The Challenges We Face

Title: 

The Challenges We Face

in Frederick M. Abbott and Graham Dukes, GLOBAL PHARMACEUTICAL POLICY: Ensuring Medicines for Tomorrow's World 1-15 (2009)(Edward Elgar Publishing)

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Pharmaceutical products play a central role in the prevention and treatment of disease. Making safe and effective pharmaceutical products available and affordable to individuals around the world is a central challenge to the global governance system. There are however myriad obstacles to achieving and maintaining effective worldwide availability of medicines.

Despite the fact that people around the world face largely similar challenges from disease, the policy framework for promoting innovation and regulating pharmaceutical supply is remarkably disjointed. Innovation policy, insofar as it is implemented at all, is established on a country-to-country basis with minimal attention to coordination of research and development. Regulatory structures are almost equally fragmented. Each country has its own set of approval standards and regulatory procedures that must be dealt with, and only to a limited extent are there cooperative procedures or systems of mutual recognition. Corporate decisions concerning where to concentrate innovative efforts, what to produce, where to supply it and on what terms are based on the likely impact on profits and capital markets.

There are wide disparities in levels of income both among countries and within countries. Prices that are reasonably affordable for individuals covered by health insurance in developed countries are likely to be unaffordable for individuals without health insurance in developed and developing countries. There are compelling needs for new medicines to treat diseases affecting both the rich and poor, such as diabetes, cancer, heart disease and the degenerative disorders of old age. Innovation in these areas is costly, yet even with substantial sums invested in research and development rates of innovation are surprisingly low. There are equally compelling needs for new medicines to treat disease conditions predominantly afflicting tropical regions where poverty rates are typically high. Far less is invested in the diseases of the poor because of a lack of market demand.

Medicines must be safe and effective. Making and keeping them so is a challenge for both private and public sector suppliers, for the regulators charged with promoting and protecting public health and for the policy makers who determine the framework within which regulation operates. This book examines the state of play of the international system for the development and supply of pharmaceutical products, and offers insights into how some of its challenges might be addressed. This system is enormously complex, with many moving parts, and there is not likely to be a quick fix for the many challenges. There are quite a few good ideas circulating among individuals and groups involved in formulating and implementing public policy in the field of medicines. 

Certainly new initiatives are needed in this field, and existing initiatives can and should be improved. We try to identify and explain those areas in which present policies are not working, and we offer suggestions regarding ways to improve them. We put forward our own proposals regarding directions that global public policy in the field of medicines should take. We do not claim a monopoly on promising ideas. We hope that this volume will succeed at least in moving the dialogue on these subjects forward.