The Law and Ethics of the Pharmaceutical Industry

Front Cover
Elsevier, Nov 4, 2005 - Medical - 422 pages
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.

*Provides a balanced picture of the current role of the pharmaceutical industry in society
*Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases
*This is the only book addressing the legal implications of big pharma activities and ethical standards
 

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Contents

Chapter 1 The Pharmaceutical Industry and Its Products
3
Chapter 2 Sources of Standards for Business and Industry Generally
17
Chapter 3 Sources of Standards Specific to the Pharmaceutical Industry
85
Acceptance and Implementation of Standards
135
Chapter 4 Ensuring Quality Safety and Efficacy
137
Chapter 5 The Industry As a Source of Information Persuasion and Education
183
Chapter 6 Pharmaceutical Pricing and Profits
215
Chapter 7 The Industry as Innovator
235
Chapter 8 The Industry and the Developing World
263
Chapter 9 Special Situations
291
Chapter 10 The Duties of the Generic Manufacturer
329
Chapter 11 The Pharmaceutical Industry and Social Controversy
345
The Way Ahead
353
List of Selected References
369
Index
393
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Page 373 - An act for preventing the manufacture, sale, or transportation of adulterated or misbranded, or poisonous, or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes...
Page 25 - There should be no confusion (of which there is evidence) of the duties which Mr. Ford conceives that he and the stockholders owe to the general public, and the duties which in law he and his codirectors owe to protesting, minority stockholders. A business corporation is organized and carried on primarily for the profit of the stockholders. The powers of the directors are to be employed for that end.

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