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The Law and Ethics of the Pharmaceutical Industry M.N.G. Dukes (Oslo, Norway)

The Law and Ethics of the Pharmaceutical Industry By M.N.G. Dukes (Oslo, Norway)

The Law and Ethics of the Pharmaceutical Industry by M.N.G. Dukes (Oslo, Norway)


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Summary

As one of the massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community. This book provides a picture of the role of the pharmaceutical industry in society and includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases.

The Law and Ethics of the Pharmaceutical Industry Summary

The Law and Ethics of the Pharmaceutical Industry by M.N.G. Dukes (Oslo, Norway)

As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation.Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change.

The Law and Ethics of the Pharmaceutical Industry Reviews

...Although Dukes doesn't attempt to catalogue all relevant laws, he provides categories and examples that serve as a useful starting point for understanding the types of policies and laws that should be considered in particular cases. In addition, Dukes includes stories that led to the adoption of some of the laws and policies, which helps to make the process more accessible to the reader. --Jeremy Sugarman, M.D., M.P.H., Johns Hopkins University for THE NEW ENGLAND JOURNAL OF MEDICINE(2006) ...a measured walk through most of the beter-known public policy issues revolving around drug research, marketing and use. --PharmaceuticalCommerce.com (2006)

Table of Contents

PREFACE ACKNOWLEDGEMENTS PART A: THE DEFINITION OF STANDARDS 1. INTRODUCTION: THE PHARMACEUTICAL INDUSTRY AND ITS PRODUCTS 2. SOURCES OF STANDARDS FOR BUSINESS AND INDUSTRY 3. SOURCES OF STANDARDS SPECIFIC TO THE PHARMACEUTICAL INDUSTRY PART B: ACCEPTANCE AND IMPLEMENTATION OF STANDARDS 4. THE INDUSTRY AS A DEVELOPER, MANUFACTURER AND SUPPLIER 5. THE INDUSTRY AS A SOURCE OF INFORMATION, PERSUASION AND EDUCATION 6. PHARMACEUTICAL PRICING AND PROFITS 7. THE INDUSTRY AS INNOVATOR 8. THE INDUSTRY AND THE DEVELOPING WORLD 9. SPECIAL SITUATIONS 10. THE DUTIES OF THE GENERIC MANUFACTURER 11. THE PHARMACEUTICAL INDUSTRY AND SOCIAL CONTROVERSY 12. POSTSCRIPT: THE WAY AHEAD SELECTED REFERENCES

Additional information

NPB9780444518682
9780444518682
0444518681
The Law and Ethics of the Pharmaceutical Industry by M.N.G. Dukes (Oslo, Norway)
New
Hardback
Elsevier Science & Technology
2005-11-04
422
N/A
Book picture is for illustrative purposes only, actual binding, cover or edition may vary.
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