[A2k] Experts call on WHO to implement Health/IP Global Strategy

[Sangeeta]

Please find below a news report on discussions during a seminar on the
Implementation of WHO's Global Strategy & Plan of Action (GSPA) on Public
Health, Innovation & Intellectual Property, organized by a Geneva-based NGO,
at the end of September.

Best Regards
Sangeeta Shashikant
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Experts call on WHO to implement Health/IP Global Strategy
SUNS #6561 Monday 6 October 2008

Geneva, 3 Oct (Sangeeta Shashikant) -- Several experts called on WHO to show
leadership in implementing the global strategy and action plan on public
health, intellectual property and innovation, a large part of which has been
adopted in May by the World Health Assembly.

They were speaking at a seminar on the Implementation of WHO's Global
Strategy & Plan of Action (GSPA) on Public Health, Innovation & Intellectual
Property, organized by IQ Sensato, a Geneva-based NGO, at the end of
September. Participants spoke in their personal capacity.

Rodrigo Estrela, a diplomat with the Permanent Mission of Brazil, said that
a "strong WHO" was a pre-condition for a new international environment
created by the GSPA for those countries wishing to make use of the
flexibilities contained in the TRIPS agreement and other agreements related
to IP rights. If WHO is a "mere observer of processes", this will "undermine
national and international conditions to undertake public health policies".

James Love from Knowledge Ecology International called on the WHO to show
leadership and imagination as the present systems of access and innovation
are not sustainable.

Nicoletta Dentico, Advisor to IQ Sensato, stressed the need to put in
substance to the GSPA, adding that an important unresolved matter is the
sustainable financing for R&D of developing-country diseases. The
Intergovernmental Working Group that negotiated the GSPA did not resolve
this issue, thus the World Health Assembly mandated the Director-General of
WHO to set up an expert working group to examine current and future
financing. The immediate terrain for implementation of the elements of GSPA
is the discussion on virus and benefit sharing, she said.

Charles Clift of the UK Department for International Development (DFID) said
that international organisations have an important facilitating role, in
particular where collective action is required and that for implementation
of GSPA, there needs to be "buy in from many different parts of WHO". For
example, he said that the Draft WHO Medicines Strategy 2008-2013 does not
mention GSPA at all but has a key role in implementation of Element 6 of
GSPA, which is about improving delivery and access.

He also said that there was a need to define the role of different parts of
WHO in implementing the strategy and to ensure adequate staffing. He added
that there was an important role for WHO in the selection of the Expert
Working Group (EWG) to provide necessary weight and in guiding EWG to a
conclusion that commands wide support and is capable of implementation.

The critical issue is finding new sustainable financing mechanisms, he said,
which will be the responsibility of the expert working group and "one of the
most important outcomes" of the process.

The GSPA was adopted at this year's World Health Assembly in May. It has
been the subject of heated debate in the WHO in the last two years.
Discussions on Element 5 on the application and management of IP and WHO's
role on IP and health were among the most contentious issues.

Resolution WHA 61.21, which adopted the GSPA, urged the WHO Director-General
to finalize the outstanding components of the Plan of Action (POA), to
prepare a quick-start programme with adequate budget provision and begin
immediately to implement the elements of the GSPA that fall under the
responsibility of WHO; and to establish an expert working group to examine
finance and coordination of research and development, as well as proposals
for new and innovative sources of funding.

To date, there has been little information on how WHO intends to proceed
with implementation, in particular how it intends to proceed with completing
the POA, about the quick-start programme as well as the process by which the
expert working group is to be selected.

Malebona Precious Matsoso, who is a director in the WHO Secretariat on
Public Health, Innovation, and Intellectual Property, speaking at the
seminar, said that the "silence of the WHO doesn't mean we haven't been
doing work". Matsoso added that WHO had "consciously identified those
partners we think need to work with us" and that the organisation had
several meetings with different stakeholders.

Matsoso also said the WHO is working on a "matrix" detailing activities
mentioned in the global strategy which already exist, those which need
scaling up, and those which constitute new work, so that the organisation
can decide how to budget the programmes. Also, the WHO DG will inform
Members on what will be done about paragraphs in the POA which are still in
brackets.

Matsoso also said that the GSPA  would inform many different programmes at
WHO and that it provides a guidance to WHO.

Estrela said that Members were still in a negotiation process as the Plan of
Action will be finalized in the next Executive Board in January 2009, adding
that this will "lessen some persistent doubts concerning implementation and
the role of WHO vis-a-vis other Organizations". He stressed that the GSPA
which has been agreed, even if incomplete, does not represent a limitation
of WHO's role.

He said that the GS created a more positive environment for those countries
wishing to make use of the flexibilities contained in the TRIPS agreement
and other agreements related to IP rights.

There was need for a "more balanced international environment" and the GS is
an important step in order to change the environment and reveal to many
developing countries that there is legal remedy against growing prices of
medicines, poor quality of patents, and the TRIPS-plus-plus Agenda
(specially when related to health sectors and health products and the
negative impact such measures may have in access to health products), he
said.

He added that one pre-condition for such a new environment/new culture is a
"strong WHO", i.e. an organisation which is not a mere observer of processes
that, in the end, tends to undermine national and international conditions
to undertake public health policies.

Estrela also stressed on the implementation of paragraph 15 of the GS. He
said that the objective was not to diminish the mandate of other
Organizations, but for WHO to take the lead on "Health-Related Aspects of IP
or Trade Issues", so that there is a balance between "trade-related" and
"health-related" agendas.

Paragraph 15 of the GSPA which is on "Principles" states that the WHO shall
play a strategic and central role in the relationship between public health
and innovation and intellectual property, bearing in mind other relevant
intergovernmental organizations.

He added that the GS goes beyond the Doha Declaration in that it spells out
flexibilities such as bolar and research exemptions and covers controversial
areas such as anti-competitive practices not only for access purposes but
also for objectives related to innovation and research.

The GS also promotes innovation by seeking alternative policy approaches and
new incentives for R&D specially in those areas where the current IP system
is not functioning very well, he added.

Estrela also stressed on financing the Public Health and Innovation
Programme in WHO, as a condition to implementing the GS, adding that Brazil
has contributed about $500,000.

James Love referred to the mention of exploratory discussions on an
essential health and biomedical R&D treaty in the GS. He said that there was
a need for independent assessment of drugs, and if clinical trials are done,
it is information the entire world benefits from. The problem is that of
having "collective action". The "next phase" has got to be "imaginative".

With regard to access, he said that the present incentive system was
expensive and that it was a market exclusivity system, which made access to
medicines difficult since the prices were high. He suggested that this
system was not sustainable. Either there is a "de-link" between the cost of
R&D and the price of medicines or everyone "pretends" that the system is
sustainable.

He questioned whether there is leadership in WHO to look at these issues,
and asked whether the WHO would appoint people that are insightful to the
expert taskforce.

Nicoletta Dentico said it was important for WHO to show "leadership" and
that WHO should support member states not just on TRIPS flexibilities but
also ensuring "needs innovation are secure".

Peter Beyer from the Swiss Federal Institute of IP said that countries and
stakeholders need to see what actions they have to implement and what they
can do to implement, adding that governments have to take responsibility. He
said WIPO and WTO should be in the lead with regards to the application and
management of IP.

He said that actions in Element 5 of the GS, on the application and
management of IP, should feed into the work plan of WIPO's Committee on
Development and IP.

Clift from DFID, who headed the Commission on Intellectual Property Rights,
Innovation and Public Health, whose report led to the global strategy, said
he had many concerns about the global strategy.

The document contains "too many commitments, that are too weak and too
vague," and the progress indicators are not measurable. There is a "missing
middle column" in the plan of action: there are actions to take on one side,
and stakeholders on the other, but no detail on what needs to be done to
meet objectives.

As to what is required, he stressed on prioritising health financing at the
national level, strengthening health system; developing enhanced and more
sustainable funding mechanisms for R&D; creating systems for prioritisation
of R&D, coordination and performance monitoring; developing further
innovative financing mechanisms to promote development of, and access to,
new health technologies; investigating new intellectual property mechanisms
to promote innovation and access; monitoring the impact of intellectual
property rights on innovation and access; improving the clinical trials and
regulatory infrastructure to facilitate product introduction and monitoring
progress against the targets in the plan of action.

Chikosa Banda from the University of Cambridge said that one of the main
issues in implementation is whether developing countries take advantage of
the reforms, particularly in implementing it at the national level.

He added that often the donors determine the research priorities. In Malawi,
researchers just implement what the donors say. Also, the ability to make
use of flexibilities is highly prejudiced by the lack of institutional
capacity, so there is need to build capacity to take advantage of the
flexibilities.

A Third World Network official noted that the debate on virus and benefit
sharing taking place in WHO is relevant to the issues of access (i.e., to
affordable vaccines and antivirals) and innovation (since most of the
influenza virus related research and production of vaccines takes place in
developed countries). Since the WHO is looking to develop a more equitable
framework for sharing of viruses and benefits resulting from the use of the
viruses, steps should be taken to implement some elements of the GSPA.

For example, one of the elements of the GSPA is about exploring new ways to
facilitate transfer of technology. So, in the context of virus and benefit
sharing, it could be proposed that a recipient of viruses (i.e., a vaccine
manufacturer) gains access to the biological materials (that are given by
countries to WHO) from WHO linked laboratories in return for access to and
sharing of technology and know-how from the vaccine manufacturer, e.g.
through granting royalty-free licences. +