WHO Flu Framework Looks At Virus Genetic Information Sharing, Private Sector Contribution

How to deal with genetic information rather than physical samples of pandemic influenza virus continues to be discussed at the World Health Organization. For the moment, only physical samples are part of a framework of access and benefit sharing set up and run by the WHO. This week, the framework advisory group is meeting and according to sources, suggested steps to establish guidance on how to address virus genetic information will be shared by the WHO during the meeting.

Other topics are expected to include the industry contribution to the framework and the next-level implementation plan from this contribution, starting in 2018.

The Pandemic Influenza Preparedness (PIP) Framework Advisory Group is meeting from 28-31 March. The agenda of the meeting is not available from the WHO.

The meeting is closed, except for separate sessions on 30 March for the private sector and civil society, WHO member states, and the WHO Global Influenza Surveillance and Response System (GISRS). GISRS is an international network of influenza laboratories conducting year-round surveillance of influenza viruses. It serves as a global alert mechanism for the emergence of influenza viruses with pandemic potential, according to the WHO. Press is not allowed in any of the stakeholders’ sessions.

According to a meeting document seen by Intellectual Property Watch titled, “Development of Guidance on the sharing of influenza viruses with pandemic potential, genetic sequence data and information under the PIP Framework,” the PIP Advisory Group has been tasked with addressing concerns regarding a decrease in the number of influenza viruses with human pandemic potential shared with GISRS since 2013. The PIP secretariat was requested to look into that matter, the document says.

The document states that the PIP Advisory Group “will develop guidance on the sharing of IVPP [influenza viruses with pandemic potential] genetic sequence data, and information, to support the PIP Framework principles and objectives of efficient, fair, equitable access and benefit sharing for pandemic preparedness and response.”

Genetic sequence data (GSD) contain the genetic information that determines the biological characteristics of an organism or a virus. Access to a virus GSD by a well-equipped laboratory would allow that laboratory to reproduce the virus and thus bypass the PIP Framework mechanism of access and benefit sharing, according to sources.

The guidance is expected to include possible triggers for sharing benefits from GSD for influenza viruses with pandemic potential, and defining the data sharing principles promoting timely and systematic access to GSD, and the fair and equitable sharing of benefits arising from their use, the document says.

The PIP Framework was reviewed by a review group in 2016 and the group’s concluding document [pdf] suggested that the PIP Framework should be amended to include public domain databases as a way of sharing GSD.

That raised concerns from different stakeholders on how the benefit-sharing mechanism could be applied if data obtained from publicly accessible databases could not be traced. The PIP Framework was set up following concerns by developing countries that the sharing of viruses would not bring any facilitated access to treatments back to them, and only serve commercial purposes of private sector firms.

The guidance will be directed to all PIP Framework stakeholders, including GISRS laboratories, and “other authorized laboratories,” the private sector, data sharing initiatives and databases that host influenza GSD, researchers, and other stakeholders, it says.

The GSD issue in the PIP Framework has been discussed in the context of the review of the PIP Framework in 2016 (IPW, WHO, 30 August 2016), and at the WHO Executive Board in January (IPW, WHO, 21 January 2017).

During the January Executive Board, Germany, commenting on the findings of the PIP Framework Review Group, underlined the Global Initiative on the Sharing All Influenza Data (GISAID), launched in 2008. Germany hosts a key database of the initiative called EpiFlu, which provides for a legally binding licensing mechanism (EpiFlu Database Access Agreement) that recognises the ownership of rights to the data and provide legal certainty on its use. Most GISRS laboratories use GISAID, according to several sources, including some WHO documents.

During the WHO Executive Board, Alan Hay, scientific liaison officer at GISAID, told Intellectual Property Watch that contrary to what has been observed in the PIP Framework, “there is a continuing increase in virus data submitted to GISAID’s EpiFlu database which is commensurate, for example, with recent reports of human cases of H7N9 and H5N6 influenza in Asia, and avian H5N8 outbreaks in Europe. These data are shared in a very timely manner, often within one to two weeks.”

Hay added, “At the start of H7N9 outbreak in 2013, GISAID proposed a concrete mechanism to the WHO and its PIP Advisory Group to facilitate the link between the sharing of GSD and benefit sharing under the PIP Framework. The reports by the PIP AG and Review Group do not reflect this and the WHO has yet to take advantage of this facility.”

“The PIP AG will undertake its work in a transparent, consultative and inclusive manner,” the PIP Advisory Group meeting document states, and adds that the draft guidance “will be shared for comments as part of a public consultation.”

The final guidance document is expected to be submitted to the WHO director-general by October 2017, so the newly-elected director-general.

The PIP Advisory Group is expected to discuss the draft conceptual approach and scope, consult with stakeholders, and finalise the conceptual approach and scope this week, according to the document.

Partnership Contributions, Transfer Agreements

According to the PIP secretariat, the PIP Advisory Group this week is also expected to discuss the industry partnership contribution implementation, and in particular a draft high-level partnership contribution implementation plan II. A meeting document seen by Intellectual Property Watch indicates that the plan starts from 2018 to 2023. The previous implementation plan ran from 2013-2017.

The partnership contribution is an annual cash contribution that the private sector pays the WHO for using the WHO GISRS. Industry has been questioning the transparency of the use of this contribution by the WHO and asked for an independent audit, according to sources. The draft implementation plan II includes “improved clarity on how implementation of PIP PC will strengthen national International Health Regulations core capacities.”

According to the meeting document, the annual amount to be received by WHO should equal 50 percent of the running cost of GISRS, which in 2010 amounted to about US$56.5 million. The WHO thus sought an annual partnership contribution from 2011 to 2016 of US$28 million. The amount remains unchanged under the implementation plan II “for planning purposes,” the document says.

The PIP secretariat also told Intellectual Property Watch that the Standard Material Transfer Agreement 2 (SMTA2) is expected to be discussed this week. SMTA2 is a legally binding contract between the WHO and a company, laboratory, or other institution that receives PIP biological materials from a laboratory part of GISRS, according to WHO.

 

Image Credits: Catherine Saez