E-drug: MSF on access to antiretroviral drugs
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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
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 <pierchir@club-internet.fr>
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.
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