[A2k] SUNS: Slow progress in talks on IPRs and innovation

[Sangeeta]

WHO: Slow progress in talks on IPRs and innovation
Published in SUNS #6441 dated 26 March 2008

Geneva, 25 Mar (Riaz K. Tayob) -- Slow progress was made last week at a
sub-group meeting of the WHO's Intergovernmental Working Group (IGWG) on
Public Health, Innovation and Intellectual Property Rights.

The sub-group deals with indicators for actions in eight areas of public
health, including managing intellectual property rights, research and
development, technology transfer, improving access to medicines and
financing mechanisms.

The IGWG is the main body under the WHO that deals with the related issues
of IPRs, innovation for new medicines, and access to medicines.

The World Health Assembly has tasked it with producing a global strategy and
a plan of action based on recommendations of the Commission on Intellectual
Property Rights, Innovation and Public Health (CIPIH) and also to promote
and fund health research and development relevant to diseases that
disproportionately affect developing countries.

The IGWG's sub-group on indicators for the Plan of Action met on 17-19 March
in Geneva. Diplomats from developing countries, after the meeting ended,
remarked that there was only slow progress.

One key obstacle is the lack of agreement by the IGWG so far on the "global
strategy". Since the fundamental issues that are to comprise the strategy
are not yet settled, it is quite premature or difficult to agree to
"indicators of progress," commented the diplomats.

Before the meeting were three documents. Delegations were asked to go
through the proposals on indicators of actions in the Plan of Action and to
amend or add to them.

The sub-group meeting is supposed to provide inputs to the next full meeting
of the IGWG on 28 April-3 May.

The IGWG and the sub-group are considering 8 elements for the global
strategy and a separate plan of action: (1) Prioritizing research and
development needs; (2) Promoting research and development; (3) Building and
improving innovative capacity; (4) Transfer of technology; (5) Management of
intellectual property; (6) Improving delivery and access; (7) Ensuring
sustainable financing mechanisms; and (8) Establishing monitoring and
reporting systems.

The WHO Secretariat issued three papers for the sub-group. The first is a
report by the Chair of the indicators sub-group (Dr. Huda Gashut of Libya).
The second paper, compiled by the Secretariat, contains a table containing
specific actions listed in the Plan of Action (as drawn up at the IGWG's
second session) with other columns specifying the stakeholders (that will
take action), the time frame, and progress indicators for each action.

A third paper contains the Secretariat's views on "Summary Indicators/
Reporting Components" and it contains some indicators chosen by the
Secretariat from the full list, or indicators which have been consolidated
or reduced, as well as new language on indicators.

Outside the meeting, some developing country delegates expressed
dissatisfaction with this third paper. They were concerned that some
indicators had been changed, while the Secretariat did not clearly indicate
which of them had been changed or why. Also, the summary indicators were
mostly quantitative and they could not relate these to what the global
strategy intended.

India, supported by some other developing countries, said that it reserved
the right to revisit the indicators once the global strategy is finalised.
India said it is difficult to agree to the finer points concerning
indicators when the broader perspective provided by the Global Strategy had
not yet been agreed to. It was important to have an overall view that can
adequately inform the plan of action and indicators.

[One point lacking agreement is whether the Global Strategy applies only to
14 diseases, as proposed by the WHO Secretariat, or to a broader range of
diseases as proposed by some member states - see SUNS #6360 of 7 November
2007.]

A document on the status of discussions at the end of 18 March indicated
that there was no consensus on one of the indicators under element 1, i. e.
to map global R&D with a view to identifying gaps. However, there was
agreement on indicators on another action, i. e. to formulate explicit
prioritised strategies for R&D at country and regional levels.

According to delegates, during the discussions under element 2, promoting
R&D, Bolivia made a proposal to promote open access publishing of research
supported by public funding, and the promotion of new standards and norms at
national and international levels for free access to such publications. Some
developed countries opposed this, saying that they did not see it as an
indicator.

Under element 3 on building developing countries' R&D capacity, an indicator
agreed to was the number of capacity-building programmes and the annual
increase in personal trained and incorporated in research.

Regarding traditional medicine, agreement was reached on quantitative
indicators for implementing the WHO Good Manufacturing Practice guidelines
(GMP) and evidence-based standards for quality, safety and evaluation.

On element 4, transfer of technology, agreement was reached on some
indicators to support improved collaboration and coordination including
reporting on measures taken to facilitate local and regional networks, the
number of countries and the measures taken to promote training to increase
absorptive capacity for technology transfer for health products.

Under discussions of paragraph 4.2. b (North to South technology transfer),
Brazil sought as an indicator the number of countries that fully comply with
Article 66.2 of TRIPS. The US opposed this indicator. [Article 66.2, of the
TRIPS Agreement, is about promoting transfer of technology to least
developed countries and some countries have previously complained that
little or nothing had been done under this article regarding public health
needs - SUNS #6158 dated 8 December 2006.]

Under element 5, the management of intellectual property, there was
consensus only on one sub-element, measures taken to enhance collaboration
to promote information sharing across government departments and national,
regional and international institutions.

There was discussion on the proposal for a R&D treaty for which an indicator
proposed by the Secretariat was "Report on conclusions from a meeting to be
convened of experts and other stakeholders to explore feasibility of
instruments or mechanisms for essential health and biomedical R&D, including
an essential health and biomedical research and development treaty."

The US countered this proposal with an indicator that a public consultation
be convened by interested entities to discuss essential health and
biomedical R&D. The US made a reference to the report of the Commission on
Intellectual Property Rights, Innovation and Public Health (CIPIH) which it
reportedly said was indirect and vague on the treaty.

For element 6, improving delivery and access, there was agreement to include
as indicators the percentage increase in human resource development
investment in the health sector, and the number of manufacturers complying
with good manufacturing practices and those inspected by WHO.

On element 7 (financing), there was agreement to report on best practices of
public-private and product development partnerships and tools to assess
them. Also agreed is a report on these entities' R&D initiatives supported
in developing countries.

For element 8, it was agreed that effective systems would be put in place
for monitoring and evaluation.

Santiago Alcazar, head of the Brazilian delegation, said after the meeting
that slow progress had been made. Alcazar said that the key issue in a
nutshell was how to preserve and enhance availability and access to drugs,
vaccines and diagnostics tools for public health needs in developing
countries.

Getting into detail is not sound at this juncture because we have not
finished discussions on the global strategy, he said. Discussing indicators
and stakeholders at this stage poses the risk of losing sight of what was
important since we need to be clear on the goals and objectives of the
Global Strategy, over which there is limited agreement so far.

This also applied to the notion of summary indicators (proposed by the
Secretariat in WP3), and he said that the timing for issuing this was wrong.

Another participant told SUNS that the important issues will only be
discussed at the next full IGWG meeting. This meeting had focused only on
areas in which there was already consensus, and the more controversial
issues would only be discussed in April.

The participant was concerned of a "real risk" that if countries did not
have high levels of ambition, "we would end up with an agreement that merely
reflects the status quo, and this is not acceptable. If countries, are not
prepared, we will end up with a document that will simply not make a
difference to public health."

She was also worried that there was almost no reference at the meeting to
the CIPIH report. The only time the CIPIH was mentioned was when the US
referred to the report to bolster its argument to limit the R&D treaty and
not to advance it.

"Referring to the CIPIH recommendations is really important and member
states should regularly refer to them as it is really what informs this
whole exercise," said the participant.

Alcazar, after the meeting, expressed concern about the tendency in the
discussions to leave out important issues, like the impact of intellectual
property on public health. He said this is one of the main issues but
discussion was limited as the meeting only focused on indicators. It became
a technical discussion and sight was lost of the important policy issues,
such as transfer of technology, what is it that must be transferred and on
what conditions.

Alcazar added that the quality of the indicators was more important. While
quantitative indicators are important, there is a need to know what they
mean. For example, it is not always important to measure the number of
countries that have agreements on transfer of technology. What a country is
achieving with the transfers is what is important, so we could measure what
products are developed, for instance.

Another participant told SUNS that the technology transfer discussion had
focused on LDCs, while leaving out the needs of other developing countries,
including those that could have better ability to use technology which would
provide a better impetus for quicker results.

On indicators, one developing country delegate said privately that the
Secretariat should not only give guidance to members but find out what needs
they seek to meet. The Secretariat should also build trust and go beyond
emphasising cost and feasibility.

Another delegate said after the meeting that it would not like to see what
is achieved in the strategy be watered down in the indicators. What exactly
we want from each of the elements needs to be identified along with how we
are going to achieve them.

One delegate complained that the three papers for this meeting had come
late. Another was concerned that the next meeting of the IGWG would be
difficult for small delegations to follow, since three groups may be meeting
at the same time.

Bolivia was concerned about the constraints of small delegations to take
part effectively. It was especially upset by an incident at the meeting,
when it submitted a written proposal during the meeting, and the US seemed
to object by enquiring how much it would cost to have the paper distributed.

Later, the Secretariat replied that the cost of distribution and translation
would be $4,000 to $6,000. China supported the inclusion of the paper and
that the guideline that papers be submitted at least 24 hours before the
meeting be waived.

After the meeting, Bolivia said it had a small delegation and it had
difficulty in participating meaningfully in important debates. Spanish is an
official language of the UN and it was entitled to submit documents using
it. Bolivia seemed incredulous that the US had intimated that the poorest
Latin American country pay the costs of translating and distributing the
document.

Bolivia said it was considering a specific provision in WHO procedures for
small and vulnerable countries to submit a document at any time so that they
are not excluded from debates.

Reflecting on the attitude of developed countries at the meeting, some
diplomats from developing countries were of the view that the former were
satisfied that the meeting focused on small details while the bigger issues
in the strategy were not yet settled by the IGWG.

While there is some willingness to do something to stimulate health
research, the developed countries do not want to discuss the more
fundamental questions challenging the current system of IP, control over
technology and access to medicines.

Some participants were in particular concerned that the European Commission
was getting more active in the discussions. The EC has the mandate over IPR
issues (as it negotiates in TRIPS in the WTO) while EU member states have
jurisdiction over other areas.

However, the EC was reported to have ventured regularly into areas beyond
its competence. That is a concern because the EC lacks a strong public
health perspective.

After the meeting, another developing country delegate described the
discussions with the developed countries as follows. The developing
countries want food on their table, while the developed countries are
saying, I know you need some food, but I can give you a bicycle. The
developing countries are saying, we do not want a bicycle, but food. The
reply is that, I know you do not want a bicycle but this is what I can
give.+