# \[e-drug\] MSF on access to antiretroviral drugs **URL:** \ **Category:** e-drug\ **Created:** [August 17, 2000, 6:52am UTC](https://talk.edrugplus.org/t/e-drug-msf-on-access-to-antiretroviral-drugs/8948 "2000-08-17T06:52:25Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![pierchir](https://avatars.discourse-cdn.com/v4/letter/p/3d9bf3/32.png) [@pierchir](https://talk.edrugplus.org/u/pierchir)\ **Post date:** [August 17, 2000, 6:52am UTC](https://talk.edrugplus.org/t/e-drug-msf-on-access-to-antiretroviral-drugs/8948/1 "2000-08-17T06:52:25Z")
E-drug: MSF on access to antiretroviral drugs --------------------------------------------- AIDS: patent rights versus patient's rights Lancet 2000; 356: 502 - 503 (with kind permission from Lancet. Copyright Elsevier Science Ltd) [http://www.thelancet.com/sub/issues/vol356no9228/news\_hhr502.html#aids](http://www.thelancet.com/sub/issues/vol356no9228/news_hhr502.html#aids) patentrightsversuspatientsrights After the discovery of combination antiretroviral therapies that could transform HIV infection from a death sentence to a chronic disease, the use of such combinations spread widely in more-developed countries, and AIDS-related mortality in Europe and the US dropped by more than 70%.1 In less-developed countries --home to 95% of people living with HIV--the past 4 years have been starkly different, characterised more by death and societal disruption than by hope and treatment. Access to AIDS drugs in less-developed countries took centre stage at the International AIDS conference in Durban, South Africa last month (July 9-14). To propose that all people with AIDS in less-developed countries should immediately be given combination antiretroviral therapy is not realistic. In the poorest countries enormous efforts are necessary to even offer the most basic treatment of opportunistic infections. An adequate health structure and trained and committed staff are also needed. But to conclude that the focus should therefore be on activities such as prevention 2 is simply to abandon about 30 million people with HIV/AIDS in poor countries. Issues of cost-effectiveness are also invoked: preventing vertical trans-mission would be cost-effective for a resource-poor country but life-long antiretroviral medication would not.3 In such circumstances the cost of the medicines--which should be the subject of debate--is instead set in stone. Moreover, without treatment there is no hope and so little reason to take an HIV test. We can expect that increasing access to treatment will reinforce prevention activities. Unfortunately, the high price of drugs often limits de facto any action or willingness to act. And this high price--currently around $US10000 for a year's triple therapy--is difficult to justify. Zidovudine was first synthesised in 1964. Most of the research that showed the drug's effectiveness as an antiretroviral was done by the US National Institutes of Health.4 Nevertheless, Glaxo Wellcome, having obtained the patent for zidovudine for the treatment of AIDS, brought the drug onto the market in 1987 as one of the most expensive ever sold. 13 years later, the drug remains unaffordable for most people with AIDS. They will have to wait another 5 years before the patent expires. The story is the same for most antiretrovirals: often discovered by public laboratories, developed in short time-frames in clinical trials supported by public funds, and then sold at a high price. Public research institutes have heavily funded anti-retroviral development, including that for didanosine, abacavir, stavudine, zalcitabine, and the concept of protease inhibitors. Researchers comparing the time-to-approval of AIDS drugs found that antiretrovirals were approved in an average of 44�6 months, close to half the industry-wide average of 87�4 months for the approval of drugs.5 Patents for didanosine, stavudine, and zalcitabine are held by public authorities (www.fda.gov/cder/ob/default.htm ; www.patents.ibm.com ), but rights to commercialisation have been granted to private companies on an exclusive basis. Thus, the usual explanation proffered by industry to justify their high prices--that research and development is a long and expensive process--is extremely weak here. Nothing explains why companies charge so much except that they were initially put on the market in the USA, a rich country without price controls. Unfortunately for most of the world's 34 million people infected with HIV, pharmaceutical companies impose US prices on the rest of the world. Donations and discounts do not address the issue of fair and equitable pricing. On May 11 five big pharmaceutical companies loudly announced that they would make substantial discounts on their AIDS drugs. The price cuts currently suggested (85%) are extremely modest in comparison to those already in place for vaccines and oral contraceptives. 3 months on, and details and commitments are still being discussed, but no medicines have reached patients. The refusal or reticence of drug companies to substantially lower their prices in poor countries naturally attracts attention to their market monopolies granted through patents. Least-developed countries that are part of the World Trade Organisation (WTO) have until 2006 at the latest to adopt intellectual property laws that enshrine 20 years of patent protection for medicines. Because this is not a retroactive agreement, generic sources of antiretrovirals exist from countries that did not respect patents before entering the WTO. In these countries, as is always the case when there is market competition rather than monopoly, the price comes down. The production of generic antiretrovirals in India (zidovudine, stavudine, lamivudine, and nevirapine) and Thailand (zidovudine, stavudine, and didanosine) has increased access to treatment. Brazil has been able to afford to put 90000 people with AIDS on combination therapy because generic competition has reduced prices of antiretrovirals by more than 70% during the past 5 years. Less-developed countries unable to produce antiretrovirals themselves could import them from Brazil, India, or Thailand (through compulsory licensing if they are patented), but usually come under intense pressure from the pharmaceutical industry and western governments not to do so. The gap between the prospects for people with AIDS living in the western world and those living in less-developed countries makes the problem of access to AIDS treatments much more than a medical concern. This gap is also a social, economic, moral, and political issue. The question of AIDS treatment leads to a wider reflection of the balance between public and private interests, between patent rights and the rights of patients. Access to health care and to medical progress as a human right is a challenge that AIDS poses to humanity. It is no longer morally acceptable to debate if antiretrovirals should be provided. We should now concentrate on how quickly they can be provided. P Chirac,\* T von Schoen-Angerer, T Kasper, N Ford \*Medecins Sans Frontieres, 8 rue Saint Sabin, 75554 Paris, Cedex 11, France Pierre Chirac \ 1 Palella FJ, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 1999; 279: 853-60. 2 Ainsworth M, Teokul W. Breaking the silence: setting realistic priorities for AIDS control in less-developed countries. Lancet 2000; 356: 55-60. 3 Zwi K, S�derlund N, Schneider H. Cheaper antiretrovirals to treat AIDS in South Africa BMJ 2000; 320: 1551-52. 4 Mitsuya H, Weinhold K, Yarchoan R, Bolognesi D, Broder S. Credit government scientist with developing anti-AIDS drug. The New York Times September 28, 1989. 5 Kaitin K, Healy E. The new drug approvals of 1996, 1997, and 1998: drug development trends in the user fee era. Drug Inform J 2000; 34: 1-14. -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. 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