[Ip-health] IP watch: WHO Session On IP And Health Clashes On Vision, Practicalities

[Judit Rius Sanjuan]

WHO Session On IP And Health Clashes On Vision, Practicalities


http://www.ip-watch.org/weblog/index.php?p=3D818


By William New with Kaitlin Mara

Government officials tasked this week through the United Nations with
finding ways to develop and deliver treatment for overlooked diseases
afflicting the globe=92s poor are making uneven but persistent progress in
negotiations.

Debate has been slow at times, according to participants, sticking on
the lofty introductory language to the draft text under negotiation,
which will form a strategy and the basis for an ensuing action plan. An
agreement was reached to keep open discussion of alternatives including
a research and development treaty. But disagreements have slowed
progress in areas such as access to drug compound libraries, and the
overall aim of the negotiations, participants said.

The World Health Organization Intergovernmental Working Group on Public
Health, Innovation and Intellectual Property (IGWG) is meeting from 5 to
10 November. The group has focused mainly on the strategy, and, with two
days left to go, some participants are projecting that another meeting
will be needed to finish work sometime early next year. The group must
complete work by the May World Health Assembly.

The basic problem being addressed by the group is that industry has not
been able to conduct research and development on some drugs
disproportionately afflicting the developing world because the markets
cannot meet the costs of drug development. Talks are occurring in two
groups simultaneously, each taking different sections of the draft text.
As of Thursday night, intellectual property provisions had not been
discussed directly.

Negotiations bogged down on the aim of the group, according to sources,
as the United States and possibly others balked at the suggestion that
the group is to come up with alternative incentive schemes, versus
complementary ones. This goes to a philosophical disagreement over
whether the existing system is working and might be added on to, or
whether significant change is needed.

The language on 8 November read: =93encourage and support the application
and management of intellectual property in a manner that maximizes
health-related innovation, especially to meet the R&D needs of
developing countries, protects public health and promotes access to
[health products]/[medicines] for all, as well as explore and implement,
where appropriate, [innovative]/ [alternative] incentive schemes for R&D
[to complement the existing ones].

Another sticking point on which agreement was not possible relates to
the creation of accessible compound libraries, especially in developing
countries, so that innovation might grow. Discord arose over the
dissemination of information, with caveats suggesting it be =93where
appropriate=94 and on a voluntary basis, sources said. The 8 November text
of Article 2.5 of Element 1 on prioritising R&D needs included language
that is not agreed on whether there should be open databases and
compound libraries that include unrestricted =93access to drug leads
identified through the screening of compound libraries.=94

One breakthrough, according to some participants, is the consensus to
continue discussions on instruments to address research and development
(R&D). The agreed language states: =93Encourage further exploratory
discussion on the utility of possible instruments or mechanisms for
essential health and biomedical R&D including inter alia an essential
health and biomedical R&D treaty.=94

This idea, which could potentially lead to the revamping of the global
system based on high drug prices to recover R&D costs, was embraced by
public health advocates, though it was downplayed by industry and US
sources.

=93We were all surprised to see the language of the R&D treaty move
forward without brackets,=94 said James Love, director of Knowledge
Ecology International, who credited Canada, India, Kenya, Norway, United
Kingdom and =93surprisingly=94 the United States.

Love said removing any reference to an R&D treaty was a top priority of
the pharmaceutical industry, and he called on industry to support it.
=93It=92s not an attack on them,=94 he said. =93It=92s really an attempt to=
 solve
some problems of identifying research priorities, finding money to do
things and setting other norms which advance the idea of research and
development.=94

Love added: =93I think this demonstrates that there=92s a growing consensus
that it=92s time for a consumer interest and the public health community
be more proactive and take charge of the R & D agenda.=94

Industry representatives denied privately that the R&D treaty was their
top priority, and said they were not opposed to the language as written
as it is rather broad and does not overtly call for a treaty. Developed
countries and their industries have been wary of any call for a treaty
negotiation on health and IP or innovation.

But another health advocate, who said generally that the text does not
sufficiently commit countries to action, said the R&D treatylanguage is
important to ensure global momentum is kept up to address the problems.
Funding is another key concern, the source said.

Yet others have raised concern that the text under negotiation does not
refer much to the predecessor report of the Commission on Public Health,
Innovation and Intellectual Property that led to the IGWG=92s creation.
Many of the issues being discussed here were addressed in carefully
negotiated terms in that process, which finished in 2006.

Negotiations are being taken rather seriously, some have sought to
remind officials that this is not a treaty negotiation and the outcome
is not legally binding.

Geopolitics at Play

As in any negotiation, attempts are made to form coalitions, or to break
up others=92. But reports suggest that efforts to prevent some policies
from getting through have reached beyond usual diplomacy. For instance,
the United States appears to have used pressure at the national capital
level prior to and outside of the working group meeting with the effect
of breaking up consensus among Latin American nations.

Apart from Colombia, which generally has remained close to the United
States on issues, there appeared to be general support in the region for
positions developed by a number of governments in Rio de Janeiro in
September. The document from what is now referred to as the =91Rio Group=92
includes principles aimed at ensuring social rights to public health
take precedence over intellectual property rights.

But Mexico has drawn criticism at the meeting for a surprise turnaround
in its position. It signed on to the Rio document but now in the meeting
has argued against the inclusion of provisions from Rio, which has led
to speculation of its being pressured by the United States.

Several Latin countries have reported receiving phone calls and
demarches from the United States. Demarches are high-level
intergovernmental communications hand-delivered directly from one top
official to another. According to a copy obtained by Knowledge Ecology
International, governments were warned that support for certain
provisions might violate the terms of bilateral trade agreements signed
with the United States. The use of demarches has been confirmed by
/Intellectual Property Watch/.

After being contacted, some health ministries were confronted with
trade, intellectual property, and foreign policy officials within the
countries, sources said.

Within the European Union, there also is some difference of opinion as
certain countries such as Sweden have been seen as taking a hard line
against the WHO=92s role in IP issues, and provisions on flexibilities
within the World Trade Organization Agreement on Trade-Related Aspects
of Intellectual Property Rights (TRIPS), according to a nongovernmental
participant.

Industry groups, according to a representative, are concerned about
preserving data exclusivity, which gives the rights holder control over
its test data for five to 10 years.

Many of the issues being debated were discussed at well-attended
Saturday event hosted by M=E9decins sans Fronti=E8res.

Chan Urges Progress

WHO Director-General Margaret Chan opened the second session of the IGWG
with a call to focus
<http://www.who.int/dg/speeches/2007/20071105_igwg/en/index.html> the
negotiations on the need for equitable access to medicine and the need
to stimulate R&D on health issues affecting primarily the developing world.

Public health, which she said is essential to achieve poverty reduction,
=93cannot move forward without innovation.=94 Such innovation is needed
constantly, both to extend treatment to people and places that are
underserved - either because little research has been done on diseases
that disproportionately affect their communities, or because diagnostic
and treatment methods are too complicated to be implemented in those
communities - and to ensure that available treatment keeps pace with
changing needs, as diseases mutate or sick individuals develop drug
resistance.

While acknowledging the complexity of issues surrounding research and
development of new medicines, especially those involving trade, legal,
and economic regulation, Chan pointed out the importance of
affordability in health care and also the urgency of implementing
workable solutions to public health problems.

/William New may be reached at wnew@ip-watch.ch./

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

Knowledge Ecology International (KEI)
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