[e-drug] Lancet editorial on TRIPS and access to medicines

[Kirsten Myhr <myhr@online.no>]

E-drug: Lancet editorial on TRIPS and access to medicines
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[Copied as fair use. KM]

The Lancet, 10 November 2001
(Vol 358, No. 9293)
http://www.lancet.com/journal/journal.isa

Editorial

On October 24, Tommy Thompson, Secretary of the US 
Department of Health and Human Services, and Helge Wehmeier, 
president of the Bayer Corporation, announced the federal purchase 
of 100 million tablets of ciprofloxacin (Bayer's Cipro) at half price. 
This emergency price cut was agreed after the US government 
threatened to override Bayer's patent on Cipro. The US 
government's action was sparked by the Canadian health ministry's 
decision to commission a local drug company to make ciprofloxacin, 
violating Bayer's patent rights. Bayer responded by donating a large 
amount of Cipro to Canada, and promising more in the event of an 
emergency, which led the Canadian government to agree to acquire 
ciprofloxacin exclusively from Bayer for the duration of the patent 
agreement.

No new anthrax cases have been reported in Canada, yet the threat 
to public health was deemed enough for the Canadian government 
to challenge Bayer's patent rights. Events in the USA after 
September 11 have proven the bioterrorist threat to be real with 
documented cases of anthrax, but it is hard to justify the need for 
patent challenge on public-health emergency grounds, especially 
because the anthrax isolates seem to be sensitive to doxycycline.
Bayer's patent for Cipro is protected by the Trade-Related Aspects 
of Intellectual Property Rights (TRIPS) agreement, which sets 
minimum standards of patent law for member states of the World 
Trade Organisation.  Under TRIPS, patent protection lasts for 20 
years, although compulsory licensing (production of medicines by 
companies other than the patent holder) is allowed in public-health 
emergencies or where there are unfair pricing practices.  The US 
government's action on Cipro is in stark contrast to US trade 
pressure on less-developed countries to limit compulsory 
licensing and parallel importing (importing of medicines from 
countries other than the country of manufacture).  Parallel importing 
is also allowed under TRIPS, and is, like compulsory licensing, 
widely practised by western countries.

Even where there is clear evidence of a public-health emergency, 
such as the HIV crisis in Africa and many parts of Asia, the US 
government has used its might to limit those countries' options to 
provide affordable drugs.  For example, in 1998, under threat from 
the USA to increase tariffs on imports of wood products and 
jewellery, the Thai government limited the right to issue compulsory 
licences for pharmaceuticals.  Last year, the US government filed a 
complaint with the World Trade Organisation over a law that 
enabled Brazil to produce cheap generic versions of antiretroviral 
drugs, stating that Brazil's patent law broke the TRIPS agreement.
The number of AIDS-related deaths in Brazil has halved since 1995, 
partly due to the availability of cheap antiretroviral drugs.  In June of 
this year, the US government retracted its complaint, after outcry 
from international aid agencies.  In April, after a 3-year lawsuit, the 
Pharmaceutical Manufacturers Association of South Africa and 39 
international drug companies dropped action to prevent the South 
African government from importing cheaper drugs for HIV and 
AIDS. TRIPS allows such imports but it took this case to prove that 
the AIDS epidemic, which has now affected more than 58 million 
people worldwide, killing 22 million, is of sufficient proportion to 
warrant recognition as a public-health emergency in TRIPS terms. 
Clarification of and changes to the TRIPS agreement to favour 
public-health needs over patent protection are urgently needed and 
have been called for by aid agencies and less-developed countries 
on the eve of the World Trade Organisation summit to take place in 
Qatar on November 9-13.  So far, however, the US government, 
backed by Japan, Switzerland, and Canada, is opposing change.

In June at the UN General Assembly Special Session on HIV/AIDS, 
the USA pledged $200 million for a global AIDS fund, which was 
judged by many as a paltry sum.  A task force to ensure a 
"comprehensive and coordinated effort" by the USA to combat AIDS 
was announced, chaired by Secretary of State Colin Powell and 
Tommy Thompson.  It is time that the US government recognised 
that a "comprehensive and coordinated effort" means that public-
health needs may have to override trade profits, and that putting 
money into a fund while doing its utmost to prevent life-saving 
treatments reaching those who need them is duplicitous.  The US 
government should apply the same standards abroad as at home in 
defining what is, or is not, a public-health emergency.


The Lancet


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