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There are many who see the World Health Organization mechanism to prepare and face the next influenza pandemic and insure availability of treatments as a success. However, some questions remain.

The mechanism was reviewed last year and the World Health Assembly is expected to discuss issues such as how to deal with the sharing of the genetic information of viruses instead of their biological samples, the possible revision of the industry financial contribution to the framework, and whether the mechanism should be extended to other influenza virus, not only those with pandemic potential.

The Pandemic Influenza Preparedness (PIP) Framework was adopted in 2011 and seeks to increase access to vaccines and other pandemic-related supplies for developing countries, and improve and strengthen the sharing of influenza viruses with human pandemic potential, according to a WHO question and answer document.

One of the issues expected to be discussed at the World Health Assembly next week is the proportional division of funds between pandemic preparedness measures and response activities, according to the secretariat’s report [pdf].

The WHA is taking place from 22-31 May. A guide to the WHA has been published by Intellectual Property Watch (IPW, WHO, 16 May 2017).

The first review of the PIP Framework was carried out in 2016 by a Review Group, which provided a report in November 2016, with a number of recommendations (IPW, WHO, 23 November 2016).

Genetic Sequence Data

One of the questions that is expected to be discussed at the World Health Assembly next week is how to deal with the sharing of the genetic information of influenza viruses (genetic sequence data – GSD) with human pandemic potential (IVPP) rather than their biological material. Flu viruses are shared through the Global Influenza Surveillance and Response System (GISRS), which is a network of national institutions recognised by WHO.

Faced with a reduction of the sharing of IVPP from some countries with the PIP Framework, the PIP Framework secretariat provided a study of the reasons for this recent decline. The study found that countries have varying interpretations of the PIP Framework, and some countries are sharing GSD rather than biological material. The study also found that “The political nature of decision-making at country level regarding virus sharing can impact the timeliness and completeness of virus sharing.”

Industry Partnership Contribution

Also expected to be discussed is the annual partnership contribution, one of the key elements of the PIP Framework benefit-sharing mechanism, which is requested of pharmaceutical manufacturers using GISRS. The total partnership contribution funds received as of June 2016, since 2012, amounted to US$ 92,800,499, according to the report.

Not all companies pay their due in time, according to the WHA report, while the pharmaceutical industry has been asking for an independent financial audit showing how their contribution is being used by the PIP Framework (IPW, WHO, 5 April 2017).

In particular the partnership contribution has been based on the running cost of GISRS, but none of it is actually going to cover the running cost of the network. The WHA report says that the running costs for GISRS “are likely to have increased from the 2010 estimate.”

The PIP Framework Advisory Group (AG), which monitors the implementation of the framework, recommended that the formula for the partnership contribution be revised, in collaboration with industry “to facilitate the timely payment” of the contribution. The group also suggested to set up an “escalation response to underpayment, late payment or default of” the contribution.

The report notes that the advisory group should request regular financial reports and audits, and request the PIP Framework secretariat to “illustrate how the Partnership Contribution Response funds will be severely inadequate in a pandemic.”

The PIP Framework secretariat told Intellectual Property Watch that “in 2017 there has been an increase in the rate of IVPP shared with GISRS.” As a follow-up to the study, the WHO secretariat developed, “in collaboration with GISRS, draft technical guidance for GISRS laboratories and other authorized national laboratories, clarifying the sharing of IVPP under the Framework,” they said.

PIP Framework Special Instrument Under Nagoya?

Also in the report of the secretariat for the WHA is an issue of whether the PIP Framework can be recognised as a specialised international instrument of access and benefit-sharing under 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. The report notes that the Nagoya Protocol does not expressly identify a mechanism to recognise such an instrument.

The report also indicates that the WHO should undertake a study to determine the implications and desirability of including seasonal influenza viruses in the PIP Framework, and that member states should agree on the timing of the next review of the PIP Framework, which “should be” before the end of 2021.