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Healthy Skepticism Library item: 17061

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Electronic Source

Mara K
Chan Launches Inquest On Leaked WHO Documents; Meetings Proposed On R&D Expert Report
Intellectual Property Watch 2010 Jan 20
http://www.ip-watch.org/weblog/2010/01/20/chan-launches-inquest-on-leaked-who-documents-meetings-proposed-on-rd-expert-report/


Full text:

The first public discussion of an expert report on how to finance the often costly process of research and development to create new medicines, vaccines and diagnostics needed by the poor to address diseases that disproportionately effect them began this week at the World Health Organization. There were immediate concerns about the last-minute release of the report’s full text as well as concerns from several governments that it came up short on critical areas, and it was decided that an informal consultation process will take place over the next few months.

Meanwhile, World Health Organization Director General Margaret Chan said she has already begun an investigation to find out who leaked drafts of the expert group’s work to an international industry group in December (IPW, WHO, 9 December 2009). But she challenged those concerned to come up with evidence indicating there was undue influence by the pharmaceutical industry in the work of the WHO, and said she attaches “great importance to avoidance of conflict of interest.”

Chan said she was “extremely, extremely troubled by the leakage of documents,” and vowed to “find out exactly where the breach is” and if it was internal to the WHO to take action, to the point of waiving the diplomatic immunity of all staff “to facilitate proper investigation.”

Meanwhile, progress on the rest of the implementation of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property continues apace, according to a report of programme coordinator Precious Matsoso, delivered yesterday. Progress cited includes an agreement on cooperation between the WHO, the World Trade Organization and the World Intellectual Property Organization at the director general level to guide work on IP and public health as well as a completed study on technology transfer and a framework for monitoring and evaluating the implementation of the strategy.

One member of the expert working group said in an interview concerns remain about the inclusion of key issues in the report.

Separately, the proposal being circulated this week by Canada for an open-ended intergovernmental working group to address outstanding issues in preparing for influenza pandemics is available herecanada-non-paper-eb-2010. Pandemic influenza is the subject of discussions at the WHO today.

All these discussions are happening in the context of the WHO Executive Board meeting, taking place in Geneva from 18-23 January. Recommendations made by the board are sent to the World Health Assembly, the WHO’s decision-making body, which the director general announced today will take place from 17-22 May.

Informal Discussions to be held on Expert Report

Comments on the report were somewhat hindered by the fact that its full text was not out until the Friday evening before the Executive Board commenced on Monday – and then only in English – so governments were basing discussions off of an extended executive summary of the work [pdf] made available in late December.

This concerned several states. For example, Thailand said using only the executive summary for discussion was uncomfortably close to signing a blank check and Brazil proposed that there be informal meetings to discuss the full text prior to the May assembly. Uganda on behalf of the African region supported Brazil “considering that we are unable to have an informed discussion at this moment.”

Chan promised that the translated reports would be available in all six UN languages and transmitted to governments before the end of February, and after a lengthy discussion member states decided to undertake a web-based consultation on the final report, culminated in a face-to-face consultation to be held 13 May, immediately prior to the WHO Programme, Budget and Administration Committee.

Leaked Documents

Many – both governments and civil society – expressed concern over selective transparency due to draft documents that were apparently leaked to the International Federation of Pharmaceutical Manufacturers and Associations.

“It’s no secret” Chan said, that in the past WHO staff have leaked documents to forward their own agenda. But she refused to take the criticism levelled at the WHO in response to the leak “until there is evidence to say that we are being influenced, or that the group of experts is being influenced.” She then cautioned against putting too much weight on what she called rumour and innuendo.

The working group chair, George Alleyne of the Pan American Health Organization, said he “rejected completely” the idea that pharmaceutical companies had influenced the group. In fact, he told Intellectual Property Watch, the group was so careful not to appear impure in any way that they refused to privately meet with any stakeholders during the process of their report writing.

A spokesperson for the IFPMA told Intellectual Property Watch the “EWG is doing critical and important work which depends on the contribution of many different stakeholders. IFPMA believes participation and views of all stakeholders should be welcomed as we all work together to develop increased support and financing mechanisms for diseases of the developing world.”

Chan promised that she would give governments a report of her investigation when it is finished.

Questions on Gaps in Report and Secretariat Answers

Governments also questioned the WHO on substantive issues related to the expert report, as several states wondered why certain issues had not been included.

The “report confirms our views that the poor bear double burdens on diseases” as well as that “commercial incentives provided by IP rights have not provided solutions to health” issues faced by the developing world, the delegate of India told the board Monday. But it would have been “most important and cost effective” to explore technology transfer in more depth, she added, as it is one of the most promising ways to increase medicines access. And it provides neither road map nor guidance for greater access and wider dissemination of the technologies already available, she added.

There were contradictions between earlier work done by the WHO on intellectual property and health and report, said Brazil, including the reintroduction of elements that had previously been rejected, such as tax exemptions.

“The paucity of attention paid to IP” in the report is a “serious omission” for which the document does not provide justification, said Bangladesh, adding that it should also have looked at de-linking the cost of research and development from the price of products, concerns later echoed by Médecins Sans Frontières (Doctors Without Borders). “In our experience,” said the statement of India, “the greatest impediment to access to medicines has been their high cost and the encumbrances posed by” IP rights.

The United States expressed concern about a proposal that the WHO host and manage a patent pool initiated by UNITAID, saying it required careful consideration of what role the WHO should be playing in global health architecture and should not be rushed into.

A member of the expert group, senior Colombian Senator Cecilia López Montaño, sent a 15 January open letter to the Executive Board arguing that the report was incomplete and should not be accepted. She had agreed to take up a position on the group to discuss the importance of intellectual property rights, she told Intellectual Property Watch in an interview yesterday.

But, she was “very surprised that IP rights were not discussed,” and when she tried to bring them up to the group they were resisted. “I couldn’t find the space to discuss the one subject for me that was crucial, which was patents and intellectual property rights.”

If poor people in poor countries are to have cheaper medicines, she said, “you cannot ignore the debate” on IP. What the working group came out with as a result was “for me some sort of charity” mechanism, she added. Her position is not hers alone, she said, but also held by Colombian civil society groups whom she consulted during the process. She also said she thought there might be other members of the expert group who agreed with her.

López Montaño said yesterday she is satisfied that members of the Executive Board raised the concern about IP in the discussion of the working group report, and that the issue should come up in the upcoming consultations on the issue.

Both Brazil and India proposed inviting the UN special rapporteur on the right to health to the assembly to speak to delegates about a March 2009 report on IP and access to medicines (IPW, Public Health, 16 June 2009). It is unclear what became of this suggestion.

Alleyne said that they were limited by a narrow mandate, and that access to medicines outside of the research and development system – while a matter “dear to my personal heart” – was not a part of that mandate.

“I am in perfect agreement with almost every one of the comments,” about significant areas of public health and IP not touched on in the report, he told Intellectual Property Watch. “But many of them did not pertain to the mandate… our remit was research and development” and not the wider issue of availability of medicines, he explained.

 

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