Do Patents Make HIV/AIDS Medication Inaccessible to Patients in Sub-Saharan Africa? Abstract There has been debate surrounding the issue of patents and their effect on the affordability of HIV/AIDS medications. Through financial gain and notoriety, medical patents provide an incentive for people to perform scientific research and develop new drugs. 1 At the same time, especially with respect to HIV/AIDS medications in Sub-Saharan Africa, the majority of the people who need these medications cannot afford them. 3 The pharmaceutical companies, the heads of Sub-Saharan African countries, the World Trade Organization and UNAIDS need to work together to find a way to make HIV/AIDS medications affordable while protecting intellectual property rights. A good place to start would be to negotiate a lower price for these medications under certain circumstances. A campaign could also be organized to encourage employers to take the initiative to provide HIV/AIDS coverage to their employees. Another option would be for the developing countries to work with more industrialized nations to set up a manufacturing technology transfer program. There has been debate surrounding the issue of patents and their effect on the affordability of HIV/AIDS medications. Through financial gain and notoriety, medical patents provide an incentive for people to perform scientific research and develop new drugs. 1 At the same time, especially with respect to HIV/AIDS medications in Sub-Saharan Africa, the majority of the people who need these medications cannot afford them. 3 The pharmaceutical companies, the heads of Sub-Saharan African countries, the World Trade Organization and UNAIDS need to work together to find a way to make HIV/AIDS medications affordable while protecting intellectual property rights. A good place to start would be to negotiate a lower price for these medications under certain circumstances. A campaign could also be organized to encourage employers to take the initiative to provide HIV/AIDS coverage to their employees. Another option would be for the developing countries to work with more industrialized nations to set up a manufacturing technology transfer program. Introduction In the struggle to find a solution and reverse the effects of HIV/AIDS in Sub-Saharan Africa, there is debate about providing affordable HIV/AIDS medication for the impoverished. In the mid-1990’s, the World Trade Organization (WTO) created a set of regulations that resulted in the agreement called the trade-related aspects of intellectual property rights (TRIPS). 2 This agreement essentially protects pharmaceutical patents internationally by ensuring that a registered patent can be held exclusively by the patent holder for 20 years until becoming available for generic purposes. This agreement is under scrutiny because it is viewed as a hindrance to the distribution of HIV/AIDS medications in developing nations. 6 There are exceptions to the TRIPS agreement, however, because any country that declares itself in a state of emergency can receive compulsory licensing, which allows those other than the patent holder to copy patented products and processes. But it is understood that in order to receive compulsory licensing, a country has to have the capability to manufacture the product. 7 In the struggle to find a solution and reverse the effects of HIV/AIDS in Sub-Saharan Africa, there is debate about providing affordable HIV/AIDS medication for the impoverished. In the mid-1990’s, the World Trade Organization (WTO) created a set of regulations that resulted in the agreement called the trade-related aspects of intellectual property rights (TRIPS). 2 This agreement essentially protects pharmaceutical patents internationally by ensuring that a registered patent can be held exclusively by the patent holder for 20 years until becoming available for generic purposes. This agreement is under scrutiny because it is viewed as a hindrance to the distribution of HIV/AIDS medications in developing nations. 6 There are exceptions to the TRIPS agreement, however, because any country that declares itself in a state of emergency can receive compulsory licensing, which allows those other than the patent holder to copy patented products and processes. But it is understood that in order to receive compulsory licensing, a country has to have the capability to manufacture the product. 7 The pharmaceutical companies have stated that, while there are many hindrances to the lack of access to medications in Sub-Saharan Africa, patents are not the cause of the problem because in many African nations the drug patents are not even enforced. 8 The stance of many of these companies is that even if the HIV/AIDS medication were widely available, distributing these drugs would be ineffective due to a lack of medical infrastructure. An infrastructure within each African nation is needed to support the distribution of the drugs along with patient care and follow-up. The risks of distributing medications without proper supervision can include mutations of the virus that make it resistant to the patented medication. The pharmaceutical companies have stated that, while there are many hindrances to the lack of access to medications in Sub-Saharan Africa, patents are not the cause of the problem because in many African nations the drug patents are not even enforced. 8 The stance of many of these companies is that even if the HIV/AIDS medication were widely available, distributing these drugs would be ineffective due to a lack of medical infrastructure. An infrastructure within each African nation is needed to support the distribution of the drugs along with patient care and follow-up. The risks of distributing medications without proper supervision can include mutations of the virus that make it resistant to the patented medication. The integrity of the patenting process is also an important issue. Patent incentives drive the free market to develop and test new products. If there was not enough notoriety or money attached, which could happen if registered patents could immediately become available to any producer, then this scientific creativity and investigation process could be stifled. The integrity of the patenting process is also an important issue. Patent incentives drive the free market to develop and test new products. If there was not enough notoriety or money attached, which could happen if registered patents could immediately become available to any producer, then this scientific creativity and investigation process could be stifled.References The people involved in this negotiation would be: Pharmaceutical companies that produce HIV/AIDS medications Heads of state of Sub-Saharan African countries The World Trade Organization (WTO) NGOs such as UNAIDS that have a purpose to eradicate the HIV/AIDS retrovirus The interests to be met are: To protect intellectual property rights To get medication to those with HIV/AIDS To develop an infrastructure for drug distribution and patient follow-up The options for negotiating a solution could be: Work with UNAIDS or NGOs to develop a better medical infrastructure within Sub-Saharan African nations Develop a campaign to encourage employers to provide HIV/AIDS coverage for its employees Set up a program where developing countries and industrialized nations can work together to transfer manufacturing technology Negotiate lower drug prices for countries under special circumstances Expand freedoms in the TRIPS agreement to bypass patent rights under special circumstances Objective Criteria The amount of money lost each year due to intellectual property theft The number of people in Sub-Saharan Africa with HIV/AIDS without access to the proper medications An annual average of the individual costs of both proprietary and generic HIV/AIDS medications A list of the countries in Sub-Saharan Africa who do not enforce patent protection laws Conclusions It is important that all parties involved in eradicating the HIV/AIDS retrovirus identify their common interests and work together to solve this problem. Negotiating an affordable price for HIV/AIDS medications may be the best solution, and would probably work best if combined with a program to build up the medical infrastructure within Sub-Saharan Africa. Stephanie DiBello Beloit College Draft as of Feb. 15, 2006