Special Report: WHO Advisory Group On Flu Preparedness Hears Comments, Addresses New Genetics Issue

World Health Organization members and stakeholders were invited to provide comments this month on the organisation’s framework to spur preparedness for future influenza pandemics and ensure treatments will reach developing countries. The framework is expected to undergo a review in 2016. The advisory group to the initiative also went through issues such as contributions by manufacturers, and how to deal with genetic sequence data.

The Pandemic Influenza Preparedness Framework (PIP Framework) Advisory Group met from 15-16 October, with a special session taking place on 13-14 October. All of the meetings were entirely closed to the press.

The special session of the PIP Framework Advisory Group was to invite member states and other stakeholders to share views on the PIP Framework, as noted in the draft agenda [pdf].

According to the framework [pdf], the PIP Framework is expected to be reviewed by 2016 “with a view to proposing revisions reflecting developments as appropriate, to the World Health Assembly in 2017, through the Executive Board.” The Executive Board meets in January and the annual Health Assembly is held in May.

William Ampofo, chair of the PIP Framework Advisory Group and senior research fellow and head of Virology at the Noguchi Memorial Institute for Medical Research of the University of Ghana, told Intellectual Property Watch that the special session was an interaction with member states and other stakeholders.

It was convened to discuss the review of the PIP Framework, he said, and some suggestions were made by member states and other stakeholders on the scope of the review. The advisory group considered those suggestions and advised the WHO director general to consider the suggestions for an independent, transparent process, and that the review be conducted according to the objectives of the framework, which is to ensure that benefits are shared with all member states that contribute viruses, he added.

“We expect that the Director General will draft the terms of reference of the review and will discuss it with member states at the Executive Board,” he said. Because the deadline for completion for the review is October 2016, we expect full interaction with member states and other stakeholders during this transparent review of the PIP Framework, according to Ampofo.

Benefit Sharing: Transfer Agreements

The benefit sharing mechanism of the framework is two-pronged: the first is the standard material transfer agreement (SMTA 2); and the partnership contribution.

The regular session of the advisory group addressed the status of SMTA2, which refers to a contract between manufacturers and research institutions that receive biological material from the WHO Global Influenza Surveillance and Response System (GISRS), to ensure the manufacturers or research institutions will share with WHO some of the benefits arising from this access. Benefit can include pandemic influenza vaccines, antiviral medicines or other pandemic-related products or technologies.

According to a briefing note [pdf] for the special session, since the adoption of the PIP Framework, 29 agreements were signed with academic institutions, “several of which have indicated their willingness to provide training as a form of benefit-sharing,” according to the briefing note.

According to the WHO, three SMTA 2’s have been signed with manufacturers (Glaxo Group Limited, Sanofi Pasteur, and Serum Institute of India).

Discussions and negotiations are ongoing with several manufacturers, including five Japanese vaccine manufacturers, and 12 manufacturers of other products, says the note.

The process met several challenges, including the novelty of the undertaking, the lack of awareness of the PIP Framework and its objectives, the lack of understanding about prequalification and other requirements for donation or sale of vaccine, medicines and other products to WHO, according to the note.

Partnership Contributions

The partnership contribution is an annual contribution to WHO from flu vaccine, pharmaceutical and diagnostic manufacturers which use the GISRS. According to the briefing note, for the period 2012-2016, 70 percent of the contributions should go to preparedness and 30 percent to response. This repartition might be revised by the review committee that will be set up to review the framework, Ampofo said.

According to Ampofo, the group was satisfied with the progress on the partnership contribution. “We appreciate the efforts by the associations of industry and their constant engagement with the WHO secretariat. The advisory group recommended that the secretariat continue the efforts to make sure the partnership contribution is made and reach out to industry to explain how the contribution will be used in accordance with the requirements that were developed,” he told Intellectual Property Watch.

According to the WHO, as of 1 April 2015, the WHO received US$ 25,925,690 from 30 contributors.

“The process and formula to identify companies and divide the annual payment among them, was developed in close consultation with manufacturers during 2012 and completed in May 2013. In a show of good faith and support for the Framework, many companies voluntarily paid a contribution in 2012 to enable it to start as required under the Framework,” said the briefing note.

Some companies found it difficult to pay contributions in a single payment, the note said, and “following guidance from the AG, the PIP Secretariat has given companies the option of paying in instalments.”

To improve understanding of the PC collection process, a new explanatory video was developed in 2015 and is available in all six WHO languages, according to the note,

Hot Issue: Genetic Sequence Data, Benefit Sharing, IP Issues

The session also addressed the issue of genetic sequence data (GSD). Recent development of synthetic biology technologies allows the production of flu candidate vaccine viruses using only genetic sequence data. This raises issues in respect of benefit sharing under the PIP Framework.

According to Ampofo, the advisory group was required to advise the director general on the best process to handle GSD.

The advisory group has set up two technical working groups. The first one concluded its work and submitted a report [pdf], he said. A second working group was appointed to look into the issue of optimal process for monitoring GSD.

The second working group is still work in progress and “we are expecting the working group will provide a report by February 2016 so that the advisory group can look into it in details during its next meeting in April,” he said.

According to the briefing note, GSD is covered by the PIP Framework but its handling remains unresolved.

“Several laboratories are now able to synthesize influenza candidate vaccine viruses, and influenza virus proteins or antibodies using only GSD,” said the report of the technical working group. It also states that since an increasing number of vaccine manufacturers are using GSD as an alternative to conventional whole virus approaches, “there is an increasing utilisation of genetic information for the generation of clinically relevant vaccines and other therapeutic developments.”

GSD can be accessed from various sources including electronic databases, the report said, specifying that, “Some of these databases could require, as a condition of access to the data, that the user contact the provider of the data if use of the data will lead to a product that can be commercialized.”

However, “whether GSD or products of GSD can be subject to intellectual property protections is dependent on the laws of the country in which the intellectual property rights are sought and will therefore vary between WHO Member States,” the report said, adding that in most jurisdictions GSD might not be patentable.

The PIP Framework does not specifically address issues relating to the management of intellectual property rights, the report says. However, SMTA 1, which refers to transfer of PIP biological materials within the WHO GISRS “provides that ‘Neither the provider nor the recipient should seek to obtain any intellectual property rights (IPRs) on the Materials.’”

“Thus, the clear intent of SMTA 1 is to prevent the patenting of PIP biological material within GISRS; the same condition should apply to GSD in cases where protection over such data were available under the applicable law,” the report said.

Moreover, in most jurisdictions, “influenza GSD would not be considered patentable subject matter. However, innovations from the development of influenza-related products could be protected if the patentability requirements, as applied in the countries where protection is sought, are met. This may lead to a complex IP environment for vaccines and other products using GSD and synthetic DNA.”

An additional issue is that GSD of PIP biological material can also be generated by non-GISRS laboratories, and “in that case, WHO will likely not know of this, and the sharing of such will be more difficult to monitor.”

Global Action Plan for Vaccines

The Global Action Plan for Vaccines (GAP) is a WHO initiative aimed at increasing pandemic vaccines production capacity.

According to the briefing note, manufacturing capacity has increased from 500 million doses in 2006 to 1,503 million doses a year in 2013 and is anticipated to expand to at least 1700 million doses by 2016. The GAP is expected to close in 2016.

“We are aware that the GAP will close in 2016 and the issue will probably be discussed at the next WHA to find a consensus among member states on the way forward,” said Ampofo.

A set of draft recommendations on all issues in the agenda by the advisory group is being finalised and is expected to be transmitted to the director general in a couple of weeks, according to Ampofo.

Background

The Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access vaccines and other benefits (the PIP Framework) was adopted by the World Health Assembly in May 2011. The PIP Framework aims to facilitate the sharing of flu viruses with human pandemic potential with WHO’s Global influenza Surveillance & Response System (GISRS), and the access to vaccines and sharing of other benefits.

The advisory group monitors and evaluates implementation. In formulating its advice to the director general, the advisory group interacts with industry and other stakeholders. It consists of 18 members, drawn from three member states in each WHO region, with a skill mix of internationally recognized policymakers, public health experts and technical experts in the field of influenza, according to the WHO.

 

Image Credits: FLickr – Sanofi Pasteur