TWN Info Service on Intellectual Property Issues (Feb17/06)
London, 6 February (Sangeeta Shashikant) – The Pandemic Influenza Preparedness Framework (PIP Framework) adopted by the World Health Assembly in 2011 is a “bold and innovative tool” and a “success story”.
These views were expressed at discussions at the 140th meeting of the Executive Board (EB) of the World Health Organization (WHO) on the findings of the review of the PIP Framework. The meeting took place at the WHO headquarters in Geneva on 23-31 January 2017.
Professor William Ampofo, head of the virology department of the Noguchi Memorial Institute for Medical Research at the University of Ghana presented to the EB the findings of an expert group that reviewed the functioning of the PIP Framework.
He said that the Framework’s foundational principle of treating virus sharing and benefit sharing on an equal footing “remains as relevant today as it was 5 years ago”, adding that when the PIP Framework was created “it broke new ground.” “There was no guarantee that it would work. Yet it has worked extremely well and through its success forged path for greater equity in benefit sharing from sharing of other pathogens,” he added.
Prof. Ampofo further said that “access to antiviral should not depend on where you live or how much money you have. The PIP Framework represents an important step to achieving health equity”.
However, he also highlighted several important aspects that require further consideration in relation to the PIP Framework such as handling of genetic sequence data, linkage with the Nagoya Protocol on access and benefit sharing (a treaty under the Convention on Biological Diversity) and the sharing of seasonal influenza viruses.
The Framework governs the sharing of influenza viruses of pandemic potential (“PIP biological material” as known in the Framework document). It came about following realization of the inequities prevailing in the then Global Influenza Surveillance Network (GISN) which only emphasized virus sharing, operating in conflict with the principles and provisions of the Convention on Biological Diversity. The Convention establishes sovereign rights of a country over its natural resources which includes microorganisms, and that access to genetic resource is subject to prior informed consent, mutually agreed terms and fair and equitable benefit sharing. The Nagoya Protocol further elaborates on the implementation of fair and equitable benefit sharing.
The PIP Framework overhauled WHO’s influenza virus sharing system. It set up the WHO Global Influenza Surveillance and Response system (GISRS) laboratories and provided their Terms of References. Two Standard Material Transfer Agreements (SMTAs) were developed. All sharing of PIP biological material among WHO GISRS laboratories became subject to SMTA1 while sharing of PIP biological material with non-GISRS entities is subject to SMTA2 which also lists benefit-sharing options to which entities receiving PIP biological material have committed. Influenza vaccine, diagnostic and pharmaceutical manufacturers further have to pay to the Partnership Contribution to the sum of US$ 28 million (based on 50% of the running costs of the WHO GISRS laboratories).
Prof. Ampofo, in delivering the findings, reported that thus far the SMTA2s with manufacturers have secured 350 million doses of influenza vaccines in real time during a pandemic, which is a “significant step forward for building pandemic preparedness.” He stressed on the importance of having assurance from countries with in-country vaccine production capacity to allow manufacturers to release to WHO on a real time basis, pandemic vaccines and other products secured by WHO under SMTA2s.
[Finding 34 of the Review report also notes that some institutions have not yet been contacted to sign an SMTA2. To date five SMTA2s have been completed with manufacturers of vaccines and/or antivirals, one with a manufacturer of diagnostics and other products, and 54 with academic and research institutions.]
The Partnership Contribution, which funds all aspects of the PIP Framework, is indispensable to this success, Prof. Ampofo added, stating that the 96% collection rate in 2014 and 2015 is impressive. As at June 2016, the Partnership Contribution collection was about US$ 92,800,499.
Several WHO Member States chimed in to acknowledge the success of the Framework. Norway and Australia referred to it as a “groundbreaking model” in support of public health.
New Zealand acknowledged the success of the Framework, adding that it “resulted in much enhanced preparedness”.
Thailand said securing delivery of vaccines in real time is an “achievement” but also cautioned that it was “ far below” the demand in the event of a pandemic.
The Review of the PIP Framework follows a clause included in the Framework requiring its review by 2016 “with a view to proposing revisions reflecting developments as appropriate, to the World Health Assembly in 2017, through the Executive Board”.
In 2015, the WHO Director-General convened a group of 8 experts to undertake the Review. To facilitate the Review, the experts focused on three questions:
What are the achievements since the PIP Framework was adopted?
During the Executive Board meeting, Prof. Ampofo presented the main findings of the Review Group. However, of the many findings presented the handling of genetic sequence data, linkage with the Nagoya Protocol and the sharing of seasonal influenza viruses dominated discussions. WHO Members called for more discussions and consultations on these issues.
Genetic Sequence Data (GSD)
Prof. Ampofo highlighted that “technological changes already have an impact on how influenza viruses are shared. Advances in the ability to use GSD to substitute for physical viruses have important implications for the influenza community especially in the production of vaccines anti-virals and other measures”. He stressed that the handling of GSD under the PIP framework is not resolved and it is clear to the review group that this is a critical issue for WHO Members going forward.
The Review Group makes several recommendations on GSD. Of particular importance is Recommendation 12, which proposes amending the definition of “PIP biological material” in section 4.1 of the PIP Framework to include GSD, which would mean that access to and use of GSD will trigger fair and equitable benefit sharing.
Of some concern are several other recommendations that stress on sharing of GSD with public databases in the absence of legal certainty, whether or not access to and use of GSD will trigger benefit sharing, and implementation of mechanisms for tracking and monitoring users of GSD.
The subject of GSD is not a new issue, as the Framework covers it. During negotiations of the PIP Framework, disagreements emerged over the handling of GSD, and Member States requested the Director-General to consult the Advisory Group on the best process for further discussion and resolution of issues relating to the handling of genetic sequence data from H5N1 and other influenza viruses with pandemic potential as part of the Pandemic Influenza Preparedness Framework.
Several WHO Members such as New, Zealand, Canada, Thailand, Indonesia and Brazil supported the recommendation to amend the definition of PIP biological material.
New Zealand said amending the definition was an “increasingly urgent piece work” to recognize substitution for GSD of biological material.
Brazil said that the PIP Framework should evolve to include GSD and establish a workable system for tracking access and use with a view to meeting the required balanced outcome of rapidly sharing virus GSD as needed for pandemic purposes and ensuring fair and equitable benefit sharing on equal footing, adding that because viruses can be synthesized from GSD, it is clear that maintaining the Framework on the basis of biological materials alone will not be viable or relevant in the long term.
Brazil said that we would also further study implications for the PIP system, of databases and bio-banks outside the GISRS, to ensure structured access to GSD for public health response and sharing of benefits.
The United States, however, expressed its opposition to redefining PIP biological material to include GSD. “It is essential to maintain a conceptual definitional distinction between PIP biological material itself and data about that material,” it said. The U.S. 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, adding 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, which hosts a major flu database, the Global Initiative on the Sharing All Influenza Data (GISAID) said that the matter needed further discussion, and “Further clarity is needed on realistic approaches to monitor the use of GSD and on models to share benefits for the use of GSD,” adding that GISAID allows the traceability of GSDs.
[It is important to note that the Technical Working Group (TWG) on the sharing of influenza GSD set up by the Advisory Group to consider the “Optimal Characteristics of an Influenza Genetic Sequence Data Sharing System under the PIP Framework” has concluded that “In order to promote benefit-sharing under the PIP Framework, all data users would ideally be asked to accept a standard data access and use agreement that would specify the obligations and expectations of the PIP Framework.” A data access and use agreement allows the tracking of users of GSD, which is fundamental to realize fair and equitable benefit sharing.]
In a joint statement, civil society organizations (CSOs) Medicus Mundi International, the Peoples’ Health Movement and Third World Network called for the Framework to treat sequence data the same way as the viral isolate, thus agreeing with the call to amend the definition of PIP biological material.
The CSOs emphasized that access to and the use of sequence data should trigger benefit sharing, adding that databases that wish to host sequence data should implement a standard user agreement that applies benefit sharing obligations of the PIP Framework to users that access the sequence data and allows the tracking of users of sequence data. In this context, they expressed concern with several of the recommendations of the Review Group pertaining to GSD.
Linkage with Nagoya Protocol
Another issue highlighted by Prof. Ampofo was the designation of the PIP Framework as a specialized instrument of the Nagoya Protocol.
4 of the Nagoya Protocol allows its Parties to developing specialized access
and benefit-sharing agreements, provided that they are supportive of and do not
run counter to the objectives of the CBD and the Protocol.
Brazil said that the narrative points towards establishing the PIP Framework as a specialized access and benefit sharing instrument of the Nagoya Protocol, but stressed that the discussion must be led by the members of the CBD, referring to a decision taken in December 2016, by Parties to the Nagoya Protocol requesting the CBD Secretariat (that is also secretariat to the Protocol) to “conduct a study into criteria that could be used to identify what constitutes a specialized international access and benefit-sharing instrument, and what could be a possible process for recognizing such an instrument, and to refer the study for further consideration by the Subsidiary Body on Implementation before consideration by the Conference of the Parties serving as the meeting of the Parties at its third meeting” in 2018.
CSOs, in their intervention emphasized that WHO Members should be guided by that study on specialized international instruments and its consideration by the Parties to the Nagoya Protocol in 2018.
A diplomatic source informed SUNS that it may be premature to declare the PIP Framework as a specialized instrument under the Nagoya Protocol as implementation of the Framework is at an early stage, several aspects are uncertain, adding that many SMTA2s with vaccine manufacturers have yet to be signed and issues pertaining to GSD are outstanding.
WHO Members also called on WHO to engage with the CBD Secretariat on the matter and to report to the World Health Assembly. This call was reflected in the decision text adopted by the Executive Board.
As a non-Party to the CBD (and thus not eligible to ratify the Nagoya Protocol), the U.S., unsurprisingly perhaps, took a different stance. It said that it did not “consider the Nagoya Protocol to be applicable to pathogens of pandemic potential. We believe these issues fall within the public health community’s remit”.
Seasonal Influenza Viruses
According to the Review report, each year 28,000 seasonal viruses are shared with WHO Collaborating Centres, and viruses undergo “antigenic drift” through mutation, often requiring an update of the viruses in the seasonal vaccines. It further states “the bulk of GISRS work is based on seasonal risk assessment, virus characterization, the development of candidate vaccine viruses (CVVs), reagents and diagnostic kits, and vaccine virus recommendations for the seasonal vaccine”.
Finding 11 of the Review Group states that it “received wide-ranging views from key informants, including Member States, industry and civil society, on this complex and challenging issue, with strong views both for and against including seasonal influenza under the PIP Framework” and recommends that the implications of including seasonal influenza need to be studied further.
Some WHO Members preferred that the scope of the PIP Framework be limited to potentially pandemic flu viruses while others called for more discussion.
CSOs called for WHO Members to initiate a new instrument to govern the sharing of seasonal influenza viruses, rather than a study on the implications of expanding the PIP Framework to include seasonal viruses, as an expansion of the Framework would adversely affect a successfully functioning Framework.
Decision of the Executive Board
The Board concluded its deliberations with the adoption of a decision to extend until 28 February 2018 the application of decision EB131(2) (2012) wherein it was earlier decided that, for five years (2012?2016) approximately 70% of the partnership contributions received should be used for pandemic preparedness measures and approximately 30% should be reserved for response activities.
The decision also requests the WHO Director-General to propose, in accordance with section 6.14.5 of the Framework, a new proposal on which proportion of partnership contributions should be used for inter-pandemic preparedness measures, and which proportion should be reserved for response activities in the event of a pandemic, based on the advice of the PIP Advisory Group, for consideration by the Executive Board at its 142nd session in January 2018.
The decision further requests the Director-General to continue consultations with the CBD Secretariat and other relevant International organizations, as appropriate, in the context of the existing international commitments, on access to pathogens and fair and equitable sharing of benefits, in the interest of public health, and to report thereon to the Seventieth World Health Assembly in May 2017.
[In December 2016, the Meeting of Parties of the Nagoya Protocol agreed (CBD/NP/MOP/DEC/2/5) to request the Secretariat of the Protocol to inter alia share with the World Health Organization relevant information provided by Parties in their national reports on the national implementation of the Nagoya Protocol, including its Article 8(b); to conduct a study into criteria that could be used to identify what constitutes a specialized international access and benefit-sharing instrument, and what could be a possible process for recognizing such an instrument, and to refer the study for further consideration by the Subsidiary Body on Implementation before consideration by the Conference of the Parties serving as the meeting of the Parties at its third meeting; to continue to engage with relevant ongoing processes and policy debates, including in the World Health Organization, to collect information on current discussions on the relationship between the use of digital sequence information on genetic resources and access and benefit-sharing arising out of the utilization of genetic resources.].