[afro-nets] WHO to Debate Global R&D Framework

[Claudio Schuftan <claudio@hcmc.netnam.vn>]

WHO to Debate Global R&D Framework
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from Wim De Ceukelaire <wim.deceukelaire@intal.be>


WHO to Debate Global R&D "Framework"
By James Love
March 2006
Real Health News. No. 4
http://www.globalforumhealth.org/realhealthnews/RealHealthNews4.pdf

On 27 January, 2006, the World Health Organization Executive
Board - a small group of states that prepares the programme for
the coming World Health Assembly in May - agreed to forward for
debate a resolution concerning a new "Global Framework on Essen-
tial Health Research and Development."

The debate over this resolution is an attempt to involve the WHO
in a new role of pro-actively re-shaping global policies regard-
ing the support for R&D for new medicines. It is controversial.
First submitted by the governments of Kenya and Brazil, the
original version of the resolution touched on a number of dif-
ferent aspects of the global system for supporting medical R&D,
including topics such as the equitable sharing of the costs of
R&D; the need for better priority setting ("needs-driven R&D");
the importance of both access and innovation, including follow-
on innovation; various problems concerning intellectual property
rights and trade agreements; and the promise of new "open mod-
els" for the development of medical science.

It called for the creation of a group of member states to con-
sider proposals to establish a global framework for supporting
needs-driven research, consistent with appropriate public inter-
est issues, and for a variety of other measures that were de-
signed to promote access to medicines and a needs-driven R&D
agenda.

The 1,200 word version of the resolution that emerged from the
WHO EB (EB117.R13) contained most but not all of the original
ideas, but also a number of proposed modifications, including
several that would weaken or change the direction of the resolu-
tion. There are now 32 areas where the text of the resolution is
bracketed, including even the words "Global Framework" in the
title, indicating divisions among the WHO EB members on the most
important issues.

The existence of so many areas of disagreement raises questions
about the degree to which the WHA members - the world's govern-
ments, represented by their ministers of health - can reach con-
sensus on the proposal at all, or if they do, what the final
product of negotiations will look like.

Nevertheless it is a remarkable effort to fashion the landscape
for financing R&D on new medicines, and if it is embraced, it
could open the way for a new and important way of addressing
medical R&D at the global level.

A Global Framework for Essential Health R&D

But what would a "global framework" for needs-driven health R&D
actually look like? By definition, a framework is a "basic
structure underlying a system." This could take many different
shapes.

Brazil and Kenya's proposal for the creation of a working group
of member states to consider the global framework would be a
first step - a step toward multilateral negotiations, open to
any interested country, to discuss and set norms about the ap-
propriate level of support for medical R&D, and the creation of
new mechanisms to address priority setting for R&D.

It could be a simple set of 'soft' norms, such as a suggestion,
without enforcement, that a certain percentage of a country's
global GDP or health care budget supports essential medical R&D.

It could also be a more formal obligation, such as an agreement
or treaty that required members to directly or indirectly sup-
port medical R&D.

It could also include new mechanisms to identify priority R&D in
areas of greatest need, opportunity or benefit, and incentives
or obligations to address these priorities.

It could address issues of technology transfer and capacity
building in developing countries.

Such a framework could be completely outside of and separate
from other frameworks that support medical R&D, like existing
provisions in trade agreements such as the WTO's TRIPS agreement
or the many bilateral accords that touch on drug patents or drug
prices.

But it could also be a model for an alternative and competing
paradigm, based upon public health perspectives, that could
eventually replace the older agreements, in terms of determining
who will pay for the costs of R&D for new medicines. The choice
of the word 'framework' is general enough that any of these out-
comes are possible. The resolution simply opens the door for
discussions on these topics to start. It does not say how they
will conclude.

The need for a new framework to support innovation

The resolution notes a number of areas where medical R&D is in-
adequate. Much of the emphasis is on areas of particular rele-
vance to persons living in poverty, singling out for example the
need for new vaccines, diagnostics, and medicines, including mi-
crobicides, for the treatment of AIDS, Tuberculosis and Malaria,
as well as other illnesses that disproportionately affect per-
sons living in poverty in developing countries.

But the resolution also addresses other concerns, such as the
importance of the development of treatments for diseases that
have small client populations (often referred to as 'orphan'
diseases in the US or Europe), and more broadly, it notes that
more than 70% of all new drug approvals are for medicines that
do not provide incremental benefits over existing ones.

The resolution also makes reference to the importance of global
public goods, such as the Human Genome Project, and other "open
and accessible public research in advancing science and the
transfer of technology."

The resolution recognizes the importance of both public and pri-
vate investment in the development of new medical technologies.
It states that intellectual property rights are one of several
important tools to promote innovation, creativity, and the
transfer of technology, but also notes the importance of "pro-
viding for a proper balance between intellectual property rights
and the public domain," and "the need to implement intellectual
property rules in a manner that is consistent with the fundamen-
tal right of every human being to the enjoyment of the highest
attainable standard of health and the promotion of follow-on in-
novation." Concerns about access to medicine are mentioned sev-
eral times.

Reconciling access and innovation

The resolution notes the need to "reconcile the public interest
in accessing the products derived from new knowledge, with the
public interest in stimulating invention."

Civil society supporters of the proposed resolution, which in-
clude a large number of public health, development and public
interest NGOs, hundreds of well-known scientists, including sev-
eral Nobel Prize winners, and many economists and other experts,
see the resolution as a first step in a new approach to global-
ization that addresses the issue of R&D for new medicines as a
public health matter, rather than strictly commercial concern.

The TRIPS accord of the WTO and the plethora of new bilateral
and regional trade agreements that deal with drug patents and
other measures that raise drug prices are seen as:

* raising barriers for access to medicine everywhere

* ineffective in promoting certain types of medical R&D, includ-
ing investments in global public goods, or the development of
medicines that are most relevant to persons living in poverty.

A new approach of focusing directly on the need to support R&D,
with a realistic discussion of who will pay, is seen as a neces-
sary step in addressing the legitimate concerns that the global-
ization mechanisms provide sustainable sources of finance for
R&D.

By recognizing the importance of both public and private sector
investments, and the need to also address market failures and
priority setting, the new framework can be a better mechanism -
one that helps rather than hurts consumer interests.

In the January debate over the resolution, most developing coun-
tries on the WHO EB supported the resolution. Unfortunately,
most countries with annual per-capita incomes greater than US$
10 000 were less supportive. The United States, Japan and the
European Union (which acted on behalf of its member states) all
sought a number of changes that would cumulatively reduce the
resolution to a highly general appeal to provide more incentives
for pharmaceutical companies to invest in neglected diseases.

These countries insisted on brackets on virtually every mention
of global public goods, the public domain, open research pro-
jects, public sector financing of research, or market failures
outside of infectious diseases, and they also put brackets
around every mention of the need to provide for global mecha-
nisms that would ensure equitable sharing of the costs of essen-
tial medical R&D.

Without support from the US, Japan and the EU, there will not be
a new global framework - only an increasing emphasis on more and
more bilateral and regional trade agreements that raise drug
prices.

The high-income countries, particularly the United States,
should reconsider their initial negative reaction to this impor-
tant initiative. For years the United States government has
claimed it is looking for new ways of getting its trading part-
ners to share the costs of medical R&D. This is of course the
rationale for the many new global trade agreements, such as the
US/Australia Free Trade Agreement (FTA), or the many similar
agreements recently negotiated with developing countries.

The US has also made several announcements at recent G8 meet-
ings, calling for broader participation in global open source
projects to develop new vaccines for AIDS and other public
health threats, like SARS or avian influenza. If they reject
this effort, it will appear as though they are more interested
in getting higher prices for the products US companies sell,
than on actually doing something constructive and positive with
regard to the sharing of R&D costs. Europe should also recon-
sider its position on the new global framework. Like the US,
Europe is facing a growing crisis of access to the newest medi-
cines for severe illnesses, like cancer. If Europe continues to
back only those globalization initiatives to boost drug prices
at the expense of access, its own consumers, including in par-
ticular the new members of Europe, will face their own access
problems.

The Kenya/Brazil proposal, which will be debated in May 2006,
should not be seen as a North/South fight, but rather as a posi-
tive measure - one that takes a balanced look at the R&D issue,
and calls for serious negotiations on the core issues of who
will pay for R&D, and what type of R&D do we really need? This
can be an example of good globalization.

READ ON

WHO Executive Board draft resolution EB117.R13: [Global frame-
work on] essential health research and development
http://www.who.int/gb/ebwha/pdf_files/EB117/B117_R13-en.pdf

The draft text of an expert's proposal for a Medical R&D Treaty
http://www.cptech.org/workingdrafts/rndtreaty.html

A February 2005 expert's letter to the EB, proposing evaluation
of a Medical R&D Treaty
English http://www.cptech.org/workingdrafts/24feb05WHOen.pdf
French http://www.cptech.org/workingdrafts/24feb05OMSfr.pdf
Spanish http://www.cptech.org/workingdrafts/24feb05OMSes.pdf

Open letter from scientists in support of World Health Organisa-
tion resolution proposed by Brazil and Kenya
http://www.whoscientistsletter.org/

Neglected Diseases R&D Appeal
http://www.researchappeal.org/