Global strategy and plan of action on public health, innovation and intellectual property

SIXTY-FIRST WORLD HEALTH ASSEMBLY
WHA61.21
Agenda item 11.6
24 May 2008
Global strategy and plan of action on public health,
innovation and intellectual property

The Sixty-first World Health Assembly,
Having considered the report of the Intergovernmental Working Group on Public Health,
Innovation and Intellectual Property;1
Recalling the establishment pursuant to resolution WHA59.24 of an intergovernmental working
group to draw up a global strategy and plan of action in order to provide a medium-term framework
based on the recommendations of the Commission on Intellectual Property, Innovation and Public
Health, and to secure, inter alia, an enhanced and sustainable basis for needs-driven, essential health
research and development relevant to diseases that disproportionately affect developing countries,
proposing clear objectives and priorities for research and development, and estimating funding needs
in this area;
Recalling resolutions WHA49.14 and WHA52.19 on revised drug strategy, WHA53.14 and
WHA54.10 and WHA57.14 on HIV/AIDS, WHA56.27 on intellectual property rights, innovation and
public health, WHA58.34 on the Ministerial Summit on Health Research, WHA59.26 on international
trade and health; and WHA60.30 on public health, innovation and intellectual property;
Welcoming the progress made by the Intergovernmental Working Group in elaborating the
global strategy and the identification of the stakeholders in the plan of action,
1.
ADOPTS the global strategy and the agreed parts of the plan of action2 on public health,
innovation and intellectual property, attached to this resolution;
2.
URGES Member States:3
(1)
to implement the specific actions recommended in the global strategy and plan of action
on public health, innovation and intellectual property;

1 Document A61/9.
2 On the specific actions and stakeholder components.
3 Where applicable, also regional economic integration organizations.

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(2)
to support actively the wide implementation of the global strategy and plan of action on
public health, innovation and intellectual property, and to consider providing adequate resources
for its implementation;
3.
CALLS UPON relevant international organizations and other relevant stakeholders to give
priority within their respective mandates and programmes to implementing the global strategy and
plan of action on public health, innovation and intellectual property;
4.
REQUESTS the Director-General in implementing the global strategy and agreed parts of the
plan of action without prejudice to the existing mandates:
(1)
to provide support for Member States, upon request, in implementing the global strategy
and plan of action on public health, innovation and intellectual property and in monitoring and
evaluating its implementation;
(2)
to support effective promotion and implementation of the global strategy and plan of
action on public health, innovation and intellectual property;
(3) to continue to implement the mandates contained in resolutions WHA49.14 and
WHA52.19 on revised drug strategy, WHA53.14 and WHA54.10, WHA57.14 and WHA56.30
on HIV/AIDS, WHA56.27 on intellectual property rights, innovation and public health,
WHA59.26 on international trade and health, and WHA60.30 on public health, innovation and
intellectual property, as well as WHA55.11 on health and sustainable development, WHA55.14
on ensuring accessibility of essential medicines, and WHA60.18 on malaria, including proposal
for establishment of World Malaria Day;
(4) to finalize urgently the outstanding components of the plan of action, concerning
timeframes, progress indicators and estimated funding needs, and to submit the final plan of
action including the open paragraphs on stakeholders for consideration by the Sixty-second
World Health Assembly through the Executive Board;
(5)
to coordinate with other relevant international intergovernmental organizations, including
WIPO, WTO and UNCTAD, to effectively implement the global strategy and plan of action;
(6) notwithstanding the request in subparagraph (4) above, to prepare a quick start
programme with adequate budget provision and begin immediately to implement the elements
of the global strategy and plan of action on public health, innovation and intellectual property
that fall under the responsibility of WHO;
(7)
to establish urgently a results-oriented and time-limited expert working group to examine
current financing and coordination of research and development, as well as proposals for new
and innovative sources of funding to stimulate research and development related to Type II and
Type III diseases and the specific research and development needs of developing countries in
relation to Type I diseases, and open to consideration of proposals from Member States, and to
submit a progress report to the Sixty-second World Health Assembly and the final report to the
Sixty-third World Health Assembly through the Executive Board;
(8) to reflect, as appropriate, the global strategy and plan of action on public health,
innovation and intellectual property in the further development of WHO’s research strategy;


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(9) to include adequate resources in the forthcoming proposed programme budgets for
effective implementation of the global strategy and plan of action on public health, innovation
and intellectual property;
(10) to monitor performance and progress in implementing the global strategy and plan of
action on public health, innovation and intellectual property, and to report progress to the Sixty-
third World Health Assembly through the Executive Board, and subsequently every two years,
until the fulfilment of the time frame, to the Health Assembly, through the Executive Board.




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ANNEX
Global strategy on public health, innovation and
intellectual property


The context
1.
In resolution WHA59.24 the Health Assembly recognized the growing burden of diseases and
conditions that disproportionately affect developing countries, and particularly women and children.
Reducing the very high incidence of communicable diseases in those countries is an overriding
priority. At the same time, it is important for WHO Member States and the WHO Secretariat to
recognize and better address the increasing prevalence of noncommunicable diseases in those
countries.
2.
Currently, 4.8 billion people live in developing countries, representing 80% of the world
population. Of this number, 2.7 billion, representing 43% of the world population, live on less than
US$ 2 a day. Communicable diseases account for 50% of the developing countries’ burden of disease.
Furthermore, poverty, among other factors, directly affects the acquisition of health products1 and
medical devices, especially in developing countries.
3.
Member States,2 the pharmaceutical industry, charitable foundations and nongovernmental
organizations have taken initiatives in recent years to develop new products against diseases affecting
developing countries and to increase access to existing health products and medical devices. However,
these initiatives are not sufficient to surmount the challenges of meeting the goal of ensuring access
and innovation for needed health products and medical devices. More efforts should be made to avoid
suffering and reduce preventable mortality and to meet the health-related Millennium Development
Goals and to implement States’ obligations and commitments arising under applicable international
human rights instruments with provisions relevant to health.
4.
Proposals should be developed for health-needs driven research and development that include
exploring a range of incentive mechanisms, including where appropriate, addressing the de-linkage of
the costs of research and development and the price of health products and methods for tailoring the
optimal mix of incentives to a particular condition or product with the objective of addressing diseases
that disproportionately affect developing countries.
5.
Advances in biomedical science have provided opportunities to develop new, affordable, safe
and effective health products and medical devices, particularly those that meet public health needs.
Urgent efforts should be made to make these advances more affordable, accessible and widely
available in developing countries.

1 The term “health products” hereafter should be understood to include vaccines, diagnostics and medicines in
accordance with resolution WHA59.24.
2 Where applicable, also regional economic integration organizations.



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6.
The Report of the Commission on Intellectual Property Rights, Innovation and Public Health
provides an analysis of the problems and makes recommendations that form a basis of future actions.
7.
Intellectual property rights are an important incentive for the development of new health-care
products. This incentive alone does not meet the need for the development of new products to fight
diseases where the potential paying market is small or uncertain.
8.
The Doha Ministerial Declaration on the TRIPS Agreement and Public Health confirms that the
agreement does not and should not prevent Members from taking measures to protect public health.
The declaration, while reiterating commitment to the Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS), affirms that the Agreement can and should be interpreted and
implemented in a manner supportive of the rights of WTO Members to protect public health and, in
particular, to promote access to medicines for all.
9.
Article 7 of the TRIPS agreement states that “the protection and enforcement of intellectual
property rights should contribute to the promotion of technological innovation into the transfer and
dissemination of technology, to the mutual advantage of producers and users of technological
knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and
obligations”.
10.
The Universal Declaration of Human Rights provides that “everyone has the right freely to
participate in the cultural life of the community, to enjoy the arts and to share in scientific
advancement and its benefits” and that “everyone has the right to the protection of the moral and
material interests resulting from any scientific, literary or artistic production of which he is the
author”.
11.
The price of medicines is one of the factors that can impede access to treatment.
12.
International intellectual property agreements contain flexibilities that could facilitate increased
access to pharmaceutical products by developing countries. However, developing countries may face
obstacles in the use of these flexibilities. These countries may benefit, inter alia, from technical
assistance.
The aim
13.
The global strategy on public health, innovation and intellectual property aims to promote new
thinking on innovation and access to medicines, as well as, based on the recommendations of the
CIPIH report, provide a medium-term framework for securing an enhanced and sustainable basis for
needs driven essential health research and development relevant to diseases which disproportionately
affect developing countries, proposing clear objectives and priorities for R&D, and estimating funding
needs in this area.


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14.
The elements of the global strategy, which are designed to promote innovation, build capacity,
improve access and mobilize resources, will:
(a)
provide an assessment of the public health needs of developing countries with respect to
diseases that disproportionately affect developing countries and identify their R&D priorities at
the national, regional and international levels
(b)
promote R&D focusing on Type II and Type III diseases and the specific R&D needs of
developing countries in relation to Type I diseases1
(c)
build and improve innovative capacity for research and development, particularly in
developing countries
(d) improve, promote and accelerate transfer of technology between developed and
developing countries as well as among developing countries
(e)
encourage and support the application and management of intellectual property in a
manner that maximizes health-related innovation, especially to meet the R&D needs of
developing countries, protects public health and promotes access to medicines for all, as well as
explore and implement, where appropriate, possible incentive schemes for R&D
(f)
improve delivery of and access to all health products and medical devices by effectively
overcoming barriers to access
(g)
secure and enhance sustainable financing mechanisms for R&D and to develop and
deliver health products and medical devices to address the health needs of developing countries
(h)
develop mechanisms to monitor and evaluate the implementation of the strategy and plan
of action, including reporting systems.
The principles
15.
The WHO Constitution states that “the objective of WHO shall be the attainment by all peoples
of the highest possible level of health”. Accordingly, the WHO shall play a strategic and central role in
the relationship between public health and innovation and intellectual property within its mandates
(including those contained in relevant WHA resolutions), capacities and constitutional objectives,
bearing in mind those of other relevant intergovernmental organizations. In this context, the WHO,
including the regional and, when appropriate, country offices, need to strengthen its institutional
competencies and relevant programs in order to play its role in implementing this global strategy with
its plan of action.
16.
The enjoyment of the highest attainable standard of health is one of the fundamental rights of
every human being without distinction of race, religion, political belief, economic or social condition.

1 For the purposes of this strategy, the definitions of Type I, II and III diseases, are as referred to by the Commission on
Macroeconomics and Health and as further elaborated in the CIPIH report: Type I diseases are incident in both rich and poor
countries, with large numbers of vulnerable populations in each. Type II diseases are incident in both rich and poor countries,
but with a substantial proportion of the cases in poor countries. Type III diseases are those that are overwhelmingly or
exclusively incident in developing countries. The prevalence of diseases and thereby their categorization in the typology can
evolve over time.




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17.
(Deleted)
18.
(Deleted)
19.
The promotion of technological innovation and the transfer of technology should be pursued by
all states and supported by intellectual property rights.
20.
Intellectual property rights do not and should not prevent Member States from taking measures
to protect public health.
21.
International negotiations on issues related to intellectual property rights and health should be
coherent in their approaches to the promotion of public health.
22.
The strengthening of the innovative capacity of developing countries is essential to respond to
the needs of public health.
23.
Research and development of developed countries should better reflect the health needs of
developing countries.
24.
The global strategy and the plan of action should promote the development of health products
and medical devices needed by Member States, especially developing countries, that are:
(i)
developed in an ethical manner
(ii)
available in sufficient quantities
(iii) effective,
safe and of good quality
(iv) affordable and accessible
(v)
used in a rational way.
25.
Intellectual property rights are an important incentive in the development of new health care
products. However, this incentive alone does not meet the need for the development of new products
to fight diseases where the potential paying market is small or uncertain.
26.
Several factors contribute to the price of health products and medical devices, and public
policies should address these factors to increase their affordability and accessibility. Among others,
competition and reduction or elimination of import tariffs on these products and devices can contribute
to the reduction of prices. Countries should monitor carefully supply and distribution chains and
procurement practices to minimize costs that could adversely influence the price of these products and
devices.
The elements
Element 1. Prioritizing research and development needs
27.
Health research and development policies of developed countries need to reflect adequately the
health needs of developing countries. Gaps in research on Type II and Type III diseases and on the
specific R&D needs of developing countries in relation to Type I diseases need to be identified


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urgently. A better understanding of the developing countries' health needs, and their determinants is
essential to drive sustainable research and development on new and existing products.
28.
The actions to be taken to prioritize research and development needs are as follows:
(1.1) mapping global research and development with a view to identifying gaps in research and
development on diseases that disproportionately affect developing countries
(a)
develop methodologies and mechanisms to identify gaps in research on Type II and
Type III diseases and on developing countries’ specific R&D needs in relation to Type I
diseases
(b)
disseminate information on identified gaps, and evaluate their consequences on
public health
(c)
provide an assessment of identified gaps at different levels – national, regional and
international – to guide research aimed at developing affordable and therapeutically
sound products to meet public health needs.
(1.2) formulating explicit prioritized strategies for research and development at country and
regional and inter-regional levels
(a)
set research priorities so as to address public health needs and implement public
health policy based on appropriate and regular needs assessments
(b) conduct research appropriate for resource-poor settings and research on
technologically appropriate products for addressing public health needs to combat
diseases in developing countries
(c)
include research and development needs on health systems in a prioritized strategy
(d)
urge the leadership and commitment of governments, regional and international
organizations and the private sector in determining priorities for R&D to address public
health need
(e)
increase overall R&D efforts on diseases that disproportionately affect developing
countries, leading to the development of quality products to address public health needs,
user friendly (in terms of use, prescription and management) and accessible (in terms of
availability and affordability).
(1.3) encouraging research and development in traditional medicine in accordance with
national priorities and legislation, and taking into account the relevant international instruments,
including, as appropriate, those concerning traditional knowledge and the rights of indigenous
peoples
(a) set
research
priorities
in traditional medicine
(b)
support developing countries to build their capacity in research and development
in traditional medicine




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(c)
promote international cooperation and the ethical conduct of research
(d)
support South-South cooperation in information exchange and research activities
(e)
support early-stage drug research and development in traditional medicine systems
in developing countries.



Element 2. Promoting research and development
29.
There are many determinants of innovation capacity. Political, economic and social institutions
in each country should participate in the development of health research policy, taking into
consideration their own realities and needs. The range of measures to promote, coordinate and finance
public and private research in both developed and developing countries into Type II and Type III
diseases and into the needs of developing countries in relation to Type I diseases needs to be
substantially enhanced. Greater investment, in both developed and developing countries, is essential.
30.
The actions to be taken to promote research and development are as follows:
(2.1) supporting governments to develop or improve national health research programmes and
establish, where appropriate, strategic research networks to facilitate better coordination of
stakeholders in this area
(a) promote cooperation between private and public sectors on research and
development
(b)
provide support for national health research programmes in developing countries
through political action and, where feasible and appropriate, long-term funding
(c) support governments in establishing health-related innovation in developing
countries.
(2.2) promoting upstream research and product development in developing countries
(a) support discovery science, including where feasible and appropriate, voluntary
open-source methods, in order to develop a sustainable portfolio of new products
(b)
promote and improve accessibility to compound libraries through voluntary means,
provide technical support to developing countries and promote access to drug leads
identified through the screening of compound libraries
(c)
identify incentives and barriers, including intellectual property-related provisions,
at different levels – national, regional and international – that might affect increased
research on public health, and suggest ways to facilitate access to research results and
research tools
(d)
support basic and applied scientific research on Type II and Type III diseases and
on the specific R&D needs of developing countries in relation to Type I diseases


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