The World Health Organization today declared it will launch a review of the global – including its own – response to the H1N1 swine influenza epidemic, as questions swirl around whether the UN agency trumped up the importance of H1N1. The WHO also faces charges this week that it has acted without transparency and inclusiveness in leading a process to find alternative financing for research and development into medicines for diseases occurring predominately in developing countries.

The WHO will prepare an interim version of its review of the global H1N1 response in time for the next World Health Assembly in May, WHO Director General Margaret Chan announced to the WHO Executive Board today. Meanwhile, a new proposal emerged from governments on how to proceed on the related issue of pandemic flu access and benefit sharing, and is expected to be discussed Wednesday.

All the issues are on the agenda of the WHO Executive Board, meeting from 18-23 January. The board’s recommendations will be carried forward to the annual World Health Assembly in May.

Bigger issues of governance and funding for the WHO are in the background this week as well, as Chan on 12-13 January held a meeting on this with some 30 people from UN missions and ministries of health and finance. A report from the meeting will be made public for comments on the WHO website and a paper reflecting the results are expected to be submitted to the Board within a year, she said.

Chan in her opening remarks listed several subjects that members see a need to address at the international level, including public health, innovation and intellectual property. The WHO in recent years has developed a global strategy and plan of action on these issues, and the financing aspect is a final step.

It is under this topic that the World Health Assembly mandated (Resolution 61.21) an Expert Working Group on R&D financing come up with ideas for encouraging research into diseases for which there are not significant markets for private sector R&D investment. The board began work on the topic, agenda item 4.3 of this week, late this afternoon.

The working group produced a report in December that found there is no evidence of global coordination on research and development in neglected diseases.

According to working group Chairman George Alleyne, the working group worked through nearly 100 proposals, chose from among proposals they thought would be most efficient and doable. Alleyne in his report to the board skimmed over numerous proposals, such as prize funds and patent pools, which are generally unpopular with industry.

Three proposals were highlighted by the working group report: some variation of a new indirect, consumer-based tax; voluntary business and consumer contributions (like purchase of a product that includes a donation to the cause); and new donor funds for health R&D. The group also recommended the creation of a global health research and innovation coordination and funding mechanism.

Transparency Concerns

But transparency questions plagued the working group, as media was shut out of its progress for the past year, and non-governmental groups raised steady concerns. “We have serious concerns about the transparency of the process,” Health Action International said in a 15 January open letter to the Executive Board, adding that the report avoids substantive issues and intellectual property. Chan in the past has stated that intellectual property is not a public health issue.

The most troubling accusation came from one of the experts on the working group, Colombian Senator Cecilia López Montaño, who said in a 15 January open letter urged board members to reject the report. She said she felt “utilized to legitimize a process in which neither I nor the majority of the members of the group participated in a full manner.” She said there was poor information from the WHO secretariat, documents were sent at the last minute, meetings rushed, and intellectual property issues were avoided despite being germane to the group’s mandate. She also said she requested information from WHO official Germán Velásquez, another Colombian, who would have normally been involved in the issue, but he was “sidelined” from the report. Transparency concerns raised along the way were ignored by the WHO, she said.

Alleyne and the Executive Board Chairman quickly dismissed the Colombian letter without mentioning specifics, saying only that it should have been brought up in the same working group that López Montaño said was unresponsive. Alleyne referred to the letter only as “that little mishap.”

Alleyne said it was “humanly impossible” to finish the report and get it translated in time for the Board meeting, so they were only provided with a summary. The translated full report will follow in the next 4-6 weeks, he said.

India and Brazil criticised aspects of the working group report. India said it “falls well short” of the plan to address Type II and III diseases (affecting mostly developing and least developed countries), and lacked a clear focus on technology transfer, the best solution in its opinion. Brazil said intellectual property issues can be addressed from a public health standpoint, proposed the director general convene intergovernmental meetings in the lead-up to the May assembly, and signalled interest in the global health R&D coordination and funding mechanism.

[Update: Brazil said there appear to be discrepancies between the original mandate and the report. Brazil statement available here.]

H1N1 Assessment

While all countries on the Board lined up to praise the WHO’s response to the H1N1 pandemic that broke out in spring 2009, a variety of countries asked that WHO review its work on the pandemic, and Japan suggested it could look at measures in future to assess the seriousness of any flu outbreak, such as number of patients hospitalised.

But developed countries such as the United Kingdom and the European Union represented by Hungary particularly spoke against criticism that has arisen of the WHO’s strong actions against what has amounted to a less lethal flu pandemic than feared. The UK urged members not to become “complacent” as a result of the criticism, but rather to continue to keep high levels of response. The European Parliament recently begun considering launching an investigation into the WHO’s behaviour on H1N1.

Chan proclaimed in her opening statement that the moderate nature of the pandemic is the best health news of the past decade. She said a number of things could have gone worse: the virus could have mutated, resistance did not develop to oseltamivir and the vaccine could have been less effective, she said.

She cited the generosity that has led to “well over 23,000 viruses and other specimens” being submitted to WHO network laboratories for analysis.

Chan said in some countries in the northern hemisphere the worst may be over, but, she cautioned, “there is quite a lot of winter left,” and the southern hemisphere will enter its influenza season soon. She urged countries to continue to push their populations to get vaccinations, and said for developing countries “concerned about their access to pandemic vaccines, WHO is ramping up its donation programme.” She also noted the difficulties in communicating to populations the need to get vaccinated.

Chan also said the pandemic has been the first test of the 2005 International Health Regulations, which some countries are proposing to review. The regulations are a “system of checks and balances,” said Chan. “They ensure that no one, myself included, has unfettered power.”

Reliable estimates of deaths from the current pandemic will take one or two years after the pandemic has ended, she said.

A WHO official said 265 million doses of vaccine have been distributed. Next autumn and winter expect another influenza season, he added. The virus has all the characteristics of one which will be long term.

Pandemic Access and Benefit Sharing

The international system for access and benefit sharing related to pandemic influenza, a key agenda item of the week, was postponed to Wednesday to allow, sources said, time for governments to discuss the issue among themselves. A new proposal has emerged from about a dozen countries such as Canada and the United States on procedure for what should be done next on the flu issue, which arose about two years ago when Indonesia declined to share its strain of the avian flu virus (H5N1) out of concern that it would be used in research by developed countries, patented and sold back to Indonesia at too-high prices. It is not about H1N1, the so-called swine flu, a proponent government source said.

The new proposal, not publicly available, would establish a member working group at the next assembly in May, encourage governments to consult in the meantime, and promote mission briefings on the issue, according to a copy seen by Intellectual Property Watch.

Other Issues

From the outset, the Board meeting quickly hit a subtle North-South overtone as two urgent late addition agenda items were discussed: pneumonia, which affects developed countries and was proposed by the United Kingdom, and Hansen’s disease (leprosy), which affects developing countries and was proposed by Brazil. Japan, the meeting chair, and the director general, pressured Brazil to postpone or marginalise its request (e.g., in an informal side meeting), but Brazil held its ground. Brazil said it raised the issue after 44 WHO members met in New Delhi and drafted a global strategy on the disease, for which there was last a strategy in 2001.

Also, Uganda on behalf of the African region proposed the development of a joint framework among the heads of the WHO, World Trade Organization, and World Intellectual Property Organization, to report to the next meeting.