WHO Flu Pandemic Framework Working, Group Says; Some Concerned 30/08/2016 by Catherine Saez, Intellectual Property Watch 3 Comments Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)A World Health Organization framework to respond to influenza pandemics is working successfully, the confidential draft report of a review team has found. But some areas, such as virus genetic information, still need more work. Stakeholders, meanwhile, are challenging some findings and a concern was raised that lawyers may be influencing the science behind decisions on this issue. Theresa Tam, deputy chief public health officer of the Public Health Agency of Canada, chairing the PIP Review Group yesterday In its preliminary findings, the group tasked to review a 2011 WHO instrument adopted to help the world be better prepared for future flu pandemics applauded the progress made by the mechanism and called for the contributions to the mechanisms, such as that country contributions should be more visibly recognised. Meanwhile some issues remain, such as how to address virus genetic information under the mechanism to make sure to identify users of that information. Preliminary findings of the review dated from 19 August were discussed in a closed yet publicly webcast session on 29 August with member states, industry, civil society and other stakeholders. The experts reviewing the WHO Pandemic Influenza Preparedness (PIP) Framework are expected to deliver their report in mid-October and are holding their last face-to-face meeting from 29 August to 2 September, in a meeting closed to stakeholders after the first day. The 29 August webcast session was organised to allow 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. Many of the comments during the public webcast referred specifically to the preliminary findings which nevertheless were not available to anyone following the webcast other than authorised stakeholders. Theresa Tam, deputy chief public health officer of the Public Health Agency of Canada, chaired the 29 August session, in the absence of the Review Group chair, Christine Mwelwa Kaseba-Sata of Zambia. Genetic Sequence Data The 19 August preliminary findings were generally positive. They said the PIP Framework has improved global influenza pandemic preparedness through implementation of its benefit-sharing mechanism, and enabled WHO to successfully secure access to vaccines and antiviral in the event of an influenza pandemic. But the findings raised concern about genetic sequence data (GSD), which are data containing the virus genetic information, can in some cases substitute for physical samples for pandemic risk assessment and the development of commercial products. This assessment is in contradiction to some scientific information which state that GSD and biological samples are interchangeable, as some laboratories can engineer a virus from GSD, and thus manufacture a vaccine. According to the WHO secretariat, it is important to define what would trigger a partnership contribution when a virus GSD is accessed. For biological material, use of the Global Influenza Surveillance and Response System (GISRS) by manufacturers is what triggers partnership contribution from users. That access is self-assessed by manufacturers, the secretariat said. The GISRS monitors the evolution of influenza viruses and serves as a global alert mechanism for the emergence of influenza viruses with pandemic potential, according to the WHO. Access to GSD does not trigger anything under the PIP Framework, and unless a trigger is defined, there might not be any benefit sharing. The issue of GSD could not be solved at the time of the PIP Framework discussions, the WHO representative said, adding that several options are considered by the review group to address that gap in the framework. Findings: Don’t Monitor Access, Just Track Commercial Products The preliminary findings state that monitoring all access to GSD may not be feasible “given the many public and private ways of sharing and accessing GSD” The review group also found that “…given that GSD can be shared easily through private means that are not recorded anywhere (e.g. email), if GSD benefit sharing is to be based on tracking of access to GSD, it would not be feasible to ensure fairness and equity in benefit sharing; concerns over free-riders simply could not be addressed.” The document also states that “monitoring all access to GSD would have significant consequences in terms of workload for the WHO PIP Framework Secretariat, without necessarily leading to a substantial increase in benefit sharing.” The group found instead that monitoring use in commercial end-products would be feasible using “an appropriate search engine,” and that tracking commercial products, rather than access to GSD, would be practicable, achievable and cost-effective, to best achieve the goals of access and benefit-sharing. Tam said the review group was not seeking to duplicate the work of the PIP Framework Advisory Group on GSD. The PIP Advisory Group monitors the implementation of the PIP Framework and provides assessment and recommendation regarding its functioning. The Review Group is an independent group of experts tasked with reviewing the framework. Findings Challenged Brazil said the country has “great concern” that if no clarity is provided on what would trigger benefit sharing in case of access to GSD, “in five years’ time, at the next review, we will be closing this mechanism,” given the speed of technological development. The Brazilian delegate called for an evidence-based discussion on a credible way of following and tracking access to GSD. Edward Hammond of the Third World Network (TWN) said he disagreed on the finding about tracking GSD, “we don’t think the WHO is hostage to the different ways that genetic sequence data is shared but WHO should play the role of shaping how genetic sequence data is shared.” Hammond said the TWN favours databases with user agreements. The Review Group found that changing the definition of the PIP Biological Materials to include GSD would require substantive amendments to the existing text, and suggested that an annex be created to Article 6 of the PIP Framework (Pandemic influenza preparedness benefit sharing system) to include GSD. This finding was challenged by the TWN. Hammond said Article 6 only deals with benefit-sharing but not about access and said it is not really possible for the PIP Review Group to say that amending the definition of biological materials is impossible. The suggestion should be replaced by something saying that GSD may be resolved by clarifying the PIP biological material, he said. Niteen Wairagkar from the Bill and Melinda Gates Foundation said viruses do not have to be physically shared to develop vaccines. But he asked how to make sure that the use of GSD in public databases or any database to manufacture a vaccine is going to lead to any benefit sharing. He suggested exploring the possibility of using the WHO Influenza Virus Traceability Mechanism to track GSD. This suggestion was agreed upon by Hammond who also cited the GISAID Initiative database as an example of a publicly accessible database with a user agreement. GISAID: Countries Might Be Stripped of Choice Peter Bogner, speaking on behalf of the GISAID Initiative, remarked in the session that the PIP Framework gives member states the choice of how they want to share their viruses, either through publicly accessible database with a user agreement, such as GISAID, or with public domain databases. GISAID has provided and continues to provide an alternative through which countries are more comfortable sharing their data, he said (IPW, Public Health, 26 August 2016). GISAID is concerned about a recommendation made this year at the World Health Assembly [by the PIP Advisory Group], calling for a redundancy of data-sharing systems for pandemic influenza GSD, and the suggestion that data held in GISAID database also be shared “somewhere else,” he said If there is a possibility to establish a very complex search engine to look at who has developed medical interventions and make money from it, how will they be approached? he asked. What “stick” is there to make them comply and take part in the partnership contribution, he added. “There is not a single country, including Switzerland, host to WHO headquarters, that does not deposit their data in GISAID,” he argued. The biggest question for the Review Group is the question of governance, he said. There is concern that “we might find a scenario where the initiative of GISAID is being redefined in all the [WHO] documentation and reduced to a database versus as sharing mechanism that is used by all member states….” Are Lawyers Upstaging Science at WHO? GISAID has tried to engage with the PIP Secretariat and the PIP Advisory Group, and provided information on the possibility to track the access of GSD in the GISAID database, but without luck, Bogner told the meeting. “We are dismayed that discussions are led in a legal context when this is all about public health, and you would hope that you have a scientist leading these discussions,” he said. He criticised the “legal team of the PIP secretariat that is, for better or for worse, the ones who decide who joins what meeting and who joins which working group and who does not.” Comments were also made on preliminary findings regarding the expansion of the system to seasonal flu viruses; the linkages with 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; and benefit-sharing. These issues will be addressed in a story to follow. 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