PHA-Exchange> WHO to Debate Global R&D Framework

[Wim De Ceukelaire]

http://www.globalforumhealth.org/realhealthnews/RealHealthNews4.pdf

WHO to Debate Global R&D "Framework"
James Love
March 2006.
Real Health News. No. 4

On 27January, 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 Essential 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 regarding 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 different 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 models" for the development of medical science.

It called for the creation of a group of member states to consider
proposals to establish a global framework for supporting needs-driven
research, consistent with appropriate public interest issues, and for
a variety of other measures that were designed 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 resolution. 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 governments,
represented by their ministers of health - can reach consensus 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 appropriate 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 support
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 outcomes 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
inadequate. Much of the emphasis is on areas of particular relevance
to persons living in poverty, singling out for example the need for
new vaccines, diagnostics, and medicines, including microbicides, for
the treatment of AIDS, Tuberculosis and Malaria, as well as other
illnesses that disproportionately affect persons 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 private
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 "providing 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 fundamental right of every human being to the
enjoyment of the highest attainable standard of health and the
promotion of follow-on innovation." Concerns about access to medicine
are mentioned several 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 include a
large number of public health, development and public interest NGOs,
hundreds of well-known scientists, including several Nobel Prize
winners, and many economists and other experts, see the resolution as
a first step in a new approach to globalization 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, including
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 necessary step
in addressing the legitimate concerns that the globalization
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 countries
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 projects,
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 mechanisms that would ensure
equitable sharing of the costs of essential 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 important
initiative. For years the United States government has claimed it is
looking for new ways of getting its trading partners 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 meetings,
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 reconsider its position on the new global
framework. Like the US, Europe is facing a growing crisis of access
to the newest medicines 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
particular 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 positive 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 framework on]
essential health research and development  http://www.who.int/gb/
ebwha/pdf_files/EB117/B117_R13-en.pdf

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

A February 2005 experts letter to the EB, proposing evaluation of a
Medical R&D Treaty
English http://www.cptech.org/workingdrafts/24feb05WHOen.pdf
Français http://www.cptech.org/workingdrafts/24feb05OMSfr.pdf
Español http://www.cptech.org/workingdrafts/24feb05OMSes.pdf

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

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






________________________________________________________________________

Wim De Ceukelaire, south department
wim.deceukelaire at intal.be | tel.: +32 2 209 23 55 | fax: +32 2 209 23 51
| mobile: +32 484 119231
intal – http://www.intal.be | http://www.g3w.be
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