Elements and sub-elements - WHO€¦ · Web viewThese are set out in White Paper 3: Secretariat Draft text with proposed reporting components /summary indicators (March 2008 Version)

White Paper 2

3 March 2008

Sub-group of Drafting Group B meeting: 17-19 March 2008

Plan of Action: progress indicators, timeframes and lead stakeholders

Secretariat Draft Text

Introduction

1. The second session of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property, established by resolution WHA59.24, met in Geneva from 5-10 November 2007, suspended its work on 10 November 2007, and will resume from 28 April to 3 May 2008.

The Sub-group of Drafting Group B met on 8-9 November 2007. It reviewed the draft plan of action for Elements 1 and 2 and made proposals to Drafting Group B of the Intergovernmental Working Group for (a) stakeholders, (b) time-frames and (c) progress indicators for consensus (unbracketed) sub-elements and specific actions . The output of the Sub-group’s work is set out in White Paper 1: Outcome Document of IGWG2 Sub-group discussions (November 2007 version - Report of Sub-group Chair and Plan of action - Elements 1 and 2.)

In advance of the resumption of the Intergovernmental Working Group second session on 28 April 2008, the Sub-group of Drafting Group B will meet on 17-19 March 2008 to continue its work and review proposals for stakeholders, time-frames and progress indicators for all consensus (unbracketed) sub-elements and specific actions in Elements 3-8. It will also review its proposals for Elements 1 and 2 in the light of its further discussions.

This White Paper 2 provides the Secretariat’s draft text for consideration by the Sub-group. It should be reviewed in conjunction with the paper on the Draft Global Strategy and Plan of Action (A/PHI/IGWG/2/2) and White Paper 1.

Development of indicators, timeframes and stakeholders

At its November meeting, there was consensus within the sub-group that the draft plan of action in A/PHI/IGWG/2/2 contained too many indicators, which would be costly and difficult to apply. The attached paper therefore seeks to meet their request that the number of performance indicators should be reduced to the minimum possible to achieve effective monitoring and evaluation. Because the specific actions generally have a specific focus and

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sometimes appear distant from the sub-element, progress indicators have been developed at specific action level.

However, in addition, to provide a tighter focus for action, the Secretariat also proposes a small number of summary indicators (where this is practicable) or ‘reporting components’ at the level of the eight elements of the draft global strategy and plan of action. These are set out in White Paper 3: Secretariat Draft text with proposed reporting components /summary indicators (March 2008 Version).

In a few instances, a footnote has been included to clarify an indicator or to cross reference to another sub-element or specific action in the action plan.

Several indicators are based on the number of countries or projects meeting a specified requirement, eg the proposed indicator for specific action 1.2(a): number of developing countries with established research priorities, and mechanisms in place to maintain and update them and to contribute to global priority-setting and public health policies. In these cases, the Secretariat proposes that the number produced during the first report should provide the baseline for future monitoring comparisons. At that stage, a target should be set for achievement within an appropriate timeframe. In preparing the new text on the plan of action, the Secretariat has adopted the Sub-group’s suggestion of using a landscape format to make the plan easier to read. The plan of action is provided in both Excel and Word format for ease of use by member states.

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Elements and sub-elements

Specific actions Lead Stakeholder(s)

Time frame Progress indicators

Element 1. Prioritizing research and development needs

(1.1) map 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’ needs in relation to Type I diseases]

WHO in consultation with relevant stakeholders

2008

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

WHO Initial output 2009 with regular follow-up (see 8.2(a))

Report on gap analysis and the public health consequences of these gaps in developed and developing countries produced, published and disseminated.

[(c) provide an assessment of identified gaps at different levels – national, regional and international - to initiate research in affordable and therapeutically sound products to meet public health needs]

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(1.2) formulating explicit prioritised 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

Governments; regional organisations

2008–2015 (i) No. of developing countries with established research priorities, and mechanisms in place to maintain and update them and to contribute to global priority-setting and public health policies. (ii) No. of developed countries with established research priorities for diseases that disproportionately affect developing countries, and mechanisms in place to maintain and update them and to contribute to global priority-setting and public health policies.

(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

WHO; Governments; academia; pharmaceutical industry; national research institutions; public–private partnerships; other relevant stakeholders

2008–2015 Report (and mapping) of ongoing and completed research which responds to identified research priorities.

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

Governments; WHO; academia; national research institutions; public–private partnerships; other relevant stakeholders

2008-2015 Report (and country lists) of completed research, including health systems research, aligned to priorities.

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[(d) ensure the leadership and commitment of governments, regional and international organizations in determining priorities for R&D according to public health needs.]

[(e) increase overall R&D efforts on health problems that predominantly affect developing countries, leading to the development of quality products adapted to public health needs, user friendly (in terms of use, prescription and management) and accessible (in terms of availability and affordability).]

[[(1.3) prioritising research and development in traditional medicine [and knowledge][in accordance with the relevant provisions of international instruments]/ [without prejudice [of making consultation with the right holders in agreement with the national legislation of the party] to the relevant provisions of international instruments referring to the rights of indigenous [peoples] and local communities]]

(a) developing countries to set research priorities in traditional medicine

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

(c) promote international cooperation and transparency in 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.]




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Element 2. Promoting research and development(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 (consensus)

(a) [promote cooperation between private and public sectors [in support of national health programmes]/ [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 (consensus)

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

2008–2015 (i) Assessment of and report on health research programmes in each developing country.

(ii) Assessment of and report on the number and type of research networks established at national, regional, and/or global levels. Note: Indicator for funding to be covered by performance indicators in 7.1

(c) support governments in establishing health-related innovation in developing countries (consensus)

Governments; regional organisations; WHO (technical assistance); other relevant stakeholders

2008-2015 Voluntary reporting by governments on the technical support received and unmet needs.

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(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

Pharmaceutical industry; academia; international and national research institutions; Governments; WHO; other United Nations organizations; donor agencies; development partners; other relevant stakeholders

2008–2015 (i) No. of stakeholders participating in existing networks and/or discovery science partnership activities, specifying categories of stakeholders.

(ii) No. of discovery science projects underway to which developing countries are significantly contributing.

(iii) No. of novel leads for health products to which developing countries have significantly contributed.

(b) [facilitate upstream research and] improve accessibility to compound libraries [[including]/[in particular] through voluntary means], provide technical support to developing countries in order to create libraries at both national and regional levels and promote access to drug leads identified through the screening of compound libraries.

[Pharmaceutical industry; academia; international and national research institutions; WHO; development partners]

[2008–2015] [(i) Required target profiles for new medicines, diagnostics and vaccines for Type II and Type III diseases defined and accessible.

(ii) Increased investment in the establishment of new drug-screening tools for Type II and Type III diseases.

(iii) No. of countries with drug screening fully integrated into the product innovation cycle.]

[(c) identify IP-related provisions at different levels – national, regional and international - that might negatively affect increased research on public health, and suggest ways to facilitate access to research results and research tools]

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(d) support basic and applied scientific research on Type II and Type III diseases [and [the needs of developing countries]/[developing countries’ needs] in relation to Type I diseases]

Governments; WHO; pharmaceutical industry; academia; international and national research institutions; other United Nations organizations; donor agencies; development partners; non-governmental organisations; other relevant stakeholders

2008–2015 (i) No. of operational collaborative projects in support of basic and applied scientific research involving developing countries.

(ii) No. of peer-reviewed publications on Type II and Type III diseases wholly or partially authored by researchers from developing country institutions.

(iii) No. of programmes supporting training for researchers, and no. of researchers trained, from institutions in developing countries.

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

Governments; WHO; pharmaceutical industry; academia; international and national research institutions; other United Nations organizations; donor agencies; development partners; non-governmental organisations; other relevant stakeholders

2008–2015 No. of operational collaborative projects in support of early-stage drug research and development involving developing countries (reporting to be coordinated with 2.2(d)).

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(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 (consensus)

Governments; pharmaceutical industry; academia; WHO; United Nations organizations; development partners; charitable foundations; public-private partnerships; non-governmental organisations; other relevant stakeholders

2008–2015 (i) No. of new clinical trials, which meet best practices and address ethical standards, funded and implemented in developing countries.

(ii) No. of developing countries with data management capabilities.

(iii) No. of quality assurance systems, and regulatory legislation and systems, established and/or strengthened in developing countries or regions.

[(g) enable and support the acquisition of new knowledge and technologies that will facilitate the development of new health products and medical devices to tackle the health problems of developing countries]

Or

[promote new knowledge to facilitate the development of new products to tackle the health problems of developing countries]

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

(a) stimulate and improve global cooperation and coordination in research and development, [using systematic reviews and needs assessment] in order to optimise resources

Governments;Pharmaceutical industry; academia; international and national research institutions; WHO; other United Nations organizations; donor agencies; development partners; other relevant stakeholders

2008–2015 [No. of operational collaborative North-South projectsNo. of operational South-South projects]

(i) No. of partnered coordination instruments, such as databases for information exchange.(ii) No. of public–private partnerships engaged in health research.(iii) Qualitative assessments (opinions of stakeholders) made of increased coordination and harmonization of international efforts. (iv) Quantitative assessments (listed activities and examples) made of increased coordination and harmonization of international efforts.(v) Indicators (ii) and (iii) with focus on assessment of developing country opinion and quantitative examples. (vi) Best practices in promoting research and development in resource poor settings documented.

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

Governments; WHO; other relevant stakeholders

2008–2015 No. and type of mechanisms in place to facilitate information sharing, interaction and coordination between public and/or private partners, and comprehensiveness of engagement of stakeholders in these mechanisms.

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(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 (consensus)

[Governments;] non-governmental organisations; national research org. regional org., academia; [WHO]; interested stakeholders

[2008–2010] Report on conclusions from a meeting to be convened of experts and other stakeholders to explore feasibility of instruments or mechanisms for essential health and biomedical R&D, including an essential health and biomedical research and development treaty.

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


2008-2015 No. of developing countries building technological capacity.

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


2008-2015 No. of developing countries with a defined innovation process.

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

(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 (consensus)

Governments; WHO; academia; research institutions; pharmaceutical industry; other United Nations organizations; non-governmental organisations; publishers; other relevant stakeholders

[2008-2015] (i) No. of generally accessible public health libraries established, and/or upgraded, including those with internet access.

(ii) No. of online journals made freely accessible to developing countries and no. of subscribers from developing countries, including via HINARI and open-source journals.

(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 (consensus)

Governments; WHO; other United Nations organizations; academia; research institutions; other relevant stakeholders

2008-2015 No. of peer-reviewed manuscripts, resulting from publicly funded research, which are freely accessible.

[(c) support the creation of open databases and compound libraries, including [unrestricted]/[promoting] access to drug leads identified through the screening of compound libraries.]

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[(d) encourage developed countries, universities and donors to require that publicly or donor funded medical inventions and know-how be made available through open licensing for use in developing countries on reasonable and affordable non-discriminatory terms.Ordelete subparagraph (d)] [(e) consider the incorporation of research exemptions in legislation of developing countries to address public health needs, consistent with their obligations, if any, under the Agreement on Trade-Related Aspects of Intellectual Property Rights and the Doha Declaration on TRIPS and Public Health Or delete subparagraph (e) ].

2.5 Establish and strengthen national and regional coordinating bodies on research and development.

(a) develop and coordinate a research and development agenda (consensus)

Governments; regional organisations*; WHO; other relevant stakeholders,

2008–2015 (i) No. of coordinating bodies on research and development established at national and/or regional levels.

(ii) No. of these coordinating bodies that have established research and development agendas.

Note: regional organizations are referred to here and elsewhere in the action plan. Identification and assignment of specific roles for regional entities will be done during further development of the plan.

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

Governments; regional organisations; WHO; other relevant stakeholders

2008-2015 (See progress indicators in 2.4)

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Element 3. Building and improving innovative capacity

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

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

Developing country Governments; development partners; United Nations organizations

2008–2015 No. of countries providing funding for training.

Note: data to be obtained through National Health Accounts initiative.

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

Governments; regional organizations; UN organizations; research and development groups; pharmaceutical industry; development partners

2008–2015 (i) No. of centres of excellence at regional and sub regional level.

(ii) No. of existing and new R&D groups and institutions receiving support.

(c) strengthen health surveillance and information systems. (consensus)

Governments; WHO, regional organizations, NGOs, research institutions, academia, other relevant organizations

2008–2015 No. of countries that have developed and are implementing plans to strengthen surveillance and information systems.

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(3.2) Framing, developing and supporting effective policies that promote the development ofcapacities for health innovation. (consensus)

(a) establish and strengthen regulatory capacity in developing countries. (consensus)

Governments; WHO; national and regional regulatory agencies

2008–2015 (i) No. of countries that have established an R&D regulatory system in developing countries. (ii) No. of countries implementing a programme for strengthening regulatory capacity. (iii) No. of developing countries able to undertake QA and product regulation to international standards.

(b) strengthen human resources in research and development in developing countriesthrough long-term national capacity building plans. (consensus)

Governments; UN organizations; development partners; international and national research institutions

2008–2015 No. of countries with long-term national capacity building plans for human resource research and development in developing countries.

(c) [encourage international cooperation to develop effective policies for retention of health professionals including researchers [in developing countries] and [provide developing countries and their institutions with support to ] alleviate the [negative] impact of health workforce migration taking into account the work of WHO and other relevant organizations]or[urge Member States to mitigate the adverse impact of the loss of health personnel through migration, including means for the receiving developed countries to support the strengthening of health systems, in particular human resource development in the countries of origin

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

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

Governments; WHO; other UN organizations; academia; research institutions; pharmaceutical industry

2008–2015 No. of countries with a health innovation strategy.

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

Governments; academia; research institutions; WHO; other UN organizations; pharmaceutical industry

2008–2015 No. of publications which include authors from more than one country, including a developing country. (linked also to 2.2 (d))

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

Governments; WHO; academia; research institutions

2008–2015 No. of countries with nationally accredited ethics review committees, including capacity to review clinical trials in developing countries.

(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 (consensus)

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

(b) [promote [protection and] documentation of traditional knowledge and natural genetics resources] [in an international sui generis protection framework]or[encourage and promote national and international policies on traditional medicine to facilitate prior art for patent regimes and disclosure and benefits sharing ]

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[(c) [encourage [all countries to ensure]]/[ensure] high standards of safety and efficacy for traditional medicine and promote and fund research for standardization of traditional medicine systems.]

[(d) encourage research on mechanisms for action and pharmacokinetics of chemical entities used in traditional medicine]

(e) promote South-South collaboration in traditional medicine (consensus)

Governments, WHO; research institutions; regional bodies; academia; other relevant organizations

2008–2015 (i) No. of countries that have a traditional medicine strategy or include traditional medicine in their innovation strategy (see also 3.3). (ii) No. of countries with MOUs, publications on traditional medicines.

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

Governments; WHO; other UN organizations; regulatory agencies; pharmaceutical industry

2008–2015 (i) No. of countries implementing GMP guidelines for traditional medicine. (ii) Evidence-based standards for quality and safety evaluation of traditional medicines developed.

[(3.5) developing and implementing [alternative] incentives for innovation

(a) establish and support award schemes for innovation at national, regional and international levels

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

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Element 4. Transfer of technology(4.1) promoting transfer of technology and the production of health products in developing countries (consensus)

(a) [[explore the need for [devise] [to develop and implement alternative] new [increase and improve] mechanisms, or] make better use of existing [ones]/[mechanisms] to facilitate transfer of technology and technical support [to build and improve innovativecapacity for research and development, particularly in developing countries].]

[(b) devise a list of [essential] technologies related to research and local production of health products relevant to developing countries].

(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 (consensus)

Governments; academia; UNCTAD; other UN organizations; nongovernmental organizations; development partners; charitable foundations; pharmaceutical industry

2008–2015 (i) Transfer of technology guidelines available in developing countries.

(ii) No. of countries with joint research projects between private and/or public partners.

(iii) No. of countries providing training in technology management and production methods.

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(d) [encourage]/[promote] the dissemination of [health related] technological and other information contained in patents and published patent applications, as well as published information related to patent status, oppositions, revocations and nullifications.]

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

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

Governments; WHO; pharmaceutical industry; international and national research institutions; academia; other United Nations organizations; nongovernmental organizations; development partners

2008–2015 (i) No. of countries with North-South and South-South technology transfer cooperation agreements.

(ii) No. of countries with health-related technology transfer strategy (cross reference with 4.2 (d)).

[(b) [make arrangements to promote technology transfer] / [support technology transfer from North to South] related to research and development on natural products [for therapeutic use]]

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

Governments; WHO; pharmaceutical industry; national research institutions; academia; other United Nations organizations; nongovernmental organizations.

2008–2015 No. of publications on product development.

(d) 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 (consensus)

Governments; WTO; WIPO; WHO; academia; research institutions; pharmaceutical industry

2008–2015 No. of countries with health-related technology transfer strategy (cross reference with 4.2 (a)).

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

Governments; WHO; regional organisations; research institutions,

2008–2015 No. of countries providing necessary training to increase absorptive capacity for technology transfer.

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(4.3) [promote transfer of key health related technology] / [developing mechanisms to manage intellectual property] [in a rational and health-oriented manner] in order to promote transfer of and access to key technologies [, including sharing of patent databases]

(a) examine the feasibility of [voluntary] patent pools of upstream and downstream technologies to promote innovation [and access to] health products and medical devices [for diseases [disproportionately] affecting developing countries]

(b) [consider [and if feasible develop]] additional [voluntary] effective, sustainable and complementary [or alternative] mechanisms [including appropriate patenting and licensing policies] to promote innovation of [and access to] products [of relevance to public health needs of developing countries]/[ for priority diseases in developing countries]/ [for diseases that disproportionately affect developing countries]] [, for instance, licensing guidelines and policies that promote humanitarian and access objectives.]

(c) [encourage appropriate patenting and licensing policies that maximize access to innovations for development of products of relevance to the public health needs of developing countries]

or delete subparagraph (c)

or move to element 5]

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Element 5. Application and Management of intellectual property to contribute to innovation and promote public health (consensus)(5.1) NB No wording for sub-element

[(a)] [supporting 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]

OR

[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]

(b) [promote and support national, regional institutional frameworks as well as international cooperation, to build and strengthen capacity to manage and apply intellectual property, in a manner oriented to public health needs and priorities of developing countries] (consensuspending decision by the USA)

(c) [to compile, maintain and update user friendly global databases on the status of health-related patents in all countries and facilitate widespread access to these databases, in particular by developing countries, [as well as]/[to] strengthen national capacities of analysis and the quality of patents.]

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(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. (consensus)

Governments; WHO; academia; international and national research institutions; development agencies; nongovernmental organizations; pharmaceutical industry

2008-2015 Mechanism for exchange of information among government departments and national, regional and international institutions established or strengthened.

(e) [to strengthen education and training in the granting, application and management of intellectual property from a public health perspective including use of flexibilities contained in the TRIPS Agreement]

(f) [developing countries should be encouraged to develop Traditional Knowledge digital library]or [WHO to encourage Member States to use traditional knowledge digital libraries for their patent examination procedures in order to prevent misappropriation of traditional knowledge]

(g) [urge active and effective participation of health representatives in IP-related negotiations in order to ensure that the outcomes of such negotiations incorporate all the flexibilities important to address public health needs]

(h) [establish measures to avoid unethical experiments involving human beings as a requirement for registration of medicines and technologies]

(i) [to create a Coordination Committee among WHO, WIPO and WTO for looking at solutions on the issue of public health and intellectual property]

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Element 6. Improving delivery and access (consensus)(6.1) encourage increased investment in the health-delivery infrastructure and financing of health products in order to strengthen the health system (consensus)

(a) invest in developing health-delivery infrastructure and ensure financing of [essential] health products.

(b) develop effective and sustainable mechanisms in least-developed countries in order to improve access to existing medicines, making full use of the transitional period until 2016 [, if necessary]

(c) prioritise health care in national agendas (consensus)

Governments; WHO ; other United Nations organizations.

2008–2015 No. of countries with an increased percentage of national budget allocated to health.

(d) encourage national health authorities to improve national management capacities [in order] / [with a view] to [guarantee] / [improve] / [increase] delivery and access to medicines and other health products with quality, efficacy, safety and affordability [and to develop strategies to promote rational use of medicines]

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

Governments; WHO; development agencies, other UN organizations; nongovernmental organizations; charitable foundations

2008–2015 Percentage increase in human resource development investment in the health sector in each country.

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

Governments; development partners

2008–2015 No. of countries with poverty reduction strategies which include clear health objectives.

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[(g) encourage pooled procurement mechanisms in developing countries]

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

(a) [develop and] strengthen [ [medicines] / [drugs] regulatory authority] capacity to monitor the quality, safety and efficacy of [priority] health products [and services], and [accelerate] / [prioritise] the regulatory approval of [strategic] [life-saving] products[with potential utility] [for national public health programs][while maintaining quality and respecting ethical review standards]

(b) [conduct]/ [promote] operational studies to maximize the [therapeutic] value and use of new [and existing] products [and treatments in health systems] [in high disease-burden settings with inadequate health services]

(c) [develop and] implement national and international disease-control policies [that are based on evidence that use of new and existing products has an impact]/ [that make use of innovative medicines based on scientific evidence of efficacy, safety and comparative costs with regard to therapeutical and economical advantages offered by existing products that are used rationally for such diseases]

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

Governments; WHO; national regulatory bodies; pharmaceutical industry; development partners

2008–2015 (I) No. of countries reporting compliance with GMP and on safety.

(ii) No. of WHO prequalified manufacturers in each developing country.

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Element 7. Promoting sustainable financing mechanisms (consensus)(7.1) [endeavour to secure adequate and sustainable financing for research and development in order to address the health needs of developing countries]or[Improve and align the existing global health R&D funding architecture, through an assessment of existing funding mechanisms, to increase global coordination and to provide sustainable support to programmes, particularly those led by developing countries]

(a) develop and implement a resource mobilization planor[(a) [Establish in 2008 an expert task force to:]• examine current financing, coordination and prioritization of research and development on health products for [diseases that disproportionately affect developing countries]/[Type II and Type III diseases and the needs of developing countries in relation to Type I diseases], building on the work already done• identify ways to improve coordination and sustainability of existing financing mechanisms and to expand them as appropriate• explore proposals for new and innovative models of financing for health research and development, as needed with contribution from both developed and developing countries, taking into account lessons learned from UNITAID, IFFIm and AMCs• [devising and setting up sustainable sources of funding for needs-driven R&D according to criteria of equitable participation and access, adequacy and affordability of health technologies for those who need them.] • progress report on process to the 62nd WHA• report with concrete recommendations to the 63rd WHA through the Executive Board]

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(b) [consider]/[encourage] channelling additional funds to health-oriented researchorganizations as appropriate in both the private and public sector of developingcountries [and promote good financial management to maximize its effectiveness][in linewith WHA resolution 58.34]1

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

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

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

Governments; WHO; research institutions; public-private partnerships

2008–2015 Best practices in public-private and product development partnerships developed and disseminated.

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

Governments; WHO; research institutions; public-private partnerships; charitable foundations

2008–2009 Tools developed to assess performance of public- private and product development partnerships.

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

Governments; WHO; other United Nations organizations; pharmaceutical industry; charitable foundations; development partners; nongovernmental organizations; academia; research institutions

2008–2015 No. of public-private partnerships, product development partnerships and other appropriate research and development initiatives supported in developing countries.

[(7.3) Setting up a global R&D fund to address the identified R&D gaps in Type II and Type III diseases and the needs of developing countries in relation to Type I diseases.

(a) of this fund, money will be earmarked and provided for research in the form of grants for R&D for these diseases in advance, as well as prize/rewards for path-breaking research after it is accomplished.

(b) of this fund, money will be earmarked and provided to buy out patents to ensure that health products are made available at affordable prices in developing countries.

(c) financing for this fund will come from contributions by countries, donors, industry and taxing of international financial transactions as agreed to by Member States.

(d) an operational mechanism will be set up for this fund as agreed to by Member States.]or delete proposed 7.3

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Element 8. Establishing monitoring and reporting systems(8.1) measuring performance and progress towards objectives contained in the plan of action (consensus)

(a) establish systems to monitor performance and progress of the implementation of each element of the Global Strategy and Plan of Action (consensus)

Governments; WHO

2008–2015 Systems to monitor performance and progress of the implementation of the Global Strategy and Plan of Action developed and operational.

(8.2) monitoring [the factors that could affect innovation and access to medicines and other health products] / [the impact of intellectual property rights and other factors on innovation and access to medicines and other health-care products]

(a) 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 (consensus)

Governments; WHO

From 2009 Report to WHO`s governing bodies every 2 years on the gaps and needs related to health products and medical devices in developed and developing countries.

[(b) monitor [and report] [, in collaboration with the WTO and WIPO,] the impact of intellectual property rights and other factors on innovation [of] and access to health-care products [in consultation as appropriate with other international organizationscompetent in intellectual property] ]OR[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 Commission’s report,] on the development of, and access to, health care products, and to report thereon to the Health Assembly]1ORdelete subparagraph (b)

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[(c) monitor and report the impact of [new]/ [innovative and alternative] mechanisms on innovation and access to health products and medical devices] OR delete subparagraph (c)

[(d) monitor and]/[report on] investment in research and development to address the health needs of developing countries.]

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Documents

Elements and sub-elements - WHO€¦ · Web viewThese are set out in White Paper 3: Secretariat Draft text with proposed reporting components /summary indicators (March 2008 Version)