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by
Kaitlin Mara
Intellectual Property Watch
December 10, 2009
from
WikileaksMirror Website
Spanish version
Confidential documents related to the
World Health Organization Expert Working Group on innovative
financing for research and development surfaced today, revealing the
group’s thinking as well as pharmaceutical industry thinking about
the WHO process.
The documents immediately raised concern
about possible undue access to the process by industry; the WHO told
Intellectual Property Watch the industry group was not supposed to
have the documents.
The documents appear to have come from the International Federation
of Pharmaceutical Manufacturers and Associations (IFPMA), and
include draft reports on innovative financing mechanisms from the
working group as well as an analysis by the IFPMA on the reports’
contents.
They were released on
WikiLeaks, a
website that anonymously publishes sensitive documents.
”IFPMA was not supposed to have
working drafts of the expert working group in their possession
and they were not given these documents,” said Precious Matsoso,
director of Public Health Innovation and Intellectual Property
(PHI) at the WHO, under whose auspices the expert working group
falls.
“It was understood by the working
group that its report is intended for the director general and”
WHO members, she added.
Public health advocates reacted strongly
to the leaked documents.
“The IFPMA document confirms much of
what had been feared,” that there is “a larger WHO strategy to
protect the status quo, particularly as it relates to
intellectual property issues,” said James Love, the director of
Knowledge Ecology International, a non-profit group focused on
transparency in policymaking and which has been advocating for
prize funds, a biomedical R&D treaty, and other initiatives to
fund R&D.
An introductory letter included with the
documents addressed to the Public Health Advocacy Committee at IFPMA
says,
“the overall result [of the working
group’s report] is in line with most of the industry positions
on this matter,” but says that “there is still room for them to
introduce new language” as the documents date from before the
final working group meeting concluded on 2 December.
The Expert Working Group’s “comparative
analysis of innovative financing proposals for health R&D,”
available
here below [pdf], divides aspects of drug
development into six categories and then lists the ideas from “least
likely” to “most likely” to work.
The six categories are:
-
fundraising
-
research and development
capacity building in developing countries
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basic research and
product discovery
-
product development
-
manufacturing and
distribution
-
efficiencies
The leaked documents are all
available here.
Expert
Analysis
The draft reports available on Wikileaks do not contain final
recommendations.
These will be available only in the
final report, expected to be released this week (IPW,
WHO, 7 December 2009). Instead, it contains an analysis
of all proposals made thus far, through two calls for advice from
the public, and ranks them on efficacy and feasibility.
Within “fundraising,” proposals considered “least likely to work”
include diverting existing resources to health, reducing tax evasion
and havens, levying new charges on services or access rights. A
proposal for a “Green IP” system (IPW,
Inside Views, 27 June 2008) is currently “too hard to
operationalise” but some elements could potentially be useful.
Most likely to work include new indirect taxes, for example on
internet users; voluntary private contributions, new donor funds,
and taxes on pharmaceutical profits. Taxing pharmaceutical profits
is estimated to generate only USD 160 million versus, for example, a
potential USD 2 billion from internet taxes.
On building research capacity, specific recommendations are not
made, but the report says there is a lot of potential in this idea
as innovative pharmaceutical development is often done in commercial
ventures and, in developing countries,
“commercial targets often have
significant overlap with public health targets,” as local
markets demand treatment for neglected diseases.
On basic research, prize systems and
prize funds for completed drugs, as well as a “health impact fund,”
are deemed least effective, as is the idea of a biomedical R&D
treaty.
“Endstage prizes” and the treaty were
also seen as not particularly beneficial for product development.
Prizes have been advocated as a solution to R&D financing problems
by several health advocacy NGOs (IPW,
Public Health, 12 February 2009).
Deemed more effective in incentivising research were funding for
product development partnerships, grants to companies working on
neglected diseases, and prizes for reaching “milestones” (such as
those provided by Innocentive). Similar incentives were considered
beneficial for product development.
Prizes were seen as possible incentives for manufacturing and
distribution, though “likely only for diagnostics” as opposed to
vaccines or medicines.
“Absolutely
Fair Towards the Industry”
The draft report, the IFPMA
said, is “absolutely fair” regarding
industry concerns, using “real figures” on the cost of drug and
vaccines developments and containing,
“many references to the
importance of intellectual property… to achieve further
innovation.”
As far as streamlining the current R&D system, which the report
calls “unwieldy,” removing data exclusivity was seen as less
effective compared to harmonizing medicine regulatory systems and
“pre-competitive platforms” for R&D.
The IFPMA analysis raised two major concerns.
The first relates to proposed taxes on the pharmaceutical industry,
which the IFPMA document says,
“places the burden of the R&D …
exclusively on industry and reinforces the negative image of
pharmaceutical profits.”
“Operationalising this proposal may lead to companies increasing
prices to compensate which would be counterproductive,” it adds.
Further, it is not certain to be acceptable by all partners “as
the tax should be imposed on the whole pharmaceutical sector,
generic included.”
The second area of concern is
drug-purchasing mechanism
UNITAID’s proposed patent pool, and in
particular its structure for royalty payments to IP owners.
These payments would be determined based
on the,
“therapeutic benefits and the
affordability of royalties in particular countries,” the
analysis says, adding that this “does not follow past or current
patent pool structures” and emphasizing that voluntary
participation should be an “essential prerequisite.”
A UNITAID board meeting on 14-15
December will review an expert study on the patent pool, which the
UNITAID board agreed in principle to establish in July 2008.
In May 2009, the board instructed the
organization's secretariat to prepare an implementation plan. An
expert team analyzed a range of issues and its report, completed in
November, clearly recommends the implementation of the pool, sources
told Intellectual Property Watch.
The IFPMA analysis also called for vigilance regarding the potential
use of open source systems.
NGOs -
Documents “A Step Backwards”
Love said the expert working group process was,
“a step backwards” and “evidence of
a deeper problem in WHO regarding the influence of the
pharmaceutical industry, and its philanthropic supporter, the
Microsoft founder’s Gates Foundation.”
”This is a very disturbing set of documents,” said Sarah
Rimmington, from nongovernmental organization Essential Action’s
Access to Medicines Project.
She added that the report,
“embraces
the status quo and rejects the feasibility of almost every
single important proposal aimed at truly solving these
complicated problems.”
Big Pharma Inside the WHO
Confidential Analysis of Unreleased WHO Expert
Working Group Draft Reports, 8 December 2009
December 9, 2009
from
WikileaksMirror Website
Spanish version
Summary
This is a confidential pharmaceutical industry trade association
dossier about the WHO Expert Working Group (EWG) on R&D Financing.
The International Federation of Pharmaceutical Manufacturers &
Associations (IFPMA; "Big Pharma") gave its members 4 documents:
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a
non-public draft report of the WHO EWG
-
a non-public Comparative
Analysis done by the working group
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the IFPMA Overview of the EWG
Comparative Analysis
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IFPMA summary slide on the EWG
Draft Report
The compilation of documents shows the influence of "Big Pharma" on
the policy making decisions of the WHO, the UN body safeguarding
public health. These confidential documents were obtained by the
drug industry before their public release to WHO member states
(scheduled to be released May 2010).
The document also illustrates
that the WHO expert group was highly responsive to industry lobbying
- a result that public health groups had feared since early 2009,
when the expert group met with the industry, but refused to meet
with public health groups known to be industry critics.
The likely audience for these documents include countries, public
health policy makers, civil society, industry, academia, media,
patients and the general public.
Journalists can contact,
-
Dr Margaret Chan, Director-General of WHO: chanm@who.int
-
Malebona Precious Matsoso, WHO Director, Public
Health, Innovation and Intellectual Property: matsosom@who.int
According to our source, the English version of the final report of
the EWG with its recommendations is expected to be released to
member state countries this week.
Contents
Video
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December 1, 2010
from
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Attorney Mark Lanier on why Wikileaks is going after drug companies
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