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TWN Info Service on Health Issues (Aug08/03)
19 August 2008
Third World Network

WHO: Concerns over Chair's text on sharing of flu viruses and benefits
Published in SUNS #6539 dated 15 August 2008

Below is a news story on the latest draft Chairís text on virus and benefit sharing. The draft Chairís text came out at the end of June 2008. Comments on the draft Chairís text had to be given by the end of July 2008. A revised Chairís text will be released by the end of September 2008.

The next WHO meeting of virus and benefit sharing will take place from 9-15 November 2008.

The Chairís text has not been released publicly but is available at http://wikileaks.org/wiki/World_Health_Organization_Avian_Flu_draft_2008

Best Regards
Sangeeta Shashikant
Third World Network
Email: ssangeeta@myjaring.net

Geneva, 14 Aug (Sangeeta Shashikant) -- The issue of the balance between the sharing of the influenza virus and the sharing of the benefits from the use of the virus (especially vaccines and other medical products to counter the deadly avian flu) is being handled by a process in the World Health Organisation, in which developed and developing countries are negotiating the terms of a decision that covers rights and obligations in the sharing of virus, the research and commercial use of the virus, and the access to the vaccines and other products.

A step in the process has been the issuing at the end of June of a draft text on virus sharing and benefit sharing by the Chair of the Intergovernmental Meeting (IGM) on Pandemic Influenza Preparedness. The Chair is Jane Halton, Secretary of the Department of Health and Ageing, Australia.

The text is giving rise to concerns among officials of some developing countries as well as independent experts, who feel that the Chair's text does not adequately reflect, even as alternative options, many of the ideas and suggestions put forward by developing countries. In particular, Indonesia, the African Group and Thailand had submitted comprehensive proposals as inputs to the drafting of the text.

The IGM on Pandemic Influenza Preparedness was set up by the 2007 World Health Assembly through Resolution 60.28, to undertake reform of the WHO Global Influenza Surveillance Network (GISN) and in particular to formulate Standard terms and conditions for virus sharing and benefit sharing as well as to review the terms of reference of the WHO Collaborating Centres dealing with influenza.

A Working Group of the Intergovernmental Meeting held on April 3-4, 2008 in Geneva, agreed that the various proposals contained in the consolidated text of EB 122/5 would contribute towards preparation of a Chair's text, which is to be the basis for discussion at the next WHO meeting on virus and benefit sharing on 9-15 November 2008.

The Chair's draft takes the form of a "streamlined" text, as if there is agreement on almost all aspects of the document, although to date very little discussion has actually taken place on the proposals. In some areas, it summarises proposals put forward to the extent it misrepresents the original proposal.

It also excludes several issues that could hurt the sensitivities of major industrialized countries such as the US and EU, whose businesses are major beneficiaries of the present virus sharing system. This is most obvious in the way the Chair's text treats intellectual property (IP) issues.

The paper excludes any provision that the recipients of viruses should not have IP claims over the products derived from viruses donated. Such a provision is supported by Indonesia, the Africa Group and by Thailand, but heavily contested by industrialized countries.

According to sources, during the Working Group meeting, in reply to a query by a Member state, it was confirmed that if there is dissatisfaction with the Chair's text, member states at the forthcoming November meeting could rely on the consolidated text of EB 122/5, which contains all the proposals of member states.

According to some diplomats, although it is not expressly mentioned in the outcome document of the Working Group, the understanding is that the Chair would prepare a text that would merge similar proposals and present as options proposals which diverge.

However, the present Chair's text disregards many of the proposals put forward, and where it puts forward options, it does so selectively. The Chair also presents what she believes to be "compromise text" in areas that have not been the subject of an in-depth discussion nor any agreement on the compromise.

Halton explains her actions in an email to delegations. She says that "some have expressed a preference to retain all of the original language and alternative concepts as proposed in submissions to the IGM in November 2007, while others have expressed a preference for a streamlined text with a minimal number of areas of disagreement".

She adds that an attempt has been made to balance the various comments, with two key guiding principles: (1) where a compromise position seems feasible, this has been put forward as streamlined text (adding that this approach has chiefly been used with regard to virus sharing, which has had more lengthy discussion); (2) where positions cannot be reconciled, or where issues have not been debated, an attempt has been made to retain all of the competing concepts and ideas, though not in full detail or in the original terminology (this approach has chiefly been used in benefit sharing, which has not yet been discussed in the working group).

She asked countries to comment on: (I) concepts or issues which are included in EB122/5 and which do not appear in the draft Chair's text; (ii) concepts or issues which have been paraphrased in the draft Chair's text but which do not adequately capture the proposals as they appear in EB122/5; (iii) textual suggestions to improve the technical correctness of the draft Chair's text; and (iv) Member States' views on issues in the draft Chair's text, particularly where they have not been debated to date and also where there may be room for compromise.

Some developing countries have privately indicated that the Chair's text in its present form is unacceptable.

Further, unlike the relatively open debate of the WHO's Intergovernmental Working Group on IP, Innovation and Health (whose negotiating document and comments on the document by countries as well as by NGOs were made available on a public website), secrecy shrouds the Chair's text and the comments on the Chair's text, all of which are not publicly available.

According to an email message sent by Halton and received by some delegations, "contributions received from Member States will be considered by the Chair in preparing a final version of the text" and "that on 28 July, all contributions will also be posted in the original language of submission, on a password-protected website", adding further that "information on accessing the website will be sent to Bureau Members before that time".

A WHO official informed SUNS that "a password-protected web community" has been set up for Member States to access contributions received from Member States on the Draft Chair's text, and this has been communicated to the Bureau Members (which should in turn inform other countries that they represent).

Some delegates contacted by SUNS were however unaware of this website, while others who were aware of this could not use the password.

Concerns on the Chair's text, some of which are mentioned in some developing country submissions, include the following:

(1) The Chair's text presents a mostly streamlined text on virus and benefit sharing, on the assumption that much of the content has already been agreed to by member states, although the actual situation is to the contrary.

(2) The text does not adequately reflect even as alternative options, many of the proposals put forward by developing countries, i. e. Indonesia, the African Group and Thailand. For example, termination clauses proposed in the Africa Group and in Thai papers have been left out of the Chair's text.

Another example is that Indonesia, Thailand and the Africa Group have stated that there should be no IP claim by WHO-designated laboratories and other entities that receive biological materials, over the substances, processes and products derived from the use of the biological material. However, no mention of this is made in the Chair's text.

(3) The Chair's text also drops crucial details from original proposals and sometimes even narrows proposals put forward to the extent it misrepresents the original proposals. For example, para 6.11 of the Chair's text states that "Vaccine manufacturers shall set aside x% of each production cycle of vaccines for H5N1 and other influenza viruses of human pandemic potential for the provision to the WHO stockpile free of charge," while para 6.12 of the Chair's text states "Vaccine manufacturers shall also set aside x% of each production cycle of pandemic vaccine for provision through the WHO on the basis of public health need".

These paragraphs seem to be taken from the Africa Group proposal, but it inadequately captures what the African paper states. While the Chair's text only speaks of providing vaccines to the WHO, the Africa paper also advocates prioritizing the needs of developing and least developed countries and that X% should be reserved for developing countries and provided at an affordable price. It also proposes a method of calculating the affordable price. (Para 6 (b) (I) & (ii) of the Africa Group paper A/PIP/IGM/7).

Another example is para 6.16 of the Chair's text, which narrows the scope of the proposal in the Africa Group paper to vaccine manufacturers providing royalty free licence to any influenza vaccine manufacturer based in the member states from where the relevant clinical specimen was collected from. The African proposal was broader; it required third parties to grant on request, a non-exclusive, royalty free license to any domestic influenza vaccine manufacturer from developing and least developed countries and in particular to the country providing the specimen.

Para 6.16 also does not make any reference to the proposal in the Africa Group paper, which talks about access to and transfer of technology and know-how in vaccine development as well as capacity building for domestic influenza manufacturers from developing and least developed countries. (The proposals are in the African paper, para 6 (a) (I) (ii) of Section H).

(4) A positive element in the Chair's text is that it refers to "Standard Material Transfer Agreement" (SMTA), thus accepting the concept in principle. However, there is concern that the SMTA in the Chair's text shows no characteristics of being legally binding on the recipient of the specimens and viruses provided through the WHO virus and benefit sharing system.
According to a developing country's submission in response to the text, the Chair's text is not clear on who are the signatories to the SMTA; the format of the SMTA; how the SMTA will be executed; or the dispute settlement mechanism if a party to the agreement fails to comply with the terms and conditions in the SMTA.

The Chair's text thus appears to pay "lip-service" to the concept of "SMTA". The Africa Group has presented a paper which allows implementation of the SMTA through "Implementing Letters", which are signed by the provider and the recipient as relevant, but these also do not feature in the Chair's text.

(5) The Chair's text places benefit-sharing obligations of the recipients and dispute settlement in a section separate from the terms of the SMTA with the result that the recipients of biological materials need not commit to benefit sharing through an agreement. In addition, if there is non-compliance with the terms of the SMTA, there is no mechanism for the provider of materials to take action against the recipient (e. g. the manufacturer). The dispute resolution provided in the Chair's text is only between Members.

The resulting effect is that countries that fail to comply with sharing the viruses (Chair's text states that Members agree to routinely provide clinical specimens) may be brought to the Health Assembly but no action may be brought against the recipients that do not fulfill their benefit sharing obligations or do not comply with the terms of the SMTA. For an effective virus and benefit sharing mechanism, benefit-sharing obligations have to be a part of the SMTA. The papers of Indonesia, Thailand and Africa Group require recipients of the virus to be bound to sharing of benefits through a written agreement. The Africa paper further proposes a dispute settlement mechanism between the provider of biological materials and the recipient.

(6) The section on benefit sharing in the Chair's text presents tasks and routine obligations of WHO as the primary benefit to be obtained by developing countries in "benefit sharing" arising from the use of the viruses. This detracts attention from the real issue at hand, i. e. what are the benefit sharing obligations of recipients of biological materials such as the vaccine manufacturers, etc.

(7) Para 5.1.1 (a) and (b) of the Chair's text are about entities that would be allowed to receive the "clinical specimens or viruses". Basically, it requires countries to share viruses with a WHO Collaborating Centre for Influenza or a H5 Reference Laboratory (H5RL) of their choice.

But through these laboratories, the materials can be shared with: (I) laboratories in the WHO Network, which according to the definition, is comprised of National Influenza Centres; WHO Collaborating Centres On Influenza; H5 Reference Laboratories (H5RL), and essential regulatory laboratories; (ii) vaccine manufacturers; (iii) diagnostic manufacturers; (iv) pharmaceutical manufacturers; and (v) public health researchers. In effect, the Chair's text allows free flow of "clinical specimens and viruses" once the materials are given to the WHO Collaborating Centre/H5RL.

There are at least two issues that arise. First is the wide authority given to the WHO designated centres (although the mandate for H5RLs is only to diagnose H5 infection) to decide to whom to give the biological materials to, bypassing the WHO Secretariat.

Second is the fact that the Chair's text not only requires the transfer of the vaccine virus (i. e. the modified virus used for vaccine development) but also the clinical specimens (e. g. throat swabs), and the isolated viruses to third parties (i. e. entities other than the WHO designated centres).

This is in total disregard of proposals put forward in particular by the Africa Group, which wants to limit the number of parties that receive the clinical specimens and the vaccine viruses and limiting the type of materials transferred to third parties to vaccine virus.

(8) The lack of clarity as to whether the definition of "biological materials" extends to parts of the biological material such as genes, sequences etc, since it is not explicitly mentioned. According to Edward Hammond, an expert on virus and benefit sharing: "With current technology, vaccine companies and other biotechnology enterprises do not necessarily need to receive specimens, viruses, or other biological materials from WHO collaborating centres in order to obtain viruses (and viral genes) that are submitted to the WHO system. The copying of viruses and their parts from sequence data only takes a few days at present, and will get easier and faster in the near future."

Therefore, he adds, it is imperative that the same benefit sharing mechanisms should apply to the sequence data itself and to the biological material generated (i. e. synthesized) from that data through the application of computational and laboratory techniques.

(9) The Chair's text repeatedly uses the phrase "global public health security" although the concept of "security" in WHO documents has been objected to by several developing countries even in the context of virus and benefit sharing.

(10) The text proposes that the review of the Terms of Reference of the WHO-designated centres be done by the Advisory Committee and not by the IGM. However, the concern here is that there will likely be little coherence between the Standard Material Transfer Agreement and the Terms of Reference, if the review of the latter is left to the Advisory Committee.

(11) The overall effect of paragraphs 5.2.1 and 5.3.2 is that laboratories that share clinical specimens will have to register those specimens in the traceability mechanism as pandemic influenza preparedness biological materials (PIP biological materials). Those who receive the PIP biological materials will have to register receipt of the materials and comply with any other data requirements of the traceability and associated reporting mechanisms.

However, the proposed traceability mechanism in the Chair's text should also track movement of the vaccine virus; parts of the virus (e. g. genetic and other components, genes, sequences and polynucleotides as well as the polypeptides they encode); report on the "use" of the materials by laboratories that may be part of the WHO network (e. g whether the lab did isolation, developed vaccines virus, developed diagnostic kit etc.) and by the vaccine, diagnostic, and pharmaceutical manufacturers and public health researchers; track the benefits shared by recipients of biological materials with the WHO system and member states; and documents executed (e. g. MTAs signed) in the process of virus and benefit sharing.

Some submissions by countries also suggest that consideration should be given to the recently concluded "Global strategy and plan of action on public health, innovation and intellectual property" (WHA Resolution WHA 61.21).

The Strategy mentions concepts such as "appropriate licensing policies, including but not limited to open licensing", "patent pools", open-source approaches and it would be interesting to see how these concepts may be applied in the context of virus and benefit sharing particularly in resolving tensions surrounding IP. +

 


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