Civil society calls for fair framework for sharing of virus samples as well as vaccines

Civil society organisations backed the demand of developing countries at the WHA for the establishment of a fair and equitable virus-sharing framework. The following is the text of a statement endorsed by some civil society groups active on health matters and issued before the WHA met on 14 May.

WE the civil society organisations listed below call on member states of the World Health Assembly (WHA) as well as the WHO Secretariat to establish a fair and transparent mechanism and framework to govern the sharing of virus samples as well as the equitable distribution of vaccines and medical products relating to the avian influenza.

Early this year Indonesia suspended sending samples of avian influenza viruses to the WHO Laboratories, calling for the WHO [to] set up a new framework for virus sharing that has better terms for developing countries.

Indonesia, a country severely affected by avian influenza thus far causing about 81 deaths, was offered by [a] vaccine manufacturer vaccines at an unaffordable cost of US$20 per dose although the vaccine was produced using the Indonesian virus strain, and without the knowledge of the Indonesian authorities. We believe that this is an unfair situation which no country should be subjected to.

Developing countries simply cannot afford to pay high vaccine prices especially if entire or major parts of the populations have to be vaccinated. This highlights the inequities in [the] current global health system.

Availability of vaccines in a timely manner and in sufficient quantities is also a major problem. Developed countries having financial and other resources are already booking in advance treatments including vaccines for pre-pandemic and pandemic use. As supply capacity is less than demand, especially in the event of a pandemic, acute shortages are forseen.

In the event of a global pandemic, and in the absence of a fair global framework, there is a fear that it will be 'each country for itself', with those countries that have stockpiled vaccines being reluctant or unwilling to share their stockpile of vaccines with other countries. Developing countries would likely face a situation of non-availability or acute shortage of badly-needed vaccines, including countries that have contributed their viruses.

Although developing countries voluntarily donate their viruses to the WHO collaborating centres and reference laboratories at present, these centres and laboratories have been passing on the virus or parts of it, or vaccine strains containing parts of the viruses, to companies, without the knowledge or permission of the countries. This is in violation of the WHO 2005 Guidance on sharing virus samples, which states that the viruses will not be distributed to parties outside the collaborating centres and laboratories without prior permission of the contributing countries.

Moreover, patents are already being sought by several companies and research institutes on products and materials containing parts of the viruses. The vaccine products are also to be patented. The resulting monopoly situation results in high profits for the companies holding patents, while health needs are sacrificed.

The current framework also disregards internationally recognised rights of affected developing countries. The Convention on Biological Diversity [CBD]explicitly recognises States' sovereign rights over their own biological resources, the right to grant access on agreed terms, the principle of prior informed consent and fair and equitable sharing of benefits arising from the commercialisation and other utilisation of the viruses.

Instead, the current framework favours the industry that already benefits from grants and subsidies by the developed governments for research and development of vaccines, and that will reap millions or billions of dollars from vaccine sales. It also favours the developed countries that have the financial resources to build up stockpiles of pre-pandemic vaccines and to purchase in advance pandemic vaccines.

The losers are the poorer countries that will not have vaccines and other necessary medical supplies in a timely manner in the event of a pandemic although they may have contributed their viruses leading to vaccine development and have rights under the CBD.

Our action proposals

1.         Noting the existing inequitable framework for sharing viruses, we call on the WHA to immediately establish a new global framework on avian flu for the equitable sharing of both the viruses and the relevant medical products, including vaccines and diagnostics.

2.         The highest priority and goal of the framework should be to meet public health needs, particularly in developing countries. As such the over-riding goal is to ensure that people in developing countries have access to vaccines and other medical products when they need these. The framework must establish systems by which scarce pandemic vaccines can be produced, stocked and distributed according to the principles of public health needs (where and when they are needed) and not according to financial and technological capacity and power (i.e. vaccines channelled to those who can pay for them).

3.         Such a framework must recognise the principles of national sovereignty over genetic resources, prior informed consent of and benefit-sharing with the countries in which the viruses originate.

3.         The framework should ensure that the WHO collaborating centres and laboratories, as well as companies and other institutions do not patent the viruses or the gene sequences or parts of the sequences nor research tools and medical products that make use of the viruses or their parts or their sequences.

4.         If there is intention that information contained in the virus, including gene sequences, [is] put in the public domain, the framework should require that any party that [wants] to make use of the data should not seek proprietary rights over the data or parts of the data.

5.         WHO must provide information on the viruses that have been provided to its collaborating centres and reference laboratories, what research has been done on these, whether the viruses or vaccine strains produced from them have been distributed to other organisations and if so to which ones, whether patent applications have been made and for what, the commercial activities being undertaken, and whether the countries contributing the viruses have been informed, their permission obtained and the benefit-sharing arrangements, if any. There should be an inquiry and remedial action if collaborating centres or reference laboratories have not acted in good faith, or have not followed the relevant WHO guidelines, especially the WHO Guidance on sharing of influenza viruses (March 2005).

6.         WHO should encourage and promote local pharmaceutical R&D and production activities in developing countries, including not-for-profit and public-owned organisations, and facilitate technology transfer and capacity building. WHO should build the capacity in developing countries for vaccine development and production, including the scientific research capacity to make this possible.

7.         Prices of vaccines and other medical products should not be determined or influenced by monopolistic factors such as patenting. The products should be priced at levels that are at cost or non-profit for developing countries so as to assure their affordability.

8.         The public health system should be strengthened to offer the best chances for prevention of avian flu pandemic, and to ensure an effective delivery of health services in the event of [a] pandemic.

9.         Governments should increase public investment in research and development for vaccine production in developing countries, and in building the capacity for local pharmaceutical production, particularly for production of affordable vaccines and other medical products.

10.        We hope that the WHA can reach agreement on these points so that a framework for the sharing of viruses and vaccines and other medical products can be reached at this WHA.             

Civil society groups endorsing this statement include:

People's Health Movement (International), Third World Network, Medico International, Gonoshasthaya Kendra (Bangladesh), AHED (Egypt), Health Unlimited, Asian Community Health Action Network, All India Drug Action Network, Initiative for Health, Equity and Society (India), Consumers' Association of Penang (Malaysia), Institute of Science in Society (UK), Palestinian Medical Relief Society, PHM Latin America, PHM United States, PHM South Africa, PHM Australia and New Zealand