1 Centre for Biomedical Ethics, National University of Singapore. Block MD11 #02-03, 10 Medical Drive Singapore 119228. Email: email@example.com
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.
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.