[Ip-health] SUNS: R&D resolution, with brackets, to be transmitted to WHA

[Thiru Balasubramaniam]

*Health
R&D resolution, with brackets, to be transmitted to WHA
*
*Geneva, 29 Jan (Sangeeta Shashikant)* - The WHO Executive Board agreed
last Friday evening to send the draft resolution proposed by Kenya and
Brazil on "Global framework on essential health research and
development" to the 59th World Health Assembly (WHA) for its consideration.

However, many parts of the draft that could not be agreed on were placed
in square brackets, with the task given to the WHA (which meets in May)
to sort out the differences in positions among the member states.

Many developing countries and civil society organizations that have
supported the Resolution saw the Decision as a significant step towards
creating a global framework on essential health R&D.

The decision was taken after a small group of Board members met last
Thursday and Friday to discuss the text of the Resolution. During these
discussions, many aspects of the proposed Resolution were opposed by
several developed countries such as Japan and the US, which is why much
of the final version of the Resolution that was agreed by the Executive
Board for submission to the 2006 WHA remains in brackets.

Several parts of the preamble of the Resolution that was proposed by
Kenya and Brazil were also deleted. In particular, there was objection
to there being any reference in the preamble of the Resolution to the
UNDP's Human Development Report 2005 that states that "the WTO's Trade
Related Intellectual Property Rights (TRIPS) agreement, along with
'TRIPS plus' variants in regional and bilateral agreements, strikes the
wrong balance between the interests of technology holders and the wider
public interest".

The Resolution comes at a time when there is increasing realization of
the need to develop affordable medicines for illness that primarily
affect the poor especially considering that resistance to many of the
medicines for tuberculosis, AIDS and malaria is growing.

Also, many NGOs and some legal experts have criticised the trend that
many new drugs being patented and sold are so-called "me-too" drugs that
do not provide incremental benefits over existing ones. Prioritizing R&D
into safe and affordable new health products, drugs, vaccines and
diagnostics is thus seen as crucial for developing countries.

The main aim of the Brazil-Kenya Resolution, which is based on the
principle of equitable sharing of the costs of R&D, is to create a
global framework to direct R&D priorities so that it addresses the needs
of the people particularly in the poor countries.

The draft resolution urges member states to emphasise priorities in R&D
addressed to the needs of poor patients and harness collaborative R&D
initiatives involving disease-endemic countries; establish a framework
for defining global health priorities in support of essential medical
research and development based on the principle of equitable sharing of
the R&D costs of research and incentives to invest in R&D in the areas
of patients' need and public interest; ensure that progress in basic
science and bio-medicine is translated into improved, safe and
affordable health products to respond to all patients' and clients'
needs; encourage that bilateral trade agreements take into account the
flexibilities contained in the WTO TRIPS Agreement and recognized by the
Doha Declaration on TRIPS and Public Health.

The draft resolution also requests the WHO Director-General to establish
a working group of interested Member States to consider proposals to
establish a global framework for supporting incentives and mechanisms
for needs-driven research, consistent with appropriate public interest
issues; submit an annual progress report on the working group and a
final report and to suggest alternative simplified systems for the
protection of intellectual property, with a view to enhance
accessibility to health innovations and building capacity for product
development uptake and delivery in developed and developing countries.

The text is heavily bracketed, with alternative texts given, denoting
lack of agreement.

Prior to the discussions on the Resolution last Thursday, there was some
controversy over how to deal with the Resolution and the Report by the
Commission on Intellectual Property Rights, Innovation and Public Health
(CIPIH). Several countries such as Canada, Bolivia, Luxembourg,
Australia and Portugal on behalf of the European Union, were of the view
that discussion on the Resolution should await the Report of the
Commission (which is expected to be released in April) and a discussion
on it by a smaller group of the Executive Board representatives that
would convene for that purpose.

Kenya and Brazil noted that there was urgency in discussing the
Resolution and there was no need to wait for the Report to discuss the
Resolution.

The WHO Secretariat suggested that the Commission Report should be
followed by a resolution that will be prepared by the Secretariat,
taking into account the comments of the smaller group that would
convene. In response, Kenya and Thailand said it was early to judge
whether a resolution on the Report was necessary. Thailand stressed that
there should not be two conflicting resolutions at the 2006 WHA.

The controversy over procedures came about as both the items were being
discussed together at the Executive Board last Thursday.

The Chairperson of the Commission Madame Ruth Dreifuss confirmed that
the Report of the Commission was not ready and said that it is expected
to be finished by April. She said that the reasons for the delay was
because of the "method of work" i.e. the consultations that took longer
than planned, the "ambition" of the Commission and the "difficulties"
faced in trying to obtain consensus among its 10 diverse members.

She said that the report had been completed but the Commission has to
shape recommendations and proposals for action and sketch the next stage
for WHO.

Several countries expressed disappointment at the delay by the
Commission in finishing the report, which had been scheduled to be
presented to the present Board meeting.

Kenya, on behalf of the African Region, expressed disappointment that
there was no CIPIH report. It said that there was a serious need to
analyse the systemic and current issues on R&D. Access to products of
R&D and vaccines is key to health in Africa. It also said that support
to health must be seen in the larger context of human development. All
efforts to support developing countries will not yield positive results
if access to new product R&D is not put in place, it added.

It stressed the African Group's interest in needs-driven R&D, stating
that the current structure is inadequate and said that the WHO has a
role to play in assisting countries to achieve the Millennium
Development Goals.

It added that because of the urgency of the matter and the growing
concern over the lack of support in R&D and increase in people that lack
access to medicines, it has proposed the Resolution.

Brazil also expressed disappointment that the report was not ready and
reiterated that there are great problems faced by peoples in having
access to vaccines, drugs and diagnostics. On its joint proposal with
Kenya, it said developing countries must participate in the research
activities and it was urgent that the problems be dealt with.

The Resolution by Kenya and Brazil was supported by Sudan, Guinea
Bissau, Bhutan, Jamaica and Lesotho during their interventions. On the
CIPIH report, Bolivia insisted that the Executive Board (EB) has to look
at the report prior to the Assembly, have a position and give an opinion
on it. It proposed that a group from the EB, representing the different
regions, discuss the report prior to the Assembly. It said that the
Resolution by Kenya raised big queries and the EB cannot take a stance
before knowing all the reports, thus it was important for the sub-group
to digest the CIPIH report before the Assembly.

Canada acknowledged that the issues raised in the Resolution were of
great importance and that it is committed to participate in the search
of a solution to the problem of affordable access to medicines and
development of medicines particular to those poor that carry the
heaviest disease burden. It also said that if there is no consensus,
there should be transparency of divergence of views and there should not
be undue delay.

On the Kenya Resolution, it said that it was necessary not to pre-empt
the completion of the Commission's work but to build upon the
Commission's research and consensus on practicable solutions. It agreed
with Bolivia's suggestion. The Canadian suggestion was also supported by
Australia, Portugal on behalf of the EU and Luxembourg.

Thailand, supporting the Kenya and Brazil Resolution, said that there
were 9 more years to go to achieve the Millennium Development Goals. It
also said that the target may not be achieved by the least developed
countries in Africa and South Asia. It added that if the proposal of
Bolivia is taken up, it will delay the entire process and it will be
three to four years before any action is taken. It made a plea to the EB
that the Resolution be considered by the 2006 WHA. Kenya, responding to
the procedural issues, said both its resolution and the resolution on
CIPIH could proceed at the same time. Brazil, in support of Kenya,
emphasized that little time was available and that it was very important
to discuss the draft resolution that has been submitted.

A senior official from the Director-General's Office said that there was
strong support for discussion on the Resolution to proceed. Following
Bolivia's proposal, it suggested that two Members from each region
participate in a group to meet in Geneva once the CIPIH report is out.
The open-ended group can formulate thoughts on the report which then
will be submitted to WHA. The Secretariat said that it will prepare a
Resolution on the Report to go to the WHA.

Both Kenya and Thailand raised the fact that the outcome of the group
that will meet on the Report should not be anticipated, particularly on
whether there needs to be a Resolution. The latter was particularly
concerned that the resolution by the Secretariat on the Report may send
a wrong signal and stressed that there should not be two conflicting
resolutions.

The Resolution has also received very strong support from the civil
society organizations. Consumers International, representing 234
consumer groups and organisations in 113 countries, read a statement in
support of the Resolution. The statement is also endorsed by Medecins
sans Frontieres' Access to Essential Medicines Campaign, Health Action
International, Medico International, Third World Network and Consumer
Project on Technology.

It said that the Resolution "provides a new way of looking at
innovation" and the Resolution "correctly recognizes the important role
of both public and private sector R&D efforts". The Resolution
"acknowledges the importance of providing the right balance between the
protection of intellectual property and the public domain, and the need
to implement intellectual property rules in a way that is consistent
with human rights, the public interest and the promotion of follow-on
innovation", it said.

The organizations are of the view that there is a "need for a balanced
global framework for R&D" i.e. "a mechanism that encourages R&D in areas
of priority, while allowing governments to protect consumers from high
prices and access barriers" and the Resolution is "a step in that
direction".

"Unfortunately, a sense of urgency that resulted in swift and efficient
responses to the SARS outbreak and the potential avian flu pandemic is
entirely lacking when it comes to R&D for diseases that predominantly
affect poor people in developing countries," CI added.

The CI said that "WHO as the global health agency is well placed to host
and encourage the discussion on a new global framework that will ensure
that medicines, diagnostics, vaccines and other essential health
technologies are developed and made available to all".

Sir John Sulston FRS, Nobel Laureate and Former Director of the Wellcome
Trust Sanger Institute in UK, read an open letter to the Executive
Board, that was signed by over 240 scientists expressing support for the
Kenya and Brazil 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 at a time of huge progress in basic research science and more
money being spent on bio-medical R&D than ever before.

Following the Board's decision to transmit the Resolution to the 2006
WHA, Consumer Project on Technology, stated that "WHO took an important
step forward in addressing the issues of setting priorities, and
determining how to share the costs, for essential health research and
development R&D)".

It referred to the heavily bracketed text of the Resolution and
expressed the need for "a more positive engagement from developed
countries" for the process to move on. It asked the US to "reconsider
its largely negative posture toward the resolution" as the world leader
in funding public sector health R&D projects, and the EU to evaluate
it's position, and see the value of a new global framework that
emphasizes R&D contributions rather than high drug prices, as EU members
increasingly struggle to provide their own citizens with access to
important new medicines.

It also applauded the governments of Kenya, Brazil, Thailand and South
Africa for having played a particularly important role in moving the
initiative forward.

It added that the developing world is reeling from an onslaught of
highly harmful bilateral trade pressures from the US, the European
Community and Japan, which will lead to higher drug prices and
predictable access problems and that the 2006 WHA should address this
issue, perhaps calling for a moratorium on such agreements. This might
be more effective if done in a separate resolution.