Gerard Porter

Oversight for Clinical Uses of Autologous Adult Stem Cells: Lessons from International Regulations

Autologous adult stem cells (ASCs) are being administered by physicians for indications that have not been demonstrated as safe and effective in formal clinical trials. Examination of regulatory frameworks across five countries suggests that balancing the demands of research with clinical freedom has created structural weaknesses that are being exploited.

Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies.

Global Bionetworks and Challenges in Regulating Autologous Adult Stem Cells

funded by the Ministry of Education, Singapore, and the Humanities and Social Sciences (HSS) Division of the Office of the Deputy President (Research and Technology) at the National University of Singapore (NUS

Human rights and ethical considerations for a tobacco-free generation

In recent years, a new tobacco ‘endgame’ has been proposed: the denial of tobacco sale to any citizen born after a certain year, thus creating new tobacco-free generations. The proposal would not directly affect current smokers, but would impose a restriction on potential future generations of smokers. This paper examines some key legal and ethical issues raised by this proposal, critically assessing how an obligation to protect human rights might limit or support a states ability to phase out tobacco.

The Medical Innovation Bill: Still more harm than good

The Medical Innovation Bill continues its journey through Parliament. On 23 January 2015, it was debated for the final time in the House of Lords and with one final amendment, the House moved to support the Bill, which then moved to the House of Commons on 26 January. It will be debated again on 27 February 2015. The Bill’s purpose is to encourage responsible innovation in medical treatment. Although this goal is laudable, it is argued that the Bill is unnecessary and has the potential to undermine the very cause it aims to advance. More useful for encouraging responsible innovation is the continued education of health-care professionals on how the law already supports practitioners who look to improve care through responsible innovation.

Preventing the selection of “deaf embryos” under the Human Fertilisation and Embryology Act 2008: problematizing disability?

Section 14(4) of the Human Fertilisation and Embryology Act 2008 imposes – within the general licensing conditions listed in the Human Fertilisation and Embryology Act 1990 – a prohibition to prevent the selection and implantation of embryos for the purpose of creating a child who will be born with a “serious disability.” This article offers a perspective that demonstrates the problematic nature of the consultation, review, and legislative reform process surrounding s 14(4). The term “serious disability” is not defined within the legislation, but we highlight the fact that s 14(4) was passed with the case of selecting deaf children in mind. We consider some of the literature on the topic of disability and deafness, which, we think, casts some doubt on the view that deafness is a “serious disability.” The main position we advance is that the lack of serious engagement with alternative viewpoints during the legislative process was unsatisfactory. We argue that the contested nature of deafness necessitates a more robust consultation process and a clearer explanation and defence of the normative position that underpins s 14(4).

Malpractice litigation in acute stroke care – where are we now?:

Acute stroke care has undergone momentous changes in recent years with the introduction of intravenous thrombolysis, mechanical thrombectomy and integrated stroke services. While these are welcome developments, they also carry unique medico-legal challenges. In 2015, a patient from Greater Manchester was awarded over £1 million in compensation after ambulance paramedics failed to admit her to a specialist unit. This paper explores the medico-legal implications of this first but over looked thrombolysis-related claim in the United Kingdom. It is submitted that the highly time-dependent and multidisciplinary nature of acute stroke care may expose a host of healthcare personnel, both medical and non-medical, to risks of legal pursuit for failing to provide appropriate care, and that available scientific evidence will likely support such claims. The situation calls for an urgent and concerted effort at implementing improvement measures at national levels. A reminder of the legal consequences of substandard acute stroke care is timely and necessary.

How Civil Society Organisations Changed the Regulation of Clinical Trials in India

ABSTRACT In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5–6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research.

New Hong Kong statute protects factual statements in medical apologies from use in litigation

Providing an apology which contains a factual explanation following a medical adverse incident may facilitate an amicable settlement and improve patient experience. Numerous apology laws exist with the aim of encouraging an apology but the lack of explicit and specific protection for factual admissions included in “full” apologies can give rise to legal disputes and deter their use. The new Hong Kong Apology Ordinance expressly prohibits the admission of a statement of fact in an apology as evidence of fault in a wide range of applicable proceedings and thus provides the clearest and most comprehensive apology protection to date. This should significantly encourage open medical disclosure and the provision of an apology when things go wrong. This paper examines the significance and implication of the Apology Ordinance in the medico-legal context.