[Ip-health] Bridges Weekly: 'REVISED WHO PLAN FOR PHARMACEUTICAL R&D CALLED A 'REASONABLE PLACE TO START'

[Thiru Balasubramaniam]

<SNIP>

Although critics called the new draft vague and unfocused, WHO
officials defended the decision to include most proposals rather than
discarding several to produce a more targeted plan of action. There is
"a thin line to be walked between including too little or too much,"
argued one vice-chair of the committee. Another official told Bridges
that a less inclusive text would not have been consonant with the
secretariat's approach to the talks in the IGWG. "We have sought to
sort out the concerns of all parties with a passionate interest in
advancing research and development for neglected diseases," added WHO
Assistant Director-General Howard Zucker.

GlaxoSmithKline's Jon Pender said that the text formed "a reasonable
basis for discussion."

<SNIP>

Additionally, the draft proposes a focus on 14 diseases, including
diabetes, cardiovascular disease, cancer, HIV/AIDS, tuberculosis,
Chagas disease, dengue, leishmaniasis, and malaria. One source admitted
that he was "puzzled" about where this came from, especially since as
it was not raised in the country submissions.

Another close observer of the process noted that the plan failed to
include concrete instructions on precisely how to accomplish the
various priorities, such as identifying research gaps. Also absent were
details on how any of this would be funded.

<SNIP>

Guilherme Patriota, a counsellor at Brazil's mission in Geneva, said
that he was "not dissatisfied" with the draft and called it a "fair
start." He noted that it contains two important elements: the use of
flexibilities under the 2001 Doha Declaration on TRIPS and Public
Health, and work on new models for innovation, especially those that
aim to decouple drug prices from research funding, such as the prize
fund model.

<SNIP>

Spring Gombe and Thiru Balasubramaniam of Knowledge Ecology
International were mixed in their response to the draft. They noted
that it "contains some welcome statements of access to medicines,
support for the use of TRIPS flexibilities and new methods to create
incentives for research and development for new medicines," but said
that "the plan of action is vague with neither a clear sense of
ownership nor any sense of urgency."

M=E9decins Sans Fronti=E8res' Ellen 't Hoen was similarly lukewarm, telling
Intellectual Property Watch that "the document lacks clear direction
and allocation of responsibilities. However, it is encouraging to see
that it does not shy away from including new proposals such as a patent
pool to deal with immediate access issues and new rules to incentivise
R&D."

<SNIP>

In principle, the final plan of action should be ready for members to
adopt at the May 2008 meeting of the World Health Assembly, though
members such as Bolivia and Bangladesh, have recommended a one-year
extension.

The WHO's Zucker anticipates "a very lively discussion" at the
committee's meeting in November.

-----------

http://www.ictsd.org/weekly/07-09-05/story4.htm

'REVISED WHO PLAN FOR PHARMACEUTICAL R&D CALLED A 'REASONABLE PLACE TO
START'

The World Health Organization has released an updated version of a
potential plan to spur innovation aimed at developing affordable
treatments for diseases that disproportionately affect poor countries.

The forty-one page document, dated 31 July, contains a wide range of
ideas for how to identify research needs, ramp up pharmaceutical
development and innovative capacity, and improve access to medicines.
Notably, it highlights the relationship between intellectual property
and pharmaceutical innovation, both through the use of flexibilities in
WTO rules and the exploration of incentives outside the traditional
patent system. The suggestions in the draft plan were based on a text
developed at the last meeting of the WHO's Intergovernmental Working
Group (IGWG) on Public Health, Innovation, and Intellectual Property as
well as written comments submitted by 22 countries and regional groups
(see BRIDGES Weekly, 25 April 2007).

Although critics called the new draft vague and unfocused, WHO
officials defended the decision to include most proposals rather than
discarding several to produce a more targeted plan of action. There is
"a thin line to be walked between including too little or too much,"
argued one vice-chair of the committee. Another official told Bridges
that a less inclusive text would not have been consonant with the
secretariat's approach to the talks in the IGWG. "We have sought to
sort out the concerns of all parties with a passionate interest in
advancing research and development for neglected diseases," added WHO
Assistant Director-General Howard Zucker.

GlaxoSmithKline's Jon Pender said that the text formed "a reasonable
basis for discussion."

Health activists say that only a small share of global spending on
medical research focuses on problems faced predominantly by developing
countries, even though they account for the bulk of avoidable
ill-health. Some see the ongoing deliberations at the WHO as an
opportunity to explore alternatives to drug patents as a means of
encouraging innovation and the development of new and affordable drugs.

Nuts and bolts of the new draft

The draft global strategy states that despite recent progress on
innovation and access to medicines, the sheer scale of "avoidable
suffering and mortality" means that "more must be done." To this end,
it aims to "provide a medium-term framework for an enhanced sustainable
basis for needs-driven, essential research and development relevant to
diseases that disproportionately affect developing countries." It
focuses on "diseases or conditions of significant public health
importance in developing countries for which an adequate treatment for
use in resource-poor settings is not available."

Like the previous version, the revised plan of action is structured
around eight elements: prioritising research and development needs;
promoting research and development; building and improving innovative
capacity; technology transfer; managing intellectual property;
improving delivery and access; ensuring sustainable financing
mechanisms; and establishing monitoring and reporting systems. It
simplifies parts of the earlier text, and incorporates many -- though
not all - suggestions by governments. The new draft presents the plan
in table format, linking specific actions to stakeholders, time frames,
and measurable indicators of progress.

Additionally, the draft proposes a focus on 14 diseases, including
diabetes, cardiovascular disease, cancer, HIV/AIDS, tuberculosis,
Chagas disease, dengue, leishmaniasis, and malaria. One source admitted
that he was "puzzled" about where this came from, especially since as
it was not raised in the country submissions.

Another close observer of the process noted that the plan failed to
include concrete instructions on precisely how to accomplish the
various priorities, such as identifying research gaps. Also absent were
details on how any of this would be funded.

Alternatives to patents discussed

The new draft softens language on the appropriate level of intellectual
property protection in bilateral trade agreements, following questions
from the US and Australia about whether the WHO text should address
issues dealt with in other international fora. For instance, a phrase
saying that governments should "assure that bilateral trade agreements
do not seek to incorporate 'TRIPS-plus' protection" is replaced with
"promote bilateral trade agreements that do not incorporate
'TRIPS-plus' protection."

As highlighted by several country submissions, the draft calls for
greater collaboration between the WHO, the WTO and the World
Intellectual Property Organization for purposes such as strengthening
education and training in the management of intellectual property. In
this regard, sources at WIPO and the WTO have indicated that they are
providing technical advice to the WHO upon request. However, they added
that implementing proposals that assign tasks to other international
organisations might require further reflection, since institutions have
their own mandates and accountability structures.

At the same time, the revised text added items suggested by countries,
such as Brazil's proposal to assess the impact of data-exclusivity
regulations. In response to the South-East Asia region's call for the
WHO "to compile good practice and lessons on the implementation of
TRIPS flexibilities," the new draft highlights the dissemination of
best practices as a means of promoting legislation that makes use of
TRIPS flexibilities.

The draft does not change the element entitled, "management of
intellectual property." The US government, a traditionally strong
proponent of far-reaching intellectual property rights, had called this
"unclear." Brazil, on the other hand, criticised it for "mistakenly
assum[ing] that the problems faced by developing countries on this
matter are circumscribed to administrative concerns" alone, rather than
obstacles to innovation and access arising from the structure of
existing intellectual property protections.

However, the draft does not adopt some specific suggestions by
countries, such as the South-East Asia Region's call for an
"operational interpretation of 'inventive steps,'" relating to the
technical term used in the evaluation of whether a patent applicant's
invention is sufficiently innovative to deserve a patent. Nor does the
draft adopt Egypt's suggestion for a set of guidelines for the transfer
of technology.

Guilherme Patriota, a counsellor at Brazil's mission in Geneva, said
that he was "not dissatisfied" with the draft and called it a "fair
start." He noted that it contains two important elements: the use of
flexibilities under the 2001 Doha Declaration on TRIPS and Public
Health, and work on new models for innovation, especially those that
aim to decouple drug prices from research funding, such as the prize
fund model.

The draft also calls for further discussion of 'patent pools', a
medical research and development treaty, advanced market commitments
and public-private partnerships, as ways of encouraging innovation and
lowering drug costs. Patent pools, for instance, are created when
patent owners agree to licence their innovations as a package, allowing
third party licensees to exploit the technology encompassed by the
entire bundle. Although such arrangements can lead to economies of
scale, lower prices, and increased innovation, no pharmaceutical patent
pool has yet been formed. Advanced market commitments are binding
promises, generally by governments, to purchase a vaccine or medicine
if and when it is developed. Canada, Italy, Norway, Russia, and the UK
this year launched one such attempt, encouraging research targeting
pneumococcal diseases, a major cause of pneumonia and meningitis.

The new text also makes strong links between trade-related issues and
access to medicines, including support for generic production of
essential medicines, the removal of tariffs and taxes on health care
products, and the use of best manufacturing practices.

Spring Gombe and Thiru Balasubramaniam of Knowledge Ecology
International were mixed in their response to the draft. They noted
that it "contains some welcome statements of access to medicines,
support for the use of TRIPS flexibilities and new methods to create
incentives for research and development for new medicines," but said
that "the plan of action is vague with neither a clear sense of
ownership nor any sense of urgency."

M=E9decins Sans Fronti=E8res' Ellen 't Hoen was similarly lukewarm, telling
Intellectual Property Watch that "the document lacks clear direction
and allocation of responsibilities. However, it is encouraging to see
that it does not shy away from including new proposals such as a patent
pool to deal with immediate access issues and new rules to incentivise
R&D."

Several member governments were reluctant to comment on the text, as
they will soon have to enter into negotiations on it. Regional
consultations are scheduled for August and September, and the second
meeting of the IGWG is scheduled for 5-10 November.

In principle, the final plan of action should be ready for members to
adopt at the May 2008 meeting of the World Health Assembly, though
members such as Bolivia and Bangladesh, have recommended a one-year
extension.

The WHO's Zucker anticipates "a very lively discussion" at the
committee's meeting in November.

ICTSD reporting; "WHO Draft Negotiating Text on IP Cautiously
Received," INTELLECTUAL PROPERTY WATCH, 8 August 2007

---------------------------------
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@keionline.org