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The book’s focus is on advancing medical and health technologies (“innovation”) and ensuring they reach the people who need them (“accessibility”). A huge amount of analytical and factual material is available on access to medicines and other medical technologies, and on innovation. Here, it is brought together in one concise volume.
The book is designed to support governments and others — particularly in developing countries — who face an increasing demand to act, when governments want to increase access to effective treatments while containing costs.
The underlying theme is: policies on these issues have to be viewed together in order to make real progress.
Who is the book for?
Policy-makers inside and outside governments, international organizations and their regional counterparts. Academics and researchers. The study also strengthens the three organizations’ training activities for officials and others. It is a tool for well-informed decision-making to meet the evolving worldwide burden of disease, providing a comprehensive source of information on all the key aspects of the issues. But it stops short of prescribing any way to deal with a country’s particular health problems. Armed with the study, policy-makers can decide for themselves.
What’s in the book?
A description of the options available for policies involving health, intellectual property and trade together, and related empirical data. The latest developments in the three organizations and the work they have produced.
The study looks at ways to tailor systems so that innovation is encouraged, yielding new treatments for the diseases of the poor, and how to ensure sustainable and equitable access to these innovations. It is structured so readers can start with the essential points of policy in the first two chapters, and then dig deeper into issues that interest them:
- Chapter I. Fundamentals: the background of health policy and medical technology, the work of the three organizations, the burden of disease that challenges health policy, and the factors shaping that policy. Much attention has been paid to diseases such as HIV/AIDS, malaria and tuberculosis, but non-communicable diseases such as cancer, diabetes and heart diseases are a rising challenge.
- Chapter II. The policy context: the international framework, linking health policy, intellectual property and trade, the contributions of economic analysis, and the use of traditional medical knowledge in research.
- Chapter III Innovation in greater detail: the evolution of research and development, alternative ways of promoting innovation for neglected diseases, the role of intellectual property rights, with examples.
- Chapter IV Access: how to ensure pharmaceuticals and other medical technology reach the people who need them: pricing policies, taxes and import duties, procurement, regulation, technology transfer, local production, patents, compulsory and voluntary licences, trade agreements, and competition policies, etc.
What’s the problem?
Access and availability — patients unable to obtain medicines and medical technologies, and how to develop new treatments for them. There is rarely a single, isolated reason for these — far from it. The same goes for single solutions. Part of the solution is in this study: information that used to be difficult or impossible to get.
For public health policies, key challenges include: the selection and use of medicines rationally; whether patients and public health services can afford them; sustainable financing; reliable health and supply systems; the regulation of medicines to ensure they are of a high quality, without obstructing innovation and access.
The intellectual property system’s rules, the way rights such as patents or trademarks are obtained and managed, the way policy options and flexibilities are applied — these are all vital components of the solutions.
International trade and its rules are also important. The way they are applied can determine whether medicines are available, and what prices patients have to pay — for example through duties charged on imported products. Competition policy is part of this. It can promote innovation, and improve access to medicines. Respecting transparent and non-discriminatory procurement procedures can help governments get the best deal for sustainable and affordable access.
The work is not complete. There is more to be done in the future, as the study points out. For example, the impact of the steadily growing number of bilateral or regional free trade agreements has not been systematically analysed, particularly for public health. And yet these agreements also set standards for protecting and enforcing intellectual property rights, cut preferential tariffs and affect competition policy and government procurement.
The emphasis on the links between the three subjects, and how the activities of the three organizations can reinforce each other, ultimately to meet objectives such as the right to health and the UN Millennium Development Goals.
- Trade. Relevant WTO agreements are explained simply for non-specialists and practitioners. This includes: intellectual property provisions on test data; how rules on services relate to access to medical technologies; and the role of competition policy and government procurement rules.
- Also included are: a brief review of the economics literature and business models in the pharmaceutical sector; an analysis of the relevant provisions of free trade agreements. Trade figures show that a few developed countries still dominate the market for health-related products, with some emerging economies increasing their presence.
- Health. Material from WHO and elsewhere is brought together with references so readers can delve deeper. The study tracks new trends in the global disease burden. It examines the importance of regulation for innovation and access to quality medical products, and the challenge of innovation to address neglected diseases. It includes a summary of the work of various agencies.
- Intellectual property. The book explains intellectual property, what it means and how it is used for innovation in health technologies and for access to treatments. It looks at a number of current issues, including the role of information about patents in public health policy and how to obtain it, the impact of protecting test data and trade agreements on public health, trends in voluntary and compulsory licensing, and traditional medical knowledge. It covers WIPO’s current work related to public health, and the contribution to tackling neglected diseases.
Example: the relationship between trademarks and generic (“international nonproprietary”) names. WIPO and WTO agreements lay down the international rules for trademarks; WHO regulates the use of these names; WIPO notifies generic names to national trademark offices.
The study is available here: WHO website; WIPO website; www.wto.org/trilateralstudy2013
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