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The Law and Ethics of the Pharmaceutical Industry - 1st Edition - ISBN: 9780444518682, 9780080459363

The Law and Ethics of the Pharmaceutical Industry

1st Edition

Author: M.N.G. Dukes
Hardcover ISBN: 9780444518682
eBook ISBN: 9780080459363
Imprint: Elsevier Science
Published Date: 4th November 2005
Page Count: 422
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Description

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.

Key Features

*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

Readership

Pharmaceutical Industry, Government policy makers, Academic Health policy researchers

Table of Contents

PREFACE ACKNOWLEDGEMENTS PART A: THE DEFINITION OF STANDARDS

  1. INTRODUCTION: THE PHARMACEUTICAL INDUSTRY AND ITS PRODUCTS

    1. The concept of a pharmaceutical product
    1. The development of the pharmaceutical industry
    1. The unique nature of the pharmaceuticals field and the need for rules
    1. The various roles of the pharmaceutical industry today
    1. Types of firms engaged in the pharmaceutical field
  2. 5.1. Research-based companies x

  3. 5.2. Generic manufacturers

    1. The reputation of the pharmaceutical industry
  4. SOURCES OF STANDARDS FOR BUSINESS AND INDUSTRY

    1. Grounds for defining and respecting business standards
  5. 1.1 General

  6. 1.2. A basis in h uman rights

  7. 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

    1. Some laws and regulations relating to business generally
  8. 2.1. Laws of contract and Sale of Goods

  9. 2.2. The law of tort and non-contractual liability

  10. 2.3. Consumer Protection Legislation

  11. 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

  12. 2.5 Social and employment law

  13. 2.6 Environmental law

    1. Competitive and financial pressures
    1. Political influences
    1. The influence of litigation
    1. Public opinion and the public image
    1. The location of the company conscience
    1. Company and industry codes of behaviour
  14. 8.1. Types of Codes

  15. 8.2. Style and content of codes

  16. 8.3. The usefulness of Codes

    1. Transnational corporations and influences
    1. "Corporate social responsibility" and Governments
  17. SOURCES OF STANDARDS SPECIFIC TO THE PHARMACEUTICAL INDUSTRY

    1. General considerations
    1. Standards based on human rights in health
    1. Standards originating from pharmacy practice
  18. 3.1. A basis in trust

  19. 3.2. Standards of knowledge

  20. 3.3. Fields of knowledge

  21. 3.4. Trade interests versus professional interests

  22. 3.5. Codification of standards in pharmacy

  23. 3.6. Pharmacy standards in the Pharmaceutical Industry

    1. Standards originating from medical law and ethics
  24. 4.1. Primary duty to the patient

  25. 4.2. Current medical expertise

  26. 4.3. The duty of care

  27. 4.4. Confidentiality

    1. Standards set by pharmaceutical legislation and regulation
  28. 5.1. The evolution of modern drug regulation

  29. 5.2. The scope of legislation and regulation

  30. 5.3. Issues of responsibility and liability

  31. 5.4. Relationship of the applicant to the regulatory agency

  32. 5.5. The global coverage of law and regulation

  33. 5.6. Old versus new products

  34. 5.7. Criticism of regulatory developments 3 5.8. The emergence of deregulation

  35. 5.9. The adequacy of regulation today

  36. 5.10. The role of WHO

    1. Self-regulation in the pharmaceutical industry

PART B: ACCEPTANCE AND IMPLEMENTATION OF STANDARDS 4. THE INDUSTRY AS A DEVELOPER, MANUFACTURER AND SUPPLIER 4.1. Pre-marketing and Post-marketing Duties 4.2. Exactness of standards 4.3. The Quality of Drugs 4.4. The Safety of Drugs 4.5. The Efficacy of drugs

  1. THE INDUSTRY AS A SOURCE OF INFORMATION, PERSUASION AND EDUCATION

    1. Basic information
    1. Persuasion
  2. 2.1. Advertising to the health professions

  3. 2.2. Advertising of prescription medicines to the public

  4. 2.3. Non-explicit advertising

  5. 2.4. Disease mongering

  6. 2.5. Financial incentives

    1. Education
    1. Future Developments
  7. PHARMACEUTICAL PRICING AND PROFITS

    1. Pharmaceutical Prices and Controversies
    1. The Level of Spending
    1. The Manufacturer's costs
    1. The ethics of pricing and profits
    1. How does society control the prices of medicines?
  8. 5.1. Calculation of the "fair" price of a medicine

  9. 5.2. Reference pricing

  10. 5.3. Economic evaluation of prices

  11. 5.4. Control of profits and expenses

    1. Differential and equity pricing
    1. Parallel Importation and Re-importation
    1. Future approaches to pricing
  12. THE INDUSTRY AS INNOVATOR

    1. Innovation and duty
    1. The Innovation Controversy
    1. Statistics and Analyses
  13. 3.1. The real cost of a new drug

  14. 3.2. Research expenditure within the company

  15. 3.3. Innovation trends over time

  16. 3.4. The spectrum of drugs reaching the market

  17. 3.5. The non-industrial role in drug innovation

    1. Future trends and corrective measures
  18. 4.1. Should the innovation process change?

  19. 4.2. Can industry adapt?

  20. 4.3. Is outside action necessary?

  21. 4.4. The DfND Initiative

  22. 4.5. Governments, Communities and Donors

  23. 4.6. Independent non-profit research centres

  24. 4.7. Official incentives to true innovation

  25. 4.8. A total approach to innovation

  26. THE INDUSTRY AND THE DEVELOPING WORLD

    1. Pharmaceuticals in developing countries
    1. Atttitudes of the industry to developing markets
    1. Duties relating to exports
    1. Access within the developing world
    1. Other Duties within the developing world
    1. Relationship to international organizations and donors
    1. The industry in public-private partnerships
  27. SPECIAL SITUATIONS

    1. Ethics of Animal Studies
    1. Ethics of Human Studies Studies
    1. Self Medication
    1. Vaccine Manufacturing and Supply
    1. Blood and Blood Products
    1. Controlled Substances
  28. 6.1. The Nature of risk and injury

  29. 6.2. Statutory and civil duties

    1. Alternative and Complementary Medicines
    1. Traditional Medicines
    1. Borderline Products
  30. 9.1. Foods and medicines

  31. 9.2. Cosmetics as medical products

  32. 9.3. Contraceptives as health products

  33. 9.4. Medical devices with pharmacological activity

  34. 9.5. "Recreational substances"

    1. Veterinary Products
  35. THE DUTIES OF THE GENERIC MANUFACTURER

    1. The nature of the generic industry
    1. The significance of the generic industry
    1. Governments, laws and generics
    1. Generic drugs in U.S. Law
    1. Generic drugs in the European Union
    1. Generic drugs in India
    1. Generic substutution
    1. Generic biologicals, biogenerics and biosimilars
    1. The future status of the generic pharmaceutical industry
  36. THE PHARMACEUTICAL INDUSTRY AND SOCIAL CONTROVERSY

  37. POSTSCRIPT: THE WAY AHEAD SELECTED REFERENCES CONTENTS

Details

No. of pages:
422
Language:
English
Copyright:
© Elsevier Science 2006
Published:
4th November 2005
Imprint:
Elsevier Science
Hardcover ISBN:
9780444518682
eBook ISBN:
9780080459363

About the Author

M.N.G. Dukes

Affiliations and Expertise

Oslo, Norway

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)

Ratings and Reviews