WHO Pandemic Flu Review Group Meets Next Week

The review of a World Health Organization mechanism for sharing pandemic influenza viruses while ensuring access to vaccines for developing countries is nearing conclusion. Next week, the reviewers will hold their last meeting, including an open session for governments and stakeholders to share views. The review is addressing issues such as the mechanism’s relationship with other international rules, and how to handle the rising use of genetic data instead of biological samples.

The sixth and final meeting of the Review Group of the 2011 WHO Pandemic Influenza Preparedness (PIP) Framework is taking place from 29 August to 2 September.

The Review Group, chaired by Christine Mwelwa Kaseba-Sata, Zambian, specialist in obstetrics and gynaecology, and former WHO Goodwill Ambassador against Gender-based Violence, is expected to deliver its review by 31 October, so that it can be considered by the WHO Executive Board in January 2017 and the World Health Assembly in May 2017.

Two sessions of next week’s meeting will be webcast: an open session with member states and stakeholders from 2-5 pm on 29 August, and a debrief session about the outcomes of the week meeting on 2 September at 2pm. The webcast will be available through this link.

The PIP Framework was adopted in 2011 with the objective of improving sharing of flu viruses with pandemic potential so that research on vaccines can be conducted. The objective also is to ensure developing countries have access to vaccines and other life-saving products during a pandemic.

The review will measure: Achievements since the PIP Framework was adopted, and whether the framework implementation improved global pandemic flu preparedness, including inter-pandemic surveillance and capacity to respond. It also will identify challenges and possible ways of addressing them.

The Review Group was requested [pdf] by the PIP Advisory Group – which provides recommendations to the director general on the functioning of the PIP Framework – to pay particular attention to issues such as virus-sharing, including genetic sequence data (data containing the genetic information that determines the biological characteristics of a virus).

The group also is looking at: benefit-sharing, including partnership contribution; governance; and linkages with other instruments, such as 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 (CBD).

The next meeting of the PIP Advisory Group is to be held from 18-21 October.

Member states were asked to send submissions to the Review Group no later than 15 July, as underlined by Mwelwa Kaseba-Sata at the last meeting of the Review Group in late June (IPW, WHO, 6 July 2016).

A set of questions was submitted to member states and stakeholders, essentially the same for both:

• Has the PIP Framework helped better prepare Member States for a pandemic? How could this capacity be improved?
• What are the key challenges in the implementation of the PIP Framework? What are possible ways to overcome these challenges?
• Are the principles underpinning the PIP Framework, e.g. transparency, fairness, equity, efficiency, and virus sharing and benefit sharing on an equal footing, being implemented?
• How should the PIP Framework ensure it remains relevant and effective?
• Have there been any collateral benefits (i.e. benefits beyond the initial intent) arising from implementation of the PIP Framework? If so what are these benefits?
• What views do Member States have on using the PIP Framework as a model for sharing of other pathogens?
• How well is the work of the PIP Framework communicated to Member States?
• How do Member States view their interaction with the PIP Framework Secretariat? How could this interaction be strengthened?

The PIP Advisory Group, in its April meeting report [pdf] to the WHO director general, provided a set of recommendations pertaining to some issues expected to be explored by the Review Group.

Nagoya Protocol, Sharing of Pathogens

During the January 2016 session of the WHO Executive Board, member governments requested that WHO conduct a study to analyse how the implementation of the Nagoya Protocol might affect the sharing of pathogens and the potential public health implications.

At the request of the WHO, the CBD launched a consultation on the Nagoya Protocol and the sharing of pathogens. The CBD sent a consultation notification to national focal points on access and benefit-sharing, as well as focal points to the CBD.

In the notification, they said that the preamble to the Nagoya Protocol requests member states to be mindful of the International Health Regulation of the WHO and underlines the importance of ensuring access to human pathogens for public health preparedness and response purposes.

The Protocol further requests that “Parties may take into consideration the need for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources, including access to affordable treatments by those in need, especially in developing countries,” the notification said. Recipients were requested to submit information to the PIP Secretariat by 31 July.

The WHO secretariat is expected to deliver a written report on the impact of the Nagoya Protocol on the sharing of pathogens by the end of October 2016.

According to terms of reference [pdf] posted on the WHO website, a consultant(s) was expected to be engaged to produce a study on the issue. The consultant’s work was expected to involve engagement with WHO’s member states, WHO secretariat, stakeholders, as well as relevant intergovernmental organisations, such as the CBD, the South Centre, the United Nations Conference on Trade and Development (UNCTAD), the World Trade Organization, the World Intellectual Property Organization, but also civil society, and research institutions such as Institut Pasteur, as well as industry and academia.

The secretariat has engaged two external consultants to produce a study on the subject, it said in July. It was unclear at press time who the two consultants are.

Sharing of Biological Virus Samples Declining

In their April report, the Advisory Group said using data from the Influenza Virus Traceability Mechanism (IVTM), the WHO secretariat presented an overview of virus sharing in recent years. While the sharing of PIP biological materials initially increased after adoption of the PIP Framework, recent data point to a decreasing trend in virus sharing, the report said.

Possible reasons for this trend given by the secretariat, according to the report, are: a lack of understanding among national influenza centres that the sharing of genetic sequence data of influenza virus with pandemic potential “does not replace sharing biological material”; export procedures that can be lengthy and involve ministries other than health; and lack of clarity by laboratories with dual roles as both a national influenza centre and a WHO Collaborating Centre about their international sharing responsibilities.

Genetic Sequence Data Under PIP

Technological progress allows access to genetic material that has been sequenced into data, and the reproduction of this material without the need to access the physical form of the material.

According to scientific sources, a well-equipped laboratory can recreate a virus from its genetic sequence data.

It is not clear whether or not genetic sequence data (GSD) are covered by the PIP Framework, and how they should be handled. Some have expressed concern about the ability to access pandemic flu virus through GSD, circumventing the PIP Framework, which was essentially geared toward biological samples of viruses.

In its April report, the Advisory Group underlined “the importance of maintaining equal footing for the sharing of viruses and the sharing of benefits when considering handling of GSD under the Framework.”

The group found that a diversity of databases is best for optimal data sharing and resilience and recommended that a “sufficient degree of redundancy” be offered “including through multiple databases, on order to secure sustainability of access to data.”

In an October 2015 statement, Germany, which entered into a public-private partnership with the GISAID Initiative, and has hosted a publicly accessible database (EpiFlu) since 2010, explained that the initiative uses “a unique sharing mechanism which ensures that inherent rights [such as IP rights] of contributors of GSD are not forfeit.”

The WHO Collaborating Centers for Influenza provide scientific oversight, they said, and most Global Influenza Surveillance and Response System (GISRS) laboratories use GISAID, the Global Initiative on Sharing Avian Influenza Data.

During the last meeting of the Review Group, Germany commented on the Advisory Group’s April report and advised against creating parallel systems to GISAID’s database for GSD so as not to duplicate efforts.

“We already have reliable and considerable access to data in current databases and one example is GISAID,” the German delegate said in June.

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

GISAID currently holds over 590,000 flu virus sequences.

 

Image Credits: Flickr – Sanofi Pasteur