Dukes, Braithwaite and Moloney reach the depressing conclusion that 'corporate crime in the pharmaceutical industry appears to be on the rise.' Their approach to this problem is much more nuanced than just throwing people in jail. They advocate for a pyramid of regulatory strategies including qui tam legislation and equity fines. There is an opportunity for a radical transformation of the pharmaceutical industry and the authors offer us a road map to begin that journey.' - Joel Lexchin MD, York University, CanadaThe pharmaceutical industry must exist to serve the community, but over the years it has engaged repeatedly in corporate crime and anti-social behavior, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health, with deep experience of the industry, documents problems ranging from false advertising and counterfeiting to corruption, fraud and overpricing. It is a fresh and revealing look at the unacceptable pressures brought to bear on doctors, politicians, patients and the media. Uniquely, the book presents realistic and worldwide solutions for the future, with positive policies encouraging honest dealing, as well as partial privatization of enforcement and a transformation of science policy to develop the medicines that society needs most. The authors examine in turn each of the main facets of the pharmaceutical industry's activities - research, manufacturing, information, distribution and pricing - as well as some questionable aspects of its relationship with society. Offering a considered analysis of pharmaceutical rights and wrongs as they have developed, particularly over the last half-century, this book is rich in new insights for managers in the pharmaceutical industry, regulatory agencies and health agencies. Contents: Essay Part I: Setting the Scene Introduction Part II: A View of Rights and Wrongs 1. Creating a Medicine: Why, How and How Not 2. Safe, Unsafe and Improper Manufacturing Practices 3. Aggressive or Misleading Promotion 4. The Dark Art of Manipulation: The Industry and its Puppets 5. Corruption, Counterfeiting and Fraud 6. Prices, Monopolies, Abuses and the Law Part III: Transforming the Way Ahead 7. A Criminological Perspective on a Worsening Crisis 8. Positive Regulation: The Complementary Role of Supports and Sanctions 9. A Responsive Criminal Law of Pharmaceuticals 10. Privatising Enforcement 11. A New Capitalism: A New Drug Diplomacy Index

Pharmaceuticals play a central role in health care throughout the world. The pharmaceutical industry is beset with difficulties as increasing research and development expenditure yields fewer new treatments. Public and private budgets strain under the weight of high prices and limited access. The world's poor see little effort to address diseases prevalent in less affluent societies, while the world's wealthy are overusing prescription drugs, risking their health and wasting resources. The debate over health care reform and the ongoing global economic crisis form the backdrop for this extraordinarily timely examination of the global system for the development, production, distribution and use of medicines. The authors are acknowledged experts in the fields of pharmaceutical law and policy, with many years experience advising governments, multilateral organizations and policy-makers on issues involving innovation, access and use of medicines. Supported by a team of independent scientists, doctors and lawyers, they take an insightful look at the issues surrounding global regulation of the pharmaceutical sector, and offer pragmatic suggestions for reform. This book will be of interest to government policy-makers, members of industry, healthcare professionals, teachers, students and lawyers in the fields of public health, intellectual property and international trade.

Pharmaceuticals play a central role in health care throughout the world. The pharmaceutical industry is beset with difficulties as increasing research and development expenditure yields fewer new treatments. Public and private budgets strain under the weight of high prices and limited access. The world's poor see little effort to address diseases prevalent in less affluent societies, while the world's wealthy are overusing prescription drugs, risking their health and wasting resources. The debate over health care reform and the ongoing global economic crisis form the backdrop for this extraordinarily timely examination of the global system for the development, production, distribution and use of medicines. The authors are acknowledged experts in the fields of pharmaceutical law and policy, with many years experience advising governments, multilateral organizations and policy-makers on issues involving innovation, access and use of medicines. Supported by a team of independent scientists, doctors and lawyers, they take an insightful look at the issues surrounding global regulation of the pharmaceutical sector, and offer pragmatic suggestions for reform. This book will be of interest to government policy-makers, members of industry, healthcare professionals, teachers, students and lawyers in the fields of public health, intellectual property and international trade.

Dukes, Braithwaite and Moloney reach the depressing conclusion that 'corporate crime in the pharmaceutical industry appears to be on the rise.' Their approach to this problem is much more nuanced than just throwing people in jail. They advocate for a pyramid of regulatory strategies including qui tam legislation and equity fines. There is an opportunity for a radical transformation of the pharmaceutical industry and the authors offer us a road map to begin that journey.' - Joel Lexchin MD, York University, CanadaThe pharmaceutical industry must exist to serve the community, but over the years it has engaged repeatedly in corporate crime and anti-social behavior, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health, with deep experience of the industry, documents problems ranging from false advertising and counterfeiting to corruption, fraud and overpricing. It is a fresh and revealing look at the unacceptable pressures brought to bear on doctors, politicians, patients and the media. Uniquely, the book presents realistic and worldwide solutions for the future, with positive policies encouraging honest dealing, as well as partial privatization of enforcement and a transformation of science policy to develop the medicines that society needs most. The authors examine in turn each of the main facets of the pharmaceutical industry's activities - research, manufacturing, information, distribution and pricing - as well as some questionable aspects of its relationship with society. Offering a considered analysis of pharmaceutical rights and wrongs as they have developed, particularly over the last half-century, this book is rich in new insights for managers in the pharmaceutical industry, regulatory agencies and health agencies. Contents: Essay Part I: Setting the Scene Introduction Part II: A View of Rights and Wrongs 1. Creating a Medicine: Why, How and How Not 2. Safe, Unsafe and Improper Manufacturing Practices 3. Aggressive or Misleading Promotion 4. The Dark Art of Manipulation: The Industry and its Puppets 5. Corruption, Counterfeiting and Fraud 6. Prices, Monopolies, Abuses and the Law Part III: Transforming the Way Ahead 7. A Criminological Perspective on a Worsening Crisis 8. Positive Regulation: The Complementary Role of Supports and Sanctions 9. A Responsive Criminal Law of Pharmaceuticals 10. Privatising Enforcement 11. A New Capitalism: A New Drug Diplomacy Index

Most national governments have created agencies with the responsibility for deciding which medicinal drugs should be imported or manufactured and made available through their health systems. Many of these agencies were set up some twenty years ago in the wake of the thalidomide disaster. Since that time they have developed in quite different ways in response to national, cultural and economic influences. Their direct cost is very small in comparison to overall health budgets but their indirect effects, both in terms of health and the economy, can be substantial. In 1980 the World Health Organization (WHO) Regional Office for Europe set up a series of studies of drug evaluation in the European region aimed at determining the effects of the work of regulatory agencies on the availability of drugs, on the pharmaceutical industry, and on the health of individuals in the countries concerned. This book sets that work in a historical context and describes the sources of the data used by the project team and the methods used by WHO and others in assessing the work of these agencies and its repercussions for the community. Finally, it presents an analysis of current knowledge and the plans and prospects for future research. The first draft of this book was presented to a meeting of experts in the field of drug regulation at Oslo in March 1984, and the present text embodies the views and conclusions of that meeting.