[Ip-health] SUNS:Working Group discusses elements of global strategy, plan of action

[Sangeeta]

=A0
SUNS #6157 Thursday 7 December 2006

Working Group discusses elements of global strategy, plan of action

Geneva, 6 Dec (Sangeeta Shashikant) -- The World Health Organization's
Intergovernmental Working Group on Public Health, Innovation and
Intellectual
Property (IGWG), at its meetings on Tuesday and Wednesday, held discussions
on
the elements of a global strategy and plan of action in relation to
intellectual
property, health R&D and public health.

>From the discussions, two documents - one on a global strategy and the othe=
r
on a
plan of action - are expected to be the two outputs of the Working Group,
which is
holding its first session from 4-8 December.

The Working Group was established by the World Health Assembly in May 2006
through resolution 59.24.

According to the resolution, the Working Group is tasked with "drawing up a
global strategy and plan of action in order to provide a medium-term
framework
based on the recommendations of the Commission [on Intellectual Property
Rights, Innovation and Public Health]".

The resolution stresses that "Such a strategy and plan of action aims at,
inter alia,
securing an enhanced and sustainable basis for needs-driven, essential
health
research and development relevant to diseases that disproportionately affec=
t
developing countries, proposing clear objectives and priorities for researc=
h
and
development, and estimating funding needs in this area."

At the meeting, Working Group Chair Peter Oldham of Canada said that the
objective of the documents would be to try to summarize what the meeting ha=
d
discussed and to instruct the Bureau of the Working Group and the
Secretariat so
that they can get on with the work in the coming year. Drafting of and
discussions
on the documents is expected to start on Thursday.

Thus far, most of the discussions (which began on Tuesday) have been on wha=
t
will form the 'Elements of a Global Strategy and Plan of Action' and the
basis of
the discussions is WHO document A/PHI/IGWG/1/4 dated 2 November 2006
(Secretariat Document) wherein areas for action have been identified for th=
e
categories of prioritisation of research and development needs; promoting
research
and development; building innovation capacity; improving delivery and
access;
ensuring sustainable financing mechanisms; and establishing monitoring and
reporting systems.

Two other categories of IP and transfer of technology were added upon
request by
some Member States, and in a recent Secretariat Document (A/PHI/IGWG/1/4
Add.1), these categories have been elaborated.

Discussions on the "Elements" is expected to inform the drafting of the
documents
on a Global Strategy and Plan of Action.

The move towards having these documents comes following support for such an
approach from many developing countries including India, Thailand and Sudan=
.

Several developing countries and NGOs however raised concerns during the
discussions that the Secretariat Document does not fully capture the
recommendations of the Commission on Intellectual Property, Innovation &
Public Health (CIPIH).

Brazil said that the main issue was that many of the vaccines, medicines an=
d
diagnostics have not been designed yet, and how much was it going to cost
the
health systems and individuals to access medicines. It added that IP was a
central
issue and greater efforts have to be made to ensure that science delivers.

Sudan, on behalf of the Eastern Mediterranean Region, agreed with Brazil
that
there was a need for clarity about the objective of the work that is to be
carried out.
It added that it was logical to develop a strategy before a work plan. It
also said
that it needs to be ensured that the recommendations in the Secretariat
Document
are sufficient.

India supported the idea of an overarching strategy and plan of action put
forward
by Sudan. It said that financial mechanisms have to be looked at as well, a=
s
funds
will be needed.

India proposed that drafts on these areas be prepared within the current
session of
the Working Group so that in the inter-sessional period, further submission=
s
can be
asked for, and in the subsequent session a fairly mature draft can be
negotiated and
finalised for the purposes of the WHA. It also proposed the convening of a
workshop to consider the proposed Global Strategy and Plan of Action and
enable
countries not present to make a contribution.

It guided the meeting by saying that following the discussion on Elements, =
a
drafting group could be formed to draft the overarching strategy and
following that
identify elements that should be included in the plan of action.

On the issue of financing, Brazil proposed that the Heads of Government sig=
n
an
agreement that 0.7% of gross domestic product be dedicated to R&D.

Iran called for a revisit of the proposed elements by the Secretariat,
adding that the
document did not properly capture the recommendations of the Commission's
report. It gave the example of Recommendation 4.26 of the Commission's
report,
which states that bilateral trade agreements should not incorporate TRIPS
plus
provisions, which is not included in the Secretariat Document.

Thailand was supportive of the Indian proposals and proposed a
re-categorisation
of the 6 categories proposed in the Secretariat Document and breaking up
into
smaller groups to come up with the necessary texts.

Kenya stressed that it was important in the early stage of deliberations to
identify
issues that affect the direction of the IGWG's work. It also raised the
issue of
financing for research and development.

Australia said that while it welcomed the report of the CIPIH, many
recommendations have to be prioritised, preferably those that are practical=
.
It also
mentioned the need to be mindful of the other bodies that have technical
expertise
and interest in IP issues.

Ghana, on behalf of the African Group, said that the Secretariat Document
does
not contain some of the recommendations of the Commission's report. It
proposed
that areas of transfer of technology and management of IP be included.

Most of Tuesday and Wednesday were spent by Member States making specific
comments on each of the categories identified in the Secretariat paper.

On the category of prioritising research and development needs, the
Secretariat
Paper identified the following areas of action: (1) identify gaps in curren=
t
coverage
of research in Type II (diseases incident in both rich and poor countries,
but with a
substantial proportion of the cases in poor countries) and Type III Disease=
s
(diseases that are overwhelmingly or exclusively incident in the developing
countries); (2) expand prioritization to include neglected diseases, as wel=
l
as
HIV/AIDS, malaria and tuberculosis; (3) set research priorities in
developing
countries so as to address public health needs and implement public health
policy;
(4) conduct research on affordable and technologically appropriate products
to
combat Type I diseases in developing countries; and (5) improve
accessibility of
compound libraries for identification of potential compounds.

Kenya, in endorsing the elements, stressed that the elements should be
linked to
the recommendations of the Commission because only then can it be clarified
who
are the actors to implement the recommendations and to capture certain
actions
that may not be included. It added that the African Group recommendations
numbered 1, 2, 3, 4, 5, 6, 11 referred to in Doc. A/PHI/IGWG/1/2 should be
adopted as elements.

The US indicated that it would have a problem with allowing open access to
all
compound libraries. It also asked what is the definition of "affordable and
technologically appropriate products" and who will determine the definition=
.

Thailand said that it saw action areas numbered (3) and (4) as low hanging
fruit
that can be achieved. However, it stressed that prioritising also depends o=
n
the
region. On the latter issue, it added that there is a need for a global
mechanism. It
strongly favoured making compound libraries accessible, saying that WHO
should
be better equipped to do so.

On the issue of compound libraries, the Swiss delegation raised the issue
that
many of the compound libraries are privately owned by companies and cannot
be
made public. It added that there are 3 kinds of approaches to research -
market
driven research done usually by the private sector, public funded curiosity
research
or needs driven research. Which part of the first two approaches should be
needs
driven, it asked.

Brazil said that it is appropriate for the mandate of the IGWG to establish
a field
investigation to find out bottlenecks when it comes to medicines and
diagnostics.
Brazil added that compound libraries are of great importance. It also
stressed that
an analysis to establish which compound libraries have been built on the
basis of
public funding needs to be undertaken.

As to the category of "promoting research and development", the Secretariat
paper
lists the following areas for action: (1) devote a larger proportion of the
health
research and development budget of developed countries to the health needs
of
developing countries;  (2) provide support for national health-research
programmes through appropriate political action and long-term funding in
developing countries; (3) set up a forum to enable more organized
coordination
and sharing of information; (4) promote discovery science in order to
identify,
validate and build up a sustainable portfolio of new products, whose
development
is facilitated through appropriate legal arrangements permitting
unrestricted access
to drug leads identified through the screening of compound libraries for
diseases
relevant to the public health needs of developing countries; and ( 5)
promote
early-stage drug research and development in developing countries (includin=
g
basic research, lead identification, lead optimization and pre-clinical
trials).

On this section, Kenya said that the region has identified key
recommendations
which if implemented would ensure that the proposed action points are dealt
with
exhaustively. It also proposed that recommendations 13, 14, 18 found in
document
A/PHI/IGWG/1/2 be adopted as elements.

The recommendations suggested for adoption include recommendations that
governments, national authorities, and donors assign a higher priority to
research
on the development of new animal models, bio-markers, surrogate end-points
and
new models for assessing safety and efficacy which would increase efficienc=
y
of
product development; to enhance sustainability of public private
partnerships; to
recognise the need for an international mechanism to increase global
coordination
and funding of medical research and development. In this regard, examine th=
e
proposal of a treaty for R&D submitted to the CIPIH.

The US said that for the most part these are areas that it can support
although it is
the way that implementation is done that will matter. On the area of action
no. 1, it
said that it supports the objective, although the issue is how it is
expressed in the
plan of action. It made clear that it was against a mandatory approach,
although it
qualified its position by saying that if it had to do more,  that is not a
problem. In
relation to action no. 2, it said that it was desirable to know what the
parameters
were as there are many implications of a fora. In relation to action no. 4,
it said
that the matter raised proprietary issues that needs to be looked at
appropriately.

Finland, on behalf of the EU, said that the EU is a considerable funder of
R&D
and indicated that it was prepared to allocate funding. However, it
emphasised the
need for policy coherence and said that supporting health research needs to
be
negotiated within development cooperation. It added that the WHO Secretaria=
t
should gather information on mechanisms that promote health research and
should
at the next meeting provide a proposal for funding arrangements, and
estimate the
costs of sharing information and the relation between this forum and other
global
actors. It also said that the Plan of Action should also include mechanisms
to
promote innovative R&D.

Brazil said that it was important to establish a link between priorities
defined
under the first heading with the actual promotion of research and
development. It
stressed that there was a need to know what funds are available once the
priority
diseases has been identified, what is the research capacity in developing
countries,
which institutes are available and capable of carrying out R& D as there is
a need
to build bridges between the institutions, as in that way, technology and
research
capacity can be transferred from developed to developing countries. It also
said
that the issue was not just financial cooperation but to provide a machiner=
y
to
provide R&D.

Thailand said that action area number 1 was not an effective recommendation=
.
Commenting on recommendation 17 (Doc. A/PHI/IGWG/1/2) which is about
governments continuing to develop forms of advance purchase schemes which
may contribute to moving later stage vaccines, medicines and diagnostics as
quickly as possible from development to delivery, it explained that
medicines and
vaccines were too costly for governments, in particular, poor governments t=
o
be
able to afford them, to be able to benefit from advance purchase schemes.
This is
the case unless there are donors available.

Thailand strongly supported recommendation no 18 in document
A/PHI/IGWG/1/2 which speaks about the need for an international mechanism t=
o
increase global coordination and funding of medical research and
development,
and in this regard the sponsors of the treaty proposal on medical research
and
development should undertake further work to develop these ideas so that
governments and policy-makers may make an informed decision. It also
indicated
that the other South East Asian countries were similarly supportive of the
idea of a
global R&D treaty.

Under the category of "Building Innovative Capacity", the areas of action
identified by the Secretariat are: (1) provide support for development of
innovative
capacity through investment by developing countries in human resources and
the
knowledge base, especially in tertiary education; (2) intensify North-South
or
South-South partnerships and networks to support capacity building; (3)
strengthen education and training in research and development, including
management of intellectual property; (4) promote transfer of technology and
production in developing countries through action by developed countries an=
d
pharmaceutical companies; ( 5) strengthen product regulatory capacity in
developing countries, including improvement of ethical-review standards and
clinical-trials capacity; (6) promote patent pools of upstream technologies
or other
mechanisms to promote innovation of products for priority diseases in
developing
countries; and (7) document and disseminate best practices in innovation
observed
in developing countries.

Kenya, on behalf of the African Group, proposed that an additional point on
promotion of traditional medicines be added. It also spoke of a merger of
points 3
and 4 into point 7 and the replacement of the word "or" with "and" in point
no. 2.
It further proposed the adoption of recommendations no. 47, 48, 52, 56 in
document A/PHI/IGWG/1/2. Kenya said that investment in human resources, as
well as development and promotion of traditional medicines is key to future
strategies. The latter has been ignored except in a few developing
countries, it said.

The US cautioned that members should not ignore the work of other actors,
member states, private sector and other international organisations such as
WTO,
WIPO and OECD. It underlined that the WHO should not be assigned
responsibility that belongs to another organisation.

Thailand noted that the Secretariat's paper did not capture recommendation
numbered 51 (Doc. A/PHI/IGWG/1/2) that states that "Developed countries
should
comply with their obligations under Article 66.2 of the TRIPS agreement and
paragraph 7 of the Doha Declaration", although it is the lowest hanging
fruit.


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