Elements and sub-elements by wxQbknDC

VIEWS: 6 PAGES: 30

									                                                                           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


                                                                                             1
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.




                                                                                                2
Elements and sub-                              Specific actions                    Lead                Time frame Progress indicators
elements                                                                           Stakeholder(s)
Element 1. Prioritizing research and development needs
(1.1) map global research     (a) develop methodologies and mechanisms to          WHO in              2008
and development with a        identify gaps in research [on Type II and Type III   consultation with
view to identifying gaps in   diseases and on developing countries’ needs in       relevant
research and                  relation to Type I diseases]                         stakeholders
development on diseases
that disproportionately
affect developing
countries                     (b) disseminate information on identified gaps,  WHO                     Initial output   Report on gap analysis and the public health
                              and evaluate their consequences on public health                         2009 with        consequences of these gaps in developed and
                                                                                                       regular          developing countries produced, published and
                                                                                                       follow-up        disseminated.
                                                                                                       (see 8.2(a))




                               [(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]




                                                                                                                                                                   3
(1.2) formulating explicit   (a) set research priorities so as to address public Governments;     2008–2015 (i) No. of developing countries with established
prioritised strategies for   health needs and implement public health policy regional                       research priorities, and mechanisms in place to
research and                 based on appropriate and regular needs              organisations              maintain and update them and to contribute to
development at country       assessments                                                                    global priority-setting and public health policies.
and regional and inter-
regional levels                                                                                                 (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-    WHO;                  2008–2015 Report (and mapping) of ongoing and completed
                             poor settings and research on technologically     Governments;                    research which responds to identified research
                             appropriate products for addressing public health academia;                       priorities.
                             needs to combat diseases in developing countries pharmaceutical
                                                                               industry; national
                                                                               research
                                                                               institutions; public–
                                                                               private
                                                                               partnerships; other
                                                                               relevant
                                                                               stakeholders


                             (c) include research and development needs on    Governments;          2008-2015   Report (and country lists) of completed research,
                             health systems in a prioritised strategy         WHO; academia;                    including health systems research, aligned to
                                                                              national research                 priorities.
                                                                              institutions; public–
                                                                              private
                                                                              partnerships; other
                                                                              relevant
                                                                              stakeholders




                                                                                                                                                              4
                                [(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   (a) developing countries to set research priorities
and development in              in traditional medicine
traditional medicine [and
knowledge][in accordance
with the relevant               (b) supporting developing countries to build their
provisions of international     capacity in research and development in
instruments]/ [without          traditional medicine
prejudice [of making
consultation with the right     (c) promote international cooperation and
holders in agreement with       transparency in research
the national legislation of
the party] to the relevant
provisions of international     (d) support South-South cooperation in
instruments referring to        information exchange and research activities
the rights of indigenous
[peoples] and local
communities]]                   (e) support early-stage drug research and
                                development in traditional medicine systems in
                                developing countries.]




                                                                                      5
Elements and sub-                           Specific actions                  Lead              Time frame Progress indicators
elements                                                                      Stakeholder(s)


Element 2. Promoting research and development
(2.1) supporting           (a) [promote cooperation between private and
governments to develop public sectors [in support of national health
or improve national health programmes]/ [on research and development]
research programmes
and establish, where       (b) provide support for national health research   Governments;       2008–2015 (i) Assessment of and report on health research
appropriate, strategic     programmes in developing countries through         regional                     programmes in each developing country.
research networks to       political action and, where feasible and           organizations;
facilitate better          appropriate, long-term funding (consensus)         WHO (technical               (ii) Assessment of and report on the number and
coordination of                                                               assistance); other           type of research networks established at national,
stakeholders in this area                                                     relevant                     regional, and/or global levels.
(consensus)                                                                   stakeholders
                                                                                                           Note: Indicator for funding to be covered by
                                                                                                           performance indicators in 7.1


                           (c) support governments in establishing health-    Governments;       2008-2015   Voluntary reporting by governments on the
                           related innovation in developing countries         regional                       technical support received and unmet needs.
                           (consensus)                                        organisations;
                                                                              WHO (technical
                                                                              assistance); other
                                                                              relevant
                                                                              stakeholders




                                                                                                                                                           6
(2.2) promoting upstream   (a) support discovery science, including, [where          Pharmaceutical    2008–2015   (i) No. of stakeholders participating in existing
research and product       feasible and appropriate] [voluntary] open-source         industry;                     networks and/or discovery science partnership
development in             methods, in order to develop a sustainable                academia;                     activities, specifying categories of stakeholders.
developing countries       portfolio of new products                                 international and
                                                                                     national research             (ii) No. of discovery science projects underway to
                                                                                     institutions;                 which developing countries are significantly
                                                                                     Governments;                  contributing.
                                                                                     WHO; other United
                                                                                     Nations                        (iii) No. of novel leads for health products to which
                                                                                     organizations;                developing countries have significantly
                                                                                     donor agencies;               contributed.
                                                                                     development
                                                                                     partners; other
                                                                                     relevant
                                                                                     stakeholders
                           (b) [facilitate upstream research and] improve       [Pharmaceutical   [2008–2015] [(i) Required target profiles for new medicines,
                           accessibility to compound libraries [[including]/[in industry;                     diagnostics and vaccines for Type II and Type III
                           particular] through voluntary means], provide        academia;                     diseases defined and accessible.
                           technical support to developing countries in order international and
                           to create libraries at both national and regional    national research              (ii) Increased investment in the establishment of
                           levels and promote access to drug leads identified institutions; WHO;              new drug-screening tools for Type II and Type III
                           through the screening of compound libraries.         development                   diseases.
                                                                                partners]
                                                                                                               (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]




                                                                                                                                                                   7
(d) support basic and applied scientific research   Governments;          2008–2015     (i) No. of operational collaborative projects in
on Type II and Type III diseases [and [the needs    WHO;                               support of basic and applied scientific research
of developing countries]/[developing countries’     pharmaceutical                     involving developing countries.
needs] in relation to Type I diseases]              industry;
                                                    academia;                           (ii) No. of peer-reviewed publications on Type II
                                                    international and                  and Type III diseases wholly or partially authored
                                                    national research                  by researchers from developing country
                                                    institutions; other                institutions.
                                                    United Nations
                                                    organizations;                     (iii) No. of programmes supporting training for
                                                    donor agencies;                    researchers, and no. of researchers trained, from
                                                    development                        institutions in developing countries.
                                                    partners; non-
                                                    governmental
                                                    organisations;
                                                    other relevant
                                                    stakeholders
(e) support early-stage drug research and           Governments;          2008–2015 No. of operational collaborative projects in support
development in developing countries                 WHO;                            of early-stage drug research and development
(consensus)                                         pharmaceutical                  involving developing countries (reporting to be
                                                    industry;                       coordinated with 2.2(d)).
                                                    academia;
                                                    international and
                                                    national research
                                                    institutions; other
                                                    United Nations
                                                    organizations;
                                                    donor agencies;
                                                    development
                                                    partners; non-
                                                    governmental
                                                    organisations;
                                                    other relevant
                                                    stakeholders




                                                                                                                                      8
(f) build capacity to conduct clinical trials and     Governments;       2008–2015 (i) No. of new clinical trials, which meet best
promote public and other sources of funding for       pharmaceutical               practices and address ethical standards, funded
clinical trials and other mechanisms for              industry;                    and implemented in developing countries.
stimulating local innovation, taking into account     academia; WHO;
international ethical standards and the needs of      United Nations                (ii) No. of developing countries with data
developing countries (consensus)                      organizations;               management capabilities.
                                                      development
                                                      partners;                    (iii) No. of quality assurance systems, and
                                                      charitable                   regulatory legislation and systems, established
                                                      foundations;                 and/or strengthened in developing countries or
                                                      public-private               regions.
                                                      partnerships; non-
                                                      governmental
                                                      organisations;
                                                      other relevant
                                                      stakeholders

[(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]




                                                                                                                                9
(2.3) improving              (a) stimulate and improve global cooperation and    Governments;       2008–2015 [No. of operational collaborative North-South
cooperation, participation   coordination in research and development, [using   Pharmaceutical                projects
and coordination of health   systematic reviews and needs assessment] in        industry;                     No. of operational South-South projects]
and biomedical research      order to optimise resources                        academia;
and development                                                                 international and
(consensus)                                                                     national research               (i) No. of partnered coordination instruments, such
                                                                                institutions;                   as databases for information exchange.
                                                                                 WHO; other                     (ii) No. of public–private partnerships engaged in
                                                                                United Nations                  health research.
                                                                                organizations;                  (iii) Qualitative assessments (opinions of
                                                                                donor agencies;                 stakeholders) made of increased coordination and
                                                                                development                     harmonization of international efforts.
                                                                                partners; other                 (iv) Quantitative assessments (listed activities and
                                                                                relevant                        examples) made of increased coordination and
                                                                                stakeholders                    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     Governments;        2008–2015 No. and type of mechanisms in place to facilitate
                             for new mechanisms, in order to improve the        WHO; other                    information sharing, interaction and coordination
                             coordination and sharing of information on         relevant                      between public and/or private partners, and
                             research and development activities (consensus)    stakeholders                  comprehensiveness of engagement of
                                                                                                              stakeholders in these mechanisms.




                                                                                                                                                               10
(c) encourage further exploratory discussions on    [Governments;] [2008–2010] Report on conclusions from a meeting to be
the utility of possible instruments or mechanisms   non-governmental           convened of experts and other stakeholders to
for essential health and biomedical R&D,            organisations;             explore feasibility of instruments or mechanisms
including inter alia, an essential health and       national research          for essential health and biomedical R&D, including
biomedical R&D treaty (consensus)                   org. regional org.,        an essential health and biomedical research and
                                                    academia; [WHO];           development treaty.
                                                    interested
                                                    stakeholders




(d) support active participation of developing      Governments;      2008-2015   No. of developing countries building technological
countries in building technological capacity        WHO; other                    capacity.
(consensus)                                         relevant
                                                    stakeholders




(e) promote the active participation of developing Governments;       2008-2015   No. of developing countries with a defined
countries in the innovation process (consensus) WHO; other                        innovation process.
                                                   relevant
                                                   stakeholders




                                                                                                                               11
(2.4) Promoting greater    (a) promote the creation and development of           Governments;        [2008-2015]   (i) No. of generally accessible public health
access to knowledge and    accessible public health libraries in order to        WHO; academia;                    libraries established, and/or upgraded, including
technology relevant to     enhance availability and use of relevant              research                          those with internet access.
meet public health needs   publications by universities, institutes and          institutions;
of developing countries.   technical centres, especially in developing           pharmaceutical                    (ii) No. of online journals made freely accessible to
(consensus)                countries (consensus)                                 industry; other                   developing countries and no. of subscribers from
                                                                                 United Nations                    developing countries, including via HINARI and
                                                                                 organizations; non-               open-source journals.
                                                                                 governmental
                                                                                 organisations;
                                                                                 publishers; other
                                                                                 relevant
                                                                                 stakeholders



                           (b) promote public access to the results of           Governments;        2008-2015     No. of peer-reviewed manuscripts, resulting from
                           government funded research, by strongly               WHO; other United                 publicly funded research, which are freely
                           encouraging that all investigators funded by          Nations                           accessible.
                           governments submit to an open access database         organizations;
                           an electronic version of their final, peer-reviewed   academia;
                           manuscripts (consensus)                               research
                                                                                 institutions; other
                                                                                 relevant
                                                                                 stakeholders

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




                                                                                                                                                                 12
                          [(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.
                          Or
                          delete 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         (a) develop and coordinate a research and         Governments;      2008–2015 (i) No. of coordinating bodies on research and
strengthen national and   development agenda (consensus)                    regional                    development established at national and/or
regional coordinating                                                       organisations*;             regional levels.
bodies on research and                                                      WHO; other
development.                                                                relevant                      (ii) No. of these coordinating bodies that have
                                                                            stakeholders,                 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      Governments;       2008-2015   (See progress indicators in 2.4)
                          research and development outcomes                regional
                          (consensus)                                      organisations;
                                                                           WHO; other
                                                                           relevant
                                                                           stakeholders




                                                                                                                                                       13
Elements and sub-                            Specific actions                    Lead               Time frame Progress indicators
elements                                                                         Stakeholder(s)
Element 3. Building and improving innovative capacity
(3.1) building capacity of   (a) support investment by developing countries in   Developing         2008–2015 No. of countries providing funding for training.
developing countries to      human resources and knowledge bases,                country
meet research and            especially in education and training including in   Governments;                    Note: data to be obtained through National Health
development needs for        public health. (consensus)                          development                     Accounts initiative.
health products                                                                  partners; United
(consensus)                                                                      Nations
                                                                                 organizations

                             (b) support existing and new research and           Governments;      2008–2015 (i) No. of centres of excellence at regional and
                             development groups and institutions, including      regional                    sub regional level.
                             regional centres of excellence, in developing       organizations; UN
                             countries. (consensus)                              organizations;              (ii) No. of existing and new R&D groups and
                                                                                 research and                institutions receiving support.
                                                                                 development
                                                                                 groups;
                                                                                 pharmaceutical
                                                                                 industry;
                                                                                 development
                                                                                 partners
                             (c) strengthen health surveillance and information Governments;        2008–2015 No. of countries that have developed and are
                             systems. (consensus)                               WHO, regional                 implementing plans to strengthen surveillance and
                                                                                organizations,                information systems.
                                                                                NGOs, research
                                                                                institutions,
                                                                                academia, other
                                                                                relevant
                                                                                organizations




                                                                                                                                                            14
(3.2) Framing, developing (a) establish and strengthen regulatory capacity in Governments;        2008–2015   (i) No. of countries that have established an R&D
and supporting effective developing countries. (consensus)                    WHO; national and               regulatory system in developing countries.
policies that promote the                                                     regional regulatory
development of                                                                agencies                        (ii) No. of countries implementing a programme for
capacities for health                                                                                         strengthening regulatory capacity.
innovation. (consensus)
                                                                                                              (iii) No. of developing countries able to undertake
                                                                                                              QA and product regulation to international
                                                                                                              standards.


                          (b) strengthen human resources in research and Governments; UN 2008–2015 No. of countries with long-term national capacity
                          development in developing countriesthrough long- organizations;          building plans for human resource research and
                          term national capacity building plans. (consensus) development           development in developing countries.
                                                                             partners;
                                                                             international and
                                                                             national research
                                                                             institutions


                          (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




                                                                                                                                                            15
(3.3) providing support for (a) develop successful health innovation models          Governments;      2008–2015 No. of countries with a health innovation strategy.
improving innovative        in developing innovative capacity (consensus)            WHO; other UN
capacity in accordance                                                               organizations;
with the needs of                                                                    academia;
developing countries                                                                 research
(consensus)                                                                          institutions;
                                                                                     pharmaceutical
                                                                                     industry

                               (b) intensify North–South and South–South              Governments;      2008–2015 No. of publications which include authors from
                               partnerships and networks to support capacity         academia;                    more than one country, including a developing
                               building (consensus)                                  research                     country. (linked also to 2.2 (d))
                                                                                     institutions; WHO;
                                                                                     other UN
                                                                                     organizations;
                                                                                     pharmaceutical
                                                                                     industry

                               (c) establish and strengthen mechanisms for           Governments;      2008–2015 No. of countries with nationally accredited ethics
                               ethical review in the research and development        WHO; academia;              review committees, including capacity to review
                               process, including clinical trials, especially in     research                    clinical trials in developing countries.
                               developing countries (consensus)                      institutions

(3.4) supporting policies      (a) establish and strengthen national and regional
that will promote              policies to develop, support, promote [and protect]
innovation based on            traditional medicine.
traditional medicine within    (b) [promote [protection and] documentation of
an evidence-based              traditional knowledge and natural genetics
framework in accordance        resources] [in an international sui generis
with national priorities and   protection framework]
taking into account the        or
relevant provisions of         [encourage and promote national and
relevant international         international policies on traditional medicine to
instruments (consensus)        facilitate prior art for patent regimes and
                               disclosure and benefits sharing ]




                                                                                                                                                               16
                           [(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              Governments,       2008–2015 (i) No. of countries that have a traditional medicine
                           traditional medicine (consensus)                      WHO; research                strategy or include traditional medicine in their
                                                                                 institutions;                innovation strategy (see also 3.3).
                                                                                 regional bodies;
                                                                                 academia; other                 (ii) No. of countries with MOUs, publications on
                                                                                 relevant                        traditional medicines.
                                                                                 organizations

                           (f) formulate and disseminate guidelines on good      Governments;       2008–2015 (i) No. of countries implementing GMP guidelines
                           manufacturing practices for traditional medicines     WHO; other UN                for traditional medicine.
                           and laying down evidence-based standards for          organizations;
                           quality and safety evaluation (consensus)             regulatory                      (ii) Evidence-based standards for quality and
                                                                                 agencies;                       safety evaluation of traditional medicines
                                                                                 pharmaceutical                  developed.
                                                                                 industry

[(3.5) developing and      (a) establish and support award schemes for
implementing [alternative] innovation at national, regional and international
incentives for innovation levels

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




                                                                                                                                                             17
Elements and sub-                         Specific actions                  Lead                Time frame Progress indicators
elements                                                                    Stakeholder(s)
Element 4. Transfer of technology
(4.1) promoting transfer of (a) [[explore the need for [devise] [to develop and
technology and the          implement alternative] new [increase and
production of health        improve] mechanisms, or] make better use of
products in developing      existing [ones]/[mechanisms] to facilitate transfer
countries (consensus)       of technology and technical support [to build and
                            improve innovative
                            capacity 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 Governments;         2008–2015 (i) Transfer of technology guidelines available in
                            of health products in developing countries through academia;                     developing countries.
                            identification of best practices, and investment       UNCTAD; other
                            and capacity building provided by developed and UN organizations;                (ii) No. of countries with joint research projects
                            developing countries where appropriate                 nongovernmental           between private and/or public partners.
                            (consensus)                                            organizations;
                                                                                   development               (iii) No. of countries providing training in
                                                                                   partners;                 technology management and production methods.
                                                                                   charitable
                                                                                   foundations;
                                                                                   pharmaceutical
                                                                                   industry




                                                                                                                                                         18
                           (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 (a) encourage North–South and South–South              Governments;        2008–2015 (i) No. of countries with North-South and South-
collaboration and          cooperation for technology transfers, and             WHO;                          South technology transfer cooperation
coordination of technology collaboration between institutions in developing      pharmaceutical                agreements.
transfer for health        countries and the pharmaceutical industry;            industry;
products, bearing in mind (consensus)                                            international and               (ii) No. of countries with health-related technology
different levels of                                                              national research               transfer strategy (cross reference with 4.2 (d)).
development (consensus)                                                          institutions;
                                                                                 academia; other
                                                                                 United Nations
                                                                                 organizations;
                                                                                 nongovernmental
                                                                                 organizations;
                                                                                 development
                                                                                 partners

                           [(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]]




                                                                                                                                                               19
(c) facilitate local and regional networks for    Governments;         2008–2015 No. of publications on product development.
collaboration on research and development and     WHO;
transfer of technology (consensus)                pharmaceutical
                                                  industry; national
                                                  research
                                                  institutions;
                                                  academia; other
                                                  United Nations
                                                  organizations;
                                                  nongovernmental
                                                  organizations.




(d) continue to promote and encourage             Governments;         2008–2015 No. of countries with health-related technology
technology transfer to least-developed country    WTO; WIPO;                     transfer strategy (cross reference with 4.2 (a)).
members of the WTO consistent with Article 66.2   WHO; academia;
of the Agreement on Trade-Related Aspects of      research
Intellectual Property Rights (consensus)          institutions;
                                                  pharmaceutical
                                                  industry




(e) promote the necessary training to increase    Governments;         2008–2015 No. of countries providing necessary training to
absorptive capacity for technology transfer       WHO; regional                  increase absorptive capacity for technology
(consensus)                                       organisations;                 transfer.
                                                  research
                                                  institutions,




                                                                                                                                20
(4.3) [promote transfer of     (a) examine the feasibility of [voluntary] patent
key health related             pools of upstream and downstream technologies
technology] / [developing      to promote innovation [and access to] health
mechanisms to manage           products and medical devices [for diseases
intellectual property] [in a   [disproportionately] affecting developing
rational and health-           countries]
oriented manner] in order
to promote transfer of and
access to key                  (b) [consider [and if feasible develop]] additional
technologies [, including      [voluntary] effective, sustainable and
sharing of patent              complementary [or alternative] mechanisms
databases]                     [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]




                                                                                      21
Elements and sub-                        Specific actions                    Lead             Time frame Progress indicators
elements                                                                     Stakeholder(s)
Element 5. Application and Management of intellectual property to contribute to innovation and promote public health (consensus)
(5.1) NB No wording for [(a)] [supporting information sharing and capacity
sub-element              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] (consensus
                        pending 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.]




                                                                                                                                   22
(d) stimulate collaboration among pertinent             Governments;        2008-2015   Mechanism for exchange of information among
national institutions and relevant government           WHO; academia;                  government departments and national, regional
departments, as well as between national,               international and               and international institutions established or
regional and international institutions, in order to    national research               strengthened.
promote information sharing relevant to public          institutions;
health needs. (consensus)                               development
                                                        agencies;
                                                        nongovernmental
                                                        organizations;
                                                        pharmaceutical
                                                        industry
(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]




                                                                                                                                  23
Elements and sub-                         Specific actions                  Lead               Time frame Progress indicators
elements                                                                    Stakeholder(s)
Element 6. Improving delivery and access (consensus)
(6.1) encourage increased (a) invest in developing health-delivery
investment in the health- infrastructure and ensure financing of [essential]
delivery infrastructure and health products.
financing of health         (b) develop effective and sustainable mechanisms
products in order to        in least-developed countries in order to improve
strengthen the health       access to existing medicines, making full use of
system (consensus)          the transitional period until 2016 [, if necessary]
                            (c) prioritise health care in national agendas       Governments;      2008–2015 No. of countries with an increased percentage of
                            (consensus)                                          WHO ; other                 national budget allocated to health.
                                                                                 United Nations
                                                                                 organizations.
                            (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            Governments;      2008–2015 Percentage increase in human resource
                            development in the health sector (consensus)         WHO;                        development investment in the health sector in
                                                                                 development                 each country.
                                                                                 agencies, other
                                                                                 UN organizations;
                                                                                 nongovernmental
                                                                                 organizations;
                                                                                 charitable
                                                                                 foundations
                          (f) develop effective country poverty reduction   Governments;       2008–2015 No. of countries with poverty reduction strategies
                          strategies that contain clear health objectives   development                  which include clear health objectives.
                          (consensus)                                       partners




                                                                                                                                                         24
                              [(g) encourage pooled procurement mechanisms
                              in developing countries]
(6.2) establishing and        (a) [develop and] strengthen [ [medicines] /
strengthening                 [drugs] regulatory authority] capacity to monitor
mechanisms to improve         the quality, safety and efficacy of [priority] health
ethical review and            products [and services], and [accelerate] /
regulate the                  [prioritise] the regulatory approval of [strategic]
quality, safety and           [life-saving] products
efficacy of health products   [with potential utility] [for national public health
and medical devices           programs][while maintaining quality and
(consensus)                   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 Governments;            2008–2015 (I) No. of countries reporting compliance with GMP
                              safety standards, efficacy and quality of health      WHO; national                and on safety.
                              products (consensus)                                  regulatory bodies;
                                                                                    pharmaceutical               (ii) No. of WHO prequalified manufacturers in each
                                                                                    industry;                    developing country.
                                                                                    development
                                                                                    partners




                                                                                                                                                            25
Elements and sub-                            Specific actions                      Lead             Time frame Progress indicators
elements                                                                           Stakeholder(s)
Element 7. Promoting sustainable financing mechanisms (consensus)
(7.1) [endeavour to          (a) develop and implement a resource
secure adequate and          mobilization plan
sustainable financing for    or
research and                 [(a) [Establish in 2008 an expert task force to:]
development in order to      • examine current financing, coordination and
address the health needs     prioritization of research and development on
of developing countries]     health products for [diseases that
or                           disproportionately affect developing
[Improve and align the       countries]/[Type II and Type III diseases and the
existing global health       needs of developing countries in relation to Type I
R&D funding architecture,    diseases], building on the work already done
through an assessment of     • identify ways to improve coordination and
existing funding             sustainability of existing financing mechanisms
mechanisms, to increase      and to expand them as appropriate
global coordination and to   • explore proposals for new and innovative
provide sustainable          models of financing for health research and
support to programmes,       development, as needed with contribution from
particularly those led by    both developed and developing countries, taking
developing countries]        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]




                                                                                                                                     26
                          (b) [consider]/[encourage] 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][in line
                          with WHA resolution 58.34]1

                          (c) [create a database of possible sources of
                          financing for R & D]
(7.2) facilitating the    (a) document and disseminate best practices in      Governments;          2008–2015 Best practices in public-private and product
maximum use of, and       public-private and product development              WHO; research                   development partnerships developed and
complementing as          partnerships (consensus)                            institutions; public-           disseminated.
appropriate, existing                                                         private
financing, including that                                                     partnerships
through public-private and
product development
partnerships, in order to
develop and deliver safe,
effective and affordable
                           (b) develop tools to periodically assess           Governments;          2008–2009 Tools developed to assess performance of public-
health products and
                           performance of public-private and product          WHO; research                   private and product development partnerships.
medical devices.
                           development partnerships (consensus)               institutions; public-
consensus)
                                                                              private
                                                                              partnerships;
                                                                              charitable
                                                                              foundations




                                                                                                                                                             27
                           (c) support public-private and product                 Governments;         2008–2015   No. of public-private partnerships, product
                           development partnerships and other appropriate         WHO; other United                development partnerships and other appropriate
                           research and development initiatives in                Nations                          research and development initiatives supported in
                           developing countries (consensus)                       organizations;                   developing countries.
                                                                                  pharmaceutical
                                                                                  industry; charitable
                                                                                  foundations;
                                                                                  development
                                                                                  partners;
                                                                                  nongovernmental
                                                                                  organizations;
                                                                                  academia;
                                                                                  research
                                                                                  institutions

[(7.3) Setting up a global (a) of this fund, money will be earmarked and
R&D fund to address the provided for research in the form of grants for
identified R&D gaps in     R&D for these diseases in advance, as well as
Type II and Type III       prize/rewards for path-breaking research after it is
diseases and the needs of accomplished.
developing countries in
relation to Type I         (b) of this fund, money will be earmarked and
diseases.                  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




                                                                                                                                                              28
Elements and sub-                            Specific actions                        Lead             Time frame Progress indicators
elements                                                                             Stakeholder(s)
Element 8. Establishing monitoring and reporting systems
(8.1) measuring         (a) establish systems to monitor performance and Governments;                 2008–2015 Systems to monitor performance and progress of
performance and         progress of the implementation of each element WHO                                      the implementation of the Global Strategy and
progress towards        of the Global Strategy and Plan of Action                                               Plan of Action developed and operational.
objectives contained in (consensus)
the plan of action
(consensus)
(8.2) monitoring [the       (a) monitor and report periodically to WHO’s   Governments;               From 2009   Report to WHO`s governing bodies every 2 years
factors that could affect   governing bodies on the gaps and needs related WHO                                    on the gaps and needs related to health products
innovation and access to    to health products and medical devices in                                             and medical devices in developed and developing
medicines and other         developed and developing countries (consensus)                                        countries.
health products] / [the
impact of intellectual      [(b) monitor [and report] [, in collaboration with the
property rights and other   WTO and WIPO,] the impact of intellectual
factors on innovation and   property rights and other factors on innovation [of]
access to medicines and     and access to health-care products [in
other health-care           consultation as appropriate with other
products]                   international organizations
                            competent 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]1
                            OR
                            delete subparagraph (b)




                                                                                                                                                            29
[(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.]




                                                 30

								
To top