TWN Info Service on Intellectual Property Issues (May09/06)
26 May 2009
Third World Network

Dear All,

Please find below a news report on the outcome of the Intergovernmental Meeting on Virus and Benefit Sharing that was held from 15-16 May in Geneva It was first published in SUNS and is reproduced here with permission.

Sangeeta Shashikant
Third World Network

WHO: Key elements of virus and benefit-sharing framework still unresolved
Published in SUNS #6703 dated 19 May 2009

Geneva, 18 May (Sangeeta Shashikant) -- A two-day World Health Organization Intergovernmental Meeting (IGM) to finalise negotiations on the framework for influenza virus and benefit-sharing ended on 16 May with the understanding that there was agreement on "most elements of the PIP [pandemic influenza preparedness] framework. However, further work needs to be undertaken on some key remaining elements."

While the outcome of the IGM suggests some progress, crucial core elements of the framework remain unresolved, with significant divergences between developed and developing countries.

One element that is particularly contentious is the Standard Material Transfer Agreement (SMTA). Although the SMTA is an agreed component of the framework, the two-day meeting (15-16 May) saw several developed countries attempting to roll back on that agreement.

According to a diplomat, the US strategy from the first day of the IGM was to not accept the SMTA as part of the framework being negotiated.

There was also an attempt to roll back on the traceability mechanism that has been established with the intent of infusing transparency into the WHO influenza network. The mechanism tracks all the viruses that have been given to the WHO and subsequent transfers.

Dr. Keiji Fukuda, a WHO official, mentioned repeatedly that the mechanism was increasing the workload of the laboratories analysing the specimens, particularly in the pandemic period.

Several delegates said privately that the traceability mechanism was very important, as it was the only tool available that provides transparency as to what biological materials are provided to WHO laboratories and subsequently to other entities.

The IGM generally agreed on several aspects of the Principles, Scope, Definitions, the Terms of Reference of the National Influenza Centres, WHO Collaborating Centres, and Essential Regulatory Laboratories.

The benefit-sharing section in the framework has also been agreed to.

However, a developing-country delegate pointed out that the agreement on benefit-sharing is not applicable because it is voluntary in nature. The benefit-sharing section needs to be concretized and operationalised through the SMTA, the delegate said.

Reflecting the benefit-sharing elements in the SMTA is one of the key concerns of developed countries, thus, the clear attempts during the IGM to avoid making the SMTA a component of the framework.

A Material Transfer Agreement (MTA) is commonly used for the transfer of biological materials. It is a contractual agreement between the providers and the recipients of biological materials and sets out the terms of use of the biological materials provided and benefit-sharing obligations.

In the case of the IGM, a Standard MTA is proposed wherein the form and content of the SMTA is negotiated by WHO members, thus, every transfer of biological materials will be subject to the same terms and conditions.

The need for the SMTA to be a component of the framework was already agreed to by the IGM in a previous meeting. However, last week's IGM saw several developed countries attempting to roll back on the agreement.

An African delegate said privately that the US, in particular, was trying to "scuttle the negotiations", as it did not wish to see the development of the SMTA.

According to some delegates, the concerns that developed countries have with regard to the SMTA is that it will require their entities, in particular, the manufacturers to share benefits such as vaccines and anti-virals with the WHO for distribution to affected countries.

There is also concern that obligatory benefit-sharing provisions will hamper the fulfillment of advance purchase agreements that many developed countries have entered into with manufacturers. According to media reports, the United Kingdom, Canada, Sweden, Switzerland, Denmark and Austria have begun to snap up available capacity.

In addition, developed countries are concerned that rules in relation to intellectual property rights (IPRs) will also be set out in the SMTA and be binding on the WHO laboratories and commercial entities that receive the virus samples.

Some WHO laboratories and commercial entities that have received biological materials from the WHO have in the past made specific IPR claims over the materials, their parts, as well as over specific uses of the materials and resulting products.

According to sources, the US initially refused to begin discussion on the basis of the SMTA prepared by the Secretariat.

It presented its own SMTA for discussion, which according to some sources, was more a "shipping document" than a contractual agreement for the transfer of biological materials, and was thus rejected.

Most developing countries could not accept the finalisation of negotiations without an SMTA, which they felt is key to implementing the framework and ensuring a transparent, fair and equitable system for virus and benefit-sharing.

Indonesia, on behalf of the group of South East Asian countries (known as SEARO), stressed that "implementation of SMTA will facilitate the rapid, systematic and effective transfer of PIP-biological materials", and that it was "the ultimate and concrete indicator of trust in virus sharing and benefit sharing". It added that the SMTA can be executed in a simple way.

Indonesia said that "some member states cast doubt on the ongoing IGM process and certain components that are being discussed, despite the fact that this process is our collective effort to build a fair, transparent and equitable Framework for pandemic influenza preparedness and response".

It also said that it recognised the emergency nature of the present situation arising out of the outbreak of H1N1. It added that "if some member states feel that virus sharing should take place without an SMTA, then recognizing the same emergency nature of this situation, there should be no IPRs on the vaccines, diagnostic kits, and anti-virals, and sufficient stockpile of such materials should be made available to developing countries".

Indonesia further said that "the current pandemic response measures are not fair, transparent and equitable", as the increase of pandemic alert levels are not accompanied by adequate and comprehensive public health measures.

Until now, the WHO has not supported nor recommended that countries with production capacity start making their own generic supplies of anti-virals, and developed countries have signed deals with vaccine makers to ensure that they get the first batches of pandemic vaccine off the production line, leaving developing countries at risk, Indonesia added.
It said that the laboratory management system and the virus traceability system can be designed and implemented in such a way that it facilitates, instead of imposing a burden, on tracing, tracking and information sharing of PIP-biological materials and gene sequences.

During the two-day discussion, Brazil read the Declaration of the Group of Like-Minded Megadiverse Countries that was made at the Access and Benefit Sharing negotiations of the Convention on Biological Diversity (CBD) on 8 April 2009 in Paris.

The declaration recognized the sovereign right of States over their biological resources and that "Virus and other pathogenic organisms are biological resources and therefore are included in the scope of the CBD".

The declaration also states that the negotiations on the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits should be consistent with the objectives of the CBD, in that they must recognize the sovereign rights of States over their biological resources; the authority of States to determine access to genetic resources; the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from commercial and other utilization of genetic resources with the Party providing such resources; and that access to and transfer of technologies may be provided to developing countries under fair and most favourable terms, including on concessional and preferential terms.

The declaration further states that the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits "shall not prejudice, pre-empt or prejudge the outcome of the ABS [access and benefit sharing] negotiations under the Convention on Biological Diversity".

In response to the statement, the EU and the US said that there was no linkage between the CBD and the subject matter under negotiation.

A Brazilian delegate told SUNS, that viruses are without a doubt part of the CBD.