[Ip-health] TWN Info: Pandemic flu Framework a ³success story² with challenges

Sangeeta Shashikant sangeeta at twnetwork.org
Wed Feb 8 05:35:49 PST 2017


Title : TWN Info:  Pandemic flu Framework a ³success story² with challenges
 Date : 2017-02-07

 Contents: 

TWN Info Service on IP and Health
7 February 2017
Third World Network
www.twn.my <http://www.twn.my>

Pandemic flu Framework a ³success story² with challenges
Published in SUNS #8396 dated 7 February 2017

London, 6 February (Sangeeta Shashikant) ­ The Pandemic Influenza
Preparedness Framework (PIP Framework) adopted by the World Health Assembly
in 2011 is a ³bold and innovative tool² and a ³success story².

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 Framework¹s foundational principle of treating virus
sharing and benefit sharing on an equal footing ³remains as relevant today
as it was 5 years ago², adding that when the PIP Framework was created ³it
broke new ground.²  ³There 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,² he added.

Prof. Ampofo further said that ³access 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 equity².

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
(³PIP biological material² 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 WHO¹s 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 ³significant step forward for
building pandemic preparedness.² 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 ³groundbreaking model²
in support of public health.

New Zealand acknowledged the success of the Framework, adding that it
³resulted in much enhanced preparedness².

Thailand said securing delivery of vaccines in real time is an ³achievement²
but also cautioned that it was ³ far below² 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 ³with a view to proposing revisions reflecting
developments as appropriate, to the World Health Assembly in 2017, through
the Executive Board².

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:

(1) What are the achievements since the PIP Framework was adopted?
(2) Has implementation of the PIP Framework improved global pandemic
influenza preparedness, including inter-pandemic surveillance, and capacity
to respond?
(3) What are the challenges, and possible ways of addressing them?

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 ³technological 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 measures². 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
³PIP biological material² 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 ³increasingly urgent piece
work² 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. ³It is essential to maintain a
conceptual definitional distinction between PIP biological material itself
and data about that material,² 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 ³pros and
cons.² ³One could ask whether it is realistic to limit free access and
mobility of GSD, including through open gene banks,² 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  ³Further clarity is needed on realistic approaches to
monitor the use of GSD and on models to share benefits for the use of GSD,²
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
³Optimal Characteristics of an Influenza Genetic Sequence Data Sharing
System under the PIP Framework² has concluded that ³In 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.² 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 Peoples¹ 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.

Article 4 of the Nagoya Protocol allows its Parties to develop 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.

Several WHO Members pointed out that the appropriate forum for the
discussion about the designation of the PIP Framework a specialized
instrument of the Nagoya Protocol was the Protocol itself, pointing to
recent decisions taken by the Protocol Parties on the matter.

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 ³conduct 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 meeting² 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 is 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 ³consider the Nagoya Protocol to be applicable to
pathogens of pandemic potential. We believe these issues fall within the
public health community¹s remit².

Seasonal Influenza Viruses

According to the Review report, each year 28,000 seasonal viruses are shared
with WHO Collaborating Centres, and viruses undergo ³antigenic drift²
through mutation, often requiring an update of the viruses in the seasonal
vaccines. It further states ³the 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 vaccine².

Finding 11 of the Review Group states that it ³received 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 Framework² 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.].


 


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