Academic journal article Bulletin of the World Health Organization

A Proposal for Measuring the Degree of Public Health-Sensitivity of Patent Legislation in the Context of the WTO TRIPS Agreement

Academic journal article Bulletin of the World Health Organization

A Proposal for Measuring the Degree of Public Health-Sensitivity of Patent Legislation in the Context of the WTO TRIPS Agreement

Article excerpt


In April 1994, the General Agreement on Tariffs and Trade (GATT) Uruguay Round negotiations culminated with the creation of the World Trade Organization (WTO) and the signing of a series of multilateral agreements, including the Trade Related Aspects of the Intellectual Property Rights (TRIPS) Agreement. (1) Since that time, issues relating to intellectual property rights (IPR) have acquired greater importance in the international trade environment. All WTO Members are obligated to grant intellectual property protection in all technological fields, including patents for pharmaceutical products and processes.

Science-based companies consider patent protection one of the main forms of expanding their powers of appropriation. (2) Powers of appropriation are those mechanisms, including legal rights and entitlements, which allow individuals or entities to control the distribution of value created. (3)

However, as the monopoly conferred by the patent delays market competition, it enables the patent holder to set high prices for the protected product. (4-7)

The high price of patented products has been pointed out as one of the most important barriers to their widespread adoption, in particular hindering access to medicines in low- and middle-income countries. (8-10) One example is provided by Brazil's National Programme on Sexually Transmitted Infections/HIV/AIDS, which guarantees universal and free access to treatment for all persons infected with human immunodeficiency virus (HIV). The programme provides 17 antiretrovital (ARV) medicines, but is currently facing serious financial problems because the cost of three patented ARVs (Efavirenz, Lopinavir/Ritonavir and Tenofovir) consumes over 60% of the Ministry of Health's budget for HIV/AIDS medicines. (11-14)

TRIPS challenges countries to identify strategies that enable them to abide by international trade agreements while allowing for national policies that promote economic, technological and social development. Correa recommends that developing countries strive to integrate IPR-related policies and policies for national development, targeting industrial development, public health, food safety, education and other areas. (15) In addition, he argues that public health can best be protected through "health-sensitive" patent legislation incorporating all TRIPS flexibilities that enable governments to act efficiently in the public health sector, including those that augment access to medicines. (16-17)

Studies conducted from the public health perspective have analysed the TRIPS Agreement implementation process. (16,18-24) These studies adopted a descriptive approach, so they do not discuss or propose different degrees of importance for each of the TRIPS flexibilities related to public health protection. Therefore, they do not measure the degree of health sensitivity in legislation, nor perform country comparisons.

In a previous study, we showed that developing countries from Latin America and the Caribbean (LAC) had not incorporated into their patent legislation all the TRIPS flexibilities. (16) The present paper proposes to advance the discussion by answering the following questions: How important is each of the TRIPS flexibilities to health-sensitive patent legislation? How health-sensitive is LAC countries' patent legislation that has been modified to comply with international trade agreements?

To answer these questions, a framework to measure health sensitivity in patent legislation was developed, tested and validated. It is, however, important to point out that the LAC countries' use of the TRIPS flexibilities was not within the study's scope.

From an academic perspective, a framework's development contributes to advancing the scarce existing knowledge in this field. Additionally, this type of study generates new questions and academic challenges to be explored in future studies. …

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