By: Ebey P. Soman
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The World Trade Organization (WTO) and its member nations met in Uruguay in 1994 to establish international norms for trade, economy, and development. They developed the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which provided patent protection for pharmaceutical companies to make brand name medications and market those medications to the foreign market without fears of illegal or unauthorized production of generics. With the explosion of HIV/AIDS during the 1980s and the 1990s, countries struggled to provide affordable HIV drug combinations (or „cocktails‟) to their populations. With the majority of the African continent facing a HIV/AIDS pandemic and countries being unable to provide treatment for their people, the WTO modified their TRIPS provision to allow its member nations to produce generic medications only during a national emergency.
The WTO‟s actions opened the flood gates. Brazil, India, and several African nations authorized the production of brand name anti-retroviral drugs under this emergency clause. Companies like Merck, which produces efavirenz (Sustiva®), deeply contested these actions, claiming infringement of patent protection and the need for pharmaceutical companies to make money for developing new drugs. In essence, the pharmaceutical industry foresaw that the emergency clause would not be limited to simply HIV or other infectious diseases. The clause may eventually be used to allow the production of other medications. Drug manufacturers‟ suspicions were confirmed in 2008 when Thailand issued orders to make generic cancer medications after price negotiations with pharmaceutical companies failed.
The issue was pushed to the forefront again when the World Health Organization (WHO) stated that chronic dis-ease account for 60% of the deaths globally, with a bulk of these deaths occurring in developing nations. The statement worried researchers because already it takes 10 to 15 years for drug manufacturers to research and develop an efficacious, safe, and financially-viable medication. United States patent laws include safety trials and research as part of the patent period. Drug manufacturers have no choice but to rush the drug onto the market to produce a profit and to recoup some of the research costs. However, most drugs never stay as brand names for a long enough time for the drug maker to recoup Research and Development (R&D) costs. Over the past decade, we have seen a sharp drop in R&D budgets for drug manufacturers.
On the other hand, the introduction of generic drugs has provided a safe and cost effective way for low income patients from all over the world to receive treatment. Countries like Brazil, China and India have emerged as the leaders in the world providing treatment for a wide range of diseases at a fraction of the cost. A recent study by UNITAID titled “A lifeline to treatment: the role of Indian generic manufacturers in supplying anti-retroviral medicines to developing countries” found that over 80% of anti-retroviral drugs are donated or sold to poor nations at a low cost. India now provides 91% of pediatric anti-retroviral volume and is the “pharmacy” for the developing world.
The issue was again on the forefront during the United Nations meeting on September 2011. India and China announced plans to work together to develop generic biotech medications. They wished to include generics for drugs such as trastuzumab (Herceptin®, Genentech) for breast cancer, bevacizumab (Avastin®, Genentech) for colon cancer, rituximab (Rituxan®, Genentech) for non-Hodgkin’s lymphoma, and etanercept (Enbrel®, Amgen/Pfizer) for rheumatoid arthritis. The announcement resulted in an intense conflict be-tween nations. Developed nations and the pharmaceutical industry fight for patent rights, while developing nations, like India and China, push for cheaper and more accessible generic medications. Already, an Indian company (Cipla Ltd) and a Chinese company (BioMab) have announced plans for a joint venture for biotech drug manufacturing. The pharmaceutical innovators and manufacturers have geared up for a showdown. Cancer, diabetes, and cardiovascular issues are the core, profit-generating components of the pharmaceutical industry, and companies are not going to give that up easily.
So, the question remains: what is the right balance to this dilemma that we are facing? How can we encourage R&D and allow drug manufacturers to recoup the costs, while providing low-cost, effective, and accessible medications to the third world nations? Feel free to send letters to the editors with your proposed solutions and other comments.
SOURCES:
- Harris, G. (2011, September 18). China and India Making Inroads in Biotech Drugs. New York Times. Retrieved from http://www.nytimes.com/2011/09/19/health/policy/19drug.html
- Johnson, T. (2011, August 3). The Debate Over Generic-Drug Trade. Council on Foreign Relations (CFR). Retrieved from http://www.cfr.org/drugs/debate-over-generic-drug-trade/p18055
- Waning B, Diedrichsen E, Moon S. A lifeline to treat-ment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries. J Int AIDS Soc. 2010 Sep 14;13:35.