WHO Debates Expansion Of Role In Virus-Sharing

The global treatment of influenza is under reconsideration at the World Health Organization this week, as a review group of a WHO influenza pandemic framework looks at issues such as its relationship with an international treaty protecting countries’ ownership biological resources.

The WHO Pandemic Influenza Preparedness (PIP) Framework is being encouraged to be recognised as a specialised international instrument on access and benefit-sharing of biological resources related to pandemic flu.

The group of experts reviewing the 2011 PIP Framework has found in preliminary findings that the world is better prepared to face a pandemic but their findings left many questions open.

Open issues include whether the mechanism should include seasonal viruses, how the mechanism will interact with a protocol protecting countries’ ownership of biological resources, and the seemingly slow rate of vaccines manufacturers joining the system. Some governance issues were also mentioned.

The experts reviewing the 2011 Pandemic Influenza Preparedness (PIP) Framework are expected to deliver their report mid-October and are holding their last face-to-face meeting from 29 August to 2 September.

On 29 August, a webcast open session was organised to allow for member states and stakeholders to offer comments on the PIP review group preliminary findings, soon to be posted on the WHO website, according to the WHO (IPW, WHO, 30 August 2016).

“The Framework has improved global influenza pandemic preparedness through implementation of the benefit-sharing mechanisms that have enabled WHO to successfully: secure, via standard material transfer agreements: access to vaccines and antivirals in the event of an influenza pandemic; funding of capacity building in priority countries with limited or no national ability to detect, monitor and share novel influenza viruses; and establishment of a reserve fund for response,” said the preliminary findings.

Theresa Tam, deputy chief public health officer of the Public Health Agency of Canada, was chairing the meeting in the absence of review group Chair Christine Mwelwa Kaseba-Sata of Zambia.

Expanding the Framework

One of the findings of the group is that the expansion of the PIP Framework to seasonal influenza “would eliminate the current disconnect between the handling of seasonal and pandemic influenza viruses under the Framework.”

According to the document, this expansion would also “contribute to the recognition of the PIP Framework as a specialised international access and benefit-sharing instrument for all human influenza viruses.”

They added that it would be consistent with the objectives 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).

“Consultations with Member States, industry and civil society would be needed to address the challenges of ensuring the adequacy of benefit sharing for the inclusion of seasonal influenza viruses,” the findings said.

Other Views

The pharmaceutical industry voiced concerns about extending the framework to cover seasonal flu viruses. If the scope of the framework is extended, “it could happen that the obligations that have already been committed by the third parties … for example industry, would need to be revised,” and that would add another layer of complexity, a representative of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said.

Niteen Wairagkar from the Bill and Melinda Gates Foundation supported expanding the framework to cover seasonal influenza viruses and said this suggestion should be explored further.

A representative of the WHO Collaborating Centre from the United Kingdom said the suggestion to include seasonal flu viruses needs thorough investigation about the implications of this inclusion from all sides.

Who Decides WHO’s Status with Nagoya Protocol?

The delegate from Japan asked if the PIP Review Group had direct interaction with the Nagoya Protocol in establishing findings. Tam confirmed that the review group had not engaged with the Nagoya Protocol.

The WHO legal counsel responded that the WHO has been mandated to prepare a study on public health implications of the Nagoya Protocol on pathogens sharing and has been in contact with the CBD secretariat in coordinating a questionnaire.

Brazil remarked that the WHO cannot decide for itself that it is a specialised agency under the Nagoya Protocol. He asked if this option was considered by the WHO secretariat or just an idea of the review group.

Edward Hammond of the Third World Network also said the WHO cannot declare itself that the PIP Framework is a specialised instrument under the Nagoya Protocol, that is a decision of the conference of the parties to the Nagoya Protocol to take, he said.

Biological Virus Sharing Declining?

As remarked upon by Tam on 29 August, the findings stated that virus-sharing is not optimal in all regions. The preliminary findings said that sharing in some countries in the WHO regional offices for eastern Mediterranean, South East Asia, and the western Pacific has not been satisfactory.

The group found that the sharing of PIP biological materials initially increased after the adoption of the PIP Framework, but sustained a steady decline over the past two years. Tam said a more in-depth study would be recommended to understand that trend and why that might be happening.

The UK WHO Collaborating Centre representative asked who would conduct the study on the reduction of virus sharing. He encouraged the person tasked with the study to make sure to speak to all WHO Collaborating Centres for influenza and Essential Regulatory Laboratories to investigate the matter thoroughly “because it is so important that we understand” if the decline is happening. “I mean is this real?” he asked.

One member of the review group said the findings were a collection [clarified] of viewpoints of various stakeholders.

Benefit Sharing, Need More Engagement

The review group preliminary findings state that four standard material transfer agreements (SMTA2, for non-WHO laboratory users) with vaccine manufactures using influenza pandemic virus biological materials have been signed so far. They also remarked that although the SMTA2s were designed to be broad enough to accommodate a range of commitments, no companies to date have agreed to provide technology transfer.

The group also found that “the good progress on securing prequalified vaccines and antivirals has been achieved through the PIP secretariat’s clear strategic approach of prioritizing agreements with multinational companies before moving on to negotiations with medium to small companies.”

Hammond remarked that it is “worrying” that major players in the vaccine industry have not yet signed any SMTA2s. He suggested changing the wording of the finding to indicate that SMTA2 should be concluded with all major players. He added the focus should not be going after small and medium-sized manufacturers, until larger players have been enrolled.

In the PIP Framework, the SMTA2 foresees that users of pandemic influenza virus biological materials can consider voluntary contributions such as donations of vaccines, antivirals, medical devices, diagnostic kits and granting of sublicences to WHO, known as category C contributions.

Brazil said that there is no information on those voluntary contributions from institutions. It is a blank area, and there is a need to know what is the current status on those category C, not only what has been signed but also promised, the delegate said.

PIP Framework and IHRs

The review found that the PIP Framework partnership contribution funds may have collateral benefits in improving the International Health Regulations (IHR) core capacities, especially in the areas of laboratory and surveillance.

However, since the partnership contribution funds “began to be distributed in 2014, data on the relationship between PC funds and IHR core capacities are not yet available.”

The group suggested an analysis of the partnership contribution funds’ impact on the IHR core capacities be undertaken at the next review of the PIP Framework.

Brazil said the country has some doubts and sensitivities about the connection of the PIP Framework and the International Health Regulations. In PIP, there is a balance between access and sharing of biological materials on one side, and access to benefits on the other side.

“That is an important balance that we managed to get” in the PIP Framework which is not automatically reproduced within the IHRs’ logic and system, the delegate said.

Brazil was concerned that the PIP Framework could be brought under the IHRs and lose all benefit sharing, he said.

Review, Governance

Wairagkar of the Gates Foundation said they had just received the preliminary findings and had only initial comments. He said at the last meeting he asked the review group and the PIP secretariat to combine meetings and not to have morning and afternoon sessions. This week on Monday morning the review group met with member states, and in the afternoon stakeholders and member states were invited to provide comments on the findings in a webcast session.

According to Wairagkar, holding two sessions is not beneficial for all stakeholders. There needs to be transparency and interaction between member states and other stakeholders, he said. Holding two different sessions does not provide opportunity for fair dialogue between member states and stakeholders, he said.

The IFPMA suggested an external audit be conducted on the PIP Framework, which would be useful for different stakeholders, and for example would provide industry information on how their participation is used in terms of pandemic preparedness.

Tam said the review group did not have feedback from all member states about pandemic preparedness activities.