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A committee at the World Health Assembly yesterday decided to seek a closer look at consequences of potential changes to the WHO framework on pandemic influenza. The decision, still to be confirmed by the World Health Assembly, requires in-depth analysis of how to handle pandemic flu viruses under the framework, whether the framework should cover seasonal influenza, and whether the framework should become a specialised international instrument on access and benefit-sharing.

The decision [pdf] on the WHO Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits was taken on 25 May, during the World Health Assembly (WHA), taking place from 22-31 May.

A draft decision was submitted on the first day of the WHA by Australia, Finland, Pakistan, and the United States, later joined by Switzerland and Mexico (IPW, WHO, 24 May 2017).

The decision was adopted with two amendments, mainly focused on regulatory capacities, proposed by Tanzania, with inputs by Finland and the US.

The first amendment includes the words “and regulatory capacities” in paragraph 3, so the paragraph reads: to emphasize the importance of prioritizing and supporting global pandemic influenza preparedness and response, including through the strengthening of domestic seasonal influenza virus surveillance and manufacturing and regulatory capacities and international coordination and collaboration through the Global Influenza Surveillance and Response System (GISRS) to identify and share influenza viruses with pandemic potential rapidly;

In paragraph 8, another paragraph has been inserted between sub-paragraph b and sub-paragraph c to read: To continue supporting strengthening of regulatory capacities and carrying out burden of disease studies which are fundamental foundation for pandemic preparedness.

The strengthening of regulatory capacities is sometimes considered as raising the level of what can be asked from countries, and seen as creating more difficulties for developing and least-developed countries, unable to meet that level.

The decision was supported by a number of countries, such as Thailand, Russia, Norway, Germany, the European Union. Canada and Thailand said they co-sponsor the decision.

The PIP Framework was reviewed by a Review Group in 2016, which delivered a report with recommendations, in November (IPW, WHO, 23 November 2016).

The recommendations of the Review Group address different aspects of the PIP Framework, including how to deal with the genetic information of influenza virus with pandemic potential in the framework, whether the framework should be considered as a special benefit-sharing instrument under the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the UN Convention on Biological Diversity, and whether the framework should cover seasonal influenza viruses.

Prof. William Ampofo, head of the Virology Department of the Noguchi Memorial Institute for Medical Research, at the University of Ghana, and member of the PIP Framework Review Group, presented the findings of the group.

Capacity Building Needs

Several countries called for a strengthening of capacities, such as Tanzania, Qatar, Indonesia, Tunisia, Ecuador, and Paraguay.

Bahrain said there should be a mechanism to evaluate progress made in countries, with a set of measurable indicators. This was echoed by Qatar, on behalf of the Eastern Mediterranean region, which said progress of the partnership contribution funds implementation should be monitored, and challenges faced during implementation identified across WHO regions.

Qatar also asked that more middle and low-income countries of the Eastern Mediterranean region as recipients of the PIP Partnership Contribution funds.

The Bahamas underlined the necessity of affordable treatments, and also asked for more effective communication on the progress of the framework to WHO member states, as did Botswana and Paraguay.

Seasonal Flu

Some countries, such as Russia and Norway, cautioned against expanding the framework to other pathogens, in particular seasonal influenza, while some others, such as the co-sponsors of the decision, such as the European Union countries and the United States asked for in-depth evaluation.

Malaysia also had reservations and said a potential inclusion of seasonal influenza would pose the challenging issue of resource diversion.

Genetic Sequence Data

Most countries taking the floor expressed the need to tackle the question on how genetic sequence data (GSD) should be handled under the PIP Framework. The US asked for a thorough analysis through a consultative process, Lesotho for the African region said there is a need for clarity, and the EU asked for a comprehensive impact assessment on all possible scenarios to be considered by the WHO Executive Board in January 2018.

Lesotho for the African region mentioned need clarify how GSD should be handled and should extend to seasonal – underlined achievements on the implementation of the PIP Framework in the region, mentioning for example trainings, and the development, revision and update of the regional generic protocol for influenza sentinel surveillance.

Germany said it is crucial that the Global Action Plan for Influenza Vaccines (GAP) (expired in 2016) be renewed so that the production of seasonal vaccines be encouraged. Without sufficient production capacity for seasonal vaccines, there will not be sufficient capacity for pandemic vaccines, the delegate said.

On GSDs, the German delegate said the exchange of GSDs has “tremendously increased” since the time of the adoption of the framework. GSDs are becoming more important in research, and have a growing importance in the development of commercial products.

Two issues have to be particularly taken into account, he said: the first is that the existing exchange of GSDs should not be slowed down, and secondly the role of established database platforms, one of which is hosted by Germany. He was referring to the EpiFlu database from the Global initiative on sharing all influenza data.

PIP: Example of Successful Public-Private Partnership

Malta, for the European Union, remarked that the PIP Framework is a unique public-private partnership resting on two financial mechanisms. Countries guarantee the continuity of samples collection and risk analysis by financially supporting the GISRS network, on the one hand, and on the other hand, industry provides the partnership contribution.

Switzerland underlined the growing importance of public-private partnerships, of which the PIP Framework is a successful example.

Peter Salama, executive director of the WHO Health Emergencies Programme, said an independent impact evaluation of the PIP Framework is ongoing and is expected to be issued shortly. The WHO secretariat supports the draft decision and is “fully prepared” to undertake the study, but funds need to be found to this effect, he said.

Pharma Welcomes Audit, Civil Society Wants More

In its statement, the International Federation of Pharmaceutical Manufacturers and Associations said they are not in favour of the extension of the PIP Framework to seasonal influenza. They welcomed the upcoming external audit of the activities of the PIP Framework (as indicated in the secretariat’s report) and said they continue to support the framework but believe “there are opportunities to strengthen its operations and continued successful execution.” They encouraged the WHO “to support calls for elevating both the PIP Framework and the GISRS mechanisms to the status of international instruments.”

Knowledge Ecology International in its statement said one weakness of the PIP Framework “is the voluntary nature of the funding from the vaccine and device manufacturers, a factor in limiting the scope of the agreement..,” while Medicus Mundi called for the amount of Partnership Contribution that should be paid by manufacturers, “to be updated given the increase in the running costs of WHO GISRS.”

In its statement Medicus Mundi further said WHO members “need to initiate a process to address access and benefit sharing with regard to seasonal influenza viruses as annually thousands of seasonal flu viruses are being shared without fair and equitable benefit sharing.”

The CBD confirmed that it has to define what constitutes a special international instrument of access and benefit-sharing under its Nagoya Protocol, and discussion among CBD member states are ongoing.

A study has been mandated by the CBD to be considered in July 2018 and later during the Conference of the Parties, in November 2018, the CBD representative said.

[Update:] The Third World Network (TWN) provided a statement on the outcome on this issue.

“The first high level implementation plan has given focus to support to burden of disease studies and building regulatory capacity for pandemic preparedness. Continued call to focus on these aspects has become a demand of the pharmaceutical industry as the second high level implementation plan is being discussed as they wish to increase sales of their influenza vaccines and to expedite commercialisation of their products,” said TWN’s Sangeeta Shashikant. “At this stage, pandemic preparedness would be better served by focusing on other aspects such as supporting strengthening of national health systems. In the context of Ebola, weak health systems contributed to the undetected and later unchecked spread of Ebola in the post-conflict states of Liberia, Sierra Leone and Guinea. Investing in health system strengthening, including primary health care, functioning clinical facilities, workforce development, robust programmes for infection control is far more important.”