[e-drug] WHO IGWG outcome - Most Important Document Since Doha, IP & Public Health

[e-drug@healthnet.org]

E-DRUG: WHO IGWG outcome - Most Important Document Since Doha, IP & Public Health
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[Here is a comprehensive summary of the outcome of the WHA negotiations on IGWG. Cross posted from IP-HEALTH with thanks. WB]

http://www.ip-watch.org/weblog/wp-trackback.php?p=1067 
Intellectual Property Watch
29 May 2008

WHO Adopts Most Important Document Since Doha On IP And Public Health
By William New

The annual World Health Assembly on Saturday adopted a global strategy
aimed at filling the research gap for diseases afflicting developing
countries that places the UN agency squarely in global intellectual
property policymaking and despite compromises is the most significant
reference document on IP and public health in years, according to
sources involved in the drafting.

This is the most important document since the Doha Declaration on
Public Health, said a leading developing country official negotiator.
It deals with many issues to some extent not dealt with in the Doha
Declaration.

That declaration from the 2001 World Trade Organization ministerial in
Doha, Qatar reaffirmed flexibilities in applying rules in the 1994 WTO
Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS) available to developing countries.

World Health Organization Director General Margaret Chan in her closing
remarks to the assembly plenary called the outcome on IP and innovation
a huge step forward. With it, she said, public health leaps
ahead in addressing two fundamental and long-standing needs: to improve
access to existing interventions, and to include diseases of the poor in
the drive to develop new products.

This is a major breakthrough for public health, and I congratulate
you all, Chan said. This is a breakthrough that will benefit many
millions of people for many years to come. This is a contribution to
fairness in health, and this is pro-active public health at its very
best.

Health advocates and developing country officials also praised the
outcome despite substantive modifications during negotiations. Industry
groups and developed countries appeared silent on the outcome.

James Love, director of health advocacy group Knowledge Ecology
International, stated afterward: Six and a half years after the Doha
Declaration, and five years after the CIPIH was created, the WHO has
taken a big step forward to change the way we think about innovation and
access to medicines.

Love called the outcome a lengthy and substantive document, that
represents consensus on difficult topics, sometimes with impressive
clarity, that were considered controversial only a short time
ago.

The new WHO Global Strategy and Plan of Action on Public Health,
Innovation and Intellectual Property also reaffirms the TRIPS
flexibilities, plus requires a look to be taken at the health impact of
trade measures, and contains a new paragraph on competition policy to
prevent abuse of intellectual property rights, among nearly 50
provisions.

Key elements of the strategy include providing an assessment of health
needs in developing countries and identify research and development
priorities; implement possible incentive schemes for R&D; improve R&D
capacity in developing countries; boost technology transfer; improve
access to all health products; and secure sustainable financing for R&D
in developing countries.

A primary goal is to promote R&D on diseases that disproportionately
affect people in developing countries, as well as diseases substantially
affecting both rich and poor nations.

The strategy, if implemented, will address equitable access and
address a long-term need for sustainable innovation, Elil
Renganathan, who heads the IP and public health effort at the WHO, told
reporters on Wednesday. We are very encouraged.

Next Steps

Portions of the plan of action will be worked out in the coming year,
including a progress indicator and costing of the plan, and come back to
the Executive Board and 62nd Health Assembly in May 2009, Renganathan
said.

A key issue in the action plan is who will be the lead stakeholders on
each action item, after governments. The debate is focussed on how
prominent WHOs role should be on IP issues, sources said. Developed
countries and developed country pharmaceutical and biotechnology
industries have pushed to limit WHOs involvement in these issues.

The resolution and strategy seek that WHO plays a central and
strategic role in IP and innovation, within its mandate, he said.

The director general will select an expert group designated by the
adopted strategy, hopefully to be operating in the next 2-3 months in
order to have something to report to the next WHO Executive Board
meeting in January 2009, Renganathan said.

The secretariat will organise the follow-up work, including
finalisation of the action plan, formation of the expert group, and
monitoring and evaluating. It is unclear what the budget is for the
activities in the current WHO budget, or what the costs are expected to
be.

The WHO section on innovation and intellectual property will oversee
the efforts, working with different WHO sections such as Tropical
Disease Research, Initiative for Vaccine Research, Department of
Medicines, Non-Communicable Diseases, and with regional offices. There
will be a degree of scaling up and new activities, said
Renganathan.

The assembly resolution is technically non-binding, but when members
agree to a resolution, its a commitment in some sense that will
take this forward, he said.

In order to determine the cost of the resolution, the WHO department
that handles financing will work over the coming months to develop a
plan which will enable a determination of cost, he said. Then member
states and stakeholders would step up.

KEIs Love said his group was impressed that the assembly was strong
on the use of compulsory licensing and other flexibilities, and
recommended that drug registration requirements conform to the
Declaration of Helsinki on Ethical Principles for Medical Research
Involving Human Subjects. He also highlighted the assemblys support
for work on a biomedical R&D treaty, collective management of
intellectual property rights, and the use of new mechanisms, like
prizes, to provide innovative incentives that are not linked to product
prices.

But Love called it unfortunate that the assembly left unfinished
the estimation of funding needs for priority R&D or the creation of a
framework for sustainable sources of funding. These and discussion of
new mechanisms that de-link R&D incentives from product prices
await member states in the next round of negotiations, he said.

Speaking in committee just prior to the final plenary, Bolivia made an
intervention concerning the relationship between the resolution and six
proposals from Bolivia and Barbados from April 2008 that suggested
alternative approaches. Bolivia asked that the meeting minutes reflect
the fact that these proposals were appropriate for consideration by the
expert group working on creative methods of finance to stimulating R&D,
according to a participant. The request by Bolivia was agreed upon.

Background

Patents on medical products provide right holders with monopolies for a
limited period of time, intended as the reward for research and
development. Most patents are held by owners in developed countries.

WHO undertook to draft a strategy on IP and health after it was agreed
that incentives are lacking for industry to invest substantially in
diseases predominantly affecting poor populations, known as neglected
diseases. This assembly marks the end of the two-year mandate of the
Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG), set up by the 2006 assembly.

In a fact sheet circulated this week, WHO said, member states
endorsed by consensus a strategy designed to promote new thinking in
innovation and access to medicines, which would encourage needs-driven
research rather than purely market-driven R&D to target diseases which
disproportionately [affect] people in developing countries.

The texts

The final texts of the 19-24 May World Health Assembly resolution,
global strategy and plan of action will not be available for days,
according to the WHO. The strategy contains eight overarching elements,
in addition to the context and principles.

The latest available texts were from Saturday morning, 24 May,
available for subscribers on www.ip-watch.org.

If this strategy is put in place, we will have new medicines for
diseases for which there are now a limited number of medicines,
Renganathan said.

The resolution and global strategy changed slightly on the final day of
the assembly, mainly to reflect the unfinished plan of action.

Item 1 of the resolution changed to now say the assembly Adopts the
global strategy and agreed parts of the plan of action [footnote: on the
specific actions and stakeholders components] on public health,
innovation and intellectual property, attached to this resolution.

The stakeholders components refers to who will be lead stakeholders and
who will be secondary, a subject of significant debate in the plan of
action during the week. A key aspect is whether WHO has a lead role on
some IP issues, sources said.

Resolution item 4.1 now requests the director general to provide
support for member states, upon request, in implementing the global
strategy and agreed parts of the plan of action without prejudice to
existing mandates.

Also, member states removed the list of five actions under the Quick
Start programme, including to: map global R&D activities, establish
baselines and identify research gaps; improve cooperation, collaboration
and information-sharing in health R&D; support R&D and promote
standard-setting for traditional medicines in developing countries;
develop and strengthen regulatory capacity, including safety, efficacy,
quality and ethical review; and support information-sharing and capacity
building in the application and management of intellectual property for
health innovation and public health, in collaboration with other
relevant international agencies.

Also on the last day, members dropped references to a right to health
(referenced by Bolivia above) and the World Intellectual Property
Organization Development Agenda (IPW, WHO, 24 May 2008).

Provisions related to data exclusivity, test data, patentability
criteria, anti-counterfeiting as provisions cut from the text Friday
night after differences could not be surmounted (IPW, WHO, 24 May
2008).

A separate assembly draft resolution on counterfeiting was deferred to
next year. And, in another matter, a new, more centralised WHO
publication policy was pushed through the Executive Board meeting
immediately after the assembly (see story to follow).

WHO and some member states insist the plan will make a difference. 

Developing countries will get additional support in the R&D going on
in their countries, said Renganathan. It includes centres of
excellence, training of researchers, a push for technology transfer, and
provides a format for flexibilities under the WTO TRIPS agreement.
Governments also hope to receive funding to support activities in
their countries.

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

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