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

Adverse effects of drugs are a constant source of medical problems but also of professional and legal confrontations. More than a quarter of all malpractice suits brought against physicians or other health professionals revolve around drug injury; for drug manufacturers, civil cases brought by patients are growing problem. Where conflicts do not reach the courts they are often the subject of settlements or of decisions taken by professional disciplinary councils. Uniguely, this book analysis and documents the responsibilities which all parties bear in law and ethics to render drug treatment as safe as it can be, and the liability whidh arises when injury is siffered. Special attention is devoted to the apportionment of liability, where faults may have been made by more than one party, and to the establishment of facts in a field where the evidence is likely to be heavily challenged. The pproach is global, since drugs, their makers and their users are much the same across the world; what is more systems of law and ethics have borrowed solutions from one another, while in some parts of the world - notably in consultations between the United States, Europe and Japan, medicinal policies and regulations are fast being harmonized. Contents: Six chapters in the book document the general medical and legal background to drug safewty and injury; seven set out the duties and liability of the parties concerned ranging from health professionals through governments and institutions to the patient himself. Eight chapters provide in-depth guidance on special issues including drug injury to the unborn child, vaccines, liability in alternative medicine and existing compensation schemes.

The future place of medicines in health care is both exciting and uncertain. With an aging population, an increasing number of chronic sick, a growing range of treatment options and a developing European market, the one certainty is that medication patterns will change radically over the next 15 years or so. How the future might look, in terms of quality, volume and cost of pharmacotherapy, is the subject of this report. Four scenarios for the future are set out, all of which take account of already visible trends. Sobriety in sufficiency envisages rational and restrained consumption patterns. Risk of avoidance is dominated by fears of iatrogenic harm and hence minimal drug use. The central feature of Technology on demand, in contrast, is confidence in technological progress. Free market unfettered, finally, is marked by a Europe without frontiers and minimal state intervention. The reader is encouraged to reflect without preconceptions on the future of medicines in health care. No ready-made answers are offered; rather, a wealth of information and analysis is provided which serves to underpin decision making and policy development, not just by central government but also by every institution concerned with the role of medicines in health care.