who medicines strategy - libdoc.who.int - World Health Organization
who medicines strategy - libdoc.who.int - World Health Organization who medicines strategy - libdoc.who.int - World Health Organization
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%
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COMPONENTS OF THE STRATEGY | 37Meeting the challenges in 2004-2007Over the next four years WHO will:Many developing countries and countries <strong>int</strong>ransition 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 a<strong>medicines</strong> development agenda based onpriority public health needs and develop asystematic methodology for this together withan initial list of recommendations for publicinvestment in <strong>medicines</strong> 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 <strong>medicines</strong>.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%
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