February 2001

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Patent Protection and Patients' Access to HIV/AIDS Drugs in Sub-Saharan Africa

by Lee Gillespie-White

The HIV/AIDS epidemic poses an enormous threat to development in sub-Saharan Africa, which accounts for more than 70 percent of all HIV/AIDS cases globally. HIV/AIDS has reversed social, economic and political gains made over the past three decades in several countries (UNAIDS, 2000a, July 2000). As starkly put by the International Partnership Against AIDS in Africa, "[t]he speed, spread and scope of the epidemic is unprecedented in modern times… By threatening a generation of youthful, productive people, the disease is mortgaging the continent's future" (International Partnership, p. 2). The devastating effects of HIV/AIDS in sub-Saharan Africa, predicted since the early 1990s, is now evidenced by falling life expectancies, increasing numbers of orphans, and terrible tolls on households, learning, teaching, health systems, agriculture, and business sectors across the board (UNAIDS, 2000a, pp 8-11).

Estimates of adult infection rates for the countries hardest hit by the HIV/AIDS epidemic in sub-Saharan Africa, as of the end of 1999, are shown in table 1.

Despite concerted and intensified efforts to address the HIV/AIDS crisis, however, the epidemic rages on in several sub-Saharan African countries with more devastation than even the worst estimates predicted.

The key question asked by most people in facing these facts is: Why do HIV/AIDS sufferers in Africa not have access to the drugs and therapies that in the United States, Canada, and some European countries have successfully curbed the death rate?

There are currently three types of antiretroviral drugs (ARVs) approved by the US Food and Drug Administration (FDA) for the treatment of HIV/AIDS: nucleoside reverse transcriptase inhibitors (e.g., AZT®, ddI®, ddC®, 3TC®, and d4T®); non-nucleoside reverse transcriptase inhibitors (e.g., Nevirapine® and Rescriptor®); and protease inhibitors (Saquinavir®, Ritonavir®, Indinavir®, and Nelfinavir®). The ideal treatment strategy in developed countries involves the use of at least three of these drugs in combination, in a so-called "cocktail" of drugs, that includes a protease inhibitor or non-nucleoside reverse transcriptase inhibitor. Since FDA approval of the first protease inhibitor in 1996, use of the ARV drug cocktail in developed countries has brought impressive results. Mortality rates from HIV/AIDS have been reduced by 75 percent over three years, for example, in the United States (Hirschel and Francioli, pp. 906-908).

Despite the remarkable results achieved by these drugs in developed countries, the vast majority of HIV-infected individuals live in developing countries and do not have access to them. Several factors contribute to the lack of access to affordable medicines in sub-Saharan Africa, including infrastructure problems (logistical supply and storage problems); ability to administer and monitor complex and potentially toxic drug regimens, including laboratory testing, patient follow-up, and treatment of drug side effects; and financing and affordability.

In addition to the factors set out above, the question of intellectual property rights and their relation to access to medicines has become a critical part of the attempt to enhance access to essential medicines and particularly HIV/ AIDS medicines in sub-Saharan Africa.

AIDS and health activists contend that patents and the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS") have the effect of denying access to HIV/AIDS drugs. The drug companies contend that patent protection is essential to provide a return on their research & development investment and to encourage the development of new drugs. In furtherance of this view, drug companies have fiercely defended their patent rights and generally opposed any efforts by governments to permit parallel imports¹ or issue compulsory licenses.

Quite understandably, however, notwithstanding the drug companies' concerns, the call for more affordable drugs has become a major issue with activists who argue that in a health emergency such as the HIV/AIDS crisis, compromises on patent protection should be made.

However, it is not at all clear whether attempts to abrogate patent protection through, for instance, compulsory licensing and parallel importation, will ultimately result in better access to HIV/AIDS medicines and health care.

In collecting information from the patent offices of the sub-Saharan countries and pharmaceutical companies, the International Intellectual Property Institute (IIPI) has found that there is a clear suggestion that in countries where the drugs are not patented, there is still poor access to drugs.

What this means is that even where the pharmaceutical companies have not availed themselves of the protection which would have been afforded to them if they had applied for patents in those countries, patients do not have access to the drugs. An example of the extent of patent protection in sub-Saharan Africa is the patent status of the drug commonly known as AZT. In the whole of sub-Saharan Africa, AZT is patented only in Kenya and South Africa. This is also true of d4T. Crixivan® is registered only in Democratic Republic of Congo and South Africa.

Outside of South Africa, few sub-Saharan African countries offer patent protection. Nevertheless, generic manufacturers are not supplying their drugs to these countries.

Where patents do exist, TRIPS permits a great deal of flexibility to seek compulsory licenses or parallel imports of drugs under patent. The United States and the European Union have indicated that they will not oppose such practices provided that they are consistent with the broad provisions of TRIPS.

While it may be convenient to use the drug industry as a scapegoat, it is apparent that intellectual property rights do not in themselves block access to HIV/ AIDS medications in sub-Saharan Africa.

Even if antiretroviral HIV/AIDS drugs were made available at no cost tomorrow, the lack of health care infrastructure to test, store, and distribute medications, and then monitor patient compliance with what are often very complicated regimens would result in continued lack of access to patients. Nils Daulaire, President of the Global Health Council, is among a growing chorus acknowledging that the challenge is much deeper than cheaper medications: "Even if AIDS drugs were free, no more than 10 to 20 percent of Africans would benefit as the health infrastructures do not exist to manage infections in each individual" (Mutume, July 26).

The lack of availability of HIV/AIDS medicines is the result of a wide and complex range of causes, primary amongst which is a lack of financial resources to fund the health care system in general. Per capita incomes, and hence the availability of private resources for expenditures on medicines (whether generic or branded), are among the lowest in the world in sub-Saharan Africa. Governments also lack the resources to adequately fund health care infrastructure given their high debt burdens and the vast number of competing spending needs.

According to the WHO, public spending on drugs in over three dozen countries, many in sub-Saharan Africa, is less than $2 per capita per year. "In such countries, inadequate and misdirected financing is arguably the greatest barrier to access to life-saving essential drugs" (World Health Organization, p. 39).

Current levels of foreign assistance are completely inadequate to support the required costs to build the needed infrastructure and support drug purchase costs. This is true whether the purchase of generic drugs or patented drugs is involved. As noted recently in the newsletter of the AIDS advocacy organization Project Inform:

The cost of drugs is only a small part of the problem. Building the necessary medical infrastructure will also be costly, as will be meeting the most fundamental needs for food and clean water.… President Clinton has declared the spread of AIDS in developing nations an urgent matter of US national security. If we believe this, then he and other western heads of state must begin to treat it as such. Just as they met to discuss intervention in Bosnia or to launch warfare against Iraq, they must now meet to plot out national and international strategy against this threat.  They must begin negotiations and planning efforts with the heads of the affected nations, as well as grass roots representatives of the people in those nations. And they must begin to adjust their thinking in terms of dollars. (Project Inform, p. 14)

Renewed dedication from all sectors is urgently needed to stem the tide of suffering and death, to address the threat to peace and security, and to make significant inroads in combating the HIV/AIDS epidemic in sub-Saharan Africa. Blaming the WTO, the TRIPS Agreement, or patent holders for the lack of access to medicines will not further this effort.

The intellectual property rights of pharmaceutical companies and the TRIPS Agreement are not, in themselves, impediments to the availability of HIV/AIDS therapies in sub-Saharan Africa. It is incorrect to assume that without restrictions imposed by the WTO through TRIPS and without patents, HIV/AIDS patients would have access to drugs crucial to their survival. With such an enormous and devastating crisis as this, attention should properly be directed to the real factors constraining the availability of and access to these drugs in these countries.

Note

¹ Parallel imports are drugs which have been shipped from a country where drugs are lower-priced to a country where drugs are higher-priced without the patent-holder's permission.

References

Hirschel B. and P. Francioli (1998). "Progress and Problems in the Fight Against AIDS." New England Journal of Medicine 338(13).

International Partnership Against AIDS in Africa, The (2000). "AIDS in Africa: Development in Crisis," UNAIDS/00.11E, May.

Mutume, Gumisai (2000). "Development: Africa Shuns US Move Allowing Access to Cheaper AIDS Drugs." Inter Press Service, July 26. Internet: www.oneworld.org/ips2/July00/20_17_075.html.

Project Inform (2000). "Drug Pricing, AIDS and the Developing Nations." Perspective 30 (August).

UNAIDS (2000a). Report on the Global HIV/AIDS Epidemic. UNAIDS/00.13E. English original, June.

UNAIDS (2000b). "UNAIDS Calls on G8 for Massive Increase in Resources to Fight AIDS." Press Release. Geneva, July 20. Internet: www.unaids.org/whatsnews/press/eng/pressarc00/geneva200700.html.

World Health Organization, WHO Medicines Strategy 2000-2003. On internet at: www.healthnet.org/programs/e-drug-hma/e-drug.

Lee Gillespie-White is a South African lawyer currently residing in Washington, DC. She is a contributor to the International Intellectual Property Institute's report "Patent Protection and Access to HIV/AIDS Pharmaceuticals in Sub-Saharan Africa" (2000).

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