who medicines strategy - libdoc.who.int - World Health Organization

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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%
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