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

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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
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REFERENCES | 1471Annual report 2000
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