TWN Info Service on Intellectual Property Issues (May17/01)
12 May 2017
Third World Network
WHO R&D Blueprint: Where’s the Benefit Sharing?
- Lessons from the Pandemic Influenza Preparedness Framework -
By Sangeeta Shashikant
Third World Network
(11 May 2017)
The 70th World Health Assembly that will meet in Geneva from 22 to 31 May is
set to consider progress on the World Health Organization’s “Blueprint for
research and development preparedness and rapid research response”.
The document is a global strategy aimed at facilitating targeted research and
development (R&D) for prioritized pathogens, with the overall goal “to
reduce delays between the identification of an outbreak and deployment of
effective medical interventions to save lives and minimize socioeconomic
disruption”, according to the WHO Secretariat’s report to the World Health
Assembly (WHA) contained in document A70/10.
The Blueprint followed the Ebola outbreak in West Africa in the spring of 2014,
as well as the current Zika virus epidemic wherein the global health community
found itself ill-prepared to cope: there were no vaccines, few diagnostics, and
insufficient medical teams and trained responders.
Hence the overall goal of the R&D Blueprint is to improve emergency preparedness
and response for prioritized pathogens which as at January 2017 were the
viruses causing renaviral hemorrhagic fevers (including Lassa Fever),
Crimean Congo Haemorrhagic Fever; filoviral diseases (including Ebola and
Marburg); Middle East Respiratory Syndrome Coronavirus; other highly pathogenic
coronaviral diseases (such as Severe Acute Respiratory Syndrome,Nipah and
related henipaviral diseases); Rift Valley Fever; Severe Fever with
Thrombocytopenia Syndrome; Zika and any disease identified using the
Blueprint’s decision instrument.
A cornerstone of the Blueprint is the sharing of data and samples which the WHO
report (A70/10) notes is crucial for informed research and development efforts.
In what is almost a repeat of the contents of the R&D Blueprint, the report
vaguely lists the multiple activities that have been or will be undertaken in
relation to sharing of data and samples, such as:
initial expert consultation on data sharing (Geneva, 1-2 September 2015);
global norms for sharing data and results;
mechanisms for collaboration and data sharing during public health
a process to reach consensus on principles for open access repositories of
biological samples (bio-banks) including the development of a virtual
resource linking national bio-banks through an information sharing
of principles for a shared system of governance and decision-making;
of a Material Transfer Agreement (MTA) capacity-building tool to inform
negotiations at country level on sharing biological samples.
What the document also reveals is a patchwork of initiatives often in
partnership with different external actors and engagement of selected
stakeholders. For instance on 16 December 2016, WHO jointly held with the
Institute Pasteur in Paris an informal consultation on developing an MTA
guidance tool in preparedness for public health emergencies. The participation
list obtained by the author shows engagement predominantly with a select group
of entities based in developed countries.
This meeting was preceded by several other similar consultations: First WHO
Consultation on biobanking (13 May 2015 in Geneva); Second WHO consultation on
biobanking (6-7 August in Sierra Leone); WHO consultation on data sharing (1-2
September 2015); Wellcome Trust meeting on biobanking tools (14 January 2016);
Wellcome Trust meeting on intellectual property, sample and data sharing and
public healthemergencies (9 May 2016).
The most glaring gap in WHO’s approach to handling of biological samples and
data is the absence of a transparent and inclusive intergovernmental process
driving the development of appropriate norms and standards in a cohesive
Almost all WHO Member States are party to the Convention on Biological
Diversity (CBD), which entered into force in December 1993, and which
recognizes a State’s sovereign right over its natural resources, that access to
and use of genetic resources (e.g. any pathogen) is subject to prior informed
consent and fair and equitable benefit sharing on mutually agreed terms. The
Nagoya Protocol on Access and Benefit Sharing, which entered into force in
October 2014, further elaborates on these elements.
Given this, the approach taken by the R&D Blueprint raises concerns and
hence important questions such as: how will these fundamental rights of WHO
Member States be implemented; what will be the terms for accessing biological
samples and related data; what is the mechanism for recording and tracking
biological materials that have been shared, who will have ownership over the
biological material, how is intellectual property dealt with; what forms of
benefit sharing will be realized, and how will it be ensured that such benefit
sharing is fair and equitable.
Further, will an assortment of bilateral MTAs (presumably maintained
confidentially) withdifferent terms and conditions among different parties be
able to secure access to knowledge, technology and affordable treatments
arising from the use of the samples and data (e.g. by multinational companies)
in a prompt and timely manner during an emergency? How will such
MTAs ensure affordability and timely availability of medical interventions, in
particular that the manufacturers will prioritize the needs of the global
health community (especially vulnerable or affected communities) over the
special interests of particular countries, especially developed countries that
often enter into exclusive licenses and advance purchase agreements with
In addition, what are the rules, systems and mechanisms in place to ensure that
the activities of the R&D Blueprint are transparent, accountable, and will
deliver and fair and equitable outcomes.
Pathogens & Controversies
Over the years, several controversies over access and benefit sharing for
pathogens, patents and other intellectual property, and timely access to
affordable medical interventions have erupted.
In 2003, following the outbreak of severe acute respiratory syndrome (SARS),
teams of scientists in Canada, Hong Kong, and the United States, brought
together by WHO to address the outbreak, filed patent applications on all or
part of the SARS virus genome and on the virus itself which were reported to be
sufficiently broad to allow their holders to claim rights over most diagnostic
tests, drugs, or vaccines that have been or would be developed to cope with the
outbreak. Several of the applicants were reported to be in negotiations with
commercial partners to develop diagnostic tests and other products.
This prompted WHO to issue a notice in May 2003 stating that it “intends to
monitor the effects of patents (and patent applications) on the speed with
which SARS diagnostic tests, treatments, and vaccines are developed and made
available for use and on the manner in which prices are set for these
technologies”, adding that “In the longer term, the manner in which SARS patent
rights are pursued could have a profound effect on the willingness of
researchers and public health officials to collaborate regarding future
outbreaks of new infectious diseases”.
In 2007, another controversy erupted as Indonesia, severely affected by the
highly pathogenic H5N1 influenza virus, suspended the sharing those viruses,
asserting that the then WHO virus-sharing scheme (Global InfluenzaSurveillance
Network - GISN) was “unfair”. Under this system, affected countries would
send influenza virus samples to certain laboratories designated as WHO's
Collaborating Centres located in developed countries. These laboratories would
characterize the viruses, develop candidate vaccine strains and in violation of
WHO guidelines, send viruses to the commercial sector for vaccine development,
without the consent of the contributing country. Worse still, the vaccines
developed by the private sector using viruses obtained from the GISN were
unavailable and/or not affordable for developing countries.
Moreover, patent claims were filed by WHO designated laboratories and companies
alike, over influenza viruses and virus parts, i.e. viral gene segments and
their sequences, shared in good faith with the GISN by avian influenza affected
countries such as Indonesia, Vietnam, China and Thailand.
Thus the GISN virus sharing system had a clear set of winners: the vaccine
companies thatgained access to flu viruses, and developed proprietary flu
vaccines that are sold at high prices; developed countries that enter into
advance purchase agreements with vaccine manufacturers for the supply and
stockpile of vaccines, and laboratories in those countries that gain access to
flu vaccines, sometimes claiming patents. On the other hand, losers were
especially developing countries facing dangerous outbreaks, astronomical bills
for the purchase of vaccines and other treatments, and even difficulty in
accessing such supplies at all, due to their limited availability. Technologies
and know-how used in vaccine development and production are also largely based
in developed countries and protected by intellectual property.
In 2014, another dispute exploded, this time over the Middle East Respiratory
Syndrome (MERS) as it emerged that Erasmus University in the Netherlands had
filed patent applications over the MERS virus which had sent to the Netherlands
without permission from the country of origin, Saudi Arabia. An nternational
patent application, WO2014045254, claimed the MERS virus as a whole, and its
genetic material, particularly the unique variations that differentiate the
MERS virus from related viruses and appear to enable it to infect humans.
Erasmus’ patent claims then go on to include any MERS diagnostics, as well as
use of the virus in a vaccine.
Thus, the WHO Blueprint, if it does not take on board the lessons from such
past controversies by ensuring fair and equitable benefitsharing in harmony
with the CBD, will run a high risk of repeating past mistakes and generating
More recently, several civil society organisations, e.g. Knowledge Ecology
International and Médecins Sans Frontières (MSF) have opposed the United States
Army’s proposed grant of exclusive royalty bearing licenses to Sanofi Pasteur
on the US Army’s pending patent on a Zika vaccine (US applications 62/343,315,
“Zika Virus Vaccine and Methods of Production” and 62/370,260, “Zika Vaccine and
Methods of Preparation”).
MSF urged the US government to consider the negative impact an exclusive
agreement will have on the development, affordability and availability of a
Zika vaccine, which is urgently needed for people affected by the Zika virus in
the US and worldwide. MSF requested the US government to consider instead
granting an open non-exclusive patent license with appropriate and publicly
available terms and conditions to help ensure that further development of this
US government funded-technology will prioritize all health needs and ensure
sustainable and affordable access of any resulting vaccine.
There is no requirement on Sanofi to make the vaccine available at an
affordable price and to all that need it, both in the US and other countries.
In its response, the US army rejected the objections, and expressed its intent
to grant the exclusive license, expressing belief that market competition among
the Zika solutions can fairly determine the availability and market for
These disputes point to the need for clear rules in the WHO with regard to use
ofpathogens and related data that have been shared and accessed, and securing
of fair and equitable benefit sharing that will allow the WHO to promptly
respond, in times of emergencies, with adequate supplies of affordable
diagnostics, vaccines and treatments. And here lessons may be learned from the
Pandemic Influenza Preparedness (PIP) Framework.
Lessons from PIP Framework
The PIP Framework is a historic landmark agreement adopted in May 2011 by the
WHA Resolution 64.5 that sets out international rules in the WHO with regard
toaccess to influenza viruses of pandemic potential, and fair and equitable
sharing of benefits arising from their use. Its adoption was preceded by
intense intergovernmental negotiations beginning in 2007.
It emerged from outrage over the WHO’s flu virus sharing scheme, i.e. that the
GISN system was inequitable and especially harmful to the interests and needs
of developing countries, while its operations were inconsistent with the legal
rights of WHO Member States that are also Parties to the CBD.
The Framework overhauled the WHO’s approach to sharing of influenza viruses of
pandemic potential (IVPP). For the first time, in the WHO, access to such
viruses was linked to access to vaccines and other benefits on an “equal
footing”. The Framework also substituted the WHO GISN scheme with a
WHO Global Influenza Surveillance and Response System (also known as “WHO
It set up a transparent traceability mechanism that track in real time the
movement of IVPP biological material shared by WHO Members known as the
“Influenza Virus Tracking Mechanism” (IVTM).
All sharing of IVPP biological material among WHO-designated GISRS laboratories
(e.g. national influenza centres, WHO Collaborating Centres) and with entities
outside the GISRS (e.g. pharmaceutical companies) is subject to Standard
Material Transfer Agreements (SMTAs), These agreements negotiated by WHO Member
States, form part of the Framework.
A specific agreement (SMTA 1) governs the sharing of IVPP biological material
among WHO-designated laboratories. This SMTA requires inter alia that
the receiving laboratory comply with its Terms of Reference; any shipments of
IVPP biological materials be recorded in the tracking mechanism; actively
involve scientists from the originating laboratories especially those from
developing countries in scientific projects on clinical specimens or the
influenza viruses and to actively engage them in preparation of manuscripts for
presentation and publication and acknowledge their contributions. SMTA 1 also
makes clear that neither the provider nor the recipient laboratory should seek
to obtain any intellectual property on the IVPP biological materials.
Another agreement, known as SMTA 2, list benefit-sharing options that non-GISRS
entities (e.g. influenza vaccines, diagnostic, pharmaceutical manufacturers,
academic institutions) receiving IVPP biological material have to commit
to. The options include donation of real-time pandemic vaccine and/or
anti-virals to the WHO; reservation of real time pandemic vaccine and/or
anti-virals for supply at affordable prices; and the grant of royalty free
licenses to manufacturers in developing countries or to the WHO (which can be
sub-licensed), for the production of pandemic influenza vaccines, adjuvants,
antivirals products and diagnostics needed in a pandemic.
As at March 2017, the WHO has signed 9 agreements with vaccine and antiviral
manufacturers, which according to the WHO provides real-time access to an
estimated 400 million doses of pandemic vaccine during the next flu pandemic.
However, none of the agreements have yet committed the manufacturers to the
technology transfer options.
The WHO has also concluded 50 SMTA 2 with academic and research institutions
and received 22 benefit sharing offers. While the specific details of these
offers are unknown, according to the WHO, most of these institutions have
offered to provide laboratory and surveillance capacity building as a benefit contribution.
In addition to SMTA 2 commitments, influenza vaccine, diagnostic and
pharmaceutical manufacturers also have to commit to payment of partnership
The Framework requires influenza vaccine, diagnostic and pharmaceutical
manufacturers to make an annual partnership contribution to the WHO set at “50%
of the running costs of the WHO GISRS”, with the understanding that costs may
change over time and the partnership contribution will change accordingly. At
the point of the Framework’s adoption, these running costs were estimated to be
Hence, companies that use the GISRS system (i.e. access the IVPP biological
materials and data) are collectively responsible for contributing US$28 million
annually. How much each company pays is based on a formula agreed among the
industry representatives. As at 31 January 2017, the total partnership
contribution collected, beginning from 2012, from 47 contributors amounted to
US$117,758,149. Presently 30% of this amount is reserved for response
activities in the event of a pandemic, while 70% is allocated for preparedness
activities in different regions.
The Framework also builds in certain checks and balances for its
implementation. For example, an Advisory Group has been set up to specifically
monitor implementation of the PIP Framework, and there is detailed reporting to
the Executive Board and the WHA. Information on IVPP biological material
shared, SMTAs signed, benefitssecured, partnership contributions collected and
spent, is publicly available on the WHO website.
Implementation of the Framework has not been without challenges as has been
revealed by the findings of an expert team that reviewed implementation of the
Framework in2016. It faces issues such as rapid technological developments,
which has brought to the forefront, the importance of treating genetic sequence
data in a manner equivalent to viral isolates, its use linked to fair and
equitable benefit sharing and other obligations of the Framework.
The same Expert Review team, however, also unequivocally confirms that the
Framework is a “bold and innovative tool for pandemic influenza preparedness”,
and “its implementation has led to greater confidence and predictability in the
global capacity to respond to an influenza pandemic”.
Noteworthy also is the review’s conclusion that “the principle of the Framework
of placing virus sharing and benefit sharing on an equal footing remains
relevant today,” and that the Framework “is a foundational model of reciprocity
for global public health that could be applied to other pathogens”.
On a similar note, the Review Committee on the Role of the International Health
Regulations (2005) in the Ebola Outbreak and Response found that a number of
State Parties continue to be concerned that data-sharing would not be balanced
by benefit-sharing and concluded that the PIP Framework serves as an example of
an agreement that facilitates sample and, potentially, gene sequence
data-sharing, with benefit-sharing on an equal footing. Accordingly the Review
Committee concluded that the WHO and State Parties should ensure that sharing
of samples and sequence data is balanced with benefit-sharing on an equal
WHO Member States are thus faced with a choice. The continued development
of the Blueprint, and so-called “open access” bio-banks for samples and data,
without sufficient attention paid to national sovereignty over genetic
resources and fair and equitable benefit sharing, will lead tofuture
controversies over patents and access to vaccines for developing countries like
those that have come before, e.g. with H5N1 influenza.
But instead of repeating past mistakes and reliving past controversies, Member
States should ensure that the Blueprint sets clear rules for access to
pathogens that include restrictions on intellectual property and requirements
for benefit sharing by users that utilize and derive commercial benefit from
viral genetic resources (e.g. vaccine companies). These rules uphold the
principles and requirements of the CBD and can improve timely access to and
affordability of vaccines, diagnostics, and antiviral drugs in developing