TWN Info Service on Intellectual Property Issues (June08/01)
02 June 2008
Third World Network

Below is a news story on discussions on avian flu and small pox that took place at the recent 61st World Health Assembly in Geneva (19th - 24th May).

Best Regards
Sangeeta Shashikant
Third World Network

WHA discusses avian flu, smallpox virus stocks
SUNS #6479 Thursday 22 May 2008

Geneva, 21 May (Sangeeta Shashikant) -- The first substantive discussions at the 61st World Health Assembly (WHA), which took place this week, included the issues of  "Pandemic Influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits"; "Smallpox Eradication: Destruction of variola virus stocks", as well as international health regulations and poliomeliyitis.

On avian flu and smallpox, the Secretariat presented reports and updates, which were duly noted by member states after several interventions by developing countries stressing the need for more benefit sharing such as access to research outcomes, transfer of technology, and capacity building.

On Monday, at the opening session, WHO Director General Dr Margaret Chan highlighted several issues including the food crisis, climate change, pandemic influenza outbreak, and the inability to fulfill the Millennium  Development Goals.

She said this year's upcoming World Health Report will be on Primary Health Care (PHC). This coincides with the thirtieth anniversary of the Alma-Ata  Declaration on PHC.

A drafting group was set up on Tuesday by the WHA Chair to finalise the Draft Global Strategy on Public Health, Innovation and IP. There are about 18 bracketed paragraphs that need to be agreed to before the Global Strategy can be adopted.

The most contested paragraphs are on intellectual property rights.

Thus far, progress on the matter is slow with the US insisting on opening up language which enjoys consensus from all other countries. As a result, some delegates suggested that work on the Global Strategy may not complete by the end of WHA.

Ms. Jane Halton of Australia, the Chair of the Intergovernmental Meeting (IGM) on virus and benefit sharing, which was set up at the last WHA, said that although the IGM met in November, followed by an open-ended working group meeting in April, it had not concluded matters, as they were extensive, technical and complex.

The next meeting of the open-ended working group as well as intergovernmental meeting is to take place on 9-15 November.

Halton added that a draft Chair's text was being prepared and the intention was to finalise it by the end of May. Thereafter, the text will be translated and that will be sent to all members through the bureau (made up of vice-chairs) by 29 June. The first draft can then be considered by all member states, which are suppose to provide inputs on the text by 27 July. The bureau will finalize the Chair's text and send it to member states by September 2008 before the members reconvene in November.

Thailand said that in its experience there were difficulties in getting the vaccine industry to transfer technology on an industrial scale. It also said that the vaccine manufacturers offered price reduction but not "vaccine self reliance".

It also expressed disappointment over the slow progress of the IGM and the fact that a mechanism could not be finalized. It also said that the IGM should focus first on benefit sharing, adding that equitable benefit sharing will encourage virus sharing. It urged the WHO Director General to continue to support vaccine procurement and development as well as transfer of technology on an industrialized scale.

Malawi said that mechanisms should be available for transferring technology for vaccine manufacturing and supporting countries with limited resources that want to acquire the said technology.

Ivory Coast, on behalf of the African Group, said that the impact of the pandemic flu was considerable for those with lower economic incomes. Africa faced many challenges, particularly that the epidemiological systems are weak.

Indonesia said that it was seeking a fairer mechanism than the current Global Influenza Surveillance Network (GISN) for sharing viruses.

India said that there was a need for coordinated global action. It noted with appreciation that the IGM has sought to address the global concern of fair and equitable and transparent sharing of benefits.

This would enable developing countries to gain access "to adequate affordable vaccines, diagnostic and to all tools for local and indigenous production of vaccines", all of which were critical for pandemic preparedness. The virus tracking system also needed further refinements.

While the developing countries focused on the importance of benefit sharing, the developed countries were more interested in the virus sharing aspect.

Slovenia, for the EU, said that it was convinced that there was an urgent need for virus and sequence data sharing, adding that it wanted to improve the transparency and efficiency of the GISN. It also said that the November meeting should be the group's final meeting.

The US stressed that timely access to all epidemiological information in all countries is important. It also said that the November meeting should be the final meeting.

UK and Northern Ireland said that it was essential that all viruses are shared as otherwise it would put the world at risk. It, however, recognized the imbalance in developing benefits to help fight a pandemic and called for more donations to the WHO virus sharing networks.

Russia said the report assembly contains only interim results and thus it was not easy to assess the progress. It said that it needed to have reports on viruses, antivirals, mobilisation of resources, reports on patenting, setting up of advisory mechanism, to assess whether progress has been made towards transparent, fair and equitable benefit sharing.

China said that exchange of viruses should be done respecting international conventions and national legislation in countries as well as the fair and equitable sharing of viruses and benefits including economic benefits. It stressed the need for assistance to countries for surveillance and participation in the research conducted on the viruses.

Malaysia stressed the need for recognition of the rights of states over biological resources and on benefit sharing. It was willing to shares viruses as and when available but urged for fair and equitable benefit sharing and also for innovative financing mechanisms to facilitate purchase of vaccines.

Other countries such as Nigeria, Iran and Cuba also stressed on fair and equitable benefit sharing.

The issue of virus and benefit sharing also came up during speeches in the plenary.

The US Secretary of Health, Michael Leavitt, called on "countries everywhere to share influenza samples openly and rapidly, without pre-conditions." He added that "We must all participate fully in the Global Influenza Surveillance Network".

Responding to the comments by Leavitt, the Minister of Health of Indonesia Dr. Siti Fadilah Supari said that she was not sure that the WHA would agree that having a global capacity of less than 5% to produce human influenza vaccines is something that can be defined as a great public health success.

She said it was actually a great failure since technology access and transfer have not been made available to developing nations. This situation contributes to the fact that the stockpile program failed to meet the challenge faced by global influenza pandemic preparedness.

She added that the virus sharing and benefits sharing are the joint responsibility of not only developing countries, but also developed countries.

She said that the "mechanism of virus-sharing that was used by WHO where GISN is under the jurisdiction of the US Government" and "does not deliver the desired level of fairness, transparency and equity".

She said that GISN must be replaced and the genesis of a new mechanism is inevitable since GISN can never be a fair and equitable system since states' sovereign rights and their respective governing laws are not taken into account.

She added that as an organization which governs the global health system, WHO must not take sides in favour of  any single member state in its undertakings, but deliver its services to all member states. The WHO should protect poor and developing countries from exploitation by rich and strong developed countries.

She shared the views of India that developing nations cannot feel confident in this current system, until benefits are shared, and until all of us stand to experience the story of success.

She said that Indonesia is never afraid to embrace responsibility of virus sharing as long as the system gives the benefits for the developing countries and conducted in a fair, transparent and equitable manner.

On the issue of the smallpox virus (stocks of which are kept in laboratories in the US and Russia under a WHO programme), South Africa, on behalf of 46 African countries, asked several questions with regards to: (a) the composition of the WHO Advisory Committee on Variola Virus Research which is supposed to comprise experts from each region; (b) the legal status of the virus stocks as there is uncertainty as to the ownership of the variola virus stocks; and ( c) what is being done to ensure that approved research proposals, research outcomes and the benefits of this research are made available to all Member States.

It added that WHO member states were firmly committed to reach a date for the eventual destruction of the remaining stocks.

Last year, the adopted resolution requested the Director-General to (1) undertake a major review in 2010 of the results of the research undertaken and the plans and requirements for further essential research so that the 64th WHA may reach global consensus on the timing of the destruction of existing variola virus stocks; (2) review the membership of the WHO Advisory Committee and the representation of advisers and observers at meetings of this Committee, in order to ensure balanced geographical representation, with the inclusion of experts from developing countries and substantial representation of public-health experts, and the independence of the members of this Committee from any conflict of interest; and (3) to ensure that approved research proposals, research outcomes and the benefits of this research are made available to all Member States.

Tunisia, on behalf of the Eastern Mediterranean Region, said that it is wrong to hold the virus stocks and that a destruction should be set no later than 2010.

Indonesia, on behalf of the South East Asian Region, also pushed for the process of destruction to begin. It stressed that there was a need for countries to transfer technology and to share research outcomes.

Thailand raised concerns about the ethical concerns in the issue, adding that there was a need to review research proposals thoroughly and to avoid unnecessary delay on destruction. It reiterated concerns that access to results of smallpox research was limited.

France also favoured the destruction of variola virus stocks. However, Japan and the Russian Federation invoked the fear of bio-terrorism as a reason to retain the variola virus stocks.

Responding to the member states, Dr David Heyman of the WHO secretariat said that the report of the Advisory Committee showed that there were promising vaccines. He added that there was a need to increase vigilance about the transfer of DNA fragments of the viruses through Material Transfer Agreements.

The legal counsel of WHO said that "the ownership landscape is variable and incomplete." He added that the Secretariat looked at its records and also asked countries, which shared their virus stocks before the eradication of the virus (in 1977), about the transfer of stocks and the legal title. The legal status of the various specimens should be seen in the factual and actual history of each virus based on the records and the replies.

Some countries relinquished ownership in the late 1970s or early 1980s while others retained title. The legal counsel added the caveat that those countries that retained title retained the right of return.

He also said that some countries have replied that they do not have records. Regarding the retention of virus stocks for which ownership is uncertain, WHO Collaborating Centres are required to maintain such stocks under their Terms of Reference with WHO. In addition, there are safety regulations that apply to infectious substances.

At the opening session on Monday Dr Margaret Chan said the world faced three crises that are health security threats - the food crisis, climate change and pandemic influenza . These crises are clear threats to international health security Chan said.

On pandemic influenza, Chan stressed that it is vital for public health to present a united front as countries consider the sharing of influenza virus (samples) and access vaccines and other benefits.

Chan said that WHO had made progress on health in Africa and for women. The lack of progress on reducing maternal mortality was outrageous, despite twenty years of efforts. Chan said efforts need to be redoubled.

Chan commended the progress made on the negotiations of the Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property Rights. Chan urged members to continue to show flexibility and to resolve the outstanding eighteen paragraphs of the IGWG Global Strategy.+