Sarah Devaney

Regulate To Innovate: Principles-Based Regulation of Stem Cell Research

The application of Principles-Based Regulation (PBR) to stem cell (SC) research has been adopted with little apparent controversy. However, this was the form of regulation being used in the financial sector leading up to the current financial crisis, giving rise to questions about its ability to regulate fast-moving areas effectively. This article will explore whether PBR is an appropriate form of regulation for SC research.1 It will conclude that PBR is well-suited to this area, being reflective and facilitative of the process of scientific innovation. However, lessons must be learned from the financial sector about how to apply it effectively.

Tissue Providers for Stem Cell Research: the Dispossessed

The global business of biotechnology is thriving. Stem cell (SC) research is no exception, with significant investments being made in those private companies, university laboratories and clinical departments that hope to realise its potential to provide therapies for serious diseases.2 The corollary to such investment (and its impetus) is the potential financial reward for those researchers (and their financial sponsors) who succeed in these endeavours. SC science is part of the growing trend of emerging technologies which depend for their success on the physical contribution of human raw materials—that is, tissues such as ova and embryos—by willing providers. These vital contributors, without whom many SC research projects would simply fail to be undertaken, are however excluded by UK law from sharing in the potential commercial successes that will accompany therapeutic advances3 and from receiving any appropriate financial recognition for the value of their contribution to the science. Tissue providers (TPs) are the dispossessed of the research arena. In addition to the commercial stimulus to carry out SC research, the hope that effective SC therapies will be developed for the benefit of patients—the ‘social utility aim’

Breaches in good regulatory practice - the HFEA policy on compensated egg sharing for stem cell research

Abstract The Human Fertilization and Embryology Authority policy on permitting ova provision for research purposes breaches good regulatory practice in being inconsistent, unaccountable and untargeted. This article will illustrate how these breaches have resulted in a policy which is unfair to ova providers who wish to contribute to stem cell research and undermines the intentions behind the policys very inception. (This article is based on a paper entitled Appropriate Recompense for Oocytes in Stem Cell Research presented at the Stem Cells: Hope or Hype debate, North West Genetics Knowledge Park, Manchester in May 2007.)

REGULATORY ‘DESIRABLES’ FOR NEW HEALTH TECHNOLOGIES

This paper examines the relationship between health, technology and regulation, focusing in particular on what happens in the context of innovation. Key elements identified that inform (or should inform) the regulation of new health technologies include the following: (1) hybridity, (2) regulatory certainty and stability; (3) a move away from risk-based regulation alone; and (4) regulatory legitimacy through participation and information.

Contextualising the Regulation of Health Technologies

Explores key themes in journal special issue on Contextualising the Regulation of Health Technologies

The Transmutation of Deference in Medicine: An Ethico-Legal Perspective

This article critically considers the question of whether an increase in legal recognition of patient autonomy culminating in the decision of the Supreme Court in Montgomery v Lanarkshire Health Board in 2015 has led to the death of deference to doctors, not only within the courts and healthcare regulatory arenas in England and Wales but also in the consulting room and the health care system more broadly. We argue that deference has not been eradicated, but that the types of deference paid to doctors and to the medical profession have changed. In addition, whilst traditionally deference was extended towards the medical profession, increasing instances of deference being shown to other parties in the healthcare setting can be identified, allowing wider debate or recognition of the complexity of understandings, interests and aims of all those involved. Finally, we note instances in which deference to the medical profession has become more hidden.

Improving healthcare through the use of ‘medical manslaughter’? Facts, fears and the future:

The criminal law looks set to play a larger role in regulating healthcare. Until recently, health professionals only faced the prospect of criminal liability if it could be proved that their gross negligence resulted in the death of a patient. In such a case, the professional could face a charge of gross negligence manslaughter (GNM). Prosecutions for ‘medical manslaughter’ have generated concern among doctors worried about what is perceived as a rise in the number of doctors facing criminal prosecution and the impact prosecutions are having on healthcare practice. May more frequent resort to the criminal process damage rather than promote better health care? In seeking to try to answer this question, the first problem is that reliable data in this area about how many prosecutions are brought and how they fare are limited due to the way cases are recorded. What evidence does exist is often based on media reports or samples that are not representative. This paper will argue that, while the real risk of being prosecuted for medical manslaughter remains low, such fears should not be dismissed because, as Donald Berwick has argued, ‘fear is toxic’ – for health professionals and their patients.