Stem Cell Research and the Law
Many countries around the world have enacted laws to govern stem cell research (SCR) (see map). Stem cell laws are commonly found in dedicated statutes (for e.g., in Australia and Germany) or in legislation which deals primarily with reproductive technologies (such as in vitro fertilization (IVF)) and related research (as is the case in Canada and the United Kingdom).
Most SCR laws also place criminal sanctions on various research activities, especially those that raise unresolved social, scientific, ethical, and legal questions (such as the controversy over the moral and legal status of the embryo, and over whether embryos should be used for scientific research). Some of the SCR techniques covered in stem cell legislation include the derivation of stem cells from spare human embryos remaining after the IVF process is completed, the creation of human embryos for stem cell derivation, somatic cell nuclear transfer (SCNT), and inter-species somatic cell nuclear transfer (SCNT, using animal ova).
There is a great deal of variation in the laws governing SCR in countries around the world. Such variations exist even among countries with similar socio-political, economic, and cultural environments, such as Canada, Australia, the United States, Germany, and the United Kingdom. Stem cell laws range from restrictive to permissive policies depending on the number of restrictions placed on various SCR techniques. Canadian law (The Assisted Human Reproduction Act), is classified as intermediate because it allows some research practices (research on spare IVF embryos, animal-human hybrid embryos, etc.) while prohibiting others with criminal sanctions (creation of embryos for research, somatic cell nuclear transfer, etc.). Countries on the permissive end of the legislative spectrum include the United Kingdom, Israel and Singapore, and on the restrictive end, there is Germany, France and Italy.1 The United States is in a unique position with respect to stem cell regulation – while there is no explicit legislation at the federal level governing SCR, current U.S. federal executive policy forbids the use of public funds for many SCR activities. However, several states, such as California, New Jersey, and Massachusetts have passed legislation which can be described as permissive.
What kind of matters are covered in stem cell research legislation?
Irrespective of the range of research techniques allowed, most legislation provide for a strict oversight and licensing scheme. What this means is that researchers must first obtain a license from a government regulator (such as Health Canada and the U.K. Human Fertilisation and Embryology Authority) before engaging in research, and must conduct their research in accordance with strict guidelines laid down by the government regulator or in research ethics documents (such as the Canadian Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans). These guidelines include substantive, procedural and ethical safeguards which serve to ensure research integrity, protect research participants, and promote the safe and ethical conduct of research.2 In the case of embryo-based stem cell research, most (if not all) stem cell laws prohibit the implantation of research embryos in humans, as well as the development of the embryo beyond a certain period after fertilization (usually 14 days, or until the appearance of the primitive streak, whichever is earlier).
Beyond the scope of primary legislation, a variety of legal issues arising from the conduct of SCR remain unresolved. Examples include the propriety of granting patent rights on stem cell lines derived through the destruction of human embryos, the proper limits of embryo donors’ rights to withdraw consent to the continued use of donated embryos or stem cell lines derived from such embryos for research, and the necessity of creating special guidelines to limit apparent conflicts of interest involving stem cell researchers. Questions have also been raised about the legal status of emerging techniques for stem cell derivation (such as induced pluripotent stem cells, parthenogenetic embryos, and single blastomere extraction from cleavage-stage embryos).3 These techniques are designed to avoid some of the technical challenges and social controversies surrounding embryonic stem cell research. Because most of these techniques were not known or contemplated at the time stem cell laws were enacted in many countries, regulators are expected to decide whether or not they are governed by existing regulations.
Finally, there is some evidence suggesting that concern over the moral status of the embryo was a primary motivation for the Canadian legislation.4 However, this concern is not expressed in the legislation. Instead, the key purposes identified in the legislation include the protection of vulnerable persons (women and children) who may be affected by SCR, and the protection and preservation of human individuality, diversity, and integrity. How then can the legislature justify the complete ban on embryo research activities that are not intended for human reproduction, and which pose no special dangers to women and children that could not be managed by setting strict research guidelines? Or allowing research combining human and animal cells, but not exclusively human cells? These questions have no easy answers, but demand continued exploration as nations grapple with the challenges of regulating controversial technologies like SCR.
|Author :||Ubaka Ogbogu, Doctoral Student
Faculty of Law
University of Toronto
For a complete list of countries on the spectrum, see Rosario M. Isasi & Bartha M. Knoppers, "Mind the Gap: Policy Approaches to Embryonic Stem Cell and Cloning Research in 50 Countries" (2006), European Journal of Health Law 13; 9.
See Rosario M. Isasi & Bartha M. Knoppers, "Beyond the Permissibility of Embryonic and Stem Cell Research: Substantive Requirements and Procedural Safeguards" (2006), Human Reproduction 21; 2474.
Ubaka Ogbogu & Peter Rugg-Gunn, "The Legal Status of Novel Stem Cell Technologies in Canada" (2008), Journal of International Biotechnology Law 5; 186.
Timothy Caulfield & Tania Bubela, "Why a Criminal Ban?: Analyzing the Arguments Against Somatic Cell Nuclear Transfer in the Canadian Parliamentary Debate" (2007), American Journal of Bioethics 7; 51.