TRIPS, Pharmaceutical Patents and Access to Essential ...

1 TRIPS, Pharmaceutical Patentsand Access to Essential Medicines:Seattle, Doha and BeyondEllen F. M. t HoenKey words: TRIPS; Patents ; generic drugs; Researchand Development; intellectual property; reasons for the lack of Access to Essential medicines are manifold, butin many cases the high prices of drugs are a barrier to needed drug prices are often the result of strong intellectual property pro-tection. Governments in developing countries that attempt to bring the price ofmedicines down have come under pressure from industrialized countries andthe multinational Pharmaceutical World Trade Organization (WTO) Trade-Related Aspects of IntellectualProperty Rights Agreement (TRIPS)

2 Sets out the minimum standards for theprotection of intellectual property, including Patents for TRIPS does offer safeguards to remedy negative effects of patent pro-tection or patent abuse, in practice it is unclear whether and how countries canmake use of these safeguards when Patents increasingly present barriers tomedicine health advocates welcomed the Doha Declaration as an importantachievement because it gave primacy to public health over private intellectualproperty, and clarified WTO Members' rights to use TRIPS safeguards.

3 Butthe Doha Declaration did not solve all of the problems associated with intel-lectual property protection and public health. The recent failure at the WTOto resolve the outstanding issue to ensure production and export of genericT 25/06/2003 11:08 Page 39medicines to countries that do not produce may even indicate that the optimismfelt at Doha was sum Parmi les diff rentes raisons de l absence d acc s aux m dicaments essentielsdans les pays en d veloppement, leur prix lev constitue un obstacle prix prohibitifs sont souvent le r sultat de la protection tr s forte de lapropri t intellectuelle.

4 Les gouvernements des pays en d veloppement quitentent de r duire ces prix sont l objet de fortes pressions de la part des paysindustrialis s et de l industrie pharmaceutique multinationale. Les accordsADPIC(Accords sur les Droits de Propri t Intellectuelle qui touchent auCommerce) de l Organisation Mondiale du Commerce (OMC) d finissent desnormes minimales pour la protection de la protection de la propri t intellec-tuelle, incluant les brevets pour les m dicaments. Si ces accords offrent desm canismesde sauvegarde pour compenser les effets n gatifs de la protectionou des abus li s aux brevets, en pratique, l utilisation appropri e de ces m ca-nismes, lorsque les brevets constituent des obstacles majeurs l acc s auxm dicaments.

5 N est pas d fenseurs de la sant publique ont consid r la D claration de Dohacomme une tape importante parce qu elle donnait la primaut aux consid ra-tions de sant publique sur celles de propri t priv e intellectuelle et clarifiaitles modalit s d utilisation des clauses de sauvegarde des ADPIC pour lesmembres de l OMC. Mais la D claration de Doha n a pas r solu les probl mesassoci s la protection de la propri t intellectuelle et la sant chec r cent l OMC des tentatives pour r soudre la question relative laproduction et l exportation de m dicaments g n riques vers les pays quin en produisent pas confirme que l optimisme post-Doha tait pr matur.

6 IntroductionInfectious diseases kill over 10million people each year, more than 90%ofwhom are in the developing world [1]. The leading causes of illness and death inAfrica, Asia, and south America-regions that account for four-fifths of the world spopulation are HIV/AIDS, respiratory infections, malaria, and particular, the magnitude of the AIDS crisis has drawn attention to thefact that millions of people in the developing world do not have Access to themedicines that are needed to treat disease or alleviate suffering.

7 Each day,Economics of AIDSand Access to 25/06/2003 11:08 Page 40close to eight thousand people die of AIDS in the developing world [2]. Thereasons for the lack of Access to Essential medicines are manifold, but in manycases the high prices of drugs are a barrier to needed treatments. Prohibitivedrug prices are often the result of strong intellectual property in developing countries that attempt to bring the price ofmedicines down have come under pressure from industrialized countries andthe multinational Pharmaceutical World Trade Organization (WTO) Trade-Related Aspects of IntellectualProperty Rights Agreement (TRIPS or Agreement )

8 , which sets out the mini-mum standards for the protection of intellectual property, including Patents forpharmaceuticals, has come under fierce criticism because of the effects thatincreased levels of patent protection will have on drug prices. While TRIPS does offer safeguards to remedy negative effects of patent protection or patentabuse, in practice it is unclear whether and how countries can make use ofthese safeguards when Patents increasingly present barriers to medicine Fourth WTO Ministerial Conference, held in 2001in Doha, Qatar,adopted a Declaration on TRIPS and Public Health ( Doha Declaration or Declaration ) which affirmed the sovereign right of governments to takemeasures to protect public health.

9 Public health advocates welcomed the DohaDeclaration as an important achievement because it gave primacy to publichealth over private intellectual property, and clarified WTO Members rightsto use TRIPS safeguards. Although the Doha Declaration broke new ground inguaranteeing Members Access to medical products, it did not solve all of theproblems associated with intellectual property protection and public recent failure at the WTO to resolve the outstanding issue to ensureproduction and export of generic medicines to countries that do not producemay even indicate that the optimism felt at Doha was Access problem and intellectual propertyA number of new medicines that are vital for the survival of millions arealready too costly for the vast majority of people in poor countries.

10 In addition,investment in Research and Development (R&D) towards the health needs ofpeople in developing countries has almost come to a standstill. Developingcountries, where three-quarters of the world population lives, account for lessthan 10%of the global Pharmaceutical market. The implementation of TRIPS isTRIPS, Pharmaceutical Patents , and Access to Essential 25/06/2003 11:08 Page 41expected to have a further upward effect on drug prices, while increased R&Dinvestment that aims at addressing health needs in developing countries, despitehigher levels of intellectual property protection, is not expected [3].