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

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.