Industry Contributions, Benefit Sharing, Virus Genetic Data Discussed By WHO Flu Experts 21/10/2016 by Catherine Saez, Intellectual Property Watch 1 Comment 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)The group of experts tasked to monitor the World Health Organization pandemic influenza framework met this week with discussions on the partnership contributions that industry is expected to provide to the system, and how influenza viruses’ genetic sequence data should be handled in the context of the framework. WHO headquarters, Geneva The WHO Pandemic Influenza Preparedness (PIP) Framework Advisory Group met behind closed doors from 18-21 October. The Advisory Group monitors the implementation of the PIP Framework, and provides assessment and recommendations regarding its functioning. Although the agenda of the meeting was not publicly available, according to the Advisory Group Chair Jarbas Barbosa da Silva, director-president of the Brazilian Health Regulatory Agency (ANVISA), the group discussed partnership contributions from industry, and how to handle pandemic flu virus genetic sequence data (GSD) in the PIP Framework. Genetic sequence data contain the genetic information that determines the biological characteristics of an organism or a virus. Partnership Contribution/Benefit Sharing The Partnership Contribution is one element of the PIP Benefit Sharing System. It is an annual cash contribution to WHO by influenza vaccine, diagnostic and pharmaceutical manufacturers who use the WHO Global Influenza Surveillance and Response System (GISRS), according to the WHO. “Every year WHO issues a questionnaire that identifies potential contributors. It is distributed to existing contributors, to all companies and institutions that conduct research and development in the field of influenza, and to all recipients of PIP biological material recorded in the Influenza Virus Traceability Mechanism (IVTM) database,” states the WHO website. Barbosa told Intellectual Property Watch today that in their meetings, the members of the Advisory Group receive information from the secretariat about the partnership contributions. At the inception of the framework, he said, there was an estimation of the running costs of the GISRS and it was foreseen that the partnership contribution would cover 50 percent of those running costs. “It has been accomplished,” he said. The PIP Framework is a unique mechanism providing benefit-sharing, he said, adding that “we always highlight to the industry that their commitment is very important because the partnership is fundamental if you want to strengthen the capacity to have early warnings of a new pandemic virus.” “We are now moving to other fields than vaccines and medicines,” in which there are a relatively small number of stakeholders, to the field of diagnostic kits and products in which there are maybe thousands of stakeholders, he said. This is a challenge, he added. The benefit-sharing system of the PIP Framework includes the industry partnership contribution and benefit-sharing through standard material transfer agreements (SMTA2) by which manufacturers and research institutions that receive PIP biological material share some of the benefits arising from their access to the material with the WHO. Members of the Advisory Group also receive reports from the secretariat on agreements that have been signed by industry, Barbosa said, adding, “this is not an easy task, because the secretariat needs to negotiate case by case, because each agreement is different, because the recipient of the material can choose from a list of options what their contribution [to benefit-sharing] will be.” The number of agreements is increasing, he said, and it is a good sign of an acceptance from industry that they need to sign the agreement and to make clear what kind of contribution they will make in case of a pandemic. Handling of GSD The PIP Advisory Group has been discussing since 2013 on how to handle genetic sequence data (GSD) inside of the PIP Framework. In particular, how to make sure that manufacturers or research institutions accessing GSD of pandemic viruses will also contribute to the benefit-sharing system of the PIP Framework. “It is very clear that GSD are also part of the virus sharing [system], but we need to adapt the procedures to this new technology,” Barbosa said. “There is no doubt that the PIP Framework also covers products made using GSD influenza virus, because the information is coming from a real virus biological material” that was collected and analysed in a laboratory that is part of GISRS, he added. Now clear guidance is needed about responsibilities: who is using the GSD, not for scientific articles, but to develop a vaccine, medicine or a diagnostic kit. Responsibilities are the same as when biological materials are accessed, he said. Technical guidelines for GSD are expected to be issued in 2017, he clarified. Why Advisory Group Meetings Are Private According to Steven Salomon, principal legal officer of WHO, the reason why the meetings of the Advisory Group are private is because that is consistent practice with such advisory groups of WHO. The aim of those private meetings is to foster the fullest possible exchange of ideas, “and our experience is that keeping these meetings of independent experts private does foster those ideas.” However, he added, transparency is important for public understanding. Barbosa told Intellectual Property Watch that consistent with WHO transparency policy, the Advisory Group is considering how to be more informative. “We are discussing with the secretariat and the Director General” so that a press release can be available, he said. The PIP Advisory Group regularly holds consultation sessions with stakeholders, and has an information session after each meeting to which stakeholders are invited, but not the press. 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