PIP Framework Review Ongoing; Last Call For Country Submissions

World Health Organization member states have until 15 July to submit views on a five-year-old mechanism allowing for swifter sharing of pandemic influenza viruses and benefit-sharing measures, according to the group tasked with providing a report on the review.

The WHO Pandemic Influenza Preparedness (PIP) Framework is currently being reviewed by an expert group as mandated by WHO member governments. The PIP Framework was adopted in 2011 with the objective of improving sharing of flu viruses with pandemic potential and ensuring access to vaccines and other life-saving products to developing countries during a pandemic.

The 5^th meeting of the PIP Framework review group was held from 27 June-1 July in Geneva. Review Group Chair Christine Mwelwa Kaseba-Sata presented an update of the Review Group’s work. The webcast is available here.

Deadline for Submissions

Mwelwa Kaseba-Sata said the group is still awaiting written submissions from member states and stakeholders and pressed member states to send their written submissions by 15 July.

On 29 August, the review group will have an open and consultative session with member states. This will be an opportunity for countries to submit oral comments outside of the questions which were sent previously to build the report, and for which answers are due by 15 July.

Questions for member states and stakeholders are on this WHO webpage.

The group is exploring the possibility of engaging with member states through regional committee meetings, she said.

Broad Questions?

During the update given by the group, representatives of France and the United States commented on the questions and said some of them were very broad, which makes them challenging.

The US said it is concerned that it may not be able to give a full response by 15 July and asked for some flexibility on the deadline.

Mwelwa Kaseba-Sata said the group would consult with the WHO secretariat on a possible extension of the deadline but that such an extension might hamper progress in the finalisation of the group’s report.

Germany Concerned Over Advisory Group Recommendations

Germany commented on recommendations issued by the PIP Advisory Group on the handling of genetic sequence data (gene sequencing) under the PIP Framework. The German delegate said some recommendations provide for potential uncertainty.

In particular, Germany underlined the recommendations on the handling of genetic sequence data by the PIP Advisory Group in its report to the WHO Director General in April.

One of the recommendations is that in order to facilitate virus sharing sustainability, “a sufficient degree of redundancy” should be ensured, including through multiple databases.

Germany said although it agrees that sustainability of access to data must be secured, creating parallel systems should be avoided as multiple databases might imply a duplication of efforts.

“We already have reliable and considerable access to data in current databases and one example is GISAID [the Global Initiative on Sharing Avian Influenza Data],” the delegate said.

“We would like to underline that one of the reasons for the German government to host GISAID EpiFlu database is to ensure sustainability,” she added. The agreement the German government has with GISAID is concluded without any time limit, she said.

The PIP Framework review is focusing on answering three main questions:

• What are the achievements since the PIP Framework was adopted?
• Has implementation of the PIP Framework improved global pandemic influenza preparedness, including interpandemic surveillance, and capacity to respond?
• What are the challenges, and possible ways of addressing them?

Ongoing Work

Mwelwa Kaseba-Sata said the group has conducted interviews with key informants and WHO regional officers. The group received briefings from the WHO secretariat on 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 and the implication of its implementation for the PIP Framework and public health.

According to a WHO source, in January 2016, the WHO Executive Board requested the WHO secretariat to analyse how the implementation of the Nagoya Protocol might affect the sharing of pathogens and the potential public health implications. To assist in the preparation of its report, the WHO secretariat engaged two external consultants to produce a study on the subject, the source said.

“During their last closed session, the PIP Framework review group invited the consultants to give an update on the findings and answer specific questions,” the source told Intellectual Property Watch.

The outcomes of that conversation will be reflected in both the PIP review final report and in the secretariat report on the above mentioned subject. Both will be available for next Executive Board 140th session in January 2017, the source said.

According to Mwelwa Kaseba-Sata, the group analysed written submissions of WHO regional offices looking at the main achievements in each region since the adoption of the PIP Framework and the impact of the PIP Framework in each region on pandemic influenza preparedness, in particular on inter-pandemic surveillance and capacity to respond, she said.

“We are two-thirds of the way through our work,” she said. “We are in the process of developing findings and recommendations as we draft our report.”

It is expected that the review group will provide its final report to the director general by October 2016, so that it may be considered by the Executive Board in January 2017 and the annual World Health Assembly in May 2017.