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Good summer reading:Global strategy and plan of action on public health, innovation and IP by WHA/CIPIH

June 6 2008, IP Watch reported (1) the publication on line of, "Global strategy on public health, innovation and intellectual property" (WHA61.21 May 24, 2008 61st World Health Assembly).(2)

The document has been called the most important document since the Doha Declaration on IP and public health...a breakthrough that will benefit many millions of people for many years to come. (World Health Organization Director General Margaret Chan) The report outlines practical measures for using the [IP] system to promote innovation to achieve public health goals, particularly on diseases which disproportionately affect developing country or underserved areas.
Excerpts from the Report:
The Context
Poverty benchmark: 4.8 billion people live in developing countries=80% of the world poplation...43% live on less than US$2 a day. Poverty, among other factors, directly affects the acquisition of health products (including vaccines, diagnostics and medicines and medical devices), especially in developing countries.
Member States, the pharmaceutical industry, charitable foundations and nongovernmental organizations have taken initiatives in recent years to develop new products against diseases affecting developing countries and to increase access to existing health products and medical devices, [however] these are not sufficient to surmount the challenges to meet the goal of ensuring access and innovating for needed health products and medical devices.

More efforts should be made:
-to avoid the suffering,
-to reduce preventable mortality
-to meet health related Millennium Development Goals
-to implement States' obligations and commitments arising under applicable international human rights instruments with provisions relevant to health.

Proposals should be developed for health-needs driven research and development that include exploring a range of incentive mechanisms, including where appropriate
the de-linkage of the costs of research and development and the price of health products..

The Universal Declaration of Human Rights provides that 'everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits…everyone has the right to the protections of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author'...[T]he WHO Constitution states that 'the objective of WHO shall be the attainment by all peoples of the highest possible level of health'.
Thus WHO will play a strategic and central role in the relationship between public health and innovation and IP within its mandates, capacities and constitutional objectives.
The global strategy and plan of action should promote the development of health products/ medical devices needed by Member States that are:developed in an ethical manner,available in sufficient quantities,effective, safe and of good quality,affordable and accessible and used in a rational way.

(1)http://www.ip-watch.org/weblog/index.php?p=1083 The Intellectual Property Watch Monthly Reporter is a 16-page monthly selection of the most important, updated stories and features available only for monthly subscribers.
(3) http://www.who.int/intellectualproperty/en/ The Report of the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) See also many first rate submission papers archived from the on line public discussion conducted by CIPIH.

StakeholdersGovernments (WHO Member States), other international intergovernmental orgs, other relevant stakeholders including international and national research institutions, academia, national and regional regulatory agencies, relevant health related industries, including both public and private, PPPs, public-private and product development partners, charitable foundations , publishers, research and development groups and regional bodies and regional orgs.

CIPIH's Report provides an analysis of the problems and makes recommendations that form a basis of future actions.
Element 1 Actions to prioritize research and development.
Map global research and mechanisms to identify gaps certain gaps in R&D,
formulate explicit prioritized strategies for R&D at country, regional,inter-regional levels
encourage R&D in traditional medicine.
Element 2 Promoting R&D-There are many determinants of innovations capacity. Political, economic, and social institutions in each country should participate in the development of health research policy, taking into consideration their own realities and needs.
Element 3 Building and improving innovative capacity.
Frame, develop, support effective policies that promote development in developing countries related to health innovation.
Key areas include investment capacities relating to science and technology, local productions of pharmaceuticals, clinical trials, regulations, IP and traditional medicine.
Element 4 Transfer of technology via development cooperation, partnerships, and networks need to be supported in order to build and improve transfer of technology related to health innovations.
Element 5 Application and management of IP to contribute to innovation and promote public health.
Element 6 improving delivery and access, support and strengthening of health system is vital for success of this strategy. Mechanisms to regulate the safety, quality, and efficacy of medicines and other health products, coupled with adherence to good manufacturing practices, and effective supply chain management are critical components of a well functioning system.
Element 7 promoting sustainable financing mechanism.
Further funding on a sustainable basis is essential to support a long term R&D effort for products to meet health needs of developing countries. Identify and analyze most serious gaps in financing for health products and R&D covered by this strategy.
Maximize use of and complement, as appropriate and feasible, current initiatives thereby contributing to a flow of resources into innovation and implementation
Element 8 establishing monitoring and reporting systems.
Progress report every 2 years, a comprehensive evaluation of the strategy undertaken after 4 years.

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