[A2k] SUNS: Overhaul of health R&D & alert on WHO publications policy

[Sangeeta]

NGOs call for overhaul of health R&D system
SUNS #6466 Wednesday 30 April 2008

Geneva, 29 Apr (Kanaga Raja) -- The medical humanitarian organization
Medecins Sans Frontieres (MSF) has called on governments attending a World
Health Organization health R&D meeting here to show the courage needed to
push essential reforms through, so that new life-saving drugs, diagnostics
and vaccines are developed for people in poor countries.

MSF was one of a number of NGOs that are currently in Geneva as the final
phase of talks get underway in a resumed second session of the WHO
Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG), which has been tasked to prepare a global
strategy and plan of action on essential health research to address
conditions disproportionately affecting developing countries.

The resulting draft global strategy and plan of action is to be presented to
the World Health Assembly in mid-May.

The first session of the IGWG was held on 4-8 December 2006. A second
session took place on 5-10 November 2007, but suspended its conclusion to
resume again from 28 April-3 May this year.

According to MSF, the more than 150 countries attending this session of the
IGWG have a chance to put right a great wrong. At the heart of the problem
is a broken system of medical research and development (R&D) which largely
disregards the health needs of millions of people in developing countries.

The failure of today's system is well illustrated by tuberculosis (TB), said
MSF, pointing out that the most widely used test to diagnose TB was
developed in the 1880s and actually misses more patients than it detects.
With the spread of resistant strains, the drugs to treat TB are growing ever
more ineffective, and are unable to stem the resurgence of the disease. But
funding for TB research remains virtually flat.

MSF said that new initiatives such as prize funds are being explored which
could help steer medical R&D towards where it is most needed, and find a way
of paying for medical R&D in a way that doesn't mean that drugs are priced
too high. MSF is looking for governments to support new mechanisms that
allow this to happen.

At a press briefing on Monday, Ellen T'Hoen of MSF's Access to Essential
Medicines Campaign thought that the IGWG process has real opportunities, and
that one of the opportunities of the IGWG is to move towards a more
health-needs R&D versus health R&D that is primarily driven by market
opportunities.

She was also of the view that the IGWG has an opportunity to make a real
advance to resolve the problems of access to and high price of medicines,
where patents and intellectual property rights are at the root of these
problems.

She also saw very interesting proposals on the table on having a more
pro-public health management of intellectual property.

She noted that the most important task of this process was to draw up
proposals that de-link paying for the cost of R&D from the price of the
product.

T'Hoen also highlighted some risks in the IGWG process, saying that MSF was
here not only to push the issues but also to monitor the process.

There are dangers in the sense that the IGWG may be used by certain
countries to push for a more restrictive interpretation of the Doha
Declaration on TRIPS and Public Health.

There is also a risk that the IGWG process will sanction or condone other
forms of monopolies, for example, through certain wording on data
exclusivity requirements or linking a system where drug regulatory agencies
cannot register drugs that are patented.

Another area of worry is the World Health Organization, said the MSF
activist. "We would like to see an enlarged and expanded role of the WHO in
this field. We think that the area of access and innovation has suffered
from the fact that the WHO has not been able to play a more pro-active role
in this field and we very much want that role to be expanded." She noted
that there seems to be a push to further minimize the role of the WHO.

The greatest risk is if this meeting is just going to be about
business-as-usual in that there isn't any real courage to explore new ways
of dealing with access and innovation.

T'Hoen pointed to proposals that have been tabled by Barbados and Bolivia
this week, where they have suggested a series of prize funds. "Those are the
kinds of new thinking that we really need to de-link paying for the cost of
research and development from high prices."

Sangeeta Shashikant of Third World Network said that one of the most
important outcomes of the IGWG process is for governments to give WHO
direction as to the role it should play in promoting access to medicines as
well as to promote R&D on health problems affecting developing countries.

"With regard to access to medicines, we see WHO as the primary public health
institution, and so it should have leadership on this issue, as opposed to
WIPO or the WTO which do not really have a key mandate on public health,"
she said.

She wanted to see WHO take a pro-active role on how to exploit flexibilities
on access to medicines; supporting from a public-health perspective
countries that are entering into IP negotiations; and highlighting the
negative impact of trade and investment agreements on access to medicines.

Whatever mandate is given to WHO in the IGWG process should not be diluted
by other WHO policies, she said, pointing, as an example, to a recent WHO
publications policy that was presented to the Executive Board in January.
This publication policy treats controversial issues differently from other
issues, she added.

The publications policy that has been put forward by the WHO to the
Executive Board seems to require something more than just a technical
review, because all publications, whether from regional offices or from
headquarters, would have to go through the Director-General's office.

It seems to require some kind of a political review of publications, which
would hamper the neutrality and independence of WHO, the TWN representative
said.

In the area of health R&D, the IGWG process needs to give a very strong
mandate to WHO to ensure that it assists developing countries to have a
better understanding of the assessment of public health needs, Shashikant
said.

"In this, we want to see a mechanism of prioritizing R&D which will be very
useful at the national and regional level for donors because they know these
are the priorities in the different countries and different regions," she
said, noting that there is no such mechanism currently that sees coherence
in R&D and the funding that goes to it.

There is also a need to look at new incentive models, new ways of looking at
R&D for health problems of developing countries. The general principle would
be de-linking the cost of R&D from the price of medicines, so that the price
of medicines is more affordable, she said.

Dr Maryam Hinds, Director of the Barbados Drug Service, highlighted six
proposals that Barbados and Bolivia decided to put together (and tabled at
the IGWG) as one of the innovative ways of thinking, and of rewarding
innovations. She said that the six proposals attempt to address different
solutions to promote R&D on specific issues.

(According to a working document by Barbados and Bolivia, the six proposals
are for the possible use of new incentive mechanisms for innovation that
separate linkages between rewards to innovation and the price of medicines,
vaccines, diagnostic kits and other health-care products.

(Each of the proposals attempt to address different solutions to promote R&D
on specific health issues - Proposal 1: Prize fund for development of
low-cost rapid diagnostic test for tuberculosis - initially resourced at
$100 million; Proposal 2: Prize fund for the development of new treatments
for Chagas Disease - resourced at $250 million; Proposal 3: Priority
medicines and vaccines prize fund; Proposal 4: Prizes as a reward mechanism
for new cancer treatments; Proposal 5: Licensed products prize fund for
donors; Proposal 6: a global agreement on the funding of clinical trials as
public goods, as one of the possible elements of a possible biomedical R&D
treaty.)

Spring Gombe of Knowledge Ecology International said that what is incumbent
upon member states to do is to consider ways to stimulate innovation and to
secure access to medicines both at the same time.

This is a complex challenge and the debate is very polarized with one side,
predominantly composed of rich countries, focusing on the question of who
will pay for innovation, and the other focusing on the question of how to
secure access for their populations.

"What we think is that the key is the price of medicines. We are using high
prices to secure research and development of medicines and by doing that we
are limiting of necessity a number of people who can access the medicines."

"So we are asking intelligent people, recognizing that this is both a
political and a technical challenge, to come together and to find a way that
doesn't treat these two issues (innovation and access) as if they are not
related to each other, because they are," she said.

She said that the negotiators need to come up seriously with concrete
proposals that establish a framework for how they will manage any of the new
ideas that they have generated.

She further said that the TRIPS Agreement, which to some extent deals with
the treatment of private goods, is not adequate to tell us how to deal with
public goods.

A new framework is needed for that, and the new framework needs to take into
account not just securing health, but also knowledge, which is another
public good, Gombe concluded. +