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A briefing paper for DFID : update on China and India and access to medicines

GRACE, Cheri
November 2005

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This paper looks at the major developments in the Indian and Chinese pharmaceutical industries and the major opportunities. It considers how the agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) has been translated into domestic law in both countries; and the role India and China might play for either finished product or active pharmaceutical ingredient supply for domestic use or export, with regards to first-line recommendations for diseases like malaria and HIV

Willingness and ability to use TRIPs flexibilities : Kenya case study

LEWIS-LETTINGTON, Robert
MUNYI, Peter
September 2004

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This paper examines Kenyan legislation and policy in light of the international intellectual property rights framework, in particular the World Trade Oorganization’s Doha Ministerial Declaration decision. It considers the existing sources of supply and associated trends in pricing of pharmaceutical products in Kenya, placing the focus on medicines that are, or are likely to be, affected by these rights

Access to medicines in under-served markets : what are the implications of changes in intellectual property rights, trade and drug registration policy?

DFID HEALTH SYSTEMS RESOURCE CENTRE (HSRC)
September 2004

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This overview draws on seven studies commissioned by the UK's Department for International Development. After providing some background, it considers the implications of stronger intellectual property protection for access to medicines; the prospects for supply in emerging and under-served markets; and makes recommendations for increasing access

Processes and issues for improving access to medicines : willingness and ability to utilise TRIPS flexibilities in non-producing countries

BAKER, Brook K.
August 2004

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This paper addresses the varied ways by which a non-medicine producing country may lawfully utilise the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) flexibilities, primarily by importing. However, it also briefly discusses means for promoting local production through pharmaceutical capacity building and through both compulsory and voluntary licensing. To help decision-makers in understanding and evaluating the opportunities and constraints of each alternative, the paper briefly describes their respective advantages and disadvantages in terms of developing countries’ sustainable access to more affordable medicines, highlighting differing legal interpretations, political realities and pragmatic administrative and economic constraints

Emerging challenges and opportunities in drug registration and regulation in developing countries

HILL, Suzanne
JOHNSON, Kent
May 2004

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This study describes current drug regulation and registration processes in selected countries, in order to understand how they affect the quality and availability of medicines in developing countries. It puts forward policy recommendations as to how systems can more efficiently allow appropriate quality drugs to be marketed and examines the emerging challenges and requirements posed by compulsory licensing, drugs for neglected diseases, anti-retroviral (ARV) and anti-tuberculosis (TB) drugs

Processes and issues for improving access to medicines : the evidence base for domestic production and greater access to medicines

GUIMIER Jean-Marc Guimier
LEE, Evan
GRUPPER, Michel
2004

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This study addresses the question of whether access to medicines can be improved in sub-Saharan Africa by producing them locally. For this production to be sustainable, it must be both economically viable while meeting quality standards, and result in the improvement of access along one or more of the following dimensions: geographical accessibility, physical availability, affordability and acceptability

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