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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.
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