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
Pharmaceutical Industry, Government policy makers, Academic Health policy researchers
PART A: THE DEFINITION OF STANDARDS
INTRODUCTION: THE PHARMACEUTICAL INDUSTRY AND ITS PRODUCTS 1.1. The concept of a pharmaceutical product
1.2. The development of the pharmaceutical industry
1.3. The unique nature of the pharmaceuticals field and the need for rules 1.4. The various roles of the pharmaceutical industry today 1.5. Types of firms engaged in the pharmaceutical field
1.5.1. Research-based companies x 1.5.2. Generic manufacturers 1.6. The reputation of the pharmaceutical industry
SOURCES OF STANDARDS FOR BUSINESS AND INDUSTRY 2.1. Grounds for defining and respecting business standards 2.1.1 General
2.1.2. A basis in h uman rights
2.1.3. The notion of business ethics
(i) Ethics in daily practice? (ii) Individual and company standards (iii) The purpose of business (iv) The Friedman dogma (v) Loyalty to the Company (vi) Distance from society (vii) The attitude of management 2.2. Some laws and regulations relating to business generally
2.2.1. Laws of contract and Sale of Goods 2.2.2. The law of tort and non-contractual liability 2.2.3. Consumer Protection Legislation 2.2.4. Intellectual property: trade marks, patents and data exclusivity (i) Property and Human Rights (ii) Trade Marks and Counterfeiting (iii) Patent Law (iv) The TRIPS Agreement (v) The "evergreening" of patents (vi) Claims of data exclusivity (vii) The ethics of data protection 2.2.5 Social and employment law 2.
- No. of pages:
- © Elsevier Science 2006
- 4th November 2005
- Elsevier Science
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"...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)