Developing countries look to WHA for solution to flu virus issue

Geneva, 11 May (Martin Khor and Sangeeta Shashikant) -- The issue of equity in the sharing of avian influenza viruses on one hand and access to affordable vaccines on the other hand is expected to be a "hot topic" at the World Health Assembly starting on Monday.

It will come up in the discussion on the resolution on avian and pandemic influenza that has been adopted by the WHO's Executive Board (EB) and transferred to the WHA.

According to some diplomats, Indonesia and possibly some other developing countries are also expected to propose a new resolution on the issue. The United States may also submit a draft resolution related to the topic.

The Indonesian proposal is expected to reflect the outcome of a meeting of Health Ministers and senior officials from over 20 countries in Jakarta on 28 March.

The meeting was convened as part of an effort to resolve the stand-off between Indonesia and the WHO after the country suspended the transfer of viruses to WHO collaborating centres when it found out that the viruses were used for commercial activities without its knowledge or permission.

Indonesia and other developing countries are asking the WHA to set up a framework to ensure that developing countries share the benefits from their sharing of viruses.

The stated aim of the Jakarta meeting was "to explore the modalities of a framework that strongly emphasizes the need for developing countries to share in the benefits resulting from the open and timely and equitable sharing and dissemination of information, data and biological specimens related to influenza, and especially the development and production of influenza vaccines that are accessible and affordable for all countries in order to accelerate local, regional and global preparedness and response to the threat of pandemic avian influenza".

The meeting adopted the Jakarta Declaration, which requested the "WHO to convene the necessary meetings, initiate the critical processes and obtain the essential commitment of all stakeholders to establish mechanisms for more open virus and information sharing and accessibility to avian influenza and other potential pandemic influenza vaccines for developing countries".

The Jakarta meeting was attended by Ministers from 12 avian flu-affected countries and 23 other developed and developing countries. It also endorsed the "Recommendations on Responsible Practices for Sharing Avian Influenza Viruses and Sequence Data" which was developed at a technical meeting just before the Ministerial.

The technical meeting proposed the establishment of a framework for affordable and equitable access to influenza vaccines, including pandemic influenza vaccines as part of pandemic preparedness. It would also include responsible influenza specimen and data sharing practices.

According to the meeting's conclusions, WHO member countries should commit to strengthen the Global Surveillance Network "leading to a more transparent and equitable sharing of benefits from the generation of information, diagnostics, drugs, vaccines and other technologies."

Among its recommendations are that:

-- any uses of the influenza viruses outside the specific mandate of the WHO Collaborating Centres will require the prior consent of the country contributing the virus;

-- the terms of reference related to virus sharing will be reflected in a standard material transfer document that will be included as part of the shipping documents sent with each specimen by the country sharing virus;

-- WHO should intensify its capacity building activities in developing countries. It should act immediately to designate more developing countries as WHO H5 influenza reference laboratories;

-- WHO mobilize financial and technical support for stockpiling H5N1 and other potential pandemic influenza vaccines that may be used in developing countries;

-- For countries with the capacity for filling and packaging of vaccines, consideration should be given to local stockpiling of vaccines in bulk, as soon as possible;

-- WHO facilitate the transfer of technology to establish influenza vaccine production;

-- WHO draft, through a participatory process, a guideline for the equitable and appropriate distribution of effective pandemic influenza vaccines, to be applied if a pandemic occurs.

The call by Indonesia and other affected countries for a fair framework for access and benefit sharing is consistent with the Convention on Biological Diversity (CBD), the main international law governing access to biological resources.

The CBD recognizes the sovereign right of States over their own biological resources including genetic resources and parts thereof. It establishes that the authority to determine access to genetic resources rests with the national governments and that access to the genetic resources shall be "on mutually agreed terms" and subject to prior informed consent of the country providing the resources.

Also, each CBD member shall take measures to share in a fair and equitable way the results of the research and the benefits from the commercial and other utilization of genetic resources, with the country providing the resources and that "such sharing shall be on mutually agreed terms".

The CBD also obligates a Party to endeavour to carry out scientific research based on the genetic resources provided by another country with the full participation of, and where possible, in the country providing the resources.

CBD also requires its parties to take measures to provide developing countries with access to and transfer of technology, and to take measures with the aim that the private sector facilitates access to joint development and transfer of technology for the benefit of developing countries.

Avian flu viruses are genetic resources, and thus their ownership is regulated by the CBD and access to the virus should be subject to the principles of prior informed consent and fair and equitable sharing or benefits arising from the use of the virus.

However, this has not been the case, causing Indonesian health officials to raise the alarm over the unequal situation.

Dr. Triono Soendoro, Director General of Indonesia's National Institute of Health Research and Development, told the Jakarta Post that Indonesia had stopped sharing its bird flu samples with the WHO after CSL, an Australian drug-maker, developed and tried to market vaccines using the Indonesian strain of the virus without the Health Ministry's consent.

Soendoro said that when bird flu broke out, health officials and scientists around the world were in panic, and so they scrapped the requirement for a Material Transfer Agreement to accompany virus transfer, although such a MTA is required by Indonesian national law. Instead, the transfer was based only on trust. Just because it is the WHO, does not mean that they can violate the rules, said Soendoro.

A MTA is a contractual instrument that defines the rights and obligations of the provider and the recipient of genetic resources and facilitates access and benefit sharing arrangements. It is often used in intergovernmental fora to facilitate the transfer of genetic resources or materials, spelling out clearly issues involving proprietary rights and benefit sharing arrangements.

For example, the Food and Agriculture Organisation (FAO) has an international treaty on plant genetic resources and under this there is a standard material transfer agreement that is to be used when a party wants to access the materials.

Although the MTA is a regular feature in transfers of materials, and MTAs are used by WHO collaborating centres when they transfer vaccine strains containing parts of the donated viruses to companies, the WHO's top bird flu official Dr. David Heymann is reported by Reuters as saying that "An MTA is not a solution and a MTA will slow down the process of doing assessment and also vaccine development". He was referring to the request by Indonesia and other countries that the terms of their transfers of virus be based on a MTA, with the country of origin as a partner.

There is a double standard here - while the WHO's centres are themselves signing MTAs with companies, the countries contributing the viruses are told by the WHO that they should not request for a MTA because this would slow down assessment and vaccine development.

A WHO notification of March 2006 stated that "An H5N1 recombinant vaccine strain developed from A/Indonesia/5/2005, by the WHOCC in Centres for Disease Control and Prevention, Atlanta USA, is available for distribution, under a Material Transfer Agreement (MTA)."

A WHO notification in May 2006 stated that "Now, two new H5N1 recombinant vaccine strains developed from A/Bar headed goose/Qinghai/1A/2005 and A/Whooping swan/Mongolia/244/2005 selected from the new genetic group, by the WHO Collaborating Centre at the St. Jude Children's Research Hospital, Memphis USA, are available for distribution, under a Material Transfer Agreement (MTA)."

A June 2006 WHO notification stated that "A new H5N1 recombinant vaccine strain, NIBRG-23, has been developed by the National Institute for Biological Standards and Control, England from A/turkey/Turkey/1/2005, selected from a genetic group containing the majority of A(H5N1) viruses since mid-2005. NIBRG-23 is available for distribution, under a Material Transfer Agreement (MTA)."

From these WHO notices, it is obvious that the WHO secretariat is fully aware of the transfer of vaccine strains containing the viruses (or their parts) to companies from the national institutions that are WHO collaborating centres, and that this is done with MTAs between the centres and the companies. Yet a senior WHO official takes a position that it is undesirable for countries contributing the viruses to require that a MTA accompanies the sharing of virus.

This became an issue at the Jakarta meetings. Eventually, the Jakarta documents mention instead that a 'standard material transfer document" will be included as part of the shipping documents sent with each specimen by the country sharing virus.

It is not clear from the Jakarta documents the distinction between a material transfer agreement which is a commonly used term in bilateral and international dealings and a "material transfer document."

Some officials and analysts are concerned that a "material transfer document" could refer to information relating to characteristics of the material being transferred and the logistical aspects of its transfer without expressing a relation of rights of the parties involved in transferring and receiving the material.

It is also interesting to note that the WHO document (A60/INF. DOC./1) on best practice for sharing influenza viruses and sequence data (dated 22 March 2007) contains "best practices" that conflict with the rights of countries of origin of genetic resources that were established by the CBD.

One of the "best practices" is that no national influenza centre laboratory, WHO Collaborating Centre or H5 Reference Laboratory should charge fees or sell influenza viruses or strains or in any way seek to profit from participation in the WHO Global Influenza Surveillance Network. They can only seek to recover the costs of shipping, handling, storage or other direct administrative overheads.

Another "best practice" states that no national influenza centre laboratory, WHO Collaborating Centre or H5 Reference Laboratory should impose agreements or administrative procedures that may inhibit the proper functioning of the WHO Global Influenza Surveillance Network, including the timely sharing of material and information.

These "best practices" prevent or hinder the countries contributing the viruses from seeking fair benefit-sharing arrangements, in conflict with the CBD principles of access, prior informed consent and benefit-sharing.

At the same time, another WHO "best practice" states that the collaborating centres and H5 Reference Laboratories should provide candidate influenza vaccine strains to any requesting vaccine producer to develop vaccines.

This "best practice" conflicts with the provision in the March 2005 WHO Guidance that "There shall be no further distribution of viruses/specimens outside the network of WHO Reference Laboratories without the permission from the originating country/laboratory."

It also contradicts the "prior informed consent" right of countries contributing the virus and make it even more difficult for these countries to request a benefit sharing arrangement with researchers and manufacturers undertaking commercial activities.

It is obvious that the March 2007 WHO "best practices" are biased against the countries affected by avian flu, which are strongly urged (and pressurised) to "share" their viruses for the common good. They are required by the "Best Practices" not to seek or obtain benefit-sharing. There is no mention that their prior consent has to be sought for the subsequent use of their viruses. Nor is there a mention of material transfer agreements.

On the other hand, the drug companies obtain the most favourable treatment. The WHO collaborating centres and reference laboratories are obliged to offer vaccine strains to these companies freely - since neither the WHO-linked institutes nor the countries contributing the viruses are allowed to impose any benefit-sharing conditions on the companies.

But there are no limitations or obligations placed on the companies that receive the vaccine strains containing parts of the viruses.

They are not obliged by the Best Practices to ask for the consent of the countries of origin before obtaining the viruses (and their parts and sequences), or before undertaking commercial activities. They are free to obtain patents, and to sell their products without price regulation.

These biases being shown by the WHO, its "best practices" and some of its senior staff are a significant part of the reason why several developing countries are unhappy with the present situation.

Addressing the Jakarta Ministerial meeting, Indonesia's President Susilo Bambang Yudhoyono said that there was need for a new paradigm which puts equality between countries at the centre of defence strategies against avian flu.

He called for a focus on realizing equality by "examining together and in a holistic manner, all possible ways to bring all countries up to par through a more altruistic approach to sample and information that we like to call the benefit sharing approaches and practices".

All countries should be empowered to equitably develop their own preparedness and protection capacity for all infectious and life threatening diseases.

"Encouraging home-grown research, laboratory and production capabilities inside these countries and assisting them in the production of their own vaccines and drugs at affordable prices and in the development of their own prevention strategies are the key to global pandemic preparedness".

Whether the WHA can rise to the occasion to give effect to the aspiration of developing countries - to have a fair benefit-sharing system and to have affordable access to vaccines and the technology for making them - remains to be seen.