Accelerating regenerative medicines in Japan: Questions of trust, benefit and fairness

Tamra Lysaght1

1 Centre for Biomedical Ethics, National University of Singapore. Block MD11 #02-03, 10 Medical Drive Singapore 119228. Email: tlysaght@nus.edu.sg

In 2014, the Japanese National Diet introduced a new regulatory framework to promote the clinical translation of stem cells and regenerative medicine. The basic action of this new framework is to accelerate market approvals for cellular products and allow their use within private clinical practice before evidence of safety and efficacy has been demonstrated in formal clinical trials. The National Health Insurance Scheme will also provide full and partial coverage for products approved under the accelerated program. The aim of this program is to provide patients and clinicians with early access to new and innovative stem cell therapies while efficacy trial data is gathered for full market evaluation.

In this paper, I provide a brief overview of Japan’s new framework and an analysis of the major ethical implications of accelerating market approvals for novel stem cell products without scientific evidence of clinical efficacy. It is argued that even if these programs can meet minimal standards of non-maleficence, and promote limited notions of patient autonomy, they are unlikely to satisfy conditions for beneficence or distributive justice, and may further encourage deceptive marketing practices with stem cells. These practices not only undermine patient autonomy and place them at risk of undue harm, but can potentially undermine trust in the entire field of regenerative medicine as it emerges. Ethically justifiable frameworks should not only consider issues of safety and individual autonomy, but also how accelerated pathways can actually benefit patients, discourage abuses of trust, and provide fairness within resource-strained health care systems.


Biography

I am currently Director of the Phase III Health Ethics, Law and Professionalism Programme at the Centre for Biomedical Ethics. My research interests lie broadly around the ethical, sociopolitical and regulatory issues surrounding stem cell science and the clinical translation of regenerative medicines and genomics.  I am a member of the Committee for Ethics Law and Society of the Human Genome Organisation and am involved in projects investigating the ethics and regulation of translational medicine and cellular therapies, precision medicine, and One Health.

Screening technology, citizens’ autonomy and public health

Stacy M. Carter1

1 Centre for Values, Ethics and the Law in Medicine

The use of technologies to screen for risk of non-communicable disease in asymptomatic people sits on the boundary between public health and clinical health care. This leaves open the question of whether principles from clinical ethics or public health ethics are more directly applicable to evaluating the offer and provision of such services. I will argue that, in the case of screening for non-communicable diseases, screening is only weakly public. If this is accepted, then the central principle from clinical ethics of respecting and/or supporting autonomy will become normatively relevant. What this requires, however, depends on how autonomy is conceptualised. Using the work of Catriona Mackenzie, I will argue that a unidimensional, decisional conception of autonomy is insufficient for the task of ensuring that screening technologies are offered to citizens in a justified way. A multi-dimensional, relational conception of autonomy encourages attention to a wider range of normatively relevant concerns, and is more appropriately restrictive of offers of technologically-driven screening services.


Biography

Stacy’s background is in public health, and her research focuses on public health ethics. She is currently working on: normative dimensions of screening, especially cancer screening; overdiagnosis and too much medicine; de-prescribing in older people; relational conceptions of paternalism; normative dimensions of health promotion; methodology for empirical bioethics; and deliberative methods. Stacy is a qualitative researcher, and supervises a range of empirical public health ethics projects. She has a particular interest and expertise in grounded theory. She is currently a chief investigator in Wiser Healthcare, an NHMRC-funded collaboration to reduce overdiagnosis and overtreatment (wiserhealthcare.org.au). She tweets sporadically @stacymcarter.

Emerging technologies and the ‘too much medicine’ problem

Ainsley J. Newson1, Wendy Rogers2, Stacy Carter1

1 Centre for Values, Ethics and the Law in Medicine, School of Public Health, University of Sydney, NSW 2006
2 Centre for Agency, Values and Ethics and Australian School of Advanced Medicine, Macquarie University, NSW 2109

Emerging technologies such as genomics, biomarkers and imaging modalities are increasingly being implemented into healthcare. This is often an appropriate course of action. Genomic testing, for example is being used to increase diagnostic yield in groups living with rare disease. Alongside this, however, scholars are highlighting medicine’s increasing tendency to overdiagnose and overtreat. This is driven at least in part by enthusiasm among policymakers and the public for initiatives including screening for disease risk and personalised and precision medicine. Without appropriate reflection, these technologies may contribute to the problem of ‘too much medicine’; including by unnecessarily widening definitions of disease or ‘pre-disease’. In this workshop, we will argue that considerations of ‘too much medicine’ and overdiagnosis need to be made more visible in the planning and delivery of emerging technologies in health care. The workshop will comprise presentations from three academics who work in theoretical and empirical bioethics. The presenters will consider concepts such as: the balance of benefits and harm, the technological imperative, technology-led demand, our natural inclination to be ‘information seekers’, public communication, and some of the vulnerabilities created by these technologies. The workshop will advocate for critical implementation of these technologies in healthcare, including evaluation of possible concepts that can usefully inform ethical debate.


Biography

Ainsley Newson is Associate Professor of Bioethics at the University of Sydney. She undertakes research on a range of ethical issues arising from emerging technologies in health care; focusing on genetics, genomics and human reproduction. Ainsley has degrees in science and law and a PhD in Bioethics. She also leads the Sydney Bioethics Program of postgraduate coursework.

About the Association

The Australasian Association of Bioethics and Health Law (AABHL) was formed in 2009.

It encourages open discussion and debate on a range of bioethical issues, providing a place where people can ask difficult questions about ideas and practices associated with health and illness, biomedical research and human values.

The AABHL seeks to foster a distinctive Australasian voice in bioethics, and provide opportunities for international engagement through its membership, journal and conferences.

Members come from all the contributing humanities, social science and science disciplines that make up contemporary bioethics.

Many members have cross-disciplinary interests and all seek to broaden the dialogues in which all members of the wider community ultimately have an interest.

The AABHL is a supportive, creative and challenging community that provides a rich source of continuing academic refreshment and renewal.

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