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The World Health Organization mechanism to prepare the world for the next influenza pandemic is pondering its future and possible improvements. Among them are its extension to seasonal influenza, and the inclusion of genetic virus information along with biological samples to keep pace with technological developments. Member states and stakeholders (except the media) have been invited by the WHO to a consultation next month to discuss an analysis showing the potential beneficial or deleterious effects of the suggested changes to the system.

The 2011 Pandemic Influenza Preparedness (PIP) Framework was reviewed in 2016 and the PIP Framework Review Group provided a number of suggestions to better the system, two of which will be examined by member states and stakeholders on 6-7 November.

The consultation has been organised by the World Health Organization in particular to “harvest views” on a scoping paper drafted by the secretariat to facilitate discussions, according to the WHO. The scoping paper provides an analysis of possible scenarios with their opportunities, such as an increased effectiveness of the global influenza prevention and surveillance, and extending the benefit sharing mechanism of the system to more contributors. The paper also illustrates challenges and potential implications including an increased complexity, heightened burden of work for the system and for the global influenza surveillance system, and the departure from the system’s core mission.

The agenda of the meeting is here.

A guide to the consultations has been published by the WHO detailing the timeline of those consultations. The first phase of the process included the development of the scoping paper from June to October.

Following the 6-7 November consultation, the PIP Advisory Group will meet on 8-10 November. The group monitors the implementation of the PIP Framework, and provides “evidence-based reporting”, assessment and recommendations regarding its functioning.

Extension to Seasonal Viruses, Nagoya Protocol Issue

Concerning the extension of the PIP Framework to cover seasonal influenza, the scoping document lists three approaches. The first is the expansion of the framework to include seasonal influenza viruses.

The second one envisages keeping the PIP Framework as it is, and that national access and benefit-sharing regimes 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 apply to the sharing of seasonal influenza viruses.

The third approach would be to develop or adapt another instrument to cover seasonal influenza viruses, with a view to that instrument being recognised as a special international instrument under the Nagoya Protocol.

The paper says that expanding the framework to seasonal influenza viruses will increase the workload of the Global Influenza Surveillance and Response System (GISRS), would be costly and resource intensive. Overloading the GISRS network and the increased complexity associated with tracing seasonal influenza virus sharing could potentially impact laboratories’ capacity to share influenza viruses in a timely manner, it says.

Also, the extension might promote seasonal influenza prevention and control, the paper said, but it found that it might distract the PIP Framework from its health emergency focus. And if the extension increased the number of benefit-sharing contributors under the framework, it would increase the workload of the WHO secretariat, the paper said.

If the PIP Framework were to be considered as a special international instrument under the Nagoya Protocol, it would allow the framework to stay focused on pandemic influenza, and would avoid re-opening the text of the framework, according to the paper. It might, however, create legal complexity, and significantly increase the workload of GISRS due to additional negotiations and administrative requirements with potential negative impact on the timelines of seasonal preparedness, it said.

In the case of another instrument being developed, it might address the possible delay of the Nagoya Protocol on the sharing of seasonal flu viruses, but might lead to added complexity and duplication of work, the paper found. Negotiating a new instrument or adapt a current one would be complex, it adds.

How to Deal With Virus Genetic Material Information?

Genetic sequence data (GSD) contain the genetic information that determines the biological characteristics of an organism or a virus. The scoping paper looked at some recommendations of the PIP Review Group. One of them is the possible amendment of the definition of the PIP biological materials to include GSD.

Another one is to change the language of Annex 4, section 9 of the framework, on the way countries might share their GSD. Annex 4 deals with the “Guiding Principles for the development of Terms of Reference for current and potential future WHO global influenza surveillance and response system (GISRS) laboratories for H5N1 and other human pandemic influenza viruses.”

GSD is increasingly being used instead of physical material for pandemic risk assessment and the development of commercial products, according to the paper.

GSD of influenza viruses, whether seasonal or with pandemic potential, is generated by GISRS laboratories and other laboratories, which upload influenza GSD to databases or share it by other means, the paper says, adding that most GISRS laboratories currently use the GISAID EpiFlu database.

GSD was not explicitly included in the PIP Framework, leaving the door open for further discussions.

As presented in the paper, “technical, motivational, economic, political, legal and other considerations affect the speed, breadth and comprehensiveness of data sharing.”

“It is important that influenza virus genetic sequence data remain publicly accessible in sustainable databases, to enable timely, accurate and accessible sharing of these data,” says the paper, adding that amending the PIP Framework could help address some of these challenges to data sharing and could promote sharing.

The sharing of GSD might not be easily trackable, according to the paper. However, monitoring all access to GSD “is unlikely to be feasible and could result in significant workload for laboratories and/or the WHO,” it says, suggesting that mechanisms related to monitoring products generated using GSD, rather than by monitoring use of GSD, might be a solution.

The PIP Advisory Group will discuss how to take forward its work on GSD, taking into account the discussions and outcomes of the consultations of 6-7 November, according to the scoping paper.

Nagoya Protocol Ponders GSD

GSD are not expressly included in the scope of the Nagoya Protocol. The issue of “digital sequence information on genetic resources,” was examined in December 2016 by both the Conference of the Parties to the Convention on Biological Diversity (CBD), and the Conference of the Parties serving as the meeting of the Parties to the Nagoya Protoco,l and decisions were issued.

Notably, an Ad Hoc Technical Expert Group (AHTEG) has been established at the CBD to examine potential implications of the use of digital sequence information on genetic resources for the CBD and for the Nagoya Protocol.

The AHTEG is expected to deliver its outcomes for consideration by the Subsidiary Body on Scientific, Technical and Technological Advice, which will then make a recommendation to be considered by the next Conferences of Parties of the CBD and Nagoya Protocol in November 2018.

According to the scoping paper, the outcome of discussions on digital sequence information in the context of the Nagoya Protocol and the CBD “may have an impact on the sharing of influenza GSD,” adding, “The outcome may also impact the handling of other human pathogens and potentially hinder response during a public health emergency.”

IP Rights Impact Risk of Open Publication

In most jurisdictions, says the scoping paper, naturally occurring influenza GSD would not be considered patentable subject matter. However, innovations from the development of influenza-related products could be protected if they meet patentability requirements.

“The early, open publication of gene sequences of newly isolated influenza viruses may preclude obtaining patent protection for the genes as published,” according to the paper, which adds that several publicly accessible influenza viruses with pandemic potential (IVPP) sequences have been claimed as part of patents. Early publication of genetic material of potential pandemic viruses may affect patentability by placing sequences in the public domain, the paper says.

Benefit-Sharing for GSD to be Devised

Under the PIP Framework, access to GSD does not trigger a requirement to sign a standard material transfer agreement (SMTA2) with the WHO, which is a benefit-sharing mechanism through which manufacturers and research institutions that receive PIP biological material share with WHO some of the benefits arising from their access to these materials.

According to the scoping paper, the inclusion of GSD in the definition of PIP biological material would require determining an appropriate benefit-sharing system, including the trigger for benefit-sharing and the types of benefits that could be shared.

Benefit-sharing from GSD “would protect WHO’s access to pandemic influenza products or technologies generated using GSD in the event of a pandemic,” the paper found. Including GSD in the definition of PIP biological material would “allow maintaining an equal footing between data sharing and benefit sharing under the Framework and maintain relevance of the Framework,” it says.

The paper also says that because a larger number of laboratories access GSD than PIP biological materials, the inclusion of GSD in the definition of the PIP biological material could increase the number of benefit-sharing contributors leading to an increased workload for the WHO secretariat.

As a “considerably larger proportion” of laboratories make no profitable use of GSD, there is a risk that a broad pursuit of SMTA2 in this segment will constitute a large financial cost compared to the benefits solicited, the paper says.

Background

At the World Health Assembly in May, the suggestions to extend the WHO Pandemic Influenza Preparedness (PIP) Framework to seasonal influenza, and to amend the framework language on virus genetic material information, were met with concerns from member states, who required a thorough analysis of the potential consequences of those suggestions  (IPW, WHO, 26 May 2017).

This is when member states requested a thorough analysis.

The analysis should include a transparent consultation of member states and relevant stakeholders, including the Global Influenza Surveillance and Response System (GISRS), according to the WHA decision.