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Chan Launches Inquest On Leaked WHO Documents; Meetings Proposed On R&D Expert Report

by for Intellectual Property Watch 5 Comments

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 here [pdf]. 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.

Kaitlin Mara may be reached at kmara@ip-watch.ch.

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Comments

  1. James Love says

    It is quite incredible, or perhaps, not credible, for George Alleyne to say that he did not consider access to medicines part of his mandate. The WHO has passed countless resolutions on this topic, including the one that created the EWG on R&D. At PAHO, Alleyne must have appreciated that the WHO would give access a higher priority than say, the private pharmaceutical industry. To suggest that the Chair of this group did not see access as relevant to their work explains a lot, when you look at the direction of the recommendations.

    If people have the time to look deeper at the report, it will be apparent that it is mostly a search for positions acceptable to the pharmaceutical industry, and that this was even the most important aspect of the selection criteria for the funding proposals. As others have pointed out during the review of the selection criteria, the EWG should not have focused so much on what they thought was acceptable to the pharmaceutical industry, but rather what would accomplish the goals of the Global Strategy, and then present an effective case on behalf of the useful proposals to policy makers.

    The claim that the report focused only on the most practical recommendations (feasible) does not really hold up when looking at what the EWG did recommend – unless one considers the tax on arms shipments or Internet email, or an 80 percent subsidy for PDP outlays to the private pharmaceutical industry to be particularly easy to implement.

    Reply

  2. Miles Teg says

    Let us not forget that in the run-up to the negotiations on the IGWG following the CIPIH:
    1. The CIPIH was not really accepted by the membership, specifically because of the developed countries positions;
    2. the second negotiating text for the IGWG was drafted at the “very highest levels” and included a proposal that limited “neglected diseases” to 14. NO COUNTRY SUBMITTED THIS PROPOSAL TO WHO – not even the developed countries.
    3. Regional consultation documents were SPECIFICALLY sidelined as inputs to the meeting and a lot of time was wasted for some countries to insert the outcome of their consultations into the negotiating text.
    4. CSOs were granted access, but the rich countries – EU included – wanted to set international norms behind closed doors. (Perhaps they had something to hide about why the actually don’t give a hoot about poor countries.)
    5. At the First meeting of the IGWG – the WHO failed to produce the two resolutions of Kenya and Brazil that led to the establishment of the IGWG – despite repeated requests by member states.
    6. The WHO did not even display its OWN work of the TDR, its unit that deals with neglected diseases.
    7. The WHO held an event that sought to fool the WHA that all was well with the process and in large part got away with marketing itself as doing a good job despite being pounded on the matter by developing countries at the Executive Board.
    8. BigPharma, at one or two occasions, actually proposed changes to the text and had it added to the negotiated text.
    9. And the coup de grace was WHO setting about to undermine the IGWG outcomes by launching its own Research Strategy while it was trying to wangle its way out of being a stakeholder in the IGWG text. What brilliance, a strategy of add more and more processes to the table to confuse undermine whatever progress is made.
    Perhaps someone should tell the WHO – steer don’t row. Especially when there is not even the temerity to be subtle about the anti-public health stances. I guess Chan is right, he who pays the piper calls the tune…shall we dance to “rabid public health” please?

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  3. Miles Teg says

    And one more thing, WHO was so careful about the experts selected to advise the negotiators in the “open” (but closed) negotiations that one Microsoft guy did not even report his links to the company that benefits the most from IPR monopolistic tendencies. Even after it was raised by some CSOs, WHO staffers were lackadaisical about acting on it.

    But there is a silver lining, there were at least two “radicals” amongst the experts. Given the economy with the truth by WHO, perhaps rumours should be also given credence. One expert was allegedly (RUMOURED) neutralised for being too radical. This is great. It is almost like Vioxx. You select most of the experts who will tell you VIOXX ss safe and write (or ghost write that for you) and then work out the “marketing strategy”. Overall some delegates said that many of the selected experts were biased towards strong IPRs – IRRESPECTIVE OF THE FINDINGS of the CIPIH. Some were very good – but it is INSTRUCTIVE how people were neutralised.

    Let us be clear – while patents have increased the CIPIH states that development of new chemical entities a fraction of what it used to be! Wall street shortermism has infected WHO to the very core. Make money now, health research later – AND THERE is a reason for neglecting these diseases – these handout seeking bastards can’t pay. Never mind it is only 8% of the BigPharma market.

    If this is how advisors are “advising” the DG – well they are overpaid!

    Reply

  4. Belinda says

    What was the outcome of the investigation into the leaking? I can’t find out on the internet. Thanks

    Reply

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