[Ip-health] SUNS: Public support for Kenya-Brazil move at WHO on health R&D

[Thiru Balasubramaniam]

*Health
Public support for Kenya-Brazil move at WHO on health R&D
*
*Geneva, 26 Jan (Kanaga Raja)* - A proposal by Kenya and Brazil to the
World Health Organisation's Executive Board to establish a framework for
research and development on developing-country diseases has received
broad support from public interest groups and parliamentarians.

Discussion on the draft Kenya-Brazil resolution started Thursday at the
117th session of the Executive Board, which is meeting here on 23-28
January.

The draft resolution calls for the establishment of a working group of
governments to consider proposals to establish a global framework for
supporting needs-driven research, consistent with public interest
issues. It also asked the WHO Director-General to ensure that bilateral,
regional and global free-trade agreements do not jeopardize the
flexibilities of the WTO's TRIPS agreement.

Since a draft of the resolution was made public some days ago, there has
been rapidly growing public support for it, and especially for its
proposal to set up a framework for defining global health priorities and
providing support for essential medical R&D.

The support has come from over 240 researchers and scientists in an open
letter to the WHO Executive Board, as well as from several Members of
the European Parliament from various countries (Netherlands, UK, Italy
and Finland) and different political groups (Christian Democrats, Social
Democrats, Liberals and Greens).

The MEPs sent a letter Monday to EU Commissioner Kyprianou (Health and
Consumer Protection Directorate General) and the EU Austrian Presidency,
expressing support for the draft resolution. The WHO Director-General Dr
Lee Jong-Wook was also sent a copy of the MEPs letter.

Non-governmental organizations such as Medicins Sans Frontieres (MSF)
have also come out in strong support of the draft resolution.

The draft resolution (EB117/Conf.Paper No.3) by Brazil and Kenya dated
24 January urges member states to make global health and medicines a
strategic sector, to take determined action to direct priorities in
research and development according to the needs of patients, especially
those in resource-poor settings, and to harness collaborative research
and development initiatives involving disease-endemic countries.

It also urged member states to take an active part, within WHO and with
other international actors, in the establishment of a framework for
defining global health priorities, providing support for essential
medical research and development predicated on the principle of
equitable sharing of the costs of research and development, and
determining incentives to invest in useful research and development in
the areas of patients' need and public interest.

Member states are urged to ensure that progress in basic science and
bio-medicine is translated into improved, safe and affordable health
products - drugs, vaccines and diagnostics - to respond to all patients'
needs, especially those living in poverty, and that essential medicines
are rapidly delivered to people.

The draft resolution requested the Director-General to establish a
working group of interested Member States to consider proposals to
establish a global framework for supporting needs-driven research,
consistent with appropriate public interest issues and taking note of
the work of the WHO Commission on Intellectual Property Rights,
Innovation and Public Health.

It also requested the Director-General to "ensure that bilateral,
regional and global free-trade agreements and other trade agreements do
not jeopardize the flexibilities of the TRIPS agreement and are in
accordance with the Doha Declaration on TRIPS and Public Health."

The Director-General is also requested to submit a progress report of
the working group of interested Member States to the Sixtieth World
Health Assembly (May 2008) and a final report with concrete proposals to
the Executive Board at its 121st session (January 2009), and to suggest
alternative systems for protection of intellectual property, with a view
to enhancing accessibility to new medicines.

In their open letter to the Executive Board, the over 240 scientists
expressed their support for the draft resolution, saying that they were
deeply concerned with deficiencies in the way that bio-medical research
science is supported and translated into treatments that improve health
outcomes around the world.

"In the research setting, we see many possibilities to develop drugs to
treat neglected diseases, but a lack of sustainable support for the R&D
process. In the clinical setting, we see the problem of affordable drugs
to a greater or lesser extent in health care systems in all countries,"
they said.

At a time of huge progress in basic research science and more money
being spent on bio-medical R&D than ever, the scientists were deeply
concerned about the ability of existing mechanisms to translate this
into a global improvement in public health.

"We have all felt the impact and promise of the free availability of
genome sequence data, notably from the human genome project. At the same
time we see research activities increasingly complicated by legal
restrictions, such as intellectual property rights, which can interfere
with free data exchange and can limit bio-medical research progress,"
the letter said.

"We do not see a good balance between medical need and resource
allocation in the existing system to support R&D. For example, there is
less focus on neglected diseases, vaccines or replacement antibiotics
than their potential impact on global health outcomes would justify."

The resolution appears to address all of these issues in a balanced way,
the scientists said. It does not seek to eliminate the use of patents to
incentivise commercial innovation, but instead allows other incentive
systems to be used alongside and considered under trade rules. It also
proposes long-term solutions to sustainable funding, prioritisation and
access issues.

Meanwhile, the MEPs in their letter said the European Parliament has
been and remains concerned about the fact that the vast majority of the
developing world's population does not have access to safe and efficient
diagnostics, drugs, and vaccines, either because these do not exist or
because they are unavailable or un-affordable.

Today, according to the WHO, less than 1% of new drugs reaching the
market address diseases that primarily afflict the poor, or are new
treatments which would have the greatest effect in world healthcare,
they said.

"We are convinced that the resolution provides an invaluable opportunity
for the WHO and its Member States to explore how priorities for
essential health research and development can be set. The proposal also
identifies as crucial the need to ensure sufficient and sustainable
funding for R&D initiatives that address the priority health needs of
patients in developing countries," the MEPs added.

At a press briefing Wednesday, Ellen T'Hoen, Director for Policy
Advocacy for Medicins Sans Frontieres, said that the draft Kenya-Brazil
resolution, if adopted, would address in a different way priority
setting in research and development for essential health tools, and will
also address the lack of sustainable financing. It will also give a very
important role to the WHO.

She welcomed the rapidly growing public support for different approaches
to health R&D. The draft resolution had also gained broad support in the
Executive Board, she said, although the US delegation had raised
concerns over the paragraph on trade agreements not jeopardizing the
flexibilities in the TRIPS Agreement.

According to Dr Bernard Pecoul, Executive Director of the Drugs for
Neglected Diseases Initiative (DNDi), the draft resolution was important
as there is urgent need for a needs-driven health research agenda.

DNDi called for a global framework, with governments in the lead in
setting an agenda of priorities, and giving financial support. Pecoul
said only about 10% of research funding is now coming from governments,
with the majority from philanthropic organizations.

In addition, governments have a role to set 'the rules of the game',
i.e. defining the framework and identifying obstacles to health R&D such
as lack of access to knowledge, he said.

According to an MSF briefing note, the lack of safe, appropriate and
affordable diagnostics, drugs and vaccines for neglected diseases is
striking. For instance, 60 million people are at risk of contracting
sleeping sickness. Treatment is based on a highly toxic arsenic derivate
in use since the 1940s and a former cancer drug from the 1980s.

Kala-azar kills 60,000 people each year, but antimony treatment
developed in the 1930s has remained the mainstay of therapy despite
considerable toxicity and the need for injections during the four-week
treatment.

MSF also highlighted the inadequacies of the current system for health
R&D, pointing out that while global spending on health research has
increased dramatically from $30 billion in 1986 to $105.9 billion today,
90% of this money is spent on the health problems of less than 10% of
the world's population.

This huge disparity in spending has dramatic consequences for the output
of new treatments by pharmaceutical firms. Between 1975 and 2004, of the
1,556 new chemical entities marketed globally, only 20 new drugs - a
mere 1.3% - were for tropical diseases and tuberculosis, diseases which
account for 12% of the total disease burden.