Lecturer in Medical Law and Ethics

Director of Ethics & Integrity

LLB, LLM
View my full research profile

Biography

Gerard Porter is a lecturer in Medical Law and Ethics. He is a graduate of Cardiff University (LL.B. Law and Japanese) and Kyushu University, Japan (LL.M. International Economic and Business Law). His research interests include medical law, patent law and the regulation of the life sciences. He speaks Japanese and also conducts comparative research in Japanese law within these subject areas.

He has held visiting fellowships at the Centre for Studies in Ethics and Rights (Mumbai, India), the Centre for Biomedical Ethics, National University of Singapore and with the Program on Science, Technology and Society at the John F. Kennedy School of Government, Harvard University.

Websites

Mr Gerard Porter's Homepage at Edinburgh Law School

Courses Taught

Biotechnology Bioethics and Society (LLM) (Course Organiser)

Fundamental Issues in Medical Jurisprudence (LLM)

Intellectual Property Law 2: Industrial Property (LLM)

Medical Negligence (LLM) (Course Organiser)

PhD Supervisees

Himani Bhakuni  'Clinical Trials, Consent, and Context: The Indian Experience'

Books and Reports

Graeme Laurie, Shawn Harmon, Gerard Porter, Mason and McCall Smith's Law and Medical Ethics, (Oxford University Press, 2016)
Abstract: This classic textbook has provided students of medical law and ethics with a framework for exploring this fascinating subject for over 30 years. Providing coverage of all of the topics found on medical law courses, it gives an overview of the inter-relationship between ethical medical practice and the law.Medical law is significantly shaped by the courts, and as such this book provides extensive coverage of recent judicial decisions as well as statutory developments. This book has continually evolved to reflect changes in the law and shifting ethical opinions and the tenth edition continues to fulfil this remit.

Aurora Plomer, Chris Denning, Bartha M. Knoppers, John Sinden, Paul Torremans, Antonina Bakardjieva-Engelbrekt, Gerard Porter, Marcella Favalle, Åsa Hellstadius, Julie Houghton, Rosario Isasi, Elodie Petit, Adrian Viens, Carlos Romeo-Casabona, Josef Kure, Stem Cell Patents: European Patent Law and Ethics Report: FP6 ‘Life Sciences, Genomics and Biotechnology for Health’, (University of Nottingham, 2006)
Abstract: This inter-disciplinary study assesses the scope of the moral exclusion clauses in the European Biotechnology Directive in respect to the patentability of human embryonic stem cells (hESC). We analyse the diverging interpretations which have emerged and the range of legal considerations which are relevant to the resolution of the differences.

Articles

Salla Sariola, Roger Jeffery, Amar Jesani, Gerard Porter, 'How civil society organisations changed regulation of clinical trials in India ', (2018), Science as Culture
Abstract: India changed its pharmaceutical and innovation policy in 2005, facilitating a dramatic increase in international clinical trials that involved Indian sites. This policy shift has been surrounded by controversies; civil society organisations (CSOs) remain critical of how the Indian government has encouraged pharmaceutical research and development. Many CSOs lobbied for tighter research regulations, which were introduced by the Indian government in 2013 and which accelerated a decline in the number of global trials carried out in the country. What marks this activism as unique among other health social movements is the use of interpretations of global social justice as key ideas in mobilisation, as well as their success in institutionalising stricter ethical regulation at a national level as a result. While the activists shared with the government and industry confidence in randomised controlled trials and comparison as key methods for scientific knowledge production, they had significant concerns about the justice of global clinical trials in the country. These CSOs were opposed to the global hierarchies of commercial pharmaceutical research, focusing on promoting the rights of participants as well as on benefits for India as a nation. By pointing to ethical malpractices and lobbying for stricter ethical regulations that aimed to ensure justice for research participants, these Indian CSOs were able to develop an effective strategy to bring the business side of clinical research under greater control.

Gilberto Leung, Gerard Porter, 'New Hong Kong statute protects factual statements in medical apologies from use in litigation ', (2018), Medico-Legal Journal, pp 1-4
Abstract: 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.

Gilberto Leung, Gerard Porter, 'Malpractice litigation in acute stroke care: Where are we now?', (2018), Medico-Legal Journal, pp 1-5
Abstract: 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 overlooked 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 personel, both medical and non-medical, to risks of legal pursuit for failing to provide appropriate care, and that available scientific evidece 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.

Gerard Porter, 'Regulating clinical trials in India: The economics of ethics', (2017), Developing World Bioethics, Vol 17, pp 1-10
Abstract: The relationship between the ethical standards for the governance of clinical trials and market forces can be complex and problematc. This article uses India as a case study to explore this nexus. From the mid-2000s, India became a popular destination for foreign-sponsored clinical trials. The Indian government had sought to both attract clinical trials and ensure these would be run in line with internationally accepted ethical norms. Reports of controversial medical research, however, triggered debate about the robustness and suitability of India’s regulatory system. In response to civil society pressure and interventions by the Supreme Court, the Indian government proposed additional measures aimed at strengthening protections for clinical trial participants. Whilst the reforms can be seen as a victory for human rights activists, they have also been criticised as being overly burdensome for sponsors. Indeed, their announcement prompted an exodus of clinical trials from India. Fearful of losing business to ‘rival’ countries, the Indian government is revisiting some of its proposals. The Indian example suggests that research ethics frameworks and national policies for economic development are increasingly intertwined. Host countries are in theory free to improve the lot of research participants, but doing so may make them appear less attractive to foreign sponsors, who can simply shift their activities to more industry-friendly jurisdictions. Although these economic pressures are unlikely to lead to a regulatory ‘race to the bottom’, they may limit host countries’ ability to enact socially desirable reforms.

Tamra Lysaght, Ian Kerridge, Douglas Sipp, Gerard Porter, Benjamin J. Capps, 'Ethical and regulatory challenges with autologous adult stem cells: A comparative review of international regulations', (2017), Journal of Bioethical Inquiry, pp 1-13
Abstract: 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.

Yvette van der Eijk, Gerard Porter, 'Human rights and ethical considerations for a tobacco-free generation ', (2015), Tobacco Control, Vol 24, pp 238-242
Abstract: 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 state's ability to phase out tobacco.

Gillian Black, Rachael Craufurd-Smith, Smita Kheria, Gerard Porter, 'Scotland the Brand – Marketing the Myth? ', (2015), Scottish Affairs, Vol 24, pp 47-77
Abstract: The paper considers the role of Scottish culture and history, real or imagined, in the commercialisation of iconic Scottish creations such as tartan and Scotch whisky. It notes that many of the forms of legal protection available to the producers of such products were developed to encourage individual innovation, not designed to address communal interests in the preservation of national or group identities and heritage. This may be one reason why, as is illustrated by the case of tartan, these rights offer patchy and incomplete protection to ‘authentic’ Scottish products. Over time, however, the UK has developed various forms of collective protection for cultural products such as Harris Tweed, the effectiveness of which is explored in this article. The final part of the paper considers the importance, in a globalising world, of European Union and international protection for valuable cultural ‘products’. But protection, whether at the national or international level, necessitates a difficult balance to be drawn between the interest in cultural innovation and development, on the one hand, and cultural preservation and the protection of the commercial interests of specific communities, on the other. The article concludes by exploring some of the practical and conceptual challenges associated with determining whether a product should be considered part of the cultural patrimony of the world or, rather, the property of a specific nation or cultural group.

Gerard Porter, Bernadette Richards, Wendy Lipworth, Tamra Lysaght, 'The Medical Innovation Bill: Still more harm than good', (2015), Clinical Ethics, Vol 10, pp 1-4
Abstract: 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.

Gerard Porter, Tamra Lysaght, Ian Kerridge, Douglas Sipp, Benjamin J. Capps, 'Global Bionetworks and Challenges in Regulating Autologous Adult Stem Cells ', (2013), American Journal of Medicine, Vol 126, pp 941-43
Abstract: Autologous adult stem cells are increasingly being administered to patients with limited evidence from clinical trials that they are safe and effective. The marketing of autologous adult stem cells predominantly over the Internet by companies based in low-to-middle income countries, such as the Bahamas, Mexico, India, and China, is well documented. However, even in countries such as the United States, Japan, and Australia, physicians are prescribing autologous adult stem cells to patients outside the context of clinical trials. These doctors often form part of loose collaborative networks of clinicians, businesses, patients, and researchers operating both domestically and across national boundaries. The emergence of these networks not only puts patients who seek out these interventions at risk but also threatens to undermine the very basis of 'good medical practice'.

Gerard Porter, Malcom K. Smith, 'Preventing the Selection of "Deaf Embryos" Under the Human Fertilisation and Embryology Act 2008: Problematizing Disability?', (2013), New Genetics and Society, Vol 32, pp 171-89

Gerard Porter, Tamra Lysaght, Ian Kerridge, Douglas Sipp, Benjamin J. Capps, 'Oversight for Clinical Uses of Autologous Adult Stem Cells: Lessons from International Regulations', (2013), Cell Stem Cell, Vol 13, pp 647-651
Abstract: 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.

Gerard Porter, 'Review - Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow’s World ', (2011), SCRIPTed, Vol 8, pp 116-19

Gerard Porter, Chris Denning, Aurora Plomer, John Sinden, Paul Torremans, 'The Patentability of Human Embryonic Stem Cells in Europe ', (2006), Nature Biotechnology, Vol 24, pp 653-65
Abstract: The article examines the impact of the directive by the European Patent Office on human embryonic stem (hES) cells patenting strategy and its implications on biotechnology industries in Europe. The rule 23 section c of the European Patent Convention directive had prohibited patent protection for hES cell-related technology. This restriction caused patentees to engage in differential wording strategy such as the used restrictive language which limit the commercial value and scope of the technology.

Gerard Porter, 'Review: Trading the Genome: Investigating the Commodification of Bio-information', (2006), Social and Legal Studies, Vol 15, pp 465-68

Gerard Porter, 'The Regulation of Human Genetic Databases in Japan ', (2004), SCRIPTed, Vol 1, pp 449-87

Chapters

Roger Jeffery, Gerard Porter, Amar Jesani, Salla Sariola, Deapica Ravindran, 'Structure, organization and knowledge production of the Indian clinical trials industry ' in Amar Jesani, Purendra Prasad (ed.) Equity and Access (OUP India 2018)
Abstract: In India, the number of clinical trials has been radically transformed in two directions since 2005. In that year, legislation was changed to make it easier for ‘Big Pharma’ to carry out multi-sited trials in India and at the same time as elsewhere in the world. After a period of rapid growth to 500 in 2010, numbers of new trials registered with the Clinical Trials Register-India dropped to 321 in 2011 and 262 in 2012 (Chawan, Gawand and Phatak, 2015). Following a series of adverse reports, the number of approvals in 2013 dropped further to 107 in 2013, to 150 in 2014, 121 in 2015 and 6-7 a month in 2016. The future scale of the global clinical trials industry in India remains unclear. This chapter reviews the evidence about the scale and significance of these trials, using a theoretical approach derived from the theories of ‘global assemblages’. We set out some of the new social forms that have arisen to service these trials before assessing the growth in clinical trials in India since 2005. The chapter also analyses the ethical implications of clinical trials for India and its public health¬¬. We conclude by considering the implications of the reforms that have been introduced since 2012 as a result of several highly-publicized controversies that highlighted problems in the management of clinical trials. Our main argument is that the nascent Indian clinical trials industry rapidly adjusted to the opportunities provided by the 2005 reforms, linked to India’s signing of the TRIPs agreement. It exaggerated the potential benefits, but provided sites and supporting infrastructure to encourage trials to go ahead. On the other hand, Indian regulators were slow to come to terms with the challenges of responding to well-co-ordinated global assemblages (Yee 2012). Civil society institutions were able to mobilise a groundswell of opinion against trials, drawing on tropes such as the Indian population being used as ‘guinea pigs’. Despite resistance from the industry, Indian regulations have been tightened, offering some prospect that at least the worst abuses are unlikely to be repeated.We draw on research funded by the UK’s Economic and Social Research Council (ESRC) and its Department for International Development (DfID), carried out between 2010 and 2013. Our detailed understanding of the pharmaceuticals sector and the growth of clinical trials comes also from previous research (SS, RJ) and long-term engagement with issues of medical ethics (AJ) and medical law (GP).

Gerard Porter, 'Genetic Tests and Insurance in Japan The Case for a Regulatory Framework' in Margaret Sleeboom-Faulkner (ed.) Frameworks of Choice (Amsterdam University Press 2010) 145-165
Abstract: In contrast to the position in many advanced industrial countries, Japan lacks a specific regulatory framework to govern the ways in which insurance companies can make use of genetic test results. Whilst this situation has not yet given rise to major social or legal problems, this article nevertheless argues that the current policy vacuum is unsatisfactory. Some options for the development of an appropriate regulatory system are suggested that draw from the recent experiences of countries such as Australia and the UK whilst taking into account some particular features of the Japanese insurance market.

Gerard Porter, 'Human Embryos, Patents and Global Trade Assessing the Scope and Contents of the TRIPS Morality Exception' in Aurora Plomer, Paul Torremans (ed.) Embryonic Stem Cell Patents (Oxford University Press 2009) 343-67
Abstract: Can a World Trade Organization (WTO) Member exclude an invention from patentability on the grounds of ordre public or morality whilst at the same time permitting the sale and distribution of the invention within its territory? This is a question raised by recent developments in Europe, where moral restrictions have been placed on the patentability of ‘uses of human embryos’, yet human embryonic stem cell (hESC) research, which involves the destruction of human embryos, is permitted and encouraged within numerous EU Member States, and indeed, also funded through the central EU science budget. This chapter assesses whether such an incoherent regulatory landscape would survive WTO scrutiny. The chapter argues that in general, if a WTO Member has not attempted to ban the commercial exploitation of a certain invention within its borders, measures prohibiting the patenting of that invention on moral grounds would likely be viewed as constituting an unjustified restriction on international trade. More concretely, it is suggested that the WTO Member would be found to be in violation of its obligation under the TRIPS Agreement to make patents available without ‘discrimination’ as to the field of technology.

Gerard Porter, 'The Drafting History of the European Biotechnology Directive ' in Aurora Plomer, Paul Torremans (ed.) Embryonic Stem Cell Patents (Oxford University Press 2009) 3-26

Gerard Porter, 'Biobanks in Japan Ethics, Guidelines and Practice' in Margaret Sleeboom-Faulkner (ed.) Human Genetic Biobanks in Asia (Routledge 2008) 40-65

Gerard Porter, 'The Wolf in Sheep’s Clothing Informed Consent Forms as Commercial Contracts' in Gardar Arnason, Salvor Nordal, Vilhjalmur Arnason (ed.) Blood and Data (University of Iceland Press and Center for Ethics, Reykjavik, Iceland 2004) 85-93

Working Papers

Tamra Lysaght, Ian Kerridge, Douglas Sipp, Gerard Porter, Benjamin J. Capps, 'Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations' 2015
Abstract: 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.

Gerard Porter, 'Human Embryos, Patents and Global Trade: Assessing the Scope and Contents of the TRIPS Morality Exception' 2010
Abstract: Can a World Trade Organization (WTO) Member exclude an invention from patentability on the grounds of ordre public or morality whilst at the same time permitting the sale and distribution of the invention within its territory? This is a question raised by recent developments in Europe, where moral restrictions have been placed on the patentability of ‘uses of human embryos’, yet human embryonic stem cell (hESC) research, which involves the destruction of human embryos, is permitted and encouraged within numerous EU Member States, and indeed, also funded through the central EU science budget. This chapter assesses whether such an incoherent regulatory landscape would survive WTO scrutiny. The chapter argues that in general, if a WTO Member has not attempted to ban the commercial exploitation of a certain invention within its borders, measures prohibiting the patenting of that invention on moral grounds would likely be viewed as constituting an unjustified restriction on international trade. More concretely, it is suggested that the WTO Member would be found to be in violation of its obligation under the TRIPS Agreement to make patents available without ‘discrimination’ as to the field of technology.