Intergovernmental Working Group on Public Health WhitePaper

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					White Paper 3 March 2008

Sub-group of Drafting Group B meeting: 17-19 March 2008 Plan of Action: Summary Indicators / Reporting Components Secretariat Draft Text

Introduction

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 which met on 8-9 November 2007 reviewed the draft plan of action for Elements 1 and 2 and made proposals to Drafting Group B of the Intergovernmental Working Group. 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.) 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. White Paper 2 provides the Secretariat’s draft text for consideration by Sub-group B. Development of Summary Indicators or Reporting Components To support the work of the Sub-group in the next step of development in the process of defining the set of indicators for this Action Plan, the Secretariat has drawn up a small number of proposed summary indicators or ‘reporting components’. These are intended to be a list of indicators that all parties would be expected to collect as an absolute minimum in a given period. They should be considered in conjunction with White Paper 2.

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Summary indicators or reporting components are based on the following: a) Each of the 8 elements should have summary indicators b) For each element the most critical action areas have been identified as the focus for summary indicators or reporting components c) Common themes have been identified where data can be collected using the same or similar processes (for example, capacity building). Some indicators in this summary list may not differ from those in the full list. This is particularly the case when the action corresponding to the indicator is very specific. Proposed Summary Indicators or Reporting Components Element 1 (i) Report on gap analysis and the public health consequences of these gaps in developed and developing countries produced, published and disseminated. (Report to include commentary on barriers preventing implementation mechanisms, public health needs assessment and research on technology appropriate products). Number of developing countries with an R&D strengthening plan and R&D strategy. (Country reports to include sections that define needs in traditional medicine and health innovation).

(ii)

Element 2 (i) Number of developing countries receiving support for a) innovation strengthening and b) capacity for early stage drug research and clinical development. Review of policies, mechanisms and progress in improving cooperation, participation, coordination and information sharing on health and biomedical R&D, including PPPs and civil society engagement, focusing on promoting capacity development in resource poor settings. Number of generally accessible public health libraries established, and/or upgraded, including open-access journals, and online databases. Number of countries with national coordinating bodies on research and development established, and priority agendas identified.

(ii)

(iii)

(iv)

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Element 3 (i) Number of countries with national programmes for supporting capacity development in health technologies and health R&D in operation, including courses conducted and degrees awarded. Number of countries that have developed and are implementing plans to strengthen surveillance and information systems. Number of countries with national policy and regulatory frameworks to promote capacity for health innovation, including international cooperation. Number of countries with nationally accredited ethics review committees, including capacity to review clinical trials in developing countries. Number of countries with a Memorandum of Understanding (MOU) on traditional medicines. Number of countries implementing GMP guidelines for traditional medicine.

(ii)

(iii)

(iv)

(v)

(vi)

Element 4 (i) Number of countries with technology transfer legislation and operational frameworks. Number of countries with North-South and South-South technology transfer cooperation agreements and transfer of technology strategy.

(ii)

Element 5 (i) Mechanisms for exchange of information among government departments and national, regional and international institutions established or strengthened.

Element 6 (i) Percentage increase in human resources for health delivery, in the health sector. Number of countries reporting on medicines safety and manufacturers’ compliance with GMP.

(ii)

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Element 7 (i) Number of public-private partnerships, product development partnerships and other appropriate research and development initiatives supported in developing countries.

Element 8 (i) Report to WHO’s governing bodies every two years on the gaps and needs related to health products and medical devices in developed and developing countries.

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