TWN Info Service on Health Issues (April08/01)
1 April 2008
Third World Network

WHO: Slow progress in talks on IPRs and innovation

Please find below a news report on the sub-group meeting of the WHO's Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property Rights that met from 17 19 March 2007.

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 news report was first published on 26 March 2008 and is reproduced here with permission.

Best Regards
Sangeeta Shashikant
Third World Network

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. +