New Draft Decision Seeks To Deepen Analysis On WHO Pandemic Flu Framework

A new draft decision submitted this week at the World Health Assembly (WHA) by a group of countries would set out further actions to analyse the Pandemic Influenza Preparedness (PIP) Framework.

The draft decision requests an audit of how the financial contribution to the framework by the pharmaceutical industry that uses the samples is used by the framework. It also underlines the necessity that this contribution be timely and made annually, although the language for this particular paragraph is not yet agreed upon.

The draft decision, submitted by Australia, Finland, Pakistan, and the United States, is available here [pdf]. It is expected to be discussed tomorrow in committee at the annual Health Assembly, taking place from 22-31 May.

Yesterday, an earlier version of the draft decision [pdf] obtained by Intellectual Property Watch was discussed among WHO member states, and the latest version shows an additional paragraph, indicating absence of consensus on language.

The new draft shows a new paragraph 4bis. Paragraph 4 details the critical role of the WHO Global Influenza Surveillance and Response System (GISRS) in the PIP Framework. GISRS is a network of WHO-accredited national laboratories which monitors the evolution of influenza viruses, and serves as a global alert mechanism for the emergence of flu viruses with pandemic potential.

The new bracketed 4bis notes the necessity of timely and adequate partnership contribution payments. This comes after the WHO said some payments from industry have come late.

The partnership contribution is a financial payment made annually by the pharmaceutical industry to access biological samples of viruses with pandemic potential from the GISRS.

The 4bis also requests that concerns be raised over the underpayment, late payment or default on payment of partnership contribution, and “over entities that receive PIP Biological Materials, but are not entering into Standard Material Transfer Agreements [SMTA].”

SMTAs are contracts between entities getting biological samples and the WHO.

The PIP Framework Review Group delivered a report with recommendations, at the end of 2016 (IPW, WHO, 23 November 2016).

The recommendations of the Review Group address different aspects of the PIP Framework, including how to deal with the genetic information of influenza virus with pandemic potential in the framework, whether the framework should be considered as a special benefit-sharing instrument 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, and whether the framework should cover seasonal influenza viruses.

The draft decision requests the WHO director general to take forward “expeditiously” the recommendations of the Review Group’s report.

On some recommendations of the PIP Review Group, the draft decision asks for thorough analysis before actions can be taken.

For example, on the recommendations concerning GSDs, and whether seasonal influenza should be also covered by the PIP Framework, the draft decision asks that a “thorough and deliberative analysis of the issues,” be conducted, in consultation with “relevant stakeholders, including the GISRS.”

GSDs are not yet covered by the PIP Framework and discussions have been ongoing on how to integrate them into the framework.

On the Nagoya Protocol, the draft decision asks that the WHO continue consultation with the secretariat of the CBD and other relevant international organisations.

Echoing a request made by the pharmaceutical industry for some time that the PIP Framework provide an independent audit of how it uses the partnership contributions, and in line with the PIP Advisory Group’s latest meeting recommendations, the draft decision asks that the External Auditor perform and audit those contributions.

According to the draft decision, the External Auditor would provide “assurances that the WHO financial regulation have been appropriately applied in the use of funds and that the financial information reported is accurate and reliable. Further the External Auditor would “provide recommendations to further increase the transparency of reporting on the linkages between expenditure and technical impact.”

 

Image Credits: Catherine Saez