The Law and Ethics of the Pharmaceutical Industry

M.N.G. Dukes (Autor)

Buch | Hardcover

422 Seiten

2005
Elsevier Science Ltd (Verlag)
978-0-444-51868-2 (ISBN)

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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.

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.

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

Erscheint lt. Verlag	4.11.2005
Verlagsort	Oxford
Sprache	englisch
Maße	165 x 240 mm
Gewicht	930 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Medizinethik
	Studium ► Querschnittsbereiche ► Geschichte / Ethik der Medizin
	Recht / Steuern ► EU / Internationales Recht
	Recht / Steuern ► Privatrecht / Bürgerliches Recht ► Berufs-/Gebührenrecht
ISBN-10	0-444-51868-1 / 0444518681
ISBN-13	978-0-444-51868-2 / 9780444518682
Zustand	Neuware