and of on and in the eastern mediterranean region · coordination (rpc) units have both joined...

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Implementing

Global Strategy and Plan of Action on Public Health, Innovation

and Intellectual Property

in the Eastern Mediterranean Region

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Table of Contents LIST OF ACRONYMS AND ABBREVIATIONS ----------------------------------------------------------------------------------- 3 INTRODUCTION -------------------------------------------------------------------------------------------------------------------------- 4 IMPLEMENTATION PLAN OF GSPA IN EMR COUNTRIES----------------------------------------------------------------- 6

ELEMENT 1. PRIORITIZING RESEARCH AND DEVELOPMENT NEEDS ----------------------------------------------------------------- 6 ELEMENT 2. PROMOTING RESEARCH AND DEVELOPMENT --------------------------------------------------------------------------10 ELEMENT 3. BUILDING AND IMPROVING INNOVATIVE CAPACITY-------------------------------------------------------------------18 ELEMENT 4. TRANSFER OF TECHNOLOGY ---------------------------------------------------------------------------------------------23 ELEMENT 5. APPLICATION AND MANAGEMENT OF INTELLECTUAL PROPERTY TO CONTRIBUTE TO INNOVATION AND PROMOTE PUBLIC HEALTH---------------------------------------------------------------------------------------------------------------25 ELEMENT 6. IMPROVING DELIVERY AND ACCESS-------------------------------------------------------------------------------------34 ELEMENT 7. PROMOTING SUSTAINABLE FINANCING MECHANISMS-----------------------------------------------------------------41 ELEMENT 8. ESTABLISHING MONITORING AND REPORTING SYSTEMS --------------------------------------------------------------43

ANNEX 1 – RECOMMENDATIONS OF THE COMMISSION ON INTELLECTUAL PROPERTY RIGHTS, INNOVATION AND PUBLIC HEALTH --------------------------------------------------------------------------------------------44

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List of Acronyms and Abbreviations

ACHR Advisory Committee on Health Research

CIPIH Commission on Intellectual Property, Innovation and Public Health

DHS Division of Health Sector Development

EMP Essential Medicines and Pharmaceuticals

EMR Eastern Mediterranean Region

EMRO Eastern Mediterranean Regional Office

EST Evidence-based Health Situation and Trend Assessment

GMP Good Manufacturing Practice

GSPA Global Strategy and Plan of Action on Public Health, Innovation and

Intellectual Property

HEC Health Economics

HRD Human Resources Policy and Management

IGWG Intergovernmental Working Group

OECD Organization for Economic Cooperation and Development

PHI Public Health and Innovation

PHP Policy and Health Planning

RPC Research Policy and Cooperation

TRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights

UNCTAD United Nations Conference on Trade and Development

UNIDO United Nations Industrial Development Organization

WHO World Health Organization

WIPO World Intellectual Property Organization

WTO World Trade Organization

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Introduction Background Realizing the importance of the recommendations of the Commission on Intellectual Property, Innovation and Public Health (CIPIH)1, an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) was established following World Health Assembly resolution WHA59.242. The IGWG aimed at further processing and elaborating on the recommendations of CIPIH. Its work resulted in developing the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA), which is a comprehensive framework that aims at promoting “new thinking on innovation and access to medicines”3, providing guidelines that cover challenging aspects of access to medicines in developing and least developed countries. The Eastern Mediterranean Regional Office (EMRO) has started the process of contextualization, and eventually implementation, of the GSPA in the region, in a manner that is consistent with the region’s current situation and needs. This regional strategy and plan of action is presented in a format which builds on the structure and elements of the GSPA, while assigning the roles within WHO EMRO units and divisions, wherever relevant, in light of current and/or planned activities in the region. Process

1. The WHO EMRO Essential Medicines and Pharmaceuticals (EMP) and Research Policy and Coordination (RPC) units have both joined hands and resources, and started this project on the plan of implementation of the GSPA in EMR.

2. A joint memo has been sent from EMP and RPC through the Division of Health Services (DHS)

and Assistant Regional Director (ARD) to Dr. Hussein Gezairy, the Regional Director, who has supported the initiative. The memo suggested the creation of a regional advisory group with the aim of advising and overseeing the implementation of GSPA in EMR, and this has also been agreed by the RD.

3. There are other technical units in EMR that have a definite role in this implementation process,

and RPC and EMP are in the process of conducting individual consultations with those technical units to ensure their input in this implementation process.

4. EMP and RPC are working closely with WHO HQ, both through the Secretariat of Public health

and Innovation (PHI) in the Director General’s Office, as well as EMP department, in terms of developing the global implementation plan, monitoring and reporting processes and resource mobilization.

5. Once the draft plan of implementation of GSPA in EMR is concluded and agreed in-house, the

meeting of the first regional advisory group will be convened and after their input, modification of the draft and its finalisation and adoption, the implementation process will start.

Approach The approach adopted during this planning process has been deeply inspired by the CIPIH report, particularly its recommendations section (See Annex 1). The regional plan is building on the Global Plan of Action in terms of contextualizing it to the situation and priorities of the EMR. In so doing, the

1 World Health Organization (2006). Report of the Commission on Intellectual Property Rights, Innovation and Public Health. Available at: http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf 2 Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA59/A59_R24-en.pdf 3 WHA61.21 Available at: http://apps.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf

http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf

http://apps.who.int/gb/ebwha/pdf_files/WHA59/A59_R24-en.pdf

http://apps.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf

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basic framework of the Global Plan of Action, has been followed, in terms of its elements, sub-elements and identified stakeholders. Implementation Plan The implementation plan consists of three parts:

1. Elements and sub-elements of the GSPA modified for the EMR. 2. Plan of activities which will take place until the convening of the advisory group meeting, date

of which is yet to be determined 3. Monitoring mechanism of the implementation of GSPA in EMR

List of Explanatory Notes

1. EMR lead responsibility

Implementation Plan of GSPA in EMR Countries

Element 1. Prioritizing research and development needs

Sub-elements and specific actions Stakeholder(s) Comments Ongoing

activities in EMRO

Planned activities for EMRO

(1.1) mapping global research and development with a view to identifying gaps in research and development on diseases that disproportionately affect developing countries

Global responsibility WHO; Governments; other relevant stakeholders

(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 EMR responsibility

RPC

As a global activity, the lead responsibility within WHO would lie with PHI WHO/HQ in collaboration with relevant departments there (TDR, RPC etc.) and they must guide regional offices if they require input from them in the development of these methodologies.


(b) disseminate information on identified gaps, and evaluate their consequences on public health

EMR responsibility RPC

Once the methodologies have been developed and gaps have been identified, PHI WHO/HQ has to provide guidance for dissemination of this information in the region and how regional offices can collaborate on evaluation of the consequences of identified gaps 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


Guidance from and in collaboration with PHI WHO/HQ

(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

Global responsibility Governments; regional organizations

The issues highlighted in GSPA would reflect in EMR research strategy

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assessments


Global responsibility Governments; WHO; other relevant stakeholders (including academia, relevant health- related industries, national research institutions and public–private partnerships)

(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


Research appropriate for resource-poor settings and research on technologically appropriate products for addressing public health needs to combat diseases in developing countries will be reflected in EMR research strategy as a priority.

Global responsibility Governments; WHO; other relevant stakeholders (including academia, national research institutions, and public–private partnerships)

(c) include research and development needs on health systems in a prioritized strategy


Research and development needs on health systems will be reflected as a priority in EMR research strategy

Global responsibility WHO; Governments; other international intergovernmental organizations; other relevant stakeholders (including private sector)

(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 needs


It will take place through advocacy for appropriate research policy and coordination though the work of RPC.

(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)

Global responsibility Governments; WHO; other relevant stakeholders (including academia, relevant health related industries, national research institutions, and public–private partnerships)

A situation analysis paper will be developed to look at R&D efforts in the region on disease that affect countries in the region and that lead to the development of quality products to

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EMR responsibility RPC and EMP

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

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including academia; national research institutions; public–private partnerships; and concerned communities)

(a) set research priorities in traditional medicine

EMR responsibility EMP

A report will be produced in close collaboration with two WHO collaborating centres in the region on traditional medicine in on how to set research priorities in traditional medicine in the region, this work will take place also in close collaboration with traditional medicine unit in EMP at HQ

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including academia, relevant health-related industries, national research institutions, public–private partnerships)

(b) support developing countries to build their capacity in research and development in traditional medicine


A list of all institutions involved in research and development in EMR will be developed and a questionnaire will be sent to them to know about their needs for capacity building.

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Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders

(c) promote international cooperation and the ethical conduct of research


Concerns about ethical conduct of research will be reflected in the regional research strategy

Global responsibility Governments; WHO; other international intergovernmental organizations; regional organizations; other relevant stakeholders

(d) support South-South cooperation in information exchange and research activities


Guidance from and in collaboration with PHI WHO/HQ.


(e) support early-stage drug research and development in traditional medicine systems in developing countries


As in 1.3(b), a list of all institutions involved in research and development in EMR will be developed and a questionnaire will be sent to them to know about their needs for capacity building.

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Element 2. Promoting research and development

Sub-elements and specific actions Stakeholder(s) Comments

Ongoing activities in

EMRO

Planned activities for

EMRO (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


Through regional research strategy.

Global responsibility Governments; regional organizations; WHO (technical assistance); other relevant stakeholders

(b) provide support for national health research programmes in developing countries through political action and, where feasible and appropriate, long-term funding



Global responsibility Governments; regional organizations; WHO (technical assistance); other relevant stakeholders

(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


1. An annotated list of institutions involved in discovery science in EMR will be

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developed, 2. The needs for supporting discovery science in the region by these institutions will be listed and ways will be identified to support these institutions and their work.


(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 EMR responsibility

RPC and EMP

Through identifying institutions involved in discovery science, a list of those among them will be developed who maintained compound libraries, and ways will be discussed with them to provide them with support to promote access to drug leads identified though streaming their compound libraries.

Global responsibility Governments; WHO; other international intergovernmental organizations (including WIPO and WTO); other relevant stakeholders

(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 EMR responsibility

RPC and EMP

1. Through regional research strategy. 2. The issue will

be put on the agenda of the regional advisory

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committee on health research (ACHR) and their guidance will be sought for developing this work in the region.


(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

EMR responsibility RPC through regional research strategy

As in 2.2(a): 1. A list of institutions involved in discovery science in EMR will be developed, 2. The needs for supporting discovery science in the region by these institutions will be listed and ways will be identified to support these institutions and their work.

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including relevant health- related industries, academia, international and national research institutions; donor agencies; development partners; nongovernmental organizations)

(e) support early-stage drug research and development in developing countries

EMR responsibility EMP and RPC through regional research strategy

As in 2.2(a), and 2.2(d): 1. A list of institutions involved in discovery science in EMR will be developed, 2. The needs for supporting discovery science in the region by these institutions will be listed and ways will be

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identified to support these institutions and their work.

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including relevant health- related industries; academia; development partners; charitable foundations; public- private partnerships; nongovernmental organizations)

(f) build capacity to conduct clinical trials and promote public and other sources of funding for clinical trials and other mechanisms for stimulating local innovation, taking into account international ethical standards and the needs of developing countries

EMR responsibility EMP/RPC

A situation analysis report will be produced mapping institutions in the region involved in conducting clinical trials, needs for their capacity building and relevant ethical, quality and regulatory issues.

Global responsibility Governments; WHO; other international intergovernmental organizations, other relevant stakeholders (including; academia, international and national research institution; relevant health-related industries and development partners)

(g) promote the generation, transfer, acquisition upon agreed terms and voluntary sharing, of new knowledge and technologies, consistent with national law and international agreements, to facilitate the development of new health products and medical devices to tackle the health problems of developing countries


Seek guidance from and collaborate with PHI HO/HQ in connection with the ongoing project on technology transfer with the support of the European Union.

(2.3) improving cooperation, participation and coordination of health and biomedical research and development


(a) stimulate and improve global cooperation and coordination in research and development, in order to optimize resources

EMR responsibility RPC with PHI WHO/HQ


(b) enhance existing fora and examine the need for new mechanisms, in order to improve the coordination and sharing of information on research and

Global responsibility Governments; WHO; other relevant stakeholders

Through regional research strategy

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development activities EMR responsibility RPC and EMP

and through exploration with the interested member states and existing relevant and interested regional institutions.

Global responsibility Interested Governments; [WHO]; other relevant stakeholders (including nongovernmental organizations)

(c) encourage further exploratory discussions on the utility of possible instruments or mechanisms for essential health and biomedical R&D, including inter alia, an essential health and biomedical R&D treaty


Through ACHR discussion about a possible R&D Treaty and other instruments or mechanisms for encouraging essential health and biomedical R&D.


(d) support active participation of developing countries in building technological capacity




(e) promote the active participation of developing countries in the innovation process



(2.4) promoting greater access to knowledge and technology relevant to meet public health needs of developing countries

(a) promote the creation and development of accessible public health libraries in order to enhance availability and use of relevant publications by universities, institutes and technical centres, especially in developing countries (including academia, research



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institutions, relevant health-related industries; nongovernmental organizations; publishers)


Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including academia and research institutions)

(b) promote public access to the results of government funded research, by strongly encouraging that all investigators funded by governments submit to an open access database an electronic version of their final, peer-reviewed manuscripts



Global responsibility Governments; WHO; other international intergovernmental organizations (including WIPO); other relevant stakeholders (including relevant health-related industries)

(c) support the creation of voluntary open databases and compound libraries including voluntary provision of access to drug leads identified through the screening of such compound libraries


As in 2.2(b), through identifying institutions involved in discovery science, a list of those among them will be developed who maintained compound libraries and ways will be discussed with them to provide them with support to promote access to drug leads identified though streaming their compound libraries.

(d) encourage the further development and dissemination of publicly or donor-funded medical inventions and know-how through appropriate licensing policies, including but not limited to open licensing, that enhance access to innovations for development of products of relevance to the public health needs of

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including academia and national research institutions)

1. Guidance from and in collaboration with PHI WHO/ HQ.

A paper will be produced looking at existing relevant licensing policies in the region.

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developing countries on reasonable, affordable and non-discriminatory terms

EMR responsibility EMP/RPC Global responsibility Governments

(e) consider, where appropriate, use of a “research exception” to address public health needs in developing countries consistent with the Agreement on Trade- Related Aspects of Intellectual Property Rights EMR responsibility

EMP/RPC

1. Analysis of research exception provision and its availability in national patent laws in the region. 2. Appropriate action will be taken to disseminate this information to the countries which already have research exception in their laws and guide them to its use and benefits. Countries that do not have research exception available in their national laws will be supported to include it in their national laws.

2.5 establishing and strengthening national and regional coordinating bodies on research and development

Global responsibility Governments; regional organizations; WHO; other relevant stakeholders

(a) develop and coordinate a research and development agenda



(b) facilitate the dissemination and use of research and development outcomes

Global responsibility Governments; regional organizations; WHO; other relevant stakeholders


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Element 3. Building and improving innovative capacity

Sub-elements and specific actions Stakeholder(s) Comments Ongoing

activities in EMR

Planned activities for EMR

(3.1) building capacity of developing countries to meet research and development needs for health products

Global responsibility Governments; other International intergovernmental organizations; other relevant stakeholders (including development partners)

(a) support investment by developing countries in human resources and knowledge bases, especially in education and training including in public health



Global responsibility Governments; other International intergovernmental organizations; other relevant stakeholders (including research and development groups, relevant health-related industries and development partners)

(b) support existing and new research and development groups and institutions, including regional centres of excellence, in developing countries



Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including nongovernmental organizations, research institutions, academia)

(c) strengthen health surveillance and information systems

EMR responsibility EST/RPC

In collaboration with Evidence-based health Situation and Trend Assessment (EST) unit in DHS

(3.2) framing, developing and supporting effective policies that promote the development of capacities for health innovation

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Global responsibility Governments; WHO; other relevant stakeholders (including national and regional regulatory agencies)

(a) establish and strengthen regulatory capacity in developing countries


1. Through assessment of regulatory capacity which is an ongoing work of EMP in the region, 2. Technical assistance for strengthening regulatory capacity in the region, which is also an ongoing work in many countries.

Global responsibility Governments; other international intergovernmental organizations; other relevant stakeholders (including development partners; international and national research institutions)

(b) strengthen human resources in research and development in developing countries through long-term national capacity building plans



Global responsibility Governments; WHO; other international intergovernmental organizations (including International Organization for Migration and ILO); other relevant stakeholders

(c) encourage international cooperation to develop effective policies for retention of health professionals including researchers in developing countries

EMR responsibility EMRO Human Resources Policy and Management Unit (HRD)/EMP/RPC

1. Guidance from and In collaboration with PHI WHO/HQ. 2. In collaboration with HRD EMRO.

Global responsibility Governments

(d) urge Member States to establish mechanisms to mitigate the adverse impact of the loss of health personnel in developing countries, particularly researchers, through migration, including by ways for both receiving and originating countries to support the strengthening of national health and research systems, in particular human resource development in the countries of origin, taking into account the work of WHO and other relevant organizations

EMR responsibility HRD/EMP/RPC

1. Guidance from and In collaboration with PHI WHO/HQ. 2. In collaboration with HRD EMRO.

(3.3) providing support for improving innovative capacity in accordance with the needs of developing countries

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Global responsibility Governments; WHO; other international intergovernmental organizations (including WIPO, OECD and UNCTAD); other relevant stakeholders (including academia; research institutions; health related industries and developmental partners)

(a) develop successful health innovation models in developing innovative capacity.



Global responsibility Governments; WHO; other International intergovernmental organizations; other relevant stakeholders (including academia, research institutions, relevant health- related industries)

(b) intensify North–South and South–South partnerships and networks to support capacity building.



Global responsibility Governments; WHO; other relevant stakeholders (including academia and research institutions)

(c) establish and strengthen mechanisms for ethical review in the research and development process, including clinical trials, especially in developing countries EMR responsibility

EMP/RPC

As in 2.2(f), A situation analysis report will be produced mapping institutions in the region involved in conducting clinical trials, needs for their capacity building and relevant ethical, quality and regulatory issues.

(3.4) supporting policies that will promote innovation based on traditional medicine within an evidence-based framework in accordance with national priorities and taking into account the relevant provisions of relevant international instruments

(a) establish and strengthen national and regional policies to develop, support, promote traditional medicine

Global responsibility Governments; WHO; other international intergovernmental

A regional strategy will be developed in EMR to

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organizations; other relevant stakeholders (including concerned communities)


strengthen national policies to develop, support and promote traditional medicine

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including international and national research institutions, concerned communities)

(b) encourage and promote policies on innovation in the field of traditional medicine


A regional strategy will be developed in EMR to strengthen national policies to develop, support and promote traditional medicine

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including national and regional regulatory agencies; international and national research institutions; development partners; concerned communities)

(c) promote standard setting to ensure the quality, safety and efficacy of traditional medicine, including by funding the research necessary to establish such standards



Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including academia; international and national research institutions; relevant health-related industries; concerned communities)

(d) encourage research on mechanisms for action and pharmacokinetics of traditional medicine



(e) promote South-South collaboration in traditional medicine

Global responsibility Governments; WHO; other international intergovernmental

A regional strategy will be developed in EMR to

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organizations; other relevant stakeholders (including research institutions, regional bodies, academia)


strengthen national policies to develop, support and promote traditional medicine

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including national and regional regulatory agencies, relevant health-related industries)

(f) formulate and disseminate guidelines on good manufacturing practices for traditional medicines and laying down evidence-based standards for quality and safety evaluation



(3.5) developing and implementing, where appropriate, possible incentive schemes for health-related innovation

Global responsibility Governments; [WHO]/[WHO]/[WHO]; other international intergovernmental organizations [(including WIPO)]; other relevant stakeholders (including academia; international and national research institutions; development partners; charitable foundations)

(a) encourage the establishment of award schemes for health-related innovation



The idea for initiating an award scheme for health innovation in EMR will be put on the agenda of the ACHR.

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including academia; international and national research institutions; development partners; charitable foundations)

(b) encourage recognition of innovation for purposes of career advancement for health researchers



The idea for initiating an award scheme for health innovation in EMR will be put on the agenda of the ACHR.

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Element 4. Transfer of technology

Sub-elements and specific actions Stakeholder(s) Comment

Ongoing activities in EMR

Planned activities in EMR

(4.1) promoting transfer of technology and the production of health products in developing countries

Global responsibility Governments; WHO; other international intergovernmental organizations (including WTO, UNCTAD, UNIDO, WIPO); other relevant stakeholders (including; international and national research institutions; relevant health-related industries)

(a) explore possible new mechanisms and make better use of existing mechanisms to facilitate transfer of technology and technical support to build and improve innovative capacity for health- related research and development, particularly in developing countries

EMR responsibility

Guidance from and in collaboration with PHI WHO/HQ in connection with technology transfer project supported by the European Union

EMP/RPC

Global responsibility Governments; WHO; other intergovernmental organizations; other relevant stakeholders (including health-related industries)

(b) promote transfer of technology and production of health products in developing countries through investment and capacity building



Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including relevant health- related industries; academia; nongovernmental organizations; development partners; charitable foundations)

(c) promote transfer of technology and production of health products in developing countries through identification of best practices, and investment and capacity building provided by developed and developing countries where appropriate



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(4.2) supporting improved collaboration and coordination of technology transfer for health products, bearing in mind different levels of development

Global responsibility Governments; WHO; other international intergovernmental organizations (including WIPO); other relevant stakeholders (including relevant health- related industries; international and national research institutions; academia; nongovernmental organizations; development partners)

(a) encourage North–South and South–South cooperation for technology transfers, and collaboration between institutions in developing countries and the pharmaceutical industry



Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including relevant health- related industries, national research institutions, academia; nongovernmental organizations)

(b) facilitate local and regional networks for collaboration on research and development and transfer of technology




(c) continue to promote and encourage technology transfer to least-developed country members of the WTO consistent with Article 66.2 of the Agreement on Trade-Related Aspects of Intellectual Property Rights

EMR responsibility

EMP/RPC


(d) promote the necessary training to increase absorptive capacity for technology transfer

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including research

Guidance from and in collaboration with PHI WHO/HQ in connection with technology transfer

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Element 5. Application and Management of intellectual property to contribute to innovation and promote public health Sub-elements and specific actions Stakeholder(s) Comment Ongoing Planned activities

institutions)


project supported by the European Union

(4.3) developing possible new mechanisms to promote transfer of and access to key health-related technologies

Global responsibility Governments; WHO; other international intergovernmental Organizations (including WIPO); other relevant stakeholders (including international and national research institution; relevant health-related industries, nongovernmental organizations; academia)

(a) examine the feasibility of voluntary patent pools of upstream and downstream technologies to promote innovation of and access to health products and medical devices


1. Guidance from and in collaboration with PHI WHO/HQ. 2. Guidance from and in collaboration with UNITAID’s initiative on patent pools.

Global responsibility Governments; WHO; other international intergovernmental organizations (including WIPO, WTO); other relevant stakeholders (including health-related industries)

(b) explore and, if feasible, develop possible new mechanisms to promote transfer of and access to key health-related technologies of relevance to public health needs of developing countries especially on Type II and III diseases and the specific R&D needs of developing countries in respect of Type I diseases, which are consistent with the provisions of the TRIPS agreement and instruments related to that agreement, which provide flexibilities to take measures to protect public health



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activities in EMR for EMR (5.1) support information sharing and capacity building in the application and management of intellectual property with respect to health related innovation and the promotion of public health in developing countries

Global responsibility [Governments; WHO; other international intergovernmental organizations (including WIPO, WTO, UNCTAD); other relevant stakeholders (including international and national research institutions and development partners)]) [Governments; WHO; other international intergovernmental organizations (including WIPO, WTO, UNCTAD); other relevant stakeholders (including international and national research institutions and development partners)])

(a) encourage and support the application and management of intellectual property in a manner that maximizes health-related innovation and promotes access to health products and that is consistent with the provisions in the TRIPS Agreement and other WTO instruments related to that agreement and meets the specific R&D needs of developing countries


EMP will prepare a report about its work in the region in terms of supporting the application and management of intellectual property in a manner that maximizes health innovation and promotes access to health product, and that is consistent with the provisions in the TRIPS Agreement including a) assessment of national IP regimes in selected countries in the region, b) developing policy guidance to protect public health considerations in the negotiations of bilateral trade agreements, c) organizing capacity building events for policy makers on application and management of IP that contributes to innovation and promotes public health in the region, d) providing technical assistance to non-WTO Member countries in the region in terms of preparing them for new

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IP regimes and protecting public health considerations in them.

Global responsibility Governments; WHO/[WHO]; other international intergovernmental organizations (including [WIPO]/[WIPO], [WTO]/[WTO], UNCTAD; other relevant stakeholders (including international and national research institutions and development partners)

(b) promote and support, including through international cooperation, national and regional institutions in their efforts to build and strengthen capacity to manage and apply intellectual property in a manner oriented to public health needs and priorities of developing countries

EMR responsibility

As in 5.1(a), EMP will prepare a report about its work in the region in terms of supporting the application and management of intellectual property in a manner that maximizes health innovation and promotes access to health product, and that is consistent with the provisions in the TRIPS Agreement.

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Global responsibility [Governments]/[Governments]; [WHO]/[WHO]; other international intergovernmental organizations (including [WIPO]/[WIPO], [WTO]/[WTO], [UNCTAD]; other relevant stakeholders (including international and national research institutions and development partners)]

(c) Facilitate widespread access to, and promote further development of, including, if necessary, compiling, maintaining and updating, user-friendly global databases which contain public information on the administrative status of health- related patents, including supporting the existing efforts for determining the patent status of health products, in order to strengthen national capacities for analysis of the information contained in those databases, and improve the quality of patents.

EMR responsibility None

PHI/WHO HQ is to take a lead on this global work. At best ROs can collaborate with HQ on their specific requests.

(d) stimulate collaboration among pertinent national institutions and relevant government departments, as well as between national, regional and international institutions, in order to promote information sharing relevant to public health needs

Global responsibility Governments; WHO; Other International intergovernmental organizations; Other relevant stakeholders (including academia; international and national research institutions; development agencies; nongovernmental organizations; relevant health- related industries)

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Global responsibility Governments; [WHO]/[WHO]; other international intergovernmental organizations (including [WIPO]/[WIPO], [WTO]/[WTO], [UNCTAD]/[UNCTAD]); other relevant stakeholders (including international and national research institutions and development partners)

(e) strengthen education and training in the application and management of intellectual property, from a public health perspective taking into account the provisions contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights, including the flexibilities recognized by the Doha Ministerial Declaration on the TRIPS Agreement and Public Health and other WTO instruments related to the TRIPS agreement

EMR responsibility


EMP; ASD

a. EMRO collaborated with UNDP, WHO HQ and civil society organizations to hold a regional technical consultation meeting for training pharmaceutical patent examiners on examining pharmaceutical patents from a public health perspective. b. EMRO collaborated with WHO HQ and WTO to organize a regional education and training workshops for national policy makers from ministries of commerce/ economics and ministries of health. Such regional trainings have taken place in Kuwait, Jordan and another one is planned for Syria.

Global responsibility Governments; [WHO; other international intergovernmental organizations; other relevant stakeholders (including] concerned communities)

(f) facilitate, where feasible and appropriate, possible access to traditional medicinal knowledge information for use as prior art in examination of patents, including, where appropriate, the inclusion of traditional medicinal knowledge information in digital libraries

EMR responsibility Traditional medicine unit in EMP


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(g) promote active and effective participation of health representatives in intellectual property-related negotiations, where appropriate, in order that such negotiations also reflect public health needs


a. A comprehensive programme for health diplomats is being developed in EMRO which, among other issues, would also include capacity building for active and effective participation in intellectual property related negotiations. b. A policy guide for FTA negotiations is being developed for policy makers from EMR countries.

Global responsibility Governments; WHO; other International intergovernmental organizations (including WIPO, WTO, and UNCTAD)

(h) strengthen efforts to effectively coordinate work relating to intellectual property and public health among the Secretariats and governing bodies of relevant regional and international organizations to facilitate dialogue and dissemination of information to countries

Guidance from and collaboration with PHI WHO/HQ

EMR responsibility

(5.2) providing as appropriate, upon request, in collaboration with other competent international organizations technical support, including, where appropriate, to policy processes, to countries that intend to make use of the provisions contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights, including the flexibilities recognized by the Doha Ministerial Declaration on the TRIPS Agreement and Public Health and other WTO instruments related to the TRIPS agreement, in order to promote access to pharmaceutical Products

(a) consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property

Global responsibility Governments; WHO; Other international intergovernmental organizations (including WIPO,

EMRO is currently responding to requests from the countries, for

31

WTO and UNCTAD) Rights, including those recognized by the Doha Declaration on TRIPS Agreement and Public Health and the WTO decision of 30 August 2003 EMR responsibility

EMP

example Syria, Pakistan, Lebanon and Sudan.

Global responsibility Governments; [WHO; Other international intergovernmental organizations (including WIPO, WTO and UNCTAD)]

(b) Take into account, where appropriate, the impact on public health when considering adopting or implementing more extensive intellectual property protection than is required by the Agreement on Trade-Related Aspects of Intellectual Property Rights, without prejudice to the sovereign rights of Member States


a. A policy guide for FTA negotiations is being developed for policy makers from EMR countries. b. National case studies on intellectual property regimes and access to medicines were produced for some EMR countries that signed FTAs with TRIPS-plus provisions, for example Jordan and Morocco.


(c) take into account in trade agreements the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights and including those recognized by the Declaration on the TRIPS Agreement and Public Health adopted by the WTO Ministerial Conference (Doha, 2001) and the WTO decision of 30 August 2003

EMR responsibility

A policy guide for FTA negotiations is being developed for policy makers from EMR countries.

EMP


(d) consider, where appropriate, taking necessary measures in countries with manufacturing capacity to, facilitate through export, access to pharmaceutical products in countries with insufficient or no manufacturing capacity in the pharmaceutical sector in a manner consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights, the Doha Declaration on the TRIPS Agreement and Public Health and the WTO decision of 30 August 2003

EMR responsibility EPM

EMRO will provide technical assistance to the countries on their request.

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Global responsibility Governments; WHO; other international intergovernmental organizations (including WIPO, WTO, UNEP/Secretariat of the Convention on Biological Diversity); other relevant stakeholders (including concerned communities)

(e) encourage finding ways, in ongoing discussions, to prevent misappropriation of health-related traditional knowledge, and consider where appropriate legislative and other measures to help prevent misappropriation of such traditional knowledge



(5.3) exploring and, where appropriate, promoting possible incentive schemes for research and development on Type II and Type III diseases and on developing countries’ specific research and development needs in relation to Type I diseases

Global responsibility [Governments; [WHO]/[WHO]; other international intergovernmental organizations; other relevant stakeholders (including international and national research institutions; development partners; charitable foundations; relevant health related industries; nongovernmental organizations)]

(a) explore and, where appropriate, promote a range of incentive schemes for research and development including addressing, where appropriate, the de-linkage of the costs of research and development and the price of health products, for example through the award of prizes, with the objective of addressing diseases which disproportionately affect developing countries



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Element 6. Improving delivery and access

Sub-elements and specific actions Stakeholder(s) Comments Ongoing activities in EMR Planned activities in EMR

(6.1) encouraging increased investment in the health-delivery infrastructure and financing of health products in order to

strengthen the health system Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including development partners, charitable foundations, private sector and relevant health- related industries)

(a) invest in developing health- delivery infrastructure and encourage financing of health products

EMR responsibility EMP/Health Economics Unit (HEC)

A report will be produced about the existing levels of finacing in health delivery infrastructure and financing of health products in collaboration with HEC. The paper will also highlight the optimal investment needs in this area.

Global responsibility Governments; WHO; other international intergovernmental organizations (including WTO); other relevant stakeholders

(b) develop effective and sustainable mechanisms in least- developed countries in order to improve access to existing medicines, acknowledging the transitional period until 20164 EMR responsibility

EMP



(c) prioritize health care in national agendas

EMR responsibility EMRO


(d) encourage health authorities to improve domestic management capacities in order to improve delivery and access to medicines

Global responsibility Implementation of biennial joint workplans in 18 countries in the light of WHO medicine strategy to

Governments; WHO

4 In line with the extension, provided to least-developed countries, by Article 7 of the Doha Declaration on the TRIPS Agreement and Public Health. 34

and other health products with quality, efficacy, safety and affordability and, where appropriate, to develop strategies to promote rational use of medicines


improve delivery and access to medicines and other health products with quality, efficacy, safety and affordability, and development of strategies to promote rational use of medicines.

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including development partners; nongovernmental organizations; charitable foundations)

(e) increase investment in human resource development in the health sector


a. EMP/EMRO undertaking human resource mapping in pharmaceutical sector in some countries for example Sudan. b. EMP/EMRO providing fellowship opportunities to nationally nominated professionals in the area of pharmaceutical.

Global responsibility Governments; other relevant stakeholders (including development partners)

(f) develop effective country poverty reduction strategies that contain clear health objectives

EMR responsibility Policy and Health Planning (PHP)/EMP

In collaboration with PHP


(g) encourage pooled procurement mechanisms for health products and medical devices, where appropriate

EMR responsibility EMP, Division for Communicable Diseases (DCD) and Vaccine Quality Unit (VAC)

EMP in collaboration with DCD and VAC

a. Assessment of pooled procurement mechanisms in GCC by EMP/EMRO. b. EMRO working on developing a regional pooled procurement mechanism for priority vaccines.

(6.2) establishing and strengthening mechanisms to improve ethical review and regulate the quality, safety and efficacy of health products and medical devices

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Global responsibility Governments; WHO; other relevant stakeholders (including national and regional regulatory agencies and development partners)

(a) develop and/or strengthen the capacity of national regulatory authorities to monitor the quality, safety and efficacy of health products while sustaining ethical review standards


EMRO has undertaken national regulatory assessments in some of its member states and has helped in the development of institutional development plans of national regulatory authorities, for example in Sudan, Egypt and Yemen. Assessments are planned for Lebanon, Pakistan and Syria.

This is an ongoing work.

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including international and national research institutions; nongovernmental organizations, development partners and charitable foundations)

(b) promote operational research to maximize the appropriate use of new and existing products, including cost-effective and affordable products in high disease-burden settings


1. Thirteen national medicine price surveys have been conducted in the region. 2. Three countries are in the process of developing national programmes for rational use of medicines. 3. Operational research is an important strategic priority of EMP work. Apart from the above mentioned two areas, there are other pieces of work in connection with operational research

Global responsibility Governments; WHO; other relevant stakeholders (including national regulatory bodies; relevant health-related industries; development partners

(c) comply with good manufacturing practices for safety standards, efficacy and quality of health products

EMR responsibility EMP; VAC

a. Promotion of WHO GMP standards in terms of their adoption by national regulatory authorities as national standards in order for manufacturers to comply with them. b. WHO prequalification programme has been introduced systematically in the region. GMP compliance is an important component of WHO prequalification programme.

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Global responsibility Governments; WHO, other international intergovernmental organizations; other relevant stakeholders (including development partners)

(d) strengthen the WHO pre-qualification programme

EMR responsibility EMP; VAC

a. WHO prequalification programme has been introduced systematically in the region. GMP compliance is an important component of WHO prequalification programme. b. Five regional and national meetings have been conducted in EMR on pre-qualification programme.

Currently a regional plan is being developed for PQP.

Global responsibility Governments; [WHO]/[WHO]; other relevant stakeholders (including national and regional regulatory agencies, regional bodies and development partners)

(f) where appropriate, initiate programmed actions on regional and sub-regional levels with the ultimate goal of harmonization of processes employed by the regulatory authorities for drug marketing approvals


EMRO is facilitating participation of not-African countries in African Drug Registration Harmonization Initiative

A meeting of regulatory authorities is being planned for 2010.

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including national and regional regulatory agencies)

(g) promote ethical principles for clinical trials involving human beings as a requirement of registration of medicines and health-related technologies, with reference to the Declaration of Helsinki, and other appropriate texts, on ethical principles for medical research involving human subjects, including good clinical practice guidelines

EMR responsibility GMP

Promotion of good clinical practices/ good laboratory practices

Global responsibility Governments; WHO; other relevant stakeholders (including national and regional regulatory agencies, international and national research institutions, regional bodies and development partners)

(h) support regional networks and collaborative efforts to strengthen the regulation and implementation of clinical trials using appropriate standards for medicines evaluation and approval

As in 2.2(f) and 3.3(c), a situation analysis report will be produced mapping institutions in the region involved in conducting clinical trials, needs for their capacity building and relevant ethical, quality and regulatory issues.

EMR responsibility

(6.3) promoting competition to improve availability and affordability of health

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products consistent with public health policies and needs


(a) support the production and introduction of generic versions, in particular of essential medicines, in developing countries, through the development of national legislation and/or policies that encourage generic production and entry, including a “regulatory exception” or “Bolar”-type provision, and which are consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights and instruments related to that agreement


Guidance from and in collaboration with PHI and EMP WHO/HQ

Global responsibility Governments; WHO; other international intergovernmental organizations (including WTO and WIPO); other relevant stakeholders

(b) frame and implement policies to improve access to safe and effective health products, especially essential medicines, at affordable prices, consistent with international agreements


a. Thirteen national medicine price surveys have been conducted in the region. b. EMRO has initiated a programme for reforming medicine pricing policy in the member states


(c) consider where appropriate, inter alia, the reduction or elimination of import tariffs on health products and medical devices and the monitoring of supply and distribution chains and procurement practices to minimize cost and increase access


a. Thirteen national medicine price surveys have been conducted in the region. b. EMRO has initiated a programme for reforming medicine pricing policy in the member states c. The medicine pricing surveys and analysis of medicine pricing policies also include analysis of medicine price components that is duty tariffs and taxes and mark ups on medicines and medical products in the private supply chain.

(d) encourage pharmaceutical companies and other health-related industries to consider policies, including differential pricing policies, that are conducive to promoting access to quality, safe, efficacious and affordable health

Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including relevant health-

In collaboration with EMP WHO HQ.

38

related industries) products in developing countries, consistent with national law



(e) consider, where appropriate, the development of policies to monitor pricing and to improve affordability of health products; further support WHO’s ongoing work on pharmaceutical pricing


a. Thirteen national medicine price surveys have been conducted in the region. b. EMRO has initiated a programme for reforming medicine pricing policy in the member states c. The medicine pricing surveys and analysis of medicine pricing policies also include analysis of medicine price components that is duty tariffs and taxes and mark ups on medicines and medical products in the private supply chain.


(f) Consider, where necessary, and provided that they are consistent with the provisions of the Agreement on TRIPS, taking appropriate measures to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology, in the field of health products


(g) increase information among policy makers, users, doctors and pharmacists regarding generic products

Global responsibility Governments; WHO other relevant stakeholders (including nongovernmental organizations and relevant health related industry)

a. Medicine pricing policy work that EMP/EMRO has initiated includes policy options in member states regarding medicine pricing policies. b. Promotion of generic medicine policy is part of this work.

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Element 7. Promoting sustainable financing mechanisms


Ongoing activities in EMR Planned activities in EMR

(7.1) endeavouring to secure adequate and sustainable financing for research and development, and improve coordination of its use, where feasible and appropriate, in order to address the health needs of developing countries


(a) establish a results-oriented and time-limited expert working group under the auspices of WHO and linking up with other relevant groups to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of financing to stimulate R&D related to Type II and Type III diseases and the specific R&D needs of developing countries in relation to Type I diseases

EMR responsibility EMP and RPC


Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including development partners, charitable foundations, international and national research institutions, academia, private sector and relevant health-related industries)

(b) consider channelling additional funds to health-oriented research organizations as appropriate in both the private and public sector of developing countries and promote good financial management to maximize its effectiveness as recommended by the resolution WHA58.34




(c) create a database of possible sources of financing for R & D



(7.2) facilitating the maximum use of, and complementing as

41

appropriate, existing financing, including that through public- private and product development partnerships, in order to develop and deliver safe, effective and affordable health products and medical devices

Global responsibility Governments; WHO; other relevant stakeholders (including research institutions, public- private and product development partnerships)

(a) document and disseminate best practices in public-private and product development partnerships



Global responsibility Governments; WHO; other relevant stakeholders (including research institutions; public- private and product development partnerships; charitable foundations)

(b) develop tools to periodically assess performance of public-private and product development partnerships



Global responsibility Governments; WHO; other international intergovernmental organizations; other relevant stakeholders (including relevant health- related industries, charitable foundations, development partners, nongovernmental organizations; academia; research institutions)

(c) support public-private and product development partnerships and other appropriate research and development initiatives in developing countries



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Element 8. Establishing monitoring and reporting systems


Ongoing activities in EMR Planned activities in EMR

(8.1) measuring performance and progress towards objectives contained in the strategy and plan of action

Global responsibility Governments; WHO

(a) establish systems to monitor performance and progress of the implementation of each element of the global strategy and plan of action



Global responsibility Governments; WHO

(b) monitor and report periodically to WHO’s governing bodies on the gaps and needs related to health products and medical devices in developed and developing countries



Global responsibility Governments; WHO; other international intergovernmental organizations (including WIPO and WTO); other relevant stakeholders

(c) to continue to monitor, from a public health perspective, in consultation as appropriate with other international organizations, the impact of intellectual property rights and other issues addressed in the report of the Commission on Intellectual Property Rights, Innovation and Public Health, on the development of, and access to, health care products, and to report thereon to the Health Assembly



Global responsibility Governments; WHO; other international intergovernmental organizations (including WIPO and WTO); Other relevant stakeholders

(d) monitor and report on the impact of incentive mechanisms on innovation of and access to health products and medical devices






(e) monitor and report on investment in research and development to address the health needs of developing countries

ANNEX 1 – Recommendations of the Commission on Intellectual Property Rights, Innovation and Public Health

1. Discovery

1.1. Governments of developed countries should reflect adequately this objective in their research policies. In particular, they should seek to define explicit strategies for R&D and devote a growing proportion of their total health R&D funding to the health needs of developing countries, with an emphasis on upstream and translational research.

1.2. Developing countries should establish, implement or strengthen a national programme for health research including best practices for execution and management of research, with appropriate political support, and long-term funding.

1.3. Government and funder attention should be paid to upstream research that enables and supports the acquisition of new knowledge and technologies that will facilitate the development of new products, including drugs, vaccines and diagnostic tests to tackle the health problems of developing countries. Attention should also be paid to the current inadequacy of the research tools available in these fields of research. These include techniques to understand new pathways to discovery, better ways to use bioinformatics, more suitable animal models and other disease-specific technologies.

1.4. When addressing the health needs of people in developing countries, it is important to seek innovative ways of combating Type I diseases, as well as Type II and Type III diseases. Governments and funders need to assign higher priority to combating the rapidly growing impact of Type I diseases in developing countries, and, through innovation, to finding affordable and technologically appropriate means for their diagnosis, prevention and treatment.

1.5. Actions should be taken by WHO to find ways to make compound libraries more accessible to identify potential compounds to address diseases affecting developing countries.

1.6. WHO should bring together academics, small and large companies in pharmaceuticals and biotechnology, governments in the form of aid donors or medical research councils, foundations, public–private partnerships and patient and civil society groups for a standing forum to enable more organized sharing of information and greater coordination between the various players.

1.7. Countries should seek through patenting and licensing policies to maximize the availability of innovations, including research tools and platform technologies, for the development of products of relevance to public health, particularly to conditions prevalent in developing countries. Public funding bodies should introduce policies for sensible patenting and licensing practices for technologies arising from their funding to promote downstream innovation in health-care products.

1.8. Patent pools of upstream technologies may be useful in some circumstances to promote innovation relevant to developing countries. WHO and WIPO should consider playing a bigger role in promoting such arrangements, particularly to address diseases that disproportionately affect developing countries.

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1.9. Developing countries need to consider in their own legislation what form of research

exemption might be appropriate in their own circumstances to foster health-related research and innovation.

1.10. Countries should provide in their legislation powers to use compulsory licensing, in accordance with the TRIPS agreement, where this power might be useful as one of the means available to promote, inter alia, research that is directly relevant to the specific health problems of developing countries.

1.11. Developing countries should ensure that their universities and public research organizations maintain research priorities in line with their public health needs and public policy goals, in particular the need for innovative research of benefit to the health problems of their populations. This should not exclude support of health-related research which meets their industrial or export objectives and that could contribute to improved public health in other countries.

1.12. Public research institutions and universities in developed countries should seriously consider initiatives designed to ensure that access to R&D outputs relevant to the health concerns of developing countries and to products derived therefrom, are facilitated through appropriate licensing policies and practices. 2. Development

2.1. Governments and the appropriate national authorities and funders should assign a higher priority to research on the development of new animal models, biomarkers, surrogate end-points and new models for assessing safety and efficacy, which would increase the efficiency of product development. They should also work with their counterparts in developing countries to formulate a mechanism to help identify research priorities in this area for Type II and Type III diseases particularly relevant to developing countries, and provide funding for this R&D. 2.2. To enhance the sustainability of public–private partnerships:

• Current donors should sustain and increase their funding for R&D to tackle the health problems of developing countries. • More donors, particularly governments, should contribute to increase funding and to help protect public–private partnerships and other R&D sponsors from changes in policy by any major donor. • Funders should commit funds over longer time frames. • Public–private partnerships need to continue to demonstrate that they are using their money wisely, that they have transparent and efficient mechanisms for accountability, that they coordinate and collaborate, and that they continue regularly to monitor and evaluate their activities. • The pharmaceutical industry should continue to cooperate with public–private partnerships and increase contributions to their activities. • Research institutions in developing countries should be increasingly involved in executing research and trials.

2.3. WHO should initiate a process to devise mechanisms that ensure the sustainability

45

and effectiveness of public–private partnerships by attracting new donors, both from governments and the private sector, and also to promote wider participation of research institutions from developing countries. However, governments cannot passively rely on what these partnerships could eventually deliver; there is a need for a stronger commitment on their part for an articulated and sustainable effort to address the research gaps identified in this report. 2.4. Further efforts should be made to strengthen the clinical trials and regulatory infrastructure in developing countries, in particular in sub-Saharan Africa, including the improvement of ethical review standards. WHO has a role to play, in collaboration with interested parties, in an exploration of new initiatives that might be undertaken to achieve this goal. 2.5. Governments should continue to develop forms of advance purchase schemes which may contribute to moving later stage vaccines, medicines and diagnostics as quickly as possible through development to delivery. 2.6. Recognizing the need for an international mechanism to increase global coordination and funding of medical R&D, the sponsors of the medical R&D treaty proposal should undertake further work to develop these ideas so that governments and policy-makers may make an informed decision. 2.7. Practical initiatives that would motivate more scientists to contribute to this field through “open source” methods should be supported. 3. Delivery 3.1. Governments need to invest appropriately in the health delivery infrastructure, and in financing the purchase of medicines and vaccines through insurance or other means, if existing and new products are to be made available to those in need of them. Political commitment is a prerequisite for bringing about a sustained improvement in the delivery infrastructure and health outcomes. Health systems research to inform policy-making and improve delivery is also important. The integration of traditional medicine networks with formal health services should be encouraged. 3.2. Developing countries should create incentives designed to train and retain health-care workers in employment. 3.3. Developed countries should support developing countries' efforts to improve health delivery systems, inter alia, by increasing the supply of their own trained health-care workers. 3.4. Governments have an important responsibility to put in place mechanisms to regulate the quality, safety and efficacy of medicines and other products. As a starting point, adherence to good manufacturing practices and effective supply chain management can ensure product quality and will also curb the circulation of counterfeit products. 3.5. Policies for biomedical innovation must take account of the fact that health systems in many developing countries remain resource-constrained. Policies must emphasize affordable innovations adapted to the realities of health- care delivery in developing countries, and covering appropriate technologies for the diagnosis, prevention and treatment of both

46

communicable and noncommunicable diseases. Mechanisms for promoting such adaptive research in a systematic way must be improved. 3.6. All companies should adopt transparent and consistent pricing policies, and should work towards reducing prices on a more consistent basis for low and lower middle income developing countries. Products, whether originator's or generic, should be priced equitably, not just in sub-Saharan Africa and least developed countries, but also in low and lower middle income countries where there are a vast number of poor patients. 3.7. For noncommunicable diseases, governments and companies should consider how treatments, which are widely available in developed countries, can be made more accessible for patients in developing countries. 3.8. Continuing consideration needs to be given to the prices of treatments for communicable diseases, particularly of second-line drugs for HIV/AIDS treatment. 3.9. Governments of low and middle income countries where there are both rich and poor patients should formulate their funding and price regulation with a view to providing access to poor people. 3.10. Governments need to prioritize health care in their national agendas and, given the leverage to determine prices that patents confer, should adopt measures to promote competition and ensure that pricing of medicines is consistent with their public health policies. Access to drugs cannot depend on the decisions of private companies but is also a government responsibility. 3.11. Corporate donation programmes can be of great value in a number of fields in collaboration with the actions of governments and nongovernmental organizations. However, addressing health needs in developing countries requires more structured and sustainable actions by governments and other parties that stimulate accessibility to products, while generating new treatments and products adapted to the needs of developing countries. 3.12. Governments should remove any tariffs and taxes on health-care products, where appropriate, in the context of policies to enhance access to medicines. They should also monitor carefully the supply and distribution chain to minimize costs that could adversely influence the prices of medicines. 3.13. The Doha Declaration clarifies the right of governments to use compulsory licensing as a means of resolving tensions that may arise between public health and intellectual property, and to determine the grounds for using it. Developing countries should provide in their legislation for the use of compulsory licensing provisions, consistent with the TRIPS agreement, as one means to facilitate access to cheaper medicines through import or local production. 3.14. Developed countries, and other countries, with manufacturing and export capacity should take the necessary legislative steps to allow compulsory licensing for export consistent with the TRIPS agreement. 3.15. The WTO decision agreed on 30 August 2003, for countries with inadequate manufacturing capacity, has not yet been used by any importing country. Its effectiveness needs to be kept under review and appropriate changes considered to achieve a workable

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solution, if necessary. 3.16. Companies should adopt patent and enforcement policies that facilitate greater access to medicines needed in developing countries. In low income developing countries, they should avoid filing patents, or enforcing them in ways that might inhibit access. Companies are also encouraged to grant voluntary licences in developing countries, where this will facilitate greater access to medicines, and to accompany this with technology transfer activities. 3.17. Developing country governments should make available full and reliable information on patents granted. WHO, in cooperation with WIPO and others, should continue to pursue the establishment of a database of information about patents, in order to remove potential barriers to availability and access resulting from uncertainty about the patent status in a country of a given product. 3.18. Developed countries and the WTO should take action to ensure compliance with the provisions of Article 66.2 of the TRIPS agreement, and to operationalize the transfer of technology for pharmaceutical production in accordance with paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health. 3.19. The restriction of parallel imports by developed countries is likely to be beneficial for affordability in developing countries. Developing countries should retain the possibilities to benefit from differential pricing, and the ability to seek and parallel import lower priced medicines. 3.20. Developing countries need to decide in the light of their own circumstances, what provisions, consistent with the TRIPS agreement, would benefit public health, weighing the positive effects against the negative effects. A public health justification should be required for data protection rules going beyond what is required by the TRIPS agreement. There is unlikely to be such a justification in markets with a limited ability to pay and little innovative capacity. Thus, 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 into TRIPS. 3.21. In bilateral trade negotiations, it is important that governments ensure that ministries of health be properly represented in the negotiation, and that the provisions in the texts respect the principles of the Doha Declaration. Partners should consider carefully any trade-offs they may make in negotiation. 3.22. Governments and concerned international organizations should promote new purchasing mechanisms to stimulate the supply of affordable new products and to enhance the number of suppliers in order to provide a more competitive environment. 3.23. Developing countries should 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. 3.24. Countries should provide in national legislation for measures to encourage generic entry on patent expiry, such as the "early working" exception, and more generally policies that support greater competition between generics, whether branded or not, as an effective way to enhance access by improving affordability. Restrictions should not be placed on the use of generic names.

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3.25. Developing countries should adopt or effectively implement competition policies in order to prevent or remedy anti-competitive practices related to the use of medicinal patents, including the use of pro-competitive measures available under intellectual property law. 3.26. Bilateral trade agreements should not seek to incorporate TRIPS-plus protection in ways that may reduce access to medicines in developing countries. 3.27. Governments should take action to avoid barriers to legitimate competition by considering developing guidelines for patent examiners on how properly to implement patentability criteria and, if appropriate, consider changes to national patent legislation. 4. Fostering Innovation in Developing Countries

4.1. A prerequisite for developing innovative capacity is investment in the human resources and the knowledge base, especially the development of tertiary education. Governments must make this investment, and donors should support them.

4.2. The formation of effective networks, nationally and internationally, between institutions in developing countries and developed countries, both formal and informal, are an important element in building innovative capacity. Developed and developing countries should seek to intensify collaborations which will help build capacity in developing countries.

4.3. WHO, WIPO and other concerned organizations should work together to strengthen education and training on the management of intellectual property in the biomedical field, fully taking into account the needs of recipient countries and their public health policies.

4.4. Developed countries, and pharmaceutical companies (including generic producers), should take measures to promote the transfer of technology and local production of pharmaceuticals in developing countries, wherever this makes economic sense and promotes the availability, accessibility, affordability and security of supply of needed products.

4.5. Developed countries should comply with their obligations under article 66.2 of the TRIPS Agreement and paragraph 7 of the Doha Declaration.

4.6. Developing countries need to assign a higher priority to improving the regulation of medical products. Developed countries, and their regulatory institutions, should provide greater financial and technical assistance to help attain the minimum set of regulatory standards needed to ensure that good quality products are available for use. This assistance should also support infrastructure developments within a country, to ensure that good manufacturing practice and supply chain management standards are implemented and sustained.

4.7. The process of the International Conference on Harmonisation currently lacks immediate relevance to the needs of many developing countries, but those countries should maintain their participation in the process. In the meantime, developing country governments and regulatory institutions should give support to regional initiatives, tailored to the current capacities of their member countries, which offer more scope for lifting standards over time, exploiting comparative advantages, avoiding duplication, sharing information and facilities, and promoting appropriate standardization without erecting barriers to competition.

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4.8. WHO has an important role to play, in collaboration with interested parties, in helping

to strengthen the clinical trials and regulatory infrastructure in developing countries, in particular in sub-Saharan Africa, including the improvement of ethical review standards.

4.9. Apart from the European & Developing Countries Clinical Trial Partnership, donors together with medical research councils, foundations and nongovernmental organizations, need to offer more help to developing countries in strengthening clinical trials and regulatory infrastructure.

4.10. Digital libraries of traditional medical knowledge should be incorporated into the minimum search documentation lists of patent offices to ensure that the data contained within them will be considered during the processing of patent applications. Holders of the traditional knowledge should play a crucial role in deciding whether such knowledge is included in any databases and should also benefit from any commercial exploitation of the information.

4.11. All countries should consider how best to fulfil the objectives of the Convention on Biological Diversity. This could be, for instance, through the establishment of appropriate national regimes for prospecting for genetic resources and for their subsequent utilization and commercialisation; contractual agreements; the disclosure of information in the patent application of the geographical source of genetic resources from which the invention is derived and other means. 5. The Way to Support a Sustainable Global Effort

5.1. WHO should develop a Global Plan of Action to secure enhanced and sustainable funding for developing and making accessible products to address diseases that disproportionately affect developing countries. 5.2. WHO should continue to monitor, from a public health perspective, the impact of intellectual property rights, and other factors, on the development of new products as well as access to medicines and other health-care products in developing countries. 5.3. WHO, including its regional offices, should consider the recommendations of our report, in consultation with others, and recommend how these should be taken forward in each region and country.

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