E-DRUG: MSF letter to the 60e World Health Assembly
----------------------------------------------------
[The WHO Assembly is starting today; some of the essential drug issues are adressed by the MSF letter below. There will also be debate about a paediatric essential medicines list, and rational use of drugs. WB]
Dear E-drug readers,
Please find below the text of the letter we sent to the World Health
Assembly delegations. Should you wish to receive the PDF file send a message to Mai Do at Mai.do@paris.msf.org
I hope to see many of you this week in Geneva.
Kind regards,
Ellen 't Hoen
MSF Access to Essential Medicines Campaign
+ 33 1 40212836
Geneva, May 2nd 2007
Re: 60th World Health Assembly: agenda items on IGWG and on tuberculosis
On the eve of the 60th World Health Assembly (WHA), we at Médecins Sans
Frontières (MSF) would like to raise key issues related to access to
medicines that will be discussed at the WHA, under the provisional agenda
item 12.20 ³Public health, innovation, and intellectual property: progress
made by the Intergovernmental Working Group² and provisional agenda item
12.6 ³Tuberculosis control: progress and long term planning².
The task of the Intergovernmental Working Group (IGWG) is to draw up a
global strategy and plan of action to provide a framework based on the
recommendations of the Commission on Intellectual Property Rights,
Innovation and Public Health. The framework would aim, inter alia, at
securing an enhanced and sustainable basis for needs-driven, essential
health research and development relevant to diseases that disproportionately
affect developing countries.
At the Working Group¹s first meeting in December 2006, it became clear that
the IGWG has the unprecedented opportunity to address both access problems
and innovation failures related to medicines that are the result of the
current pharmaceutical R&D system.
A number of member states have since made submissions that propose ambitious
plans for a different approach to priority setting and financing of R&D. We
support the notion that the IGWG should not be satisfied with picking of
low-hanging fruit, but should be bold and ambitious in its approach.
We therefore would like to make the following suggestions:
WHO member states should insist on a strong and broad WHO mandate in the
area of R&D, access to medicines and intellectual property.
This role should not be limited to work on the most neglected diseases, nor
should this task be given to other agencies, such as the World Trade Organization (WTO)
or the World Intellectual Property Organization (WIPO). No other international
organisation has the specific WHO health perspective.
WHO should be proactive in giving technical and policy assistance to
countries that want to make use of the flexibilities in patent law to
increase access to existing medicines.
These flexibilities were agreed upon in the WTO Doha Declaration on TRIPS
and Public Health. The initial lack of support expressed by WHO for the
recent compulsory licenses issued in Thailand, is a source of concern about
the direction WHO is taking in an area where its active contribution could
greatly enhance countries¹ ability to secure access to medicines for their
populations. As an immediate action, WHO and the sixtieth WHA should express
support for countries that make use of the TRIPS/Doha flexibilities in
patent law to increase access to medicines.
The IGWG should recognise that any solution to the access and innovation
problems needs to be based on separating paying for the cost of R&D from the
price of drugs.
The current R&D model that pays for innovation through patents and high drug
prices will always create access problems for people in developing
countries, in particular now that pharmaceutical companies can apply for
patents almost everywhere and sources of generic versions of new medicines
are drying up.
The IGWG should therefore examine proposals made by member states, NGOs,
industry representatives and academia that are based on the principle of
separating the cost of R&D from the price of medicines. These include push
and pull proposals with new financing mechanisms such as tax proposals, an
essential health R&D treaty, or prize funds for R&D.
WHO should take the lead in developing a methodology for priority setting in
essential health needs driven R&D.
Such priority setting should go beyond the listing of diseases. It must
define the specific innovation needs in prevention, diagnosis and treatment
for various priority health problems. This work is essential to guide any
approaches for health needs-driven research that are to be examined by the
IGWG.
An immediate action should be to develop and support a global tuberculosis
R&D strategy as pilot activity under a global R&D framework.
The tuberculosis R&D environment is well mapped, with research priorities,
current R&D efforts and further needs comprehensively defined and
identified. This mapping allows the IGWG process to move towards some
concrete targets in the field of TB.
Important steps towards a TB R&D agenda were made at a meeting MSF organised
in January 2007 in New York where representatives from WHO, industry, the
research sector, NGOs and government agreed on a set of principles, which
are attached to this letter.
The IGWG should also support and further develop proposals for pro-health
management of intellectual property.
Such proposals should address issues such as access to compound libraries,
open source innovation models, patent pools and licensing arrangements
(voluntary and compulsory).
We would be most happy to discuss these points with you. Together with other
non-governmental groups, we will hold briefing sessions during the WHA.
Should you wish to be kept informed of these meetings, or to discuss the
points raised in this letter, please send a message to mai.do@paris.msf.org.
We look forward to meeting you in Geneva soon.
Sincerely yours,
Dr Tido von Schoen-Angerer
Executive Director
MSF Campaign for Access to Essential Medicines
Ellen t Hoen, LL.M
Director of Policy Advocacy
MSF Campaign for Access to Essential Medicines
---
Annex
NO TIME TO WAIT
Overcoming the gaps in TB drug development
Conference Statement
On 11-12 January 2007, Médecins Sans Frontières, supported by Weill Cornell
Medical College, convened a symposium entitled No Time to Wait in New York
aimed at stimulating efforts to accelerate the development of effective new
treatments for tuberculosis (TB). The symposium brought together more than
100 experts from around the world, including drug developers, clinical
researchers, health professionals, policy makers, donors, and activists.
Conference participants agreed that current approaches are inadequate to
respond to the urgency of the global TB epidemic.
* TB is a global health emergency. Every year TB kills around 2 million
people and 9 million develop the disease
* Almost half a million new cases of multi-drug resistance (MDR) TB are seen
every year, and cases of extensively drug-resistant (XDR) TB are
increasingly being detected
* TB is the leading killer of people with HIV/AIDS and the inadequacy of
tools to diagnose and treat TB are a major threat to the health and lives of
HIV/TB co-infected individuals
* We have inadequate and outdated tools for rapid diagnosis, inadequate and
outdated drugs to cure many adults and children with TB today, and an
inadequate pipeline to ensure our ability to cure the majority of TB cases
in the future[i] <#_edn1>
* We lack the basic biological understanding of this complex disease to
anticipate the most efficient routes to prevent and treat TB
* Clinical trials for drugs and combinations that could be done today are
being held back because of a lack of funding and capacity as well as
regulatory barriers
* Meaningful gains in TB control will only be made when the treatment of TB,
including drug-resistant TB, can be dramatically shortened and simplified
Participants call upon governments, intergovernmental agencies, researchers,
drug and diagnostic developers, nongovernmental organizations, and funders
to take action in five key areas.
1. Accelerate drug discovery
* The public and not-for-profit sector needs to be guaranteed access to
professional pharmaceutical services, which mostly exist in the private
sector, to develop diagnostics and drugs. Mechanisms must be established to
ensure public access to compound libraries and to build appropriate
libraries with potential to exhibit anti-TB properties, particularly novel
and natural products
2. Expand clinical trial capacity and accelerate clinical development
* Worldwide, only $20 million is spent annually for clinical trials for TB
drug compared to around $300 million for HIV drugs in the US alone.* Funding
bodies should support the creation of a TB clinical trial platform and the
massive expansion of clinical trial capacity, particularly in developing
countries
* There is an immediate priority to shorten the time of clinical drug
development. Criteria for compassionate use must be established by the WHO
and regulatory authorities for important candidate drugs
* In particular, trials for (M)DR-TB drugs must be prioritized because of
the explosive spread of drug resistance and the potential of these trials to
show efficacy rapidly
* Drug trials should seek to integrate studies of potential new diagnostics
3. Support new approaches to R&D
* The lack of TB drug development is a result of the failure of current
profit-driven drug research and development model. The TB community must
engage in the World Health Organization¹s Intergovernmental Working Group on
Innovation, Intellectual Property and Public Health to establish a global
R&D framework to help design new ways of setting R&D priorities and
financing.
* With respect to TB drug development, participants of the New York
symposium support current discussion at the WHO for a treaty on essential
health R&D that addresses the question of who pays for essential medical R&D
and de-links incentives from drug prices, instead rewarding the impact of
inventions according to health care outcomes.
4. Commit to global TB R&D leadership
* Strong political leadership is required to improve collaboration among
scientists, drug developers, care providers, and affected individuals, in
both developed and developing countries, and develop a global priority
research agenda for TB
5. Increase funding for TB R&D activities
* There is a critical funding gap for TB R&D. Around $900 million needs to
be invested annually in the development of new tools for TB, but only $206
million was invested in 2005, and the funding gap is expected to widen over
time.* A dramatic funding increase is needed to support drug research and
development activities. This is above all a matter of political
prioritization.
*Feuer C. Tuberculosis research and development: a critical analysis.
Treatment Action Group, New York, October 2006
[i] <#_ednref1> Casenghi M, von Schoen-Angerer T. Development of New Drugs
for TB Chemotherapy. Analysis of the current drug pipeline. MSF 2006