TWN Info Service on Health Issues (Nov07/03)

28 November 2007

Published in SUNS #6372dated 23 November 2007

The WHO Intergovernmental Meeting on Influenza Viruses and Benefit Sharing began on 20th November and it discussed the review and reform of the Global Influenza Surveillance Network (GISN), which pertains the sharing of influenza viruses.

On the first day of the meeting the Indonesian Health Minister Dr Siti Fadilah Supari, charged that her country had experienced unfair and non-transparent treatment by the Network, which had failed to respond to the needs of humanity. She called for the replacement of the GISN with a fairer mechanism.

The WHO Director General Dr. Margaret Chan admitted that there were problems and it was clear that changes had to be made.

Please find below a news report on the meeting. It was published in SUNS #6372 dated 23 November 2007 and is reproduced here with permission.

Best Wishes
Sangeeta Shashikant
Third World Network



Geneva, 21 Nov (Riaz K. Tayob) -- The World Health Organisation's system of monitoring and assessing global influenza has come under heavy criticism at a meeting this week, and WHO Director-General Dr Margaret Chan admitted that there were problems and it was clear that changes had to be made.

The criticisms of the Global Influenza Surveillance Network (GISN), which deals with risk assessment and response to avian influenza as among its tasks, were led by the Indonesian Health Minister Dr Siti Fadilah Supari, who 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 review and reform of the GISN is one of the items being discussed at the four-day Intergovernmental Meeting on Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits (IGM) that began on 20 November.

The meeting was mandated by the World Health Assembly last May, after a heated discussion during which developing countries led by Indonesia claimed 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.

The WHA resolution linked the sharing of viruses by countries affected by avian flu to the sharing of benefits, such as vaccines, derived from the use of the viruses. The issue has significant implications especially as the WHO predicts that a global avian flu pandemic may break out; and if it does, there will likely be a scarcity of pandemic vaccines and an expected rush for obtaining them.

Since early this year, Indonesia (the country with the highest number of human cases of avian flu) has been highlighting the imbalances in the system in that countries that contribute their avian flu viruses have not been informed of the use of the viruses, pointing out that applications have been made by various parties for patents that cover parts of the viruses, and that vaccines are offered at high cost to developing countries.

One of the aims of the meeting is to reform the GISN through the formulation of new terms and conditions of parties involved in virus sharing, risk assessment of the virus, vaccine research and manufacturing. However, by the second day, some delegations were also raising questions as to what exactly constitutes the GISN system and how it operates, which demonstrates the confusion as to what constitutes the system and how it operates.

In a strong opening statement, Dr. Siti Fadilah Supari said that Indonesia had experienced an unfair and non-transparent mechanism (referring to the GISN), adding that GISN has failed to respond to the needs of humanity. WHO needs to find a transparent and equitable mechanism for virus and benefit sharing, she stressed.

On the issue of what is the GISN, what is being referred to and how broad the system is, the WHO's Dr. Margaret Chan said that it was clear that changes had to be made as it had problems, adding the WHA Resolution had asked member states to review the GISN and to suggest ways and methods to strengthen and improve it. She said that what could emerge could be "GISN plus plus plus".

Indonesia said that it was not in a position to know whether GISN will be strengthened. It said that it emerged during a meeting in Singapore (to prepare for the present meeting) that besides the WHO designated laboratories (that are considered collaborating centres), there were other institutions involved in the GISN, and on this it had strong objections.

Indonesia also sought clarification on the GISN's operations and mechanisms. It said that it did not understand references to "Global Influenza Programme" i. e. what sort of mechanism is being talked about, what is the flow of the virus and the governing law under which GISN is operating, and who makes the seed virus (i. e. the vaccine strains provided to manufacturers to develop vaccines) - was it the WHO collaborating centres or some other institutions? Indonesia added that many issues on the present system had to be clarified in order that the mechanism can be improved.

Brazil sought clarification as to the mechanism by which the GISN was established. It stressed that there was mandate in the Resolution to re-examine the GISN mechanism. India mentioned that the wording in the Resolution to strengthen and improve could also mean to critically evaluate the GISN.

In contrast to Indonesia's critical comments, some developed countries seemed to defend the GISN, saying that its role should be maintained, expanded and strengthened. Canada proposed that GISN could be defined and it could be proposed as to whether GISN is expanded and strengthened. Switzerland said that from the resolution there was no mandate to abolish the GISN.

The Chair of the meeting, Jane Halton of Australia, also supported positions of developed countries, stating that the language in the resolution i. e. "to support strengthen and improve" the GISN is a polite way of saying that issues like transparency and governance should be fixed, but this would not extend to abolishing, renaming or deconstructing the GISN.

The questions posed by Indonesia remained unanswered, with the Chair stating that the issues will be dealt with during discussion on operational items. The Secretariat was also asked to prepare a definition on GISN.

This week's meeting is meant to consider the outcome of a smaller preparatory meeting held in Singapore on 31 July to 4 August. That Interdisciplinary Working Group (IDWG) was mandated to formulate Standard Terms and Conditions for virus and benefit sharing, to suggest an oversight mechanism and revise the Terms of Reference for WHO collaborating centres and H5 Reference Laboratories. However, the meeting could not produce an agreed document. What emerged after the meeting was a Chair's summary which did not enjoy consensus.

Also on this week's agenda is a consideration of two Secretariat reports (on benefit sharing and on patents on influenza virus and genes) as well as two other issues - the establishment of international stockpile of vaccines of H5N1 and other influenza viruses of pandemic potential; and mechanisms and guidelines for the sharing of vaccines in the event of a pandemic.

Chan in her opening speech said that avian flu poses a threat to global health security, adding that a pandemic can reach every corner of the earth within a matter of months. The meeting has the opportunity to take a hard look at the GISN. The WHO is aware of the problems of the past and of the need to operate in a more transparent manner. She added that the stakes were too high to squander this opportunity.
The Indonesian Minister said that the WHO requires countries to send the virus from victims to WHO approved laboratories, i. e. collaborating centres (CCs) under the GISN mechanism. Developing and poor countries are requested to release viruses and once they arrive at the WHO-CCs they belong fully to the WHO-CCs.

She added: "Originating countries do not have any right about the destiny of the shared viruses... We do not really know whether they are used for researchers and publication or they are shared with vaccine manufacturers for vaccine production or may be they are utilised for the development of biological weapons".

However, the moment poor countries need vaccines, they have to purchase them at high prices, said the Minister, adding: "The unfairness by WHO could threaten global health security" and this is a "new type of oppression to developing nations by developed countries".

Siti Supari gave three examples of the system's unfairness and the lack of transparency. First, when Indonesia urgently needed to procure Tamiflu, it found that it was unable to because the stocks were held in stockpiles by the developed countries.

Second, it was unfair that the sequence data information on the H5N1 virus (used for risk assessment and vaccine production) was held exclusively by a number of scientists within WHO-affiliated institutions and were not freely accessible by other scientists. Indonesia itself had to correct that by releasing H5N1 sequence data to a gene bank.

Third, when several companies had offered Indonesia vaccine and diagnostic kits from the Vietnamese strain, Indonesia again discovered the unfairness of the system. Supari said that the shared viruses had become a commercial commodity and the GISN is the only mechanism to sustain this for more than fifty years.

The Minister added: "Don't you sense that the viruses originated from our people and therefore they are owned by our country with its sovereign rights?" She said that Indonesia understands the notion to sustain GISN by the timely sharing of avian influenza viruses. "However, this should not overrule our sovereign rights," she added.

Indonesia warned that the unfairness experienced by Indonesia will also occur in other countries that have suffered from this disease.

Alluding to double standards practised by WHO, she said that Indonesia requested that a material transfer agreement (MTA) for sharing its viruses but the WHO refused this and claimed that there is no MTA for developing countries or affected countries in the GISN mechanism.

However, Indonesia was confronted with a request to sign a MTA when it tried to obtain seed viruses from an institution in the United Kingdom. The Minister referred to a letter that Indonesia received from the United Kingdom Department of Health, which started that countries that had supplied the original virus should have free access to the seed virus which has been produced by the GISN, in accordance with the MTA (prepared by the institution).

The Minister said that the current arrangements of the GISN were an "expression of unfairness of treatment between developing countries and developed countries". She added that the "GISN can never be fair nor transparent and equitable when the states' sovereign rights and their respective governing laws are taken into consideration and therefore the GISN "must be replaced and the genesis of a new mechanism is inevitable".

In relation to benefit sharing, the Minister said that the notion of benefits for developing countries "should be implemented as a part of the right, rather than a charity or good will of developed countries where vaccine manufacturers are located.

"We are here today to show the world that we care for the health of all people in the world and not to negotiate a profitable deal for companies". The world needs to be aware of the unfairness of the GISN mechanism that is dangerous for global health, she said.

Indonesia was committed to discuss the issue based on transparency, fairness and equity but there must be information on how the system works, said the Minister, adding: "We must have the assurance that the shared virus will be solely for public non-commercial public health use in an equitable manner and not only for the benefit of companies' profits, or rich people in rich countries". The multilateral system must engender trust for developing countries sharing the viruses that it must not be at the expense of sovereign rights and at the expense of their people's health, she said.

She stressed the need to formulate a new system and to get the system right. Benefits arising from the use of viruses should be equitably shared, through a fair, transparent and equitable mechanism as that is the "moral thing to do".

China said that it would be happy to see equitable, transparent arrangements and benefits to prepare for the pandemic. Nigeria said that the equitable sharing of virus and of the benefits must be made mandatory for all.

The EU said that the virus must be freely shared in a simple and straightforward system. The US said patents were critical to preserve the incentive to develop vaccines. It could not accept any approaches that undermine intellectual property. The meeting should not focus on vaccines, benefit sharing and intellectual property rights, but on preparedness. It said that we must maintain the GISN. Further, withholding the virus is inconsistent with the spirit underlying the International Health Regulations.

The EU sought clarity from WHO on Members' obligations to share the flu virus under the International Health Regulations. The WHO's legal advisor said, in what he called a preliminary view, "there is no specific obligation to share the virus as such." However, he added that the objective of the IHR is to allow a public health response to the international spread of disease and that the most important WHO function is dissemination of information, which it cannot do unless the information is shared and needs to be up to date on the strain of the virus.

On 20 November, the meeting also took note of the Director-General's reports on Identification of Frameworks and Mechanisms for Sharing Benefits (A/PIP/IGM/2), and Patent Issues related to Influenza viruses and their Genes (A/PIP/IGM/3).

During the discussions, Germany said that under mechanisms to ensure broader access to pandemic vaccine, it could not accept the possibility for member states to agree in advance to release a pre-defined quantity of pandemic vaccines from existing purchase contracts.

On the meeting's objective to formulate standard terms and conditions (STC) among parties for sharing viruses and benefits, there was disagreement about which document should be used as the basis for negotiations. Several developed countries supported using the IDWG Chair's summary (A/PIP/IGM/4) as the basis for discussion, but this was objected to by some developing countries.

Four proposals on the STC have been submitted by the developing countries - Indonesia, Thailand, the Africa Group, and the Group of the Americas.

Indonesia presented a brief paper containing principles and elements for virus and benefit sharing. It wanted these elements to be discussed first before embarking on an exercise to draw up legal texts of the STC.

Among the principles were recognition of sovereign rights; prior informed consent; mutually agreed terms and fair and equitable benefit sharing; the authority to determine access to influenza viruses rests within the national governmental and subject to national law; benefit sharing must be concrete, specific and provided to developing countries, especially affected countries and their geographic vicinities.

Some of the fundamental elements proposed include that access to specimen/virus must be done through an agreement in the form of a standard Material Transfer Agreement agreed by member states; and that no entity can acquire intellectual property rights over the virus, parts thereof and their derivatives, etc.

Thailand submitted a paper proposing that the parties to the STC should be member states and the WHO. The STC would state to whom WHO can transfer virus to, the mode through which it would be transferred and the terms of transfer. It also proposed a global fund, to which member states as well as manufacturers would contribute. The fund would be used to purchase vaccines, build capacity and licence technology.

On Wednesday, the African Group submitted a paper in the form of legal texts comprising the proposed STC. The paper proposes two separate contracts: first, a standard agreement between the country providing the virus and the WHO collaborating centres and laboratories when the specimen is transferred; and second, an agreement between the WHO and the manufacturer (committing the manufacturer to benefit sharing obligations) when the seed virus (necessary for vaccine development) is transferred.

The Group of Americas also circulated a document, containing points agreed during a meeting in Buenos Aires on 5-6 November 2007. The points are: (1) the WHO Global Influenza Surveillance Network should continue to be the main network for influenza risk evaluation and the development of vaccines, medications and other materials; (2) mechanisms should be aimed at strengthening the network, by increasing its transparency, accountability and efficiency; (3) benefits should be distributed in accordance with public health principles regardless of who supplied the virus; (4) no country including the country of origin or any other entity may exercise ownership rights over the samples submitted to the GISN; (5) the importance of building and strengthening vaccine and drug production capacity, as well as surveillance and the ability to respond to influenza in the Americas and elsewhere; (6) need to establish technically competent WHO CC in developing countries; and (7) importance of defining GISN third parties, of establishing and specifying requirements and conditions for submitting samples and of defining their responsibilities.

Following some initial disagreement on how to proceed, the meeting agreed to discuss principles first followed by the operative paragraphs. Discussions on principles were divided into several clusters i. e. on benefit sharing, collective action, sovereign rights, capacity building and technology transfer, virus sharing, intellectual property rights, oversight mechanisms, and financing.

There was a significant disagreement on which cluster to begin discussion on. Developed countries repeatedly insisted to begin discussion on principles in relation to benefit sharing while developing countries felt that discussion should proceed on virus sharing, since logically the entire process begins with virus sharing. Ultimately, the meeting decided to first discuss virus sharing principles.

Most of the second day was spent discussing virus sharing principles, scope of the Standard Terms and Conditions that is to be formulated, the GISN system itself, (i. e. what it is all about) and the parties that are to be involved as part of the system. A working group was also formed to discuss the operational aspects of virus and benefit sharing.