E-DRUG: MSF in Lancet: Historic opportunity for WHO to re-assert leadership
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The Lancet 2006; 368:1405-1406
http://www.thelancet.com/ (free registration necessary)
Historic opportunity for WHO to re-assert leadership
Rowan Gillies, Tido von Schoen-Angerer, Ellen 't Hoen
When countries gather for WHO's Executive Board meeting next month, to
appoint a new Director-General, they must select a candidate with the
courage and political leadership necessary to address the most critical
challenges the UN agency is facing today.
The recent appearance of extensively drug-resistant tuberculosis
illustrates the scale of the work ahead.1 The health threat posed by this
microbe in settings with a high prevalence of HIV highlights the urgent
need for action for WHO to set the agenda for the fast-tracked development
of new drugs and better and easier-to-use tests to diagnose tuberculosis
and detect drug resistance, to replace today's increasingly ineffective
tools.
WHO will need to lead a process involving health ministries, regulatory
agencies, drug companies, product-development partnerships, funding
bodies, and non-governmental organisations, and it will need to deliver.
HIV/AIDS is another immediate issue. With the end of the 3 by 5 programme,
WHO today lacks any strategic plan for the coming years, despite
ambitiously calling for universal access to AIDS treatment.2 Now that
newer compounds are increasingly needed to deal with resistance, the cost
of treating AIDS is set to skyrocket.3 How does the agency plan to
respond?
Research and development needs are also pressing in AIDS. These needs
include the development of new fixed-dose combinations of second-line
drugs and formulations for children, and simpler field-adapted
diagnostics. Drugs in research must be specifically developed to answer
the needs of resource-poor settings—and not only cater for populations of patients in rich countries.
On a programme level, WHO will need to address more forcefully the crying
need for greater human resources in medicine, which has become a critical
bottleneck preventing further scale-up.4 It will also need to think of the
longer term and make sure that more patients are not only started on
treatment but are also kept alive by making second-line drugs available. A
sufficient quality of country programmes must also be assured.
Malaria is another priority. The painfully slow implementation at country
level of artesunate combination therapies (ACTs) must receive urgent
attention. Although many countries have changed their treatment protocols
to ACTs, these newer life-saving drugs are still not reaching patients who
need them.5 Drugs are becoming available from an increasing number of
suppliers but production costs are decreasing slowly. Will WHO play its
role in ensuring the sustainable funding of ACTs, and challenge
governmental complacency on this issue?
Possibly the greatest challenge facing the UN health agency today is the
need to reverse the erosion of WHO's mandate, adapt to new international
environments, and re-assert its leadership on health issues. WHO must now
deal with new stakeholders: large contributions to international health
are made by the Bill & Melinda Gates Foundation and, not surprisingly, the
influence of this single private philanthropic organisation on the
international health agenda is unprecedented. How will WHO assert
leadership in view of new independent actors that come with vast
resources?
Recent years have seen life-saving products become indistinguishable from
any other tradable commodity, and actual health concerns relegated to the
point of being superfluous during trade negotiations. WHO has become a
follower rather than a leader while other agencies have promoted their
respective agendas. Not least of these agendas is the standardisation of
patent regimens by the World Trade Organization6 and assaults on
flexibilities in patent law by the World Intellectual Property
Organization.7
Ensuring access to medicines for those in need now depends more than ever
on the use of flexibilities in the Trade and Intellectual Property Rights
(TRIPS) scheme enshrined in the Doha Declaration.8 But Novartis' legal
challenge to section 3d of the Indian Patents Act is the most recent in a
series of developments that goes against the spirit of the Declaration.9
This challenge has far-reaching consequences that extend across the globe,
threatening access to essential generic medicines not only in India but
also in developing countries that import Indian generic medicines. Will
WHO take bold steps to defend health over competing interests, for example
by promoting implementation of TRIPS flexibilities in developing
countries, or will it again choose to stay silent? Worse, will it continue
to stifle dissenting voices from its staff, as it has done in the past?10
In April, WHO's Commission on Intellectual Property, Innovation and Public
Health outlined many of the key problems in research and development,
intellectual property, and access to medicines, and made several
recommendations.11 Mandated by the 2006 World Health Assembly to follow up
these conclusions, will the agency and its new leader have the resolve
necessary to seize this historic opportunity, and develop a global
framework for research and development driven by health needs and not by
commercial concerns?
Our questions can be rephrased more simply: will the WHO's Executive Board
choose a leader who is courageous enough to set the right health policies,
even if that requires standing up to vested interests, including those of
other international agencies, certain member states, and powerful lobbies?
We declare that we have no conflict of interest.
References
1. The Lancet. XDR-TB a global threat. Lancet 2006; 368: 964.
2. The Lancet. A missed opportunity?. Lancet 2006; 368: 1063.
3. MSF. Untangling the web of price reductions - a pricing guide for the
purchase of antiretrovirals for developing countries, 9th edn July 2006;
http://www.accessmed-msf.org/documents/untanglingtheweb…
(accessed Oct 16, 2006).
4. The Lancet. Responding to the global human resources crisis. Lancet
2004; 363: 1469-1472.
5. UNICEF, World Health Organization. World malaria report 2005;
http://www.rbm.who.int/wmr2005 (accessed Oct 16, 2006).
6. World Trade Organization. The legal texts: results of the Uruguay round
of multilateral trade negotiations. Cambridge: Cambridge University Press,
1999.
7. Geneva declaration on the future of the World Intellectual Property
Organization. October, 2004:
http://www.cptech.org/ip/wipo/futureofwipodeclaration.d…
(accessed Oct 16, 2006).
8. 't Hoen E. Access to medicines: why it's time to change the rules
published in 2006 Commonwealth Health Ministers Reference Book. Henley
Media Group, London: Commonwealth Secretariat, 2006:.
9. Barraclough E. Indian patent law under question. Managing Intellectual
Property Sept 26 2006;
http://www.managingip.com/?Page=9&PUBID= 198&SID=653222...
(accessed Oct 16, 2006).
10. Williams DC. World health: a lethal dose of U.S. politics. Asia Times
June 19 2006;
http://www.atimes.com/atimes/Southeast_Asia/HF17Ae01.ht…
(accessed Oct 16, 2006).
11. Commission on Intellectual Property, Innovation and Public Health. .
Public health, innovation and intellectual property rights April 2006;
http://www.who.int/intellectualproperty/en (accessed Oct 16, 2006).
Affiliations
a. Medecins Sans Frontieres, Geneva, Switzerland
b. MSF Campaign for Access to Essential Medicines, Geneva 1211,
Switzerland
c. MSF Campaign for Access to Essential Medicines, Paris, France
James.ARKINSTALL@paris.msf.org