E-DRUG: Kenya's Proposal "Global Framework on Essential Health R&D"
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[Warning: long message.]
On November 16, 2005, the Republic of Kenya asked the WHO to discuss a
proposed resolution on a "Global Framework on Essential Health Research
and Development" at the January meeting of the WHO's Executive Board.
The Kenya government later provided the WHO with a background document
that explains the resolution. The WHO EB meeting starts January 23.
Below is the text of the proposed resolution, and the background
document.
-------Text of proposed resolution----------
WORLD HEALTH ORGANIZATION
Executive Board
117th Session
January 2006
Global Framework on Essential Health Research and Development
The Executive Board,
Having considered the report of the WHO Commission on Intellectual
Property Rights, Innovation and Public Health;[1] and following current
developments regarding access to medicine and the need to urgently
develop new medicines and other health care technologies,
RECOMMENDS to the Fifty-ninth World Health Assembly the adoption of the
following resolution:
The Fifty-ninth World Health Assembly,
Recalling Resolutions WHA52.19, WHA53.14, WHA54.10, WHA56.27, and
WHA57.14;
Considering the paucity of safe, adapted and affordable new medicines
developed for infectious diseases like Aids, malaria and tuberculosis,
and the lack of drugs, vaccines and diagnostics for tropical diseases or
other illnesses that primarily affect the world’s poorest,
Recognizing the importance of supporting the development of treatments
for diseases that have small client populations,
Concerned about the need for appropriate, effective and safe health
tools for patients living in resource- poor settings,
Noting that more than 70 percent of new drug approvals are for medicines
that do not provide incremental benefits over existing ones,
Considering the importance of developing new medicines to address
emerging health threats such as multi-drugs resistant TB, and other
poverty-related and infectious diseases.
Noting the insufficient funding for research and development for new
vaccines for AIDS and other illnesses,
Recognizing the importance of global public goods such as the Human
Genome Project, and the increasing relevance of open and accessible
public research in advancing science and the transfer of technology,
Noting in addition the promise of new open models for the development of
medical science, the enhanced participation and access to scientific
advances, and increase knowledge;
Noting the importance of public private partnerships (PPPs) devoted to
the development of new essential drugs and research tools, but concerned
about the necessity for the governments in setting a needs- based
priority agenda for health, and granting political support and
sustainable sources of funding for such initiatives,
Recognizing the importance of public and private investment in the
development of new medical technologies,
.
Considering that a number of developing countries have been
strengthening their capacity for new health technologies, and that their
role will be increasingly critical,
Recognizing that intellectual property rights are one of several
important tools to promote innovation, creativity activity and the
transfer of technology,
Recognizing at the same time the importance of providing for a proper
balance between intellectual property rights and the public domain, and
the need to implement intellectual property rules in a manner that is
consistent with the basic human right to health and the promotion of
follow-on innovation,
Concerned about the impact of high drug prices on access to medicine,
and the need to implement intellectual property laws in a manner that
reconciles incentives for development of new medicines with the need to
promote access to all, consistent with Paragraph 4 of the Doha
Declaration on TRIPS and Public Health,
Aware of the need for a new global framework to provide adequate and
sustainable levels of financial support for patient-driven research, and
including in particular for priority medical research,
Having considered a 24 February 2005 request from 162 scientists, public
health experts, law professors, economists, government officials,
members of parliaments, NGOs and others calling for an evaluation of
proposals for a new global trade framework on medical R&D.
Considering the Global Appeal on R&D for Neglected Diseases launched on
8th June 2005 with the support of 18 Nobel Laureates, and the support of
over 2500 scientists and health experts, academics, NGOs, public
research institutes, governments officials and members of parliament,
calling for new policy rules to stimulate essential health R&D,
especially for the most neglected patients;
Noting the need to promote innovation in the mechanisms that support
innovation,
Recognizing the importance of strengthening research capacity of local
public institutions and businesses in developing countries to contribute
and participate in research and development efforts,
Urges Member States:
(1) to make global health and medicines a strategic sector and take
determined action to direct R&D priorities according to the needs of the
patients, especially those in resource-poor settings, and harness
collaborative R&D initiatives involving disease-endemic countries;
(2) to take an active part, together with the World Health Organization
and other international actors, in the development and establishment of
a global framework for defining global health priorities, supporting
essential medical research and development predicated upon the principle
of equitable sharing of the costs of research and development, and
incentives to invest in useful research and development in the areas of
patients’ need and public interest.
(3) to ensure that progress in basic science and biomedicine is
translated into improved, safe and affordable health products – drugs,
vaccines and diagnostics – to respond to all patients’ needs, especially
those living in poverty, and that essential medicines are rapidly
delivered to people;
Requests the Director-General:
(1) to establish a working group of interested Member –States to
consider proposals to establish a global framework for supporting
needs-driven research, consistent with appropriate public interest
issues.
(2) to submit a progress report of the working group of interested
member -States to the Sixtieth World Health Assembly (May 2008) and a
final report with concrete proposals to the Executive Board at its 121st
session (January 2009).
------------text of background document----------------
WORLD HEALTH ORGANIZATION
Executive Board
117th Session
January 2006
Background Document for Proposed Resolution on Global Framework on
Essential Health Research and Development
1. This resolution is a response to a growing concern over the
inadequacy of the current global system for supporting innovation in new
medicines and other health technologies, as well as concern about the
impact of an increasing percentage of people without access to essential
medicines and other technologies for health care, both in terms of their
financial affordability and availability.
2. The resolution seeks the establishment of a global framework for
supporting essential medical research and development predicated upon
the principle of equitable sharing of the costs of research and
development, and incentives to invest in useful research and development
in the areas of patients’ need and public interest. The process to carry
this forward include the creation of a working group of interested
Member-States that would submit a progress report to the Sixtieth World
Health Assembly (May 2008) and a final report with concrete proposals to
the Executive Board at its 121st session (January 2009). As the lead
global agency on health needs, WHO plays a crucial role in priority
setting and the development of policy recommendations on how priority
research can be carried out.
3. Member States are also asked to make global health and medicines a
strategic sector and take determined action to ensure that R&D efforts
address the areas of priority for patient needs, especially for those
living in resource-poor settings, to harness collaborative R&D
initiatives involving disease-endemic countries, and to ensure that
progress in basic science and biomedicine is translated into improved,
safe and affordable health products – drugs, vaccines and diagnostics –
and that such systems work to ensure that essential medicines are
rapidly delivered to people, with special attention to those living in
poverty.
4. Global trade agreements that focus solely on drug patents or drug
prices do not provide sufficient incentives for development of priority
medicines, including but not limited to medicines that are essential to
treat and cure diseases that primarily affect patients living in
poverty, or many of the public goods that are essential for the
development of new medical technologies. High drug prices constitute
increasing barriers to access in all countries. There are also
inadequate mechanisms to enhance the capacity of all countries to
contribute and participate in medical innovation efforts.
5. While the shortcomings of the current system are important
everywhere, the impact on those living in poverty is particularly harsh.
Every day over 35,000 people die from infectious diseases such as AIDS,
malaria, tuberculosis, and other neglected diseases such as
Leishmaniasis, Chagas disease and sleeping sickness. These diseases
affect hundreds of millions of persons, yet we lack safe, affordable,
effective, field-adapted vaccines, diagnostics, and drugs to tackle
them.
6. In cases where medicines are needed where significant numbers of
patients have higher incomes, there is disproportionate emphasis on
products that do not provide incremental benefits over existing ones. A
breakdown of the 1,035 new drugs approved by the US FDA (Federal Drug
Administration) between 1989 and 2000 revealed that more than 3/4 are
classed as having no therapeutic benefit over existing products,
so-called 'me too' drugs (NIHCM 2002). At the same time it was noted
that less than 1% addressed diseases that primarily afflict the poor and
for which new treatments would have the greatest effect on world
healthcare (WHO 2003).
7. There is a growing need to develop new medicines to address emerging
health threats such as multi-drugs resistant TB, SARS, avian flu, and
other infectious diseases. Basic science about infectious diseases
exists and biomedicine is developing extremely fast, but there exist
inadequate sustainable mechanisms and incentives to turn such knowledge
into useful products. There is continued need for new antibiotics, in
the race between society and the pathogen, where each new drug provides
only a temporary breathing space. The current systems of incentives do
not provide sufficient support for the pre- emptive development of new
drugs for resistant strains of disease since there is no market until
resistance is widespread. Growing resistance of bacteria to existing
antibiotics is already a global concern as few new treatments are being
developed. The public needs to develop more effective treatments for
potential health pandemics, like SARS or avian flu, before such
pandemics occur, and to utilize business models for drug development
that ensure that treatments are effective and accessible in resource
poor settings, and benefit everyone, including persons living in
poverty.
8. There is insufficient funding for research and development for new
vaccines for AIDS and other illnesses. Most of the 3.1 million persons
who died of AIDS related illnesses in 2005 were living in poverty. The
development of such vaccines is a global public good, and requires a
multilateral strategy for widespread access. Existing market incentives
are apparently insufficient to encourage the development of many
vaccines, and while some research has been successfully completed
outside the commercial sector, new mechanisms are required to support
the costs of vaccine development and production.
9. Global public goods such as the Human Genome Project (HGP) and other
open and accessible public research projects advance science knowledge,
and also facilitate access to that knowledge, and the transfer of
technology. It is accepted that health research has been accelerated
through immediate free access to the sequence of the human genome and
other related genomic datasets. This success can be seen as part of a
larger shift in public policy towards requiring research data to be
openly accessible (Arzberger et al. 2004) through recognition of the
additional benefit it brings. The creation of global public goods
relevant to health research could be further incentivised through
recognition of each countries support for them.
10. As well as allowing easy data sharing, the Internet has dramatically
lowered the cost of collaboration, thereby proving the potential to
substantially improve health research productivity. As a result, open
collaborative models for research and development are now proving a
competitive alternative to traditional closed proprietary models, such
as open source software development. These models have the potential to
be extended to the development of medical science (Economist, 2004).
Open access business models for scientific publishing are also proving
successful, as a result of the low cost of disseminating information
through the Internet. It has been recognised that their widespread
adoption has huge advantages for the dissemination of knowledge and
transfer of technology as well as being sustainable (Wellcome Trust
2003).
11. New public private partnerships (PPPs) devoted to the development of
new essential drugs and research tools are important, but there is a
need for sustainable sources of funding for such initiatives. Recently
some encouraging initiatives to accelerate the development and delivery
of health tools for the poor have emerged. Not-for- profit partnerships
in the field of infectious and tropical diseases have been established,
and are beginning to build a pipeline for projects, in response to the
needs of neglected patients (Moran 2005). However, the sustainability of
PPPs is in question, as the majority are mainly funded by philanthropic
actors. It is particularly unclear where the resources to finance the
very expensive later stages of development and clinical trials will come
from. Moreover, the response of PPPs remains very limited compared to
the global needs. The WHO Special Programme for Research and Training in
Tropical Diseases (WHO/TDR) has contributed significantly to the
development of new products to be safely used in developing countries,
especially in country disease-control programmes, but its health
performance has suffered from increasingly severe funding constraints.
Redirecting today’s knowledge and scientific expertise to realistically
address essential health needs will mean a substantial shift in the way
health products are valued, financed and made available.
12. A number of developing countries have been strengthening their
capacity for new health technologies, and their role in performing and
directing health care research will be increasingly critical. New models
and financial mechanisms must be pursued in order to create a better
environment for health innovation. Technology transfer and research
capacity strengthening in disease endemic countries should be at the
heart of the endeavour, by making full and appropriate use of the
scientific knowledge and resources that already exist in developing
countries. International cooperation on R&D should be encouraged, so as
to promote scientific training in all developing countries and their
increasing involvement in R&D efforts that respond to public health
problems.
13. Intellectual property rights are one of several important tools to
promote innovation, creativity activity and the transfer of technology.
At the same time, it is important to recognize the need for the proper
balance between intellectual property rights and the public domain, and
the need to implement intellectual property rules in a manner that is
consistent with the basic human right to health. and the promotion of
follow-on innovation. Stronger intellectual property rights do create
incentives to invest in some types of medical innovation, although in
some cases, at a cost of reduced access. It is also well recognized that
in some areas, intellectual property rights are not an effective or
appropriate tool to stimulate innovation. It is important that the
global framework for supporting medical innovation recognise all
mechanisms that stimulate and incentivise R&D, including public sector
funding of R&D, or new business models for stimulating private
investments, such as innovation prizes. There are increasing worries
that in some cases R&D is slowed by the complexities of dealing with
large numbers of patents (CIPRGPRI, 2005). A recent survey has
quantified how serious the situation is, showing that more than 20% of
human genes are patented, some as many as 20 times (Jensen and Murray
2005). Patent thickets can make licensing difficult and inhibit follow
on innovation. A balanced framework for medical innovation does not rely
upon a single incentive mechanism to stimulate innovation, but rather
considers a wide range of mechanisms, each with its own strengths and
weakness, within different institutional, cultural and social settings.
14. Awareness that the current system for driving innovation requires
serious examination was reflected in the establishment by WHO of the
Commission on Intellectual Property, Innovation and Public Health to
“produce an analysis of intellectual property rights, innovation and
public health, including the question of appropriate funding and
incentive mechanisms for the creation of new medicines and other
products against diseases that disproportionately affect developing
countries.” It has also led to a number of private calls for a new
global framework to support medical innovation, including for example a
24 February 2005 request from 162 scientists, public health experts, law
professors, economists, government officials, members of parliaments,
NGOs and others asking the WHA Executive Board for an evaluation of
proposals for a new global trade framework on medical R&D, and a “Global
Appeal on R&D for Neglected Diseases” launched on 8th June 2005 with the
support of 18 Nobel Laureates, and the support of over 2500 scientists
and health experts, academics, NGOs, public research institutes,
governments officials and members of parliament, calling for new policy
rules to stimulate essential health R&D, especially for the most
neglected patients. There are also many other more narrowly targeted
calls for increasing R&D funding for vaccines or microbicides to prevent
the spread of AIDS (IAVI, 2005), new treatments for TB, hepatitis, and
other areas where safe, affordable, and effective treatments are needed.
15. Other UN bodies are also considering aspects of these issues in a
serious and determined manner: in 2004, the World Intellectual Property
Organization (WIPO) began a debate on a new “Development Agenda,” which
includes discussions of how to fashion intellectual property systems in
order to promote both innovation and access. Parallel to the UN
agencies, the World Trade Organization (WTO) adopted the Doha
Declaration on TRIPS and Public Health in 2001, which asked Members to
implement intellectual property laws in a manner “to promote access to
medicine for all.”
16. It is now timely and appropriate to create a forum where WHO
Member-States can evaluate various proposals to create sustainable
mechanisms for the support of needs drive medical R&D, that are
consistent with the need for the development of and access to essential
medicines for all, including those living in poverty.
REFERENCES
Arzberger P, Schroeder P, Beaulieu A, Bowker G, Casey K, et al. (2004).
Science and government. An international framework to promote access to
data. Science 303: 1777-8.
WHO (2004). Priority medicines for Europe and the World http://
mednet3.who.int/prioritymeds/report/final18october.pdf
CIPRGPRI (2005). Reaping the Benefits of Genomic and Proteomic Research:
Intellectual Property Rights, Innovation, and Public Health, National
Academies of Science. http://
www4.nationalacademies.org/news.nsf/isbn/0309100674?OpenDocument
Economist (2004). An open-source shot in the arm? 10th June 2004.
IAVI, “Why women especially need an AIDS vaccine,” May 2005.
Jensen K and Murray F (2005). Intellectual property. Enhanced:
intellectual property landscape of the human genome. Science 310:
239-40.
Moran M (2005). A breakthrough in R&D for neglected diseases: new ways
to get the drugs we need. PLoS Med 2: e302.
NIHCM (2002). Changing Patterns of Pharmaceutical Innovation. http://
www.nihcm.org/innovations.pdf.
Wellcome Trust (2003). Costs and Business Models in Scientific Research
Publishing. http://www.wellcome.ac.uk/doc_WTD003185.html
WHO (2003). World Health Assembly Resolution 27: Intellectual property
rights, innovation and public health. http://www.who.int/gb/
EB_WHA/PDF/WHA56/ea56r27.pdf.
--
Mike Palmedo
Research and Web
Consumer Project on Technology
T – 202-332-2670
F – 202-332-2673
mpalmedo@cptech.org
James Love <james.love@cptech.org>