One year since the adoption of the Pandemic Influenza Preparedness Framework, member states emphasised the importance of the bio-sharing initiative and in some in cases raised concerns about the pace of implementation.

In a committee meeting on the last day of the 21-16 May 65th World Health Assembly (WHA), member states noted the report of the Pandemic Influenza Preparedness (PIP) Framework Advisory Group from its second meeting held in February. The report provides an overview of the work of the PIP advisory group and its recommendations to the director general.

The PIP Framework was set up as a mechanism to ensure the fair access and benefit-sharing of all countries in the event of flu pandemic. Further background is available here.

The advisory group report [pdf] will be submitted to the 131st Executive Board Session, meeting 28-29 May, which should make a decision on its recommendations.

The recommendations are regarding the proportional allocation of partnership contributions and the Standard Material Transfer Agreement 2 (SMTA 2). During the WHA committee meeting, member states commented on both items and made comments on the overall process.

Following statements, both Keiji Fukuda, World Health Organization (WHO) assistant director general for Health Security and Environment, and Director General Margaret Chan addressed member state comments.

70/30: Preparedness/Response

Based on consultations with civil society and the pharmaceutical manufacturing industry held 22-24 February, the PIP advisory group recommended that over the next five years, 70 per cent of contributions be allocated for preparedness and 30 per cent for response activities. In case of a pandemic emergency, it allows the director general to modify this proportion.

Member states widely expressed their support on the advised allocation proportion. The EU delegation supported the recommendation saying, “Capacity-building and technology transfer for vaccine production are essential elements of preparedness.”

The EU official also suggested, “The decision on how to allocate the resources for preparedness in order to develop sufficient capacity in all regions should be left to the WHO, based on advice by the advisory board, and should not be fixed.”

The delegation of Taiwan also supported the allocation proportion and the WHO’s continuing assistance “to help build influenza surveillance and laboratory capacity in developing countries.” The official also commented that some of these countries might require “further technical or financial assistance.”

The statement made on behalf of Health Action International, Berne Declaration, the Third World Network and the People’s Health Movement, called on the WHO secretariat to provide further detail on which activities would fall under the category of preparedness.

Furthermore, the non-governmental organisations (NGOs) suggested that preparedness should cover “assisting developing countries to build anti-viral and vaccine manufacturing capabilities including addressing intellectual property barriers and transfer of technology so that developing countries are better prepared to counter future influenza pandemics.”

During a telephone interview in late April, Prof. Didier Houssin, PIP advisory group chair, said that further discussions on the breakdown of preparedness contributions were scheduled to take place during teleconference meetings 3-4 May (IPW, WHO, 2 May 2012). Emailed questions to the WHO secretariat on the outcome of these meetings so far remain unanswered.

Advancing Agreement on Bio-Sharing

Beyond the contributions allocation, the advisory group has also advised the director general to develop a uniformed approach to sharing viruses to entities outside of the Global Influenza Surveillance and Response System (GISRS) prior to signing the SMTA 2, the contract that will allow such exchanges to take place.

The delegation from Brazil said the SMTA 2 is the “essential basis for the production of vaccines and the sharing of benefits, and it has to be rapidly implemented.” Several other member states also remarked on the pace of the implementation of this contract, many calling for the acceleration of the process. The United States and WHO secretariat called the PIP Framework a model for other WHO work.

Additionally, the official from Brazil said, “We expect that a reasonable level of benefits be provided, including the sharing of knowledge, technology and know-how with countries, with a view to increase and diversify the capacity to produce vaccines.”

Health Action International, Berne Declaration, Third World Network and the People’s Health Movement noted their disappointment that “not a single standard material transfer agreement has been signed between WHO and recipients of biological materials outside the network, although biological materials have been exchanged. This has also affected full implementation of SMTAs among the GISRS laboratories.”

The NGOs also called for increased transparency, asking the secretariat to “make available the annual report of the advisory group” and “information on partnership contributions made by manufacturers including the use of such contributions.” Fukuda said the report would be made available.

Financial Shortages Slow Pace

The WHO secretariat addressed a number of concerns raised by member states. Regarding the pace of the implementation of the PIP Framework, especially discussions on SMTA 2 discussions, Fukuda said, “formal discussions are underway,” and had begun with GlaxoSmithKline, Sanofi and Novartis.

Chan said that although she “understands that you want us to be fast, speed cannot be the only factor.” The director general explained that proper consultations with the advisory group, which represents the member states, was essential in order agree on the best approach to discuss with industry and avoid conflict of interest issues.

Additionally, Chan said that “money also determines speed” and that they need more of it in order to proceed in a timely manner. She also said more lawyers are needed. She thanked the US and Canada for providing some support and made an appeal to other member states to provide additional support.