E-DRUG: BMJ editorial on WTO/TRIPS Medicines
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[Herewith the very latest BMJ editorial on the WTO and TRIPS
Link: http://bmj.bmjjournals.com/cgi/content/full/327/7415/571
Copied as fair use. WB]
BMJ 2003;327:571-572 (13 September)
On 30 August 2003 the World Trade Organisation (WTO) announced that it had
resolved the issue of giving poor countries "access to essential medicines"
without breaching its own law on intellectual property. The WTO's 1994
agreement on trade related aspects of intellectual property, TRIPS, makes 20
year patent protection mandatory, allowing drug companies to charge monopoly
prices for essential medicines. TRIPS has built-in measures that allow
countries to over-ride patent protection for public health purposes but
since 2001, WTO members have been trying to reach agreement about what this
flexibility means in practice. Argument has centred on the question of
"compulsory licensing," which allows countries to over-ride patents and
manufacture cheaper generic versions, and the extent to which producers of
generic drugs can export to poor countries that have insufficient
manufacturing capacity, without the risk of trade courts imposing trade
sanctions.
A WTO declaration in 2001 stated the organisation's intention of finding an
interpretation that squared the interest of pharmaceutical industries and
developing countries.1 Last week's announcement sets out the terms on which
countries such as India and Brazil can export to least developed countries
cheaper, generic versions of patented drugs for HIV/AIDS, tuberculosis,
malaria, and the occasional infectious disease.
With the fifth WTO ministerial conference taking place on 10-14 September in
Cancun, Mexico, the organisation's new director general, Supachai
Panitchpakdi, has described the deal as a historical agreement. Members'
freedom to decide their own health policy unencumbered by trade policies has
been high on the list of controversies that sank the 1999 negotiations in
Seattle. But some WTO watchers are sceptical. They point out that the deal
reached last week is based on the same declaration that the European Union
originally opposed because it did not think access to drugs would be made
any easier for poor countries.2
There are good grounds for scepticism. TRIPS is not a treaty that benefits
less developed countries. Industrial countries hold 97% of all patents
worldwide, and 80% of patents granted in developing countries belong to
residents of industrial countries.3 TRIPS was originally pushed through by
the US government with threats of trade sanctions against non-compliant
countries and is not likely to be given up lightly.4 Last week's agreement
reduces the flexibility within the treaty, limiting a health emergency-one
of the grounds for invoking the treaty's flexibilities-to three main
diseases, whereas the 2001 declaration of intent said an accommodation
should be reached for all public health issues.5 Limiting policy autonomy in
this way reinforces the drive to vertical, drug based programmes and moves
away from attempts to build more universal and comprehensive integrated
health systems.
There are also more basic problems with TRIPS. Its mandatory norm of 20
years' patent protection means that a company can exploit its monopoly
position to charge higher prices over a longer period than it would be able
to charge were there competitors. The rationale is that monopoly pricing
will allow producers to recoup the costs of investment in research and
development and reap a profit, thereby leading to additional new medical
innovations and social gains despite the higher costs. Last week's agreement
reiterates support for the monopoly pricing principle.6
But the UK Commission on Intellectual Property Rights and Development Policy
questioned in 2002 whether a global norm for patent protection is in the
best interests of developing countries7 and whether an individual or company
should be able to take out a patent on products that have important societal
implications.8 It stated that intellectual property is of little relevance
in stimulating research and development of diseases prevalent in developing
countries. It points out that less than 5% of the money spent worldwide on
pharmaceutical research and development is for diseases that predominantly
affect developing countries. Although expenditure on total pharmaceutical
research and development in the private sector doubled to $44bn in
1990-2000, of the 1395 drugs approved between 1975 and 1999, only 13 were
specifically indicated for tropical diseases, including tuberculosis and
malaria.9 Concluding that the research agenda for pharmaceuticals is led by
market demands of the developed world rather than the needs of poor people,
the commission recommended that intellectual property rules should limit the
scope for patenting that serves more to protect markets, and exclude
competition, than promote local research and development.
In recommending more public funding for research the commission also noted
the recent encouragement by the developed world of patenting in state funded
research institutions and universities. The UK commission recommends that
most developing countries, particularly those without research capabilities,
should strictly exclude diagnostic, therapeutic, and surgical methods from
patentability, including new uses of known products. It says that developing
countries should limit the scope of subject matter that can be patented and
provide extensive safeguards to ensure that patent rights are not exploited
inappropriately. The agreement signed on 30 August 2003 falls far short of
this recommendation.
Lastly the UK commission, again, has drawn attention to the complexity of
the legal and administrative architecture of the WTO and the way in which
developing countries are disadvantaged in the negotiations and by the
absence of civic dialogue and public debate.7 Until these issues are put at
the top of the WTO agenda the real effect of this and any future trade
rounds will continue to be the entrenchment of the interests of western
countries and their industries.
Allyson M Pollock, professor
(allyson.pollock@ucl.ac.uk)
David Price, senior research fellow
Public Health Policy Unit, School of Public Policy, University College
London, London WC1H 9QU
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Competing interest: None declared.
References
WTO. Declaration on the TRIPS agreement and public health. Geneva: WTO, 20
November 2001 (WT/MIN(01)/DEC/2).
Raghavan C. Medicines won't be cheaper under TRIPS and public health
decision. Geneva: Third World Network, 31 Aug 2003.
www.twnside.org.sg/title/5409b.htm (accessed 7 Sep 2003).
Koivusalo M, Rowson M. Who will inherit the earth? Health Matters 2000;41.
www.healthmatters.org.uk/stories/rowson2.html (accessed 8 Sep 2003).
Braithwaite J, Drahos P. Global business regulation. Cambridge: University
Press 2000: 39-87.
WTO takes first step. Lancet 2003; 362: 753.[CrossRef]
WTO. Implementation of paragraph 6 of the Doha declaration on TRIPS and
public health. Geneva: WTO, August 2003 (W/TL/540).
Commission on Intellectual Property Rights. Integrating property rights and
development policy. London: CIPR, 2002.
www.iprcommission.org/graphic/documents/final_report.htm (accessed 8 Sep
2003.)
Drahos P. Biotechnology patents, markets and morality. European Intellectual
Property Review 1999; 21: 441-9.
Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing R, Ford N. Drug
development for neglected diseases: a deficient market and public health
policy failure. Lancet 2002; 359: 2188-94.
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