[Ip-health] IP Watch: UN Talks On Public Health Access and Innovation Face Challenges

[Judit Rius Sanjuan]

http://www.ip-watch.org/weblog/index.php?p=3D777&res=3D&res=3D1280_ff&print=
=3D0

10 October 2007

UN Talks On Public Health Access and Innovation Face Challenges
posted by William New @ 7:40 am
By Paul Garwood

Next month=92s round of negotiations on a United Nations plan to boost
access to medicines for the world=92s poor are set for a rough ride, with
countries and regions split on contentious issues such as intellectual
property rights and how to spur drug innovation for the benefit of all.

The World Health Organization=92s Intergovernmental Working Group on
Public Health, Innovation and Intellectual Property (IGWG) holds its
second session on 5-10 November in Geneva to try to finalise a draft
strategy and action plan on how to boost affordable drug discovery,
development and delivery for diseases, mainly those affecting the poor.
If completed, the draft will go before WHO=92s Executive Board meeting in
January 2008 and, potentially, to the World Health Assembly for
endorsement four months later.

At the heart of the plan is finding an optimal way to boost research and
development of affordable health care products so people, particularly
in developing countries, can receive treatment for diseases, with an
emphasis on neglected conditions including tuberculosis, malaria and
HIV/AIDS. But the interplay between rich and poor nations, the use of
flexibilities in international trade law for access to medicines, and
pressure from industry and civil society groups on crucial issues such
as IP and costs have handed WHO a daunting mandate to reach consensus on
a single strategy to meet the world=92s medicinal needs, according to sourc=
es.

Elil Renganathan, executive secretary of WHO=92s Secretariat on Public
Health Innovation and Intellectual Property, said the IGWG process is
the first to deal with the two most crucial aspects concerning
availability of health products: innovation and access.

=93It is clear we were never going to please everybody but we were trying
to make the process as open and transparent as possible and make sure as
many of the stakeholders are involved,=94 Renganathan told /Intellectual
Property Watch/. =93It is an extremely important process that is going to
have a major impact on innovation and access. The strategy is designed
to foster innovation, build capacity and improve access.=94

Making this happen is the hard part, with diplomats from some member
states questioning whether a compromise can be reached during only five
days of talks in Geneva.

=93There are so many actors and issues and we have to recognise the
possibility there might not be an outcome and that might mean that this
process is a failure,=94 said one official who asked to be identified only
as a Western diplomat. =93It would be unfortunate if that would be the
outcome.=94

Some developed countries, and the large pharmaceutical companies
operating within them, though in agreement on the need to stimulate
innovation on neglected diseases, are intent on ensuring that increased
access to medicines has no negative cost implications for the
drug-making industry, including loss of IP rights.

Call for Action, Leadership

But developing states and civil society groups argue more must be done
to stimulate innovation in health care products to treat neglected
diseases in poorer countries. They are also calling for increased access
to technology and knowledge, as well as capacity building, to help
produce affordable drugs, vaccines and diagnostics.

Ahmed Ogwell, head of international health relations at Kenya=92s Health
Ministry and a vice chair of the IGWG process for the African region,
said a new mechanism is needed to promote innovation of health care
products for neglected diseases.

=93Intellectual property has failed to ensure that access to health
products is possible amongst the poor, especially in Africa, so that
mechanism needs to be looked at and modified to respond to our needs,=94
Ogwell said. =93We need to look at all possible mechanisms to provide
funds so innovation is happening.=94

Ogwell was critical of the draft plan provided by the WHO Secretariat
ahead of the November meeting, arguing that it did not adequately
address the funding mechanisms needed to foster drug innovation in
markets where little profit exists for manufacturers. =93Intellectual
property is not the main issue here. If we don=92t have a proper financing
mechanism we won=92t be able address any objectives,=94 he said.

Funding mechanisms for drug research and development being floated in
the IGWG process include public-private partnerships, prizes for
innovators and advanced market commitments to subsidise the future
purchase of a vaccine not yet available.

The Kenyan official also slammed the WHO draft for not providing clear
enough guidance on who would lead the innovation and access
responsibilities in countries. =93The draft plan of action it is very
general about roles,=94 he said. =93There is a list of people going to be
responsible for a particular activity but it doesn=92t give a leader. We
must be very clear on who is responsible for delivery.=94

For weeks, regional groupings of countries, nongovernmental
organisations, industry groups and individuals have been pouring over
the draft document plan, which WHO officials said had to be as sweeping
as possible to include as many of the member state inputs as possible
before further refinement took place at the November meeting.

Consultations Ongoing

Efforts have started between South stakeholders to reach consensus on
key issues ahead of the session. =93It is critical that we seek consensus
with the other regions before the negotiations otherwise it will be very
taxing in terms of being able to do it in five days,=94 Ogwell said. =93We
are holding a lot of informal consultations across regions to thrash out
some difficult things before the meeting.=94

One such region is Latin America, led by countries like Brazil. The
Latin Americans are seeking greater access to health care product-making
knowledge, including the technological capacity needed to produce
generic drugs.

Rodrigo Estrela, of Brazil=92s UN mission in Geneva, said consensus among
the Group of Americas countries, including Latin American and Caribbean
nations, the United States and Canada, will be possible only if the
latter two agreed, at least in part, with the demands of the region=92s
developing countries.

=93It will be very difficult because many Latin American countries are
making proposals that change the entire nature of the secretariat=92s text
in some sense and we don=92t know if the United States would be willing to
accept that,=94 Estrela told /Intellectual Property Watch/.

WHO Trade Ties

Latin American countries want WHO to play a stronger role in promoting
the flexibilities in the 2001 Doha Declaration concerning the World
Trade Organization Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS), Estrela said. TRIPS contains flexibilities
allowing countries, particularly in the developing world, to issue
compulsory licenses to local manufacturers make generic versions of
drugs to safeguard public health in national emergencies or for
non-commercial purposes without seeking patent-holder approval. The Doha
Declaration reinforced these flexibilities.

=93Developed countries used to say IP rights were not an issue for WHO,
but instead for WTO,=94 Estrela said. =93Now it is clear that WHO has work
to do in this area, including supporting measures contained in TRIPS
regarding flexibilities.=94

A set of eight principles promoted in the Latin American submission,
which was formalised during a September meeting in Rio de Janeiro, was
among a number of documents the Western official criticised as being too
=93human rights based.=94

The Rio principles stress that the right to health protection is
universal and takes precedence over commercial interests. IP rights
should not restrict the promotion of technological innovation and the
transfer of technology, according to the submission. The Latin American
principles also stress the need to promote wide use of TRIPS provisions
and the importance of research and development into areas of greatest
importance for countries.

Geneva-based Thai diplomat Prangtip Kanchanahattakij agreed that the
IGWG process must enable developing countries to make better use of the
TRIPS flexibilities. =93We want to see capacity building to help countries
handle IP issues and TRIPS flexibilities,=94 Kanchanahattakij said.
=93Countries with experience in navigating the TRIPS flexibilities need to
share their experiences with developing nations needing access to
medicines.=94 Thailand has been a leader in making use of TRIPS compulsory
licensing provisions to produce AIDS anti-retrovirals, which has in turn
fuelled legal action and political wrangling with pharmaceutical
companies and Western capitals.

The Western diplomat said contentious issues on the IGWG agenda involved
data exclusivity, patent pools and the results of clinical trials, all
issues that revolve around access to knowledge. Some developed
countries, such as the United States, support the notion of data
exclusivity, which involves patent holders maintaining control over
information related to medicines and innovations. Such measures are
referred to as TRIPS-plus conditions, which run opposite to
flexibilities provided under TRIPS, and are obligations that poorer
countries often must accept to enter into bilateral trade agreements
with richer nations.

=93We continue to believe that it is important to protect IP rights and
innovation spurs the development of needed products,=94 the diplomat said.
=93At the same time there are things that countries, both developed and
developing, can do to stimulate more research in the area of neglected
diseases and come up with new financing mechanisms, from advanced market
commitments to prize funds.=94

The diplomat said there was opposition in the West to plans for a
research and development treaty, which Latin American and African
nations are supporting to help establish research priorities, as well as
identify funding needs and mechanisms. =93I don=92t think a treaty will wor=
k
because not many countries would become a party to it, including mine,=94
the Western official said.

Matti Rajala of the European Commission delegation in Geneva said WHO=92s
draft plan provided a good basis for talks in November and opportunities
existed for agreement, including in areas of boosting research and
development. But the upcoming meeting, he added, was still likely to be
challenging.

=93It will not be a very easy week in November, but we are coming to these
negotiations with positive and constructive points of departure,=94 Rajala
said. =93The areas of boosting needs-driven R&D are of utmost importance,
but the question is how can we make them work or push the development so
that there will be adequate resources in these endeavours. That remains
challenging.=94

=93There might be issues where solutions can be more easily found and some
where it could take very much effort,=94 added Rajala, saying he was
unable to elaborate.

Building on the CIPIH

M=E9decins Sans Fronti=E8res said the WHO draft plan risked =93failing to
build=94 on its pre-cursor, a report released by WHO=92s Commission on
Intellectual Property, Innovation and Public Health (CIPIH), claiming
the IGWG document did =93not sufficiently=94 advance CIPIH=92s findings and=
 60
recommendations that prompted the IGWG.

=93Some of the points of the plan of action seem to disregard the analyses
and conclusions of the CIPIH report and want to redo the work, or to
water down the language or strength of the report=92s recommendations
considerably,=94 MSF argued in its submission to the IGWG process.

In particular, MSF claimed the IGWG draft overestimated IP=92s role in
drug innovation, in which CIPIH reported that =93patents are not a
relevant factor in stimulating R&D and bringing new products to the
market=94 for diseases affecting millions in poor countries.

But WHO=92s Renganathan said the IGWG process had done its best to achieve
neutrality, while leaving the negotiations open for countries to decide
among themselves on the best way forward. =93Member states have different
interests and needs but I believe there is a spirit of wanting to work
together and come to a solution,=94 he said. =93We have tried our best to d=
o
this, but ultimately it is a member state-driven process.=94

/Paul Garwood may be reached at info@ip-watch.ch./

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--
Judit Rius Sanjuan
Attorney
judit.rius@keionline.org

Knowledge Ecology International (KEI)
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