical gap. This builds on the work ofthe Global Forum for Health Research and theUNDP/World Bank/WHO Special Programme forResearch and Training in Tropical Diseases (TDR).Challenges remaining

COMPONENTS OF THE STRATEGY | 37Meeting the challenges in 2004-2007Over the next four years WHO will:Many developing countries and countries intransition lack the capacity to undertake researchto determine priority public health needs. Publicprivatepartnerships such as the Medicines forMalaria Venture, Global Alliance for TB Research,and the Drugs for Neglected Diseases Initiativeoffer models for collaboration between publicinstitutions in the North and South to addressneglected diseases.> work with other partners to establish amedicines development agenda based onpriority public health needs and develop asystematic methodology for this together withan initial list of recommendations for publicinvestment in medicines R&D. Whereverpossible, the public health justification willbe supported by pharmacoeconomic analysisof the potential benefits. Work on the agendawill include efforts in Europe to identifypotential research needs which are relevantfor both countries in economic transition(including several new EU members) and fordeveloping countries.> seek to identify better delivery mechanismsand improved formulations for existingpreventive and therapeutic medicines.The lack of regulatory capacity in developingcountries for scientific assessment of new drugapplications for public health priority diseasesremains a challenge. In parallel with capacitybuilding in developing countries, alternativeregulatory pathways and mechanisms forscientific assessment should be elaboratedand implemented in partnership with nationalregulatory authorities from both developing anddeveloped countries.OUTCOME INDICATORS1999 2003 2007No. of countries promoting research and development ofnew active substances#REPORTING % TARGET#REPORTING % TARGETna na na 21/114 18% 22%

WHO MEDICINES STRATEGY 2004-2007 | 38EO 1.6Gender perspectives introduced inthe implementation of medicinespolicies by identifying genderdifferences in access to and rationaluse of medicines, and by supportingwomen in their central role inhealth careRationaleWhile access to essential medicines is a problemfor both women and men in many parts of theworld, in some countries gender-related barriersin access to health services and medicines aregreater for women than men due to social andcultural factors. For example, although womenhave a central role as health care providersfor the family, they do not always control thefamily income and may not be able to decidefor themselves when they need to seek healthcare or purchase medicines. In addition, theirdisproportionate share of work within thehousehold, including growing the food, collectingwater and fuel, and caring for the family, limitsthe time available to seek health care services.As a result, they often fail to see help until theirillness is at a critical stage.To address these inequalities between womenand men, WHO recommends that countriesshould introduce a gender perspective in theirmedicines policy. 11 NMPs should: ensurethat the needs of both women and men areaddressed in an equitable way; facilitate women’saccess to health; support women and women’sorganizations in their central role in providinghealth care in their home and communities; andprovide adequate education and means to ensurethat women purchase the appropriate medicinesand use them rationally.ProgressOver the past few years, WHO has been activein promoting a focus on gender in the MDGs,particularly those relating to the education of boysand girls and to other health-related goals wheregender may have a impact. WHO has also beenreporting gender disparities for various healthtopics through a series of publications entitledGender and Health 12 . These information sheetsdescribe and analyse the information available,the areas where more research is needed, andthe policy implications. The existing informationsheets cover a wide range of health problemsfrom road traffic injuries to blindness and TB.Challenges remainingDespite the availability of much data on accessto and use of medicines, there is a lack of datadisaggregated by sex and of gender-sensitivestudies on these issues. Several indicatorsincluded in the WHO survey package forassessing the pharmaceutical situation at countrylevel now differentiate the sex of the populationsurveyed. However the sample size of the varioussurveys is still too small to draw any significantconclusions about gender-related issues.Inequalities between women and men remaina major obstacle to the social and economicdevelopment of many countries. Three-fifths of the115 million children currently out of school aregirls, and two-thirds of the 876 million illiterateadults are women. 13

COMPONENTS OF THE STRATEGY | 39Meeting the challenges 2004-2007Over the next four years WHO will:> work with countries, academic institutions,and NGOs to adapt existing pharmaceuticalmonitoring tools for collecting sexdisaggregateddata and promote gendersensitivestudies on access to and use ofmedicines.> develop policy guidance to support theintroduction of a gender perspective inmedicines policies, aimed at reducing genderinequalities and improving women’s access toand use of medicines.OUTCOME INDICATORS1999 2003 2007No. of countries providing free medicines for pregnantwomen at primary public health facilities#REPORTING % TARGET#REPORTING % TARGETna na na 54/106 51% 60%

WHO MEDICINES STRATEGY 2004-2007 | 40Figure 6:National recognition of the right to health Source: Kinney ED, “The International Human Right to Health:What Does This Mean for our Nation and World?” in IndianaLaw Review, Vol 34, 2001, page 1465.EO 1.7Access to essential medicinesrecognized as a human right viaadvocacy and policy guidance torecognize and monitor access toessential medicines as part of theright to healthRationaleThe right to health is referred to in the openingparagraph of the WHO Constitution. It has alsobeen recognized in many global and regionalhuman rights treaties, such as the InternationalCovenant on Economic, Social and Cultural Rights(ICESCR) which has been signed by over 140countries. In the authoritative General CommentNo.14 (2000) by the Committee on Economic,Social and Cultural Rights, the right to healthfacilities, goods, and services in article 12.2.(d) ofthe Covenant is understood to include, inter alia,the appropriate treatment of prevalent diseases,preferably at community level, and the provisionof essential drugs as defined by WHO. While theCovenant provides for progressive realization andacknowledges the limits of available resources,State parties have an immediate obligation toguarantee that the right to health will be exercisedwithout discrimination of any kind, and to takedeliberate and concrete steps towards its fullrealization.ProgressAll countries in the world have signed at leastone of the international treaties that confirm theright to health as a human right (Figure 6); and109 countries have included the right to healthin their constitution. In an increasing number ofcountries, especially in Latin America but also inThailand and South Africa, individuals or NGOshave initiated and won constitutional court cases,demanding from their government the equitablerealization of the right to health — for example,winning universal access to certain types ofessential medicines.Within the UN system, a Special Rapporteuron the Right to Health was appointed in 2001.The Special Rapporteur is working in closecollaboration with WHO, with the aim ofincluding regular reporting on equitable access toessential medicines as part of the obligatory fiveyearreporting by State parties to the InternationalCovenant.

COMPONENTS OF THE STRATEGY | 41Meeting the challenges 2004-2007Over the next four years WHO will:> advocate a rights-based approach as oneadditional means to promote access toessential medicines, by collecting anddisseminating information on successfulactivities in developing countries and byformulating and providing practical advice toindividuals and NGOs active in this field.Challenges remaining> continue to collaborate with the UN SpecialRapporteur on the Right to Health to promoteregular reporting on access to essentialmedicines within standardized reportingsystems on the progressive realization of theRight to Health.Not all countries have recognized the right tohealth in their national constitution, and manycountries lack the means to ensure that the rightof access to essential medicines is fulfilled.But even where resources are limited, not allcountries recognize that they have an obligationto distribute equitably and without discrimination,and with special consideration for the poorand disadvantaged, whatever health servicesare possible within their means. An additionalchallenge is that many countries do not gatherany data on gender- or income-related access toessential medicines.OUTCOME INDICATORS1999 2003 2007No. of countries that provide HIV/AIDS-related medicinesfree at primary public health facilities#REPORTING % TARGET#REPORTING % TARGETna na na 60/104 58% 65%

WHO MEDICINES STRATEGY 2004-2007 | 42Figure 7: Different measures of successWHO MEDICINES STRATEGY> countries with national medicine policies> countries where less than 50% of thepopulation has access to essential medicines> percentage of key medicines available inpublic health facilities> countries with public health insurancecovering the cost of medicinesEO 1.8Ethical practices promoted and anticorruptionmeasures identified andimplemented in the pharmaceuticalsector using the experience ofsuccessful programmes addressingaspects of corruption encounteredin the pharmaceutical sectorRationaleThe ‘medicines chain’ includes many differentsteps starting from R&D and ending with theconsumption of the medicine by the patient.Each step needs to be protected from unethical orcorrupt practices to ensure that patients not onlyhave the medicine they need, but also that themedicine is safe, of good quality, has a fair price,and has not been purchased as a result of unduecommercial influence.The commercial reality of the pharmaceuticalsmarket continues to tempt the many differentactors involved, both in the public and privatesector, to test its ethical limits. This may be theresult of intentional mismanagement by anindividual, but also of the inability of individuals> countries with basic quality assuranceprocedures> countries with national medicine informationcentre.PHARMACEUTICAL INDUSTRYPERFORMANCE TARGETS> new chemical entities launched per year> potential ‘blockbuster’ medicines in thepipeline> annual growth in sales> percentage sales going ‘off patent’> annual sales per product> R&D costs and time> total shareholder returns.

COMPONENTS OF THE STRATEGY | 43to identify and manage in an ethical manner aconflict of interest that may arise while interactingwith other institutions.The gap between public health and commercialobjectives in the pharmaceutical sector is wellillustrated by the way success is measured withinthe public health arena and the pharmaceuticalindustry (Figure 7).ProgressWHO has addressed some ethical practices inthe pharmaceutical sector. These include thedevelopment of ethical criteria for medicinespromotion and advocating that patents shouldbe managed in an impartial way, protectingthe interests of the patent-holder as well assafeguarding public health principles 14 . WHOhas also advocated responsible practices in thedonation of medicines (see also EO 6.7, 7.4).In addition, WHO has initiated a dialoguebetween international experts, NGOs, and theinternational pharmaceutical industry in an effortto work together to fight corruption that hindersaccess to medicine in Latin America and theCaribbean. In 2000, the WHO Regional Officefor the Americas and the World Bank organizeda workshop on ethical business practices,which addressed the issue of corruption in thepharmaceutical sector.Challenges remainingMany examples of corruption and lack of ethicalpractices in the pharmaceutical arena arereported in the press and in scientific journals 15 .They are also highlighted by organizations suchas Transparency International, a non-profit NGOwhich aims to curb corruption 16 17 .Figure 8 summarizes some of the ethical issuesencountered throughout the medicines chain.The results of these unethical practices includereduced quality of health care, shortages ofmedically needed medicines and medicalsupplies, unsafe and poor quality products on themarket, financial losses for health care systemsdue to irrational use of medicines throughunethical promotion, and the undermining ofpublic trust in science.Meeting the challenges 2004-2007Over the next four years WHO will:> work with countries and partners to identifysuccessful programmes which have tackledcorruption and conflict of interest in thepharmaceutical sector.> based on the results obtained, developa programme for public health officialsto enable them to identify and manageconflict of interest in their interactions withcommercial enterprises and civil societyorganizations (CSOs).OUTCOME INDICATORS1999 2003 2007No. of countries with medicines legislation requiringtransparency, accountability and code of conduct forregulatory work> continue to promote the implementation ofethical practices in specific pharmaceuticalsector areas where relevant, relying alsoon guidelines issued by other impartialorganizations.#REPORTING % TARGET#REPORTING % TARGETna na na 84/114 74% 80%

WHO MEDICINES STRATEGY 2004-2007 | 44R & DMost resources spent on “lifestyle” conditions and “me-too”medicinesFigure 8:Challenges are present at every stage in themedicines chain>>CLINICAL TRIALSReal conflict of interest between manufacturers and researchersGood clinical practices not always respected in poorer countriesAdverse findings not published or falsified>REGISTRATIONFalsification of safety dataBriberyFast-track registrationCounterfeitingMedicines for ‘orphan’ diseasesTax evasion and fiscal fraudMANUFACTURINGPATENTSExcessive extension on “best-selling” medicinesUnlawful appropriation of royalties>PRICESVary between countriesArtificially inflated in some cases>DISTRIBUTIONMismanagement of goodsBriberyDONATIONSWHO guidelines not always respectedPROMOTIONDirect-to-consumer advertisingReal conflict of interest between physician and manufacturersSubtle pressure on physicians

COMPONENTS OF THE STRATEGY | 45COMPONENT 2NATIONAL POLICIES ON TRADITIONALMEDICINE AND COMPLEMENTARY ANDALTERNATIVE MEDICINE

WHO MEDICINES STRATEGY 2004-2007 | 46Populations throughout the world use traditionalmedicine to help meet their primary healthcare needs. Traditional medicine b (TM), whichhas many positive features, is a comprehensiveterm that covers a wide variety of therapiesand practices — traditional, complementary oralternative medicine (TM/CAM) — which varygreatly from country to country and from regionto region. It plays an important role in treatingillnesses as well as improving the quality of lifeof those suffering from minor illness or fromcertain incurable diseases. In addition, globalexpenditure on TM/CAM is not only significantbut growing rapidly. 18Member States have difficulty assuring thesafety, efficacy, and quality of TM/CAM productsand therapies due to the lack of nationalpolicy frameworks, appropriate legislative andregulatory measures, and education/training andqualification schemes for practitioners.In 2002, in an effort to meet the growingchallenges in the area of traditional medicine,WHO developed a comprehensive workingstrategy for TM for 2002-2005. The Strategy hasfour main objectives:> To integrate relevant TM and/or CAM withnational health care systems, as appropriate,by developing and implementing nationalpolicies and programmes.> To promote the safety, efficacy, and quality ofTM/CAM by expanding the knowledge baseon the safety, efficacy, and quality of TM/CAM,and by providing guidance on regulatory andquality assurance standards.> To increase the availability and affordabilityof TM/CAM, with an emphasis on access forpoor populations.> To promote the therapeutically sound use ofappropriate TM/CAM by both providers andconsumers.In May 2003, the 56 th World Health Assemblyadopted a resolution on TM, which urgesMember States, in accordance with establishednational legislation and mechanisms, to adapt,adopt, and implement the WHO TraditionalMedicines Strategy as a basis for nationaltraditional medicine programmes or work plans.It requests WHO to support Member States byproviding internationally acceptable guidelinesand technical standards, seeking evidence-based

COMPONENTS OF THE STRATEGY | 47Populations using traditional medicine for primaryhealth careEthiopia 90%Benin 70%India 70%Rwanda 70%Tanzania 60%Populations in developed countries who have usedcomplementary and alternative medicine at leastonceUganda 60%Germany 90%Canada 70%France 49%Australia 48%USA 42%Belgium 31%Figure 9: Use of traditional and complementaryand alternative medicineSources: Eisenberg DM et al, 1998; Fisher P and Ward A,1994; Health Canada, 2001; BMJ, 2002, 325.990; WHO,1998; and government reports submitted to WHO.information, and facilitating information sharing. 19WHO Regional Committees in AFRO, EMRO,SEARO, and WPRO have each discussed TM atrecent sessions. The WHO Regional Committeesfor Africa, Eastern Mediterranean, South-East Asia,and Western Pacific adopted resolutions on TM in2000, 2001, 2002 and 2003 respectively.WHO’s mandate is to provide adequate supportto countries to promote the safety, efficacy,quality, and sound use of traditional medicine andcomplementary and alternative medicine.

WHO MEDICINES STRATEGY 2004-2007 | 48EO 2.1TM/CAM integrated in nationalhealth care systems whereappropriate by developing andimplementing national TM/CAMpolicies and programmesRationaleNational medicines policies are the basis for:defining the role of TM/CAM in national healthcare systems; ensuring that the necessaryregulatory and legal mechanisms are createdfor promoting and maintaining good practice;assuring the authenticity, quality, safety andefficacy of TM/CAM products and therapies; andproviding equitable access to TM/CAM healthcare resources as well as information about them.In recognition of this, the WHA Resolution onTM urges Member States, where appropriate, toformulate and implement national policies andregulations on TM/CAM in support of proper useof traditional medicine, and its integration intonational health care systems, depending on thecircumstances in their countries.ProgressOver the past four years, WHO has supportedcountries in their efforts to establish nationalpolicies on TM/CAM tailored to individual countryneeds. As a result, 39 countries now have anational policy on TM/CAM, compared with 25countries in 1999, and 46 countries are eitherestablishing or intend to establish a policy. Inaddition, WHO provided technical support inresponse to requests from Member States.published a global review document on the Legalstatus of traditional medicine and complementary/alternative medicine. 20 This review includesinformation and data from 123 countries and isintended to help share their various experiencesamong Member States. In addition, in 2002-2003WHO conducted a global survey on nationalpolicy on TM/CAM, in order to assess the currentsituation and identify individual country needs fortechnical assistance from WHO.Challenges remainingIn many countries, efforts to establish a nationalpolicy and to ensure the regulation of TM/CAM medicine are hampered by the lack of:research and evidence-based information onTM/CAM; knowledge and understanding ofTM/CAM, which differs greatly from Westernmedicine in its philosophy and approaches; andeducation/training and qualification schemes forpractitioners. There is an urgent need for betterinformation sharing and for evidence-basedinformation to support Member States in efforts todevelop national policies and regulation to assurethe safety, efficacy, and quality of TM/CAM.In the Western Pacific Region, for example, theWHO Regional Office organized a series ofworkshops to support countries in developing andformulating their national policy on TM, issued adocument on the development of national policyon TM in 2000, and developed an action plan onTM in the Pacific Island States in 2001.In order to facilitate policy development, WHO

COMPONENTS OF THE STRATEGY | 49Figure 10:Development of National Policy onTM/CAMSource: Interim summary analysis of WHO globalsurvey on national policy on traditional medicineand complementary/alternative medicine, 2002-2003 Meeting the challenges 2004-2007Over the next four years WHO will:> based on the findings of the global survey onnational policy on TM/CAM in 2002-2003,analyse and review the current situationand identify the main difficulties faced byindividual Member States in formulatingthe national policy and regulation; provideguidance on the development of nationalpolicies on TM; and facilitate informationsharing among countries.> expand evidence-based information onquality, safety, and cost-effectiveness ofTM/CAM in order to support Member States,where appropriate, in their efforts to integrateTM/CAM into national health care systems.> provide intensive medium-term technicalsupport to a selected number of interestedcountries to help formulate a comprehensivenational policy/programme on TM/CAM andsupport its implementation.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries with national TM Policy C 25 na na 39/127 c 31% c 37%

WHO MEDICINES STRATEGY 2004-2007 | 50EO 2.2Safety, efficacy, and quality ofTM/CAM enhanced throughexpanding the knowledge base onthe safety, efficacy, and quality ofTM/CAM, and providing guidanceon regulation and quality assurancestandardsRationaleTM/CAM practices have evolved within differentcultures in different regions. As a result, therehas been no parallel development of standardsand methods, either national or international, forevaluating them. This is especially true of herbalmedicines, the efficacy and quality of which canbe influenced by numerous factors. The regulationand registration of herbal medicines are thekey measures to ensure their safety, quality, andefficacy.ProgressOver the past four years, WHO has developed aseries of technical guidelines to support countriesin establishing the regulations for ensuring thesafety, efficacy, and quality of TM therapies andproducts. In addition, seven regional trainingworkshops have been held in five WHO regions(covering 52 countries) to help strengthen nationalcapacity in the regulation of herbal medicines.Four WHO Regions (AFRO, AMRO, EMRO,and SEARO) developed regional minimumrequirements for registration of herbal medicinesbased on WHO technical guidelines.According to the WHO global survey on nationalpolicy on TM/CAM in 2002-2003, 82 countriescurrently regulate herbal medicines, comparedwith 60 countries in 1995-99, and 78 countrieshave a registration system for herbal medicines.In 1999, a WHO report on malaria in Africarevealed that over 60 % of sick children withfevers were treated with herbs at home and bytraditional health practitioners – often the onlyform of treatment they received. However, thesafety and efficacy of these antimalarial herbshave not been fully understood. In response,in 2000 WHO initiated a pilot project on thecontribution of traditional medicine in combatingmalaria and has been supporting national clinicalstudies on antimalarial herbal medicines in threeAfrican countries. A mid-term review of thestudies was completed in 2002.WHO has collected evidence-based informationon TM/CAM such as analysis and review ofacupuncture based on controlled clinical trials,published in 2002 in cooperation with itscollaborating centres and other research institutes.In 2003, WHO also supported China in theevaluation of research in integrated treatment forSARS cases.In addition, in 2003 WHO developed guidelineson Good Agricultural and Collection Practices(GACP) for medicinal plants and initiated thedevelopment of guidelines on assessing the safetyof herbal medicines, with particular reference toresidues and contaminants.ChallengesThe quantity and quality of the safety and efficacydata on traditional medicine are far from sufficientto meet the criteria needed to support its useworldwide. One of the reasons for the shortage ofresearch data is the lack of financial incentives asmost of these products are not covered by patents.Scientifically justified and accepted globalresearch methodology for evaluating the efficacyand safety of traditional medicine is a majorchallenge.Although there has been a recent increase inthe number of governments that regulate herbalmedicines, national regulation and registration ofherbal medicines vary from country to country.Where herbal medicines are regulated, they arecategorized in different ways (e.g. prescriptionmedicines, dietary supplements, health food).

Number of Member Statesadopting policyCOMPONENTS OF THE STRATEGY | 51However, a group of herbal products categorizedother than as medicines, may also exist withinthe same country. Moreover, the regulatory statusof a particular herbal product varies in differentcountries. Regulatory status also determines theaccess or distribution route of these products. Anadditional challenge is the increasing popularityof herbal products categorized other than asmedicines or foods. There is an increased risk ofmedicine-related adverse events, due to lack ofregulation, weaker quality control systems, andloose distribution channels (including mail orderand Internet sales).Figure 11:Growth of regulation of herbal medicines80706050403020Before 1990 1990-1994 1995-1999 2000-2003Time PeriodSource: Interim summary analysis of WHO global survey onnational policy on traditional medicine and complementary/alternative medicine, 2002-2003Meeting the challenges 2004-2007Over the next four years WHO will:> publish global guidelines on the regulation ofherbal medicines (2004).> continue to support Member States in theirefforts to establish effective regulatory systemsfor registration and quality assurance of herbalmedicines by: organizing training workshopsto strengthen national capacity on theseissues; and supporting efforts to developnational lists of medicinal plants together withinformation on their safety.> increase efforts to improve access to TM/CAMand expand the information available on thesafety, efficacy, and quality of TM/CAM by:conducting technical reviews of researchon use of TM/CAM therapies for prevention,treatment, and management of commondiseases and conditions; expanding selectivesupport for clinical research into use of TM/CAM for priority public health problems suchas malaria, HIV/AIDS, and common diseases;and collating and exchanging accurateinformation.> establish criteria for evidence-based data onthe efficacy, safety, and quality of TM/CAMtherapies, in order to facilitate research.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries regulating herbal medicines d 48 na na 82/127 d 65 d 75%

WHO MEDICINES STRATEGY 2004-2007 | 52EO 2.3Availability and affordability of TM/CAM enhanced through measuresdesigned to protect and preserveTM knowledge and nationalresources for their sustainable useRationaleWHO recognizes that TM knowledge is theproperty of the communities and nations wherethat knowledge originated and should be fullyrespected. However, in many parts of the world,knowledge of TM is often passed on orally fromone generation to the next, and can easily be lostor incorrectly transferred. The appropriate use ofTM requires the transfer of correct knowledgeand practice, in order to ensure its safety andefficacy. Preservation of knowledge of medicinalplants and medicinal plant resources — themost common form of medication in TM/CAMworldwide — is vital to ensure the safety andeffective application of herbal medicines in healthcare as well as their sustainable use.ProgressIn 2002, in response to increased awareness ofintellectual property rights issues relating to TM,WHO held an inter-regional workshop on this inBangkok, Thailand. The African Region has alsoorganized a meeting of regional experts to discussguidelines for the protection of TM knowledge.In 2003, WHO developed guidelines on GACP forcultivated and wild medicinal plants (see also EO2.2), which are designed, inter alia, to encourageand support the sustainable cultivation andcollection of medicinal plants of good quality.Many countries have started to take actionon protection of traditional medicine throughrecording the use of their traditionally usedmedicinal plants. For instance, in Côte d’Ivoire,the TM programme at the Ministry of Healthcarried out a survey involving traditional healthpractitioners in 7 of its 19 regions. As a result ofthis, a list has been drawn up of more than 1000plants used by traditional health practitionersin these regions and the TM programme hasdeveloped national monographs on 300 of thesemedicinal plants. National lists of medicinalplants have also been developed in Bhutan andMyanmar. Elsewhere, the Iranian Government

COMPONENTS OF THE STRATEGY | 53Meeting the challenges in 2004-2007Over the next four years WHO will:> support Member States in developing theirnational inventory/catalogue of medicinalplants, which can be used to: facilitate theidentification of medicinal plants used bycommunities; record their distribution;support efforts to establish intellectualproperty rights.> establish criteria and indicators to measurecost-effectiveness and equitable access to TM/CAM.has also taken steps to protect its TM knowledge– in 1991 establishing the National Academyof Traditional Medicine in Iran and Islam andin 2002 recording 2500 flora among 8000traditionally used medicinal plants in Iran.ChallengesOne of the major challenges in the use of TM isthe lack of measures to protect and preserve theTM knowledge and national resources necessaryfor its sustainable use. Another is the potentialdiscovery of active ingredients in TM that couldbe used in R&D and patented for use in Westernmedicine – leaving the country and communityof origin without fair compensation and with noaccess to the outcome of the research.OUTCOME INDICATORS1999 2003 2007No. of countries with a national inventory of medicinalplants as a means to provide intellectual property rightsprotection for traditional medical knowledge#REPORTING % TARGET#REPORTING % TARGETna na na 9/39 23% 33%

WHO MEDICINES STRATEGY 2004-2007 | 54EO 2.4Rational use of TM/CAM byproviders and consumers bypromoting therapeutically sounduse of appropriate TM/CAMRationaleRational use of TM/CAM depends on a range offactors, including the need for adequate training,registration, and licensing of providers, properuse of products of assured quality, and provisionof scientific information and guidance for thepublic.The efficacy and safe practice of TM/CAMtherapies are closely linked to the qualification ofpractitioners. Good practice in TM is dependanton proper training, the registration of practitioners,and the licensing of TM/CAM practice.ProgressIn 2002, WHO published Volume 2 of the WHOmonographs on selected medicinal plants,containing 30 monographs. Volume 3, providingan additional 31 monographs is in the finalstage of production. The European Commissionrecommends WHO monographs to its membersas an authoritative reference on the quality, safety,and efficacy of medicinal plants. Today, over 12other countries use WHO monographs for theirregulation and registration of herbal medicines.In addition, several countries, including Armenia,Benin, Mexico, Malaysia, South Africa andViet Nam, have developed their own nationalmonographs based on the WHO format. In2003, WHO developed guidelines for consumerinformation on the appropriate use of TM/CAM.ChallengesA range of health care professionals serve asqualified providers of TM/CAM, operating withineach country’s national health care deliverysystem and legislative framework. However,many countries do not have a national schemefor training, education, qualification, licensing,and registration of providers of TM/CAM. As aresult, providers of TM/CAM medicines, such asphysicians, nurses and pharmacists, may havelittle training and understanding of how herbalmedicines, for example, impact on the health ofpatients who are often taking other prescriptionmedicines as well. This information is alsorelevant when diagnostic and treatment decisionsare made.

Number of Member StatesCOMPONENTS OF THE STRATEGY | 55Figure 12:Growth of National Institutes60504030201001999 2003Source: Interim summary analysis of WHO globalsurvey on national policy on TM/CAM, 2002- 2003.Traditional medicines are increasingly used outsidethe confines of traditional culture and far beyondtraditional geographical areas, without properknowledge of their context and use. Moreover,they are also used in different doses, extractedin different ways, and used for indications whichare different from their traditional intended use.To compound the problem, contrary to their usein the traditional context, traditional medicinesare now often used in combination with othermedicines – a practice which has become a safetyconcern.There is a widespread misconception that ‘natural’means ‘safe’ and many believe that remedies ofnatural origin carry no risk. Although a great dealof information on TM/CAM is available through avariety of channels, many consumers are unableto evaluate and select reliable information inorder to make a decision on the use of TM/CAMproducts for self-medication.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to develop basic training guidelineson major forms of TM/CAM, includingchiropractice, herbal medicines, and manualtherapies.> continue to develop authoritative referencesfor Member States, such as the WHOmonographs on selected medicinal plants.> organize an inter-regional workshop toimplement WHO guidelines on proper use ofTM/CAM by consumers, to strengthen nationalcapacity in providing reliable consumerinformation on TM/CAM.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries with national research institute in the field 19 na na 56/127 e 44% e 51%of TM/CAM e

WHO MEDICINES STRATEGY 2004-2007 | 56In high-income countries, average percapita spending on pharmaceuticalsis 100 times more than in low-incomecountries – about US$ 400 compared withabout US$ 4. At the opposite ends of thespectrum, there is a 1000-fold differencebetween what the highest spending andlowest spending countries spend onpharmaceuticals.Source: WHO National Health AccountsCOMPONENT 3SUSTAINABLE FINANCINGMECHANISMS FOR MEDICINES

COMPONENTS OF THE STRATEGY | 57Figure 13:Financing medicines: the Uganda experienceUS$2.30 gap translates into – US$4.00 - US$5.00 in out-ofpockethousehold expenditures on drugs14%8%66%12%GAPPROJECTCENTRALED kits = US$0.08 per capitaDECENTRALIZEDAdequate and sustainable financing of medicinesremains a remote prospect for almost half of theworld’s population.Since 1995, private sources of finance forpharmaceuticals have become more importantin all countries, with attendant risks to publichealth objectives. Governments’ share inpharmaceutical spending has fallen faster thantheir share in total health spending. Whileexternal assistance has boosted pharmaceuticalspending in a small number of countries, mostcountries with high HIV/AIDS mortality arestill spending less than US$ 5 per capita onmedicines.Both published studies and WHO NationalHealth Accounts confirm that pharmaceuticalsexpenditure in developing countries accountsfor 25%-65% of total public and private healthexpenditure, and for 60%-90% of out-of-pockethousehold spending on health. 21In Uganda, it was estimated that annual percapita medicine needs in 2002-2003 were US$3.50. Figure 13 shows that the available fundsfrom local, central, and externally funded projectsources totalled only US$1.20 per capita, leavingUS$2.30 per capita — or two-thirds of thefinancial resources for medicines — to be metfrom household sources. From these figures it wasestimated that a typical household’s out-of-pocketspending on medicines would have to be betweenUS$4 and US$5 for needs to be met. Such aheavy financial burden will obviously hit poorerhouseholds hardest.A much greater role for public finance is needed,involving both developing country governmentsand international donors. In addition, increasedefficiency in public finance is needed in order toexpand access to essential medicines.In view of the heavy burden ofmedicines expenditure, especiallyin developing countries, and theunique aspects of managing thiscritical health resource, WHOprovides guidance on financingthe supply of medicines, in aneffort to increase the affordabilityof essential medicines in both thepublic and private sectors.

WHO MEDICINES STRATEGY 2004-2007 | 58EO 3.1Access to essential medicinesimproved, including medicines forHIV/AIDS, malaria, TB, childhoodillnesses, and noncommunicablediseasesRationaleIn 2001, the Commission on Macroeconomicsand Health 22 demonstrated the close linksbetween health and poverty reduction. The lackof access to essential medicines and other healthinterventions to prevent or treat diseases suchas HIV/AIDS, TB, and malaria results in highmortality and morbidity and holds back socialand economic development. In addition, in somecountries, the lack of medicines in health facilitieshas lowered people’s confidence in the healthcare delivery system. As a result, other servicesoffered by the health system, including vitalimmunization programmes, have been adverselyaffected.ProgressThe Stop TB Partnership and the Global DrugFacility have demonstrated that: new resourcescan be mobilized; innovative partnerships, evenat grass-roots level, can be forged for effectivecountry level action; and pooled resources cancreate an effective negotiating tool for pricesetting in non-structured markets. In addition,through joint product development agreements,WHO has been able to achieve differential pricesfor a number of key antimalarial drug products.Standard treatment guidelines for HIV/AIDS andmalaria have been reviewed and updated andreflected in the WHO Model List of EssentialMedicines and Formulary. These guidelines helpcountries to select drug products that are optimalfor their setting, taking into account both theepidemiological situation and drug resistancepatterns. WHO is also contributing to ensuring thequality of new medicines for HIV/AIDS, TB, andmalaria through the prequalification process. Inthis way, national medicine supply systems andregulatory authorities are able to make evidencebaseddecisions about medicines.Price information on selected essential medicinesis provided through a collaborative effortinvolving WHO and partners — allowing nationalprogrammes to compare medicine prices offeredby various sources. This is a valuable tool forensuring competitive pricing in the internationalmedicines market.ChallengesThe high disease burden due to HIV/AIDS,TB, and malaria in many countries is a majorchallenge for governments. Efforts to improveaccess to essential medicines for these threediseases require a substantial increase in bothhuman and financial resources, as well asstrengthened medicines supply systems. Thehigh cost of individual treatment, especially forlifelong treatment for HIV/AIDS, is a major hurdlefor many governments and individuals. Effectivedelivery of many of the medicines for thesediseases requires accurate diagnosis and closemonitoring of the patient’s response to treatment.To achieve this, it is vital that health systemsdevelop and implement the necessary supportinginfrastructure, train health staff, and providethe information needed by patients to ensureoptimal therapy. The development of resistance tocurrently available therapies is a significant threatto treatment. Innovative measures to containthe rate and extent of drug resistance need to beidentified.

COMPONENTS OF THE STRATEGY | 59Figure 14:Number of people on ARV treatment by region, 2002-20051000800600ABCDEFGHSouthern AfricaEastern AfricaWest & Central AfricaIndiaOther Asia & PacificLatin America & CaribbeanEastern Europe &Central AsiaNorth Africa | Near East4002000A B C D E F G HSource: WHO2005200420032002Meeting the challenges 2004-2007Over the next four years WHO will:> support global and sub-regional initiativesto expand access to essential medicines byadopting a more focused approach througha reorientation of the efforts of all WHOdepartments, including EDM, around thechallenges of the three diseases.> provide: the relevant standards (normativework); guidance (e.g. through the prequalificationof suppliers); information (e.g.on prices, patents, and regulatory status);essential medicines programme managementexperience and staffing; and country support.> develop and put into operation the WHOAIDS Drugs and Diagnostics Facility and theMalaria Facility. The effective functioningof these facilities will depend on the abilityof EDM to build on internal and externalpartnerships and to provide intensifiedtechnical guidance and operational support.OUTCOME INDICATORS1999 2003 2007No. of countries where less than 50% of the populationhas access to essential medicines#REPORTING % TARGET#REPORTING % TARGET29/184 16% 14% 15/103 15% 14%

WHO MEDICINES STRATEGY 2004-2007 | 60Figure 15:Per capita spending on pharmaceuticals by main source, 1990and 2000, by country income groups400350300250A World – 1990B World – 2000C Low – 1990D Low – 2000E Middle – 1990F Middle – 2000G High – 1990H High – 2000US$200150PrivateGovernment100500A B C D E F G HSource: WHO National Health Accounts DatabaseEO 3.2Public funding of medicinesincreased through increasedorganizational capacity toimplement sustainable drugfinancing strategies and systemsRationaleIn many countries today, private out-of-pocketspending on medicines is the largest componentof household spending on health. In manylow-income countries in particular, private outof-pocketspending accounts for 50%-90% ofpharmaceutical sales. (Figure 15) During the1990s, the private share of global expenditure onmedicines increased 23 . Yet governments have theresponsibility to ensure that medicine financingmechanisms are established and managed in sucha way as to achieve equitable access to essentialmedicines.While health financing reform should improvethe use of public resources, it should not beaimed at reducing public spending on health andmedicines 24 . Market-oriented reform policies arenot geared to protecting the needs of the poorestpeople and, without public financial support, thepoor may be denied access to medicines. There isa critical need to assess the effect of user chargesfor medicines in the public sector, in particulartheir impact on public health objectives.ProgressRecent progress in increasing public fundingof medicines has been inadequate due to thewidespread emphasis on health sector reform.However, all WHO regions have identifiedmedicines financing among their priorities andWHO has provided technical support in severalcountries. In SEARO, for example, WHO supportedthe appraisal of new financing options such asrevolving funds or social insurance coverage. Muchof the recent focus in medicines financing has beenon the mobilization of additional funding resourcesinternationally, through the Global Fund and theCommission on Macroeconomics and Health. Inaddition, WHO input to the Millennium Projecthas stressed the importance of rethinking domesticmedicine financing strategies, in particular therole of user charges, and of ensuring that nationalEssential Medicines Lists are recognized as astatement of resource needs for public medicinesfinancing. In recent years, WHO has developedtechnical material on health financing generally andon medicines financing in particular. 25

COMPONENTS OF THE STRATEGY | 61Meeting the challenges 2004-2007Over the next four years WHO will:> launch an evidence-based consultativeapproach to national medicines financing,involving different stakeholders.> develop medicine financing assessments toprovide guidance for adaptation and use indifferent country settings.> identify short- and medium-termfinancing strategies to achieve measurableimprovements in access, on the basis ofapproaches that have been shown to work.Challenges remaining> publish and disseminate case studies andguidelines.Medicines financing is in crisis in many countries.Policy advice from international agencies inthe last two decades has stressed the need for areduced role for the public sector and a greaterreliance on private financing and provision, andtrends in pharmaceutical spending confirm thatthis has occurred. WHO estimates that almost2 billion people are currently without accessto essential medicines — a number that doesnot appear to have declined since 1987. Manycountries need to re-affirm that finance for thepurchase of essential medicines for the poor anddisadvantaged and for diseases with a majorpublic health impact is a public responsibility,and to find effective ways of integrating privatemedicine providers into public health policy.OUTCOME INDICATORS1999 2003 2007No. of countries with public spending on medicines belowUS$2 per person per year#REPORTING % TARGET#REPORTING % TARGET38/103 37% 35% 24/80 30% 20%

WHO MEDICINES STRATEGY 2004-2007 | 62HaitiCubaDominican RepublicEl SalvadorNicaraguaCosta RicaHondurasPanamaEcuadorPeruChileArgentinaROUND 1 & 2ROUND 2ROUND 1EstoniaBulgariaRomaniaGeorgiaSerbiaCroatiaMoroccoSenegalMauritaniaMaliGuineaSierra LeoneBurkina FasoTogoCôte d’IvoireLiberiaRwandaZambiaDR CongoCentral African RepublicGhanaNamibiaBeninNigeriaBotswanaSouth AfricaUkraineMoldovaArmeniaEgyptJordanTajikistanIranYemenEritreaEthiopiaSomaliaSudanKenyaComorosMozambiqueUgandaChadBurundiSwazilandMadagascarTanzaniaMalawiLesothoZimbabweKazakhstanMongoliaKyrgyzstanNorth KoreaChinaAfghanistanPakistanNepalLaosMyanmarPhillippinesIndonesiaEast TimorVietnamCambodiaThailandBangladeshIndiaSri LankaWestern Pacific Islands**Cook Islands, Federated States of Micronesia, Fiji,Kirbati, Niue, Palau, Samoa, Solomon Islands, Tonga,Tuvalu, VauautuEO 3.3Development assistance increasedfor access to medicines, includingthe Global FundRationaleThere is increased global political will andcommitment towards investment in health. Inparticular, there is a growing realization amonghigh-income countries that investing in healthis also an investment in development and inglobal security. In 2001, the Commission onMacroeconomics and Health called for a majorincrease in donor funding for health. A year later,the Global Fund 26 was launched to mobilizeadditional resources to combat HIV/AIDS, TB,and malaria, which together account for about 6million deaths a year. Out of a total of US$ 1.5billion approved by the Global Fund by January2003, 46% has been earmarked for procurementof medicines and commodities for use over thenext two years in over 150 programmes in 93countries.Other major funding sources for these prioritydiseases include the World Bank’s multi-countryHIV/AIDS programme (MAP) 27 and more recentlythe initiative by the President of the UnitedStates, involving US$ 15 billion for HIV/AIDSover five years. The disbursement of such largeamounts of money needs to be accompanied bythe development of quality, sustainable healthservices, including national essential medicinesprogrammes, for which WHO is in a position toprovide the necessary technical assistance.WHO has developed an extensive portfolioof norms, standards, practical guidelines, andother management tools required for effectiveutilization of the above-mentioned funds atnational and global levels. Examples are theWHO prequalification scheme, price and patentinformation, interagency guidelines* on donationsand on review of and support to medicinessupplies agencies. In addition, WHO increasinglysupports Member States in their preparations forapplications to the Global Fund.Challenges remainingImproving access to essential medicines throughthe use of a range of external sources involves avariety of challenges. Of these, the need to ensuresustainability is arguably the most important anddifficult to address. Other challenges include: thegap between current funding levels and health

COMPONENTS OF THE STRATEGY | 63Figure 16:Global Fund Progress Report 2003In its first year, in two rounds of programme proposals and approvals, the Global Fund awarded US$1.5billion to 153 programmes in 92 countries and put systems in place to support efficient disbursement offunds and ensure accountability.Source: Global Fundneeds; the need for recipients to monitor fundingand report to a range of donors using a varietyof different reporting formats and cycles; andthe lack of absorptive capacity to use funds andcommodities effectively. For WHO, the challengeis to expand and further strengthen its normativeand operational guidance, not only for thefunding agencies involved but also for WHO’sown work at global, regional, and country level,which is expected to increase substantially overthe next year as part of WHO’s renewed focus onHIV/AIDS, TB, and malaria.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to actively engage with partners bothwithin and outside WHO to develop strategiestowards scaling up access to medicines forHIV/AIDS, TB, and malaria which are in linewith the essential medicines concept andwhich build on and/or strengthen nationalhealth and medicines systems.> update existing tools on a regular basisand add new ones, including databases forforecasting global demand for ARVs andguidance on fixed-dose combinations, forexample.> develop a proposal for a global facility forHIV/AIDS and a similar structure for malaria,in collaboration with the Global Fund, theWorld Bank, UNAIDS, and UNICEF.OUTCOME INDICATORS1999 2003 2007Percentage of key medicines available in public healthfacilities#REPORTING % TARGET#REPORTING % TARGETna na na 22 77% na

WHO MEDICINES STRATEGY 2004-2007 | 64EO 3.4Medicines benefits promotedwithin social health insurance andprepayment schemesRationaleDifferent forms of prepayment schemes involvingthe use of pooled resources are used by healthpolicy-makers to develop an organized healthsystem 28 . Direct public funding, expansion ofhealth insurance coverage and pharmaceuticalbenefits, extension of employer roles in healthand drug financing, support from NGOs, andcommunity financing sources have the potentialboth to increase the level of resources availablefor health and to promote equitable access.Prepayment schemes allow the healthy tosubsidize the sick and, through income-basedpremiums, the rich to subsidize the poor. Bothshifts imply that health care becomes moreaffordable for the poor and the sick.ProgressSocial and private health insurance coverage hasled to expanded medicine benefits in countriesas diverse as Argentina, the People’s Republicof China, Egypt, Georgia, India, the IslamicRepublic of Iran, Kyrgyzstan, South Africa,Thailand and Viet Nam. Some of these havespecial arrangements for rural and low-incomepopulations, and medicines represent 25%-70%of total costs for these schemes. Each country’ssocial and economic context defines the mostsuitable routes toward broader and deeperinsurance protection. In Western and CentralEurope, countries are increasingly collaboratingin the exchange of information and experienceson cost-containment measures, and in the use ofcost-effectiveness analysis as an aid to medicinesreimbursement decisions (including a WHOreview of the technology appraisal programme ofthe National Institute For Clinical Excellence inthe UK). WHO is working with such programmesto address the issue of medicines managementwithin health insurance.Challenges remainingThe development of widespread health insurancemechanisms is a capacity-intensive processwhich typically takes many years to reach fullimplementation and even then requires activemanagement. A country’s overall economicperformance in this period is a major enabling orconstraining factor. Most low- and middle-incomecountries start with a diverse set of health andmedicine financing mechanisms, with prepaymentsometimes accounting for only a minority shareof total health or medicine spending. Equitablesharing of financial risks and protection amongthe population is thus often very limited,particularly in relation to the cost of medicines.

COMPONENTS OF THE STRATEGY | 65Meeting the challenges 2004-2007Over the next four years WHO will:> support countries in all regions in reviewingthe state of national and sub-nationalprepayment and insurance arrangements, andassessing their impact and potential in termsof access to medicines.> compile and disseminate lessons fromindividual countries.> advocate for the adoption of health insuranceand prepayment schemes and provideexperience-based policy guidance tocountries.(These activities will be carried out insynchronization with those under EO 3.2)OUTCOME INDICATORS1999 2003 2007No. of countries with public health insurance covering thecost of medicines#REPORTING % TARGET#REPORTING % TARGET71/111 64% 70% 79/117 68% 73%

WHO MEDICINES STRATEGY 2004-2007 | 66Figure 17:Medicine prices: local components of privatesector prices as percentage of landed import price VATretail mark-updistribution/wholesale mark-upimporter mark-upimport taxcustoms, fees, insurance, clearance EO 3.5Medicine pricing policies and priceinformation promoted to improveaffordability of essential medicinesRationaleIn the complex national and global marketsfor medicines, access to price information forcomparable medicines is often difficult andexpensive. Yet such market intelligence is essentialfor informed purchasing decisions. In 2001,the World Health Assembly, recognizing theimportance of timely and reliable information onmedicine prices, called on WHO to:“..explore the feasibility and effectivenessof implementing, in collaboration with nongovernmentalorganizations and other concernedpartners, systems for voluntary monitoring drugprices and reporting global drug prices...and toprovide support to Member States in that regard”[WHA54.11 operative para 2.(2)]ProgressWHO is working with others in the UN familyand development partners to maintain threeinternational price information services:> Management Sciences for Health (MSH)in collaboration with WHO: InternationalDrug Price Indicator Guide. Boston, MA,Management Sciences for Health. Publishedannually.> UNICEF, UNAIDS, WHO, Médecins SansFrontières : Sources and Prices of SelectedMedicines and Diagnostics for People LivingWith HIV/AIDS. Geneva, World HealthOrganization. Published annually.> International Trade Centre: PharmaceuticalStarting Materials/Essential Drugs Report.Geneva, International Trade Centre/UNCTAD/WTO. Published monthly.The Global TB Drug Facility (as part of the Stop TBPartnership) provides web-based price informationon anti-TB medicines for use in implementingthe Directly Observed Treatment Short Course(DOTS) strategy. In addition, European countriesare increasingly putting their national priceinformation on the web.WHO also maintains regional price informationservices, including the AFRO Essential Drugs PriceIndicator, which compares national tender pricesfor essential medicines; and the Pan American

COMPONENTS OF THE STRATEGY | 67Figure 18: Variations in the price of ciprofloxacin:originator brand and genericsThe manual and accompanying workbookresulted from discussions in the regular WHO-Public Interest NGO Round Table. A revisededition, following extensive field testing andreview, is scheduled for 2005.OriginatorBrandGenericArmenia Brazil Peru Sri LankaSource: www.haiweb.org/medicinepricesHealth Organization (PAHO) website on ARVs inLatin America and the Caribbean, which providesinformation on prices, uses, and access policiesfor ARVs. The WHO website now provides linksto electronic sources of public information onmedicine prices in several languages 29 .In 2003, a new manual on the compilation andanalysis of medicine prices, Medicine Prices:a new approach to measurement 30 , was jointlydeveloped and published by HAI and WHO. Itis intended to be of use to a range of differentorganizations involved in efforts to achieve moreaffordable medicine prices in low- and middleincomecountries. It provides guidance oncollecting retail price information for selected keymedicines through surveys of health facilities indifferent sectors, and on comparing local priceswith international reference prices. Analysis isalso encouraged of the different componentsof retail price (Figures 17 and 18), and of theaffordability of treatment for selected commonconditions. The HAI (Europe) website has a publicdatabase of results from the nine pilot surveyscarried out in the development of these materials,and this will grow as more studies are undertaken.OUTCOME INDICATORS1999 2003 2007No. of countries with a pricing policy for maximum retailmark-up in the private sectorBig variations in medicine prices for the same orsimilar products, especially the newer essentialmedicines, remain the norm, both withinand between countries. Informed purchasingis therefore difficult for many individual orinstitutional purchasers, and price transparencyremains a distant goal.Meeting the challenges 2004-2007Over the next four years WHO will:> continue and, where possible, expand priceinformation in collaboration with other UNagencies and development partners.> issue an annual publication on the sourcesand prices of antimalarial medicines in2004, following the success of the annualpublication on HIV/AIDS-related medicines.> in collaboration with HAI, continue to supportworkshops in several regions for government,academic, and NGO personnel on how toundertake a survey on medicine prices.> carry out in-depth studies of HIV/AIDS andmalaria medicine prices to monitor pricechanges over time and to explore policyoptions in different national settings.> further develop information materials onprices and pricing policy guidelines to enablecountries to consider different options andstrategies for pricing mechanisms to ensureaffordable prices for essential medicines.#REPORTING % TARGET#REPORTING % TARGETna na na 36/75 48% 55%

WHO MEDICINES STRATEGY 2004-2007 | 68EO 3.6Competition and generic policiesimplemented along with guidelinesfor maximizing competition inprocurement practicesRationaleWHO has long advocated the use of genericmedicines of known quality as a cost-effectivemeans of ensuring access to and the availabilityof essential medicines 31 . Several industrializedcountries make extensive use of genericmedicines, and competitive bulk procurement bygeneric name is a central feature of most essentialdrugs programmes. Yet recent evidence fromMember States, particularly low- and middleincomecountries, suggests that the potential ofgeneric medicines is seldom fully attained inthe formulation and implementation of nationalmedicines policy. The use of generic drugs canbe promoted at various levels, from procurementto the point of purchase. In the private market,price competition can be encouraged throughgeneric prescribing and generic substitution.There are four main factors that influence theuse of generic drugs and the success of genericdrug programmes: supportive legislation, qualityassurance capacity, acceptance by prescribers andthe public, and economic incentives.ProgressWhile over half of low-income countries haveformulated NMPs, two-thirds of these havenot yet been implemented. In 1999, less than20% of WHO Member States confirmed thatthey required or allowed generic prescribing inthe public sector, though over 40% confirmedthat generic substitution was allowed at privatemedicine retail outlets 32 . Clearly, much more canbe achieved by countries to integrate genericmedicines into the daily decision-making ofpurchasers, prescribers, dispensers, and patients.Challenges remainingMajor challenges remain in the four areasidentified above. Supportive legislation is oftenlacking. Too few countries have effective qualityassurance capability, and many prescribersand patients remain sceptical about genericmedicines. The potential of generic products toincrease access to essential medicines is far fromfully utilized.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to advocate for the use of genericsand seek ways to motivate countries to adoptgeneric policies.OUTCOME INDICATORS1999 2003 2007Countries in which generic substitution is allowed inprivate pharmacies#REPORTING % TARGET#REPORTING % TARGET83/135 61% 75% 99/132 75% 81%

COMPONENT 4SUPPLYING MEDICINESCOMPONENTS OF THE STRATEGY | 69

WHO MEDICINES STRATEGY 2004-2007 | 70Efforts by WHO and other partners to scale upaccess to essential medicines for priority diseaseshave refocused attention on the need to ensurethe effectiveness of medicine supply systems.Reliable supply systems are vital 33 in order toensure that health commodities and medicaland pharmaceutical services are delivered topatients in accordance with acceptable qualitystandards, and to guarantee uninterrupted servicesand supply. A well-coordinated supply systemwill ensure that public funds available for drugpurchases are used effectively to maximizeaccess, obtain good value for money, and avoidwaste. This in turn will increase confidencein health services and promote attendance bypatients. However, good coordination betweenthese central elements of the supply system iscritical. Failures at any point in the medicinessupply system can lead to life-threateningshortages and to waste of limited resources.Therefore monitoring and evaluation of medicaland pharmaceutical services are essential toensure that any major weaknesses are identifiedand addressed.Many developing countries continue to strugglewith inefficient public supply systems unableto meet the demands of their health caredelivery objectives or the expectations of healthworkers and the general public. In response,governments have tried to introduce market forcesinto public medicine supply systems/centralmedical stores (CMS). The aim was to improveboth the efficiency and quality of services byintroducing private sector management featuresin the public medicines supply structure. Inmany countries, public sector managementperformance is characterized by low wagesunrelated to performance, limited motivation,inflexible personnel policies and inefficientadministrative and financial procedures. Bycontrast, private sector management is morelikely to be characterized by performance-basedwages, more flexible personnel policies, andstreamlined administrative procedures. The roleof governments is to ensure that both public andprivate pharmaceutical sectors are able to supplysufficient quantities of safe, effective drugs, whichare of good quality and affordable. The challengeis to find a balance between public healthobjectives and economic realities.The supply of medicines in emergency situationsposes an additional challenge. The worldcommunity is usually quick to send largeand often unsolicited donations of drugs andmedical supplies — some of which can be ofgreat help and save lives, but others which can

COMPONENTS OF THE STRATEGY | 71Figure 19:Reliable health and supply sytems – successful examples exist in all regions***Regional bulk purchasing – centralized, multi-countryDirect delivery system – privatized, centralized*Primary distributor system – privatized, centralizedAutonomous medical stores – partly private,do more harm than good. In response, in 1998WHO worked together with a large group ofinternational humanitarian aid agencies todevelop a standard kit of essential medicines,supplies, and basic equipment, ready for dispatchwithin 24 hours, for use in the first phase of anacute emergency involving large populationmovements or a sudden influx of refugees.In addition, interagency guidelines for drugdonations have been developed (1999) to helpguide donors and recipients 34 . In 2003, WHOalso published interagency guidelines for pricediscounts of single-source pharmaceuticals 35 .ProgressGovernments have developed strategies toincrease private sector involvement in theCMS system to improve their efficiency andperformance, such as divestiture, introductionof private management features, and contractingout of services. In doing so, governments hadto take into account the country’s capacitiesand economic realities as well as the possibleinvolvement of the private sector. Stronggovernment commitment and appropriate actionsappears to be essential for successful reformimplementation 36 . Examples of country progresscan be found in EO 4.1.WHO will support countries torun efficient and secure systemsfor medicines supply managementin both the public and privatesectors to ensure continuousavailability and delivery ofmedicines at all levels of thedistribution chain.

WHO MEDICINES STRATEGY 2004-2007 | 72EO 4.1Supply systems assessed andsuccessful strategies promoted toidentify strengths and weaknessesin the supply systems and improvethe performance and functioning ofnational medicines supply systemsRationaleMany countries have to contend with a twintrackmedicines supply system — comprising anoften inefficient public medicine supply systemintended to serve the entire country and a varietyof private supply systems serving mostly urbanareas. Recent experience indicates that medicinesupply systems are most effective when they arebased on an appropriate mix of public, private,and NGO procurement, storage, and distributionservices.Public medicines supplysystems are not meeting eitherthe demands or the needs ofcountriesProblems include:> organizational structure and financialmechanism are rigid and inadequate> capital and budget allocations areinsufficient for a well-functioningsystem> number and/or capacity of supply staffare not sufficient to fulfil the tasks> no career development or incentivestructure> procurement procedures are nottransparent and efficient> government interference.The CMS strategy has been successful only wherepublic funding is substantial and sustainable, andwhere the economy has been stable. This is notthe case in most developing countries. As a resultof health sector reforms, a number of differenttypes of supply strategies have evolved out of thehighly centralized public sector supply system.These vary considerably in relation to the role ofthe government, the role of the private sector, andthe use of incentives to boost efficiency.ProgressInnovative approaches to public and privatesupply systems have been adopted in countriessuch as Benin and other West African countries,Colombia, Guatemala, the Newly IndependentStates (NIS) of East and Central Europe, SouthAfrica, and Thailand. 37 These reflect differentcombinations of public and private, centralized,and decentralized approaches. The potential toimprove access through private sector channelshas also been demonstrated in countries asdiverse as Indonesia, Kenya, and Nepal. WHOhas supported developments in supply systemsin the NIS countries and the Balkan Region andprovided training to improve the effectiveness ofsupply systems in Peru and Colombia.Elsewhere, alternative supply mechanisms suchas regional and sub-regional bulk purchasingschemes have been successfully adopted bythe Gulf Cooperation Council and by theOrganization of Eastern Caribbean StatesPharmaceutical Procurement Service whichoperate pooled procurement systems for six andeight countries respectively.

COMPONENTS OF THE STRATEGY | 73MEDICINE SUPPLYSTRATEGIESCentral medical storesCentralized, fully public management,warehousing, and delivery system(Semi-)autonomous supply agencyCentralized, (semi-)privatemanagement and warehousing systemDirect delivery systemCentralized decision-making butdecentralized, private direct deliverysystemPrime distributorCentralized decision-making butdecentralized, private warehousingand delivery systemFully private supplyDecentralized decision-making, fullyprivate wholesalers and pharmaciessystem.Challenges remainingTo date there has been no systematic evaluationof the advantages and limitations of the differentsupply strategies in different (particularly lowincome)settings. Thus, empirical evidence onwhich to base policy-making is limited. Thechallenge for governments is to establish themost appropriate medicines supply strategy, andto identify the extent to which the private sector,including NGOs, can be a partner in supply anddistribution systems.Meeting the challenges 2004-2007Over the next four years WHO will:> support countries in their efforts to integrateinnovative public-private approaches throughan efficient mix of public, private, and NGOsectors in order to ensure the continuousavailability and delivery of medicines ofassured quality to all levels of the health caresystem.> carry out a multi-country study in Africa toevaluate existing public sector supply systems,including development of a comprehensiveassessment tool to enable Member States toassess their own systems.> explore with stakeholders the options fordrawing on the experiences of the NGOsector, including faith-based organizations(see also EO 4.5) to help countries formulatea feasible national medicines supply systembased on an efficient public-private mix.OUTCOME INDICATORS1999 2003 2007No. of countries with public sector procurement limited tonational essential medicines list#REPORTING % TARGET#REPORTING % TARGET71/133 53% 60% 84/127 66% 74%

WHO MEDICINES STRATEGY 2004-2007 | 74EO 4.2Medicines supply managementimproved through trainingprogrammes and careerdevelopment plans to increasecapacity and reduce staff turnoverRationaleRunning a national medicines supply systemrequires a wide range of knowledge andskills, to be applied in a professional mannerat appropriate points in the supply system.In developing countries, where medicinesaccount for 25%-65% of total health spending,improvements in medicines management skillscan result in significant savings for the publicsector.Governments have the responsibility forplanning and overseeing the training and careerdevelopment of staff in the national medicinessupply system, and for allocating adequatefunding for staff development. Managing humanresources well is a complex task, requiring effortsto ensure that the appropriate staff are trained andavailable, that staff are motivated and kept up todate, and that staff turnover is not too high. Thoseinvolved in the medicines supply system shouldreceive training in medicines management,supervision, and key administrative skills.Efficient medicines management is based on fourkey functions, which form the basis of existingtraining courses on medicines management:selection, procurement, distribution, and use.ProgressWHO and partners have organized international,regional, and national training courses inmedicines management, including:> Heidelberg University and Swiss TropicalInstitute module course on “Rational DrugManagement” as part of the TropEd EuropeanMasters programme in International Health,since 2002.> MSH/IDA course on “Managing Drug Supplyfor Primary Health Care”, annually, since1995.> MSH/IDA course on “La Gestion Optimaledes Médicaments pour les Soins de SantéPrimaires”, annually, since 2003.> World Bank course on “Integrated Approachto the Procurement of Health Sector Goods”,since 2002.> MSH/Stop TB regional courses on “DrugProcurement for Tuberculosis”, since 2001.> CPA distance learning programme forhealth care workers involved in medicinesmanagement, on “Managing Drug Supplies”,since 1995.> Pharmaceutical Assistants Training, for healthcare workers in faith-based health facilities inKenya, Tanzania, and Uganda.Challenges remainingOne of the consequences of the free movementof goods and services is the exodus of trainedprofessionals from developing countries in searchof better paid jobs in industrialized countries whichhave a shortage of trained health and pharmaceuticalprofessionals. In addition to this brain drain, manydeveloping countries are also experiencing the loss ofwell trained health and pharmaceutical personnel dueto HIV/AIDS.The procedures involved at country level in applyingfor grants from the Global Fund, the World Bank, andthe US President’s HIV/AIDS Fund, and for suppliesfrom the Global TB Drug Facility distract alreadyover-stretched medicines management staff from theirroutine tasks and duties. All these challenges resultin an increased need for trained personnel and forincentives to keep them in public service.

COMPONENTS OF THE STRATEGY | 75Figure 20:Medicines Management Cycle: Policy and LegalSELECTION>USEMANAGEMENTSUPPORTOrganizationFinancingInformation ManagementHuman ResourcesPROCUREMENT>>DISTRIBUTIONMeeting the challenges 2004-2007Over the next four years WHO will:> continue to encourage the development ofmanagement capacity at all levels throughspecific training programmes and coursesand the inclusion of appropriate referencematerials in basic training programmes.> support countries in their preparation for grantapplications to the Global Fund and othergrant providers, including capacity buildingactivities in drug management and distributionat national and district level (see also EO 3.3).> introduce the new curriculum of thePharmaceutical Assistants Training in 2004to meet national requirements for pharmacyassistants’ competencies and skills; and workin collaboration with the Confederation ofPharmaceutical Associations (CPA) to updatethe existing distance learning modules anddevelop a set of modules tailored to the needsof pharmacists in various health care settings(2004).> support the development of different forms ofregional and national training courses suchas e-learning and other distance learning, toincrease the number of people trained.OUTCOME INDICATORS1999 2003 2007No. of countries providing continuing education topharmacists and pharmacy aides/assistants#REPORTING % TARGET#REPORTING % TARGET39/103 38% na 31/111 28% 32%

WHO MEDICINES STRATEGY 2004-2007 | 76EO 4.3Local production assessed andstrengthened, on the basis of policyguidance to create a favourableenvironment for government orinternational support to domesticproduction of selected essentialmedicinesRationaleIn some countries, the development of localproduction facilities for medicines may beappropriate. For example, there may be benefitsfor the general economy from increasedemployment, for the health service in moreself-sufficiency, and additional benefits in theform of skills development and improved accessto medicines. However, local production ofmedicines has proved to be unsuccessful insome settings, in particular in countries with:limited markets; weak infrastructure; a shortageof mid-level and higher qualified staff; inabilityto maintain product quality and offer competitiveprices; lack of skilled workers; and dependenceon imported raw materials and technology andon foreign currency. Efforts to ensure that GMP isimplemented and to assure the quality of productsmay be difficult for countries with limited humanresource capacity. WHO encourages governmentsto undertake a thorough situation analysis todetermine the feasibility of any proposal toencourage or support local manufacture ofpharmaceutical products.ProgressThere are a number of examples of successfullocal production of medicines, includingsuccessful public sector involvement in countriessuch as Argentina, Bangladesh, Brazil, Cuba,and Egypt. In addition, there are examples ofsuccessful production of generic medicines byboth private and public sector manufacturersin Eastern Europe (e.g. Hungary, Slovenia, andUkraine). In most cases, local production hasbeen successful either where the domestic marketis large (India, Pakistan, China, Brazil) or whereexport markets have been established. A recentpaper has provided useful information on theissues. 38 One of the key findings of this study wasthe strong correlation between gross domesticproduct (GDP) and the value of local production.ChallengesA key challenge is understanding when to investin building local production capacity. Whilethere may be strong local support for suchenterprises, this could be at the expense of accessto quality assured products. At present there areno indicators that can be used to predict whichindustries are likely to be successful.

LOG LOCAL PRODUCTION (US$)COMPONENTS OF THE STRATEGY | 7711.00Figure 21:Value of local production and GDP (Log scales)CHINAUS$10B10.5010.00IRELANDKOREABRAZILGERMANY9.50SWEDENINDIA9.00AUSTRIA | EGYPTUKRAINE | ROMANIARUSSIAN FEDERATION8.50VENEZUELA8.007.50JORDANALGERIASOUTH AFRICANORWAYUS$10M7.00IVORY COASTKUWAITSAUDI ARABIA6.506.00MAURITIUSTANZANIA9.00 9.50 10.00 10.50 11.00 11.50 12.00 12.50US$1B US$10B US$1 TRILLIONLOG GDP (US$)Meeting the challenges 2004-2007Over the next four years WHO will:> evaluate successful local production projectsto provide tools and guidance on bestpractices in order to help countries carryout feasibility studies to assess the viabilityof local medicines production. The aim is toensure that any investment is maximized toachieve the objective of accessibility withoutcompromising quality or price.> continue to support manufacturersparticipating in the prequalification schemein preparing product dossiers to a globalstandard.> continue to carry out site inspections toassist manufacturers in ensuring that GMP isfollowed throughout the production process.> continue to help strengthen nationalregulatory authorities.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries with local producation capability na na na 36/122 30% na

WHO MEDICINES STRATEGY 2004-2007 | 78EO 4.4Procurement practices andpurchasing efficiency improvedthrough guidance on goodprocurement practices, medicinesmanagement informationsupport, and work with countriesto strengthen procurementprocedures.RationaleGood procurement practices are essential toensure access to essential medicines. Procurementinvolves efforts to quantify drug requirements,select procurement methods, prequalify productsand suppliers, manage tenders, establish contractterms, assure drug quality, obtain best prices, andensure adherence to contract terms.The aim is to:> procure the most cost-effective drugs in thequantities needed> select reliable suppliers of quality products> ensure timely delivery> achieve the lowest possible total cost.Transparent procurement procedures influencequality and affordability and are essential toensure a reliable supply of medicines 39 . Inefficientprocurement systems have been found to payup to twice the world market price for essentialmedicines. 40 Poor quality medicines or delayeddeliveries from unreliable suppliers contribute tounnecessary waste of budgets, life-threateningshortages, antimicrobial resistance, and avoidablefatalities.ProgressOver recent years, WHO has supported countries,directly or through regional efforts, in their effortsto help strengthen procurement. Savings of 25%-50% in purchase prices and procurement ofquality medicines have been documented in someof these programmes. Assistance has also beenprovided for the establishment of sub-regionalprocurement systems in West Africa and thePacific Islands.Recent policy guidance and operational researchhas included:> Operational Principles for GoodPharmaceutical Procurement, published byWHO with five UN agencies, 1999.> Practical Guidelines on PharmaceuticalProcurement for Countries with SmallProcurement Agencies. WHO Western PacificRegional Office (WPRO), 2002.> Interim Guidelines for the Assessment of aProcurement Agency. WHO, 2003,> Updated lists of qualified suppliers of selectedmedicines for HIV/AIDS, TB, and malaria.This is one of the outcomes of the PilotProcurement Quality and Sourcing Project,supported by UN agencies and the WorldBank.> Operational Package for Assessing CountryPharmaceutical Situation. WHO, 2003.

COMPONENTS OF THE STRATEGY | 79Challenges remainingExisting government policies, rules, andregulations for procurement, as well asinstitutional structures, are frequently inadequateand sometimes hinder overall purchasingefficiency. Other continuing challenges includeerratic funding, lack of accurate objectiveinformation, poor decision-making processes,and poor supplier performance. More recentchallenges include: increasing pressure onprocurement agencies to obtain the lowestpossible price; greater difficulty in assuring thesource and quality of medicines in an increasinglyglobal pharmaceutical market; and the needfor procurement agencies to better understandpatents and the available safeguards in the TRIPSAgreement. Government procurement agenciesare also affected by emerging trends such asincreasing interest in regional and sub-regionalprocurement, large-scale procurement withGlobal Fund financing, and the integration of theprocurement of products for reproductive healthinto the regular government procurement systems.Meeting the challenges 2004-2007Over the next four years WHO will:> expand its work on good procurementpractice to support regional and nationalefforts to improve procurement systems andpractices.OUTCOME INDICATORS1999 2003 2007No. of countries with at least 75% of public sectorprocurement carried out by competitive tender> complete work on the Guidelines forAssessment of a Procurement Agency.> expand the listing of qualified suppliers ofselected essential medicines and technicalguidance on patents.> provide support to at least 20 countries in theuse of the Operational Package for AssessingCountry Pharmaceutical Situation.> facilitate WHO’s ‘3 by 5’ initiative bysupporting about 30 countries with high HIV/AIDS incidence in efforts to strengthen theirnational procurement systems.#REPORTING % TARGET#REPORTING % TARGET81/88 92% 95% 58/70 83% 87%

WHO MEDICINES STRATEGY 2004-2007 | 80EO 4.5Public-interest NGOs includedin medicine supply strategies, insupport of national medicine supplystrategies to reach remote areasRationalePublic-interest NGOs and faith-basedorganizations often work in areas where theprivate for-profit health sector does not haveincentives to exist. These organizations playan important role in meeting the overall healthneeds and medicine requirements of theserural and often disadvantaged populations.WHO, in collaboration with the EcumenicalPharmaceutical Network based in Nairobi, Kenya,has undertaken a study in 10 sub-Saharan Africancountries on medicines supply and distributionactivities by faith-based organizations. Preliminaryfindings indicate that these organizations supportthe overall public health sector by covering 40%of the population and support around 80% ofhealth facilities, in mainly rural areas.WHO already works in collaboration with manypublic-interest NGOs, is involved in trainingcourses for NGO personnel, and has publishedpapers on NGO contributions. Another exampleis the close collaboration with Médecins SansFrontières (MSF) in the production of a jointreport about MSF’s experiences in procuring andsupplying ARVs in 10 countries where it operatesHIV/AIDS treatment programmes 41 . WHO alsoworks with international non-profit suppliers oflow-cost essential medicines, in particular on thecomposition and distribution of the WHO NewEmergency Health Kit, and through the GreenLight Committee for the supply of medicines formultidrug-resistant TB.As a result, faith-based organizations such asthose in the African Region have substantialexperience in the successful management ofmedicine supplies, mostly through a pooledpurchase mechanism (e.g. Ghana, Nigeria,Malawi, Zambia, Kenya, and Uganda). Inmost cases, they operate efficiently, havewell-motivated staff, and have adopted soundmanagement principles, including accountability.Although their skills, experience, andachievements are not always recognized or usedby national governments, some governmentsdo acknowledge the contribution of theseorganizations and collaborate with them to jointlysupply and distribute medicines supplies in thepublic health sector. The Joint Medical Stores inUganda and Mission of Essential Medicines andSupplies in Kenya are good examples of this kindof collaboration.

COMPONENTS OF THE STRATEGY | 81Meeting the challenges 2004-2007Over the next four years WHO will:> work with public-interest NGOs, faith-basedorganizations, and countries to support theassessment of best practices within NGOs andfaith-based organizations for incorporationinto national medicines supply policies andstrategies.Challenges remainingMany governments do not fully recognize oracknowledge the important contribution thatNGOs and faith-based organizations could makeand are already making in the equitable deliveryof basic health care. Many good examples ofcost-effective drug supply management by NGOsand faith-based organizations are ignored and notused to their full potential as examples for publicservices.> support the NGOs and faith-basedorganizations by offering them a full shareof available technical information, policyguidance, and training opportunities.> continue to promote the use of all availablechannels, including NGOs and faith-basedorganizations, in the delivery of health careto rural and disadvantaged populations(including the prevention, care, and treatmentof HIV/AIDS.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries with NGOs involved in medicines supply na na na 29/64 45% na

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COMPONENT 5NORMS AND STANDARDSFOR PHARMACEUTICALSCOMPONENTS OF THE STRATEGY | 83

WHO MEDICINES STRATEGY 2004-2007 | 84From the outset, WHO has worked to establishand promote international standards for thequality of pharmaceuticals. Under Article 2 of theWHO Constitution, WHO is required to “develop,establish and promote international standardswith respect to food, biological, pharmaceuticaland similar products”.Without assurance that medicines are relevantto priority health needs and that they meetacceptable standards of quality, safety, andefficacy, any health service is evidentlycompromised. In developed countries,considerable administrative and technical effort isdirected to ensuring that patients receive effectivemedicines of good quality. It is crucial to theobjective of health for all that a reliable system ofmedicines control is brought within the reach ofevery country.The existence of international harmonizationinitiatives in different parts of the worlddemonstrates the importance that governmentsattach to drug regulation; at the same time, itoffers opportunities for countries to review andimprove their regulatory systems. 42Member States continue to look to WHO forguidelines on the development of pharmaceuticalregulation, legislation, and quality assurance.In response, the WHO Expert Committee onSpecifications for Pharmaceutical Preparationshas adopted a large number of guidelines inthe area of quality assurance 43 . Guidelines havebeen adapted by Member States or regionalharmonization groups to meet their own needsand circumstances.Another critical pharmaceutical serviceprovided by WHO is the system of InternationalNonproprietary Names (INN), which is used toidentify each pharmaceutical substance or activeingredient by a unique and universally accessiblename. This function is fundamental to ensurethat dispensing and prescribing is governed by acommon nomenclature allowing communicationamong health professionals and consumers.This is of increasing importance in view of theglobalization of trade in pharmaceuticals and theneed for better communication among healthprofessionals. The existence of several names forthe same product can be a source of confusionand a potential risk to health.The WHO Expert Committee on Specificationsfor Pharmaceutical Preparations meets regularlyand publishes statements, guidelines, andrecommendations that provide the tools for

COMPONENTS OF THE STRATEGY | 85quality assurance systems worldwide 44 . Importantkey elements are quality assurance guidancetexts in the areas of production, testing, anddistribution of medicines. These include guidanceon: good manufacturing practices; qualityassurance for regulatory approval; prequalificationof medicines, laboratories, and supply agencies;model certificates for quality assurancerelatedactivities; quality control testing; newspecifications for inclusion in the Basic Testsseries and the International Pharmacopoeia; andInternational Chemical Reference Standards.All these elements are intended for use bynational regulatory authorities, manufacturers,and other interested parties. The InternationalPharmacopoeia is in widespread use throughoutthe world and plays a major role in defining thespecifications of pharmaceutical products. It alsoprovides a valuable tool in the quality control ofimported products 45 .control, nomenclature, and classification ofpharmaceuticals.WHO will work to strengthen andpromote global norms, standards,and guidelines for the quality,safety, and efficacy of medicine.The need to scale up access to affordable qualitymedicines for HIV/AIDS, TB, and malaria indeveloping countries has raised many challengeswithin the pharmaceutical world. Thesechallenges come on top of the reality that amongnational regulatory authorities there is a variablecapacity to interpret and apply existing norms andstandards and guidelines on regulation, quality

WHO MEDICINES STRATEGY 2004-2007 | 86EO 5.1Pharmaceutical norms, standardsand guidelines developed orupdated to promote good practicein quality assurance and regulatorymattersRationaleExisting WHO pharmaceutical norms, standards,and guidelines have to be continually updatedto keep pace with advances in pharmaceuticalscience and technology. Today, as efforts getunder way to scale up access to quality essentialmedicines in developing countries, there is anurgent need for WHO to further strengthen thedevelopment of international standards andguidelines on the assessment of multi-sourcegeneric products.In addition, the continuing sale of substandardand counterfeit medicines in some countrieshas highlighted the need for internationalagreements in order to strengthen existingpreventive measures. Elsewhere, increasing tradeand commerce, and the supply of life-savingmedicines by both private and public parties,require new approaches to quality assurance atthe international, regional, and national level.The statutory instruments, advice, andrecommendations provided by the WHO ExpertCommittee on Specifications for PharmaceuticalPreparations can help national authorities,especially national drug regulatory authoritiesand procurement agencies, to combat problemssuch as the production, distribution, and sale ofsubstandard and counterfeit medicines, financialwaste, and the emergence of resistance tomedicines for priority infectious diseases.ProgressWHO has helped raise awareness of the needfor regulatory measures covering the safety ofand trade in starting materials, including activepharmaceutical ingredients and excipients,and the implementation of GMP. In responseto a Resolution of the World Health Assembly(WHA52.19) and recommendations made invarious fora, including the 10 th InternationalConference of Drug Regulatory Authorities, theExpert Committee has adopted new mechanismsfor the control and safe trade of starting materialsfor pharmaceuticals, for action by governments,manufacturers, traders and brokers: (1) GoodTrade and Distribution Practices (GTDP); and (2)Pharmaceutical Starting Materials CertificationScheme (SMACS). Member States are beingencouraged to participate in a pilot phase.The Expert Committee has updated widely usedexisting WHO guidelines on GMP and addedspecific texts such as Guidelines on GoodManufacturing Practices for RadiopharmaceuticalProducts and the Model Certificate of GoodManufacturing Practices.A series of guidance texts have been adoptedby the Expert Committee in relation to theprequalification of suppliers of medicines for HIV/AIDS, TB, and malaria, including:> Procedure for assessing the acceptability, inprinciple, of pharmaceutical products forpurchase by UN agencies> Procedure for assessing the acceptability, inprinciple, of quality control laboratories foruse by UN agencies.

COMPONENTS OF THE STRATEGY | 87> Guidelines for drafting a laboratoryinformation file.> Procedure for assessing the acceptability, inprinciple, of procurement agencies for use byUN agencies.> Guidelines for drafting a procurement agencyinformation file.> Interim guidelines for the assessment of aprocurement agency.> Model Quality Assurance System for theprequalification, procurement, storage, anddistribution of pharmaceutical products.ChallengesCountries’ priorities, needs, resources, andrequirements in pharmaceuticals differsubstantially. This has enormous implicationsfor WHO’s work, both in developing globalguidelines and advising Member States on theiradaptation and adoption. Current developmentsin the international harmonization of drugregulation provide an opportunity for WHOto review and update existing standards andguidelines.Today, WHO is at the forefront of continuinginternational efforts to define and harmonizeclear and practical standards and guidelinesfor pharmaceuticals, particularly in responseto the increasing globalization of trade inpharmaceuticals and the supply of medicines byintermediaries. Additional regulatory guidanceis also urgently needed for the assessment ofthe quality, safety, and efficacy of fixed-dosecombination medicines for public health prioritydiseases.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to review, update, and developnorms, standards, and guidelines forquality assurance and quality assessment inmedicines registration .> improve the dissemination and promotionof WHO guidelines (e.g. quality assuranceguidance, GMP guidelines) and strengthencommunication strategies in order to ensureeffective implementation of the guidelines.> establish a Global Alliance for the Quality ofPharmaceuticals, in collaboration with otherpartners, with a particular focus on capacitybuilding in quality assurance at the nationallevel.OUTCOME INDICATORS1999 2003 2007No. of countries using the WHO Certification Scheme aspart of the marketing authorization process#REPORTING % TARGET#REPORTING % TARGETna na na 87/135 64% 75%

WHO MEDICINES STRATEGY 2004-2007 | 88EO 5.2Medicines nomenclature andclassification efforts continuedthrough assignment, promotion,and protection of internationalnonproprietary names, and thepromotion and development ofATC/DDD systemRationaleInternational Nonproprietary Names (INN)identify pharmaceutical substances or activepharmaceutical ingredients. Each INN (oftenreferred to as a “generic” name) is a unique namethat is globally recognized and is public property.The existence of an international nomenclaturefor pharmaceutical substances, in the form ofINN, is important for the clear identification andsafe prescription and dispensing of medicinesto patients, as well as for communicationand exchange of information among healthprofessionals and scientists, businesses, andgovernments worldwide. Providing INN is one ofthe oldest services that WHO provides to MemberStates. INN are made available in all six WHOlanguages (Arabic, Chinese, English, French,Russian, and Spanish) as well as in Latin. Thework of the INN Programme and the assignmentof INN are both guided by International INNExpert Group.An additional classification system has beendeveloped to serve primarily as a tool for drugutilization research. The Anatomical TherapeuticChemical (ATC) classification system togetherwith the Daily Defined Dose (DDD) continuesto be developed and maintained by theWHO Collaborating Centre for Drug StatisticsMethodology in Oslo, Norway, under thesupervision of the WHO International WorkingGroup for Drug Statistics and Methodology.The Working Group, comprised of experts inclinical pharmacology and medicines utilizationrepresenting the six WHO Regions, meets twicea year and oversees the work of the CollaboratingCentre for Drug Statistics Methodology. The ATCclassification system with its hierarchical codesdivides drugs into different groups according tothe organ system on which they act and theirchemical, pharmacological, and therapeuticproperties. In the ATC system, one drug can haveseveral ATC codes due to different therapeutic useand local application formulations. The DDD isa unit of measurement in drug utilization studiesreflecting average daily maintenance dose of thedrug when used for its main indication. AlthoughATC codes are increasingly used for classificationpurposes (i.e. in drug formularies), the main utilityof ATC codes is in conjunction with DDD for drugutilization research worldwide.ProgressThe use of the INN system is expanding withthe increase in the number of names. Its wideapplication and global recognition are also dueto close collaboration with numerous nationalmedicines nomenclature bodies in the processof INN selection. As a result, most of thepharmaceutical substances used today in medicalpractice are designated by an INN. The use ofINN is common in scientific literature, regulatoryaffairs, research, and clinical documentation. Theyare also used for administrative purposes. Theirimportance is increasing due to expanding use ofgeneric names for pharmaceutical products.Nonproprietary names are widely used in

COMPONENTS OF THE STRATEGY | 89pharmacopoeias, product labelling andinformation, advertising and other promotionalmaterials, medicines regulation, and scientificliterature, and as a basis for product names in thecase of generic medicines. The INN Programme iscollaborating closely with the WHO CollaboratingCentre for Drug Statistics Methodolology in Oslo,Norway, and the INN and ATC databases havebeen cross-linked — providing a unique source ofinformation for medicines regulatory authorities,scientists, and others in the pharmaceutical field.Information technology tools to facilitate accessto the information are being developed (e.g. webbasedaccess through MedNet, Cumulative List ofINN with additional information on CD). Activecollaboration with medicine regulatory authorities(e.g. the European Medicines EvaluationAgency (EMEA)), pharmacopoeias (e.g. JapanesePharmacopoeia), nomenclature bodies (e.g.United States Adopted Names Council), and otherinterested parties is becoming part of the mainINN Programme activities.The use of the ATC/DDD system is wideningglobally. Many regulatory authorities todayuse ATC codes for drug registration and otheradministrative purposes. ATC codes are alsoincreasingly referred to in drug formularies andother information sources. Recent publicationsby the Centre include: Guidelines for ATCclassification and DDD assignment and an Indexwith all the assigned ATC/DDDs (both issuedannually, the latest 2003). A recent publication,An Introduction to Drug Utilization Research(WHO, 2003), has broken new ground inpromoting drug utilization research by givingsimple and robust advice on how best to carry outand benefit from drug utilization research with theaim of promoting rational use of drugs.Challenges remainingThere is a continuing need to promote theimportance and use of unified classificationsystems for medicines so as to avoid confusionand facilitate the exchange of informationand research into the therapeutic use ofmedicines. The health and financial benefitsfrom methodologically sound drug utilizationresearch remain underestimated, whereas thecosts are overestimated. There is a growing needfor problem-oriented training activities that areintegrated with public health programmes.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to support and promote thecollaborative programmes in nomenclatureand classification of medicines.> increase capacity to deliver training in drugutilization research in collaboration with otherinterested partiesOUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries using INNs in medicines registration na na na 108/131 82% 90%

WHO MEDICINES STRATEGY 2004-2007 | 90EO 5.3Pharmaceutical specifications andreference materials developedand maintained for use in qualitycontrol laboratories and publicationin the International PharmacopoeiaRationaleEvidence of increasing counterfeiting activityin pharmaceuticals in both developed anddeveloping countries has prompted widespreadconcern about the quality of pharmaceuticalproducts. Without detailed specifications thatare internationally applicable it is impossible toassess quality and make a judgement as to theintegrity of a substance or a product. WHO hasplayed a central role in developing and publishingspecifications to assist Member States in theirefforts to perform quality control testing forproducts in their markets.ProgressThe WHO Expert Committee on Specifications forPharmaceutical Preparations has endorsed a rangeof statements, guidelines, and recommendationswhich provide the tools for quality controltesting, new specifications for inclusion in theseries of Basic Tests series and the InternationalPharmacopoeia, as well as International ChemicalReference Standards for national regulatoryauthorities, manufacturers, and other interestedparties. The International Pharmacopoeia is usedin a large number of countries throughout theworld and plays a major role in defining thespecifications of pharmaceutical products. It alsoprovides a valuable tool in the quality assuranceof imported products.WHO has worked in collaboration with UNagencies and other international partners toestablish quality specifications for startingmaterials and finished products. A project wasinitiated involving the development of newinternational pharmacopoeial requirements,especially for priority drugs used in the treatmentof HIV/AIDS, TB, and malaria, for many ofwhich no public standards exist. In 2003, a set ofspecifications was published in the InternationalPharmacopoeia to enable testing to be carried outon all artemisinin derivatives (active substancesas well as finished dosage forms) used in thetreatment of malaria — the only pharmacopoeiato include this set of standards so far.

COMPONENTS OF THE STRATEGY | 91Challenges remainingThere is an urgent need to establish internationalquality specifications for new medicines forHIV/AIDS, TB, and malaria in order to assistprocurement by UN and other agencies for useon a wide scale in developing countries. This isa major undertaking involving many partners,including manufacturers, national and regionalpharmacopoeia commissions, and collaboratinglaboratories. At the same time, there is a needto assess whether the more stringent productspecifications resulting from the introduction bythe International Conference on Harmonization ofRequirements for Pharmaceuticals for Human Use(ICH) of certain quality guidelines will produceadditional public health benefits. In addition,there is a continuing need to complement andupdate existing quality specifications.Meeting the challenges 2004-2007Over the next four years WHO will:> produce quality control specifications andreference materials and appropriate adviceto national quality control laboratories,especially for new medicines for public healthpriority diseases such as ARVs for HIV/AIDS.> work closely with the WHO CollaboratingCentre for Chemical Reference Substancesin Sweden, and with other centres whichvalidate the methods and challenge thespecifications developed with products ontheir national market.> support closer collaboration betweenpharmacopoeias and national regulatoryauthorities to meet the challenge ofassuring the quality of medicines tradedinternationally.OUTCOME INDICATORS1999 2003 2007No. and types of pharmaceutical specifications andreference materials developed by WHO HQ#REPORTING % TARGET#REPORTING % TARGETna na 105 96 na 50

WHO MEDICINES STRATEGY 2004-2007 | 92EO 5.4Achieving balance between abuseprevention and appropriate accessto psychoactive substances throughenhancing the implementation ofrelevant guidelines to promoterational use of controlled medicinesRationaleWHO is mandated by the 1961 UN SingleConvention on Narcotic Drugs and the 1971UN Convention on Psychotropic Substancesto undertake medical and scientific reviewof psychoactive substances for internationalcontrol with a view to preventing abuse of thesesubstances. International drug control is a jointundertaking involving WHO, the United NationsCommission on Narcotic Drugs, InternationalNarcotic Control Board, and Member States. Inparallel with fighting the illicit use of narcotic andpsychotropic drugs, the goals of drug conventionsalso include ensuring the availability of andaccess to psychoactive substances for medicaluse. To achieve these two objectives, WHOpromotes the balanced drug control policy amongits Member States.ProgressSince 1949, through its Expert Committee onDrug Dependence, WHO has reviewed morethan 410 substances. Between 1948 (whenWHO was established) and 2003, the numberof narcotic drugs under international controlincreased from 18 to 118, and the number ofpsychotropic substances from 32 to 116. In orderto facilitate the review process, in 2000 WHOamended the Guidelines for the WHO Review ofDependence-Producing Psychoactive Substancesfor International Control. 46 The anticipatedadoption of these guidelines in 2004 will furtherclarify the review principle for psychotropicsubstances.Figure 22:Formula for new HIV/AIDS medicines: didanosineHNHOONHONNHdidanosineIn 2000, WHO issued a document on AchievingBalance in National Opioids Control Policy:Guidelines for Assessment 47 for use by MemberStates. WHO also assisted the United NationsInternational Drug Control Programme (UNDCP)in drafting guidelines for national regulationsconcerning travellers under treatment withinternationally controlled drugs. The guidelines,adopted by the 45 th session of the Commission onNarcotic Drugs in 2002, are intended to facilitateand enhance the security of patients who wish tocontinue their treatment while travelling. In 2002,WHO organized a workshop with the CentralEuropean countries in Hungary on improvingaccess to opioids for pain and palliative care inthe countries of Central and Eastern Europe.

COMPONENTS OF THE STRATEGY | 93Figure 23:Global distribution of consumption of morphine in 2001Source: Report of the International Narcotics Control Board for 2002 48Europe (12.2%) • 33%Japan (2.1%) • 6%Australia andNew Zealand (0.4%) • 5%Others (80%) • 5%Canada and the United States (5.3%) • 51%Note:Percentages in brackets refer to shares of the world’s population.Challenges remainingMany new chemical substances with psychoactiveproperties continue to be synthesized, distributed,and abused. These substances should be rapidlydetected, reviewed, and put under internationalcontrol, as necessary. However, overly restrictiveregulations in many countries on the distributionof psychoactive drugs, including narcotic painkillers, continue to limit their availability, resultingin the suffering of cancer patients and others dueto inadequately treated severe pain or untreatedmental disorders. As the International NarcoticsControl Board has highlighted, significantdifferences exist between countries in the extentto which narcotic drugs are used for the treatmentof pain — with their use in most developingcountries, in particular, at an extremely low level.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to support the Expert Committeeon Drug Dependence by providing clearguidance for the review process.> enhance cooperation with the UNDCP andthe International Narcotics Control Boardand other relevant organizations in collectinginformation on new psychoactive substancesthat could be abused.> continue to advocate and promote the rationaluse of controlled medicines, particularlyin developing countries, by facilitating theimplementation of relevant guidelines inMember States.OUTCOME INDICATORS1999 2003 2007No. of substances reviewed and recommended forclassification for international control#REPORTING % TARGET#REPORTING % TARGET2/3. 66% na 5/5. 100% 80%

WHO MEDICINES STRATEGY 2004-2007 | 94COMPONENT 6REGULATION AND QUALITY ASSURANCEOF MEDICINES

COMPONENTS OF THE STRATEGY | 95Work carried out by WHO in 2001 showed that counterfeit andsubstandard medicines continue to be a major concern globally. Specificproblems included the wrong level or absence of the active ingredient.In Cambodia, for example, 50% (115/230) of samples of 24 differentpharmaceutical products collected from the market were unregistered.Laboratory tests based on registration status showed that of 98 importedregistered products, 6 (6%) failed the laboratory test. Results of testson 112 imported but unregistered products showed that in 22% of thesamples the active ingredients were lower than the amount indicated bythe label. The overall failure rate for the total of 230 samples was 13%.Studies such as these serve as a starting point for formulating nationalstrategies for fighting counterfeit drugs.(Annual Report 2001 – Essential Drugs and Medicines Policy: Extending theEvidence Base, Geneva, WHO, 2002).The production and distribution of medicinesrequires public oversight and stewardship. Unlikeordinary goods and services, an unregulatedmedicines market place will fail: it will be notonly inequitable, but also inefficient and probablydangerous to public health. 49The three main components of stewardship in themedicines market are:> Product registration: assessing and authorizingproducts for market entry, based on quality,safety, and efficacy; and monitoring theirquality and safety after entry.> Regulation of manufacturing, importation, anddistribution.> Regulation of medicine information andpromotion.Most countries have a medicines regulatoryauthority and formal requirements for registeringmedicines. However, medicines regulatoryauthorities differ substantially in their humanand financial resources and capacity. One-thirdof WHO Member States have no medicinesregulatory authority, or at best very limitedcapacity for regulation of the pharmaceuticalmarket. Regulatory gaps are common, withthe informal sector for medicines supply oftenneglected.The quality of medicines varies greatly,particularly in low- and middle-income countriesWHO has been active in supporting countriesin their efforts to assure the quality of products,particularly in response to the increasingavailability of affordable HIV/AIDS medicines. InMarch 2001, WHO launched a project to developa system for the prequalification of manufacturersof ARVs, including both innovator and genericproducers. Working closely with the InternationalPharmaceutical Coordination group (IPC),comprising WHO, UNICEF, UNAIDS, UNFPA,and the World Bank, WHO established consensuson the product standards to be met by suppliers inorder to gain prequalification status, and on theneed to establish a list of prequalified HIV/AIDSmedicines and their suppliers. 50 The system hasnow been expanded to include a prequalificationprocess for TB and malaria medicines and theirsuppliers.Other elements in a comprehensive programme topromote access to quality medicines for HIV/AIDSand other priority health problems have included:

WHO MEDICINES STRATEGY 2004-2007 | 96the creation of a WHO Model Quality AssuranceSystem for procurement; feedback to regulatorson information collected during assessmentsof ARVs, to increase their capacity to ensurethe quality of ARVs on their national market;and regional workshops for drug regulators onregistration of generic ARVs. 51In the light of the proposed expansion of ICH intopharmacovigilance, it is a challenge for WHO to:> strengthen links with ICH to avoidunnecessary duplication> become more active in developing guidelineson pharmacovigilance> disseminate its reports and data more widely> raise awareness of its work by encouragingall Member States to participate in the WHOProgramme for International Drug Monitoring.Currently, WHO attends meetings of the ICHSteering Committee and the Global CooperationGroup with observer status; these roles areimportant and should be maintained. However,appropriate strategies for consultation andcommunication with Member States need to bedeveloped to ensure that WHO is not seen as defacto automatically endorsing ICH products, butas providing advice on the potential impact ofthose products on non-ICH Member States.WHO will contribute to thequality, safety and efficacyof all medicines assured bystrengthening and putting intopractice regulatory and qualityassurance standards

COMPONENTS OF THE STRATEGY | 97EO 6.1Medicines regulation effectivelyimplemented and monitored asthe capacity of staff is increasedthrough training activities resultingin better knowledge, organization,financing, and managementRationaleProblems related to the safety and quality ofmedicines exist in many countries throughoutthe world, developing and developed countriesalike. However, the magnitude of the problem ismuch greater in developing countries, where poorquality medicines may be the only ones to reachthe poor. Some incidents have resulted in deaths,with children often the victims. They involve theuse of medicine containing toxic substances orimpurities, medicines whose claims have not beenverified, medicines with unknown and severeadverse reactions, substandard preparations, oroutright fake and counterfeit medicines. Effectivemedicine regulation is required to ensure thesafety, efficacy, and quality of medicines availablein both the public and private sectors, as well asthe accuracy and appropriateness of medicineinformation available to health professionals andthe public.ProgressWHO has provided technical and administrativesupport to countries, including the development,publication, and dissemination of varioustools ( standards, norms, guidelines, training,and software packages) and guidance toassist in the establishment or strengthening ofnational regulatory authorities as well as theimplementation of regulatory activities.In 2002, WHO published the results of a multicountrystudy which identified some of theproblems encountered by countries in promotingeffective drug regulation. The report also providedsimple conceptual frameworks for medicineregulation, for use by policy-makers as a basis fordesigning medicine regulatory systems, as well assuggested strategies for improving drug regulationperformance. In addition, the report outlinedkey features of medicine regulatory systems indifferent countries, highlighting best practices andthe lessons to be learned. 52Challenges remainingDespite the support provided by WHO andother international organizations and donorcountries to strengthen medicine regulation,in many developing countries there remains ahuge capacity gap among national regulatoryauthorities that needs to be addressed.Meeting the challenges 2004-2007Over the next four years WHO will:> in collaboration with other partners, carryout an assessment of national medicineregulatory authorities to monitor progress,identify weaknesses, and develop strategiesin consultation with national authorities toimprove medicine regulation.> facilitate training courses in the different areasof medicine regulation and provide tools andtechnical advice as needed.OUTCOME INDICATORS1999 2003 2007No. of countries implementing basic medicines regulatoryfunctions#REPORTING % TARGET#REPORTING % TARGET70/138 51% 56% 90/130 69% 74%

WHO MEDICINES STRATEGY 2004-2007 | 98EO 6.2Information management andexchange systems promoted andmade accessible through shareddatabases. Basic regulatoryinformation shared among nationalregulatory authorities and madeavailable to the general publicRationaleWhile the world is undergoing a revolution inaccess to information, almost to the point ofoverload, access to independent informationon the safety and efficacy of medicines remainslimited. Although the information exists andis available from many sources, access isconstrained either by lack of technology orby lack of understanding about how to accessit. WHO recognizes the need to establish asystem for regular exchange of information onpharmaceutical products between regulatoryauthorities in less-developed countries whichoften lack the capacity and tools to obtaininformation that is up to date. WHO alsorecognizes the need for regulatory authorities toprovide unbiased information to prescribers.ProgressEfforts by WHO to strengthen the InformationExchange system have included: the formaldesignation of National Information Officerswithin the national regulatory authoritiesin Member States; active support of drugsurveillance activities by the WHO CollaboratingCentre for International Drug Monitoringin Sweden; continued sponsorship of thebiennial International Conferences of DrugRegulatory Authorities; regular publicationsof regulatory and drug safety informationin the WHO Pharmaceuticals Newsletter,WHO Drug Information, and WHO RestrictedPharmaceuticals List updates; and ad hocpublications of Drug Alerts for the rapiddissemination of urgent safety information toMember States.In order to address the need for unbiasedinformation, a multi-country study was setup to document the variability of prescribinginformation from different sources concerningindications, side effects, and warnings about thepossible adverse effects of selected drugs. Theresults show substantial differences between thematerials available to prescribers and patients indifferent countries. Differences were even foundwithin a single country when written materialsfrom different brands of the same drug werecompared. 53

COMPONENTS OF THE STRATEGY | 99Challenges remainingWhile the WHO Information Exchange Systemcontinues to build on regular and active inputfrom the more developed Member States, manyof the less developed countries do not have thecapacity, resources, training, infrastructure oreven a mandate to contribute equally. Developingcountries should be encouraged to become morefully and actively involved in order to makethis exchange more useful, relevant, and multidimensional.In addition, the network of National InformationOfficers and the expansion of electronicexchange of information needs to be considerablystrengthened and put into action to ensure closeliaison between Member States and WHO for alldrug safety and regulatory information.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to facilitate the development andexchange of information on the safety andefficacy of medicines by: raising nationalawareness and creating political commitmentfor good regulatory practices; fosteringcollaborations and partnerships betweengovernments and the pharmaceuticalindustry, health professionals, curricula andprofessional associations; supporting trainingprogrammes for capacity building; andproviding technical assistance to regulatoryauthorities.OUTCOME INDICATORS1999 2003 2007No. of countries with a computerized medicinesregistration system#REPORTING % TARGET#REPORTING % TARGETna na na 72/135 53% 60%

WHO MEDICINES STRATEGY 2004-2007 | 100EO 6.3Good practices in medicineregulation and quality assurancesystems to ensure that qualityis maintained in clinical trials,production, supply and distribution,and post-marketing surveillanceRationaleEssential tools (standards, norms, guidelines)and guidance for good regulatory and qualityassurance practices are widely available,but need to be constantly updated. Somegood practice guidelines, such as GMP andGood Clinical Practice (GCP) guidelines, arenormative documents. Others, like GoodRegulatory Practices, may be of more generalnature and oriented to improving the overallperformance of medicines regulatory agencies.Proper implementation of these regulatory andquality assurance tools according to locallyestablished standard operating procedures isessential as a quality management step for properimplementation of regulation, and to ensurethat the medicines used are safe, effective, andof good quality. The success of regulation isdependent not only on the regulators but alsoon the full compliance of those being regulated(manufacturers and distributors).ProgressAdditional guidelines and tools have beendeveloped, such as new GMP training modulesfor validation, water, heating, ventilation, andair conditioning systems. An external qualityassurance assessment scheme for national andregional quality control laboratories has beencontinued in all six WHO regions, involving 36laboratories. In addition, WHO has developed atool for reviewing national medicine regulatorycapacity, including implementation of GMPguidelines. The review is designed to help bothWHO and the concerned national authoritiesto identify priority areas for capacity building,technical advice, and support. This collaborativework has enabled assessments to be carriedout in a number of countries in order to identifyweaknesses in national regulatory authoritiesand action needed to strengthen capacity.The experience accumulated through thiscollaborative work has helped further refine thedata collection tools and the methodology of thereviews.

COMPONENTS OF THE STRATEGY | 101ChallengesThree types of common imbalance have beenidentified in regulatory practice:> much more time is assigned to premarketingassessment than to post-marketingsurveillance> while product registration is considered amajor responsibility by all the drug regulatoryauthorities, the regulation of drug distributionchannels and information does not enjoy thesame level of attention> in many countries, GMP inspection receivesmore attention and resources than inspectionof distribution channels. 54Meeting the challenges 2004-2007Over the next four years WHO will:> promote implementation of good practice byproviding necessary guidelines, tools, andtechnical assistance> continue to help Member States to assessregulatory capacity and improve regulatoryperformance by capacity building> continue to pursue the external qualityassessment scheme for medicines controllaboratories in all six WHO regions.The quality of products in the market is at riskif regulators and those being regulated fail toapply and monitor principles of good practice inproduction, supply and distribution of medicines,and post-marketing surveillance.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries with basic quality assurance procedures 95/122 78% 80% 111/137 81% 85%

WHO MEDICINES STRATEGY 2004-2007 | 102EO 6.4Post-marketing surveillance ofmedicines safety maintained andstrengthened through the ongoingdevelopment of pharmacovigilancecentres and their involvement ininternational adverse drug reactionmonitoring systemsFigure 24: WHO Programme for InternationalDrug MonitoringWHOHQ>>>>WHOCOLLABORATINGCENTREUPPSALARationaleNATIONALCENTRES>The aims of pharmacovigilance are to promotepatient care and patient safety in relation to theuse of medicines, especially with regard to theprevention of unintended harm from the use ofmedicines; to improve public health and safetyin relation to the use of medicines through theprovision of reliable, balanced informationresulting in more rational use of medicines; andto contribute to the assessment of the risk-benefitprofile of medicines, thus encouraging safer andmore effective use of medicines. Through effortsto promote pharmacovigilance WHO seeks toensure that all medicines in all Member States aresubject to monitoring for adverse reactions.ProgressThe WHO Programme for International DrugMonitoring is comprised of three parts, eachof which is integrally linked and has a role inadverse drug reaction monitoring.The Programme has issued several guidelines onadverse drug reaction monitoring in the Safetyof Medicines series. These include: Guidelinesfor setting up and running a PharmacovigilanceCentre; The Importance of Pharmacovigilance;and A guide to detecting and reporting adversedrug reactions. The Programme has also runtraining courses on pharmacovigilance, includinga course in 2003 held jointly with Roll BackMalaria to monitor the introduction of newantimalarials in five African countries. TheProgramme network has expanded to include 72countries and the global database has increasedto over 3 million reports of adverse events fromthe participating countries.

COMPONENTS OF THE STRATEGY | 103Challenges remainingThe biggest challenge in adverse drug reactionmonitoring is under-reporting by healthprofessionals. There is an urgent need to raiseawareness among all interested parties of theimportance of monitoring medicines. Morecountries need to establish the process elementsof an Adverse Drug Reaction Centre (ADR)and consequent involvement in internationalmonitoring. The established ADR centres needto improve reporting, both qualitatively andquantitively. The scope of pharmacovigilancecontinues to broaden as the array of medicinalproducts grows. It includes the use of herbal andtraditional medicines, blood products, biologicals,and vaccines. A more recent and urgent challengehas arisen with the launch by WHO of the ‘3 by5’ initiative aimed at providing ARVs for 3 millionpeople by 2005. These new drugs are beingintroduced into populations where there is littleinfrastructure to monitor their use.Meeting the challenges 2004-2007Over the next four years WHO will:> promote pharmacovigilance through activitiesand Annual Meetings of the National Centresparticipating in the International DrugMonitoring Programme.> collaborate with existing pharmacovigilancecentres for capacity building in countriescurrently not included in the Programme.> maintain normative activities, including theannual meetings of the Advisory Committeeon the Safety of Medicinal Products and theproduction of guidelines in the Safety ofMedicines series. Forthcoming publicationsinclude: Pharmacovigilance and PublicHealth and the Safety Monitoring of Herbalmedicines.> increase efforts to provide training inpharmacovigilance.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries monitoring adverse drug reactions 56/191 29% 35% 72/192 38% 45%

WHO MEDICINES STRATEGY 2004-2007 | 104EO 6.5Use of substandard and counterfeitmedicines reduced as a result ofthe development and applicationof effective strategies to detectthe existence and combat theproduction and circulation of suchproductsRationaleGovernments have to regulate the manufacture,import, export, distribution, and supply ofmedicines in order to ensure that the productsused are safe, effective, of good quality, andrationally used. To achieve this, governmentshave to establish strong national regulatoryauthorities with adequate human, financial andother resources, and an adequate legal basis.The regulatory authorities effectively controlthe market through measures such as theestablishment of a mandatory licensing system forcompanies and products; inspection of premises;and post-marketing surveillance activities. Itis estimated that about 30% of WHO MemberStates, most of them low-income countries, haveeither no national regulatory system or one that isnot functioning well. As result, in many of thesecountries 20%-30% of samples collected frommarkets fail quality tests. The use of substandardor counterfeit medicines may cause damage tohealth, treatment failure or death, and in thelong term lead to the waste of scarce resources.Moreover, treatment with ineffective medicinessuch as antibiotics leads to the emergence ofantimicrobial resistance, which may effecta wide section of the population. Efforts tostrengthen medicine regulation will help improveimplementation of regulatory requirements andstandards by manufacturers and distributors andthereby contribute to the reduction of substandardand counterfeit medicines.ProgressWHO develops and distributes standards,norms, and guidelines to Member States to helpthem regulate the manufacture, importation,and distribution of medicines. WHO has alsoprovided guidance, technical assistance, andtraining to medicine regulatory authoritiesto help build national regulatory and qualityassurance capacity. More specifically, in thearea of counterfeit medicines, WHO hasdeveloped guidelines for combating counterfeitmedicines, organized intercountry, regional, andinternational workshops and training courses,and has undertaken advocacy activities to makegovernment decision-makers and the publicaware of the problem of counterfeit medicines. Inthe Greater Mekong Subregion (GMS) countries(Cambodia, China, Lao PDR, Myanmar, Thailand,and Viet Nam) WHO recently launched a specialprogramme to combat counterfeit medicines.WHO has also supported post-marketing qualityassessment activities in a number of countries togather information on the quality of products.

COMPONENTS OF THE STRATEGY | 105Challenges remainingIntensified advocacy is needed to gain thepolitical commitment and support of governmentsfor strong national medicine regulatoryauthorities. Governments will need to assesshow their regulatory authorities perform, identifyweaknesses, and develop strategies to helpcombat substandard and counterfeit medicines.New ways of ensuring international cooperationare needed to fight increasing cross-bordermovement of counterfeit medicines.Meeting the challenges 2004-2007Over the next four years WHO will:> work with national medicines regulatoryauthorities to promote awareness of theproblem among government decisionmakersand the public in order to strengthengovernment and public support andcommitment.> provide tools and technical advice tocountries to carry out post-marketingsurveillance activities based on riskmanagementprinciples.> assist countries to foster cooperation betweennational regulatory authorities and othernational law enforcement agencies andother stakeholders in combating counterfeitmedicines and improving exchange ofinformation.OUTCOME INDICATORS1999 2003 2007No. of countries with >10% of tested medicines failingquality tests#REPORTING % TARGET#REPORTING % TARGETna na na 20/71 28% 25%

WHO MEDICINES STRATEGY 2004-2007 | 106EO 6.6Prequalification (initial assessment,ongoing monitoring andprequalification) of products andmanufacturers of medicines forpriority diseases and of qualitycontrol laboratories, as appropriate,through procedures and guidelinesappropriate for this activityThis expected outcome comprises three activities:> finalization of the Model Quality AssuranceSystem.> prequalification of products andmanufacturers for products used in thetreatment of HIV/AIDS, TB, and malaria.> prequalification of quality control laboratories.1 Finalization of the Model QualityAssurance SystemRationaleThe objective is to finalize a model, based onnorms and standards for procurement agencies,that will ensure that all UN partners follow thesame process and procedure in procurementactivities, meeting international standards. Thisincludes good practices for prequalification,purchasing, storage, and distribution.ProgressThe third draft of the Model Quality AssuranceSystem is in the final stages and was discussed ata meeting of the IPC in New York in November2003, involving UN procurement organizationsand NGOs.Challengesor resources needed to implement qualitysystems for prequalification of productsand manufacturers, purchasing, storage,and distribution that meet internationalrecommendations. The challenge will beto harmonize the process and procedurein procurement activities amongst theseorganizations as well as to target the level atwhich the minimum standards should be set forthe Model Quality Assurance System.2 Prequalification of products andmanufacturers for products used inthe treatment of HIV/AIDS, TB, andmalariaRationaleThe prequalification of products andmanufacturers aims to assess product data andinformation as well as manufacturing sites, toestablish whether these meet internationallyrecommended norms and standards establishedby WHO. The objective is to ensure that onlyproducts meeting acceptable quality standardswill be procured. Purchasing or sourcing ofproducts that have not been prequalified frommanufacturers that are not prequalified mayresult in the supply of substandard or counterfeitproducts, or of products that do not meetspecifications, norms, and standards in relation tosafety, efficacy or quality — with obvious risks forthe patient.ProgressFollowing the launch by WHO of theprequalification project, over 400 product dossiershave been assessed and several manufacturingsites have been inspected. To date, more than 50products (including both innovator and genericproducts) have been found to meet the WHOnorms and standards. These are included in a listof prequalified products and manufacturers.Many organizations do not have the infrastructure

COMPONENTS OF THE STRATEGY | 107Challenges remainingSeveral substances and products are not includedin pharmacopoeia monographs. Some substanceshave specific properties which make assessmentmore difficult (e.g. chirality). Not all productscan be considered either innovator or genericproducts. The number of manufacturers of ActivePharmaceutical Ingredients (APIs) and finishedproducts such as those used in the treatment ofmultidrug-resistant TB are limited. The number ofmanufacturers of APIs and finished products suchas artemisinin and its derivatives, as well as theartemisinin combination therapy (ACT) products,are limited. In addition, some manufacturers donot have the resources to improve compliancewith GMP. Not all manufacturers have generatedall the required data to prove safety, efficacy, andquality of their products. More time is needed tomeet the target of prequalifying a certain numberof products and manufacturers.3 Prequalification of quality controllaboratoriesRationaleInterested quality control laboratories will beassessed as part of a prequalification procedure.The assessment should indicate whether theselaboratories meet international standards asdefined by WHO in GMP and Good Practice forPharmaceutical Control Laboratories. The resultsof analysis of products obtained from laboratoriesnot meeting international standards may beinaccurate.ProgressWHO has established norms and standards forquality control laboratories. A procedure for theprequalification of laboratories has already beendeveloped.Challenges remainingThere is a need to encourage laboratories toparticipate in the prequalification processand establish whether these laboratories havethe capability to perform analysis of complexproducts.Meeting the challenges 2004-2007Over the next four years WHO will:> establish the Model Quality AssuranceSystem through negotiation and discussion,targeting it at a level that meets minimumrequirements for norms and standards, toallow procurement organizations to establishand implement a quality control system.> improve awareness of the requirements,norms, and standards through the assessmentand appropriate training of regulators andindustry, resulting in improved regulatorycontrol of products.> assess quality control laboratories forcompliance with international standards aspart of the prequalification project.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of products assessed and approved na na na 93 na na

WHO MEDICINES STRATEGY 2004-2007 | 108EO 6.7Safety of new priority andneglected medicines enhancedthrough training workshops andincreased capacity to assess safetyissuesRationaleWith all newly registered products there is limitedexperience of large-scale operational use or ofthe safety of these medicines when used amongspecial population groups, such as infants,pregnant women, and people suffering frommalnutrition or HIV/AIDS. This is a particularproblem for new medicines for priority andneglected diseases since these are normallyintroduced with some urgency and there is aneed to ensure that this is done within acceptablestandards of safety assessment. The urgency ofthis problem is exemplified by current efforts toprovide ARVs to 3 million people by 2005 — foruse in settings which differ from those where mostof the safety studies have been carried out.ProgressA training course on pharmacovigilancewas held in Zambia in 2002, involving fiveAfrican countries which are introducing ACTfor malaria in response to increasing levels ofresistance to antimalarials (Burundi, DemocraticRepublic of Congo, Mozambique, Zambia,and Zanzibar). The course focused on basicmethods and skills for drug safety monitoring,with the aim of introducing a common system ofpharmacovigilance of new antimalarial treatmentsin each country, with access to the WHOdatabase and to international expertise. Similarcourses are planned for other diseases includingHIV/AIDS.Challenges remainingA major challenge is the need to ensure theintegration of this work throughout WHOprogrammes. The Programme to EliminateLymphatic Filariasis, for example, has introduceda system for monitoring adverse effects of thedrugs used in mass populations. Other diseaseprogrammes need to be aware of the needfor high-level coordination of these efforts.Meanwhile, as efforts get under way to scale upaccess to ARVs in developing countries, there isa need to develop plans for pilot programmesto monitor the safety of these medicines amonggroups suffering from malnutrition or affected bymore than one disease. Partnerships with otherorganizations are needed to strengthen WHO’swork in this critical area.Meeting the challenges 2004-2007Over the next four years WHO will:> increase efforts to provide training courses forpharmacovigilance in the area of neglecteddiseases and continue to raise awareness ofthis problem.> support national initiatives to conduct postmarketingsurveillance of medicines such asARVs and antimalarials.> train regulators and health care professionalsin safety monitoring, with a special focus onnew combination medicines for HIV/AIDS,TB, and malaria, and other priority publichealth diseases.OUTCOME INDICATORS1999 2003 2007No. of countries participating in training programmesfor introducing new therapies for priority and neglecteddiseases, e.g. malaria and AIDS#REPORTING % TARGET#REPORTING % TARGET0 na na 7 na 20

COMPONENTS OF THE STRATEGY | 109EO 6.8Regulatory harmonizationmonitored and promoted asappropriate, and networkinginitiatives developed, to facilitateand improve regulatory processes incountriesRationaleHarmonization of technical requirements forregistration of medicines can contribute to publichealth by improving access to safe, effective, andgood-quality pharmaceutical products. It can alsofacilitate the development of fair and transparentregulatory processes, improve internationalcollaboration, reduce duplication of work bydifferent regulatory agencies, and facilitate tradeand competition. The harmonization initiatives,whether regional or sub-regional, are ongoingin all WHO regions. The major focus of manyof those initiatives is to first harmonize basicregulatory requirements for generic medicines.The ICH, an initiative started by Europe, Japan,and the United States in 1990, has been focusingon establishing harmonized requirements toevaluate the quality, safety, and efficacy of newinnovative drugs, thereby avoiding the necessityto duplicate many time-consuming and expensivetest procedures. As a result, the time spent onregulatory approval of new drugs has beenshortening, and marketing of these products takesplace internationally with minimal delay for thepatients. By 2003, the ICH regions have largelyharmonized regulatory requirements for thequality, safety, and efficacy of new drugs.have finalized their regulatory harmonizationand are expected to join the European Unionin 2004. In the Americas, the Pan-AmericanNetwork for Drug Regulatory Harmonizationhas made considerable progress since its firstSteering Committee meeting in 2000 in PuertoRico. Other WHO-supported initiatives includethe ASEAN Pharmaceutical Harmonizationand harmonization amongst Southern AfricanDevelopment Community (SADC) countries.The non-ICH harmonization initiatives areemphasizing the importance of training ofregulators as an important vehicle to driveharmonization forward.Challenges remainingThe huge gaps in existing regulatory capacitiesare hindering harmonization. Progress has beenslowed by limited resources and lack of politicalwill. The regulatory approval of generic drugswhich are more affordable for patients remainslargely unharmonized, paradoxically more soin countries where health care systems relyheavily on the use of generic drugs. Regulatoryassessment of products by national authorities,especially in the case of new medicines, oftengives limited added value to the work alreadydone by other regulatory authorities. The potentialfor financial savings through mutual recognitionof regulatory assessments remains underestimated.There is also a tendency to adopt sophisticatedtechnical requirements before basic measureshave been put in place to protect public healthand ensure the quality (e.g. basic registrationrequirements, GMP, and supply chain inspection)of medicines.ProgressWHO/EURO actively supported the establishmentof the Collaboration Agreement of DrugRegulatory Authorities in European UnionAssociated Countries (CADREAC), which hasmade rapid progress since its first Annual Meetingin Sofia in 1997. Ten CADREAC countries

WHO MEDICINES STRATEGY 2004-2007 | 110Figure 25:Harmonization activities supported by WHO*••• •*•ASEAN (Association of South East Asian Nations:Brunei, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Thailand, Singapore, VietnamICH (International Conference on Harmonization of Technical Requirements for the Registration of PharmaceuticalsHuman Use): European Union, Japan, USAMERCOSUR (created in 1991 with the signing of the Treaty of Asuncion):Argentina, Brazil, Paraguay, UruguayPANDRA (Pan American Network for Drug Regulatory Harmonization)All the countries of the AmericasSADC (Southern African Development Community): Angola, Botswana, Congo Demoractic Republic, Lesotho, Malawi,Mauritius, Namibia, Mozambique, South Africa, Swaziland, Seychelles, Tanzania, Zambia, ZimbabweUEMOA (Monitory and Economic Union of West Africa)Benin, Burkina Faso, Côte d’Ivoire, Guinea Bissau, Maili, Niger, Senegal, TogoMeeting the challenges 2004-2007Over the next four years WHO will:> continue to promote and monitor networkingand harmonization efforts both regionally andinternationally.> continue to provide technical assistance topromising harmonization initiatives.> increase its capacity to deliver technicalassistance through increased collaboration,partnerships, and alliances with othertechnical organizations such as thePharmaceutical Inspection Co-operationScheme.> continue its observer and/or facilitator rolein international groups on harmonization,including ICH, to ensure that the viewsand needs of all countries are properlyrepresented.OUTCOME INDICATORS1999 2003 2007No. of countries participating in harmonization initiativessupported financially and technically by WHO#REPORTING % TARGET#REPORTING % TARGETna na na 15/191 8% 18%

COMPONENTS OF THE STRATEGY | 111Definition of rational use of medicines“Patients receive medications appropriateto their clinical needs, in doses that meettheir own individual requirements, foran adequate period of time, and at thelowest cost to them and their community.”(WHO, 1985).COMPONENT 7USING MEDICINES RATIONALLY

WHO MEDICINES STRATEGY 2004-2007 | 112WHO advocates 12 keyinterventions to promote morerational use:1 Establishment of amultidisciplinary national body tocoordinate policies on medicineuse2 Use of clinical guidelines3 Development and use of nationalessential medicines listIrrational use of medicines is a major problemworldwide. WHO estimates that more than halfof all medicines are prescribed, dispensed or soldinappropriately, and that half of all patients failto take them correctly. The overuse, underuse ormisuse of medicines results in wastage of scarceresources and widespread health hazards.Examples of irrational use of medicines include:> use of too many medicines per patient (‘polypharmacy’)> inappropriate use of antimicrobials, oftenin inadequate dosage, for non-bacterialinfections> over-use of injections when oral formulationswould be more appropriate> failure to prescribe in accordance withclinical guidelines> inappropriate self-medication, often ofprescription-only medicines> non-adherence to dosing regimes.4 Establishment of drug andtherapeutics committees in districtsand hospitals5 Inclusion of problem-basedpharmacotherapy training inundergraduate curricula6 Continuing in-service medicaleducation as a licensurerequirement7 Supervision, audit and feedback8 Use of independent information onmedicines9 Public education about medicines10 Avoidance of perverse financialincentives11 Use of appropriate and enforcedregulation12 Sufficient government expenditureto ensure availability of medicinesand staff.

COMPONENTS OF THE STRATEGY | 113WHO Model FormularyCountries at all levels of development – nearly160 countries in total – have used criteriaincluding safety, efficacy, quality and publichealth value to produce selective national,provincial and state lists of essential medicinesand vaccines. These have become the basis fortraining, reimbursement, public education, andother public health priorities. 55WHO has itself applied evidence-basedtechniques to develop the most recent Model Listof Essential Medicines 56 and the WHO ModelFormulary, which reflects the contents of WHOrecommendedtreatment guidelines.WHO will work to ensurethat medicines are used ina therapeutically sound andcost-effective way by healthprofessionals and consumers inorder to maximize the potentialof medicines in the provision ofhealth care

WHO MEDICINES STRATEGY 2004-2007 | 114EO 7.1Rational use of medicines byhealth professionals and consumersadvocatedRationaleDecisions about the use of medicines arestrongly influenced by health professionalsand consumers. However, it is these twogroups which can be the most reluctant toimplement policies about rational use. Forhealth professionals and prescribers, rationaluse will often conflict with peer pressure and/orcommercial interests. For consumers, especiallywhere the treatment is free of charge or in theevent of serious illness, there is a natural demandto have the ‘latest’ treatment (on the assumptionthat this equates to ‘best’) regardless of cost. Bothof these groups are influenced by the marketingand promotional activities of product patentholders. Despite the scientific logic of rationaluse training and guidance material, such astreatment protocols, there is strong resistance totheir application.ProgressThere has been a major increase in the volumeof information in support of rational use, togetherwith increasing use of objective scientificevidence to formulate protocols and policiesat international and country levels. The rapidexpansion of movements such as the CochraneFoundation has made vital information readilyavailable. WHO has contributed to this processover the past 20 years through demonstratingthe value of evidence-based action. The EssentialDrug Monitor, a twice-yearly publication witha 40 000 print-run issued in five languages, isa major channel for advocacy among healthprofessionals and policy-makers. Some of thethemes covered have included prescribing skills,improving drug use, drug donations, networkingfor action, managing drug supply, access,antimicrobial resistance, medicines promotion,and 25 years of the essential medicines concept.Other networks concerned with promotingrational use of medicines have also beensupported, including INRUD, INDIA-DRUG (anemail discussion group) and the InternationalSociety for Drug Bulletins. In 2003, in response tothe increasing problem of patient failure to adhereto therapy for chronic diseases, WHO published areview of the evidence for action. 57Challenges remainingThere is a need to engage some of the majorplayers — manufacturers, prescribers, andproviders and consumers of medicines — onthe importance of ensuring the rational use ofmedicines. The challenge is to find ways andmeans to translate the logic of the existing rationaluse messages and practice into convinced actionby the majority of practitioners and consumers.Although intervention research during the pastdecade has helped identify strategies andinterventions that are effective in promotingrational use of medicines, many of these strategieshave not been taken on board by governments.In many countries today, more than half of allpatients are not treated in accordance withclinical guidelines (WHO/EDM rational drug usedatabase, 2003).

COMPONENTS OF THE STRATEGY | 115Meeting the challenges 2004-2007Over the next four years WHO will:> adapt and distribute materials to countries andpromote the use of training and networkingwith consumer groups and professionalsocieties. While some activities willstrengthen the existing training courses, otherswill involve the more effective use of theInternet to disseminate information.> broaden the scope of rational use activitiesto include chronic diseases such as HIV/AIDS, particularly on the issue of treatmentadherence.> launch a coordinated plan of activity atcountry, regional, and headquarter levels, toensure that participants in all training coursesare followed up more closely at country level.> conduct a readership survey and evaluationof the Essential Drugs Monitor and makechanges where necessary to increasecirculation.OUTCOME INDICATORS1999 2003 2007No. of countries where the promotion of the rational use ofmedicines is coordinated at the national government level#REPORTING % TARGET#REPORTING % TARGETna na na 93/127 73% 75%

WHO MEDICINES STRATEGY 2004-2007 | 116EO 7.2Essential medicines list, clinicalguidelines, and formulary processdeveloped and promotedRationaleThe selection of a list of medicines, based on anumber of criteria including disease pattern andrecommended treatments, is the foundation of theessential medicines concept 58 . Clinical guidelinesindicate the most cost-effective therapeuticapproach, on the basis of valid clinical evidence.Their impact is greatest if the end-users,prescribers and, to a certain extent, patients areclosely involved in developing the guidelines.Formularies are commonly publications thatcombine the list of medicines with conciseguidance on their safe and rational use. Evidencefrom practice and research has demonstrated thatthe most cost-effective use of medicines may vary— depending on factors such as local marketprices, availability, and distribution costs — andthere is a need to support countries in developingor updating their rational use publications.ProgressThe WHO Model List of Essential Medicineshas been regularly revised and proved tobe a valuable tool over the past 25 years,complemented and enhanced by the publicationin 2002 of the WHO Model Formulary 59 .Collaboration within WHO has resulted in aformulary that incorporates updates in treatmentprotocols from the disease-specific departments inWHO. Access is available via the WHO EssentialMedicines Library on the WHO website 60 .The Library links essential medicines to WHOtreatment guidelines, the Model Formulary, priceinformation, pharmacopoeal monographs, andother WHO sites including information on adversedrug reactions and the ATC/DDD classification(Figure 24). There are now 135 countries withnational standard treatment guidelines and 156countries with national essential medicines lists,of which about 75% have been updated withinthe last five years.Figure 26: The WHO Essential Medicines Library (http://mednet3.who.int/eml/)Clinical guidelineSummary of Clinical GuidelineEvidence:Reasons for inclusionSystematic reviewsKey referencesWHOMODELLISTWHO Model FormularyCost:per unitper treatmentper monthper case preventedQuality information:Basic quality testsInternational PharmacopoeiaReference standards

COMPONENTS OF THE STRATEGY | 117Figure 27: Relation between treatment guidelinesand a list of essential medicinesList of common diseases and complaintsChallenges remainingThere is a continuing need within WHO forsystematic evidence-based approaches to theproduction of authoritative treatment guidelinesto assist countries and to form the basis of theModel List (Figure: 27). National formularies,lists of medicines that are reimbursable (“positivelists”), and treatment guidelines exist but are onlyoccasionally evidence-based, rarely updated,and often ignored. The challenge is to providetechnical assistance to countries to improve theirtechniques of selection and to develop or updatetheir rational use materials.Treatment choiceTreatment guidelinesTreatment TrainingSupervisionMeeting the challenges 2004-2007Over the next four years WHO will:List of essential drugsNational formularySupply of drugs> provide technical support to countries torevise their national formulary and positivelist development, using an evidence-basedapproach.> strengthen the process of developingevidence-based clinical guidelines withinWHO for use by WHO and other UNagencies (UNICEF, UNFPA, UNHCR).OUTCOME INDICATORS1999 2003 2007No. of countries with national list of essential medicinesupdated within the last 5 yearsNo. of countries with treatment guidelines updated withinthe last 5 years#REPORTING % TARGET#REPORTING % TARGET129/175 74% 75% 82/114 72% 75%60/90 67% 70% 47/76 62% 65%

WHO MEDICINES STRATEGY 2004-2007 | 118EO 7.3Independent and reliablemedicines information identified,disseminated, and promotedRationaleProgressReliable, objective, and evidence-basedThe major advance in this area has been theinformation is the foundation of rationalproduction of the WHO Model Formulary andmedicines use. With the development ofthe WHO Medicines Library (see also EO 7.2). Inspecialized networks and websites, access to such addition, a manual on the production of Nationalinformation is readily available in most parts of or Institutional Formularies based on the WHOthe world where there is access to the Internet. Model Formulary will be released in 2004.However, this still leaves many countries without This manual will be issued as a CD-ROM, alsoaccess to independent and reliable medicinescontaining the WHO Model Formulary.information. In a global survey carried out in1999, only 50% of 138 reporting countries hadDrug Information Centres. The regional rangewas 40%-89%. The lack of independent andreliable medicines information in many countriesis compounded by the pharmaceutical industry’sinvestment in marketing activities, includingdirect-to-consumer advertising. In the USA, forexample, the pharmaceutical industry spentabout US$ 15 billion on promotional activities in2000. 61

COMPONENTS OF THE STRATEGY | 119Challenges remainingInformation available to professionals andconsumers is frequently provided by themanufacturers or suppliers of medicines, bothof which have a commercial interest, ratherthan from independent sources with a consumerinterest. The imbalance in funding for suchactivities means that it is difficult for prescribers toobtain comparative unbiased information.Meeting the challenges 2004-2007Over the next four years WHO will:> provide technical support to strengthennational capacity to develop and disseminatemedicines information.> support national efforts to produce nationalor institutional formularies and national druginformation bulletins.> work with the International Society of DrugBulletins to produce a manual for use atnational level in the production of DrugInformation Bulletins.OUTCOME INDICATORS1999 2003 2007No. of countries with a national medicines informationcentre able to provide independent information onmedicines to prescribers and/or dispensersNo. of countries with a medicines information centre /service accessible to consumers#REPORTING % TARGET#REPORTING % TARGET62/123 50% 59% 53/129 41% 50%na na na 45/127 35% 40%

WHO MEDICINES STRATEGY 2004-2007 | 120EO 7.4Responsible ethical medicinespromotion for health professionalsand consumers encouragedRationaleThe rational use of medicines has often beenundermined by the unethical marketing ofmedicinal products through advertising or theactivities of medical representatives. The Reportby WHO’s Director-General to the 49th WorldHealth Assembly highlights the continued“imbalance between commercially produceddrug information and independent, comparative,scientifically validated and up-to-date informationon drugs for prescribers, dispensers, andconsumers.”Drug companies spend large amounts of moneyon promoting their products to doctors aroundthe world. In the United States, the industryspent over US$13.2 billion in 2000, whileUS$1.1 billion was spent in Italy in 1998. In thedeveloping world, promotion accounts for 20%-30% of sales revenue. There are currently over80 000 sales representatives in the United States,where the industry sponsored some 314 000physician events in 2005. Meanwhile, growth inspending on direct-to-consumer advertising ofprescription drugs, which is allowed in the UnitedStates, has been dramatic, with nearly US$ 2.4billion being spent in 2001. 62ProgressWHO and HAI/Europe have coordinated a projectto establish a database on promotional activities(http://www.drugpromo.info). It is hosted andadministered by the WHO Collaborating Centrefor Drug Information at the Science University ofMalaysia. The objectives of the project are to:> document inappropriate medicines promotionboth in developing and developed countries.> document the impact of inappropriatemedicines promotion on health.> provide information about tools that canbe used to teach health professionals aboutmedicines promotion.> promote networking among groups andindividuals concerned about medicinespromotion by providing links through thewebsite.As part of the project, four reviews have beenwritten to provide an overview of key promotionrelatedissues including:> What attitudes do people (professional andlay) have towards promotion?> What impact does pharmaceutical promotionhave on attitudes and knowledge?> What impact does pharmaceutical promotionhave on behaviour?> What interventions have been tried to counterpromotional activities, and with what results?

COMPONENTS OF THE STRATEGY | 121Challenges remainingWhile these reviews clearly document thelarge amounts spent on promotion, there islittle evidence on effective ways of addressingthis problem in different country settings. Thechallenge for WHO is to determine what canand should be done to ensure responsible ethicalmedicines promotion.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to promote criteria for medicinespromotion 63 and provide technical supportto countries in monitoring and regulating thepromotion of medicinal products.> undertake further research to evaluate theimpact of interventions aimed at: improvingthe preparation of doctors and pharmaciststo deal with promotional challenges;how guidelines affect gifts being used aspromotional inducements; and how theenforcement of Conflict of Interest guidelinesaffect promotional activities.> review and update where necessary WHO’s1988 guidelines on ethical criteria formedicines promotion to take account ofdevelopments in communication such as theInternet and direct-to-consumer advertising.OUTCOME INDICATORS1999 2003 2007No. of countries with basic system for regulatingpharmaceutical promotion#REPORTING % TARGET#REPORTING % TARGET92/132 70% 80% 83/113 73% 76%

WHO MEDICINES STRATEGY 2004-2007 | 122EO 7.5Consumer education enhancedin recognition of the growingsignificance of self-medication andof consumer access to knowledgeand advice of variable qualityRationaleConsumers of medicines are the final decisionmakerson the use of medicines, whetherprescribed or purchased over the counter withoutprescription. However, insufficient attention ispaid to consumer education on the importanceof rational use of medicines. Self-medication isincreasing in importance, either by default or asa result of deliberate public policy. In developingcountries today, out-of-pocket spending byconsumers is the main source of spending onmedicines. In many countries, the distinctionbetween prescription-only and over-the-countermedicines is meaningless as almost all medicinesare available for sale.ProgressThe need for skills development for communityeducation in rational medicine use has beenclearly identified in WHO research. In response,a new interactive and skills-oriented trainingprogramme on community education in therational use of medicines has been developedby WHO, in partnership with the Universityof Amsterdam and an experienced group ofdeveloped and developing country experts, andmade available in Asia and Africa. In addition,two manuals, one on investigating drug use incommunities and the other on interventionsto change medicines use in communities, arebeing prepared by partners at the University ofAmsterdam.Challenges remainingDespite the risks to personal health frommisguided self-medication or the inappropriateuse of prescribed treatment by consumers, the fullimpact of these practices cannot be quantified.The challenge is to promote rational use ofmedicines amongst consumers with the samelevel of success as the pharmaceutical industryachieves in marketing their products. As yetthere is limited information available as to whichare the most effective interventions for use indeveloping and transitional countries. Furtherresearch is needed in different environments andsectors.Meeting the challenges 2004-2007Over the next four years WHO will:> support efforts to provide information andeducation designed to improve rationaluse of medicines by consumers. The longtermaim of the training programme oncommunity education is to develop a networkof trained people committed to implementingcommunity education in rational use ofmedicines, evaluating the impact of theirwork, reporting on experience, and sharingexpertise.> promote and support systematic researchactivities aimed at identifying the mosteffective interventions for improving rationaluse.OUTCOME INDICATORS1999 2003 2007No. of countries that have implemented a nationalconsumer education campaign in the last two years#REPORTING % TARGET#REPORTING % TARGETna na na 72/120 60% 60%

COMPONENTS OF THE STRATEGY | 123EO 7.6Drug and therapeutics committeespromoted at institutional anddistrict/national levels.RationaleAn effective drug and therapeutic committee(DTC) will establish and monitor policiesand systems for medicines management inhospitals, health programmes or geographicalareas. Hospital DTCs are vital structures forimplementing comprehensive and coordinatedrational medicines use strategies in hospitals.They should be considered as a cornerstone ofthe hospital pharmaceutical programme, withresponsibility for developing and coordinatingall hospital policies related to pharmaceuticals,such as the selection of standard treatments andhospital formularies. These committees shouldalso be responsible for adapting the nationalclinical guidelines and essential medicines listto the needs of the hospital and for carrying outmedicines utilization studies and prescriptionreviews, as well as developing educationalstrategies to improve medicines use andmanagement.ProgressA WHO manual on the establishment andfunctions of DTCs was published in 2003. Incollaboration with MSH, an international coursewith accompanying materials was developed andfour international and four national courses wereconducted in 2000-2003. A web-based discussiongroup and a follow-up workshop for past DTCcourse participants were provided by MSH incollaboration with WHO. Several interventionresearch projects involving DTCs, aimed atpromoting better use of medicines, have beenor are currently being supported (in Cambodia,Ghana, Indonesia, Kenya, Laos, and Zimbabwe).Challenges remainingAlthough DTCs have been established in manydifferent settings, many of them fail to ensurethe correct management of medicines withinthe institution or area they represent. In manydeveloping countries, DTCs are hampered by ashortage of qualified staff and lack of capacity inmany hospitals and by the lack of incentives fromgovernments or hospital authorities to encouragestaff to attend meetings. While some DTCs areresponsible for the selection of medicines forthe hospital formulary, very few are involvedin monitoring medicines use or implementingstrategies to improve rational use.Meeting the challenges 2004-2007Over the next four years WHO will:> provide training, support, and advice tocountries seeking to establish and sustainfunctioning DCTs. This will involve regionaland international training courses as well astargeted support in response to requests fromcountries.> continue to support intervention researchprojects on promoting the rational useof medicines through DTCs and presentsome past results at the next internationalconference for improving the use ofmedicines.> ensure that future participants at internationalDTC courses are followed up more closelyat country level. Past experience has shownthat participants do not use the informationthey have learnt unless they have developeddefinite plans of action during the trainingcourses and have follow-up visits at countrylevel.OUTCOME INDICATORS1999 2003 2007No. of countries with DTCs in the majority of regions/provinces#REPORTING % TARGET#REPORTING % TARGETna na na 32/96 33% 40%

WHO MEDICINES STRATEGY 2004-2007 | 124EO 7.7Training in good prescribing anddispensing practices promotedRationaleRational use depends on the knowledge, attitudes,and practices of health care practitioners andconsumers. Educational strategies for both groupsare essential but these are often inappropriateor neglected. In basic (undergraduate) trainingof health care practitioners, for example, thereis often a focus on the transfer of narrow, timelimitedpharmacological knowledge, rather thanon the development of lifetime prescribing skillsand the ability to assess medicines informationcritically.ProgressWHO has had an impact on the training ofprescribers worldwide through the publicationof the Guide to Good Prescribing and trainingin the use of this. The Teachers Guide to GoodPrescribing was published in 2001. Work is inprogress to develop material for a Guide to GoodPharmacy Practice. Three international trainingcourses per year in English, French, and Spanishon problem-based pharmacotherapy have beensupported. An evaluation of their impact is underway.Over the past three years, in partnership withother concerned groups, WHO has conducteda wide range of training courses on differentaspects of rational use of medicines, togetherwith the production and promotion of trainingmaterials.Training courses related to therational use of medicines> Promoting the rational use ofmedicines, in collaboration withINRUD and coordinated byManagement Sciences for Health(MSH), USA. This course teachesthe investigation of medicine usein primary health care and how topromote rational use of medicinesby providers.> Promoting rational medicine usein the community, in collaborationwith the University of Amsterdam,the Netherlands. This course teachesthe investigation of medicine usein the community, and how topromote rational use of medicinesby consumers.> Drugs and therapeutics committees,in collaboration with theRational Pharmaceutical Programcoordinated by ManagementSciences for Health, USA. Thiscourse teaches methods forevaluating medicine utilizationand how to promote rational use ofmedicines in hospitals and districts.> Problem-based pharmacotherapyteaching, in collaboration withGroningen University, TheNetherlands, the University ofCape Town, South Africa, theUniversity of La Plata, Argentina(in Spanish) and the NationalCentre for Pharmacovigilance,Ministry of Health, Algiers, Algeria(in French). This course teaches a

COMPONENTS OF THE STRATEGY | 125problem-based approach to rationalprescribing based on WHO’s Guideto Good Prescribing.> Pharmacoeconomics, incollaboration with the Universityof Newcastle, Australia. This courseteaches how to do economicevaluation in medicine selection.> Medicine policy issues fordeveloping countries, incollaboration with BostonUniversity, USA. This courseteaches about general medicinespolicy including aspects relatingto promoting more rational use ofmedicines.> ATC/DDD methodology formedicine consumption, incollaboration with the WHOCollaborating Centre for DrugStatistics Methodology. Thiscourse provides an introductionto the application of ATC/DDDmethodology in measuringmedicine consumption.Challenges remainingIn many undergraduate medical curricula thereis insufficient focus on clinical pharmacotherapyand problem-based teaching methods are notused. As a result, traditional training programmesfor health professionals do not prepare themadequately for the rational use of medicines inhealth care.Meeting the challenges 2004-2007Over the next four years WHO will:> advocate for and support the inclusionof problem-based and skills-basedpharmacotherapy teaching in undergraduateand postgraduate training programmes forhealth professionals.> support an evaluation of the prescribinghabits of doctors and prescribers whoreceived problem-based pharmacotherapytraining compared with those who didnot. Such evaluation can be used toadvocate for more appropriate training onclinical pharmacotherapy teaching at bothundergraduate and postgraduate levels.OUTCOME INDICATORS1999 2003 2007No. of countries that include the concept of essentialmedicines in basic curricula for medicine and / orpharmacy#REPORTING % TARGET#REPORTING % TARGETna na na 72/88 82% 85%

WHO MEDICINES STRATEGY 2004-2007 | 126EO 7.8Practical approaches to containantimicrobial resistance developedbased on the WHO Global Strategyto Contain Antimicrobial Resistance.RationaleIrrational use of antimicrobials, including theiruse in agriculture, is one of the major driversof increasing antimicrobial resistance. As aresult, some infections are now untreatable withfirst-line antimicrobials in some parts of theworld. Surveys have revealed that 25%-75%of antibiotic prescriptions in teaching hospitalsin both developed and developing countriesare inappropriate. 64 In addition, as many as30%-60% of patients in primary health carecentres receive antibiotics (perhaps twice what isclinically needed). 65 Surveys have also revealedthat most episodes of illness are self-medicatedand that most people purchase incompletecourses of medication, including antibiotics, and/or do not adhere to the correct dosing regimes.ProgressWHO has recognized antimicrobial resistance tobe a problem of increasing public health concernand passed a number of resolutions encouragingMember States to take measures to containantimicrobial resistance 66 . The WHO GlobalStrategy to Contain Antimicrobial Resistanceand other supporting documents were publishedin 2001 67 and a follow-up meeting on how toimplement the Global Strategy held in 2002. EDMhas provided technical assistance in developingnational plans to contain antimicrobial resistancein six countries and three regions. A numberof pilot projects have been started in India andSouth Africa involving the development of amethodology for the linked surveillance ofantimicrobial use and resistance.

COMPONENTS OF THE STRATEGY | 127Challenges remainingThe continuing overuse, underuse, and misuseof antibiotics leads to antimicrobial resistancepatterns that are neither measured nor contained,with consequent health and financial implicationsfor countries — a problem that is on the increaseworldwide. At the national level there is often alack of data on antimicrobial use and data onresistance are inappropriate for use at the locallevel as resistance patterns and antimicrobial usecan vary widely within countries. In addition,there is a lack of methods applicable at the locallevel for measuring antimicrobial resistance anduse.Meeting the challenges 2004-2007Over the next four years WHO will:> work with other agencies to develop tools andpromote programmes to measure and containthe threat of antimicrobial resistance.> pursue the pilot projects aimed at developinga methodology for linked surveillance ofantimicrobial use and resistance at countrylevel and use the results to guide practicaladvice to countries.> continue to provide targeted technicalsupport, where requested, to countries andregions.> develop a policy perspective paper toadvise policy-makers on how to containantimicrobial resistance.OUTCOME INDICATORS1999 2003 2007No. of countries with national strategy to containantimicrobial resistance#REPORTING % TARGET#REPORTING % TARGETna na na 37/113 33% 40%

WHO MEDICINES STRATEGY 2004-2007 | 128EO 7.9Identification and promotion ofcost-effective strategies to promoterational use of medicinesRationaleSince irrational use of medicines is not limitedto one area of the health sector, strategiesshould be designed to cover the public andprivate sectors and to target self-medication andprescribing habits. What is needed is a majorshift in the knowledge and behavioural patternsof both individuals and social groups, includinghouseholds, communities, health professionals,educational institutions, and industry. In view ofthe financial constraints, there is a need to identifyand target priority areas. From a health economicsperspective, these areas should be those whichare expected to yield the largest improvement insocial benefit (or reduction of unnecessary socialcosts) for the money invested. 68ProgressWHO, in collaboration with partners includingMSH and the Universities of Harvard and Bostonin the United States, has supported more than20 intervention research projects in developingcountries, aimed at providers and consumers,hospitals, primary health care and the community,and private and public sectors. Technical supportfor these has included supervisory visits as wellas workshops for proposal development and dataanalysis. A policy perspective paper outlining corecomponents of a national strategy to promoterational use of medicines was published in2002. 69 WHO is also developing a quantitativedatabase of all medicine use studies from 1993onwards in order to assess global progress inpromoting rational use of medicines. In addition,WHO has supported INRUD and associatedtraining programmes. A major advance was thefirst francophone course on promoting rationaluse of medicine, conducted in Rwanda in 2003.This will be replicated in 2004 and followed upwith field activities.

COMPONENTS OF THE STRATEGY | 129Challenges remainingIrrational prescribing, dispensing, andconsumption of medicines exist even in thepresence of agreed strategies and policies forrational use, especially in developing countries.Although past research has identified theeffectiveness of many interventions, particularlywhen used in combination, many countries havenot implemented or scaled up such strategies,possibly because of the expense involved. Thechallenge for WHO is to evaluate the costeffectivenessof various strategies and to advocatea package of priority cost-effective interventions tobe adopted by countries. An additional challengeis the need to identify effective interventions toimprove medicines use in hospitals and in thetreatment of chronic diseases such as HIV/AIDS indeveloping countries.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to support intervention researchprojects to evaluate the cost-effectiveness ofinterventions to improve the rational use ofmedicines. The results of projects supportedin the last four years and the WHO rationalmedicine use database will be presented atthe 2 nd International Conference for Improvingthe Use of Medicines in April 2004 inThailand. The global agenda for the next fiveyears, to be decided at this conference, willinclude evaluation of the impact of nationalpolices on medicines use and the costeffectivenessof interventions.> continue to work with INRUD to supporttraining programmes on promoting rationaluse of medicines, running fewer coursesbut with greater follow-up of participants’activities at country level.> increase efforts to improve the rational use ofmedicines for chronic diseases.OUTCOME INDICATORS1999 2003 2007No. of countries that have undertaken a nationalassessment / study of the rational use of medicines#REPORTING % TARGET#REPORTING % TARGETna na na 57/97 59% 60%

WHO MEDICINES STRATEGY 2004-2007 | 130

IMPLEMENTINGTHE STRATEGYCOUNTRIES AT THE CORE

WHO MEDICINES STRATEGY 2004-2007 | 132REQUEST FOR SUPPORT FROM COUNTRYIf WHO has not been active in pharmaceuticals in a country before or fora long period of timeREQUEST FOR SUPPORT FROMCOUNTRIES OR REGIONSTYPE ASITUATION ANALYSIS> Determine priority needs and what further support would be mostappropriate> Financed primarily from unspecified fundsTYPE BSPECIFIC TECHNICALSUPPORTTYPE CCOMPREHENSIVEPROGRAMME SUPPORTTYPE ICINTERCOUNTRY PROGRAMMES> Timely interventions usuallyfocused on a subset of thefollowing areas: policy, access,quality safetyy and efficacy,rational use> Financed primarily fromunspecificed funds*i.e. funds for which the donor hasnot specified a particular purposeor use.**i.e. funds for which the donor hasspecified a particular purpose or use.> Ministry of Health/WHOimplementation plan coveringmost or all of the followingareas: policy, access, quality,safety and efficacy, rational use> Financed primarily fromspecified funds**> Time frames may cover two ormore biennia> Usually necessitates full-timepharmaceutical adviser incountry> May involve drug supply> Involves two or more countries,frequently from the same region> Financed primarily from unspecifiedfunds*> Usually focused on a subset of thefollowing areas: policy, access,quality, safety and efficacy, rationaluse

IMPLEMENTING THE STRATEGY | 133Working with countries – supporting andenabling national resources/capacityWorking with countries on policy and technicalissues has always been and continues to bethe highest priority for WHO in the field ofmedicines. It is essential that countries` needs andexperiences are at the core of all WHO’s work inpharmaceuticals.WHO support in medicines is demand driven. Itcan be classified into four main types, sometimesused in combination: situation analysis, specifictechnical support, comprehensive programmesupport, and intercountry programmes. In2002, WHO provided direct support in thepharmaceutical sector to 113 countries.Twenty-two countries received comprehensiveprogramme support, 85 received specifictechnical support, and WHO supported sixcountries in situational analyses 70 .Country work is also a fundamental resource forWHO. Only by undertaking such work can theOrganization develop its evidence and knowledgebase and continue to maintain its position as theleading UN technical agency on public healthissues.WHO working together – coordination,communication and collaborationWHO country support in medicines benefitsfrom effective coordination, collaboration, andcommunication between EDM teams and WHOheadquarters, regional offices, and country officesand between WHO and its partners. Workingtogether enables a unified vision for the futureand a common strategy to reach it. WHO’sguiding principles for country support are given inFigure 28.Strengthening WHO regional andcountry capacityTo improve its effectiveness at country level,WHO is implementing a strategy to strengthen itsregional and country offices. An important part ofdecentralization and strengthening WHO capacityhas been the appointment of regional and issuefocal points at headquarters, an increase in thenumber of staff in regional offices, the recruitmentof Medicines Advisers in selected country offices,and efforts to strengthen partnerships with healthcare providers, CSOs, consumers, donors, andother international agencies.Each regional office has an essential medicines

WHO MEDICINES STRATEGY 2004-2007 | 134Figure 28: Model of EDM Country SupportCOORDINATION:Teamwork within WHO andthrough expanded partnershipand collaboration networksCOMMUNICATION:> Clear channels> Appropriate informationsharing practices> Efficient and timelyproceduresCOLLABORATION:> Setting goals> Planning> Strategic thinking> Implementing> MonitoringHEADQUARTERS:> Strategy & policy-making> Planning & monitoring> Specific technical & policy support> Strategy for development & training> Partnerships & collaboration> Develop global normative materials>>>>REGIONAL FOCALPOINT>>ISSUE FOCAL>>REGIONAL OFFICES:> Oversee country operations> Planning and monitoring> Technical, policy & management support> Human resources development & training> Partnerships & collaborations> Develop regional normative materials>>COUNTRY OFFICES:> Assess needs & identify priorities for technical support> Plan & implement WHO work> Assist coordination> Partnerships & collaborations> Feedback & reportingMINISTRIES OF HEALTH:> Identify needs & priorities> Plan, implement & monitor action> Coordinate with bilateral & multilateral agencies and CSOs>>>>

IMPLEMENTING THE STRATEGY | 135Figure 29: Medicines Advisers recruited in 11African countriesCameroonChadEthiopiaGhanaKenyaMaliNigeriaSenegalRwandaTanzaniaUgandaA total of 32 Medicines Advisers provide supportin five WHO regionsteam which coordinates WHO work in the regionand facilitates sub-regional cooperation whereappropriate. There are now a total of 13 peoplein the WHO essential medicines teams in theregional offices.Country office capacity has strengthened bythe recruitment of Medicine Advisers, nationalprofessional officers (NPOs) with specializedexpertise in pharmaceuticals and medicines.Medicine Advisers are a key long-term supportmechanism for sustainable pharmaceuticaldevelopment. They work with Ministries of Healthto identify needs and priorities; plan, implement,and monitor action; and coordinate with otherpartners.Countries are prioritized for recruitment ofMedicine Advisers based on the followingselection criteria:> Geographical, cultural, language distribution> Priority/severity of need> WHO country capacity> Level of development> Likelihood of sustainable impact> Potential cost-effectiveness> Involvement of other partners.

WHO MEDICINES STRATEGY 2004-2007 | 136WORLD HEALTH ORGANIZATION> >HQ AFRO COUNTRY OFFICES>>>>COUNTRIESMINISTRIES OF HEALTH>>PARTNERS IN COUNTRY SUPPORT>WHO OPERATIONALPARTNERSUNAIDS, bilateralcooperation,public interestNGOS in health,UNDP, UNFPA,UNCTADWHO SCIENTIFICPARTNERSWHOCollaboratingCentres inpharmaceuticals,universities,research centres,internationalhealthprofessionals'associationsWHO STRATEGICPARTNERSWorld Bank anddevelopmentbanks,pharmaceuticalindustry, WTO,WIPO, EUWorking in partnership – supporters andco-workersAll available resources must be called upon andwell coordinated to promote appropriate andeffective national medicines policies, access,quality and safety, and appropriate use of essentialmedicines. EDM expertise and resources aremaximized through close collaboration and coordinationwithin EDM and between EDM and itspartners. EDM partners in country support includepublic and private sector businesses and researchinstitutes, CSOs, and global entities.Efforts to strengthen partnerships within EDMteams and departments and between EDMheadquarters and regional and country offices,and to build operational, scientific, and strategicpartnerships with others are key to fulfillingWHO’s goals in pharmaceuticals.It is in coordination withoperational partners that WHOsupports countries to develop andsustain effective pharmaceuticalsectors, including access toand appropriate use of qualitymedicines.It is with strategic partners thatWHO can promote improvementsin global public health.It is with the expertise of scientificpartners that WHO can providethe level of specialist technicaladvice requested by countries.More than 40 WHO CollaboratingCentres now work with WHO onmedicine priorities.

IMPLEMENTING THE STRATEGY | 137Examples of such partnerships in the past threeyears include:> The development in 2002 of the Handbookon Access to HIV/AIDS Treatment inpartnership with the HIV/AIDS Alliance andUNAIDS.> The project to prequalify manufacturers ofARVs, including generic producers, based inWHO and operating in collaboration with theIPC.> In 1995-2002, the development of acomputerized system for registration,involving original work in Tunisia Pharmacyand Medicines Directorate and subsequentdevelopmental work in the EMEA.Working in line with WHO Strategy– links in the knowledge chain buildingstrengthIn turning to WHO for expert advice onmedicines, countries may request data andstatistics concerning health information andadvice on a wide range of health issues or adviceon new and innovative approaches to longstandingor newly emerging health problems.WHO’s response will be in line with the corporatestrategy of fulfilling its mandate and drawingon the core function to create, synthesize, anddisseminate knowledge through a series of relatedapproaches (Figure 30)> A collaborative project with HAI Africa toimprove the involvement of civil society inpolicy development and implementation incountries in the region.> Collaboration with four WHO CollaboratingCentres to develop materials in relation toTRIPS and to monitor the impact of TRIPS andother trade agreements on public health andaccess to essential medicines.

WHO MEDICINES STRATEGY 2004-2007 | 138Figure 30: Creation, synthesis, and dissemination of knowledgeStimulating strategic and operational researchCreate knew knowledge, through networking and collaboration, to meet presentand future challenges relating to pharmaceuticals; and identify innovative andviable approaches to ensure access to, and the quality and appropriate use ofmedicines.Articulating and advocating policy optionsDevelop and disseminate needs-driven, ethical, evidence-based and actionorientedpolicy options to help countries — confronted with many difficultdecisions in a changing global context — manage their pharmaceutical sector andincrease its contribution to public health.Developing norms and standardsDevelop norms and standards as a foundation for the effective regulation, control,manufacture, and sale of medicines, and to guide international harmonization ofthe pharmaceutical trade.Producing guidelines and practical toolsProvide policy-makers and essential medicines managers with practical guidelinesand tools for implementing the components of a national medicine policy andfor promoting capacity-building, particularly when there is a lack of nationalpharmaceutical experts.Developing human resourcesBuild country capacity to effectively implement the various components of anational medicine policy by developing clear guidelines on the human resourcesrequired, ensuring that undergraduate and postgraduate curricula for all healthprofessions incorporate the essential medicines concept, and developing andpromoting in-service training and supervision for health staff at all levels.Managing informationSynthesize and disseminate information on pharmaceutical issues, includingassessing trends, comparing performance, and monitoring the potential impacts onhealth of global economic, social or political developments.

MONITORINGPROGRESS

WHO MEDICINES STRATEGY 2004-2007 | 140Figure 31: Monitoring ProgressLEVEL ISTRUCTURES AND PROCESSLEVEL IIOUTCOME INDICATORS(assessment of country NDP,household survey on access and use)LEVEL IIISPECIFIC COMPONENTS USING DETAILED INDICATORSMonitoring progress with the strategy– measuring against indicators at countrylevelIt is important to have a regular source ofinformation on the pharmaceutical situation at thecountry, regional, and global level that can be usedas a guide for governments and stakeholders. Thisinformation should link to strategies and priorityactivities implemented in countries.In recent years, WHO has developed a numberof tools to track progress on key indicators andessential components of country pharmaceuticalsituations. One of these tools is the questionnaireon the structures and processes of the countrypharmaceutical situation (the Level I questionnaire),which includes indicators that are collected fromall Member States every four years.Level I indicators provide a method to rapidlyassess the implementation of national medicinespolicies and their components. These indicatorsare evaluated through a questionnaire completedat the national level. These core indicators areused to assess existing structures and processes in anational pharmaceutical system such as legislation/regulations, quality control of pharmaceuticals,essential medicines list, medicines supply system,medicines financing, access to essential medicines,production, rational use of medicines, intellectualproperty rights protection, and marketingauthorization.Information from Level I indicators are nowbeing used by WHO to monitor its priority areasof work and to analyse country, regional, andglobal performance in the pharmaceutical sector.Country progress indicators corresponding totarget outcomes in the WHO Medicines Strategywere selected mostly from Level I indicators.Country progress indicators were identified basedon expected activity outcome and challengingissues relevant to WHO work on pharmaceuticals.However, the indicators are intended to measurethe collective efforts of the government and othergroups, agencies, and stakeholders involved inpharmaceuticals.The results of the 2003 survey have been comparedagainst targets for the WHO Medicines Strategy2000-2003 and used as baseline data for the 2004-2007 Strategy. New targets for each indicator werethen established for the conclusion of the newStrategy by 2007 (see summary table of CountryProgress Indicators below).

MONITORING PROGRESS WITH THE STRATEGY | 141Country Progress Indicators for Expected Outcomes of WHO Medicines Strategy 2004-2007Expected Outcomes and Indicators WMS 2004 - 2007 1999 1999 2003 2003 2003 2007# Reporting % Target # Reporting % TargetEO 1.1 Medicines policies developed, updated and implemented taking into consideration health, development, and intersectoral policies toachieve maximum impactCountries with an official national medicines policy document—new or updated within the last 10 yearsCountries with a national medicines policy implementation plan—new or updated within the last 5 years67/152 44% 55% 62/123 50% 59%41/106 39% 43% 49/103 48% 61%EO 1.2 Implementation of medicines policy regularly monitored and evaluated, providing data that can be used in adjusting policy and interventionsto improve access to medicinesCountries having conducted a national assessment of theirpharmaceutical situation in the last 4 yearsna na na 47/90 52% 58%EO 1.3 Public health aspects protected in the negotiation and implementation of international, regiona,l and bilateral trade agreements throughinter-country collaboration and legislative steps to safeguard access to essential medicinesCountries integrating TRIPS Agreement flexibilities into nationallegislation to protect public healthna na na 32/105 30% 45%EO 1.4 Human resources capacity increased in the pharmaceutical sector through education and training programmes to develop capacity and tomotivate and retain personnel in sufficient numbers within a clearly defined and organized structureCountries that provide both basic and continuing educationprogrammes for pharmacists54/85 64% na 34/110 31% 35%EO 1.5 Promotion of innovation based on public health needs, especially for neglected diseases, through policies and actions creating a favourableenvironment for innovation of medically needed new medicinesCountries promoting research and development of new activesubstancesna na na 21/114 18% 22%EO 1.6 Gender perspectives introduced in the implementation of medicines policies by identifying gender differences in access to and rational useof medicines and supporting women in their central role in health careCountries providing free medicines for pregnant women at primarypublic health facilitiesna na na 54/106 51% 60%EO 1.7 Access to essential medicines recognized as a human right via advocacy and policy guidance to recognize and monitor access to essentialmedicines as part of the right to healthCountries that provide HIV/AIDS-related medicines free at primarypublic health facilitiesna na na 60/104 58% 65%EO 1.8 Ethical practices promoted and anti-corruption measures identified and implemented in the pharmaceutical sector, using the experience ofsuccessful programmes addressing aspects of corruption encountered in the pharmaceutical sectorCountries with medicines legislation requiring transparency,accountability and code of conduct for regulatory workna na na 84/114 74% 80%EO 2.1 TM/CAM integrated in national health care systems where appropriate by developing and implementing national TM/CAM policies andprogrammesCountries with national TM policy 25 na na 39/127* 31%* 37%EO 2.2 Safety, efficacy and quality of TM/CAM enhanced through expanding the knowledge base on safety, efficacy and quality of TM/CAM andproviding guidance on regulation and quality assurance standardsCountries regulating herbal medicines 48 na na 82/127* 65%* 75%EO 2.3 Availability and affordability of TM/CAM enhanced through measures aiming to protect and preserve TM knowledge and national resourcesfor their sustainable useCountries with a national inventory of medicinal plants as a meansto provide intellectual property rights protection for traditionalmedical knowledgena na na 9/39 23% 33%EO 2.4 Rational use of TM/CAM by providers and consumers by promoting therapeutically sound use of appropriate TM/CAMCountries with national research institute in the field of TM/CAM 19 na na 56/127* 44%* 51%EO 3.1 Access to essential medicines improved, including medicines for HIV/AIDS, malaria, TB, childhood illnesses, and noncommunicablediseasesCountries where less than 50% of the population has access toessential medicines29/184 16% 14% 15/103 15% 14%EO 3.2 Public funding of medicines increased through increased organizational capacity to implement sustainable drug financing strategies andsystemsCountries with public spending on medicines below US$2 perperson per year38/103 37% 35% 24/80 30% 20%

WHO MEDICINES STRATEGY 2004-2007 | 142Expected Outcomes and Indicators WMS 2004 - 2007 1999 1999 2003 2003 2003 2007# Reporting % Target # Reporting % TargetEO 3.3 Development assistance increased for access to medicines, including the Global FundPercentage of key medicines available in public health facilities na na na 22 1 77 2 naEO 3.4 Medicines benefits promoted within social health insurance and prepayment schemesCountries with public health insurance covering the cost ofmedicines71/111 64% 70% 79/117 68% 73%EO 3.5 Medicine pricing policies and price information promoted to improve affordability of essential medicinesCountries with a pricing policy for maximum retail mark-up in theprivate sectorna na na 36/75 48% 55%EO 3.6 Competition and generic policies implemented along with guidelines for maximizing competition in procurement practicesCountries in which generic substitution is allowed in privatepharmacies83/135 61% 75% 99/132 75% 81%EO 4.1 Supply systems assessed and successful strategies promoted to identify weaknesses in the supply systems and improve the performance andfunctioning of national medicines supply systemsCountries with public sector procurement limited to nationalessential medicines list71/133 53% 60% 84/127 66% 74%EO 4.2 Medicines supply management improved through training programmes and career development plans to increase capacity and reducestaff turnoverCountries providing continuing education to pharmacists andpharmacy aides/assistants39/103 38% na 31/111 28% 32%EO 4.3 Local production assessed and strengthened, on the basis of policy guidance to create a favourable environment for government orinternational support to domestic production of selected essential medicinesCountries with local production capability na na na 36/122 30% naEO 4.4 Procurement practices and purchasing efficiency improved through guidance on good procurement practices, medicines managementinformation support, and work with countries to strengthen efficient procurement proceduresCountries with at least 75% of public sector procurement carriedout by competitive tender81/88 92% 95% 58/70 83% 87%EO 4.5 Public-interest NGOs included in medicine supply strategies, in support of national medicine supply strategies to reach remote areasCountries with NGOs involved in medicines supply na na na 29/64 45% naEO 5.1 Pharmaceutical norms, standards and guidelines developed or updated to promote good practice in regulatory mattersCountries using the WHO Certification Scheme as part of themarketing authorization processna na na 87/135 64% 75%EO 5.2 Medicines nomenclature and classification efforts continued through assignment, promotion and protection of international nonproprietarynames, and the promotion and development of ATC/DDD system.Countries using INNs in medicines registration. na na na 108/131 82% 90%EO 5.3 Pharmaceutical specifications and reference materials developed and maintained for use in quality control laboratories and publications inthe International PharmacopoeiaNumber and types of pharmaceutical specifications and referencematerials developed by WHO HQna na 105 96 na 50EO 5.4 Achieving balance between abuse prevention and appropriate access to psychoactive substances through enhancing the implementationof relevant guidelines to promote rational use of controlled medicinesNumber of substances reviewed and recommended for classificationfor international control2/3. 66% na 5/5. 100% 80%EO 6.1 Medicines regulation effectively implemented and monitored as the capacity of staff is increased through training activities resulting inbetter knowledge, organization, financing, and managementCountries implementing basic medicines regulatory functions 70/138 51% 56% 90/130 69% 74%EO 6.2 Information management and exchange systems promoted and made accessible through shared databases. Basic regulatory informationmade available to the general publicCountries with a computerized medicines registration system na na na 72/135 53% 60%EO 6.3 Good practices in medicine regulation and quality assurance systems to ensure that product quality is maintained in production, clinicaltrials, supply and distributionCountries with basic quality assurance procedures 95/122 78% 80% 111/137 81% 85%

MONITORING PROGRESS WITH THE STRATEGY | 143Expected Outcomes and Indicators WMS 2004 - 2007 1999 1999 2003 2003 2003 2007# Reporting % Target # Reporting % TargetEO 6.4 Post-marketing surveillance of medicine safety maintained and strengthened through the ongoing development of pharmacovigilancecentres and their involvement in international adverse drug reaction monitoring systemsCountries monitoring adverse drug reactions 56/191 29% 35% 72/192 38% 45%EO 6.5 Use of substandard and counterfeit medicines reduced as a result of the development and application of effective strategies to detect theexistence and combat the production and circulation of such productsCountries with >10% of tested medicines failing quality tests na na na 20/71 28% 25%EO 6.6 Prequalification (initial assessment, ongoing monitoring and prequalification) of products and manufacturers of medicines for prioritydiseases; and of quality control laboratories, as appropriate, through procedures and guidelines appropriate for this activityNumber of products assessed and approved na na na 93 na naEO 6.7 Safety of new priority and neglected medicines enhanced through training workshops and increased capacity to assess safety issuesCountries participating in training programmes for introducingnew therapies for priority and neglected diseases, e.g. malaria andAIDS0 na na 7 na 20EO 6.8 Regulatory harmonization monitored and promoted as appropriate, and networking initiatives developed, to facilitate and improveregulatory processes in countriesNumber of countries participating in harmonization initiativessupported financially and technically by WHOna na na 15/191 8% 18%EO 7.1 Rational use of medicines by health professionals and consumers advocatedCountries where the promotion of the rational use of medicines iscoordinated at the national government levelna na na 93/127 73% 75%EO 7.2 Essential medicines list, clinical guidelines and formulary process developed and promotedCountries with national list of essential medicines updated withinthe last 5 years129/175 74% 75% 82/114 72% 75%Countries with treatment guidelines updated within the last 5 years 60/90 67% 70% 47/76 62% 65%EO 7.3 Independent and reliable medicines information identified, disseminated and promotedCountries with a national medicines information centre able toprovide independent information on medicines to prescribersand/or dispensersCountries with a medicines information centre/service accessibleto consumers62/123 50% 59% 53/129 41% 50%na na na 45/127 35% 40%EO 7.4 Responsible ethical medicines promotion for health professionals and consumers encouragedCountries with basic system for regulating pharmaceuticalpromotion92/132 70% 80% 83/113 73% 76%EO 7.5 Consumer education enhanced in recognition of the growing significance of self-medication and of consumer access to knowledge andadvice of variable qualityCountries that have implemented a national consumer educationcampaign in the last two yearsna na na 72/120 60% 60%EO 7.6 Drug and therapeutics committees promoted at institutional and district/national levelsCountries with DTCs in the majority of regions/provinces na na na 32/96 33% 40%EO 7.7 Training in good prescribing and dispensing practices promotedCountries that include the concept of essential medicines in basiccurricula for medicine and/or pharmacyna na na 72/88 82% 85%EO 7.8 Practical approaches to contain antimicrobial resistance developed based on the WHO Global Strategy to Contain AntimicrobialResistanceCountries with national strategy to contain antimicrobial resistance na na na 37/113 33% 40%EO 7.9 Identification and promotion of cost-effective strategies to promote rational use of medicinesCountries that have undertaken a national assessment/study of therational use of medicines* Data collected from Traditional Medicine Surveyna na na 57/97 59% 60%

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WHO MEDICINES STRATEGY 2004-2007 | 150ENDNOTESaThe decision on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreementand Public Health by the WTO General Council was agreed by WTO Members on August 30, 2003. It issometimes referred to as the August 30 Decision or the Paragraph 6 Decision.bThe term “traditional medicine” (TM) is used in this document, the term “complementary andalternative medicine” (CAM) is used where the dominant health care system is passed on allopathicmedicine, or where TM has not been incorporated into the national health care system.cdefData collected from Traditional Medicine SurveyData collected from Traditional Medicine SurveyData collected from Traditional Medicine SurveyA number of relevant guidelines have been developed under the umbrella of the InteragencyPharmaceutical Coordination (IPC) group which, in addition to WHO/EDM, includes UNAIDS, UNICEF,UNFPA, and the World Bank.gBased on 22 countries that have completed the Level II surveyhAverageiBased on 22 countries that have completed the Level II surveyjAverage