[Ip-health] TWN Info: WHO R&D Blueprint - Where¹s the Benefit Sharing?

Sangeeta Shashikant sangeeta at twnetwork.org
Mon May 15 01:09:04 PDT 2017


Title : TWN Info: WHO R&D Blueprint -  Where¹s the Benefit Sharing?
 Date : 2017-05-12

 Contents: 

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

WHO R&D Blueprint:  Where¹s the Benefit Sharing?

- Lessons from the Pandemic Influenza Preparedness Framework -
http://www.twn.my/title2/intellectual_property/info.service/2017/ip170501.ht
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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 Organization¹s ³Blueprint for
research and development preparedness and rapid research response².

The document is a global strategy aimed at facilitating targeted research
and development (R&D) for prioritized pathogens, with the overall goal ³to
reduce delays between the identification of an outbreak and deployment of
effective medical interventions to save lives and minimize socioeconomic
disruption², according to the WHO Secretariat¹s 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 Blueprint¹s 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:
* an initial expert consultation on data sharing (Geneva, 1-2 September
2015); 
* developing global norms for sharing data and results;
* elaborating mechanisms for collaboration and data sharing during public
health emergencies;
* initiated 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
platform; 
* elaboration of principles for a shared system of governance and
decision-making; 
* development 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 WHO¹s 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
manner.  

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 State¹s 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 manufacturers.

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 ³intends 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
technologies², adding that ³In 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 diseases².

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 ³unfair².  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. Erasmus¹ 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
future controversies.

More recently, several civil society organisations, e.g. Knowledge Ecology
International and Médecins Sans Frontières (MSF) have opposed the United
States Army¹s proposed grant of exclusive royalty bearing licenses to Sanofi
Pasteur on the US Army¹s pending patent on a Zika vaccine (US applications
62/343,315, ³Zika Virus Vaccine and Methods of Production² and 62/370,260,
³Zika Vaccine and Methods of Preparation²).

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 products.

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 WHO¹s 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 WHO¹s 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 ³equal
footing².  The Framework also substituted the WHO GISN scheme with a WHO
Global Influenza Surveillance and Response System (also known as ³WHO
GISRS²). 

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
³Influenza Virus Tracking Mechanism² (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
contribution.

The Framework requires influenza vaccine, diagnostic and pharmaceutical
manufacturers to make an annual partnership contribution to the WHO set at
³50% of the running costs of the WHO GISRS², with the understanding that
costs may change over time and the partnership contribution will change
accordingly. At the point of the Framework¹s adoption, these running costs
were estimated to be US$56.5 million.

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 ³bold and innovative tool for pandemic influenza
preparedness², and ³its implementation has led to greater confidence and
predictability in the global capacity to respond to an influenza pandemic².

Noteworthy also is the review¹s conclusion that ³the principle of the
Framework of placing virus sharing and benefit sharing on an equal footing
remains relevant today,² and that the Framework ³is a foundational model of
reciprocity for global public health that could be applied to other
pathogens².

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 footing.

WHO Member States are thus faced with a choice.  The continued development
of the Blueprint, and so-called ³open access² 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 countries.


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