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The World Health Organization is consulting member states and stakeholders on the future of its mechanism to help prepare the world for the next influenza pandemic. It is particularly asking whether countries should submit not only the biological samples of their influenza viruses, but also their genetic information through the mechanism. Also in question is whether the mechanism should be extended to cover seasonal influenza. Stakeholders had different views but all questioned the absence of recognition by the WHO of a widely used database currently hosting most of the world’s influenza genetic information.

Two days of consultation were organised on 6-7 November by the WHO on both issues and on a “scoping paper” [pdf] drafted by the secretariat to facilitate discussions (IPW, WHO, 24 October 2017). The consultations will be followed by a draft analysis by the WHO, and another round of consultations. The progress is expected to be reported at the annual World Health Assembly (WHA) in May 2018, and recommendations on future action will be delivered.

The last Health Assembly in May decided that the WHO should conduct a “thorough and deliberative analysis” of issues raised by the Pandemic Influenza Preparedness (PIP) Framework Review Group’s recommendations on seasonal influenza and genetic sequence data (GSD), “including the implications of pursuing or not pursuing possible approaches” (IPW, WHO, 26 May 2017). The PIP Framework currently only covers influenza viruses with a human pandemic potential.

As shown in the draft agenda [pdf], the first day of the consultation was devoted to the issue of GSD, and the second day to seasonal influenza. The consultations included two sessions during which “relevant international organizations, databases and initiatives, and all interested stakeholders” could join member states, the PIP Advisory Group, and representatives of the WHO Global Influenza Surveillance and Response System (GISRS).

Press were not allowed in the sessions of the consultation organised for stakeholders.

Genetic Sequence Data, Questions on Prominent Database

The issue of genetic sequence data is that under the current functioning of the PIP Framework, only biological materials that are shared by countries and used by third parties such as industry, through the GISRS, trigger the benefit-sharing aspect of the PIP Framework and the financial contribution which is paid by third parties to use the system.

With technological advances, the sharing of influenza viruses is done more and more through the sharing of the viruses’ genetic information. Laboratories could create the viruses from this genetic information and potentially escape their benefit-sharing obligation under the PIP Framework.

According to sources, stakeholders taking the floor on 6 November included representatives of the pharmaceutical industry, civil society, and one database.

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) representative questioned the emphasis in the scoping paper on changing the framework language on databases, sources said.

The scoping paper, following the recommendation of the PIP Framework Review Group, suggests that the original language in the framework which states, “The WHO GISRS laboratories will submit genetic sequences data to GISAID and Genbank or similar databases in a timely manner consistent with the Standard Material Transfer Agreement,” be replaced. It would say, “The WHO GISRS laboratories will submit genetic sequences data to one or more publicly accessible database of their choice in a timely manner consistent with the Standard Material Transfer Agreement.”

The IFPMA representative said GISAID (Global Initiative on Sharing All Influenza Data) is used by the majority of WHO Collaborating Centers and industry alike, and this fact is not acknowledged in the scoping paper, sources said. The representative said GISAID already has a user agreement in place.

[Clarified] IFPMA told Intellectual Property Watch that they did not have a statement on the issue, but said IFPMA and BIO are currently “in a constructive dialogue with WHO Member states and we are sharing with them our comments on the scoping paper on approaches to seasonal influenza under the PIP Framework.”

The nongovernmental Third World Network, attending the consultation, remarked that the definition of PIP biological materials in the PIP Framework is non-exhaustive and open-ended, the TWN representative told Intellectual Property Watch. Any suggestion that the definition of PIP biological materials does not and should not include GSD is untenable, she said.

However, standard material transfer agreements between WHO and entities outside of WHO such as vaccines manufacturers is only triggered on access to PIP biological materials, not GSD, she said.

If the definition of PIP biological materials is not clarified, there will be uncertainty in responding to a pandemic, she said.

The PIP Framework is built on the foundational principle that sharing of influenza viruses with pandemic potential should be on an equal footing with sharing the benefits arising from the use of those viruses, and maintaining that equal footing requires the PIP biological materials to include GSD, she said.

TWN underlined the importance of a data access and user agreement for databases wishing to host GSD. The representative noted that GISAID already utilises a data access and user agreement but noted that the scoping paper fails to mention this fact.

It would be unacceptable, according to TWN, that GISRS laboratories should submit GSD to one or more publicly accessible databases of their choice since it would allow a GISRS lab to submit GSD to any database, irrespective of whether or not the database implements the PIP Framework.

GISAID: A Global Go-To Resource

According to a source, the president of the GISAID initiative reminded members of the PIP Advisory Group that GISAID’s sharing mechanism for GSD was developed over an 18-month period, before it went live in 2008. It predates the PIP Framework (2011), and was established in collaboration with low, middle-income, and industrialised nations which were both parties and non-parties to the United Nations Convention on Biological Diversity.

The objective was to provide an alternative to sharing GSD via public domain databases, where access to data takes place anonymously and providers’ rights are either unprotected or forfeited, he said, according to the source. From the very beginning, GISAID outpaced other sharing platforms and emerged as a global “go to” resource, he added.

It would be important in future documentation to recognise the role of GISRS and member states in the creation of the GISAID Initiative and also reflect the distinction between GISAID sharing mechanism and those databases such as GenBank that do not have any sharing mechanism in place, the GISAID president explained, according to the source.

GISAID expressed its ongoing concern about the PIP secretariat’s controversial role, in that past PIP documentation did not capture the significant differences relevant to PIP. GISAID has previously offered comments on these issues.

Pharmaceutical companies: Restriction Can Hinder Progress

The pharmaceutical industry, according to sources, said placing restriction on access would delay the dissemination of information in scientific and industrial circles, and might hinder progress towards pandemic preparedness.

Many companies receive both PIP biological materials and GSD, already contribute to the PIP Framework, and have signed standard material transfer agreements, the IFPMA representative said, according to sources. Companies using GSD for commercial products could self-declare, the representative said.

Civil Society Opposes Extension of Framework to Seasonal Flu

On the seasonal influenza question, the scoping paper proposed three possible approaches:

“Approach 1: Expand the PIP Framework to include seasonal influenza viruses

Approach 2: Do not expand the PIP Framework so that national access and benefit-sharing regimes under the Nagoya Protocol apply to the sharing of seasonal influenza viruses

Approach 3: Do not expand the PIP Framework and develop or adapt another instrument to cover seasonal influenza viruses, with a view to that instrument being recognized as an SII [special international instrument] under the Nagoya Protocol.”

The TWN representative said during the negotiation leading to the PIP Framework, the inclusion of seasonal influenza was considered, and rejected. Expanding the framework would mean unravelling and renegotiating the framework, she said, which does not seem advisable given its good results.

On Approach 2, the representative said there is no a priori conflict between national access and benefit sharing regimes implementing the Nagoya Protocol (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 access to seasonal influenza viruses.

TWN said that the development of a new instrument could borrow the approach of the PIP Framework with specific provisions pertaining to access and benefit sharing of seasonal influenza viruses.

TWN remarked that the scoping paper states that “to a certain degree seasonal influenza is already included in [PIP] benefit sharing arrangements,” and said this is incorrect and should be deleted.