[Ip-health] SUNS: WHO holds seminar on IPR, Innovation and Public Health Commission report

[Sangeeta]

SUNS #6025 Thursday 11 May 2006

WHO holds seminar on IPR, Innovation and Public Health Commission report

Geneva, 10 May (Sangeeta Shashikant) -- A seminar was held by the World
Health Organisation (WHO) on "The Report of the CIPIH: What Next?", on
Tuesday to discuss follow-up steps after the recent release of the report by
the Commission on Intellectual Property Rights, Innovation and Public Health
(CIPIH).

The Report, entitled "Public Health: Innovation and Intellectual Property
Rights', was published in April and will be the subject of discussion and a
resolution at the World Health Assembly later this month. The WHA in 2003
had requested for the report, and the Commission was established in February
2004.

The Report recommends actions to be taken by governments, the WHO and other
international organizations, and corporations to ensure that people in
developing countries have access to existing and new products to diagnose,
treat and prevent the diseases that affect them the most.

It also calls on WHO "to develop a Global Plan of Action to secure enhanced
and sustainable funding for developing and making accessible products to
address diseases that disproportionately affect developing countries".

Tuesday's seminar was addressed by speakers from the South Centre, Medecins
Sans Frontieres and the Global Fund for AIDS, TB and Malaria.

Sisule Musungu of the South Centre highlighted two parts of the CIPIH
mandate, i. e. the role of IPRs in stimulating the creation of medicines and
other products for diseases that disproportionately affect developing
countries, and the appropriate funding and incentive mechanisms for creating
new medicines within, in addition to, or as an alternative to the IPRs
system.

Musungu said that on the first issue, the report states the fact that a
patent can be obtained may contribute little or nothing to innovation if the
market is too small or scientific and technological capability inadequate.
He added that an earlier Report by the UK Commission on Intellectual
Property Rights (CIPR) had come to the same conclusion.

On the second question, he referred to the Report's conclusion that new
players such as public-private partnerships (PPPs) with innovative capacity
have a part to play in delivering products, and to its recommendation that
the sponsors of the medical R&D treaty proposal should further develop the
idea so that governments may make an informed decision.

The proposal (by 162 academics and NGOs) had been submitted to the
Commission. It advocated for a global medical R&D treaty, in which
governments commit to spending a certain proportion of national income on
medical R&D in a number of ways.

Musungu stressed the need to benchmark progress on the implementation of
decisions and recommendations such as CIPIH's and building the evidence base
through a technical process.

Such benchmarking would permit progress and action while allowing robust
debate, said Musungu, adding that it was a tool to keep the issue on the
agenda, for example, through an annual report on the state of R&D on
diseases that disproportionately affect developing countries. He proposed
parameters for benchmarking progress:

-- to what extent is innovation and R&D related to or based on health needs;

-- to what extent are sustainable investments being made in R&D in areas
that are of the greatest need and to what extent are available mechanisms
reducing the 10/90 gap (i. e. less than 10% of the worldwide expenditure on
health R&D is devoted to the major health problems of 90% of the
population), not just at output level but at the access (consumption) level;

-- to what extent are the mechanisms put in place consistent with the right
to health (do they pay special attention to the vulnerable and marginalised
even within developing countries);

-- to what extent does the system reflect a long-term view of the problem
and have built-in capability to permit an emergency response to unknown
epidemics;

-- to what extent does the system address concerns on burden sharing and
government responsibility for innovation and R&D?

He said the discussion on a global framework on essential health R&D
(proposed by Kenya and Brazil in a draft WHA resolution) is premised on
concepts related to defining global health priorities; incentives and
mechanisms to sustainably fund these priorities; and equitable sharing of
R&D costs. Benchmarking is an essential part in setting up and implementing
such a framework.

He added that the CIPIH's proposed global plan of action is aimed at setting
out strategic medium-term goals to advise on allocating R&D resources for
different diseases and to monitor and evaluate the impact on treatment and
delivery. Benchmarking can also be useful here.

Ellen t' Hoen from Medecins San Frontieres (MSF) said that much in the
report has been said elsewhere, in particular the CIPR report and added that
there is a growing body of evidence that something is fundamentally wrong.

Highlighting the fatal imbalance in R&D, she said that in 1975-1999, out of
1,393 new chemical entities (NCEs) marketed, only 1% of new drugs developed
were for neglected diseases, while in 1999-2004 out of 163 NCEs, only 3 new
drugs for neglected diseases were developed.

She said the Report draws attention to the changing landscape in R&D.
Although there were many initiatives to address the health priority,
sustainable financing is a challenge for all of them. Saying that research
undertaken does not address the needs of today, she gave the example of the
lack of pediatric formulations and fixed dose combinations that are needed
in developing countries.

She asked how would vaccines, additional prevention tools, adapted
treatments and treatments for children be developed without "global action".

On IPRs, she stressed that a paragraph in the Report, "There is no evidence
that the implementation of the TRIPS Agreement in developing countries will
significantly boost R&D in pharmaceuticals on Type II (such as HIV/AIDS and
tuberculosis) and particularly Type III (such as African sleeping sickness
and African river blindness) diseases. Insufficient market incentives are
the decisive factor."

She said that prices of new drugs are very much higher, thus affecting the
number of patients treated as well as health budgets. In Cambodia, South
Africa, Malawi, Kenya, Guatemala and Honduras, the first line treatment
costs less than $500 per person, while the second line treatment costs
between $1000 to over $2000 per person.

The MSF data also showed that only 2.5% of the number of patients treated
under first line can be treated under the second line treatment due to the
higher cost.

She expressed concern about the pursuit for higher levels of IP and an
upward harmonization through WIPO. She stressed that the Report states that
brakes should be put on the pursuit and recognizes "Access to drugs cannot
depend on the decisions of private companies but is also a government
responsibility".

She said that WHO that should play a larger role in this area so that global
policies that will support essential medical research can be achieved and
the money is used to meet real needs.

David Winters, on the next steps for WHO, said that it should really provide
intellectual and moral leadership, being a neutral arbiter of conflicting
interests, and holding regular forums. However, he said that the WHO is "
inherently political", and the question is "whether WHO has the stomach and
the ability to do it".

He stressed the need to establish consensus on a transparent and uniform
cost basis for drug development that includes everything: tax contributions,
initial public funding, clinical trials, advertising, tax rebates,
over-the-counter payments, etc.

He proposed new governance structures that bring private R&D investment more
in line with objectively-defined, global distributions of disease burden.

He added that if health is a human right, then how are R&D systems
understood within a rights-based framework of access and how are private
companies accountable. Also, if R&D is seen from a rights-based approach,
how equitable is the "system" and what obligations and responsibilities do
R&D systems/actors have?

Responding to a question, t' Hoen said that in the Report there is an
enormous gap between the evidence and the recommendations. "We are at a
cross road where the evidence can be ignored or some serious changes are
made," she said. She added that NGOs have concerns whether WHO has the
"stomach" to follow through on the issues, adding that the NGOs do not see a
great deal of leadership coming out of WHO. This is not defensible,
especially looking at the problems and the opportunities. She stressed that
the issue was not just about finance.

In relation to bilateral trade agreements, one of the things that WHO can
do, she said, is to start a discussion on a moratorium on provisions that
undermine the implementation of the Doha Declaration on TRIPS and Heath.

Several times during the meeting, reference was made to two draft
resolutions related to IP, innovation and public health that will be
discussed at the World Health Assembly (22-27 May).

The first resolution is a draft co-sponsored by Kenya and Brazil, on a
global framework on essential health research and development which has been
debated at the WHO Executive Board. The proposal seeks to establish a
working group to consider proposals to support and strengthen incentives and
mechanisms for needs-driven research.

The second is a draft resolution prepared by the Secretariat based on the
CIPIH report, which was discussed at the Board on 28 April.

The initial draft requested the Director General in consultation with Member
States and all interested parties, to prepare a global plan of action to
follow up the recommendations of the Commission, in particular, ways of
addressing diseases that disproportionately affect developing countries.

It also asked the DG to continue to monitor, from a public health
perspective, the impact of intellectual property rights on the development
of new health care products and to report on progress in preparing the
global plan of action.

Following discussions at the 28 April meeting, a new bracketed draft text
will be put before the WHA for further discussion.

Kenya proposed the inclusion of the following language (which is bracketed)
"To take advantage of the flexibilities contained in the WTO TRIPS Agreement
and recognized by the Doha Ministerial Declaration on the TRIPS Agreement
and Public Health in order to protect public health," and "To ensure that
bilateral trade agreements do not seek to incorporate TRIPS-plus protection
in ways that may reduce access to medicines in developing countries."

The revised draft also requests the DG to establish an intergovernmental
working group to develop a global strategy and plan of action built on the
recommendations of the Commission. The working group is supposed to work on
the recommendations of the report and in particular focus on "ways of
addressing diseases that disproportionately affect developing countries."

The revised draft also asks the DG to report on progress in developing the
global strategy and plan of action and to publish a periodic update of a
public health based Research and Development report for pharmaceuticals as
well to monitor, from a public health perspective the impact of IPRs on the
development of and access to health care products and report to the WHA.
Many aspects of the text proposed by the Secretariat are in brackets.

Brazil also proposed the initiation of consultations on the possibility of
elaborating a Framework Convention on Research Development and Innovation on
Public Health in order to define priorities and financing alternatives on
research, development and innovation in health. +