E-DRUG: MSF's comments on the WHO draft global strategy and PoA on public health, innovation and intellectual property
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Dear all,
Further the NGOs meeting in Brussels on 31st March 2008 with the European
Commission, please find below the written comments by Medecins Sans
Frontieres (MSF) on the WHO draft global strategy and plan of action on
public health, innovation and intellectual property, and our suggestions
for improving the documents during forthcoming negotiations at the IGWG
2bis.
Regards,
Alexandra
Alexandra Heumber
EU Advocacy Liaison Officer
Medecins Sans Frontieres
Access to Essential Medicines Campaign
Rue Dupre, 94. 1090 Brussels
++32 (0) 2 474 75 09 (Dir off)
++ 32 (0) 479 514 900 (Mob)
++ 32 (0) 2 474 75 75 (Fax)
21/04/2008
Comments to the European Commission on WHO draft global strategy and plan
of action on public health, innovation and intellectual property.
A/PHI/IGWG/2/Conf.Paper No. 1 Rev.1 14 December 2007
Further to our meeting in Brussels on 31st March 2008, please find below
the written comments by Medecins Sans Frontieres (MSF) on the WHO draft
global strategy and plan of action on public health, innovation and
intellectual property, and our suggestions for improving the documents
during forthcoming negotiations at the IGWG2bis (28th April - 3rd May
2008).
1. Limiting the scope of diseases is harmful
1.1 The IGWG is not the first forum where the question of limiting the
scope of diseases to a few named diseases is raised. Discussions at Doha,
and later at the WTO TRIPS Council in 2002/2003 on the issue of compulsory
licenses for export to countries with insufficient production capacity
(which resulted in the August 30th solution) also focused on this point.
On both occasions the outcome was clear: delegates concluded that the
measures to overcome the barriers to access to medicines caused by
intellectual property - and the right of countries to implement such
measures - should not be limited in scope to a named list of diseases or
treatments. Nevertheless, footnote 1 (p5) of the IGWG global strategy and
plan of action represents a further attempt to limit the scope of
diseases.
1.2 In addition, a limitation would be in flagrant disregard of the CIPIH
report's recommendations - which the IGWG is supposed to build upon. The
CIPIH report covers Type I, II and III diseases. Such a classification is
helpful, as it offers an analysis of the economic and commercial factors
that create access and R&D problems. The classification also provides a
frame which delegates can use to design solutions that are tailored to
specific problems, problems that may be relevant to one type of disease,
but not the others.
1.3 MSF sees it as crucial, for the strategy and the plan of action to be
effective, that there be no limitation to the scope of diseases. The IGWG
aims to address problems that encompass both R&D and access to medicines.
These problems vary considerably between the different types of diseases,
as classified by the CIPIH. Any limitation in the scope to certain types
of diseases only would therefore be extremely counter-productive to the
IGWG reaching the full range of objectives it has been entrusted with.
1.4 We therefore ask the Commission to support the deletion of the two
sentences that start with "For the purpose of the Strategy" in the
footnote on page 5 [Element 1].
2. R&D priority setting and financing: Proposals that address the
de-linkage of the cost of R&D and the price of health products must be
encouraged and brought forward
2.1 At a 2007 symposium in New York convened by MSF on tuberculosis drug
R&D needs, more than 100 experts from around the world including drug
developers, clinical researchers, health professionals, policy makers,
donors, drug company representatives and activists recognised that "the
lack of TB drug development is a result of the failure of current
profit-driven drug research and development model". 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�. Conference Statement - No Time to Wait, Overcoming
Gaps in TB Drug Research and Development, New York, January 2007.
Available at: http://www.doctorswithoutborders.org/events/TbSymposium/
2.2 There is growing recognition of the need for alternative approaches to
stimulate and direct medical research and development. Relying
predominantly on the patent system to stimulate and finance health R&D has
clearly shown it is unable to deliver for patients in developing
countries, or for those affected by diseases that do not represent a
commercial market.
2.3 The funding gap for R&D is colossal - tuberculosis R&D needs alone,
for example, are estimated at US$ 950 million per year Tuberculosis
Research and Development: A Critical Analysis, Treatment Action Group,
October 2006, available at: http://www.aidsinfonyc.org/tag/tbhiv/tbrandd2.html. In a
worldwide pharmaceutical market already worth US$ 600 billion in 2005 IMS
Health Total Market Estimates and Global Pharma Forecasts, available at
http://www.imshealth.com steering some of that towards R&D for priority
areas could make an enormous difference. It is crucial to bear in mind,
however, that it is not just a question of extra funding. A strategy
based solely on raising extra financial resources - and relying on product
development partnerships to substitute for the pharmaceutical industry for
diseases of little commercial value - clearly has its limitations. Indeed,
addressing the gap will require new approaches that go beyond good will
and philanthropy.
2.4 Relying on patents for financing R&D will merely perpetuate what is
recognised as an inefficient system, in particular for Type II and III
diseases. We ask the Commission to request the WHO Secretariat move
forward with Resolution WHA60.30’s call for the development of further
proposals that address “the linkage of the cost of research and
development and the price of medicines, vaccines and diagnostic kits�. The
Commission should therefore express its willingness to engage as a
stakeholder in the exploratory discussions on other instruments or
mechanisms that have a pro-health approach to priority setting and
financing of R&D and the management of intellectual property, including
inter alia, prize funds, patent pools and an essential health and
biomedical R&D treaty.
2.5 Element 5.3 on incentive schemes for research and development
therefore needs strengthening. It is essential that it be grounded in
practical and timely next steps to encourage the development of such
proposals. In that sense, a meeting to discuss proposals included under
Element 5.3 (a), such as prize funds, should be convened much earlier than
the excessively and unjustifiably lax proposed timeframe 2008-2015. We
also ask the Commission to support prize funds and specifically a prize
fund for the development of an easy to use at point-of-care tuberculosis
diagnostic test.
2.6 Advance Market Commitments are one of the mechanisms â€" and one that
has yet to be seen to deliver efficiently. Any consideration about
expanding the use of AMCs therefore seems highly premature. MSF believes
the first step must be to assess their effectiveness and efficiency before
considering expanding their use [Element 5.3 b].
2.7 The IGWG also provides an opportunity to find better ways to manage
IP, to facilitate the developments of new products. One such proposal is
the patent pool currently under discussion at the UNITAID. Patent pools
offer a potential solution to patent barriers in product development, for
example for the development of generic fixed-dose combinations (FDC) of
the new WHO recommended first-line regimen for HIV/AIDS, where three
different patent holders are involved. As such they deserve to be
mentioned under Element 2.3. In addition, the draft envisages a meeting
devoted to patent pools only in the timeframe 2008-2015 [Element 4.3 (a)].
Given the urgency of these needs, this meeting must happen earlier.
2.8 A pro-health management of IP also includes proposals on access to
compound libraries, policies to ensure access to publicly funded research
and access to compounds resulting from such research for development for
treatments needed in developing countries [Element 2.2 (b) and 2.4 (c)].
We ask the Commission to support these proposals.
2.9 In the process of implementing Resolution WHA60.30, the European
Commission must recognize the WHO as a lead stakeholder (notably
concerning discussions on a biomedical R&D Treaty [Element 2.3 (c)].
2.10 Any endeavours to further alternative mechanisms to stimulate R&D
will also deal with the question of sustainable financing and how to reach
new international agreements on burden sharing of R&D cost. These must
therefore also be mentioned in the text that calls for addressing
sustainable financing mechanisms for R&D that do not come at the expense
of access to medicines. [Element 7.1 (b)]
2.11 In order to aid the task of developing sustainable financing
mechanisms, the European Commission should request WHO to carry out an
objective assessment by independent experts of the costs of R&D, so that
the contested figures about the cost of R&D per drug may be clarified.
[Element 7]
3. Access and delivery: Availability of generic products and competition
between manufacturers must be encouraged and the use of the TRIPS
flexibilities reinforced
3.1 MSF has documented how competition between manufacturers has been the
single most effective mechanism in pushing prices down and enabling access
to medicines. Without the 99% decrease in the price of first-line AIDS
drugs, MSF would not now be able to provide antiretrovirals for over
100,000 patients in 30 countries. MSF pricing guide to antiretrovirals -
Untangling the Web of Price Reductions
www.accessmed-msf.org
3.2 The role of competition is ever more crucial in a “post-TRIPS� era.
Here the CIPIH warns: “now that the [TRIPS] transition period is over,
companies can patent new products in all WTO members (…). It is uncertain
how this might affect worldwide pricing and the accessibility of new
products, and how, in the absence of potential competitive pressure,
pricing of the kind that emerged to date in the antiretroviral market can
be sustained� CIPIH report p135. Newer generation antiretrovirals are
particularly affected â€" with the adoption of new WHO recommendations for
first-line regimens, the best generic price for a first-line is set to
skyrocket from US$99 (old regimen) to, at best, US$487 (new regimen).
Second-line regimens are a further problem: as HIV increasingly becomes a
chronic disease for which life-long treatment must be given, WHO must have
a strategy that addresses how to make these treatments affordable in a
post-TRIPS era, when generic competition can no longer be expected to come
to the rescue.
3.3 Developing countries are increasingly dealing with the double burden
of infectious and non-communicable diseases. Indeed, the World Bank
estimates that by 2015, chronic non-communicable diseases will be the
leading cause of deaths in the developing world Public Policy and the
Challenge of Noncommunicable Diseases, IBRD/World Bank, July 2007. As
such, problems related to the access of new drugs are likely to increase.
3.4 The CIPIH recommends that developing countries “adopt or effectively
implement competition policies and apply the pro-competitive measures
allowed under the TRIPS Agreement in order to prevent or remedy
anti-competitive practices related to the use of medicinal patents� CIPIH
recommendation 4.23 p147
. Yet the draft plan of action’s [Element 6.3] on the role of competition
and the pricing of medicines fails to heed that warning, contenting itself
with stimulating generic competition only after a patent has expired. But
patients cannot afford to wait the twenty-year terms for a patent to
expire before being able to access life-saving medicines. The draft plan -
with its proposal to stimulate generic competition after patent expiry -
shows a lack of understanding of the TRIPS flexibilities such as
compulsory licensing, and a lack of understanding of how they should be
used to increase access while patents are still in force.
3.5 The official European Commission’s position is that it supports the
use of TRIPS flexibilities as per the Doha Declaration on the TRIPS
Agreement and Public Health, to increase access to medicines. The
Commission also prides itself on the role it played in the negotiations
that led to the adoption of the Declaration in 2001. However recent
positions by the Commission with regard to the compulsory licenses issued
in Thailand (as illustrated by the EU Commissioner for Trade Peter
Mandelson’s letters to Thailand Minister of Commerce, dated 10th July 2007
and 21st February 2008) suggest that in practice the Commission’s
activities are at odds with its public pledges, and are reason for
considerable concern.
3.6 We urge the Commission and in particular DG Trade to show its
unequivocal support for the use of the TRIPS flexibilities and the full
implementation of the Doha Declaration in the IGWG process, as requested
by the European Parliament. Resolution of the European Parliament November
30, 2006 & Resolution of the European Parliament July 12, 2007
The Commission should support unambiguous language in Element 5 that
calls for the use of these provisions to increase access, produce and
export generics and to overcome patent barriers in research. The
Commission should not accept any restriction as to diseases or products or
circumstances, nor support procedural requirements that are â€~TRIPS plus’
(such as prior negotiations in a case of public non-commercial use).
3.7 It is important to note here that the progress indicator for Element
6.3 (d) on compulsory licensing for export to “developing countries
declaring a public health emergency� is an inaccurate interpretation of
international legislation enshrined in the TRIPS Agreement, including the
amendment of December 2005, and the Doha Declaration. A declaration of
public health emergency is not a pre-requisite for the issuance of
compulsory licenses for export. This inaccuracy must be corrected and the
italicised fragment removed.
3.8 The IGWG draft addresses issues related to â€~TRIPS plus’ in Element 5.
Developing countries have agreed to abide by TRIPS and the Doha
Declaration, partly on the understanding that this multilateral agreement
would free them from bilateral pressures to adopt higher standards in
intellectual property protection. Yet the European Commission’s trade
policy involves promoting a â€~TRIPS plus’ agenda in health - as is
evidenced by its position on the recent Thai compulsory licenses and
through the promotion of data exclusivity rules that go well beyond the
TRIPS Agreement requirement on data protection.
3.9 We therefore ask the Commission to support proposals that are aimed at
countering â€~TRIPS plus’ provisions. An example is the proposal to
discourage or avoid the incorporation of â€~TRIPS plus’ provisions in
bilateral agreements in Element 5.2 (b).
3.10 In addition, the European Commission should support the
recommendation of the CIPIH report with regard to protection of
pharmaceutical test data. Where the CIPIH report is explicit, recommending
that “developing countries should not impose restrictions for the use of
or reliance on such data in ways that would exclude fair competition or
impede the use of flexibilities built in to TRIPS� CIPIH recommendation
4.2 p122 the draft plan of action is vague and non-committal, only
requiring a diffuse group of stakeholders to “assess the impact of
data-exclusivity regulations� [Element 5.3 (c)]. The draft plan should
build on this analysis and recommendation and not seek to repeat work that
has already been done by the CIPIH.
3.11 Finally, Element 5.1 (b) calls for the exchange of information
between national regulatory authorities (NRA) and patent offices in
developing countries to be established or strengthened. It is important
that this does not result in the NRA playing an active role in patent
enforcement, as is foreseen in some countries’ trade agreements or
regulations. What is crucial is that health experts, including those at
the NRA, play the important role of providing a health perspective to
patent examiners. It is also essential that the action plan addresses the
need for NRAs including in developing countries to play a role in
stimulating R&D for diseases that disproportionately affect developing
countries. This will require developing regulatory practices that weighs
risks and benefits in a manner that reflects the reality of those
countries. The European Commission should request WHO to guide efforts to
strengthen drug regulatory agencies in developing countries and in
particular drug regulation processes that aim at finding practical
solutions regarding drug registration for new medicines disproportionately
affecting developing countries.
4. The role of WHO in IP and public health must be strengthened
4.1 WHO should be encouraged to provide technical and policy support on
issues related to measures to ensure access to medicines for all. This
should not be confined to â€~upon request’ only as this will hamper WHO’s
efforts to develop briefing material for general use and only act on a per
country basis.
4.2 WHO’s failure to provide timely technical assistance to date is to the
detriment of procurement practices in developing countries. NGOs are often
called upon to fill these gaps. The Commission should take a firm stand
and ensure that WHO can fulfil its mandate and not obfuscate the debate by
supporting the view that all trade matters belong to the WTO and all IP
matters to WIPO, or that the WHO can only act â€~upon request’ by a member
state. While there may be a need for coordination between WHO, WIPO and
WTO on the issue of public health and intellectual property [Element 5.1
(i)], it is of vital importance that WHO retain its independence in
providing health-based advice and information on IP issues.
4.3 The recent past has shown how WHO has experienced pressures from
certain key countries when providing information on IP and health â€" to the
extent of calls to withdraw publications and remove WHO’s logo from
publications. See for example:
http://www.ip-watch.org/weblog/index.php?p=409&res=1024_ff&print=0.
Letter from William R. Steiger to Acting Director General of the WHO
Anders Nordström, 18 August 2006
4.4 The Commission should actively reject this kind of pressure on the WHO
when it engages in IP issues and support clear language in the IGWG that
strengthens WHO’s role in IP and health.
5. The proposal to set up a Global Fund for Neglected Diseases should be
amended to ensure that certain conditions are fulfilled: such a fund
should be based on the principle that when R&D is financed up front, the
results of such R&D should be put in the public domain and available for
all to produce and further improve. The Fund should favour open source and
open access R&D and focus on capacity development in developing countries
and diversity in research. It should also go hand and in hand with prize
fund proposals. Instead of patent buy-out â€" which may only be an incentive
to take out more, and not fewer patents in the area of neglected diseases
â€" it may be more sensible to set up a patent pool to overcome patent
barriers to production and R&D carried out with financing of the Fund. In
addition, in order for the Fund not to be an empty promise, countries need
at the next IGWG meeting to indicate how much they are willing to pledge
to such a mechanism.