Virus Genetic Information Hot Topic At WHO; Flu Framework Under Nagoya Needs More Time 29/01/2017 by Catherine Saez, Intellectual Property Watch 5 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)World Health Organization members decided more consideration is needed to address the genetic information of flu viruses in the organisation’s pandemic framework, and the suggestion to have the framework considered as a special instrument under the Nagoya Protocol on access and benefit sharing of genetic resources. The idea of including seasonal viruses under the framework was also discussed, with many countries showing reluctance. Separately, the WHO said the sharing of virus biological material is declining while an independent sharing mechanism of virus genetic information used in particular by the WHO Global Influenza Surveillance and Response System (GISRS) says the sharing is on the rise, which might be a signal that countries are using GSD more than biological materials. The WHO Executive Board (EB) is meeting from 23 January to 1 February. Member states this week considered the Review [pdf] of the Pandemic Influenza Preparedness Framework, and a report [pdf] on the public health implications of the implementation 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. The 2011 Pandemic Influenza Preparedness (PIP) Framework includes a review requirement after five years and an independent Review Group was established to look into the progress made by the framework, the challenges to be addressed, and provide recommendations. William Ampofo, head of the virology department of the Noguchi Memorial Institute for Medical Research at the University of Ghana, member of the PIP Framework Review Group presented the PIP Framework as a success story and summarised the main recommendations of the group. In particular, he mentioned the treatment under the framework of genetic sequence data (GSD), which is genetic information about viruses. Most well-equipped laboratories can reproduce any virus if they can get the virus genetic sequence data, according to scientific sources. The Review Group suggested rewording the text of the framework so that the definition of biological material is extended to include GSD, and to give member states the choice of the databases in which they would like to deposit their GSD. Another key recommendation of the Review Group sought to address the potential delaying effect on the sharing of pathogens created by the implementation of the Nagoya Protocol. The group proposed that the PIP Framework be recognised as a specialised instrument of Access and Benefit Sharing under the Nagoya Protocol, to speed up the sharing of pathogens. The question of GSD, which could not be solved during the negotiations leading to the adoption of the PIP Framework in 2011, was recognised today by member states as a difficult question to be pondered with care. While Thailand, for example, readily agreed to the framework amendment to include GSD, other countries, such as Russia, called for caution and the need for broad discussions on the subject. The United States said it does not support redefining the biological material to include GSD. “It is essential to maintain a conceptual definitional distinction between PIP biological material itself and data about that material” the delegate said. The US asked for the PIP Framework Advisory Group, which monitors the PIP Framework to complete an ongoing assessment of how GSD might be handled under the PIP Framework before member states make any decisions. The delegate added that clear relationships should be established with nongovernmental databases that receive such data. Finland also said that the proposal to amend the PIP Framework has “pros and cons.” “One could ask whether it is realistic to limit free access and mobility of GSD, including through open gene banks,” the delegate said. Germany Defends EpiFlu Database for GSD Germany, meanwhile, said it welcomes “most recommendations of the PIP Review Group without reservation.” However, “development of additional process measures to better monitor key areas might further accelerate the framework implementation and would allow for greater clarity and progress,” the delegate said. Germany, which hosts a key database in the process said it noted the recommendation of the review group on amending the definition of biological materials to include GSD. The German delegate said, “We recommend that any decision on this amendment should be done through a continued analytic and consultative process. Potential consequences of amending this definition must be well assessed, including the risk of delaying GSD sharing.” “Further clarity is needed on realistic approaches to monitor the use of GSD and on models to share benefits for the use of GSD,” she said, adding “we would like to refer to the already well established and widely used sharing mechanism of influenza viruses from GISAID [the Global Initiative on the Sharing All Influenza Data]. This sharing mechanism is applied to GSDs uploaded in EpiFlu, which allows the traceability of GSDs.” GISAID was launched during the 61st World Health Assembly in May 2008. GISAID’s EpiFlu database, hosted by the government of Germany, is, according to the WHO Collaborating Centre for Reference and Research on Influenza (VIDRL) the most comprehensive database of flu viruses genetic sequence data (IPW, Public Health, 26 August 2016). “Germany will maintain its commitment to global influenza preparedness and to the PIP Framework. One important pillar of this commitment is our partnership with GISAID. We will continue to host the database EpiFlu, an important tool for sharing GSD in the spirit of the PIP Framework ensuring fair, timely, and transparent sharing of GSD in a sustainable way,” she said. Divergent Views on PIP Extension to Seasonal Flu, Nagoya Protocol Many countries warned about unintended consequences to extending the PIP Framework to seasonal flu virus. The US called for a “thorough and thoughtful assessment of the implications and desirability of including seasonal influenza viruses under the PIP Framework,” which would have operational implications. “We would not consider the Nagoya Protocol to be applicable to influenza viruses with pandemic potential,” the delegate said, adding, “We believe these issues falls within the public health community remit.” Germany also said the current scope of the PIP Framework should remain the pandemic influenza at this time. A number of countries called for the WHO to continue discussing with the CBD. Brazil said discussions must be held by CBD member states on the issue. CBD Confirms Close Contact with WHO According to a CBD source, the CBD is in close contact with the WHO. “During the recent UN Biodiversity Conference in Cancun, Mexico, in December 2016, linkages between the WHO, the CBD and the Nagoya Protocol were addressed by the thirteenth meeting of the Conference of the Parties (COP 13) and the second meeting of the Conference of the Parties serving as the meeting of the Parties to the Nagoya Protocol (COP-MOP 2),” the source said. The CDB Executive Secretary was requested in particular to “Conduct a study into criteria that could be used to identify what constitutes a specialized international access and benefit-sharing instrument in the context of Article 4(4) of the Nagoya Protocol and what could be a possible process for recognizing such an instrument.” “This study is to be submitted for the consideration of the second meeting of the Subsidiary Body on Implementation and the third meeting of the COP-MOP, both of which will be held in 2018,” the source said. Decline of Virus Sharing, WHO Says, GSD sharing on the Rise The Review Group underlined in its report the decline of virus biological material sharing, and a number of member states requested an analysis of the problem. “Given the recent and startling decline of the sharing of influenza viruses with human pandemic potential, we encourage the WHO and the WHO Collaborating Centers to provide documents providing greater clarity and guidance on virus sharing, in particular novel viruses, the US said. The secretariat said it would explore the reason for the decline of the sharing, and recognised that further discussions are required in particular on how to handle GSD and the potential extension of the framework to include seasonal flu viruses. According to Alan Hay, Scientific Liaison Officer at GISAID, “there is a continuing increase in virus data submitted to GISAID’s EpiFlu™ database which is commensurate, for example, with recent reports of human cases of H7N9 and H5N6 influenza in Asia, and avian H5N8 outbreaks in Europe. These data are shared in a very timely manner, often within one to two weeks.” “Technological advances and the rapid sharing of the genetic properties of the viruses complements the sharing of actual virus samples,” he told Intellectual Property Watch. Hay added that “At the start of H7N9 outbreak in 2013, GISAID proposed a concrete mechanism to the WHO and its PIP Advisory Group to facilitate the link between the sharing of GSD and benefit sharing under the PIP Framework. The Reports by the PIP AG and Review Group do not reflect this and the WHO has yet to take advantage of this facility,” he said. Decision on Partnership Contribution Postponed to 2018 The Board this week adopted a decision [pdf] to postpone decision on the private sector’s partnership contributions to the framework to 28 February 2018. Member states have to decide which proportion of the partnership contributions should be reserved for inter-pandemic preparedness measures, and which proportion should be reserved for response activities in the event of a pandemic. The partnership contributions are one element of the PIP Benefit Sharing System, and is an annual contribution to WHO by influenza vaccine, diagnostic, and pharmaceutical manufacturers who use the GISRS. 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