Morally unjustified conditions on access to scarce transplantable Uteruses

Ryan Tonkens1

1 Centre for Human Bioethics, Monash University, Wellington Rd., Clayton VIC, 3800, ryan.tonkens@monash.edu 

Uterine transplants are now a real medical possibility (Brännström et al. 2015). Like other types of transplantable human organs, wombs are expected to be in very high demand, and the supply is likely to be small. Given this, difficult decisions need to be made about (justifiable) eligibility criteria for access to the scarce transplantable uteruses available.

There have been some recent arguments in the literature that suggest that the expected parenting ability of the woman to receive the transplant ought to play a role in allocation decisions. For example, the Revised Montreal Criteria for the Ethical Feasibility of Uterine Transplantation (Lefkowitz, Edwards and Balayla 2013) includes as one of its assessment criteria that the woman “does not exhibit frank unsuitability for motherhood” (p.924). Moreover, Bayevsky & Berkman (2016) suggest that “child-rearing capacity” ought to be considered when making allocation decisions regarding available wombs. [The most recent NHMRC (2016) and TSANZ (2016) guidelines on eligibility for transplantable organs do not mention uterine transplantation at all].

The purpose of this paper is to challenge the inclusion of such non-medical eligibility criteria, regarding anticipated parenting ability: (1) As there is nothing about fertility status that says anything about parenting ability, and not all kinds of family builders are being screened prior to pursuing their family building goals, the inclusion of this information is an example of “infertilitism”, i.e. undue discrimination based on fertility status; (2) appealing to the best interests of the (potential, future) child is medically and morally irrelevant in this context, and it is not clear that uterine transplants ought to be made available exclusively for the purpose of gestating new life; and (3) parenting ability is very difficult to predict ahead of time, and medical professionals cannot be expected to have the necessary ‘expertise’ to make such assessments.


Biography

Dr Tonkens received his PhD in Philosophy in 2012. His main research areas are in applied ethics and bioethics, especially reproductive ethics, transplantation ethics, and the ethical issues accompanying recent developments in artificial intelligence and robotics research.

Exploring the intersection of innovation and autonomy

A/Prof. Bernadette Richards1, Dr Tamra Lysaght

1University Of Adelaide

In our world of continuous technological advancement it is almost inconceivable that we cannot cure every disease and ensure ongoing good health. Over time we have seen repeated examples of medical miracles where the apparently incurable becomes curable and the specter of mortality has retreated. This ongoing development of medical technologies has given rise to a broad and unquestioning acceptance that eventually, all diseases will be treatable. In this climate of enthusiastic embracing of medical advancement it becomes incomprehensible to a patient when they become aware of a potentially new form of treatment but they are denied access on grounds of safety. The current view is that the ‘new’ represents ‘improved’ and to deny access is to undermine basic right to health. It is thus unsurprising that the patient’s right to access or try innovative therapies and treatments is gaining increasing attention from scholars in biomedical ethics, law and clinical medicine. The dialogue around this issue stems from a rights based discourse with advocates of expanded access to treatment emphasising the patient’s right to treatment and therefore good health. Underlying this position is the assumption that all innovative treatment is good treatment and will be effective, thus ignoring the reality of all medical treatment that positive outcomes are not guaranteed. This paper will challenge this view and consider whether or not there is an outer limit to the right to access unproven treatment and therefore, a limit to the exercise of individual autonomy


Biography

Bernadette comes from the Law School at the University of Adelaide and researches in the areas of Tort Law, Medical Law, and Bioethics.  She has contributed to texts on medical law and co-authored  a text book on Tort Law.  Bernadette is Chair of a major clinical research ethics committee and is the Associate Editor (Law) of the Journal of Bioethical Inquiry.  She is the Deputy Director, Research Unit for the Study of Society, Law and Religion (RUSSLR) and  President of the AABHL.  Current  projects include, access to innovative treatment, issues around organ donation and medical decision-making through advance care directives.

Adaptive pathways for advanced therapies: Regulatory innovation or just de-regulation?

Dr Tsung-ling Lee1

1Research Fellow, Centre for Biomedical Ethics, National University of Singapore

One key challenge in the regulation of regenerative medicines and cell-based therapies is balancing the demands for early access to innovative treatments with the need for robust scientific evidence of that demonstrates safety and efficacy. In March 2014, the European Medicines Agency (EMA) launched a pilot program under the “adaptive pathways” scheme designed to expedite market approvals for novel therapeutics in the European Union. Under the adaptive pathways, this has seen the EMA granting a conditional market approval to Holoclar, a stem-cell treatment used to treat damaged eyes of adult burnt patients, despite of limited clinical data supporting its efficacy and safety. Proponents of the adaptive pathways applaud the scheme as an example of regulatory innovation which legitimizes state power in the risk society. In contrast, opponents argue that the scheme undermines the existing legislative framework on advanced therapies and at risk of favoring vested interests of the pharmaceutical industry.

The paper makes two contributions. First, the paper provides an overview of the adaptive pathway, identifying the features of adaptive pathways that facilitate clinical translation of advanced therapies.

Second, focusing on Holoclar, the paper critically examines whether the adaptive pathways genuinely facilitate clinical translation of advanced therapies and the extent to which the process balances the competing demands of the stakeholders.


Biography

Tsung-Ling is a research fellow with Center for Biomedical Ethics, National University of Singapore. Her research investigates the role of law in promoting public health interests, with a focus on regulatory issues in global health.

The need for responsible innovation: Autologous stem cell “therapies” in Australia

Tereza Hendl1, Cameron Stewart 2, Megan Munsie3, Ian Kerridge4

1 Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building, University of Sydney, NSW, 2006, Australia, Tereza.hendl@sydney.edu.au
2 Sydney Law School, New Law Building, University of Sydney, NSW, 2006, Australia, cameron.stewart@sydney.edu.au
3 Stem Cells Australia, Level 2 Kenneth Myer Building, The University of Melbourne, 30 Royal Parade, Parkville VIC 3010, megan.munsie@unimelb.edu.au
4 Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building, University of Sydney, NSW, 2006, Australia, ian.kerridge@sydney.edu.au

Autologous stem cells (ASCs, stem cells derived from the patient’s own body) have an established role in blood and marrow transplantation (BMT) for a range of conditions affecting adults and children. Increasingly, however, ASC therapies are being promoted for the treatment of chronic diseases, with a growing number of private clinics offering ASCs to patients of all ages for a range of conditions including osteoarthritis, motor neurone disease, autism and asthma.

According to the information package from a Sydney-based clinic offering ASC therapy, “Stem cells are extremely versatile which makes this treatment an extremely valuable scientific medical procedure. Scientists and Doctors are discovering new ways to use Stem Cell Therapy every day”. The reality, however, is quite different. Research has been slow and incremental with few ASC therapies tested in Phase 3 trials. Given uncertainty regarding their efficacy and safety, the bold and confident claims of those selling ASCs are questionable at best. But because ASCs are being offered as “innovative” therapies outside “standard practice” and formal clinical trials, patients may not be aware of the lack of evidence supporting their use. Patient advocacy organisations, likewise, have found themselves in a difficult position with regards to ASC therapies as they are aware of the needs, rights and hopes of their members and their carers and supportive of research into the development of safe and effective therapies but are also conscious that they should protect vulnerable patients from harm. In this paper, we present an overview of the clinical practice involving ASCs in Australia and the ethical implications of existing conceptual and regulatory “loopholes” that have enabled the emergence of a flourishing ASC therapeutic “industry”. We argue that there is a pressing need to develop an ethical and socially sustainable regulatory environment for innovation of ASCs treatments in Australia.

 


Biography

Tereza Hendl is a Postdoctoral Research Fellow at the Centre for Values, Ethics and the Law in Medicine (VELiM) at the University of Sydney. She completed a PhD in Philosophy at Macquarie University with a dissertation exploring ethical aspects of sex selection for social reasons. Her paper “A Feminist Critique of Justifications for Sex Selection” was awarded the 2015 Max Charlesworth Prize in Bioethics. Dr Hendl’s research interests include global aspects of biomedical practice and issues related to gender, sexuality and disability. At VELiM she works on a project focusing on the regulation of autologous stem cell therapies in Australia.

Innovative medical treatments in Singapore: How should we decide?

Associate Professor Tracey Evans Chan 1

1 Faculty of Law, National University of Singapore, 469G Bukit Timah Road, Eu Tong Sen Building, Singapore 259776

Innovative treatments in medicine have been the subject of ethical and regulatory debate. Within the past five years, their place in clinical practice has been the subject of scrutiny in two important appeals from the Disciplinary Tribunal of the Singapore Medical Council to the High Court: Devathasan v. SMC (2010) and Pang Ah San v. SMC (2013). This presentation will discuss the issues in both these appeals, their pronouncements on the categories of generally accepted treatment (under the SMC’s Ethical Code and Ethical Guidelines) and innovative treatments, and the implications for clinical ethics and regulation of innovative medical treatments in Singapore.


Biography

Tracey Evans Chan is an Associate Professor in the Faculty of Law, NUS, and specialises in biomedical law and ethics. He has published in the field both locally and internationally, and served in a number of Singapore expert committees on matters such as surrogacy, transplant ethics, human-animal combinations in biomedical research and mitochondrial germline modification.  He recently concluded a year-long secondment to the Singapore Ministry of Health as a Deputy Director in the Regulatory Policy and Legislation Division, where he assisted in the policy work for the recently enacted Human Biomedical Research Act 2015.

Ageing populations, dementia care and assistive technologies: New issues for health law and human rights

Belinda Bennett1

1 Australian Centre for Health Law Research, School of Law, Queensland University of Technology (QUT), GPO Box 2434, Brisbane, QLD, 4001, belinda.bennett@qut.edu.au

With ageing populations in many countries around the world, dementia has emerged as a significant social and economic challenge. Increasingly, use of assistive technologies, including the use of robotic carers or companions, is being considered as an option for dementia care. This paper analyses these advances and considers the potential for new technologies to provide important supports for people living with dementia and their carers. The paper analyses the use of assistive technologies through consideration of the provisions of the Convention on the Rights of Persons with Disabilities (CRPD) in order to evaluate the extent to which assistive technologies promote the human rights of people living with dementia.


Biography

Belinda Bennett is Professor of Health Law in the Law School at Queensland University of Technology (QUT). Her research explores issues related to health law and globalisation. Her research also focuses on the development of regulatory responses to new technologies in health care and the interface between social change, scientific developments and legal regulation.

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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