Developing countries call for new flu virus sharing system

Geneva, 15 May (Martin Khor) -- Twenty developing countries have presented a resolution at the World Health Assembly calling for a new international framework to be set up for the sharing of avian influenza viruses, to review the existing WHO research system and to prioritise the manufacture and availability of vaccines in developing countries.

The resolution was presented by Indonesia as the WHA started its work Tuesday. The question of equity in contributing the viruses by countries where the outbreak occurs on one hand and in the access to affordable vaccines on the other hand has emerged as the most controversial and biggest issue in this year's WHA.

The United States also presented a resolution on promoting access to influenza vaccines. Some diplomats and observers view the US resolution as an attempt to replace or strongly dilute the Indonesian-led resolution.

The developing countries' resolution advocates establishing the rights of countries contributing the viruses (including recognition of principles of sovereign right over genetic resources, prior informed consent and benefit sharing).

The resolution was submitted by Indonesia, Malaysia, Vietnam, Cambodia, Bhutan, Laos, Algeria, Brunei, North Korea, Cuba, Solomon Islands, Myanmar, Maldives, Peru, Qatar, Saudi Arabia, Sudan, East Timor, Iran and Iraq.

The resolution emerged from concerns that the WHO-led system of virus sharing had been misused as companies had engaged in profit-oriented commercial activities using the viruses, while the developing countries face high prices and lack of availability of the vaccines which have been bought or booked by developed countries and are in short supply.

By contrast, the US resolution proposes that vaccines be made available to developing countries through a stockpile that is apparently built through donations, and for WHO to technically assist developing countries to develop vaccines.

During the initial debate, the US delegation indirectly criticised the approach taken in the developing countries' resolution. It said that it opposed any material transfer agreements or "new encumbrances" that would hinder virus sharing.

Introducing the resolution, and speaking for the 20 countries, the Indonesian Health Ministry's director-general for communicable diseases said that access to vaccines for developing countries is crucial in the fight against avian influenza. "We have submitted a resolution as the current system is unfair," said Indonesia.

"Developing countries voluntarily provide viruses to WHO Collaborating Centres and Reference Laboratories which are supposed to manage them in trust for research and diagnosis in the interests of humanity and not for commercial purposes.

"As we have experienced, samples of viruses or parts thereof have been received free by companies that then commercialise them. When companies make vaccines from this, they do not inform or seek the consent of these countries and most importantly there is no mechanism to ensure that developing countries will have access to the vaccine in a timely and affordable manner. So, the goal is to have transparent, fair and equitable share of benefits from diagnostic, vaccine and other technologies.

"The framework must prioritise the needs of developing countries, particularly affected countries in accessing vaccines, diagnostics, drugs and other medical supplies in sufficient quantities and at affordable prices, particularly for the poor."

Indonesia is now the most affected country. Current figures show that in 2005 the total confirmed cases were 96 of which 76 people died.

Indonesia added that the resolution calls on the WHO Director-General "to convene an inclusive intergovernmental process to review existing mechanisms for sharing influenza vaccines, establish a new framework for sharing influenza vaccines and parts thereof based on the prior informed consent of the country providing it and fair and equitable benefit sharing of the benefits resulting from the use of the virus or parts thereof.

"These principles conform to national and international laws on biological resources under conventions and treaties in other parts of the UN system such as the Convention on Biological Diversity at UNEP and the International Treaty on Plant Genetic Resources for Food and Agriculture at the FAO."

Indonesia also proposed that the Executive Board avian flu resolution (EB120. R7) be amended, as well as a review of the WHO secretariat document on 'Best practice for sharing influenza viruses and sequence data'.

The developing countries' resolution on "Responsible practices for sharing avian influenza viruses and resulting benefits" (dated 15 May 2007) stated that industrialized countries have greater means to protect their populations but developing countries lack availability in medical supplies (relating to avian flu) and at an affordable price.

It stressed the need for transparent, fair and equitable international mechanisms for the distribution of affordable diagnostics and treatments including vaccines to those in need (especially in developing countries) in a timely manner.

It recalled the Convention on Biological Diversity principles of sovereign rights over their own biological resources, access on mutually agreed terms, prior informed consent and fair and equitable sharing of the results from using the resources.

The resolution urged member states to strengthen the WHO's Global Influenza Surveillance Network (GISN), leading to sharing of benefits through frameworks and mechanisms emphasising principles of prior informed consent and benefit sharing. These include the development and production of influenza vaccines that are accessible to and affordable for all countries.

Member states are urged to prioritize the needs of developing countries, ensuring that they have access to vaccines, diagnostics, drugs and other medical supplies; and to prioritize vaccines distribution for affected countries.

The resolution requested the WHO Director-General to convene an inclusive, participatory inter-governmental process to review existing practices/mechanisms for sharing influenza viruses, to establish new frameworks and mechanisms including principles and guidelines for sharing influenza viruses and parts thereof (encompassing genes, gene sequences, derivatives and parts thereof), based on prior informed consent and fair sharing of benefits and to review the existing Terms of the WHO Collaborating Centres and H5 Reference Laboratories based on certain principles:

-- Any international sharing of biological materials with WHO Collaborating Centres/H5 Reference Laboratories shall be conducted in accordance with national and international laws and regulations, through agreements on mutually agreed terms, based on the principles of prior informed consent, and fair and equitable sharing of benefits.

-- Any vaccines, diagnostics, anti-virals and other medical supplies arising from the use of the virus and parts thereof must be made available at an affordable price and in a timely manner to developing countries, particularly to those under the most serious threat or already experiencing the pandemic threat.

-- Priority should be given to conducting the necessary research on the viruses and parts thereof as well as storing the viruses in the affected countries.

-- Any uses of the influenza viruses and parts thereof including genes, sequences, derivatives and parts thereof provided to WHO Collaborating Centres and H5 Reference Laboratories shall be within their WHO mandates but in any event limited to scientific research in the interests of public health and to non-commercial purposes.

-- No viruses/specimens or parts thereof shall be distributed nor shall access be given to any party outside the network of WHO Collaborating Centres/Reference Laboratories without the written prior informed consent of the country contributing the virus and parts thereof.

-- Appropriate terms and conditions shall govern access to influenza related information (including sequences) in any public databases in order to ensure that such information is not appropriated in a manner that prevents others access to and use of the information and products, technologies and tools developed through the use of the information or that denies the appropriate parties fair and equitable sharing of benefits arising from the commercial or other use of information placed in the databases.

-- WHO Collaborating Centres, the H5 Reference Laboratories shall neither claim nor obtain any form of proprietary rights over the virus except with the consent of the country contributing the virus.

-- The country contributing the virus shall be entitled to establish conditions accompanying any decision on consent, which may include arrangements for sharing of benefits which may include access to sufficient quantities of vaccine and other medical supplies at affordable prices for itself and other developing countries, transfer of technology and know-how to strengthen manufacturing capacity and other capacity building activities, or that may be specified in national or international regulations.

The resolution also calls on the Director-General to intensify in developing countries capacity-building for Virus identification; Virus characterization; Identification of new virus strains; Generation and interpretation of data on or related to influenza and avian influenza; Generation of seed virus for vaccine production.

Developing countries should also be assisted in capacity building to enable them to be designated as H5 Influenza Reference Laboratories.

The Director-General is requested to seek the support of industrialized countries, other financial partners and vaccine manufacturers, to mobilize financial and technical support for the stockpiling of safe and effective H5N1 and other potential pandemic influenza vaccines that may be used in developing countries, and for providing the necessary means to developing countries that choose to establish a stockpile of vaccines or other medical supplies.

She is also requested to seek support to facilitate the transfer to developing countries of technology and know-how necessary to establish influenza vaccine production and to enable production capacity to be functional as soon as possible.

The resolution also requested the Director-General, through an inter-governmental process, to discuss and formulate mechanisms and guidelines for the fair and equitable distribution of effective pandemic influenza vaccines in the event of a pandemic in order to ensure timely availability of pandemic vaccines in developing countries.

In its statement to the WHA, the US said that preparation for and response to pandemic influenza is the most important task the WHO is involved in now. The US added that it was committed to good-faith efforts to address the needs of the developing world, but Member States cannot delay in sharing viruses and they must promptly share sequence and virus data and samples.

All countries have an obligation to immediately and freely share viruses, said the US. It supported the current system and is opposed to Material Transfer Agreements or new encumbrances to govern the sharing of influenza viruses.

The US announced its draft resolution and proposed a working group be formed at the WHA to discuss the various resolutions on this issue.

The US resolution urged member states to continue unrestricted virus sharing with WHO collaborating centres and reference laboratories. It requested the Director-General to mobilize financial support to establish a vaccine stockpile and promote access to vaccine for developing countries.

It proposed a WHO working group to advise on the size of a vaccine stockpile, operational procedures and mechanisms to promote access to vaccines. Options to establish a stockpile of candidate H5N1 vaccines as an interim measure should also be explored, said the US resolution.

Thailand, represented by its Health Minister, said that it sympathised with the concerns raised by Indonesia regarding the inequitable sharing of benefits from virus sharing.

It is un-affordable and unfair when developing countries who shared the virus are offered the vaccine at US$20 per dose. This inequity needs to be addressed at this WHA with a better and more trustworthy mechanism for virus sharing, said Thailand.

The main problem is the limited global production capacity for influenza vaccine production. The shortage is huge and the cost is also huge for developing countries, such that they would suffer without the vaccines.

The Thai Minister added that many developed countries are now stockpiling vaccines via advance market commitments which have occupied most of the capacity, leaving behind developing countries on a waiting list.

He said the WHO needs to arrange for stockpiling of vaccines which are ready to be deployed to developing countries in the greatest need in the event of a pandemic.

The present inequities can be solved by wisdom, brotherhood and collective spirit that "together we can survive." The world needs a common and collective defence mechanism to cope with this crisis. Thailand then proposed the following:

-- Urgent measures to be taken to improve vaccine production capacity in developing countries.

-- Establish an effective mechanism to address the prices of vaccines in a spirit of global solidarity, for example, through differential pricing where the rich shoulder more and the poor shoulder less.

-- Explore new mechanisms for equitable sharing of vaccines. There is need to revisit the "business as usual" approach and the modus operandi of WHO Collaborating Centres and H5N1 labs and their relationship with the vaccine industry.

The Thai Minister also said that the vaccine industry is one of the important partners in making the vaccine available to all but we should not allow a free riding system which permits them to generate huge benefits from the "global public good" such as the GISN. There is a need to call for corporate social responsibility by the vaccine industry.

More than twenty other countries were also listed to speak on the same topic.