TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS AND HIV/AIDS MEDICINES

In today’s global high-tech economy, the developed countries are regarded as 'innovators and suppliers' while the developing countries serve as markets.1 The Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) helps developed countries maintain their monopoly power over intellectual property. The objective of this article is to provide a general assessment of the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) as well as to discuss its impact on access to HIV/AIDS anti-retroviral medicines.

Since the early 1990s, the United States government, Pharmaceutical Research and Manufacturers of America (PhRMA) and other industrialized countries have pressured developing countries to strengthen their international property rights laws. In 1994, the Trade-Related Aspects of Intellectual Property (TRIPS) Agreement was endorsed at the Uruguay Round of the General Agreement on Tariffs and Trade (GATT).2 The Uruguay Round of trade negotiations ended with the signing of the Marrakesh Agreement which established the World Trade Organization (WTO).3 As part of the Marrakesh Agreement, TRIPS was adopted under the WTO. It took effect in 1995 and required all World Trade Organization member countries to implement legislation and set up patent offices that gave minimum levels of protection for intellectual property. Developing countries were granted a period of five years to introduce TRIPS into their legal system. Some countries were granted an additional five years if they had no prior patents rules in specific technological areas. Least developed countries were given until the year 2006 to comply with intellectual property rights rules. The agreement applies to copyrights, computer programs and databases, geographical indications, industrial designs, patents, layout designs, and trade secrets.4 TRIPS also extends coverage to medicines and pharmaceuticals.

The intellectual property rights agreement states that patents must be protected for at least twenty years. The agreement forces countries to offer ‘market exclusivity’ to new products until TRIPS legislation is fully implemented into a country’s domestic legal system.5 Prior intellectual property rights rules focused more on the product while TRIPS applies to both product and process patents. This new policy coupled with market exclusivity makes it difficult for developing countries to manufacture generic drugs or make similar products through a process called reverse engineering (see glossary).6 The increased life span of patents and other intellectual property rights laws also allows pharmaceutical corporations to monopolize the drug market by enforcing several WTO measures. One of these measures according to Section 301 of the Trade Act includes imposing trade sanctions.7 Pharmaceutical corporations can also sue governments that try to relax the intellectual property rights rules in order to reduce the price of HIV/AIDS drugs, as in the case of (South Africa versus GlaxoSmithKline).

According to the United Nations, tougher intellectual property rights protection will result in higher prices for HIV/AIDS medicines and increased royalty payments to developed countries from developing countries.8 The United States pharmaceutical industry often argues that it loses $500 million each year in India because of weak intellectual property rights laws, even though in 1998 it received $36 billion in royalty payments.9 These findings have grave consequences for poor countries in Sub-Saharan Africa where the affordability and accessibility of life-saving anti-retroviral HIV/AIDS is vital.

Currently, there are over 40 million people living with HIV/AIDS and about 95% of them are in developing countries.10 Yet only 760,000 people worldwide have access to anti-retroviral medicines, 500,000 of whom live in high-income countries. Only 0.1% of the 28.5 million people living with HIV/AIDS in Africa have access to HIV/AIDS medicines.11 Due to the lack of access to medicines needed to treat the disease, each day nearly eight thousand people die of AIDS related illnesses in the developing world.12

Anti-retroviral medicines are an effective means of treating HIV/AIDS, but high prices due to patents make it impossible for people of the developing world to gain access to these life-saving medicines. Pharmaceutical companies argue that high prices are critical to fund research and development. However, studies demonstrate that funding for 5 out of the 6 anti-retroviral drugs is mainly provided by national governments.13 In addition, companies also claim that the length of time needed to approve new drugs is another significant reason for high prices. However, anti-retrovirals are usually approved within 44.6 months, the shortest time for approval of any class of drugs.14

Furthermore, research and development investment for the health needs of people in the developing world has nearly disappeared. Developing countries, which represent 75% of the world population, account for less than 10% of the global pharmaceutical market.15 Pharmaceutical companies invest more resources to develop medicines to treat what some call lifestyle diseases such as obesity, baldness, and impotence.16 These companies are hardly interested in developing drugs that address diseases like malaria or tuberculosis which plague 75% of the world population.

In the developed world people are able to live a longer and more productive life because of access to anti-retroviral drugs. Countries such as Brazil and India have started producing low-cost generic anti-retrovirals, allowing poor countries to buy cheaper medicines. Fearing competition from Brazil and India, the United States pharmaceutical corporation filed complaints to the United States Trade Representative that these countries had violated intellectual property rights rules. Brazil and India were threatened with trade sanctions. However, the threats in themselves violate articles 6, 7, 8, and 31 of the TRIPS agreement which give a government the right to ensure that its residents have access to quality and affordable medication. In such cases, governments can issue compulsory licensing to allow the production of a patented product or process without the consent of the owner or parallel importing (the cross border trade of a product without permission from the manufacturer or publisher).

Technological development is supposed to improve the lives of people for the better, yet 8,000 people die each day because corporations are trying to protect their ideas. TRIPS restrains developing countries from gaining access to medicines that could be used to treat those who are infected with HIV/AIDS. There needs to be a reform of the current system. The duration of patents should be reduced. Developing countries should begin investing in research and development that addresses specific diseases that affect them. Countries should focus on diseases such as HIV/AIDS, malaria and tape worm. Furthermore, those countries that have the infrastructure and the capacity should start producing generic drugs. Technological advancement in today’s world produces wealth, more increasingly concentrated. It has tragic consequences when pharmaceutical companies try to guard not only their wealth but these lifesaving medicines as well. Health care and medicine should be mobilized to serve humanity, now more than ever.

(Notes) 1] Erich Habian, Intellectual Property Rights for the Rich and the Poor 'The Impact of TRIPS on Developing Countries,' (2001), 2. Available at: http://www.wu-wien.ac.at/usr/h99a/h9950236/iprs/impact.htm. 2] Thomas F. Mullin, 'AIDS, Anthrax, and Compulsory Licensing: Has the United States Learned Anything? A Comment on Recent Decisions on the International Intellectual Property Rights of Pharmaceutical Patents,' ILSA Journal of International & Comparative Law 9 (2002): 188. 3] Ibid. 4] Ibid. 5] Mariana Williams, 'The TRIPS and Public Health Debate: An Overview.' International Gender and Trade Network, (2001), 1. 6] Habian, 4. 7] Patents, TRIPS and Public Health-II. 8] Habian, 2. 9] Ibid. 10] United Nations Development Programme (UNDP) HIV/AIDS Statistical Fact Sheet http://www.undp.org/hiv 11] Ibid. 12] UNAIDS: Report on the Global HIV/AIDS Epidemic. 2000,125,129,133. Available at http://www.unaids.org/epidemic_update/report/Epi_report.pdf 13] Carmen Pérez-Casas, 'HIV/AIDS Medicines Pricing Report Setting Objectives: Is There A Political Will?' Médecins Sans Frontières: Switzerland, (2000), 4. 14] Ibid. 15] Ellen F. M. ‘T Hoen. 16] Habian, 4.



----Ifeoma Opara is a TransAfrica Forum/Institute for International Public Policy/Phillipe Wamba is a Research Fellow.



--Re-posted from Globalization Monitor with permission from TransAfrica Forum.