WHO Experts Seek To Have Its Flu Framework Recognised Under Nagoya Protocol

Will an international instrument protecting genetic resources get in the way of the world’s preparedness to fend off the next influenza pandemic? This is one of the questions left open for a group of experts reviewing the World Health Organization Pandemic Influenza Preparedness (PIP) Framework. On the side, one stakeholder is claiming to have been denied full and fair participation.

The 2011 PIP Framework for the sharing of influenza viruses and access to vaccines and other benefits (PIP Framework) is being assessed by a Review Group expected to give its findings in October. Preliminary findings are on the WHO website [pdf].

The review group met formally for the last time from 29 August to 2 September (IPW, Public Health, 30 August 2016).

This afternoon a closing debriefing was held for member states. Johanne Newstead, head of food policy, Public Health Directorate, Department of Health, United Kingdom, chaired the webcast debriefing to member states about the work of the review group during the week. She filled in for Theresa Tam of Canada, who herself chaired the meeting this week for the regular Review Group Chair Christine Mwelwa Kaseba-Sata from Zambia.

According to Newstead, there is consensus that the PIP Framework is working well but there are different perspectives on some issues. The intention of the group is to provide evidence-based recommendations based on evidence from key informants, she added.

Newstead said extensive input was received from member states this week, as well as from civil society and other stakeholders, and those comments have been helpful in putting the preliminary findings in context with the “real world”.

Consequently, significant time was spent revising the preliminary findings in light of those comments, she said, adding that the wording of the findings has been nuanced.

Some questions were left open, such as the expansion of the scope of the PIP Framework, and the handling of genetic sequence data (GSD), said Newstead. GSD are a set of virus genetic data. Much work is left to inform member states about those “enormously complex issues” for them to take appropriate action, she added.

PIP as a Specialised International Instrument – Who Decides?

The WHO secretariat has commissioned a study [pdf] on public health implications of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the UN Convention on Biological Diversity (CBD).

One of the preliminary findings of the Review Group is that the PIP Framework should be recognised as a specialised international instrument under the Nagoya Protocol. The Nagoya Protocol is a legally binding instrument which provides countries with a system of access to biological resources and benefit-sharing of potential commercial benefits.

The Review Group found that if the PIP Framework was considered as an international specialised instrument providing access and benefit-sharing, the sharing of pandemic influenza viruses could be governed by the PIP Framework and its own access and benefit-sharing system, and not fall under the direct obligations of the Nagoya Protocol.

Following a question by Ecuador on the mandate of the WHO to establish a protocol under the Nagoya Protocol, Viroj Tangcharoensathien, senior adviser, International Health Policy Program, Ministry of Public Health, Thailand, and member of the Review Group, said under Article 4 of the Nagoya Protocol (Relationship with International Agreements and Instruments) if the PIP Framework was recognised as an international specialised instrument, countries would not have to enter into access and benefit-sharing agreements. Such agreements would entail large transaction costs and be lengthy.

The World Health Assembly in May 2017 could potentially recognise the PIP Framework as an international specialised instrument, he said.

Ecuador remarked that currently only the International Treaty on Plant Genetic Resource for Food and Agriculture (ITPGRFA) was recognised as an international specialised instrument on benefit-sharing.

During the open session at the beginning of the week, several stakeholders remarked that the WHO could not declare itself the PIP Framework to be a specialised instrument under the Nagoya Protocol.

Tangcharoensathien said the Review Group asked the WHO to enter into conversation with the CBD.

Article 4 states:

“This Protocol shall be implemented in a mutually supportive manner with other international instruments relevant to this Protocol. Due regard should be paid to useful and relevant ongoing work or practices under such international instruments and relevant international organizations, provided that they are supportive of and do not run counter to the objectives of the Convention and this Protocol.”

It also says:

“Nothing in this Protocol shall prevent the Parties from developing and implementing other relevant international agreements, including other specialized access and benefit-sharing agreements, provided that they are supportive of and do not run counter to the objectives of the Convention and this Protocol.”

Ecuador remarked that a lot of lessons could be learned from the international plant treaty in terms of benefit-sharing funds and problems arising on tracking and identifying responsibilities.

Stakeholder Claims Undue Influence at WHO

Separately, a former director of the WHO Collaborating Centre on influenza in London has raised alarm about what he sees as a WHO department having undue influence on pandemic influenza discussions.

Alan Hay, now scientific liaison officer for the Global Initiative on Sharing All Influenza Data (GISAID), (IPW, Public Health, 26 August 2016) sent a letter to the members of the PIP Review Group raising concerns about the “undue negative influence of members of the PIP Secretariat, that should be addressed in a transparent manner.”

He said the preliminary findings of the review group do not reflect GISAID’s comment on the PIP Advisory Group’s oversight of the PIP Secretariat. The PIP Advisory Group monitors the implementation of the PIP Framework and provides assessment and recommendation regarding its functioning. The letter also said that the preliminary findings omit communication and engagement with stakeholders, such as GISAID.

For example, the letter says that Hay has received no acknowledgement to recent correspondence to the PIP Review Group, in particular correspondence in which Hay offered to meet the Review Group face-to-face. In the same manner, the scientist claimed he received no acknowledgement to a correspondence of 27 June providing answers “with detailed evidence to questions on governance concerns of the PIP Secretariat, and its undue influence in the entire review process.”

Hay said he could not attend the meeting of the PIP Review Group this week, as he was asked to give a talk at a WHO side event with the Global Influenza Surveillance & Response System (GISRS) in Chicago. He also said he was helping organise a GISAID-WHO-International Society for Influenza and Other Respiratory Virus Diseases (ISIRV) workshop on bioinformatics.