[Ip-health] Bridges Weekly: WHO ADOPTS STRATEGY ON PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY

[Thiru Balasubramaniam]

BRIDGES Weekly Trade News Digest - Vol. 12, Number 19 28 May 2008


WHO ADOPTS STRATEGY ON PUBLIC HEALTH, INNOVATION AND INTELLECTUAL
PROPERTY

The World Health Organisation (WHO) concluded its annual high-level
meeting, the World Health Assembly (WHA), with the adoption of a
resolution endorsing a global strategy on public, health, innovation
and intellectual property. The resolution, the WHO's Plan of Action,
aims to promote new thinking on innovation and access to medicines and
to provide a framework for essential health research and development
relevant to diseases which disproportionately affect developing
countries. However, only parts of the Plan of Action giving effect to
this strategy were adopted. Disagreements on the wording of the
resolution persisted until the final hours of the meeting on Saturday
before a compromise was reached.

The resolution was the culmination of the two years of work by the WHO
Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG). Established in 2006 by the WHA, the IGWG
was asked to draw up a global strategy and plan of action on ways to,
inter alia, promote needs-driven, essential health research and
development on diseases that disproportionately affect developing
countries.

The meeting started on a positive note as Director General of WHO
Margaret Chan commended members for the "tremendous progress" made in
meetings of the IGWG, noting the reduction from nearly 200 to 18
unresolved paragraphs in the global strategy document.

An open-ended working group on the remaining intellectual property
(IP) paragraphs and other contentious issues was established and
started to work early in the week ending late Friday night. According
to a WHO official, this had been the longest working group in the WHO
negotiating history.

Ultimately, consensus was reached on a number of topics that were
considered controversial only a few years ago. For instance, the
Global Strategy stipulates that "research and development of developed
countries should better reflect the health needs of developing
countries." While it recognises that intellectual property rights
(IPRs) are an important incentive for the development of new products,
it also states that "this incentive alone does not meet the need for
the development of new products to fight diseases where the potential
paying market is small or uncertain."

On this premise, the strategy encourages governments to consider new
ways to stimulate research and development into health treatment for
diseases that disproportionately affect developing countries. Examples
of potential tools include prizes to reward drug development, a
biomedical research and development (R&D) treaty, and patent pools, in
which patent holders share technology to provide a common platform for
further innovation.

One of the contentious issues in the Global Strategy relates to a
principle advanced by a number of developing countries that the right
to health should take precedence over commercial interests. However,
due to significant opposition, particularly from developed countries,
consensus was not reached on this suggested language and it was
removed from the final document.

WHO as lead stakeholder?

With regard to the Plan of Action, there is need for further work on
timeframes, progress indicators, and estimated funding needs.
Differences also focused on the matter of deciding who would be the
primary stakeholders on a number of specific actions in the Plan of
Action. In particular, countries disagreed over whether WHO will serve
as the lead stakeholder on intellectual property-related actions in
relation to other intergovernmental organisations such as the World
Trade Organisation and the World Intellectual Property Organisation
(WIPO).

Disagreements on this point played out in the last hours of the
meeting. A number of developed countries supported an amendment
stipulating that the WHO Director-General would only implement actions
in the Global Strategy and agreed parts of the Plan of Action in which
WHO is a stakeholder. Developing countries argued that the amendment
could call into question the role of WHO in areas where it already has
mandates through existing World Health Assembly resolutions,
emphasising that the differences focused not on the WHO role per se as
a stakeholder, but on its role as the lead stakeholder for some
specific actions.

In attempts to find a compromise formulation, member countries made
different wording suggestions; ultimately, agreement was reached on
language that calls on the WHO Director General to take actions "in
implementing the global strategy and agreed parts of the [Plan of
Action] without prejudice to the existing mandates."

The resolution creates an expert working group to develop new and
innovative sources of funding to stimulate research and development to
address developing country health needs. The resolution also calls on
the WHO Director General to take immediate action to finalise the
outstanding components of the plan and to submit the final version for
consideration by the 62ndWorld Health Assembly in 2009. In the shorter
term, the resolution also instructs the Director General to prepare a
Quick Start Programme to immediately begin implementing the elements
of the global strategy and plan of action that fall under the
responsibility of the WHO. A progress report on the implementation of
the Global Strategy and Plan of Action is to be presented to the 2010
World Health Assembly.

"This is a major breakthrough for public health that will benefit many
millions of people for many years to come," said WHO Director General
Dr. Margaret Chan in her closing remarks on Saturday. "This is a
contribution to fairness in health and this is pro-active public
health at its very best."

Commenting on the outcome, German Velazquez, Director of the WHO's
Committee on Public Health, Innovation and Intellectual Property,
affirmed that it was a "legitimisation of the role of WHO in the area
of public health, innovation and intellectual property." He added that
the "negotiations witnessed substantive discussions which were
animated by a constructive spirit" and that ultimately "all sides had
to make concessions in order to reach a balanced compromise."

Several member countries also praised the meeting's outcome. At the
concluding session of the WHA, developed country representatives such
as Slovenia, in the name of the EU, and Norway, expressed their
satisfaction with the general result of the negotiations. Earlier in
the week, Secretary Mike Leavitt, of the US Department of Health and
Human Services, had indicated that, although the US had a well-defined
position on many issues under discussion, including matters relating
to intellectual property and innovation, it recognised the need to
come to an agreement and was committed to finding a solution.

According to one of the main Brazilian negotiators, the "Global
Strategy is the most important and significant multilateral document
in the area of public health and intellectual property since the
adoption of the Doha Declaration on TRIPS and Public Health in
(2001)." He indicated that ultimately the role of WHO in this area was
reinforced, making reference to paragraph 15 of the Global Strategy,
which stipulates that the "WHO shall play a strategic and central role
in the relationship between public health and innovation and
intellectual property within its mandates, capacities and
constitutional objectives, bearing in mind those of other relevant
intergovernmental organisations." He added that despite discussions
over whether WHO should be the lead stakeholder in implementing a
number of measures in the Plan of Action, the principle of its role
was not contested.

Another developing country negotiator stressed the importance, in such
a long and complex process, of considering the wider picture, pointing
to the fact that "the most important achievement was a substantial
mind shift to advance a public-health-oriented needs agenda." He added
that strengthening the role of WHO in the relationship between public
health and intellectual property, and encouraging the full use of all
flexibilities to guarantee access to health care products are both
important aims of the Global Strategy and parts of the Plan of Action.

Jamie Love of Knowledge Ecology International hailed the meeting as a
"big step forwards taken by WHO to change the way we think about
innovation and access to medicines." He was particularly impressed
with the adopted language on the use of compulsory licensing and other
flexibilities to protect public health, the continued and expanded
support for work on a biomedical research and development treaty, and
the use of new mechanisms, such as prizes, to provide innovative
incentives that are not linked to product prices. He added, however,
that it was unfortunate that the WHA still has not created an estimate
of funding needs for priority R&D, nor has it developed a framework
for sustainable sources of funding. Love pointed to the fact that the
WHO Secretariat has yet to engage on the issue of new mechanisms that
de-link R&D incentives from product prices.

M=E9decins sans Frontiers also praised the outcome. "Countries have
pledged to give health interests the pre-eminence they deserve when
considering how to manage IP," said Dr. Tido von Schoen-Angerer,
Director of MSF's Access to Essential Medicines Campaign. "Some
important steps in the right direction have been made. The expert
working group now needs to take serious steps to move forward with a
set of practical proposals that are on the table. It needs to take on
more ambitious proposals to change the way essential health R&D is
financed."

The European Generics Association (EGA) expressed its satisfaction
that the provision in the Global Strategy and Plan of Action that
would have encouraged information sharing on data exclusivity had been
dropped. According to Lidia Mallo of EGA, data exclusivity "is not an
incentive for R&D and is related to the pharmaceutical regulatory area
and not to intellectual property issues and should not be used as a
market exclusivity tool."

Also discussed at the WHA was a draft resolution aimed at
strengthening WHO involvement in anti-counterfeiting of medicines.
However, that issue was ultimately deferred to the WHO Executive Board
meeting, to be held in January 2009.

ICTSD reporting


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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997