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By M.N.G. Dukes, Oslo, Norway
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.
Audience
Pharmaceutical Industry, Government policy makers, Academic Health policy researchers
Contents PREFACE
ACKNOWLEDGEMENTS
PART A: THE DEFINITION OF STANDARDS
1. 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
2. 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
2.2.6 Environmental law
2.3. Competitive and financial pressures
2.4. Political influences
2.5. The influence of litigation
2.6.
Public opinion and the public image
2.7. The location of the company conscience
2.8. Company and industry codes of behaviour
2.8.1.
Types of Codes
2.8.2. Style and content of codes
2.8.3. The usefulness of Codes
2.9. Transnational corporations and influences
2.10.
"Corporate social responsibility" and Governments
3. SOURCES OF STANDARDS SPECIFIC TO THE PHARMACEUTICAL INDUSTRY
3.1. General considerations
3.2. Standards based on human rights in health
3.3. Standards originating from pharmacy practice
3.3.1. A basis in trust
3.3.2. Standards of knowledge
3.3.3. Fields of knowledge
3.3.4. Trade interests versus professional interests
3.3.5. Codification of
standards in pharmacy
3.3.6. Pharmacy standards in the Pharmaceutical Industry
3.4. Standards originating from medical law and ethics
3.4.1. Primary duty to the patient
3.4.2. Current medical expertise
3.4.3. The duty of care
3.4.4. Confidentiality
3.5. Standards set by pharmaceutical legislation and regulation
3.5.1. The evolution of modern drug regulation
3.5.2. The scope
of legislation and regulation
3.5.3. Issues of responsibility and liability
3.5.4. Relationship of the applicant to the regulatory
agency
3.5.5. The global coverage of law and regulation
3.5.6. Old versus new products
3.5.7. Criticism of regulatory developments
3 5.8. The emergence of deregulation
3.5.9. The adequacy of regulation today
3.5.10. The role of WHO
3.6. 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
5. THE INDUSTRY AS A SOURCE OF INFORMATION, PERSUASION AND EDUCATION
5.1. Basic information
5.2. Persuasion
5.2.1. Advertising to the health professions
5.2.2. Advertising of prescription medicines to the public
5.2.3. Non-explicit advertising
5.2.4. Disease mongering
5.2.5. Financial incentives
5.3. Education
5.4. Future Developments
6. PHARMACEUTICAL
PRICING AND PROFITS
6.1. Pharmaceutical Prices and Controversies
6.2. The Level of Spending
6.3. The Manufacturer's costs
6.4. The
ethics of pricing and profits
6.5. How does society control the prices of medicines?
6.5.1. Calculation of the "fair" price of a medicine
6.5.2. Reference pricing
6.5.3. Economic evaluation of prices
6.5.4. Control of profits and expenses
6.6. Differential and equity
pricing
6.7. Parallel Importation and Re-importation
6.8. Future approaches to pricing
7. THE INDUSTRY AS INNOVATOR
7.1. Innovation
and duty
7.2. The Innovation Controversy
7.3. Statistics and Analyses
7.3.1. The real cost of a new drug
7.3.2. Research expenditure
within the company
7.3.3. Innovation trends over time
7.3.4. The spectrum of drugs reaching the market
7.3.5. The non-industrial role
in drug innovation
7.4. Future trends and corrective measures
7.4.1. Should the innovation process change?
7.4.2. Can industry adapt?
7.4.3. Is outside action necessary?
7.4.4. The DfND Initiative
7.4.5. Governments, Communities and Donors
7.4.6. Independent non-profit
research centres
7.4.7. Official incentives to true innovation
7.4.8. A total approach to innovation
8. THE INDUSTRY AND THE DEVELOPING
WORLD
8.1. Pharmaceuticals in developing countries
8.2. Atttitudes of the industry to developing markets
8.3. Duties relating to
exports
8.4. Access within the developing world
8.5. Other Duties within the developing world
8.6. Relationship to international organizations
and donors
8.7. The industry in public-private partnerships
9. SPECIAL SITUATIONS
9.1. Ethics of Animal Studies
9.2. Ethics of Human
Studies Studies
9.3. Self Medication
9.4. Vaccine Manufacturing and Supply
9.5. Blood and Blood Products
9.6. Controlled Substances
9.6.1. The Nature of risk and injury
9.6.2. Statutory and civil duties
9.7. Alternative and Complementary Medicines
9.8. Traditional
Medicines
9.9. Borderline Products
9.9.1. Foods and medicines
9.9.2. Cosmetics as medical products
9.9.3. Contraceptives as health products
9.9.4. Medical devices with pharmacological activity
9.9.5. "Recreational substances"
9.10. Veterinary Products
10. THE DUTIES OF
THE GENERIC MANUFACTURER
10.1. The nature of the generic industry
10.2. The significance of the generic industry
10.3. Governments, laws
and generics
10.4. Generic drugs in U.S. Law
10.5. Generic drugs in the European Union
10.6. Generic drugs in India
10.7. Generic substutution
10.8. Generic biologicals, biogenerics and biosimilars
10.9. The future status of the generic pharmaceutical industry
11. THE PHARMACEUTICAL
INDUSTRY AND SOCIAL CONTROVERSY
12. POSTSCRIPT: THE WAY AHEAD
SELECTED REFERENCES
CONTENTS
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