Academic journal article Bulletin of the World Health Organization

Using TRIPS Flexibilities to Facilitate Access to Medicines/ Utiliser Les Flexibilites Des Aspects Des Droits De Propriete Intellectuelle Lies Au Commerce (ADPIC) Pour Faciliter L'acces Aux Medicaments/ Como Utilizar Los Aspectos Flexibles De Los ADPIC Para Facilitar El Acceso a Los Medicamentos

Academic journal article Bulletin of the World Health Organization

Using TRIPS Flexibilities to Facilitate Access to Medicines/ Utiliser Les Flexibilites Des Aspects Des Droits De Propriete Intellectuelle Lies Au Commerce (ADPIC) Pour Faciliter L'acces Aux Medicaments/ Como Utilizar Los Aspectos Flexibles De Los ADPIC Para Facilitar El Acceso a Los Medicamentos

Article excerpt

TRIPS and access to medicines

When the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was annexed to the Agreement Establishing the World Trade Organisation (WTO) in 1994, it set minimum standards for intellectual property (IP) protection that must be observed and enforced by all WTO Member States. (1,2) TRIPS negotiations were long and complex, as documented by many commentators. (3-5) Many low- and middle income countries (as classified by the World Bank) resisted the inclusion of an IP regime in the WTO system because they feared that it might obstruct development goals and access to important goods such as essential medicines. (6) Ultimately, however, they were constrained to accept the "TRIPS package" as an indivisible component of the WTO system. Since TRIPS carne into force, bilateral and regional trade agreements have tended to set even higher standards for IP protection, in what Peter Drahos refers to as "the global ratchet" for IP rights. (7)

An extensive body of commentary has been generated on the potentially detrimental effects of various aspects of the TRIPS package on public health and development, particularly in low- and lower-middle-income countries. (8-10) Inadequate provision of basic public health care continues to afflict many of these countries. The United Nations (UN) clearly recognizes this. In 2001, the Committee on Economic, Social and Cultural Rights stated that national and international IP regimes must be consistent with the human rights obligations of states, (11) In 2011, the United Nations General Assembly recognized the need to preserve TRIPS flexibilities to facilitate measures for improving access to health care, and United Nations Member States agreed that IP rights provisions in trade agreements should not undermine these flexibilities. (12)

The World Health Organization (WHO) has taken several measures to counteract the potentially adverse health impact of IP protection. In particular, in 2008 the sixty-first World Health Assembly adopted Resolution 61.21, which endorsed the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. (13) This Global Strategy aims, among other things, to improve the delivery of and access to health products and medical devices by effectively overcoming barriers to access. Adoption of the Global Strategy followed an 18-month period of deliberations and meetings of the WHO Intergovernmental Working Group on Public Health. (14) More recent measures by the WHO include an intensive study on access to medical technologies and innovation, conducted in collaboration with the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO), (15) as well as release of its Zero Draft Global Plan for the Prevention and Control of Non-communicable Diseases 2013-2020. (16) Various forms of technical assistance have been provided by WIPO to low- and lower-middle-income countries in formulating IP laws and policies using the TRIPS flexibilities. (17)

These ongoing activities on the part of international agencies are vital in addressing the growing public health crisis in the world's poorest countries. Relevant domestic activity in the majority of industrialized nations has, however, failed to match this international activity. With this in mind, the specific question that this paper examines is whether it is possible for rich countries to create robust and workable legislative frameworks to facilitate the delivery of essential medicines to their poorer neighbours within TRIPS flexibilities. It is argued that this is necessary because the responsibility of providing health care to those most in need should not be left solely to middle-income countries that have thriving generic pharmaceutical industries, such as Brazil (which is classified as upper-middle-income) and India (lower-middle-income). It is contrary to the tenets and spirit of articles 66 and 67 of TRIPS to leave this task entirely to middle-income countries; those articles enjoin rich countries to facilitate technology transfer to low- and lower-middle-income countries and provide technical support where needed. …

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