E-DRUG: MSF on WHO Assembly
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[A copy of the MSF background paper to the WHO Assembly, which is
discussing a report on the WHO Essential Medicines Strategy. WB]
55th World Health Assembly
Regarding Access to Essential Medicines
13 May 2002
Research and Development for Drugs for Neglected Diseases
The past thirty years have witnessed unprecedented improvements in
global health, but the benefits of these advances in medicine have not
been distributed evenly. For people suffering from diseases for which
treatment options are inadequate, or do not exist, the future looks
bleak. They continue to receive archaic treatment because little is
being done to find new cures to treat diseases such as malaria,
tuberculosis, leishmaniasis, sleeping sickness and Chagas disease,
which affect populations with little purchasing power and no advocacy
groups. WHO has so far failed to play a leadership role and minimises
the R&D crisis by almost exclusively focusing on existing tools.
By acknowledging and actively communicating on the extent of the
crisis, WHO could mobilise additional activity in both the private and
public sectors. WHO must help set the research agenda for diseases
that have fallen off the radar screen of private industry and received
little attention from public research institutes.
Instead of helping countries learn to live with an ever shrinking pool
of effective drugs for neglected diseases, WHO should make R&D a part
of its overall strategy to increase access to essential medicines.
Yet, the issue of R&D for drugs for neglected diseases is absent from
this year's World Health Assembly. Radical new approaches are needed
to kick-start R&D, including new funding mechanisms in areas that are
now totally abandoned. At current funding rates, both TDR and newer
partnerships for R&D are condemned to failure.
The Doha Declaration on TRIPS and Public Health
2001 was marked by progress in the discussions on intellectual
property barriers to access to medicines at the World Trade
Organisation (WTO) and clear primacy given to public health over
intellectual property. The Doha declaration on TRIPS and Public Health
clearly laid out the measures countries can take when prices of
existing patented drugs are too high for their people to afford.
However, certain outstanding issues urgently need addressing. In
particular, action must be taken to overcome the practical hurdle of
Article 31.f of the TRIPS Agreement, which requires compulsory
licenses to be used "predominantly for the supply of the domestic
market". This clause prevents countries that are not able to produce
medicines from making effective use of compulsory licenses.
It is time for WHO to take a leadership role in the trade and health
area. Passive observation is not sufficient and betrays the mandate
given by previous Health Assemblies for the WHO to become actively
engaged in trade and health. The issue of access to medicines should
not be left to experts at the WTO and WIPO who do not have health as a
central part of their mandate. In June, when the TRIPS Council
discusses the export issue related to compulsory licensing, WHO should
go on record with recommendations supporting the developing countries'
call for exceptions to allow export of essential medicines produced
under compulsory licensing. WHO should also continue monitoring the
effects of TRIPS on access to medicines, and provide practical
technical assistance to countries implementing the Doha declaration.
Malaria treatment
On Africa Malaria Day this year, boldly challenging the status quo,
WHO urged countries faced with growing resistance to classical
antimalarials to switch to more effective artemisinin-based
combination therapy (ACT). This treatment has been used successfully
in China for decades and in South East Asia for more than ten years.
A key barrier to switching to ACT is that it is ten to twenty times
more expensive than currently used antimalarials. Some developing
countries have indicated that they will switch to ACT only if promised
long-term international help to subsidise the increased cost. So far,
only Zanzibar has received international funding to introduce ACT on a
widespread basis (through the Global Fund). At least ten African
countries need urgent financial support to stem mounting resistance
and associated mortality. Endemic countries will need to increase
their funding for malaria, but without international help it will be
impossible to meet the ambitious millennium goals of halving malaria
mortality in Africa by 2010.
It is not acceptable that an African child dies of malaria every
thirty seconds when safe and effective treatment is available.
Recommendations regarding choice of treatment are a very positive
first step, but WHO/RBM must now lay out clear plans for rapid
implementation of ACT in countries with high levels of resistance,
including changes of national protocols. This can be accomplished
through technical support and advocacy for more funding. In-country
support so far has at best been patchy and at worst detrimental.
WHO/RBM can also assist countries by validating additional and less
expensive sources of artemisinin derivatives (as is being done for
antiretroviral drugs).
Essential Medicines List (EML)
Last month, the Essential Medicines Committee added ten antiretroviral
drugs to the core essential medicines list (EML). WHO also published
specific guidelines for HIV/AIDS treatment, practical monitoring
standards and simplified regimen recommendations. Together, these
tools should help developing country governments to implement
antiretroviral treatment programmes.
The process for adding or deleting medicines to/from the list was also
revised, making it faster, more transparent, and based on systematic
reviews of scientific evidence. MSF particularly welcomes the fact
that expensive drugs will no longer be excluded from the list solely
because of price.
But the fact remains that prices of medicines, in particular
antiretrovirals, are still too high. WHO should use its technical
expertise to help countries enact measures to bring down prices both
by stimulating competition (through compulsory licenses and parallel
imports) and working toward unrestricted systematic differential
pricing policies..
Prequalification of generic manufacturers
In March this year, the World Health Organization released its first
list of prequalified AIDS drugs, including patented drugs and generic
versions. The list included 41 different drug formulations, of which
11 were antiretroviral drugs and five were drugs for opportunistic
infections of HIV/AIDS. This list will be of great assistance to
countries seeking to gain access to affordable HIV/AIDS drugs without
compromising on quality. It will also facilitate procurement that will
take place as a result of the activities of the Global Fund for TB,
malaria and HIV/AIDS.
MSF urges WHO, as part of its standard-setting role, to expand
pre-qualification work to drugs for malaria, tuberculosis and other
major infectious diseases, and urges Member States to increase
financial support for these efforts.
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