[Ip-health] South Centre Statement on TRIPS Amendment

Viviana Munoz Munoz at southcentre.int
Mon Jan 30 02:22:00 PST 2017


The South Centre issued today a statement on the amendment to the TRIPS agreement

See https://www.southcentre.int/statement-january-2017/

________________________________________
From: Ip-health [ip-health-bounces at lists.keionline.org] on behalf of ip-health-request at lists.keionline.org [ip-health-request at lists.keionline.org]
Sent: 28 January 2017 21:00
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Subject: Ip-health Digest, Vol 81, Issue 19

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Today's Topics:

   1. Re: Devex: Zika vaccine could be delayed, unaffordable after
      US Army grants exclusive rights to pharma company (Wilson, Paul A.)
   2. EB140 heats up during discussions of proposed changes to
      resolution on TOR of Overall Programme Review of GSPOA
      (Thiru Balasubramaniam)
   3. WHO EB140: Statement of India on UN HLP Report on Access to
      Medicines (Thiru Balasubramaniam)
   4. EB140: Statement of India on agenda item 8.4 Evaluation and
      review of the global strategy and plan of action on public
      health, innovation and intellectual property (Thiru Balasubramaniam)
   5. Re: Devex: Zika vaccine could be delayed, unaffordable after
      US Army grants exclusive rights to pharma company (Jamie Love)


----------------------------------------------------------------------

Message: 1
Date: Fri, 27 Jan 2017 22:29:46 +0000
From: "Wilson, Paul A." <pw2101 at cumc.columbia.edu>
To: Jamie Love <james.love at keionline.org>, Zack Struver
        <zack.struver at keionline.org>, Paul Wilson <pw2101 at columbia.edu>
Cc: Ip-health <ip-health at lists.keionline.org>
Subject: Re: [Ip-health] Devex: Zika vaccine could be delayed,
        unaffordable after US Army grants exclusive rights to pharma company
Message-ID: <D4B12FCC.CEBB%pw2101 at cumc.columbia.edu>
Content-Type: text/plain; charset="utf-8"

Hi Jamie,

I wish I could say otherwise, but I know nothing more about the deal than was in the papers, so in speaking to the reporter I was just trying to provide general background. I pointed out to her that Sanofi?s claim to be bearing future costs and risks was undercut if they were getting funding for the trials, as the earlier announcements implied. Another thing that I don?t understand is what happened to the earlier announcement of a collaboration involving Fiocruz. Do you know what happened to this?

I didn?t say that only a few big companies can make and distribute vaccines, but that until now they had been responsible in almost all cases for bringing truly new vaccines through the later phases of development. There are some exceptions (such as the Chinese Hep E vaccine) and will surely be more soon. I don?t have a good sense of how difficult this vaccine will be to bring through trials and regulatory approval, as I don?t know anything about the technology involved, although it doesn?t sound particularly new-fangled.

Another consideration that the army might have had is that no firm based in a developing country has yet gotten FDA approval for a vaccine, or at least that was the case when I last checked a while back. Is that still true to your knowledge? Presumably this is an important ambition of Serum and perhaps others.

I (and the article) made very clear that Gavi provides no protection for people in industrialized countries, or even for people in most developing countries, as the vast majority now live in countries that aren?t eligible for Gavi support. That?s why any provisions on access and affordability are so important in deals like this.

Paul

From: Jamie Love <jamespackardlove at gmail.com<mailto:jamespackardlove at gmail.com>> on behalf of Jamie Love <james.love at keionline.org<mailto:james.love at keionline.org>>
Date: Friday, January 27, 2017 at 12:44 PM
To: Zack Struver <zack.struver at keionline.org<mailto:zack.struver at keionline.org>>, Paul Wilson <pw2101 at columbia.edu<mailto:pw2101 at columbia.edu>>
Cc: Ip-health <ip-health at lists.keionline.org<mailto:ip-health at lists.keionline.org>>
Subject: Re: [Ip-health] Devex: Zika vaccine could be delayed, unaffordable after US Army grants exclusive rights to pharma company

Interesting to hear Paul Wilson's opinions.  Does he know much money Sanofi has promised to invest?
?Sanofi?
told Statnews they expected the US government to pay for the late stage trials
?.  Was Sanofi lying then, or now? ?
 Sanofi certainly is not paying for the current trials
?.  The Army won't say anything about who will be paying for the future trials, although the NIH is putting out press releases about the six year funding agreement with Sanofi.?


?T?
he 2009 vaccine for Japanese encephalitis that used the same platform as ZPIV
? wasn't developed a big pharma company, I believe it was registered by I
ntercell AG
?, a firm few have heard of.
The notion that only a few big companies can make and distribute vaccines is false.
?And in any case, Sanofi has already been given $43 million to work on this, without a license.  ?

The notion that GAVI is going to protect people in developing countries from price gouging from Sanofi would be more compelling if Sanofi was not given exclusive rights.   Why give a company a monopoly and then have a discussion about the price?   And, what about US residents who want to avoid having babies with small heads and brain damage?  If GAVI going to help them?  No.

?  Jamie?


On Fri, Jan 27, 2017 at 5:47 PM, Zack Struver <zack.struver at keionline.org<mailto:zack.struver at keionline.org>> wrote:
https://www.devex.com/news/zika-vaccine-could-be-delayed-unaffordable-after-us-army-grants-exclusive-rights-to-pharma-company-89519#

Zika vaccine could be delayed, unaffordable after US Army grants exclusive
rights to pharma company

By Sophie Edwards | 27 January 2017

The U.S. Army?s plan to grant exclusive rights to a promising Zika vaccine
to a major pharmaceutical company has raised questions about whether that
threatens its future affordability and availability to people in developing
countries.

The purified, inactivated Zika virus vaccine ? called ZP IV ? has been
developed by the U.S. Army and is currently in its first phase of testing
at the Walter Reed Army Institute of Research in Maryland and the National
Institutes of Health.

If it successfully passes clinical trials, the vaccine would have the
potential to halt the spread of the virus, transmitted by mosquitoes and
sexual intercourse, which has been reported in 69 countries since 2015,
including the United States, and is linked to serious birth defects in
children.

The deal was posted by the Army on the public Federal Register in December
and will give Sanofi Pasteur, the vaccine unit of French multinational
pharmaceutical company Sanofi, exclusive access to the new vaccine
technology, which has been developed and paid for by the U.S. government.
In return, Sanofi will take on the role of conducting clinical trials,
getting regulatory approval, manufacturing and distributing the vaccine.

The humanitarian aid organization M?decins Sans Fronti?res has criticized
the Army?s decision to grant Sanofi the patent license, which will give the
company an exclusive right to make, use and sell the vaccine for 20 years,
as well as 12 years of marketing and data exclusivity even after the patent
has expired. MSF is saying this will give the company a monopoly on the
drug and thus no incentive to make it affordable. Sanofi could also choose
to stop developing the vaccine if it decides it is commercially
unattractive.

MSF wants the U.S. Army to consider granting an ?open nonexclusive? patent
license instead, opening up the technology to other pharmaceutical
companies for testing and development. MSF argues this will increase
competition and thus bring down the price and ensure the vaccine reaches
those who need it in middle-income and developing countries.

?Ministries of Health and people around the world will only be able to
benefit from the U.S. government investment if the resulting vaccine is
effective, safe, available, affordable and suitably adapted to the
resource-limited settings where most people affected by Zika virus live,?
MSF said in a statement.

?The next step in the Zika vaccine development process, including its
licensing and technology transfer strategy, needs to ensure that U.S.
government funding and leadership in vaccine R&D results in a vaccine that
is effective and accessible for all patients in need in the U.S. and
globally, including the most neglected,? the group added.

The United Nations High Level Panel on Access to Medicines, formed in 2015
to address the lack of access to medicines in many developing countries,
appears to agree with MSF?s recommendations. In its 2016 report, the panel
said: ?Universities and research institutions that receive public funding
must prioritize public health objectives over financial returns in their
patenting and licensing practices,? and listed the use of nonexclusive
licenses, the donation of IP rights, and taking part in public sector
patent pools as potential mechanisms by which to do this.

Sanofi has responded by saying it?s assuming ?financial and opportunity
risks? by partnering with the government on Zika as there is no guarantee
of a commercial market for the vaccine.

?...we?re still assuming financial and opportunity risks because there is
no clear path to commercialization at this time, as the epidemiology of
this infectious disease is still a moving target,? according to Sanofi?s
research and development project lead, Jon Heinrichs.

The U.S. Army told Devex in an email statement: ?We believe granting an
exclusive license in this case is reasonable and necessary to most quickly
and most safely provide this potential vaccine for public use to combat the
growing international threat of the Zika virus.?

Unusually, the U.S. Army has requested to extend the time period for
comments on the announcement in the Federal Register by an additional 45
days until mid-March, the second time the comment period has been extended,
to allow time to compose written responses to the submissions.

Experts have predicted the Zika market could be worth more than $1 billion
a year, driven by U.S. and European travelers willing to pay high prices
for such vaccines, Reuters reported in October.

Sanofi is part of a race to develop a Zika vaccine

The ZP IV vaccine ? which is thought to be the furthest along in terms of
development in the Zika vaccine field ? is developed from the inactivated
Zika virus. The vaccine was shown to give 100 percent protection against
the Zika virus in mice, according to a study published in science journal
Nature last August.

Sanofi is not alone in working on the Zika virus vaccine. It is not even
the only drug company to receive U.S. government funding to work on the
issue; GlaxoSmithKline has partnered with the NIH to evaluate a new vaccine
technology for Zika known as SAM (self-amplifying mRNA), and Japanese
company Takeda has also entered the vaccine hunt with $312 million funding
from BARDA.

Another group of concerned organizations ? including Knowledge Ecology
International, a nonprofit that lobbies to increase access to medicines ?
have also written to the Army to complain about the Sanofi deal.

KEI says Sanofi does not need to be incentivized to develop the vaccine and
take it to the market ? the standard justification for granting such
exclusive licenses ? since the candidate vaccine has already received
?extensive government subsidies? and is extremely likely to get additional
funds.

?The grant of the exclusive rights in the patent is an unnecessary
incentive to bring the invention to practical application because of the
significant federal funding in the clinical trials and the grant of
additional exclusivities and subsidies,? KEI said.

In September, BARDA ? the U.S. Biomedical Advanced Research and Development
Authority, a unit within the U.S. Department of Health and Human Services ?
gave Sanofi $43.2 million ?for phase II development and manufacturing? of
the Zika vaccine, according to a Sanofi press release.

KEI communications and research associate Zack Struver explained that if
approved, Sanofi will also earn a priority review voucher from the U.S.
Food and Drug Administration, which it could ?sell on for millions of
dollars,? and so already has ?sufficient incentive? to develop the vaccine
with or without the exclusive license, he said.

Priority review vouchers are designed to speed up the review process for
new drug products and thus incentivize drug companies to work to develop
treatments for rare diseases or those without a robust market. Vouchers are
transferable and have been sold to other companies for upwards of $300
million.

However, the statement from the U.S. Army said there was a strong case for
granting Sanofi exclusive rights to the technology, due to competition from
the ?many? groups working on a Zika vaccine. Sanofi is taking on ?risk? by
accruing the license since there is a ?long way to go in terms of time and
money? before a Zika vaccine can be approved, they said. Furthermore, the
army is also yet to receive the patent from the U.S. Patent and Trademark
Office, and there is a chance it ?may never issue,? adding more ?risk? for
Sanofi.

?The federal government needs a non-federal partner with the research and
production capabilities and the willingness to invest their own substantial
funding to most quickly get this product to the market and available for
public use,? the spokesperson added.

The KEI letter to the army also asks for four conditions to be imposed on
the licensing agreement.  These include requiring Sanofi to limit the price
of the vaccine to ?no more than the median price being charged in other
high income countries;? limiting the length of time that Sanofi has
exclusive rights to the technology, requiring the vaccine be made
?available and affordable? in developing countries; and requiring Sanofi to
be transparent about the costs of research and development.

The U.S. Army responded by saying the license agreement has stipulations in
place to ?protect the public interest,? including the option to terminate
if Sanofi fails to ?bring the invention to practical application within a
reasonable time,? or ?make the benefits of the invention reasonably
accessible to the public.?

Sanofi says no ?clear path to commercialization? for Zika at this time

The pharmaceutical company says that even with the public funding from
BARDA, taking ZP IV through the many stages of testing, approval and
manufacturing requires Sanofi to take on ?financial and opportunity risks?
due to the fact Zika is ?still a moving target? and there is ?no clear path
to commercialization at this time,? according to Heinrichs, Sanofi?s
research and development project lead.

?We have modeled various commercial scenarios including current endemic
areas, spread to other geographies and the travel market, among others. The
nature of the epidemiology and spread of the virus will impact the degree
of profitability,? Heinrichs said.

Sanofi may have a point, according to Paul Wilson, assistant professor of
clinical population and family health at Columbia University?s Mailman
School of Public Health, who says there is ?genuine uncertainty?
surrounding how big the Zika problem will be and how widely a vaccine would
be used. This is compounded, he said, by the fact that the virus could
ultimately become widespread but ?without causing harm,? or even die out as
people become immune.

If this turns out to be the case, however, MSF?s and KEI?s concerns may be
valid since Sanofi would likely lose interest in the project and fail to
drive the vaccine all the way through development, WIlson said.

?I?m sympathetic to MSF?s position ? when you have a vaccine being
developed with public funding and you give the rights to one firm, you have
every right to put in place conditions to make sure vaccine will be
available to all who need it,? he said.

?The U.S. government has to at least justify why an exclusive license is
necessary,? WIlson added.

Sanofi could be the best company for the job

The company has experience with vaccines against viruses in the same family
as Zika, known as flaviviruses, having developed vaccines for Japanese
encephalitis and dengue fever.

This could explain why the U.S. Army is keen to entrust the Zika virus
vaccine to Sanofi, which is an established player and one with a track
record of supplying vaccines to developing countries, according to Wilson.

?It is still more or less true that only the big multinational
pharmaceutical companies have ever been able to successfully bring a truly
new vaccine to market. Even when you have a vaccine candidate that?s at the
stage of this Zika one is now, there are still many challenges involved in
the later stages of development,? he said.

However, the capacity of pharmaceutical firms in India, Brazil and China to
develop vaccines is ?growing rapidly? and some of these firms could
probably bring the vaccine to market, although perhaps not as rapidly as a
multinational, WIlson said.

The vaccine industry has long been dominated by four major multinational
pharmaceutical companies ? GlaxoSmithKline, Merck, Sanofi-Pasteur, and
Pfizer, which accounted for approximately 86 percent of global vaccine
revenue in 2015. Their monopoly is attributed to entry barriers such as
high start-up costs and long lead times; vaccines can take anywhere from 10
to 16 years to reach the market, preventing other companies from competing.

Phase III trials are technically difficult to conduct and many drugs and
vaccines fail them, and developing a robust manufacturing process is ?very
technical? and is subject to ?stringent regulatory requirements,? which can
be hard to navigate, Wilson explained.

?The U.S. Army may want a MNC partner because they believe that is the
surest way to ensure that the vaccine gets developed quickly. There are
only a few companies out there that have the relevant experience and have
shown an active interest in developing country markets, which Sanofi has
demonstrated,? he said.

Access will not be an issue in the poorest countries if GAVI steps in

In relation to MSF?s and KEI?s concerns about access to the vaccine, if
approved, GAVI, the Vaccine Alliance ? a partnership of major donors and
pharmaceutical companies designed to ensure access to vaccines for children
in developing countries ? could support low-income countries in purchasing
the vaccine, Wilson said.

Sanofi confirmed in an email to Devex that it has worked with GAVI on
distribution of vaccines in the past, and so working with the alliance on
the Zika vaccine was ?certainly a possibility,? but that a strategy for
?pricing and distribution? would be developed later in the process.

However, the real problem of access will be in middle-income countries,
such as Brazil, which are ineligible for GAVI funding but where the vaccine
is urgently needed.

?Sanofi doesn?t see a market in the poorest countries and so they?re happy
to provide vaccines at a reasonable price there through GAVI, since it
would be seen as bad PR not to. But they are not necessarily prepared to
make those concessions in places like Brazil and India, where the greatest
access concerns would be,? Wilson said.

Sanofi has bad track record when it comes to serving developing countries,
MSF says

MSF spoke out against Sanofi in 2015 after the company decided to stop
manufacturing a pan-African snakebite antivenom because it was no longer
lucrative, leaving a gap in supplies that MSF said would be likely to lead
to unnecessary deaths.

The NGO is worried that if given the exclusive license for the Zika
vaccine, the pharmaceutical company will follow the same path and neglect
countries with great need but less opportunities for profit, according to
Judit Rius Sanjuan, MSF?s U.S. access campaign manager.

Instead, Sanjuan wants the U.S. Army to offer Sanofi a nonexclusive
license, which she argued would be ?better public policy,? ensure the Zika
virus has broader geographical scope, and protects the U.S. government from
?having all its apples in one basket.?

There are other ways to get medicines through development and into markets

There have been successful examples of the U.S. government offering
nonexclusive licenses for patented technologies through the United Nations
backed Medicines Patent Pool, a global health financing mechanism set up in
2010 to share drug technology and research to speed up development, lower
costs and increase access to newer HIV/AIDS, viral hepatitis C, and
tuberculosis treatments in developing countries.

MPP works by signing agreements with patent holders ? such as the NIH and
the U.S. Army but also nonprofits, pharmaceutical companies and individuals
? to create a pool of relevant patents. The partners are then licensed to
generic drug manufacturers who can then produce generic versions of the
medicines, often utilizing more than one patented technology in the process
of development.

For example, in 2010, the NIH licensed a patent on Darunavir to the MPP,
which spurred the development of a new combination drug. Furthermore, Johns
Hopkins University announced on Jan. 25 that it is licensing its patent for
the drug candidate sutezolid, which could be used to treat tuberculosis,
exclusively to the MPP.

While the MPP does not currently work on vaccines, and so licensing to the
MPP was not an option for the U.S. Army, these examples set a ?good
precedent? for ?innovative? nonexclusive licensing agreements and how
effectively sharing research can expedite research and development,
increase collaboration, and diversify the medicine development process,
MSF?s Sanjuan said.

Furthermore, there have been other notable examples of the U.S. granting
nonexclusive licenses for the development of vaccines. For example, the
human-bovine rotavirus vaccine technology was licensed by the NIH to eight
organizations, one in the United States and seven in the developing
countries, to manufacture and distribute the rotavirus vaccine.


--
Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org<mailto:zack.struver at keionline.org>
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670<tel:%2B1%20%28202%29%20332-2670> Cell: +1 (914) 582-1428<tel:%2B1%20%28914%29%20582-1428>
keionline.org<http://keionline.org>
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--
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670<tel:(202)%20332-2670>, US Mobile: +1.202.361.3040<tel:(202)%20361-3040>, Geneva Mobile: +41.76.413.6584<tel:+41%2076%20413%2065%2084>, twitter.com/jamie_love<http://twitter.com/jamie_love>

------------------------------

Message: 2
Date: Sat, 28 Jan 2017 10:55:09 +0100
From: Thiru Balasubramaniam <thiru at keionline.org>
To: "ip-health at lists.keionline.org" <Ip-health at lists.keionline.org>
Subject: [Ip-health] EB140 heats up during discussions of proposed
        changes to resolution on TOR of Overall Programme Review of GSPOA
Message-ID:
        <CANi=seLOWmK8wYWAC2=_MtHOPyHSidy28cfJYH5Sw+yW0PiquQ at mail.gmail.com>
Content-Type: text/plain; charset=UTF-8

http://keionline.org/node/2718

EB140 heats up during discussions of proposed changes to resolution on TOR
of Overall Programme Review of GSPOA


   -

Submitted by thiru <http://keionline.org/user/6> on 28. January 2017

* (The author thanks the PHM Watchers for their notes of the WHO EB140
deliberations).

On Saturday, 28 January 2017, the Secretariat of the World Health
Organization (WHO) published a marked up, track changed version of the
Terms of Reference of the Overall Programme Review of the WHO Global
Strategy and Plan of Action on Public Health, Innovation and Intellectual
Property based on comments by Fiji, Thailand and the United States of
America. This document can be found here
<http://apps.who.int/gb/ebwha/pdf_files/EB140/B140_CONF7-en.pdf>:
http://apps.who.int/gb/ebwha/pdf_files/EB140/B140_CONF7-en.pdf

Among the changes requested by the United States of America was the
specific inclusion of the phrase "including public-and private-sector
entities involved in biomedical research and development" of the last
sentence of paragraph 1:

Guided by the report of the comprehensive evaluation and, where
appropriate, taking into account other evidence and involving relevant
stakeholders, *including public-and private-sector entities involved in
biomedical research and development*, the programme review will:

A new paragraph c Bis is proposed:

*(c BIS) ensure that over the course of the evaluation, there is
appropriate input and review by the three agencies specified in Resolution
WHA61.21 as implementers of the global strategy and plan of action on
public health, innovation and intellectual property, specifically WIPO, WTO
and UNCTAD;*

New language in paragraph d is proposed (new text in bold):

*(d) based on an assessment of the costs and benefits of the global
strategy and plan of action, determine whether it should be continued to
2022 and, if it is continued, provide *details of what may need to be
improved and modified in the next stage of *its* implementation

A new paragraph 2 is proposed:


*2. The final report of the overall programme review of the global strategy
and plan of action on public health, innovation and intellectual property,
focusing on its achievements, remaining challenges and recommendations on
the way forward will be presented to the Seventy-first WHA in 2018 through
the Executive Board at its 142nd session of the EB.*

On Friday evening, 27 January 2017, the Executive Board attempted a read
through of this document (with the new track changes proposed by Fiji,
Thailand and the United States).

Algeria asked the proponents to explain the rationale behind the amendments.

The United States responded:

The goal of the group should be to seek to identify areas of consensus, so
that there is some consensus in the group and that makes it easier for the
WHA to come to some decision. We are trying to avoid a situation such as
the UNHLP report where there is no consensus. This is to be done in line
with the ten principles of GSPOA. We are feeling that something we often
have not done is take the innovators in the conversation, we need to talk
to the innovators. We always talk about access, and we don?t recognize the
impact of unintended consequences of innovation.

The Chair (Raymond Busuttil, Malta) asked the Board, "can I ask, is the
process we are adopting satisfactory or we should prepare conference paper
in all languages and defer?"

Canada requested more time to digest the contents of the proposed changes
to the resolution.

The Chair suspended Friday evening's consideration of the overall programme
review of the global strategy and plan of action on public health,
innovation and intellectual property. It is expected that Executive Board
will resume discussions on the GSPOA either on Monday, 30 January 2017 or
Tuesday, 31 January 2017.


------------------------------

Message: 3
Date: Sat, 28 Jan 2017 11:22:19 +0100
From: Thiru Balasubramaniam <thiru at keionline.org>
To: "ip-health at lists.keionline.org" <Ip-health at lists.keionline.org>
Subject: [Ip-health] WHO EB140: Statement of India on UN HLP Report on
        Access to Medicines
Message-ID:
        <CANi=seLKEbhrHuure2L_T7FGFUnqz+ZX5_BObN_5zH_py3VaxA at mail.gmail.com>
Content-Type: text/plain; charset=UTF-8

Permanent Mission of India


Geneva


140th Session of the Executive Board of the WHO



8.5 Follow-up of the report of the Consultative Expert Working Group on
Research and Development: Financing and Coordination



UNHLP Report on Access to Medicines


Mr. Chairman, we had earlier made our intervention on this subject when the
provisional agenda item 2 was taken up. In addition to that, we have the
following comments to make:


Mr. Chairman,


At the cost of repetition, delegation of India would like to request WHO to
adequately respond to the UN Secretary General?s High Level Panel report on
access to medicines, since the report is directly relevant to the GSPOA and
the follow up to the CEWG.


Some of the UNHLP recommendations merit immediate consideration, such as
utilizing public health-sensitive Intellectual Property Rights. For
example, countries making full use of TRIPS flexibilities, using licensing
agreements that ensure public health returns for publicly-funded research
(e.g. non-exclusive licensing, donation of IPR, data sharing, etc).,
Creating new incentives for R&D, beyond patent monopolies, coordinating and
sustainably financing R&D through innovative models, de-linking the costs
of R&D from the price of medicines, Negotiating a binding R&D Convention or
Agreement, based on de-linkage and other principles promoting public
health, Ensuring transparency, accountability and governance in the R&D
process.


Some other recommendations which also merit immediate consideration are
that : Governments should require manufacturers and distributors of health
technologies to disclose to drug regulatory and procurement authorities
information pertaining to : (1) the costs of R&D, production, marketing and
distribution of health technology being procured or given marketing
approval with each expense category separated; and (2) any public funding
received in the development of the health technology including tax credits,
subsidies and grants.

The UNHLP report recommends inter alia that building on the current
discussions at the WHO the UN Secretary-General should initiate a process
for governments to negotiate global agreements on the coordination,
financing and development of health technologies, including a binding R&D
convention that delinks costs of R&D from end prices to promote access to
good health for all.


We would like to emphasize that without comprehensively addressing the
issue of access to medicines and vaccines guided by the principles of
affordability and equity, we would not be able to achieve the SDGs and UHC
goals. The UNHLP report can be a very useful instrument to do that. India
would like to propose, therefore, that the EB should recommend to the 70th
World Health Assembly to convene an open-ended meeting of Member States to
discuss the recommendations of the UNHLP and other relevant recommendations
in the report of the CEWG. We would also urge the EB to ask WHO to
undertake a web based consultation with Member States, before the 70th
World Health Assembly, on the UNHLP report and its recommendations.


We would also request EB to consider including this item as a separate
agenda item for the 70th World Health Assembly.

Thank you.


------------------------------

Message: 4
Date: Sat, 28 Jan 2017 11:27:14 +0100
From: Thiru Balasubramaniam <thiru at keionline.org>
To: "ip-health at lists.keionline.org" <Ip-health at lists.keionline.org>
Subject: [Ip-health] EB140: Statement of India on agenda item 8.4
        Evaluation and review of the global strategy and plan of action on
        public health, innovation and intellectual property
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Permanent Mission of India


Geneva
140th Session of the Executive Board of the WHO


8.4 Evaluation and review of the global strategy and plan of action on
public health, innovation and intellectual property


Intervention by India


Thank you Mr. Chairman for giving me the Floor.


The delegation of India has gone through the report and would like to make
the following observations based on our analysis of the report.


A major finding of the evaluation report is the widepread lack of awareness
of the GSPOA and lack of monitoring and reporting systems which were
required under Element 8. We believe that the Secretariat needs to respond
through a stronger promotion of the GSPOA.


We would like to draw the attention of the Board to the resolution WHA56.27
(2003) which requested the DG inter alia to monitor and analyse trade
agreements. However, we find no mention in the Evaluation Report of the
barriers to the full use of TRIPS flexibilities in many bilateral and
regional trade and investment agreements.


Regarding the Programme Review, we would urge the Board to include in the
terms of reference for the programme review a request to review the UN SG
HLP report on Access to Medicines and advise how GSPOA can carry these
recommendations forward. We would also urge the Board to include in the
terms of reference for the programme review a consideration of the elements
of 2003 resolution WHA56.27 (which requested the DG inter alia to monitor
and analyse trade agreements).


Mr. Chair,


India is committed to the process of programme review of the GSPOA and
would like to be actively associated with the process. However, we would
suggest that the terms of reference be approved with focus on effective
implementation and not on reopening of elements of GSPOA. As such, we are
not in agreement with the first ToR, i.e. to assess the   continued
relevance of the aim and objectives of the global strategy and plan of
action.


With these comments, we are prepared to work with WHO and Member States to
reach by consensus a revised ToR for the programme review of GSPOA.

Thank you.


------------------------------

Message: 5
Date: Sat, 28 Jan 2017 17:43:28 +0100
From: Jamie Love <james.love at keionline.org>
To: "Wilson, Paul A." <pw2101 at cumc.columbia.edu>
Cc: Zack Struver <zack.struver at keionline.org>,  Paul Wilson
        <pw2101 at columbia.edu>,  Ip-health <ip-health at lists.keionline.org>
Subject: Re: [Ip-health] Devex: Zika vaccine could be delayed,
        unaffordable after US Army grants exclusive rights to pharma company
Message-ID:
        <CA+aiKTTmb8K+Xg05XOJ81prV1wUv9nJOhJzXQDVriJ5Hf--s5g at mail.gmail.com>
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According to GAVI, these are the countries eligible for GAVI subsidies:
http://www.gavi.org/support/sustainability/countries-eligible-for-support/

Practically none are in the Western Hemisphere.

This is the cost to the US taxpayers

http://www.gavi.org/funding/donor-profiles/united-states/

Paul's point that GAVI will help poor countries implies the Army will give
Sanofi a monopoly, and then ask the US and other governments to tax
citizens to pay
? ?
Sanofi subsidies to make the vaccine cheaper to people in the GAVI eligible
countries.   Sounds like a good plan.  For Sanofi.
?  Not for the taxpayers. ?


Here is the FDA approval letter, from 2009, to the small firm that
registered a vaccine for the Japanese Encephalitis Virus, Vaccine, which,
according to the NIH,
? ?
uses the same platform as the ZKIP vaccine.

Below is a link to and some text from the November 7, 2016 NIH press
release on the first 5 clinical trials the US taxpayers are funding on the
Zika vaccine. And this
? ?
is just the beginning, if the trial results are good.

Note the press release mentions the fact that "BARDA is funding the
advanced development of the ZPIV vaccine candidate through a six-year
contract with Sanofi Pasteur, which established a collaborative research
and development agreement with WRAIR to accelerate further development of
the vaccine."

If the Army is doing the trials itself, even using military personnel as
subjects, funding Sanofi's development work on the vaccine for SIX YEARS, I
don't see how a worldwide life
?-?
of
?-?
patent exclusive license to Sanofi is legal under 35 USC 209, unless the
government
?thinks the statute is not binding.

But really, how crazy is it for the US taxpayers to invent and pay for the
development, and then have to negotiate with a French company to get the
vaccine if it works?   Negotiate a price to avoid having children born with
brain damage and small heads?  (Value based pricing experts, what is that
worth these days?)

You can't just let the NIH or the Army, and Sanofi, wave their hands and
claim an exclusive license (life of patent, worldwide) is actually
"necessary" (the statutory standard), without more transparency and
evidence than what we have now.  The reason the Army wants to avoid a
hearing (and why the NIH never gives them either), is because the facts, if
every made public, don't favor the use of an exclusive license.

Jamie

---------------

https://www.nih.gov/news-events/news-releases/testing-investigational-inactivated-zika-vaccine-humans-begins

"First of five planned clinical trials to test ZPIV vaccine."

WRAIR, NIAID and the Biomedical Advanced Research and Development Authority
(BARDA) part of the HHS Office of the Assistant Secretary for Preparedness
and Response (ASPR) have established a joint Research Collaboration
Agreement to support the development of this vaccine.

Led by WRAIR principal investigator Maj. Leyi Lin, M.D., the new study aims
to enroll 75 people ages 18 to 49 years with no prior flavivirus infection.
Flaviviruses include Zika virus, yellow fever virus, dengue virus, Japanese
encephalitis virus and West Nile virus. Participants will be randomly
divided into three groups: the first group (25 participants) will receive
two intramuscular injections of the ZPIV test vaccine or a placebo (saline)
28 days apart; the other two groups (25 participants each) will receive a
two-dose regimen of a Japanese encephalitis virus vaccine or one dose of a
yellow fever vaccine before beginning the two-dose ZPIV vaccine regimen.
Investigators chose to administer additional flavivirus vaccines because
U.S. service members are often vaccinated against these diseases before
deploying to Zika-endemic areas.

Additionally, a subgroup of 30 of the participants who receive the two-dose
ZPIV regimen will receive a third dose one year later. All participants in
the trial will receive the same ZPIV dose at each injection (5 micrograms).
A DoD Research Monitor, an independent physician not associated with the
protocol, will monitor the conduct of the trial and report any safety
issues to the WRAIR Institutional Review Board. Another independent group,
the Safety Monitoring Committee, will also monitor participant safety,
review data and report any issues to NIAID. As the regulatory sponsor,
NIAID ensures the trial follows the study protocol and informs the FDA of
any significant adverse events or risks. NIAID also maintains the
Investigational New Drug (IND) application(link is external) for the
candidate vaccine. The WRAIR study is expected to be completed by fall 2018.

Four additional Phase 1 studies to evaluate the ZPIV investigational
vaccine are expected to launch in the coming months. These include

A trial enrolling 90 adults ages 18-49 years at the Center for Vaccine
Development at the Saint Louis University School of Medicine. This site is
an NIAID-funded Vaccine and Treatment Evaluation Unit, and Sarah George,
M.D., will serve as principal investigator. All participants will receive
either two injections of ZPIV or a placebo 28 days apart. Participants will
be randomly assigned to receive either a high, moderate or low dose at both
injections to evaluate the optimal dose for use in larger future studies.
A trial enrolling 90 adults ages 21-49 years at the clinical research
center CAIMED, part of Ponce Health Sciences University in Puerto Rico. The
site is supported by NIAID via a subcontract from the Saint Louis
University School of Medicine. This trial will examine the vaccine?s safety
and immunogenicity in participants who have already been naturally exposed
to dengue virus. Participants will be randomly assigned to receive either a
high dose, moderate dose or a placebo. Elizabeth A. Barranco, M.D., will
lead the trial.
NIAID?s Vaccine Research Center (VRC) will test the ZPIV vaccine candidate
as a boost vaccination to its DNA Zika vaccine candidate, which entered
Phase 1 clinical trials in August. The next part of the study, which will
enroll 60 additional participants ages 18-50 years, will take place at the
NIH Clinical Center in Bethesda, Maryland, the Center for Vaccine
Development at the University of Maryland School of Medicine?s Institute
for Global Health in Baltimore, and Emory University in Atlanta. Half of
the participants will receive the NIAID Zika virus investigational DNA
vaccine followed by a ZPIV vaccine boost four or 12 weeks later. The
remaining participants will receive only two doses of ZPIV vaccine four or
12 weeks apart. Julie Ledgerwood, D.O., chief of the VRC?s clinical trials
program, will serve as principal investigator.
A WRAIR-funded trial enrolling 48 adults ages 18-50 years will be conducted
at the Center for Virology and Vaccine Research, part of Beth Israel
Deaconess Medical Center and Harvard Medical School in Boston. One group of
participants will receive a single dose of the ZPIV vaccine and all other
participants will receive two doses of the ZPIV vaccine at varying
intervals. Kathryn Stephenson, M.D., M.P.H., of Beth Israel Deaconess
Medical Center, will lead the trial.

BARDA is funding the advanced development of the ZPIV vaccine candidate
through a six-year contract with Sanofi Pasteur, which established a
collaborative research and development agreement with WRAIR to accelerate
further development of the vaccine.

NIAID conducts and supports research?at NIH, throughout the United States,
and worldwide?to study the causes of infectious and immune-mediated
diseases, and to develop better means of preventing, diagnosing and
treating these illnesses. News releases, fact sheets and other
NIAID-related materials are available on the NIAID website.





http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm142577.htm

On Fri, Jan 27, 2017 at 11:29 PM, Wilson, Paul A. <pw2101 at cumc.columbia.edu>
wrote:
>
> Hi Jamie,
>
> I wish I could say otherwise, but I know nothing more about the deal than
was in the papers, so in speaking to the reporter I was just trying to
provide general background. I pointed out to her that Sanofi?s claim to be
bearing future costs and risks was undercut if they were getting funding
for the trials, as the earlier announcements implied. Another thing that I
don?t understand is what happened to the earlier announcement of a
collaboration involving Fiocruz. Do you know what happened to this?
>
> I didn?t say that only a few big companies can make and distribute
vaccines, but that until now they had been responsible in almost all cases
for bringing truly new vaccines through the later phases of development.
There are some exceptions (such as the Chinese Hep E vaccine) and will
surely be more soon. I don?t have a good sense of how difficult this
vaccine will be to bring through trials and regulatory approval, as I don?t
know anything about the technology involved, although it doesn?t sound
particularly new-fangled.
>
> Another consideration that the army might have had is that no firm based
in a developing country has yet gotten FDA approval for a vaccine, or at
least that was the case when I last checked a while back. Is that still
true to your knowledge? Presumably this is an important ambition of Serum
and perhaps others.
>
> I (and the article) made very clear that Gavi provides no protection for
people in industrialized countries, or even for people in most developing
countries, as the vast majority now live in countries that aren?t eligible
for Gavi support. That?s why any provisions on access and affordability are
so important in deals like this.
>
> Paul
>
> From: Jamie Love <jamespackardlove at gmail.com> on behalf of Jamie Love <
james.love at keionline.org>
> Date: Friday, January 27, 2017 at 12:44 PM
> To: Zack Struver <zack.struver at keionline.org>, Paul Wilson <
pw2101 at columbia.edu>
> Cc: Ip-health <ip-health at lists.keionline.org>
> Subject: Re: [Ip-health] Devex: Zika vaccine could be delayed,
unaffordable after US Army grants exclusive rights to pharma company
>
> Interesting to hear Paul Wilson's opinions.  Does he know much money
Sanofi has promised to invest?
> Sanofi
> told Statnews they expected the US government to pay for the late stage
trials
> .  Was Sanofi lying then, or now?
>  Sanofi certainly is not paying for the current trials
> .  The Army won't say anything about who will be paying for the future
trials, although the NIH is putting out press releases about the six year
funding agreement with Sanofi.
>
>
> T
> he 2009 vaccine for Japanese encephalitis that used the same platform as
ZPIV
> wasn't developed a big pharma company, I believe it was registered by I
> ntercell AG
> , a firm few have heard of.
> The notion that only a few big companies can make and distribute vaccines
is false.
> And in any case, Sanofi has already been given $43 million to work on
this, without a license.
>
> The notion that GAVI is going to protect people in developing countries
from price gouging from Sanofi would be more compelling if Sanofi was not
given exclusive rights.   Why give a company a monopoly and then have a
discussion about the price?   And, what about US residents who want to
avoid having babies with small heads and brain damage?  If GAVI going to
help them?  No.
>
>  Jamie
>
>
> On Fri, Jan 27, 2017 at 5:47 PM, Zack Struver <zack.struver at keionline.org>
wrote:
>>
>>
https://www.devex.com/news/zika-vaccine-could-be-delayed-unaffordable-after-us-army-grants-exclusive-rights-to-pharma-company-89519#
>>
>> Zika vaccine could be delayed, unaffordable after US Army grants
exclusive
>> rights to pharma company
>>
>> By Sophie Edwards | 27 January 2017
>>
>> The U.S. Army?s plan to grant exclusive rights to a promising Zika
vaccine
>> to a major pharmaceutical company has raised questions about whether that
>> threatens its future affordability and availability to people in
developing
>> countries.
>>
>> The purified, inactivated Zika virus vaccine ? called ZP IV ? has been
>> developed by the U.S. Army and is currently in its first phase of testing
>> at the Walter Reed Army Institute of Research in Maryland and the
National
>> Institutes of Health.
>>
>> If it successfully passes clinical trials, the vaccine would have the
>> potential to halt the spread of the virus, transmitted by mosquitoes and
>> sexual intercourse, which has been reported in 69 countries since 2015,
>> including the United States, and is linked to serious birth defects in
>> children.
>>
>> The deal was posted by the Army on the public Federal Register in
December
>> and will give Sanofi Pasteur, the vaccine unit of French multinational
>> pharmaceutical company Sanofi, exclusive access to the new vaccine
>> technology, which has been developed and paid for by the U.S. government.
>> In return, Sanofi will take on the role of conducting clinical trials,
>> getting regulatory approval, manufacturing and distributing the vaccine.
>>
>> The humanitarian aid organization M?decins Sans Fronti?res has criticized
>> the Army?s decision to grant Sanofi the patent license, which will give
the
>> company an exclusive right to make, use and sell the vaccine for 20
years,
>> as well as 12 years of marketing and data exclusivity even after the
patent
>> has expired. MSF is saying this will give the company a monopoly on the
>> drug and thus no incentive to make it affordable. Sanofi could also
choose
>> to stop developing the vaccine if it decides it is commercially
>> unattractive.
>>
>> MSF wants the U.S. Army to consider granting an ?open nonexclusive?
patent
>> license instead, opening up the technology to other pharmaceutical
>> companies for testing and development. MSF argues this will increase
>> competition and thus bring down the price and ensure the vaccine reaches
>> those who need it in middle-income and developing countries.
>>
>> ?Ministries of Health and people around the world will only be able to
>> benefit from the U.S. government investment if the resulting vaccine is
>> effective, safe, available, affordable and suitably adapted to the
>> resource-limited settings where most people affected by Zika virus live,?
>> MSF said in a statement.
>>
>> ?The next step in the Zika vaccine development process, including its
>> licensing and technology transfer strategy, needs to ensure that U.S.
>> government funding and leadership in vaccine R&D results in a vaccine
that
>> is effective and accessible for all patients in need in the U.S. and
>> globally, including the most neglected,? the group added.
>>
>> The United Nations High Level Panel on Access to Medicines, formed in
2015
>> to address the lack of access to medicines in many developing countries,
>> appears to agree with MSF?s recommendations. In its 2016 report, the
panel
>> said: ?Universities and research institutions that receive public funding
>> must prioritize public health objectives over financial returns in their
>> patenting and licensing practices,? and listed the use of nonexclusive
>> licenses, the donation of IP rights, and taking part in public sector
>> patent pools as potential mechanisms by which to do this.
>>
>> Sanofi has responded by saying it?s assuming ?financial and opportunity
>> risks? by partnering with the government on Zika as there is no guarantee
>> of a commercial market for the vaccine.
>>
>> ?...we?re still assuming financial and opportunity risks because there is
>> no clear path to commercialization at this time, as the epidemiology of
>> this infectious disease is still a moving target,? according to Sanofi?s
>> research and development project lead, Jon Heinrichs.
>>
>> The U.S. Army told Devex in an email statement: ?We believe granting an
>> exclusive license in this case is reasonable and necessary to most
quickly
>> and most safely provide this potential vaccine for public use to combat
the
>> growing international threat of the Zika virus.?
>>
>> Unusually, the U.S. Army has requested to extend the time period for
>> comments on the announcement in the Federal Register by an additional 45
>> days until mid-March, the second time the comment period has been
extended,
>> to allow time to compose written responses to the submissions.
>>
>> Experts have predicted the Zika market could be worth more than $1
billion
>> a year, driven by U.S. and European travelers willing to pay high prices
>> for such vaccines, Reuters reported in October.
>>
>> Sanofi is part of a race to develop a Zika vaccine
>>
>> The ZP IV vaccine ? which is thought to be the furthest along in terms of
>> development in the Zika vaccine field ? is developed from the inactivated
>> Zika virus. The vaccine was shown to give 100 percent protection against
>> the Zika virus in mice, according to a study published in science journal
>> Nature last August.
>>
>> Sanofi is not alone in working on the Zika virus vaccine. It is not even
>> the only drug company to receive U.S. government funding to work on the
>> issue; GlaxoSmithKline has partnered with the NIH to evaluate a new
vaccine
>> technology for Zika known as SAM (self-amplifying mRNA), and Japanese
>> company Takeda has also entered the vaccine hunt with $312 million
funding
>> from BARDA.
>>
>> Another group of concerned organizations ? including Knowledge Ecology
>> International, a nonprofit that lobbies to increase access to medicines ?
>> have also written to the Army to complain about the Sanofi deal.
>>
>> KEI says Sanofi does not need to be incentivized to develop the vaccine
and
>> take it to the market ? the standard justification for granting such
>> exclusive licenses ? since the candidate vaccine has already received
>> ?extensive government subsidies? and is extremely likely to get
additional
>> funds.
>>
>> ?The grant of the exclusive rights in the patent is an unnecessary
>> incentive to bring the invention to practical application because of the
>> significant federal funding in the clinical trials and the grant of
>> additional exclusivities and subsidies,? KEI said.
>>
>> In September, BARDA ? the U.S. Biomedical Advanced Research and
Development
>> Authority, a unit within the U.S. Department of Health and Human
Services ?
>> gave Sanofi $43.2 million ?for phase II development and manufacturing? of
>> the Zika vaccine, according to a Sanofi press release.
>>
>> KEI communications and research associate Zack Struver explained that if
>> approved, Sanofi will also earn a priority review voucher from the U.S.
>> Food and Drug Administration, which it could ?sell on for millions of
>> dollars,? and so already has ?sufficient incentive? to develop the
vaccine
>> with or without the exclusive license, he said.
>>
>> Priority review vouchers are designed to speed up the review process for
>> new drug products and thus incentivize drug companies to work to develop
>> treatments for rare diseases or those without a robust market. Vouchers
are
>> transferable and have been sold to other companies for upwards of $300
>> million.
>>
>> However, the statement from the U.S. Army said there was a strong case
for
>> granting Sanofi exclusive rights to the technology, due to competition
from
>> the ?many? groups working on a Zika vaccine. Sanofi is taking on ?risk?
by
>> accruing the license since there is a ?long way to go in terms of time
and
>> money? before a Zika vaccine can be approved, they said. Furthermore, the
>> army is also yet to receive the patent from the U.S. Patent and Trademark
>> Office, and there is a chance it ?may never issue,? adding more ?risk?
for
>> Sanofi.
>>
>> ?The federal government needs a non-federal partner with the research and
>> production capabilities and the willingness to invest their own
substantial
>> funding to most quickly get this product to the market and available for
>> public use,? the spokesperson added.
>>
>> The KEI letter to the army also asks for four conditions to be imposed on
>> the licensing agreement.  These include requiring Sanofi to limit the
price
>> of the vaccine to ?no more than the median price being charged in other
>> high income countries;? limiting the length of time that Sanofi has
>> exclusive rights to the technology, requiring the vaccine be made
>> ?available and affordable? in developing countries; and requiring Sanofi
to
>> be transparent about the costs of research and development.
>>
>> The U.S. Army responded by saying the license agreement has stipulations
in
>> place to ?protect the public interest,? including the option to terminate
>> if Sanofi fails to ?bring the invention to practical application within a
>> reasonable time,? or ?make the benefits of the invention reasonably
>> accessible to the public.?
>>
>> Sanofi says no ?clear path to commercialization? for Zika at this time
>>
>> The pharmaceutical company says that even with the public funding from
>> BARDA, taking ZP IV through the many stages of testing, approval and
>> manufacturing requires Sanofi to take on ?financial and opportunity
risks?
>> due to the fact Zika is ?still a moving target? and there is ?no clear
path
>> to commercialization at this time,? according to Heinrichs, Sanofi?s
>> research and development project lead.
>>
>> ?We have modeled various commercial scenarios including current endemic
>> areas, spread to other geographies and the travel market, among others.
The
>> nature of the epidemiology and spread of the virus will impact the degree
>> of profitability,? Heinrichs said.
>>
>> Sanofi may have a point, according to Paul Wilson, assistant professor of
>> clinical population and family health at Columbia University?s Mailman
>> School of Public Health, who says there is ?genuine uncertainty?
>> surrounding how big the Zika problem will be and how widely a vaccine
would
>> be used. This is compounded, he said, by the fact that the virus could
>> ultimately become widespread but ?without causing harm,? or even die out
as
>> people become immune.
>>
>> If this turns out to be the case, however, MSF?s and KEI?s concerns may
be
>> valid since Sanofi would likely lose interest in the project and fail to
>> drive the vaccine all the way through development, WIlson said.
>>
>> ?I?m sympathetic to MSF?s position ? when you have a vaccine being
>> developed with public funding and you give the rights to one firm, you
have
>> every right to put in place conditions to make sure vaccine will be
>> available to all who need it,? he said.
>>
>> ?The U.S. government has to at least justify why an exclusive license is
>> necessary,? WIlson added.
>>
>> Sanofi could be the best company for the job
>>
>> The company has experience with vaccines against viruses in the same
family
>> as Zika, known as flaviviruses, having developed vaccines for Japanese
>> encephalitis and dengue fever.
>>
>> This could explain why the U.S. Army is keen to entrust the Zika virus
>> vaccine to Sanofi, which is an established player and one with a track
>> record of supplying vaccines to developing countries, according to
Wilson.
>>
>> ?It is still more or less true that only the big multinational
>> pharmaceutical companies have ever been able to successfully bring a
truly
>> new vaccine to market. Even when you have a vaccine candidate that?s at
the
>> stage of this Zika one is now, there are still many challenges involved
in
>> the later stages of development,? he said.
>>
>> However, the capacity of pharmaceutical firms in India, Brazil and China
to
>> develop vaccines is ?growing rapidly? and some of these firms could
>> probably bring the vaccine to market, although perhaps not as rapidly as
a
>> multinational, WIlson said.
>>
>> The vaccine industry has long been dominated by four major multinational
>> pharmaceutical companies ? GlaxoSmithKline, Merck, Sanofi-Pasteur, and
>> Pfizer, which accounted for approximately 86 percent of global vaccine
>> revenue in 2015. Their monopoly is attributed to entry barriers such as
>> high start-up costs and long lead times; vaccines can take anywhere from
10
>> to 16 years to reach the market, preventing other companies from
competing.
>>
>> Phase III trials are technically difficult to conduct and many drugs and
>> vaccines fail them, and developing a robust manufacturing process is
?very
>> technical? and is subject to ?stringent regulatory requirements,? which
can
>> be hard to navigate, Wilson explained.
>>
>> ?The U.S. Army may want a MNC partner because they believe that is the
>> surest way to ensure that the vaccine gets developed quickly. There are
>> only a few companies out there that have the relevant experience and have
>> shown an active interest in developing country markets, which Sanofi has
>> demonstrated,? he said.
>>
>> Access will not be an issue in the poorest countries if GAVI steps in
>>
>> In relation to MSF?s and KEI?s concerns about access to the vaccine, if
>> approved, GAVI, the Vaccine Alliance ? a partnership of major donors and
>> pharmaceutical companies designed to ensure access to vaccines for
children
>> in developing countries ? could support low-income countries in
purchasing
>> the vaccine, Wilson said.
>>
>> Sanofi confirmed in an email to Devex that it has worked with GAVI on
>> distribution of vaccines in the past, and so working with the alliance on
>> the Zika vaccine was ?certainly a possibility,? but that a strategy for
>> ?pricing and distribution? would be developed later in the process.
>>
>> However, the real problem of access will be in middle-income countries,
>> such as Brazil, which are ineligible for GAVI funding but where the
vaccine
>> is urgently needed.
>>
>> ?Sanofi doesn?t see a market in the poorest countries and so they?re
happy
>> to provide vaccines at a reasonable price there through GAVI, since it
>> would be seen as bad PR not to. But they are not necessarily prepared to
>> make those concessions in places like Brazil and India, where the
greatest
>> access concerns would be,? Wilson said.
>>
>> Sanofi has bad track record when it comes to serving developing
countries,
>> MSF says
>>
>> MSF spoke out against Sanofi in 2015 after the company decided to stop
>> manufacturing a pan-African snakebite antivenom because it was no longer
>> lucrative, leaving a gap in supplies that MSF said would be likely to
lead
>> to unnecessary deaths.
>>
>> The NGO is worried that if given the exclusive license for the Zika
>> vaccine, the pharmaceutical company will follow the same path and neglect
>> countries with great need but less opportunities for profit, according to
>> Judit Rius Sanjuan, MSF?s U.S. access campaign manager.
>>
>> Instead, Sanjuan wants the U.S. Army to offer Sanofi a nonexclusive
>> license, which she argued would be ?better public policy,? ensure the
Zika
>> virus has broader geographical scope, and protects the U.S. government
from
>> ?having all its apples in one basket.?
>>
>> There are other ways to get medicines through development and into
markets
>>
>> There have been successful examples of the U.S. government offering
>> nonexclusive licenses for patented technologies through the United
Nations
>> backed Medicines Patent Pool, a global health financing mechanism set up
in
>> 2010 to share drug technology and research to speed up development, lower
>> costs and increase access to newer HIV/AIDS, viral hepatitis C, and
>> tuberculosis treatments in developing countries.
>>
>> MPP works by signing agreements with patent holders ? such as the NIH and
>> the U.S. Army but also nonprofits, pharmaceutical companies and
individuals
>> ? to create a pool of relevant patents. The partners are then licensed to
>> generic drug manufacturers who can then produce generic versions of the
>> medicines, often utilizing more than one patented technology in the
process
>> of development.
>>
>> For example, in 2010, the NIH licensed a patent on Darunavir to the MPP,
>> which spurred the development of a new combination drug. Furthermore,
Johns
>> Hopkins University announced on Jan. 25 that it is licensing its patent
for
>> the drug candidate sutezolid, which could be used to treat tuberculosis,
>> exclusively to the MPP.
>>
>> While the MPP does not currently work on vaccines, and so licensing to
the
>> MPP was not an option for the U.S. Army, these examples set a ?good
>> precedent? for ?innovative? nonexclusive licensing agreements and how
>> effectively sharing research can expedite research and development,
>> increase collaboration, and diversify the medicine development process,
>> MSF?s Sanjuan said.
>>
>> Furthermore, there have been other notable examples of the U.S. granting
>> nonexclusive licenses for the development of vaccines. For example, the
>> human-bovine rotavirus vaccine technology was licensed by the NIH to
eight
>> organizations, one in the United States and seven in the developing
>> countries, to manufacture and distribute the rotavirus vaccine.
>>
>>
>> --
>> Zack Struver, Communications and Research Associate
>> Knowledge Ecology International
>> zack.struver at keionline.org
>> Twitter: @zstruver <https://twitter.com/zstruver>
>> Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428
>> keionline.org
>> _______________________________________________
>> Ip-health mailing list
>> Ip-health at lists.keionline.org
>> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>
>
>
>
> --
> James Love.  Knowledge Ecology International
> http://www.keionline.org/donate.html
> KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love




--
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love


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