TWN Info Service on Health Issues (Dec08/01)
19 December 2008
Third World Network

Key issues unresolved at WHO meeting on influenza virus sharing
Published in SUNS #6613 dated 18 December 2008

Geneva, 17 Dec (Sangeeta Shashikant) -- A meeting of member states of the World Health Organisation on the sharing of influenza viruses and access to vaccines and other benefits could not resolve some major issues between developed and developing countries. The meeting will resume during the May 2009 World Health Assembly.

The Intergovernmental Meeting of Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and other Benefits (IGM) met for a week in Geneva starting 8 December, tasked with establishing a framework for the sharing of the viruses and the sharing of benefits such as access to vaccines.

The meeting saw the continuation of divergences of views between developing countries that are largely providers of the biological materials linked to the flu viruses, and developed countries that have the laboratories and manufacturers that receive the biological materials and use these for producing vaccines and other medical products, and that are supposed to provide benefits in return for the viruses.

Several issues remained unresolved at the end of the meeting. These include which parties are entitled to receive the biological materials and their roles, responsibilities and benefit sharing obligations; the scope of materials that is to be shared; the issue of sovereign rights of providers of biological materials; whether the recipients of biological materials have any ownership rights over the materials and whether they should be allowed to claim intellectual property rights over the biological materials or over the products and processes developed using the biological materials.

The framework being developed by the IGM process is to govern the sharing of viruses, the roles and responsibilities of laboratories receiving the viruses (i. e. H5 Reference laboratories, WHO Collaborating Centres, Essential Regulatory laboratories) as well as that of third parties such as manufacturers or researchers (as agreed by Members) that receive the biological materials shared through the framework. A standard material transfer agreement, to be developed by the IGM, is to be signed by the providing and receiving parties.

As the issues could not be settled at last week's meeting, the IGM suspended its work and will meet again during the 2009 World Health Assembly. Informal consultations are expected before that in an effort to bridge differences, and in particular to address issues that are "political" in nature.

During the meeting, there had been little discussion on some core issues such as the parties to the framework, the scope of their tasks and the scope of materials that will be shared. Some members attempted to skirt round the issues instead of addressing them in detail despite these issues being raised by other countries on numerous occasions.

Curiously, there was also very little deliberation of the responsibilities of the vaccine and pharmaceutical manufacturers (most of which are based in developed countries), although they have the most to gain from the virus sharing process. Every time the issue of the role of manufacturers was brought up, it was quickly passed over by Jane Halton of Australia, who is the Chair of the IGM.

Some developing country delegates thought this was intentional, while other delegates felt that there was an attempt to rush through the documents before the IGM to try and obtain consensus on as many paragraphs as possible rather than have a general understanding of the various elements of the framework.

The frustration felt over the process led delegations from the South East Asian region (SEARO) to declare at the end of the meeting that "nothing is agreed until everything is agreed".

The meeting however did accept the principle that "Member States have a commitment to share on an equal footing H5N1 and other influenza viruses of human pandemic potential and the benefits, considering these as equally important parts of the collective action for global public health."

This principle was accepted after India on behalf of the SEARO pronounced its perception that the focus is toward consolidating virus sharing, while the issues of benefit was being relegated to realm of "the vague and obscure". India added that for this framework to be purposeful, there needs to be clarity how the issue of virus and benefit sharing is to be constituted.

India also said that if only virus sharing is obligatory then nothing much remains to be discussed. It added that virus sharing which has been in place for 60 years does not to our understanding deliver global public health protection in times of a pandemic. It also stated SEARO's belief that global public health protection can easily be achieved when virus sharing and benefit sharing are treated equally and on the same footing.

At the meeting, the developed countries pushed developing countries for a commitment to share viruses, but their own commitment (and the commitment of the entities in their countries that benefit from the use of the virus) to share the benefits was vague and far from being concrete in the negotiations on the text.

Several developing country delegates at the meeting noted privately that unless the benefits are concretized and effectively operationalised, the outcome is unlikely to be successful.

A decision adopted at the end of the IGM mandated that the meeting resume during the WHA and acknowledged the need for informal consultations among interested Member States and relevant regional economic integration organizations in the inter-sessional period in order to find ways and means to resolve the remaining issues.

The IGM requested the Director General of WHO "taking into account the revised IGM text, and if necessary with the advice of the Advisory Group", to:

• further develop the traceability mechanism;
• prepare the detailed terms of reference of WHO Collaborating Centres on Influenza, the WHO H5 Reference Laboratories, Essential Regulatory Laboratories, and the National Influenza Centres, following the guiding principles included the IGM text;
• prepare a revised version of the technical part of the SMTA, following the agreed principles of the IGM text;
• prepare a report identifying the needs and priorities for each of the benefits listed in Section 6 of the IGM text, in particular concerning the vaccine stockpile, as well as options for their financing.

The first day of the meeting agreed to accept text prepared by Halton as the basis of work. The Chair's text contains sections on principles, definitions, scope, objectives, on virus sharing, on benefit sharing and annexes containing a Standard Material Transfer Agreement (SMTA) and the Terms of References of the various laboratories that are to be receiving the biological materials.

In the first day the plenary discussed sections on principles, definitions, scope, objectives. Subsequently two working groups were created, one dealing with issues of governance and review as well as the TORs, and another dealing with the rest of the issues in the Chair's text.

One of the main issues raised during discussions was whether there was an obligation under the International Health Regulations 2005 (IHR) to share viruses.

The WHO's legal counsel clarified that the IHR did not require the sharing of viruses but that there was an obligation to share information, adding that the obligation of states have to be seen in light of the object and purpose of the IHR which is to prevent the international spread of disease.

[Some experts present at the meeting were of the view that the legal counsel went a little further in its interpretation of the IHR as it does not have authority to provide such an interpretation since it is clear from the IHR that there is no obligation to share viruses and where there is a dispute pertaining to the interpretation of the IHR, the matter can be brought to arbitration by the parties in dispute.]

The meeting saw developed countries, in particular the US, Japan and the EU, being very keen to impute some obligation to share biological materials under the IHR.

The US also sought the removal of any mention of the sovereign rights of countries over their biological resources from the section on principles and objected to language that made reference to the Convention on Biological Diversity.

France on behalf of the EU also on one occasion (responding to a developing country delegate that asserted sovereign rights and the right to fair and equitable sharing of benefits arising from the use of the viruses) claimed that it did not consider viruses to be a natural resource which is covered under the CBD.

The US, Japan and the EU also attempted, albeit unsuccessfully, to de-link virus sharing and benefit sharing by removing any language that spoke of benefits "arising" or "resulting" from the use of the viruses and they objected to any reference to "prior informed consent".

According to some delegates present, this attempt was so that the framework on virus and benefit sharing does not set a precedent for other diseases.

Brazil stressed the inclusion of the principle that the framework and the CBD should be mutually supportive and nothing in this framework shall be interpreted as implying in any way a change in the rights and obligations of the contracting parties under the CBD.

An acute shortcoming of the IGM was that it discussed virus sharing and the SMTA, without actually taking the time to adequately defining the parties involved in the framework or the scope of what was being shared.

This led an Indian delegate to exclaim near to the close of the meeting that "We don't know what we are sharing and with whom we are sharing".

Several countries had repeatedly requested for a better understanding of the parties involved, which was persistently ignored by others throughout the IGM.

Indonesia for example repeatedly mentioned that it was not aware of the parties involved in the virus sharing process while Thailand also made a request for "a diagram showing movement of materials in the current system" as it would be "useful for further deliberations".

US perplexed many participants at the meeting when it said it was not appropriate to ask the DG to provide information on the parties. Some other countries also mentioned that the issue of parties was a "political issue".

The US response indicates an unwillingness to discuss which recipients would be receiving the biological materials. This needs to be known in order to establish governance over the movement of biological materials received from one party to another party.

This issue is crucial as it would have illuminated clearly to which laboratories and manufacturers transfers of biological materials are allowed, and the parties to whom the materials cannot be transferred to.

Halton, the Chair of the IGM, did not insist on making this issue clear from the beginning, in particular prior to starting the discussions on the SMTA.

Halton also rushed past the definition section which would have clearly identified not only the parties but also the type of biological materials being transferred from one party to another party.

The Chair's text contains an extensive definition of "PIP biological materials", which includes the viruses shared with the system and the parts thereof i. e. the sequences, peptides, etc.

However, when the meeting came to the definition section of the text, Halton said that many in the meeting room would not be able to understand the scientific definitions and so it should be left to the technical persons (presumably referring to the participants from the WHO Collaborating Centres, Essential Regulatory Laboratories and the H5 Reference laboratory) to do the defining.

The definition of "PIP biological materials" is most crucial as it covers the subject matter that will be governed by the framework including the SMTA. Any subject matter not a part of "PIP biological materials" definition such as antibodies, will not be regulated by the framework.

The US proposed a limited definition to replace the definition in the Chair's text that excluded mention of any parts of the viruses that were being shared and focussed on the clinical specimen, the influenza virus isolate, high growth reassortant viruses and candidate vaccine viruses generated from using the influenza virus isolate. Japan and Canada were also in favour of a very limited definition.

Thailand's request to know exactly the kind of material that was transferred was from one laboratory to another laboratory was ignored.

Another issue that was not sufficiently addressed was the Terms of Reference (TOR) of the various recipients receiving the PIP biological materials. On this the key issues are the TORs for the WHO Collaborating Centres, H5 Reference Laboratories, the National Influenza Centres of the Essential Regulatory Laboratories (ERL) and the manufacturers.

This issue was repeatedly raised by developing countries such as Indonesia and Thailand. However there was some hesitance on having any TOR for the ERLs and significant resistance against having any TORs for the manufacturers.

The US strongly objected when Indonesia proposed the inclusion in the SMTA that material shared with the manufacturers should only be used for the purposes of developing and producing vaccines, pharmaceuticals and diagnostics.

The US responded saying that this was not acceptable because it would prevent manufacturers from obtaining cures for other diseases, for instance cancer.

The US response brought a strong reaction from several developing countries that made it clear that they were only sharing their biological materials for purposes of pandemic preparedness and nothing more.

Nigeria added that other uses of these materials can be done only with the informed consent of the originating laboratory.

The IGM chair herself, seemed hesitant to set TORs for manufacturer stating that this is a document agreed by member states and thus TORs cannot be set for anybody who is not a party.

[Vaccine, pharmaceutical and diagnostic manufacturers are the main beneficiaries of the virus sharing framework, and would have to follow what has been agreed in the framework through the SMTA].

Another sticky point was the method of execution of the SMTA. The US, Japan and EU preferred "self-executed" SMTAs for transfer into, within and out of the WHO network of laboratories; and when biological materials are transferred out of the WHO network laboratories to manufacturers and researchers, the receiving entities will agree in writing to comply with the SMTA.

Many developing countries could not agree to such a mode of execution particularly since its legal validity is questionable.

Instead, Indonesia proposed that the "SMTA will be executed, preferably in electronic form, and shall be duly completed and signed by institutions, organisations, and entities providing and receiving PIP biological materials".

African countries proposed that the execution should also be allowed to be done by way of fax. Nigeria proposed completing the SMTA using an implementing letter.

The approach proposed by Indonesia and the African countries could not be accepted by the developed countries, although signing a MTA is standard procedure in developed countries when biological materials are transferred. +