WHO Members Near Deal On Framework For Influenza Pandemics

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World Health Organization members trying this week to agree on elements of a framework for helping the world address the next influenza pandemic headed into the final night of the meeting in intensive negotiations. At press time, negotiations were focused on specifics of standard agreements for the transfer of genetic materials related to flu virus strains.

The last influenza pandemic, H1N1 (the so-called swine flu), left a bitter taste for some developing countries unable to access or afford the needed vaccines for their populations, including the country that provided the virus strain. Intellectual property was one focus of the discussions this week, getting in the way of agreement on text, but the issue appeared to be heading toward resolution on the last day. Diplomats were still negotiating on Friday evening to try to clean up language on the framework and provide a consensus text.

The WHO Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits (OEWG/PIP) met from 11-15 April.

The working group was aiming at providing a consensus framework to the 64th World Health Assembly (WHA), taking place from 16-24 May.

Discussions this week focussed on the standard material transfer agreements (SMTAs), which are contractual documents describing the condition of virus sharing between parties. Two kinds of SMTAs were discussed. The first one concerned sharing of viruses within the WHO Global Influenza Surveillance Network (SMTA 1), and the second dealt with the sharing of viruses outside this network (SMTA 2).

Numerous documents were issued during the week, many obtained by Intellectual Property Watch.

Intellectual property issues were at the core of the discussions, with developing countries considering IP rights as a barrier to vaccines access mainly because of associated high prices, and developed countries considering that IP rights stimulate innovation and research, according to sources.

The last World Health Assembly (May 2010) asked the WHO to provide technical studies to help members of the open-ended working group reach a final agreement on the framework. In the last version of the document [pdf], published on 4 April, the section on IP concluded that “there are no significant patent barriers to the manufacture of any of the marketed types of influenza vaccines.” The document says that although some patents protect specific processes or products, “for each of the types of marketed vaccines, there is a sufficient freedom to operate to permit manufacturers in developing and emerging economies to make the vaccine of their choice.”

For future vaccines based on new technologies, the document said, “there are potential IP barriers, however it is not known which, if any, of those technologies could make marketable vaccines that could be sustainably produced.”

In the current situation, under the WHO surveillance network, national influenza centres located in a number of countries around the world collect samples from patients “with influenza-like illness,” according to the WHO website. The samples are shared with WHO Collaborating Centres for influenza (CCs), located mostly in developed countries: Australia, China, Japan, the United Kingdom, and two in the United States. Those CCs perform analyses of samples received from the national influenza centres to determine if current vaccines “answer” the new epidemic strains. The CCs also maintain repositories of different virus strains.

SMTA 1 concerns the laboratories that have been “designated or recognized by WHO and have accepted to work under agreed WHO terms of reference,” according to a draft document [pdf] issued late on 14 April, and obtained by Intellectual Property Watch. In Article 6 of this SMTA, which is meant for members of the WHO surveillance network, “neither the provider, nor the recipient should seek to obtain any intellectual property rights on Pandemic Influenza Preparedness biological materials.” However, paragraph 6.2 says that “the provider and the recipient acknowledge that any intellectual property rights existing as of the date of adoption of the framework by the WHA will not be affected” by the SMTA.

A number of versions of SMTA 2 were circulated for discussion this week. In the version published on 14 April [pdf], the recipient of an influenza virus should comply with a number of obligations. Entities not holding IP rights on technology for essential production of influenza vaccines, adjuvants, antivirals and/or diagnostics, would have to choose from a list of options what they would give in exchange for the virus.

Entities holding IP rights on essential technology for pandemic preparedness and response have the same obligations but mandatorily have to choose one option relating to IP rights. They could choose either option 5, granting developing country licences with affordable royalties, or option 6 on granting royalty-free licences or waiving royalties under licence agreements.

This version of SMTA 2 was still heavily bracketed. Forcing industry to take an option on IP rights was a problem for some developed countries, a developed country source told Intellectual Property Watch. They would like to be able to choose two options that would not be IP-related, with other options to choose from, such as donations of medical devices, or capacity building for laboratories, production or surveillance.

Early on 15 April, a new version of the SMTA 2 [pdf] was circulated with new language in Article 4 on “obligations of the recipient,” that did not force IP rights holder to choose benefit sharing in the form of an IP-related option.

According to several sources, as of the evening of 15 April, it appeared that consensus might have been found on the IP-related language of SMTA 2, but one country still insisted that SMTA 2 retain the obligation for industry to pick one IP-related option, according to a source.

SMTAs were important to the negotiation, in particular for developing countries, because SMTAs would provide contractual obligations in the framework, a developing country delegate told Intellectual Property Watch. SMTAs would bring more certainty to the process, he said.

Another issue being discussed this week is the benefit sharing aspect of the framework.

In a draft text [pdf] issued by the co-chairs on 13 April, pharmaceutical manufactures using the WHO network system would pay an annual partnership contribution, from 2012. The total of all annual contributions would be 50 percent of the running cost of the WHO network, according to the text.

According to the document, the contribution would be “guided” by an advisory group composed of a number of members to be determined, and the WHO director general would “determine the use of the contributions.” A small working group was set up to discuss the governance and review of the advisory group and presented a document to the meeting plenary on 12 April.

Accusation of Profit-Seeking over Public Health

There has been some concern about the objectives of governments in the negotiations.

Sangeeta Shashikant, legal advisor for Third World Network, said, “This week the developed countries, in particular the US, [have] made all efforts to dilute benefit sharing provisions and to carve key components of biological materials from the scope of the framework. It is apparent in the positions taken that their focus is not public health but the protection of their industries, their profits and the intellectual property they hold.”

At press time, co-chairs Bente Angell-Hansen of Norway and Juan Jose Gomez-Camacho of Mexico told Intellectual Property Watch they were optimistic about the outcome of the meeting.

“We are optimistic that we will have a very successful week,” Gomez-Camacho said.

In the framework, the working group is building a role for civil society and industry in a time of pandemic, said Angell-Hansen. This has been an innovative negotiation, in which channels were open to stakeholders, she said, adding, “This is a modern agreement.”

One of the aims of the framework was to obtain a strong commitment from industry on vaccines and antivirals, diagnostic kits, capacity building, and surveillance laboratories, she said. Under the framework, the world will be taken to a different level when it comes to preparedness, she said, with a faster response system, more predictability, and transparency.

Catherine Saez may be reached at info@ip-watch.ch.

Creative Commons License"WHO Members Near Deal On Framework For Influenza Pandemics" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

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