Committee Examines Undue Influence, Coordination In WHO Pandemic Flu Response
Published on 15 April 2010 @ 5:28 pm
By Kaitlin Mara, Intellectual Property Watch
A review of the World Health Organization’s response to the 2009 pandemic influenza outbreak kicked off this week, with firm statements from those involved in the response that they were not unduly influenced by outside stakeholders. Still, serious questions remain about the coordination effort, as a nearly a year after the pandemic was declared developed countries find themselves having to dispose of excess vaccines while poorer countries are reporting they have yet to obtain as many as they need.
The response to the global spread of H1N1, or “swine flu”, is being examined under the rubric of reviewing the WHO International Health Regulations. The final report of the 29-member expert body [pdf] tasked with the review is not expected until the World Health Assembly in May 2011, but this meeting was the start of a process intended to improve responses to future health emergencies.
This week’s meeting ran 11-14 April. Future meetings are planned for three consecutive days during the week of 28 June and again during the week of 27 September, though exact dates are not yet decided. Between meetings the expert group is expected to gather information, including from intergovernmental agencies and nongovernmental groups.
Meanwhile, the pandemic is still ongoing, the expert review body was told by John MacKenzie, the chair of International Health Regulations (IHR) Emergency Committee, an advisory body tasked with providing recommendations to the WHO director general in cases of global emergency. The Emergency Committee is waiting for more evidence from the Southern Hemisphere to asses what they say is an ongoing threat, and is “not at any stage yet where we would terminate the public health emergency,” he said.
As the Emergency Committee was an important part of WHO’s response effort, their actions will be one of the many areas analysed by the review body.
Review Committee
The review committee experts are questioning the details of the WHO’s response to the H1N1 to determine if it was handled as well as it could have been. The mild nature of the virus has left many wondering if the threat was exaggerated, and there has been speculation that the thread was deliberately trumped up in order to trigger the production of pre-ordered vaccines to the benefit of the pharmaceutical industry (IPW, Public Health, 26 January 2010).
But this possibility was vehemently rejected by MacKenzie, who told the review body “I was not approached by anyone in the pharmaceutical industry.”
The Emergency Committee members’ names were kept secret, MacKenzie said, in part to prevent the possibility of such conflicts of interest. “My name was the only one known outside the committee, and so I was the only one who could have been approached. And I certainly wasn’t.”
The examination work of the review committee is so far divided into five areas: the preparedness phase, the alert phase (everything leading up to the declaration of “pandemic”), the response phase, communication (including with the public and the press), and aspects of the International Health Regulations outside influenza, review committee Chair Harvey Fineberg told a press conference immediately following the 11-14 April meeting. Fineberg is president of the Washington, DC nonprofit The Institute of Medicine.
One issue that received several questions during the review committee on 14 April was on whether the WHO had changed its definition of “pandemic.” In particular, the WHO has been accused of altering its guidelines – which were updated in April 2009 from an earlier 2005 [pdf] document – to remove references to the severity or seriousness of the disease. WHO has denied these accusations, saying that the definition of pandemic has never changed (IPW, WHO, 25 January 2010).
WHO flu expert Keiji Fukuda said the organisation “always recognised that severity was important,” but that poses a practical problem. It is difficult to define and even harder to measure, and measure quickly, as is needed for a pandemic response, he said. This is especially so since severity may range widely in different populations and countries, and since influenza outbreaks often look different at the beginning than they do in the end. The organisation tries to address severity, he added, but does not hold up decisions on it.
And MacKenzie said that this pandemic “is much more severe, I believe, than people tend to talk about,” citing deaths among young, healthy adults.
Distributing Vaccines, Information
Another major question likely to come up is how vaccines and treatments can be distributed equitably.
News reports, such as this one from the Washington Post reporting that the United States has used less than half of the vaccines it purchased, have said that the US and several European countries are finding themselves with more doses of vaccine than they can use before it expires.
Meanwhile, some developing countries have said they were unable to get the vaccines they needed – notably Mexico, where the virus originated and who provided the strains needed to manufacture vaccines worldwide (IPW, WHO, 20 January 2010).
WHO’s role in facilitating technology transfer and capacity building on access to vaccines was “touched on” during this week’s discussions and is something “we expect we will be investigating, along with other topics, in coming months,” said Fineberg in response to an Intellectual Property Watch question.
Also at issue, according to conversations at the meeting, is how to communicate with media more effectively, in particular using so-called “new media” such as text messaging and blogging and practicing what a member of the committee called “rumour management.”
In a separate development, the European Federation of Pharmaceutical Industries and Associations reported the results of a pilot project to combat counterfeit medicines. The project involved labeling each medicine packet with an individualised code. The final report, available here, called the project a success.
The WHO’s Pandemic Alert Response: Emergency Committee Meetings
25 April 2009
First meeting of the IHR Emergency Committee
Declaration of “Public health emergency of international concern”
27 April 2009
IHR Emergency Committee issues temporary recommendations for flu response
Pandemic is moved from phase 3 to phase 4
Containment not considered possible; focus shifts to mitigation
29 April 2009
Smaller meeting with Emergency Committee chair, vice chair and rapporteur
Sustained transmission of H1N1 seen in at least two countries (US and Mexico)
Phase moved from 4 to 5 after agreement from full EC reached electronically
5 June 2009
Phase 5 continues, as EC did not believe there was enough information to go further
11 June 2009
Evidence of sustained transmission in at least two, if not three, WHO regions
Information received from Mexico, US and Canada as well as Spain, the UK, Japan and Australia
Phase 6 — official pandemic — declared with unanimous EC support
Recent meetings of EC on:
23 September 2009
26 November 2009
23 February 2010
Reports of these meetings are available here.
Kaitlin Mara may be reached at kmara@ip-watch.ch.
Categories: News, English, Patent Policy, Public Health, Technical Cooperation/ Technology Transfer, WHO
16 April 2010 at 1:04 am
Very interesting report indeed. Names are being kept secret of committee members to avoid conflicts of interests arising. Is this not like insisting on driving with a seatbelt while driving drunk?
So the quest is on for the proof of “exaggeration” of severity and where the problem lies. Some focus on the definition others on the composition of experts and others still on the science to find the “smoking gun”.
On severity, given the definition, and declaring a pandemic where was common sense when a definition is merely a platitude that cannot substitute for sound judgement (by “disinterested” experts)? If this sounds rhetorical, then let us take the word of the experts and see how prepared WHO was with countries who could have been eligible for receiving the vaccine? It is surprising that very few countries were ready to receive the vaccine even at a very late stage in the evolution of the virus. Why was this issue not escalated politically by WHO if this was the case?
On the science, it is hard to verify the qualifications of the experts let alone the voracity of the scientific judgement applied. Yet scientists presenting at the Counsel of Europe came to different conclusions.
Also on severity, the influenza virus is plastic and adaptable. So it is unpredictable, mutates. A dangerous mutation could well have led to many deaths. Yet this plastic virus was not plastic enough to pose a danger for WHO (along with OIE and WTO) to issue a statement protecting the pork industry (it is the H virus not Swine flu!). BUt at that time, with reduced testing and monitoring of samples, the risk posed actually increased (and it was well known that not even the US had/applied enough testing capability/resources). It simply does not add up!
On managing of conflicts of interest, the one thing that is undeniable that vaccine manufacturers have made a killing on these sales. And let us be clear, WHO still does not have a viable business model for sharing “benefits” with developing countries, even if they share their protected biodiversity (yes it is protected). But that did not stop WHO from violating its own guidelines and sharing the specimens with commercial entities that invoked patents on gleaned derivatives. Those guidelines were also removed from the web (replaced with best practices) and not because anyone was driving drunk.
Now the song and dance can continue. WHO still does not have a solution that works even for business (unless it really thinks that vaccine production capability can effectively remain monopolised) – the vaccine business is very cyclical, and hence business need to make “fat” for the “lean” times. Profit is not an indicator of the costs given the peaks and troughs of profits in the sector.
WHO will now of course be transparent about its “donations” to vaccine producers (in intellectual property terms) but still has no way to be compliant with the legally binding Convention on Biological Diversity. One would have been perhaps too optimistic to expect the Secretariat of the UN Agency on Health(with WHO being a lead implementer of the Delivering-as-One UN reform process) to follow the convention and make it standard practice.
In fact Indonesia was being ostracised for not sharing viruses as if it had no legal rights. The legal advisor of WHO even said that not sharing virus samples breaks the spirit of the IHR, even if not the text. Yet many parties to the preparatory talks on the IHR were clear that sharing of biological samples was not
part of its scope.
At least the DG has had the temerity recognise the systemic problem of funding the WHO (which may constrain its freedom from conflicts of interest) and seeks to address it. If donors are actually serious about aid effectiveness they should rise to the DGs challenge and immediately and unconditionally convert at least 80 to 90% of their discretionary funding to the UN to direct budget support. This would increase member oversight overnight and increase WHO/UN independence. And not having so many closed expert meetings would be a nice touch in addition to changing the feudal Civil Society recognition process.
In the final analysis, the smoking gun is visible and open for all to see, but it is not being looked at. A serious omission to the detriment of developing countries.
29 March 2011 at 4:38 pm
[...] The assessment of the global response to the H1N1 pandemic, so-called Swine flu, was requested at the January 2010 WHO Executive Board meeting, and the IHR Review Committee was asked to review both the pandemic response and the functioning of the IHR. It started in April 2010 (IPW, Public Health, 15 April 2010). [...]