Memorandum by the Organisation for Economic
Cooperation and Development (OECD)
GENERAL REMARKS
1. The Organisation for Economic Cooperation
and Development brings together 30 countries committed to democracy
and the market economy to support sustainable economic growth,
boost employment, raise living standards, maintain financial stability,
assist other countries' economic development and contribute to
growth in world trade. The reach of the Organisation is increasingly
global. In May 2007, OECD countries agreed to invite Chile, Estonia,
Israel, Russia and Slovenia to open discussions for membership
of the Organisation and offered enhanced engagement, with a view
to possible membership, to Brazil, China, India, Indonesia and
South Africa. The OECD also shares expertise and exchanges views
with more than 100 other countires and economies.
2. The Organisation is a global source of
statistics, and economic and social data. The OECD monitors trends,
conducts analyses and develops forecasts of economic and social
changes in numerous fields including in health and science and
technology. The Organisation provides a setting where governments
compare policy experiences, seek answers to common problems, identify
good practice and coordinate domestic and international policies.
3. With regards to the Committee's inquiry,
the current OECD focus is mainly on identifying steps that can
be taken to improve the availability of medical innovations for
neglected and emerging infectious diseases, especially those that
principally affect developing countries.[1]
However, the Organisation has a broad range of other related interests
and activities under, for example, its Health Committee, Development
Assistance Committee, and Africa Partnership Forum as well as
elsewhere, that encompass from time to time issues related to
accessibility and affordability.
4. Together with the Government of the Netherlands,
the OECD recently held a High Level Forum on Medicines for Neglected
and Emerging Infectious Diseases (Noordwijk, the Netherlands,
June 2007). The Forum brought together over 200 high-level participants
from OECD and developing countries, industry, researchers, funders,
academics, philanthropic foundations, international and non-governmental
organisations. Forum participants agreed the Noordwijk Medicines
Agenda (www.oecd.org/sti/biotechnology/nma)
which identifies a number of actions necessary to stimulate innovation
and radically accelerate the development and delivery of new medicines,
vaccines and diagnostics for neglected and emerging infectious
diseases that disproportionately affect developing countries.
The "Noordwijk Medicines Agenda" identified some of
the best opportunities for creating a coherent policy environment
for innovation.
5. OECD member countries are currently considering
how to take forward action related to the Noordwijk Medicines
Agenda within the Organisation's work programme and the Committee's
inquiry is particularly timely in this respect.
RESPONSES TO
SPECIFIC QUESTIONS
Q5. What do you consider to be the principal
blockages to achieving progress in the prevention or control of
the four diseases? And how might these blockages be removed by
more, or better-targeted or better-coordinated intergovernmental
action?
6. There are without doubt blockages remaining
at many levels to achieving progress, but the principal focus
of recent OECD work has been on overcoming the failure of health
innovation systems to deliver appropriate and affordable novel
vaccines and therapies. The approaches advocated under the Noordwijk
Medicines Agenda would not simply improve health through innovation
but may also serve to improve the health of the very system of
innovation itself.
7. In short, there is a dearth of new treatments
and preventive technologies for the major infectious diseases
which primarily affect the developing world. While more than a
billion people are affected, the drug "pipeline" is
weak and in many cases running dry due to the lack of research
and, thus, discovery of new treatments. It is thus becoming clear
that a major blocking factor is becoming upstream research and
discovery as well as downstream delivery. The improvement of upstream
research efficiency and effectiveness is thus of increasing importance
for a continued pipeline of drug and vaccine leads (this "productivity
problem" is of course a more general problem than for infectious
diseases specifically).
8. The OECD has focussed on the question
of whether and how health innovation systems can be improved,
and new incentives schemes created, so as to encourage more investment
in research for the public good. It has also asked how to improve
policy coherence so that research, health, development and finance
policies in member countries can be complementary and work toward
achieving the goal of needed new medicines for neglected infectious
disease.
9. More focused intergovernmental action
could help improve innovation and availability by:
(i) Making the health innovation system for
infectious diseases more open by encouraging the use of more open
business models (as exemplified by the new product development
partnerships) and facilitating global partnering;
(ii) Increasing R&D capacity and take
measures that broadens the involvement of researchers, academic
institutions, laboratories and companies globally;
(iii) Developing innovative mechanisms and
sources of financing based on both for- and not-for profit models;
(iv) Improving access to information, know-how,
technologies and encourage (or create mechanisms) that facilitate
more sharing of knowledge and more collaborative approaches to
research; and
(v) Encouraging dialogue between the health,
research, development, and financial policy communities.
10. Each of these issues is addressed specifically
in the Noordwijk Medicines Agenda. The OECD is well placed to
play a role in taking action forward, not least since it is able
to draw together the key players (governmental, non-governmental,
industry, researchers and civil society) in developing innovation
systems and in delivering innovation.
Q6. What role does your organisation play
in combating the four diseases? Do you believe that it is correctly
configured and adequately resourced to do the job? With which
other organisations do you collaborate? How would you assess the
degree of synergy?
11. The OECD has expertise in several substantive
areas, including:
(i) Mapping, measuring and analysing innovation
systems and economic analysis of policy options to spur innovation
to meet public needs, primarily through its Committee on Scientific
and Technological Policy;
(ii) Aligning and making more effective overseas
development assistance, through the Development Assistance Committee;
(iii) The measurement and improved effectiveness
of health system through its Committee on Health;
(iv) Its analysis of development needs and
policy effectiveness, through the Development Centre and Africa
Partnership Forum.
12. It is widely recognised that no single
specific policy community—nor international committee that
serves it—is likely on its own satisfactorily to address
the full range of issues required to improve upstream innovation
for neglected and emerging infectious diseases. This is as true
for the OECD as for any other intergovernmental organisation.
However, the OECD has the capacity to convene constructive multi-stakeholder
expert discussions of policy options, including with industry
and non-governmental organisations drawing on its diverse committee
structure which ensures representation from most member Country
policymaking communities.
13. The OECD has a very broad base of collaborations
with other organisationas within this subject area. Perhaps most
significantly, the OECD collaborates closely with the WHO (through
the Intergovernmental Working Group on Public Health, Innovation
and IPR (WHO/IGWG) and through WHO/TDR). This collaboration between
WHO and OECD has been fruitful and the Noordwijk Medicines Agenda
calls for action by OECD and other players in conjunction with
the WHO/ IGWG. Discussions on innovation and intellectual property
issues (IP) related to global health are ongoing within the WHO,
as the IGWG develops its Strategy and Plan of Action to be presented
to the 2008 World Health Assembly. This notwithstanding, there
are strong arguments to support deeper partnership for the future
between the two organisations on health innovation for infectious
diseases. Clear recognition of such, and a substantive mechanism
for achieving it, is likely to be in the interests of both organisations
and their members and constituents.
14. A full accounting of the breadth of
OECD ties with other organisations active in the field is beyond
the scope of this paper but is available if necessary. Some key
illustrative partnerships include those with the International
AIDS Vaccine Initiative (IAVI), The Institute for Strategic Threat
Analysis and Response (ISTAR) at the University of Pennsylvania,
United States and the International Federation of Pharmaceutical
Manufacturers & Associations (IFPMA).
Q12. To what extent do you consider that the
rise in infections in the four diseases is attributable to increased
microbial resistance to antibiotics? What intergovernmental action
is taking place in this area?
15. While the OECD has no current work on
microbial resistance to antibiotics, the issue of resistance has
been raised repeatedly by countries as one that needs greater
international attention, and a driver for the reappearance and
spread of diseases including in the OECD countries. The problems
of developing new anti-microbials are said to be similar to the
incentive problems that hamper investment into new vaccines and
therapies for neglected infectious diseases. There is thus an
opportunity for work on improving the policy environment necessary
to spur development of new anti microbials.
Q13. In a number of countries, including the
UK, there is a problem with hospital-acquired infections. What
intergovernmental sharing of knowledge is taking place to help
bring this problem under control?
16. Patient safety is a main focus of current
developmental work on Health Care Quality Indicators in OECD countries.
OECD developmental work on this issue is currently focused on
moving towards allowing consistent coding of hospital discharge
records across OECD countries. This should lead to better and
more reliable measures of the relative impact of hospital acquired
infections.
Q14. Are there any difficulties with regard
to patents or intellectual property which are impeding the flow
of medicines or other control methods to those infected? Is intergovernmental
action needed to improve the situation?
17. The protection and use of intellectual
property rights (IPRs) are important in encouraging investments
in research and development of medicines, vaccines, and diagnostics.
Those involved in developing new health care technologies for
infectious diseases seem generally to agree that patents have
not been a brake in the development process. Broad licensing agreements
(such as set out in the OECD Guidelines on Licensing of Genetic
Inventions, www.oecd.org/sti/biotechnology/licensing)
play an important role in ensuring access to and dissemination
of inventions.
18. However, patents have also not proven
sufficient to stimulate innovation for neglected and emerging
infectious diseases. Complementary reward systems have an important
role in incentivising R&D for these diseases, though further
robust analysis is perhaps necessary for how alternative financing
mechanisms can contribute to the development of medicines, their
strengths and limitations, and an understanding of what mix of
alternative mechanisms could feasibly be put in place.
19. The Noordwijk Forum highlighted the
need for a sustainable architecture that promotes the sharing
and exchange of knowledge, data and research tools necessary for
the discovery of medicines, vaccines and diagnostics for neglected
and emerging infectious diseases. Increased collaboration and
more open innovation could help accelerate and reduce costs of
research in this field. The OECD is exploring the potential value
of collaborative mechanisms for IPRs (such as patent pools or
other IP and data management entities) in the life sciences generally,
and will consider its application to infectious diseases.
Q17. What intergovernmental planning has been
undertaken to cope with the impact of an outbreak of infectious
disease caused by deliberate release of micro-organisms into the
environment? Is there adequate liaison between the various agencies
involved, including intelligence, law enforcement and health care
professionals? How could action by intergovernmental bodies help
further?
—and—
Q18. Though our remit is focused specifically
on known infectious diseases, we would be interested to know how
you view the global threat from new or previously unrecognised
ones and from the transmission of infections from animals to humans
20. In 2001 the OECD introduced the concept
of networking repositories and providers of high quality biological
materials and information, Biological Resource Centres (BRCs).
BRCs are considered a key element of the international scientific
infrastructure, whether within the health sector, the industrial
sector or other sectors. In 2007 an OECD Task Force issued "OECD
Best Practice Guidelines for BRCs" (www.oecd.org/biotechnology/brc)
which cover, inter alia, specific guidelines for BRCs holding
and supplying micro-organisms, specific guidelines for supplying
human-derived materials and biosecurity-related issues.
21. The threat of bioterrorism gives rise
to the need for security measures in legitimate bioscience facilities
that work with, store or transfer dangerous biological material
to protect them from being lost or stolen and subsequently misused
for malevolent ends. In March 2007, the OECD Committee on Scientific
and Technological Policy (CSTP) agreed "Best Practice
Guidelines on Biosecurity for BRCs". The Guidelines on
Biosecurity contain a framework on Risk Assessment to guide BRCs
in classifying pathogens, for example, according to one of four
biosecurity risk levels, and robust Risk Management measures that
may be applied as a function of a particular pathogen's biosecurity
risk level.
Q19. What resources (subscriptions, staff,
training, medicines etc) does the UK Government commit to intergovernmental
bodies to help in the fight against the four diseases listed?
22. The UK has been a leader in the field
of thinking about how to improve the availability and accessibility
of medicines for infectious diseases. The UK role in establishing
an Advanced Market Commitment for pneumoccal disease and the International
Financing Facility for immunisation are impressive examples of
its forward thinking.
23. However, much remains to be done to
both to (1) increase the incentives for research and development
investment into neglected infectious diseases and (2) improve
the efficiency of the international research so that it can deliver
needed new technologies to combat these diseases.
24. The UK could focus more attention on
the "upstream" part of the innovation cycle and it could
encourage the development of open, international research infrastructures
that to help both increase global capacity in neglected disease
drug and vaccine development, and network that capacity so to
break down silos, increase the flow of knowledge and know-how,
and accelerate the discovery of promising new leads.
Q20. Do you wish to provide any other relevant
information in addition to what you have said in answer to the
above?
25. There are several ongoing OECD initiatives
which have elements relevant to the policy discussion around how
innovation systems can better respond to global health needs.
These include the OECD Innovation Strategy which is considering
"global challenges" including health, and the G8-O5
Dialogue on Innovation and Intellectual Property Rights which
is part of the Heiligendamm process.
26. At the OECD Ministerial Council Meeting
in May 2007, Ministers requested that the OECD develop an
OECD Innovation Strategy. Ministers noted "that tools and
networks that promote open access to knowledge and innovative
products and processes are needed to ensure that IP policies continue
to encourage innovation and foster the diffusion of knowledge".
Other aspects of the OECD Innovation Strategy also tie directly
into the NMA (for example, meeting global challenges, including
health).
27. The 2007 G8 Summit in Heiligendamm
mandated the OECD be used as a platform for the Heiligendamm
Dialogue Process between the G8 and Brazil, China, India, Mexico
and South Africa, which includes dialogue on innovation and intellectual
property protection. Moreover it invited countries to identify
priorities that could be enhanced by collaborative research efforts,
joint initiatives, and programmes on areas of common interest.
Actions in the NMA are directly related to these two outcomes
of the 2007 G8 summit.
1 February 2008
1 These diseases generally are designated by the WHO
as Type III diseases which are overwhelmingly or exclusively incident
in developing countries and include: leishmaniasis, schistosomiasis,
onchocerciasis, lymphatic filariasis, Chagas disease, malaria,
leprosy, African trypanosomiasis and dengue. Some experts also
include HIV/AIDS and tuberculosis, which are Type II diseases
incident in both the advanced and developing countries, but with
a substantial proportion of the cases occurring in developing
countries where drug specifications may need to be different.
The OECD work is pertinent to both groups of diseases. Back
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