Service on WTO and Trade Issues (Jan10/05)
Sharing Working Group set up, pandemic flu response to be reviewed
Geneva, 25 Jan (Sangeeta Shashikant) -- The response to the H1NI pandemic influenza and unfinished business in respect of the pandemic influenza preparedness framework for virus and benefit sharing were a key focus of the 126th session of the Executive Board meeting last week.
These issues surfaced during the WHO Director-General's address to the Executive Board (EB), which met from 18-23 January, as well as under the agenda items of "International Health Regulation" and "Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits" (PIP framework).
On the first day of the EB on 18 January, Director-General Dr. Margaret Chan dedicated 23 out of 56 paragraphs of her address at the EB (in document EB 126/2) to the issue of the H1N1 pandemic influenza and the response to the pandemic.
While her response to the pandemic received "praise" from some Members, country interventions clearly revealed underlying dissatisfaction and frustration with the response.
During the discussion on the Report by the Director-General (DG) on the Implementation of the International Health Regulations (IHR) 2005 (EB 126/5), several countries called for the WHO to review its response to the pandemic, including the definition of "pandemic".
The call for this review comes amidst recent news reports about the apparent undeclared close financial ties between the pharmaceutical companies and the Strategic Advisory Group of Experts (SAGE), a WHO advisory group on vaccines and immunization, and questions surrounding the definition of "pandemic".
The discussion on the PIP framework further revealed discontentment over the response. Several developing countries pointed to the lack of access to anti-virals and vaccines during the H1N1 pandemic; the need for benefit sharing since viruses were being shared; and to ensure that IPRs (intellectual property rights) do not impede public health. They also called for a Member-driven process to finalize the remaining elements of the PIP framework for virus and benefit sharing.
(According to the Director-General's report, "To date, well over 23,000 viruses and other specimens have been submitted to the WHO Network laboratories for analysis".)
The agenda item on International Health Regulations (IHR) concluded with Dr Chan promising to activate the IHR Review Committee to review the functioning of the IHR, as well as the scope and effectiveness of the global response and the WHO Secretariat' response to the H1N1 pandemic, as well as identify the lessons learned.
(The IHR is a legal framework for the management of the global response to the pandemic. The H1N1 outbreak has been the first test of the IHR.)
Dr Chan also said that she would organize a meeting for the review before the World Health Assembly (WHA) in May, although she envisaged that the review would not be completed by then. She further said that she intended to provide an interim report in May and that the review would continue after May.
With regards to the PIP framework, it was agreed that an open-ended working group for negotiations between Member states would be convened on the basis of the outcome of the Intergovernmental Meeting (A62/5 Add. 1).
The meeting would be convened on 10-12 May just prior to the WHA and it would focus on the remaining elements of the framework and report to the May WHA. The EB also requested the DG to facilitate the process.
was reached after informal consultations among countries.
According to sources, the Secretariat was also not keen on holding a negotiation session before the WHA, citing as a reason financial and other resource limitations. However, ultimately, the developed countries and the Secretariat both capitulated to the demand for an open-ended working group session prior to the WHA.
The push for
a PIP framework that includes fair and equitable benefit sharing was
initiated at the 2007 WHA following
It also emerged that patent claims had been filed over several of the viruses and parts thereof that were contributed to laboratories under the authority of the WHO.
Ongoing negotiations in the form of an Intergovernmental Meeting (IGM) on the PIP framework came to a halt last year, as developed countries refused to renew its mandate. It was then agreed that the DG would initiate a transparent process to finalize the remaining elements of the PIP framework, including the SMTA.
Last October, Dr Chan initiated consultations over the issues of benefit sharing, IPRs and SMTA, and made proposals on these issues in an attempt to "find a middle ground to bridge the wide divergences". The DG's proposals are contained in document EB 126/4. However, agreement remains elusive.
Developed countries wished to see voluntary benefit sharing with no links to virus sharing and to allow entities receiving biological materials from the WHO to make patent claims over the materials and parts thereof, as well as over the products developed using the biological materials. They were resistant to the idea of an SMTA being the contractual document for the sharing of biological materials, although developed countries and their laboratories commonly use it for the purpose of sharing viruses.
On the other hand, developing countries stressed the need for entities receiving biological materials from the WHO to commit to benefit sharing through SMTA, and for entities receiving biological materials to not claim IPRs over the biological materials, adding an exception, i. e. industry may claim IPRs over the products developed using the biological materials but such IPRs must be licensed to developing-country entities on a royalty-free basis.
A group of
like-minded countries (LMG) including
The LMG also noted that while they applauded the efforts of the DG "to engage in negotiations with industry, the central focus that should guide these efforts with industry should be the interests of public health and not the parameters of what the industry is willing to do". They stressed that while innovation was important, the benefits of innovation have to be accessible at an affordable price. On IPRs, the LMG reiterated their conviction that the WHO is mandated to consider issues of IPRs from an access perspective, adding that IPRs must be balanced in the context of rights and obligations including those pertaining to the public at large.
During the EB meeting, developing countries strongly supported the need for effective benefit sharing, SMTA, as well as stressed that IPRs should not impede public health.
It drew attention to the fact that countries wishing to import from the global vaccine manufacturers are required to enter into detailed contractual agreements that are confidential and absolve all liabilities with the adverse outcome vesting only with the importer. It added that such mandatory contractual obligations are neither transparent nor ethical and are against the principle of equity. It further said that it would like the WHO to share the agreement entered into with the originator vaccine manufacturers which would empower members who are purchasing vaccines.
It said that benefits such as the WHO stockpile of vaccines, medicines and other supplies are important in the short term but these are not "sustainable long term solutions", stressing the need to expand global capacity for manufacturing influenza vaccines including that in developing countries. Thus, technology transfer and capacity building should be given high priority, it said.
(SAGE is charged with advising WHO on overall global policies and strategies, ranging from vaccine and technology, research and development, to delivery of immunization and its linkages with other health interventions).
It cautioned that the "middle ground" position pushed by the DG may lead to more ad hoc arrangements, also pointing out that certain conclusions in EB 126/4 do not capture the views of all Member states. It supported the call for open-ended consultations among Member states, stressing on the need to conclude the PIP framework.
behalf of the European Union, said that international collaboration
was paramount to a rapid response and that lessons learned from the
H1N1 (outbreak) should be fed into future deliberations. On the issue
to issues raised by
Dr Chan added that the WHO has a policy that requires experts to make a declaration of interest. All the experts that participate in SAGE have declared conflicts of interest, which are then shared with other experts in SAGE, she said, adding that is an important peer check and balance. "Whether or not experts give full disclosure is an ethical issue. Where we know that no full disclosure has been made, an immediate investigation will be conducted and this is what we have been doing," she said, adding: "We have special arrangements whereby we excluded certain participants and observers from the decision-making process".
In terms of real experts on influenza, there are not too many, she said, and thus, these experts are sought after for their professional experience by the industry, academic institutions and research institutions. "I would not deny the world in getting the best advise," Dr Chan added. "We will do our utmost to counter the misinformation and protect the independence of experts. It is my duty to guard against undue influences," Dr Chan said.
The issue of the link between pharmaceutical companies and SAGE has come about as a result of recent news reports revealing the apparent close ties between SAGE experts and the industry.
According to a news report dated 13 January by Nagrajan from TNN, "None of the WHO members on the vaccine board, barring one, declared any conflict of interest despite having extensive financial ties with the pharmaceutical companies in the form of research grants and consultancies".
The same news report mentions that the Danish Freedom of Information Act revealed that Prof. Juhani Eskola, a Finnish member of SAGE, received almost 6.3 million euros in 2009 from vaccine manufacturers for his vaccine research programme and that Danish journalists have reported on six other SAGE members with financial ties to various pharmaceutical companies.
The news report further draws attention to the fact that the "names and affiliations of members of SAGE and SAGE working groups are published on the WHO web-site together with meeting reports and declarations of interest submitted by the experts" but that it found no declaration of conflict of interest by the SAGE members on the WHO web-site.
Another news report by Pharma Times dated 6 January reported that the Parliamentary Assembly of the Council of Europe (PACE) is to hold an emergency debate and inquiry this month into the "influence" exerted by drug-makers on the WHO global H1N1 flu campaign.
It cites Dr Wodarg, a doctor and former SPD member of the German Bundestag, as charging that WHO, "in cooperation with some big pharmaceutical companies and their scientists, re-defined pandemics," removing the statement that "an enormous amount of people have contracted the illness or died" from its existing definition and replacing it by stating simply that "there has to be a virus, spreading beyond borders and to which people have no immunity".
Some delegates at the Executive Board said privately that they expected the issues raised in the news reports to be addressed during the review of the response to the H1N1 pandemic to be conducted by the WHO. +