United Kingdom ethics

In the UK, the United Kingdom Ethics Committees Authority (UKECA) is responsible for establishing, recognising and monitoring ethics committees. The Authority may establish ethics committees to act for the entire UK or for each area of the UK and the description or class of clinical trial in relation to which it may act. The categories are listed in Table 6.3. 

Other chapters in this book deal with the evolution of the legal controls over medicinal products and the structure of the European Union regulatory systems set up to authorise business activities and dealings in these products, and to enforce the rules and restrictions the law places upon them. This chapter aims to select some specific legal and ethical issues that arise in relation to product development, authorisation and sale and supply both within the United Kingdom and within the context of the European systems. 

The granting of a product licence in the United Kingdom, or its equivalent in other countries, is a dividing line that places firm constraints on what studies can and cannot be done in the pre- and post-marketing periods. Because it would be medically and ethically unacceptable to permit doctors (investigators) to use an unapproved drug in unrestricted circumstances, it is essentially impossible to conduct clinical trials... 

Timimi, S. (2004). Developing nontoxic approaches to helping children could be diagnosed with ADHD and their families Reflections of a United Kingdom clinician. Ethical Human Psychology and Psychiatry, 6, 41-52. 

Wehrli (1997) stated case reports from Australia, the United States and the United Kingdom and the activities of the Pharmaceutical Security Institute (PSl), which was founded by the majority of ethical pharmaceutical companies and operates under the auspices of the International Federation of Pharmaceutical Manufacturers Association (IFPMA). Wehrli further indicated that an API may be counterfeited in one country, passed by a circuitous route into another for formulation, from there to a third country where the product is sold. 

There are clear signs that exactly this process is happening. For example, Hermes is a large asset manager in the United Kingdom that started out managing the pension fund assets of BT (then British Telecom). Today, Hermes has 44 billion under management. Hermes has recently required the leaders of firms held in portfolio to explain how their companies have value at stake on SEE (social, environmental and ethical issues) (Monks, 2001). 

The medical profession is incorporating CPD into plans for demonstrating continuing competency to practise, based on annual appraisals and, for example in the United Kingdom, a proposed 5-yearly assessment for revalidation in order for a practitioner to remain on the general medical register and be certified to practise. Everyone should undertake a professional and ethical obligation to remain up to date with best practice standards in the role that they perform. 

The editors of scientific journals, vehemently expressing their abhorrence of research and publication fraud, established the Committee on Publication Ethics (COPE) in the United Kingdom in 1997. They recommend peer review and require all named authors to sign the letter of submission, coupled with clear declarations from all parties as to conflict of interest. Such procedures would have prevented Pearce s fraud as the paper on the reimplantation of the ectopic fetus had not undergone peer review, and the co-authors were not required to detail their involvement. 

All European countries require, in common with the United States, and in conformity with the Declaration of Helsinki, that ethics committees (the European version of institutional review boards in the United States) review protocols from phase I-IV and the general conduct of trials outside the formal protocol document. However, there is wide variation in Europe as to how this procedure is enacted. In countries such as France, Spain and Germany, there is a national system of ethics committees that duplicate similar work at a local level. In the United Kingdom, there are a wide variety of ethics committees, such as commercial committees, those set up by the Royal College of Physicians, and those run by local area health authorities or hospital trusts. 

In the United Kingdom, inspectors from the Health and Safety Executive (HSE) have the power to close down any operation which they deem unsafe and to fine and imprison companies and individuals who carry out, authorise the operation of or allow unsafe practices to be carried out. Corresponding government bodies have similar powers in almost all other countries in the world. Thus, the law provides strong motivation for ensuring the safety of chemical processes, in addition to the ethical and financial (loss avoidance) reasons for doing the same. 

---