Advisory Group Supports Industry Demand For Audit Of WHO Pandemic Flu Framework

The World Health Organization has been recommended to provide details on its spending of funds provided to its pandemic influenza framework by the private sector.

Last week, a longstanding demand by the private sector – the major financial contributor to the framework – was clearly heard by the framework’s advisory group, which recommended an independent audit, according to sources.

Other topics addressed by the meeting included the management of virus genetic data under the framework, and how to address the decreasing number of viruses shared with the framework.

The WHO Pandemic Influenza Preparedness (PIP) Framework Advisory Group met from 28-31 March. The Advisory Group monitors the implementation of the PIP Framework, and provides recommendations on its functioning.

The weeklong meeting was closed, but on 30 March, the private sector, civil society, WHO member states, and the WHO Global Influenza Surveillance and Response System (GISRS) were invited to share their views (IPW, WHO, 28 March 2017).

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 (IVPP).

Industry Slow to Pay, Demands Audit

One of the components of the PIP Framework is the Partnership Contribution (PC), which is an annual cash contribution to WHO by influenza vaccine, diagnostic and pharmaceutical manufacturers who use GISRS.

The newly elected chair of the Advisory Group, Prof. Mahmudur Rhaman, former director of the Institute of Epidemiology, Disease Control & Research & National Influenza Centre (NIC) in Bangladesh, and the newly elected vice-chair, Prof. John Watson, deputy chief medical officer for England, were interviewed by Intellectual Property Watch on the outcome of last week’s Advisory Group meeting.

They said that some companies are dragging their feet on the partnership contribution, and the Advisory Group sought to understand the possible impediment and concerns, and how to address them. According to the chair and vice-chair, the PIP secretariat “has gone a long way” to diminish concerns.

The WHO has a webpage on the implementation of the partnership contribution, including a partnership contribution implementation portal, which displays the 2012-2016 budget.

According to sources, industry representatives in the meeting last week pointed to the partnership contribution received as of January 2017 of US$117,758,149. They said that the justification for this contribution was becoming increasingly difficult to explain to industry senior management, in the absence of transparency, the sources said.

The private sector has been remarking for some time that not enough details are provided by the WHO on the use of their contribution, and requested an independent financial audit.

The Advisory Group chair and vice-chair told Intellectual Property Watch that the group will make a recommendation in its report to the WHO director general that an independent financial audit of the use of the partnership contribution be conducted.

Another complaint of industry was about the basis of calculation for the partnership contribution, sources said. The partnership contribution was established on the basis of the GISRS running cost (US$56 million) and is equivalent to 50 percent of this running cost (US$28 million). The partnership contribution however does not cover the GISRS running costs.

According to the PIP secretariat, the partnership contribution indirectly supports GISRS through activities such as training and increasing surveillance capacity.

Industry voiced preference for the contribution be calculated based on project spending from the previous 4-year period, sources said.

The PIP secretariat could not give the exact extent to which industry is late in paying their contributions.

Partnership Contribution High-Level Implementation Plan

According to the WHO, the partnership contributions are being used to strengthen capacities in five areas of work: laboratory and surveillance capacity, knowledge of burden of disease, regulatory affairs capacity, planning for deployment of pandemic response supplies, and risk communication. Outcomes, outputs, and key activities for each area of work is detailed in a high-level implementation plan. The first implementation plan (HLIP I) ran from 2013-2016, and has been extended to the end of 2017.

Last week, the PIP Advisory Group considered a new HLIP II (2018-2023). According to the chair and vice-chair, consultations on the plan are ongoing with industry and it seems it will be very challenging to have the plan ready to be implemented at the start of 2018. If consultations with industry are not over by the next Advisory Group meeting in October, another one year extension of the HLIP I might be required, they said.

According to sources, industry said in the meeting the plan should be strategy-based, and the budget should be built from demonstrated pandemic preparedness needs and objectives, rather than allocation of available funds.

Also according to sources, the Third World Network (TWN), which represented NGOs in the room during the 30 March session, said that the HLIP II implementation plan should contribute to the strengthening of health systems, and the estimates to formulate policy needs to take into account the fact that developing countries have competing health challenges.

Genetic Sequence Data, Databases In Question

The issue of viruses genetic sequence data, which contain the genetic information that determines the biological characteristics of an organism or a virus is complicated, said the chair and the vice-chair. A range of different views from different actors has to be considered, they said, and some compromises need to be made to “best serve the purpose of the PIP Framework.”

The PIP Advisory Group started its work on the issue in June 2013, according to the WHO. At the end of 2016, a Review Group tasked with reviewing the functioning of the PIP Framework issued a report [pdf] with recommendations on how to handle genetic sequence data (GSD). The issue with GSD is how to integrate them into the PIP Framework so that the framework principle of access and benefit-sharing applies.

The Review Group recommendations advised in particular that the language of the framework be amended to say that the WHO GISRS laboratories would submit GSD “to one or more publicly accessible database of their choice…” instead of naming particular databases routinely used by GISRS: The Global Initiative on the Sharing All Influenza Data (GISAID) database EpiFlu, hosted by Germany and US-based Genbank.

According to the sources, industry said GSD should continue to be shared according to the original principles of the PIP Framework. They also said that GSD of IVPP (influenza viruses with pandemic potential) are not currently defined as WHO PIP biological materials.

Suggestions were made, they said, for a new database for GSD to be developed. However, industry said that existing databases are serving the purpose and there is no need to develop another one, underlining the fact that the majority of influenza GSD is already being deposited in EpiFlu, sources said (IPW, Public Health, 26 August 2016).

Representatives of GISRS reportedly said GISAID was designed by and for GISRS scientists for timely sharing of influenza GSD, and fulfilling responsibilities of GISRS laboratories, sources said. GISRS representatives said GSD shared through GISAID platform is also accessed by research scientists, public and animal health officials and the pharmaceutical industries for risk assessment and vaccine development.

According to sources, TWN made a series of arguments to the meeting. It said it is a flawed approach to distinguish between the physical material of viruses and GSD. The TWN representative told the meeting that it has always supported the idea that databases hosting IVPP GSD implement a common data access and use management. It also said a WHO-operated database was highly desirable, and would guarantee the expectations of the PIP Framework, in particular its benefit-sharing component.

Flu Virus Sharing Increasing, in PIP Framework Decreasing

The PIP Framework Review Group underlined in its report that the sharing of IVPP through the PIP Framework has been declining since 2014, although last week the PIP secretariat told Intellectual Property Watch that the situation is improving. On the other hand, GISAID has been saying that influenza virus GSD is steadily increasing.

The Advisory Group sought last week to understand the reasons for this discrepancy. According to the chair and the vice-chair, some countries’ rules and regulations for the shipment of biological samples could affect the sharing with the PIP Framework.

To address the issue of the sharing of GSD under the PIP Framework, the PIP Advisory Group has been tasked to develop guidance on the sharing of influenza viruses with pandemic potential, genetic sequence data and information under the PIP Framework. The issue of the declining sharing of IVPP has been incorporated into the upcoming guidance document. A concept note tabled last week was considered by the Advisory Group and stakeholders.

According to the concept note seen by Intellectual Property Watch, the guidance would cover three areas: virus sharing, GSD, and information sharing. Consultations with “a diverse group of stakeholders, as needed,” are expected, and the guidance document is foreseen to be submitted for consideration of the WHO director general by October 2017.

GISRS Wants Framework for Governance 

GISRS is a loose network of laboratories, which sources said lacks centralised governance. According to the WHO website, the network was established in 1952 and includes 143 institutions in 11 WHO member states, which are recognised by WHO as National Influenza Centres; 6 WHO Collaborating Centres; 4 WHO Essential Regulatory Laboratories; 13 WHO H5 reference laboratories, and ad hoc groups established to address specific emerging issues.

According to sources, representatives of the GISRS attending the stakeholder sessions last week said the network supports the development of a formal governance body to represent the GISRS. The WHO Global Influenza Programme (GIP) along with the WHO collaborating center, and other GISRS laboratories are working to establish a framework for the GISRS governance body, sources said.

 

Image Credits: Flickr – Reynermedia