[Ip-health] Bridges Weekly: WHO Committee Makes Progress, But Falls Short Of Agreement on Health Innovation

Fri May 9 06:49:04 2008

BRIDGES Weekly Trade News Digest - Vol. 12, Number 16 7 May 2008

WHO COMMITTEE MAKES PROGRESS, BUT FALLS SHORT OF AGREEMENT ON HEALTH
INNOVATION

Government negotiators in a World Health Organization committee last
week fell short of finalising a potential plan to encourage
pharmaceutical innovation that better responds to the needs of people
in poor countries. Although they agreed on much of the content of a
draft global strategy, they had to leave some of the most contentious
issues on the links between intellectual property and innovation
unresolved.

The WHO's Working Group on Public Health, Innovation and Intellectual
Property (IGWG) was created in 2006 with a two-year mandate to develop
a global strategy - and financing plan - for identifying needs and
promoting the discovery, development, and delivery of medicines. The
committee was mandated to pay special attention to neglected diseases
that predominantly affect people in poor countries. It was also
charged with finding ways to encourage pharmaceutical innovation in
developing nations.

The committee's recent meeting, which ran from 28 April to 3 May, was
supposed to agree on a strategy and implementation plan to submit to
the World Health Assembly later this month. Instead, the WHO's top
decision-making body will have to determine how to deal with a number
of potential provisions on which negotiators proved unable to find
common ground.

Although this was scheduled to be the IGWG's last session, it is
conceivable that the World Health Assembly could call for the group's
work to be continued.

WHO Director-General Margaret Chan, in her opening remarks to the
session, called the committee's work "a unique opportunity for public
health" that could spur innovation and make healthcare products more
affordable. "In essence, you are forging ways to tackle the gaps in
access to healthcare, and, in so doing, to reduce the gaps in health
outcomes," she said. "You are making the benefits of advances in
medicine and science more inclusive."

Some have viewed the group's deliberations as an opportunity to
explore alternatives to drug patents as a means of encouraging
research, innovation and the development of new and affordable drugs.
They argue that the patent-based model, which rewards innovation by
allowing inventors to charge high monopoly prices, provides no
incentive to respond to medical conditions suffered predominantly by
poor people in developing countries. And by relying on high drug
prices, it fails to balance innovation with affordability and access,
they claim.

Certain public health advocacy groups expressed dissatisfaction with
the outcome of the IGWG meeting, arguing that it had not prescribed
any concrete action. M=E9decins Sans Fronti=E8res said that the
negotiations had "failed to capitalise on the historic opportunity."
Governments had failed to prescribe concrete change to a "broken
system," said Tido von Schoen-Angerer, who heads MSF's Access
Campaign. "What we need to see is a wider, more ambitious framework
for R&D and political leadership, in particular from [the] WHO. The
negotiations have left the greater part of the job undone."

Campaigners called it absurd that a provision stating that drug prices
could impede access to treatment -- a point that they deem obvious --
was the subject of much heated debate before negotiators agreed on it.
A number of issues were ultimately left within square brackets
signalling disagreement, dealing with the right to health, the use of
policies to prevent anti-competitive practices with respect to
medicine and other healthcare products, and ensuring that future
bilateral trade agreements do not provide intellectual property
protections on healthcare that go beyond WTO requirements.

Others, including some government officials, countered that even the
consensus parts of the draft strategy text represented an
unprecedented affirmation of the WHO's ability to address intellectual
property concerns. As critically, the text, brackets and all, did not
close the door to future work on establishing incentives for
innovation that would separate R&D costs from drug prices, such as
prizes or creating a global treaty on medical research and development.

MSF acknowledged that proposals for research and development reform
had remained on the table, crediting the efforts of their developing
country sponsors. "It is now up to the World Health Assembly in May to
translate bold ideas into concrete action, since this meeting failed
to do so," said MSF in a press release.

James Love, of civil society group Knowledge Ecology International,
said that the WHO negotiations were likely to continue beyond the May
World Health Assembly into 2009 - and a new US presidential
administration. Although he praised the draft strategy for mentioning
issues such as prizes and patent pools, he said that it was "weak on
the details of the follow-through." The committee had done little to
identify research and development priorities or lay the groundwork for
future funding, he said.

The International Federation of Pharmaceutical Manufacturers and
Associations' Guy Willis said that his organisation's members were
"pleased that the IGWG process has
resulted in agreement on many practical measures to help address
remaining gaps" in improving healthcare in developing countries.

The 18-page draft strategy reached by 3 May, like earlier versions,
focuses on eight elements: prioritising research and development
needs; promoting research and development; building and improving
innovative capacity; technology transfer; managing intellectual
property for innovation and public health; improving delivery and
access; promoting sustainable financing; and establishing monitoring
and reporting systems.

In a provision from which the US is currently withholding consensus,
the draft calls for the WHO to "play a strategic and pro-active role
in contributing to pursue the agenda on 'public health, innovation and
intellectual property'."

A consensus paragraph specifies that "Intellectual property rights are
an important incentive in the development of new health care products.
However, this incentive alone does not meet the need for the
development of new products to fight diseases where the potential
paying market is small or uncertain."

The text outlines several objectives for supporting research and
development, particularly in developing countries, from creating
public health libraries to making the results of government-funded
research publicly available. It also calls for government to consider
a "research exception" to address public health needs in developing
countries, consistent with the WTO Agreement on Trade-Related Aspects
of Intellectual Property Rights (TRIPS).

One potential provision would have urged governments to consider
pursuing competition policies in order to prevent "anti-competitive
practices related to health products." Governments such as Italy have
suspended patent protection for some drugs after finding patent-
holders to have abused dominant market positions. However, US
opposition meant that the provision remained within brackets, said
Knowledge Ecology International's Thiru Balasubramaniam, who described
it as "distressing" to see progress on remedying anti-competitive
practices "roadblocked."

Fundamental disagreements notwithstanding, Health Action
International's Christian Wagner-Ahlfs observed that governments had
managed to find "consensus on items which some years ago they would
not have even talked about."

The fate of remaining roadblocks will first be determined at the World
Health Assembly, scheduled for 19-24 May.

The draft strategy text is available athttp://www.who.int/phi/documents/IGW=
G_Outcome_document03Maypm.pdf
.

ICTSD reporting.

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

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997