WHO Members On Verge Of New Framework For Pandemic Flu Response

Enthusiasm and relief were palpable at the World Health Assembly last week when member states in committee adopted a resolution on global preparedness in case of influenza pandemic, and in particular on the sharing of viruses and access to vaccines for developing countries.

The resolution will have to be formally approved in a plenary session of the annual World Health Assembly (WHA), taking place from 16-24 May.

Delegates were asked to approve the report of the Open-Ended Working Group on Pandemic Influenza Preparedness on the sharing of influenza viruses and access to vaccines and other benefits, and the resulting “Pandemic Influenza Preparedness Framework,” agreed in April by member states in the working group (IPW, WHO, 18 April 2011).

Discussions on the sharing of viruses and the ensuing benefits arose when developing countries found they could not access vaccines even though they had shared influenza virus samples with the World Health Organisation (WHO). The WHO has a global network designed to facilitate such sharing.

The framework proposed by the working group includes benefit sharing for developing countries in exchange for the expedited sharing of influenza viruses.

It includes standard material transfer agreements (SMTAs), one for entities inside the WHO network, known as the WHO Global Influenza Surveillance and Response System (GISRS), and the other one for entities outside it, such as companies.

In the SMTA for entities outside the WHO network, the recipient of the virus has to commit to at least two options of benefit sharing, such as donate at least 10 percent of vaccine production to WHO, or reserve treatment courses of needed antiviral medicine for the pandemic at affordable price, or grant royalty-free licences to manufacturers in developing countries.

The framework also states that “influenza vaccine, diagnostic and pharmaceutical manufacturers” using the WHO network “will make an annual partnership contribution to WHO for improving global pandemic influenza preparedness and response.”

The framework further indicates that the contribution should be equivalent to 50 percent of the running costs to the GISRS. The GISRS includes national influenza centres, WHO collaborating centres, WHO reference laboratories and essential regulatory laboratories, according to WHO.

Nagoya Protocol Reference Out

During the working group discussions in April, delegates could not agree on common language in the WHO pandemic framework to refer to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. This instrument adopted in October 2010 aims at sharing the benefits arising from the utilisation of genetic resources in a fair and equitable way. The protocol includes reference to viruses.

The working group finally recommended that the WHA be asked to consider options related to the Nagoya Protocol “contained in brackets in the draft resolution, with a view to moving the agreed language into the Pandemic Influenza Framework without otherwise re-opening it.”

The bracketed language said the framework should be the designated access and benefit sharing instrument for pandemic influenza preparedness biological materials, in accordance with the objectives of the Convention on Biological Diversity and the Nagoya Protocol.

Australia opened discussions at the WHA by proposing that the bracketed language referring to the Nagoya Protocol be deleted from the proposed framework to avoid divergent views on the subject that could hinder agreement on the framework.

Many countries followed with support for the deletion, such as Indonesia, speaking for the South-East Asia region, Norway, Switzerland, and Zimbabwe. The European Union concurred with Australia, but said it was important to recognise that the framework governs the sharing of influenza viruses.

A developing country source said that it remains a grey area where the WHO framework and the Nagoya Protocol overlap.

Developing Countries: No Barriers from IP Rights

Brazil said that the agreement reached in April was a milestone, not only because it was a multilateral framework but also included contractual instruments: the SMTAs.

The framework is “an example for current and future exercises at WHO,” the delegate said. Despite “being a member-driven process, it did not exclude other actors,” such as civil society and industry.

The end result of the negotiation process is a step in the right direction, she said. Through the SMTAs, a legal regime has been established for WHO, the WHO laboratories network, and interested manufacturers, she added.

Intellectual property rights have a central role to play in this new system, the Brazilian delegate said. The sharing of technology and access to processes for making vaccines more accessible in time of crises will be crucial. “We need solidarity, not profit,” she said.

Developing countries will need to be granted non-exclusive licences at affordable royalties, or royalty-free, she said, and the framework’s implementation balanced, effective, and transparent.

Several other countries also said that IP rights should not constitute a barrier to access vaccines and treatments, and asked for non-exclusive licences for interested developing countries. The access to essential technologies was also mentioned by several delegations, as the building up of vaccine capacities would not be possible without technology transfer.

Switzerland said it is time to move towards the framework implementation as the world is insufficiently prepared for the next pandemic, with too little vaccine capacity.

Bolivia’s Concern

Bolivia submitted a national position to the Open-Ended Working Group on 15 April, expressing concerns with the SMTAs for entities outside the WHO GISRS network. This appeared as a corrigendum [pdf] in the WHA document on the influenza framework.

Bolivia said on 19 May that during the meeting of the Open-Ended Working Group, the country “presented a proposal to ensure that the biological material and parts thereof shared through the Pandemic Influenza Preparedness Framework are not appropriated by entities outside the WHO GISRS through the patent system,” according to their statement [pdf]

“It is our view,” the Bolivian delegate said, “that allowing the patenting of influenza biological materials and parts thereof particularly in the context of pandemic preparedness is against public health interests and thus contradicts the primary objective of the World Health Organization that is the attainment by all peoples of the highest possible level of health.”

“We also firmly believe that it is unethical and runs counter to the beliefs, traditions and cultures of many people around the world, including the indigenous peoples of Bolivia, and could have severe adverse effects for pandemic risk assessment and response including on research and development as well as on promoting access to vaccines and other medical technologies and supplies,” he added.

However, in the spirit of constructiveness and flexibility, Bolivia said it withdrew its proposal but said it reserved its rights to seek a prohibition of the patenting of influenza biological materials outside WHO GISRS.

Resolution Adopted With Amendments

Jamaica said the resolution appeared to emphasise more the sharing of viruses than benefits, and asked for an amendment to the resolution on a mechanism to facilitate access to affordable vaccines by countries in need. This brought some comments from Germany and Indonesia who said that this consideration was already part of the framework and asked that Jamaica withdraws its proposed amendment.

WHO Director General Margaret Chan then promptly approached Jamaica, and the delegate said Chan had convinced her that paragraph 6 of the resolution to be approved included a benefit-sharing system including facilitated access to vaccines at affordable prices. Jamaica withdrew its amendment.

The United States said that rapid, transparent virus sharing remains critical. The delegate asked that language be added to the resolution to include a mention that it is in accordance with Article 23 of the WHO constitution. Article 23 states: “The Health Assembly shall have authority to make recommendations to members with respect to any matter within the competence of the Organization.”

The WHO legal counsel said in answer to a question about the addition of language on Article 23 that the framework is only a recommendation to member states, but the SMTAs would be binding contracts under law.

The resolution was adopted by WHA Committee A, working on technical and health matters, with three amendments. One is the deletion of the mention of the Nagoya Protocol, the second is the mention of Article 23 of the WHO Constitution, and the last one is that the WHO reports on the framework on a biannual basis to the WHA through the Executive Board of the organisation.

NGO Reaction

A group of non-governmental organisations including the Third World Network, Berne Declaration, Churches Action for Health, and the Peoples Health Movement said in a statement [pdf] that the “amount of monetary contributions and the level of in-kind contributions expected of the industry could have been higher since they make great profits from WHO’s virus sharing system.”

They also stated that the granting of non-exclusive licences at affordable royalties or royalty free to developing countries for vaccines and other needed products should have “been listed as a stand-alone mandatory benefit to facilitate the sharing of knowledge, technology, and know-how, which developing countries need to counter influenza pandemic.” They called member states to ensure the framework and SMTAs are implemented in a way that is consistent with the objectives of the CBD and the Nagoya Protocol.