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 subelements
Specific actions
Lead
Stakeholder(s)
Time frame Progress indicators
WHO in
consultation with
relevant
stakeholders
2008
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
(b) disseminate information on identified gaps,
and evaluate their consequences on public health
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]
3
(1.2) formulating explicit
prioritised strategies for
research and
development at country
and regional and interregional levels
(a) set research priorities so as to address public Governments;
health needs and implement public health policy regional
organisations
based on appropriate and regular needs
assessments
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.
WHO;
(b) conduct research appropriate for resource2008–2015 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
health systems in a prioritised strategy
Governments;
2008-2015
WHO; academia;
national research
institutions; public–
private
partnerships; other
relevant
stakeholders
Report (and country lists) of completed research,
including health systems research, aligned to
priorities.
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
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.]
5
Elements and subelements
Specific actions
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
appropriate, strategic
programmes in developing countries through
research networks to
political action and, where feasible and
facilitate better
appropriate, long-term funding (consensus)
coordination of
stakeholders in this area
(consensus)
(c) support governments in establishing healthrelated innovation in developing countries
(consensus)
Lead
Stakeholder(s)
Time frame Progress indicators
Governments;
2008–2015 (i) Assessment of and report on health research
regional
programmes in each developing country.
organizations;
WHO (technical
(ii) Assessment of and report on the number and
assistance); other
type of research networks established at national,
relevant
regional, and/or global levels.
stakeholders
Note: Indicator for funding to be covered by
performance indicators in 7.1
Governments;
2008-2015
regional
organisations;
WHO (technical
assistance); other
relevant
stakeholders
Voluntary reporting by governments on the
technical support received and unmet needs.
6
(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
2008–2015
industry;
academia;
international and
national research
institutions;
Governments;
WHO; other United
Nations
organizations;
donor agencies;
development
partners; other
relevant
stakeholders
(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
[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
on Type II and Type III diseases [and [the needs
of developing countries]/[developing countries’
needs] in relation to Type I diseases]
(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; nongovernmental
organisations;
other relevant
stakeholders
Governments;
WHO;
pharmaceutical
industry;
academia;
international and
national research
institutions; other
United Nations
organizations;
donor agencies;
development
partners; nongovernmental
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.
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)).
8
(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;
2008–2015 (i) No. of new clinical trials, which meet best
pharmaceutical
practices and address ethical standards, funded
industry;
and implemented in developing countries.
academia; WHO;
United Nations
(ii) No. of developing countries with data
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; nongovernmental
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
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
(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;
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
projects
No. of operational South-South projects]
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.
(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.
10
(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;] [2008–2010] Report on conclusions from a meeting to be
non-governmental
convened of experts and other stakeholders to
organisations;
explore feasibility of instruments or mechanisms
national research
for essential health and biomedical R&D, including
org. regional org.,
an essential health and biomedical research and
academia; [WHO];
development treaty.
interested
stakeholders
(d) support active participation of developing
countries in building technological capacity
(consensus)
Governments;
WHO; other
relevant
stakeholders
2008-2015
No. of developing countries building technological
capacity.
(e) promote the active participation of developing Governments;
countries in the innovation process (consensus) WHO; other
relevant
stakeholders
2008-2015
No. of developing countries with a defined
innovation process.
11
(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;
[2008-2015]
WHO; academia;
research
institutions;
pharmaceutical
industry; other
United Nations
organizations; nongovernmental
organisations;
publishers; other
relevant
stakeholders
(i) No. of generally accessible public health
libraries established, and/or upgraded, including
those with internet access.
(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;
2008-2015
WHO; other United
Nations
organizations;
academia;
research
institutions; other
relevant
stakeholders
No. of peer-reviewed manuscripts, resulting from
publicly funded research, which are freely
accessible.
(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.
[(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
2.5 Establish and
strengthen national and
regional coordinating
bodies on research and
development.
[(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) ].
Governments;
(a) develop and coordinate a research and
development agenda (consensus)
regional
organisations*;
WHO; other
relevant
stakeholders,
(b) facilitate the dissemination and use of
research and development outcomes
(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.
2008-2015
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.
(See progress indicators in 2.4)
13
Elements and subelements
Specific actions
Lead
Stakeholder(s)
Time frame Progress indicators
(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.
(b) support existing and new research and
development groups and institutions, including
regional centres of excellence, in developing
countries. (consensus)
Governments;
2008–2015 (i) No. of centres of excellence at regional and
regional
sub regional level.
organizations; UN
organizations;
(ii) No. of existing and new R&D groups and
research and
institutions receiving support.
development
groups;
pharmaceutical
industry;
development
partners
Element 3. Building and improving innovative capacity
(3.1) building capacity of
developing countries to
meet research and
development needs for
health products
(consensus)
(c) strengthen health surveillance and information Governments;
WHO, regional
systems. (consensus)
organizations,
NGOs, research
institutions,
academia, other
relevant
organizations
Note: data to be obtained through National Health
Accounts initiative.
2008–2015 No. of countries that have developed and are
implementing plans to strengthen surveillance and
information systems.
14
(3.2) Framing, developing (a) establish and strengthen regulatory capacity in Governments;
2008–2015
WHO; national and
and supporting effective developing countries. (consensus)
policies that promote the
regional regulatory
development of
agencies
capacities for health
innovation. (consensus)
(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 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
improving innovative
in developing innovative capacity (consensus)
capacity in accordance
with the needs of
developing countries
(consensus)
(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)
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;
2008–2015 No. of publications which include authors from
academia;
more than one country, including a developing
country. (linked also to 2.2 (d))
research
institutions; WHO;
other UN
organizations;
pharmaceutical
industry
(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.
(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 ]
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
traditional medicine (consensus)
(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; 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).
Governments;
WHO; other UN
organizations;
regulatory
agencies;
pharmaceutical
industry
2008–2015 (i) No. of countries implementing GMP guidelines
for traditional medicine.
(ii) No. of countries with MOUs, publications on
traditional medicines.
(ii) Evidence-based standards for quality and
safety evaluation of traditional medicines
developed.
[(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 subelements
Specific actions
Lead
Stakeholder(s)
Time frame Progress indicators
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
collaboration and
cooperation for technology transfers, and
coordination of technology collaboration between institutions in developing
transfer for health
countries and the pharmaceutical industry;
products, bearing in mind (consensus)
different levels of
development (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 SouthSouth 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]]
19
(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.
20
(4.3) [promote transfer of
key health related
technology] / [developing
mechanisms to manage
intellectual property] [in a
rational and healthoriented 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]
21
Elements and subelements
Specific actions
Lead
Stakeholder(s)
Time frame Progress indicators
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
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]
23
Elements and subelements
Specific actions
Lead
Stakeholder(s)
Time frame Progress indicators
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]
Governments;
(c) prioritise health care in national agendas
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]
Governments;
(e) increase investment in human resource
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
strategies that contain clear health objectives
(consensus)
Governments;
development
partners
2008–2015 No. of countries with poverty reduction strategies
which include clear health objectives.
24
[(g) encourage pooled procurement mechanisms
in developing countries]
(6.2) establishing and
strengthening
mechanisms to improve
ethical review and
regulate the
quality, 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 Governments;
2008–2015 (I) No. of countries reporting compliance with GMP
WHO; national
safety standards, efficacy and quality of health
and on safety.
products (consensus)
regulatory bodies;
pharmaceutical
(ii) No. of WHO prequalified manufacturers in each
industry;
developing country.
development
partners
25
Elements and subelements
Specific actions
Lead
Stakeholder(s)
Time frame Progress indicators
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 plan
or
[(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]
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]
(a) document and disseminate best practices in
public-private and product development
partnerships (consensus)
(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
(b) develop tools to periodically assess
health products and
performance of public-private and product
medical devices.
development partnerships (consensus)
consensus)
Governments;
2008–2015 Best practices in public-private and product
WHO; research
development partnerships developed and
institutions; publicdisseminated.
private
partnerships
Governments;
2008–2009 Tools developed to assess performance of publicWHO; research
private and product development partnerships.
institutions; publicprivate
partnerships;
charitable
foundations
27
(c) support public-private and product
development partnerships and other appropriate
research and development initiatives in
developing countries (consensus)
Governments;
2008–2015
WHO; other United
Nations
organizations;
pharmaceutical
industry; charitable
foundations;
development
partners;
nongovernmental
organizations;
academia;
research
institutions
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 (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 subelements
Specific actions
Lead
Stakeholder(s)
Element 8. Establishing monitoring and reporting systems
(8.1) measuring
(a) establish systems to monitor performance and Governments;
performance and
progress of the implementation of each element WHO
progress towards
of the Global Strategy and Plan of Action
objectives contained in
(consensus)
the plan of action
(consensus)
(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
Governments;
governing bodies on the gaps and needs related WHO
to health products and medical devices in
developed and developing countries (consensus)
Time frame Progress indicators
2008–2015 Systems to monitor performance and progress of
the implementation of the Global Strategy and
Plan of Action developed and operational.
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 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