WHO Asked To Speed Up Exploration Of Including Flu Virus Information In Benefit Sharing Scheme

A hundred years ago, the Spanish flu infected a third of the world population, and killed more people than the two world wars combined. The World Health Organization is seeking to help the world prepare for the next pandemic, which they say, is only waiting to happen. The recent World Health Assembly agreed to ask the WHO to complete an analysis on the implications of including seasonal influenza virus and pandemic virus genetic information into its benefit-sharing mechanism to help the world face the next influenza pandemic.

Separately, the UN Convention on Biological Diversity (CBD) issued a study on how to handle virus genetic information, and voiced preference for publicly accessible databases for sharing this information, rather than public domain databases, as the latter raise issue of traceability of the information from originators and also from users. And a WHO official issued a call for WHO member states to become involved in activities of the CBD’s Nagoya Protocol on access and benefit-sharing to ensure health priorities are put before environmental priorities on genetic resources.

The 71st World Health Assembly (WHA) took place from 21-26 May.

Following a 2016 review of the WHO Pandemic Influenza Preparedness Framework (PIP), the 70th WHA last year adopted a decision [pdf] requesting the WHO to act on a number of recommendations from the review group.

No decision was taken however on the feasibility and the implications of two of the recommendations of the expert group. One was the inclusion in the PIP Framework of seasonal influenza viruses, and the other one on the inclusion and the management of genetic pandemic influenza viruses information (genetic sequence data – GSD) in the framework.

WHO Asked to Speed Up

Last week, a WHA draft decision foresaw that the WHO would provide an in-depth analysis of those two issues and to provide a first version at the 72nd WHA, followed by a final text at the 73rd WHA. However, following a request from Brazil, supported by countries such as Australia, Tanzania, the United States, and Thailand, the WHA decided that the final text of the analysis should be submitted to the 72nd WHA (2019).

Nigeria for the African Group noted the disparity between health systems and that Africa, despite its efforts, remains vulnerable to many public health threats, including influenza. The Nigerian delegate called for increased transparency and accountability in the global influenza response, and for the sustained engagement in exploring innovative treatments.

Indonesia suggested that the PIP extend the scope of its budget to cover activities to strengthen member state capacity, and include technology transfer for vaccine development. GSD needs to be recognised as a form of biological material under the PIP Framework, the delegate said. Thailand also underlined the importance of capacity building in vaccine production capacity in developing countries.

Brazil remarked on the relationship between the WHO and the Convention on Biological Diversity, in particular on the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization.

Botswana noted the need for continuous support of regulatory capacities in developing countries, and the need to address existing gaps in influenza surveillance. Burundi also called for support to build national capacity.

Thailand supported the extension of the PIP Framework to seasonal influenza viruses, and the inclusion of GSD as biological material. Thailand also supported the idea that the PIP Framework should become a special instrument of access and benefit-sharing under the Nagoya Protocol.

Japan remarked that careful consideration should be given to both issues, in particular because any measures taken should not hinder access to genetic information which could be available for research and development.

Peter Salama, WHO deputy director-general for Emergency Preparedness and Response, said the WHO Director General undertook a process to develop an analysis on seasonal influenza virus and GSD and consulted all stakeholders in November 2016 and an information session was held in April.

“We continue to work closely with the PIP Advisory Group, and the WHO GISRS [Global Influenza Surveillance and Response System] network to develop the analysis further,” he added.

CBD, Genetic Sequence Data, Scoping Study, WHO Fact Sheet Missing

The 2017 WHA decision also asked the WHO to consult with the secretariat of the CBD, which the secretariat said [pdf] it has been doing since the decision was adopted. At stake is the timely sharing of influenza viruses, which might be hindered by the rules of the Nagoya Protocol.

The April information session was focused on GISRS, and several fact sheets which were due to be published ahead of the session were missing and still are. A WHO source told Intellectual Property Watch that they would be published after the WHA. The missing fact sheets are on GISRS, on GSD and databases, and on new technologies.

GSD happens to be one of the prickly issues of the PIP Framework discussion, as more and more laboratories, researchers, and companies are using viruses’ genetic information, and not biological materials. This might allow users to circumvent the benefit sharing system of the PIP Framework. No agreement was found during the negotiations leading to the adoption of the PIP Framework in 2011 on whether or not to include GSD into the framework.

One of the recommendations of the PIP Advisory Group, instructed by the findings of a Technical Expert Working Group (TEWG), was to allow wider access to GSD by asking countries to share their virus genetic information with public domain databases or publicly accessible databases. Some member states have expressed concerns about the traceability of GSD shared with public domain database. The WHO GISRS currently mostly uses the Global Initiative on Sharing All Influenza Data (GISAID), which is a sharing mechanism that identifies users of the system through a database access agreement. GISAID celebrated its 10th anniversary during the WHA.

Separately, the CBD Conference of the Parties, also working on the issue of GSD as regards the Nagoya Protocol, asked the CBD secretariat to work on the issue and deliver a study. In January, the CBD issued a Fact-finding and scoping study [pdf] on digital sequence information on genetic resources in the context of the convention on biological diversity and the Nagoya Protocol.

According to the scoping study, public domain databases do not require a data access or user agreement, nor registration or log-in, in contrast with the identified user access required by GISAID and other specialised databases.

“Clearly in cases of certain virus and pathogens data, biosecurity concerns would suggest the need to not only identify contributors and users, but to track use, with the added benefit of allowing researchers to acknowledge and potentially collaborate with genetic sequences data providers,” it says.

GISAID was launched “in part as an alternative to public domain databases, so that data providers would have a choice in how they shared their data with the public,” the CBD said in the study. It added that “the arrangements of ‘conditional’ access used by GISAID might provide useful lessons and insight to ABS [access and benefit sharing] discussions.”

One of the solutions described by the PIP Advisory group to remedy the absence of traceability from public domain databases was to monitor use of GSD from commercial end products.

According to the CBD scoping study, “by working back from commercial products and utilization, the PIP Framework seeks to ensure benefit-sharing results from open-access regimes, but there are significant questions about how this will work in practice, and it is unlikely to be as effective as linking digital sequence information to provenance early in the research process.”

In November, the WHO commented [pdf] on the CBD scoping study and said, “WHO believes that DSI [Digital Sequence Information] from pathogens is a global public health good that should be widely available to all.”

The WHO also suggested that the CBD’s scoping study focus be broadened to include the emergence and growth of digital sequence information in research and development and public health.

WHO Official Urges Member States to Engage with UN Environment Agency

WHO’s Anne Huvos speaks at the Graduate Institute last month

On the eve of the WHA, the WHO’s Anne Huvos spoke to an audience at the Graduate Institute and described the pandemic flu framework, and talked about genetic resource access and benefit-sharing.

She talked about the framework’s achievements on access to vaccines, and partnership between member states, industry, civil society, “and other relevant stakeholders.”

Huvos described the framework as a way to share materials and provide access to “lifesaving” vaccines. Since concluding an agreement in 2011, the WHO has successfully signed legal binding contracts with all major flu vaccine manufacturers, she said. They have agreed to provide to WHO in the next influenza pandemic “in real time” about 10 percent of their pandemic vaccine production – which is equivalent to about 400 million doses of vaccine.

“This is something that is quite new for WHO,” she said.

At the same time they negotiated access to antiviral treatments, Huvos said, some 10 million doses and about 250,000 kits.

For perspective, she said to look back at 2009, the last pandemic. At that time, WHO had about 110 million doses of vaccine. So through the PIP framework, said Huvos, WHO has “significantly increased the prospect of fairness and equity” for the next pandemic.

She noted that an expert group looked at the first 5 years of the framework and worked over a year, coming up with 36 recommendations to the director general.

One of the changes they noted since the start of the framework was the adoption of the Nagoya on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity.

Later this year there will be a number of meetings in the context of Nagoya and CBD, Huvos said, and she encouraged WHO members to become involved in order to ensure that health is at the forefront of considerations at the environmental agency.

In July there will be meetings of a subsidiary body on implementation, and a subsidiary body on science and technology, she said. Then there will be the Conference of Parties in November.

“WHO would encourage all member states who plan to attend those … to really coordinate amongst themselves, and by that we mean that the health sector and the environment sector really start talking and take an active approach to health, so that the implications for public health are prioritised in those discussions,” she said.

She referred to a paper developed last year by the WHO secretariat on the potential health implications of the Nagoya Protocol.

Separately, Huvos was asked whether the WHO secretariat has a mandate from its member states to press the CBD on these issues. She explained again the need to emphasise the health aspect of access and benefit-sharing, and also stressed that there is a high level of transparency around the Pandemic Influenza Framework.

 

Image Credits: William New.

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