WHO Board Sceptical On Changes To Global Flu Framework, Sends Issue To WHA 04/02/2019 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)The World Health Organization Executive Board last week remained uncertain on the way forward on questions of access to influenza viruses as countries are increasingly implementing an international protocol regulating the sharing of genetic resources. The Board requested informal discussions be held in the lead-up to the annual World Health Assembly in May. Influenza virus Another question relates to ways to avoid companies or entities potentially trying to evade the benefit-sharing system of the WHO Pandemic Influenza Preparedness (PIP) Framework by making indirect use of PIP Framework biological materials. Also in question is whether the language of the framework should be amended to include virus genetic information, and whether the framework should include seasonal influenza virus. In a resolution [pdf] last week, Board members decided to let the World Health Assembly in May discuss and agree on the draft decision contained in the Board document [pdf] including diverse amendments introduced last week by the European Union and the United States, and marked as such in the text. Nagoya Protocol Spreading, WHO Concerns on Sharing The UN’s 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 came into force on 12 October 2014. As more countries (now 114) became parties to the protocol and are implementing it, some concerns were raised at the WHO about the protocol potentially slowing the process of sharing of influenza viruses with the established WHO Global Influenza Surveillance and Response System (GISRS). A recently updated (December) analysis [pdf] produced by the WHO, states that the Nagoya Protocol is a source of both opportunities and challenges, and gives anonymous examples of two situations having arisen “in recent months with respect to seasonal influenza virus sharing,” affecting both GISRS and vaccine manufacturers. The first case relates to additional requirements for sharing seasonal flu viruses by a country due to its implementation of the Nagoya Protocol. The other case is about companies being asked by a Nagoya Protocol focal point in a country to notify the competent authorities of any products containing the virus and/or its derivatives prior to their commercialisation, creating “uncertainties at the beginning of a time-sensitive process.” “The Nagoya Protocol is bigger than the PIP Framework,” WHO Director General Tedros Adhanom Gheyebresus (Dr Tedros) said, closing the item, and adding he would establish a taskforce to discuss the possible implications of the Nagoya Protocol implementation and how to move forward. Dr Tedros remarked on the world’s vulnerability to a deadly influenza pandemic. Ebola compared to influenza is nothing, he said, remarking on the need for collaboration and solidarity. Genetic Sequence Information Sharing, a Brainteaser The question of whether genetic sequence data (GSD) are included in the PIP Framework gives way to different interpretations. In general, most advanced countries, whose technical capacities allow to reproduce viruses in a laboratory from GSD, are objecting to the inclusion of GSD. Less advanced economies, meanwhile, would like GSD to be considered on an equal footing to biological material, and to open the same benefit-sharing and obligations stemming from their sharing under the PIP Framework. The Japanese delegate said that influenza GSD are currently shared freely without charge, and the WHO should be cautious not to hinder this practice. Germany and the US also did not support inclusion of GSD in the framework, and the US said the public health implications of the Nagoya Protocol go well beyond influenza. The Swiss delegate remarked in her statement [pdf] that the question of benefit-sharing on GSD is still a contentious subject at the CBD (IPW, Biodiversity/Genetic Resources/Biotech, 30 November 2018). Indonesia, as well as India, on the other hand, said GSD should be treated in equal manner to biological material in the framework, but recognised that views are divided on the issue. The Indonesian delegate suggested that the WHO discuss the question in an “open, transparent, and timely,” manner, and called for informal discussions prior to the WHA, with member states and stakeholders. This suggestion was supported by other WHO EB members, such as Brazil, and accepted by the WHO. A number of countries such as Russia and Japan said the PIP Framework should not be extended to include seasonal influenza viruses, while Indonesia called for further discussions. Indonesia in its statement [pdf] also suggested that the discussion on sharing seasonal viruses should happen with a “vision to develop another mechanism or specific framework with is consistent with CBD and Nagoya Protocol.” Addressing Loophole Entities wanting to have access to potential pandemic influenza virus biological material from the GISRS network have to sign a standard material transfer agreement (SMTA). The PIP Advisory Group suggested to amend a footnote in SMTAs to prevent a potential loophole allowing indirect access to PIP biological material, without benefit-sharing obligations. The resolution contains a proposal to amend a footnote in the SMTA. The amendment adds to the list of recipients, to include “entities that engage with recipients of PIP Biological Materials for the purpose of supporting development, testing, or regulatory processing of an influenza-related product.” Switzerland voiced reservation on the footnote amendment, saying it needs further discussions, and Norway in its statement [pdf] questioned the rationale of amending the SMTA2 loophole at this time and asked for an example of what it seeks to address. Industry, Civil Society, Different Lens on Sharing According to [pdf] Medicus Mundi International,” GSD is already part of the PIP Framework,” and use of GSD should trigger the same obligations as biological material. However, the International Federation of Pharmaceutical Manufacturers and Association (IFPMA), in its statement [pdf], urged WHO to consider the impact of “any future approaches” related to GSD and to wait for further clarity from the ongoing discussions with the CBD. The IFPMA representative said, “there are increasing examples of delayed virus-sharing as some countries seek to implement the Nagoya Protocol,” adding, “If virus sharing is delayed or even worse, halted, global public health security and emergency response becomes highly compromised and the investment case for the PIP Framework is greatly diminished.” The WHO Executive Board met from 24 January to 1 February. Image Credits: Flickr – Sanofi Pasteur 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) Related Catherine Saez may be reached at firstname.lastname@example.org."WHO Board Sceptical On Changes To Global Flu Framework, Sends Issue To WHA" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.