PHM-Exch> Big Pharma caught spying on the WHO: Wikileaks reports

[Claudio Schuftan]

*Big Pharma caught spying on the WHO*

December 10, 2009

By Kaitlin Mara (Intellectual Property Watch)[1]

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 focussed 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 from Wikileaks here [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,

basic research and product discovery, product development, manufacturing and
distribution, and

efficiencies.

The leaked documents are all available from Wikileaks 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 harmonising 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 royalities in
particular countries,” the analysis says,

adding that this “does not follow past or current patent pool structures”
and emphasising 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

organisation’s secretariat to prepare an implementation plan. An expert team
analysed 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.”

Kaitlin Mara may be reached at kmara at ip-watch.ch.

As published in Intellectual Property Watch. Thanks to Kaitlin Mara and IP
Watch for covering this

material. Copyright remains with the aforementioned.

Source documents:

Big Pharma inside the WHO: confidential analysis of unreleased WHO Expert
Working Group draft

reports, 8 Dec 2009
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://phm.phmovement.org/pipermail/phm-exchange-phmovement.org/attachments/20101219/ec104510/attachment.html>