A global comparative overview of the legal regulation of stem cell research and therapy : lessons for South Africa : legislation

• Pages: 12-22
• DOI: 10.10520/EJC180556
• Author: M.S. Pepper,M. Nothling Slabbert
• Published date: 01 August 2015
• Date: 01 August 2015

12 August 2015, Vol. 8, No. 2, Supplement 1 SAJBL

Few advances in medical research have generated

as much interest and controversy as those relating

to stem cell research and its potential applications

in cell and gene therapy, regenerative medicine and

tissue engineering. Recent techniques involving induced pluripotent

stem cells (iPSCs) and human somatic cell nuclear transfer (SCNT)

have raised new ethical and legal questions. The predominant early

focus on an ‘embryo-centric’ approach in this eld is slowly being

overtaken by an approach focused on the globalisation of research

and a concomitant need for ‘policy interoperability’.[1]

Globally, policies and legislation regulating these developments are

complex and varied, both within and between jurisdictions, described

by some authors as ‘a patchwork of patchworks’.[2] In addition to

variation in national laws and policies with regard to biomedical

research and the development of therapeutic applications, variation

also exists with regard to other related activities, such as research

funding, normative and ethical principles and standards, governance

mechanisms, quality assurance and access to stem cell material and

data.[3] The regulatory environment is also deeply influenced by social,

religious, cultural, economic, historical, ideological and political

factors. Competing interests and values promoted and propagated by

various agents from, among others, the scientific community, political

parties, consumer organisations, interest groups (patient groups,

religious organisations and pro-life organisations), the media and the

general public, are also relevant.[4] Moral perceptions regarding the

human embryo have shaped and informed substantive requirements

and procedural safeguards regarding the use of human embryonic

stem cells (hESCs) in many jurisdictions.[5]

National policy development in this field is guided by international

and regional instruments, guidelines and regulations that span

biomedical research and related activities, adding a further layer of

complexity. The United Nations Educational, Scientific and Cultural

Organisation (UNESCO), Council of Europe and the EU have all

addressed aspects of stem cell research and its clinical applications

through various reports, treaties, resolutions, declarations and

guidelines. Guidelines and recommendations by international

organisations, such as the Council for International Organisations

of Medical Science (CIOMS), the Hinxton Group, the International

Consortium of Stem Cell Networks (ICSCN), the International Stem

Cell Forum (ISCF) and the International Society for Stem Cell Research

(ISSCR) are an instructive resource for policymakers. Nonetheless,

human stem cell research, which involves the embryo and its clinical

translation, remains a matter for national policy and lawmakers.

The impact of conflicting regulatory regimens is manifold and

may affect, among others, the conduct of research, efficiency,

collaboration, the clinical translation and commercialisation[6] of

research.[3] Although regulatory variation is a natural consequence of

heterogeneous contexts, unintended and unforeseen consequences

may arise in areas where there are legal regulatory lacunae. One

example is the need to balance innovative therapies with rigorous

oversight and regulation in the exploitation of vulnerable patients

through unproven and potentially harmful stem cell treatments

A global comparative overview of the legal regulation of

stem cell research and therapy: Lessons for South Africa

M Nöthling Slabbert,1 BA, BA Hons, MA, DLitt, LLB, LLD; M S Pepper,2 MB ChB, PhD, MD

1 Department of Jurisprudence, School of Law, University of South Africa, Pretoria, South Africa

2 Department of Immunology, Faculty of Health Sciences; Institute for Cellular and Molecular Medicine and MRC Extramural Unit for Stem Cell Research

and Therapy, University of Pretoria, South Africa; Department of Genetic Medicine and Development, Faculty of Medicine, University of Geneva,

Switzerland

Corresponding author: M Nöthling Slabbert (slabbmn@unisa.ac.za)

Stem cell research and its potential translation to regenerative medicine, tissue engineering and cell and gene therapy, have led to controversy

and debates similar to the calls nearly 25 years ago for a ban involving recombinant DNA. Global legislative eorts in this eld have been

characterised by many legal, ethical and practical challenges, stemming from conicting views regarding human embryonic research

and cloning. National policy and regulatory developments have primarily been shaped by dierent understandings of relevant scientic

objectives, as well as those relating to the moral and legal status of the human embryo, which have been used to justify or limit a range of

permissible activities. Legal obscurity in this eld, a consequence of inconsistent or vague legislative responses at a national and international

level, leads to negative results, which include, among others, ethical violations; lack of collaboration and co-operation among researchers

across national borders; stunted scientic progress; lack of public trust in stem cell research; proliferation of untested ‘stem cell therapies’;

and safety issues. The purpose of this article is to explore the legal regulation of stem cell research and therapy globally, by comparing the

permissibility of specic stem cell research activities in 35 selected jurisdictions, followed by a comparison of the regulatory approaches with

regard to stem cell-based products in the European Union and the USA. A clearer understanding of the global regulatory framework will assist

in formulating more eective legal responses at a national level and in navigating the uncertainties and risks associated with this complex

and evolving scientic eld.

S Afri J BL 2015;8(2 Suppl 1):12-22. DOI:10.7196/SAJBL.8004

LEGISLATION