TWN Info Service on Intellectual Property Issues (Nov07/05)

28 November 2007

WHO MEETING ON AVIAN FLU VIRUS ENDS WITH DRAFT DOCUMENTS
Published by SUNS #6374 dated 27 November 2007

The four-day WHO Intergovernmental meeting on Influenza Viruses and Benefit Sharing ended on Friday (23 November) without an agreed framework, but with a decision to meet again for a resumed session next year.

Please find below a news report on the outcome of the meeting. The news report was published by SUNS #6374 dated 27 November 2007 and is reproduced here with permission.

Best Wishes
Sangeeta Shashikant
Third World Network
email: ssangeeta@myjaring.net

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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 Australia, also produced two important documents that emerged from the meeting's two parallel processes:

* 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, in Geneva, prior to the 2008 World Health Assembly.

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 Indonesia and the draft was the result of four days of discussions at the meeting's plenary.

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 Thailand.

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 from Brazil said that the IGM has managed to come out with something positive, from a meeting that was convoluted and not well prepared.

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 in particular Indonesia, Thailand and the African Group submitted concrete proposals and elements for discussion on revising the framework on virus sharing, developed countries remained elusive, with no proposals coming from them on establishing the new framework.

The developed countries, particularly the European Union and the United States, seemed at most times to be resisting the suggestion that the current system needed to be significantly reformed and they were intent on conserving the status quo. They were also most concerned to have a conclusion that required the developing countries to continue to share their viruses.

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 Benefits" 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.

Nigeria, on behalf of the African Group, said that the Group had been "rushed" into discussing the Statement and that it was "not comfortable" making it part of the report of the meeting, adding that they were not part of the drafting process and have no mandate to endorse the document.

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, Kenya, on behalf of the African Group, reiterated the Group's unhappiness with the process, stressing that in the future this should not be done. It further stated that "in the spirit of solidarity, we are all equal" and that it was not in its interest to block the process.

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 Member State.

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 Indonesia. This led the Director-General to actively participate, as she went around from regional group to regional group, trying to find consensus.

US was also keen to achieve consensus on the Statement and was seen trying to broker consensus between Indonesia and the EU.

Portugal, on behalf of EU, proposed the deletion of that phrase, and to add instead in the paragraph, ensure "global health security" and "due consideration to relevant national and international laws and regulations". Portugal explained that the latter sentence was from the WHA resolution 60.28.

Indonesia vehemently objected to the EU language, saying that it was not even comfortable with the original text, and at such a late hour it was difficult to accept the EU's addition, which diluted the message it wanted.

EU agreed to delete only the phrase "global health security", to which Indonesia said that it had no flexibility in relation to the second addition of "due consideration to international laws and regulations".

Indonesia added that the Statement was only an interim mechanism and since there is no new agreed mechanism in place, Members cannot simply add text from WHA 60.28 which pertains to the development of a new mechanism.

Brazil said that Members could not simply cherry pick one principle from a list of principles that were included in the WHA Resolution 60.28 that pertained the development of a new framework.

To this Portugal responded that it could alternatively accept "consistent with national laws and regulations and with the guiding principles of WHA 60.28".

Indonesia once again responded that the guiding principles were for the establishment of a new mechanism. It also said that if the paragraph was to be deleted (if there could be no agreement on the language) then there was no need for the statement.

India concurred with Indonesia and added that whatever that was sought to be achieved by adding international laws and regulations had already been covered by the International Health Regulations.

Thailand also weighed in supporting Indonesia, adding that "What we are doing is for an interim mechanism" and "We are doing this in good will".

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.

To this Brazil responded that it was not clear why the concept of "global public health security" was brought back into the text, adding that it had "difficulty" with the phrase.

India sought clarification from EU as to why it was so important to make reference to "global health security".

Portugal in response said that while they respected national laws and regulations, they would like to see that these rules have a background of international laws or something like "Global Health Security". It added that it thought that "Global Health Security" should prevail over other laws.

[This response by Portugal actually reveals the double standards practiced by the developed countries. The WHO laboratories based in the developed countries (i. e. US, UK, Australia and Japan) are subject to national law and it is for that reason that some of these laboratories have refused the request made by Indonesia to return to it some of the isolated viruses and seed viruses that the laboratories have, although they are isolated and developed from the specimens provided by Indonesia. The Indonesian Health Minister referred to this in her opening speech].

India countered that while it agreed on the need to ensure global health security in the context of pandemic influenza, it was not sure that by including "global public health security", the objective that is desired would be achieved. It added that it understood the background thinking and crystal ball gazing, further adding that the EU should consider whether the IGM is the appropriate forum to achieve the objective they have.

Brazil also said that there is no reference in the WHA 60.28 to "global health security" and that it was not committed to working under the security concept.

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.

Indonesia, in its final oral statement, asked the meeting to record its understanding that the sharing of the virus would be implemented in the form of a Material Transfer Agreement.

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).

Indonesia also added that the new system cannot work without trust and that all parties should respect fairness, transparency, equity and the sovereign rights of states.

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. Portugal, on behalf of the EU, suggested that the mechanism be a technical or expert advisory group. However, Indonesia said that it did not prefer such an approach and that the mechanism should include different kinds of people.

To this, Portugal, on behalf of the EU, said that they would like the main composition to be expert people but that does not mean that there are no discussions at the political level.

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.