WHO meeting on avian flu virus ends with draft documents
Geneva, 24 Nov (Sangeeta Shashikant) -- A four-day meeting of the World Health Organisation on the contentious issue of the sharing of avian influenza viruses and of benefits (such as vaccines) derived from the use of viruses ended late on Friday
(23 November) without an agreed framework, but with a decision to meet again for a resumed session next year.
The Intergovernmental Meeting (IGM) on Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits produced an "interim statement" which in effect sets up interim measures before a permanent system is established.
The main interim measures are a "traceability" system to track the movement and use of H5N1 viruses and other viruses with pandemic potential contributed to the WHO system on influenza by countries, and an advisory group to be set up by the WHO Director-General Dr Margaret Chan.
The IGM, which was chaired
by Jane Halton of
* A draft text on principles on virus sharing, benefit sharing, financing, collective action, sovereign rights, capacity building and technology transfer, intellectual property, and oversight mechanism.
* A draft on operational components (on Virus Sharing, Benefit Sharing, Financing and Oversight Mechanism). This is a compilation of draft texts proposed by various countries for "operational components" (i. e. the standard terms and conditions which are to govern the operations of countries, WHO collaborating centres and laboratories receiving specimens and viruses from countries, and companies and institutions receiving seed viruses which are used for developing vaccines).
A "dictionary of terms" was also issued, although it had not been properly discussed. All three documents were attached as annexes to the Report of the IGM. The statement was incorporated within the Report itself.
These documents are to be the subject of further negotiations at two further meetings. The IGM decided to continue its work in an open-ended working group
(with balanced representation
from developed and developing countries) to be convened by the Chair,
The open-ended working group will report to a resumed session of the IGM that will meet after the 2008 World Health Assembly that is usually held in May.
None of the attached documents are agreed documents (except the agenda and the participants' list); in fact, some of the documents were not even discussed adequately (e. g. the document "Dictionary of Terms").
The document on principles
had been originally proposed by
The document on "operational components" contains the proposals on the "nuts and bolts" of the reformed system to be established. The draft compiles proposed texts, usually in legal language, of the conditions under which countries are to contribute viruses, the WHO collaborating centres are to conduct their research activities, and the companies are to share the benefits of their eventual products.
Some of the proposed texts include letters of agreements between the countries and the WHO or its designated centres, and between the WHO and the companies obtaining virus strains from the centres. Among the conditions proposed are the limitations on applications for patents by the centres and companies, and measures by which the companies are to provide benefits to developing countries (such as contribution to a vaccine stockpile, to a fund, and to technology transfer).
The compilation of the "operational
components" includes proposed texts by the Africa Group and
The final expected outcome of the process is a reform of the WHO's present Global Influenza Surveillance Network (GISN), which has come under strong criticism from developing countries led by Indonesia, for requiring countries to contribute their viruses to WHO collaborating centres, and which provides candidate vaccine strains (containing parts of the viruses) freely to companies, but which does not give benefits in return to the contributing countries, or to developing countries in general, which then have to purchase scarce vaccines at high cost.
In the interim statement provisionally agreed to at the end of the meeting, there is an admittance of "a breakdown of trust" in the existing GISN system and that it does not deliver "fairness, transparency and equity".
This issue has taken on an urgency -- admitted by the Director-General who said that she had never taken a WHO meeting so seriously -- because of the highly-publicised reluctance of Indonesia to continue to share its avian flu viruses under the GISN system because of what it claims are the abuses in the system and the lack of benefits accruing to developing countries like itself.
At the start of the meeting, Indonesian Health Minister Dr Siti Fadilah Supari charged that her country had experienced unfair and non-transparent treatment by the system, which had failed to respond to the needs of humanity. She called for the replacement of the GISN with a fairer mechanism.
The IGM was mandated by the World Health Assembly last May, following a lengthy discussion during which developing countries complained that they were not deriving benefits such as access to affordable vaccines although they had freely shared their influenza viruses with WHO collaborating centres under the GISN scheme.
Although the IGM was unable to complete its work last week, many developing country delegations as well as health-related NGOs who were present were satisfied with the results, as the discussion and the documents were seen to have laid the foundation for a fundamental reform of the flawed GISN system.
On the outcome, a diplomat
The Director-General has important tasks to improve transparency of the system, the delegate said.
It is clear, the diplomat added, that the current system cannot just proceed on the basis of goodwill, further adding that agreement will be difficult to reach, to change a system that has never been questioned before and that has existed for about fifty years.
In fact, much of the initiative and many of the new ideas on reforming the system as well as the texts had come from several developing countries and their groupings during the week.
While developing countries
The developed countries,
particularly the European Union and the
These developed countries tried to make use of the WHO's International Health Regulations to argue that countries are legally obliged to contribute their viruses. A heated controversy also developed when the EU was determined to put in language on "global health security" in the context of virus sharing. This was rejected by the developing countries.
In the last five to six hours of the meeting, on 23 November, the participants were occupied with negotiating a one-page "Interim Statement of the Inter-governmental Meeting on Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccine and Other Bbenefits" which was to be included in the report of the meeting.
A draft of the statement was presented late in the afternoon, with discussion going on to 11 p. m. A majority agreed to adopt the statement, with the Africa Group registering reservations.
The interim Statement importantly acknowledges, "a breakdown of trust" in the existing GISN system and that it does not deliver "fairness, transparency and equity".
However, as a demonstration of goodwill, Member States "agree to take urgent action to develop fair, transparent and equitable international mechanisms on virus sharing and benefit sharing" and "agree that viruses and samples are to be shared within the WHO system, consistent with national laws, as the detailed framework for virus sharing and benefit sharing continues to be developed".
The Statement also recommends the establishment of a traceability mechanism as well as an advisory mechanism, without going into specifics in relation to the establishment, leaving it to the WHO Director-General to take action.
The Africa Group, (with about 46 member states) reserved its endorsement, as it was unhappy that it was not consulted and with the un-transparent process by which the Statement was prepared and its late presentation, which did not allow its members to obtain the instructions from capitals.
However, on the repeated insistence of the Chair who appeared very keen to see the Statement go through, the African Group allowed the Statement to be discussed.
Later, following discussion
on the Statement,
The group said that it would revert to the Chair next week with some information. It added that this should never be repeated, and that the group will do everything to see that the process is blocked if it is excluded from future consultations.
This statement by the African Group led the Chair to conclude the meeting, stating that as yet (i. e. by the end of the IGM) there was no consensus on the Statement.
In the preamble, the Statement reaffirms Resolution 60.28 adopted this year at the WHA, which began the critical reform of the GISN system, and the obligations under the International Health Regulations (2005).
The preamble stresses the
"critical importance of global public health". In view of
the threat of an influenza pandemic, it acknowledges the importance
of international collaboration and collective action, timely sharing
of viruses and specimens, the development and production of preventive
and curative measures such as vaccines and anti-virals as well as other
measures to protect public health globally and in each
It also acknowledges the urgent need for transparent international mechanisms aimed at ensuring fair and equitable access to H5N1 vaccines and fair and equitable benefits, taking into account needs of developing countries.
Importantly, the statement acknowledges that "there has been a breakdown of trust" in the existing system for sharing of influenza viruses i. e. the GISN, and that it "does not deliver the desired level of fairness, transparency and equity".
It further states that pending agreement on a "detailed framework for virus sharing and benefit sharing" and as a demonstration of good will, Member States "agree to take urgent action to develop fair, transparent and equitable international mechanisms on virus sharing and benefit sharing" and "agree that viruses and samples are to be shared within the WHO system, consistent with national laws, as the detailed framework for virus sharing and benefit sharing continues to be developed".
The phrase "consistent
with national law" caused significant disagreement, especially
between the EU and
US was also keen to achieve
consensus on the Statement and was seen trying to broker consensus between
EU agreed to delete only
the phrase "global health security", to which
However, the EU seemed extremely keen to add some reference in the paragraph to either "international laws/regulations" or to "global health security", that it once more (after agreeing to its deletion) persisted that the latter should be added, if not the former.
[This response by
As a compromise, it was finally agreed that the concept of "global health security" and other additions would be dropped in favour of adding "global" to the phrase "public health" in the preamble so as to read "Stressing the critical importance of global public health".
A participant present at the meeting claimed that the EU and other developed countries were keen to add references to international laws/regulations and global health security in an attempt to make a link between virus sharing and the International Health Regulations, although at the meeting, it was already clarified explicitly by the legal counsel of the WHO that there was no positive obligation in the IHR for Member states to share specimens or viruses.
The Indonesian statement is an attempt to rectify the double standards currently existing within the present system, i. e wherein country contributing viruses that wishes a MTA to be signed for transfer of viruses is denied its request but the WHO designated laboratories transfer the seed virus (developed from the viruses contributed for vaccine development) only on completion of a MTA, so as to protect the IP rights of the patent holder of reverse genetics (a technique used to develop the seed virus).
The Statement also states that Member States agree on two immediate measures for delivering transparency. The first is a traceability mechanism that is to be established to track all shared H5N1 and other potentially pandemic human viruses and their parts. A report on the progress of the implementation of the system will be provided to the 61st WHA.
The Statement adds that pending the functioning of such a mechanism, an interim system providing full disclosure of information on transfer on movement of virus shall be made operational immediately.
The second measure is the establishment of an advisory group to the WHO Director-General to monitor, provide guidance to strengthen the functioning of the system and undertake necessary assessment of the trust based system needed to protect public health. The group is to be appointed by the DG in consultation with Member States based on equitable representation of the WHO regions and of affected countries.
The composition of the mechanism
also became a point of contention.
Finally, it was decided that more general terminology would be used and that it would be left to the DG to take the appropriate decision, bearing in mind the concerns raised by Member States.
The Statement invites the Director-General within her existing mandates under the WHA Resolution 60.28 to take forward the actions outlined in the Statement with the support of the Member States.
At the closing, the DG agreed that the GISN system needed fixing, adding that it has to be fair, equitable and transparent.