The pharmaceutical industry operates both for commercial objectives and primary health interest. There is the need to earn money, to cover investments for new drug development and to reward investors and shareholders. The health interest requires for patients the discovery and provision of safe and effective medicines that maintain or restore health. In ethical terms, these functions can be seen to be in fundamental conflict.
Graham Dukes adds a new perspective to ethics and the pharmaceutical industry and continues discussions on the topic that have been covered recently in two other publications.1, 2 Dukes is a physician and lawyer by training, with extensive professional experience in the pharmaceutical industry, a national drug regulatory authority and a regional pharmaceutical programme of the World Health Organization (WHO) in Europe. It is hard to imagine a better pedigree for an author of this type of book.
The book has two parts. The first 130 pages are devoted to describing the history and development of the laws, norms and standards for the pharmaceutical industry and its products, namely medicines. The remaining two-thirds of the book concentrate on a critical discussion of how the norms and standards have been accepted and implemented in everyday operations. Ethical aspects are discussed in both parts of the book, whenever relevant, in regard to the topic.
Dukes covers laws, regulations and guidelines for pharmaceuticals both at the national and international levels, without forgetting special problems in the developing world and the role of WHO. Similarly, operations of the pharmaceutical industry and emerging ethical dilemmas are described both at the national and global levels, providing many examples from real-life situations. Interviews with several experts increase the understanding of problems within industry, regulatory agencies and the consumer community. The book also discusses at length the duties and operations of generic manufacturers.
The book emphasises that the pharmaceutical industry has, in fact, its roots in pharmacy practice and that the pharmaceutical profession has a key role to bring professionalism and professional ethics into operations. Dukes recognises that physicians and the medical profession have increasing importance within the industry. Physicians have to follow the principles of medical ethics, must protect the patient, assure that clinical trials on medicines are scientifically sound and provide expertise on the safety and efficacy of therapeutic products.
There are chapters describing the role of the industry as a source of information, persuasion and education, the industry as an innovator and deciding on pharmaceutical prices and profits. A special chapter addresses issues related to the industry and the developing world.
There are only a few pages on the ethics of human studies and clinical trials on medicines. The history and development of Good Clinical Practice (GCP) for human clinical trials receives little attention. GCP guidelines have, however, played a central role in the ethical conduct of clinical research starting from the first concepts in France and the UK in the early 1980s, refined and extended subsequently by the Nordic countries and resulting in global advice from WHO in the mid-1990s. GCP has contributed significantly to the quality of scientific documentation of pharmaceuticals and has thus contributed to the safe use of medicines by patients.
Dukes refers to the Declaration of Helsinki as a set of ethical principles for human studies but it would have been useful to cover globally recognised ethical guidelines and declarations from such institutions as UNESCO, the Council of Europe, the Council for International Organizations of Medical Science (CIOMS) and the Nuffield Council on Bioethics. The issuance of these documents has in recent years inspired an international and trans-cultural debate on the ethics of research, which has increased the understanding of ethical principles and harmonised the ethical conduct of human studies worldwide.
Chapter 10 is devoted to the duties of generic manufacturers. Dukes recognises the generic pharmaceutical industry as a major player in the world of drug supply, contributing to the accessibility of medicines. In the USA alone, some 50 per cent of prescriptions are for generic products, though because of their lower prices they command only 10 per cent of the American market. Moreover, generic manufacturers are dominant suppliers for the developing world, helping to secure access of patients to medicines in resource-poor countries. The legal status of generic products in the USA, the European Union and India is described. Data exclusivity, generic substitution as well as concepts of generic biologicals, biogenerics and biosimilars are discussed in detail.
Dukes lists some interesting issues with relevance for the future of the generic industry, which need to be considered and solutions found. There are patent issues related to TRIPS and the demonstration of bioequivalence of generic biologicals. Will the science-based industry continue to accept generic manufacturers as a competitor or will major science-based firms seek to control the situation by increasingly obtaining the manufacturing ownership of generic companies? This could lead to an impairment of competition, resulting in decreased accessibility for patients to low-price medicines.
Dukes concludes the book with a futuristic postscript in which he tries to predict what the way ahead will be for the pharmaceutical industry and whether there will be major changes in the social and ethical course and role of the industry.
The book is an excellent source of information regarding laws, regulations and ethical norms, and their development and implementation in recent decades. The presentation is compact and solid. It should be read by anyone working in the pharmaceutical industry or a drug regulatory agency. In particular, the book would be an excellent introduction to young professionals starting their career within the pharmaceutical sector.
