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Regulation of Stem Cell Technology in Malaysia: Current Status and Recommendations

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Abstract

Stem cell technology is an emerging science field; it is the unique regenerative ability of the pluripotent stem cell which scientists hope would be effective in treating various medical conditions. While it has gained significant advances in research, it is a sensitive subject involving human embryo destruction and human experimentation, which compel governments worldwide to ensure that the related procedures and experiments are conducted ethically. Based on face-to-face interviews with selected Malaysian ethicists, scientists and policymakers, the objectives and effectiveness of the current Guideline for Stem Cell Research and Therapy (2009) are examined. The study’s findings show that the guideline is rather ineffective in ensuring good ethical governance of the technology. A greater extent of unethical conduct is likely present in the private medical clinics or laboratories offering stem cell therapies compared with the public medical institutions providing similar services, as the latter are closely monitored by the governmental agencies enforcing the relevant policies and laws. To address concerns over malpractices or unethical conduct, this paper recommends a comprehensive revision of the current stem cell guideline so that adequate provisions exist to regulate the explicit practices of the private and public stem cell sectors, including false advertising and accountability. The newly revised Malaysian stem cell guideline will align with the Guidelines for Stem Cell Research and Clinical Translation (2016) of the International Society for Stem Cell Research (ISSCR) containing secular but universal moral rules. However, a regulatory policy formulated to govern the technology remains the main thrust of empowering the guideline for compliance among the stakeholders.

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Notes

  1. For more information on Braithwaite’s Theory please see Ayres and Braithwaite (1992).

  2. UKM is Universiti Kebangsaan Malaysia also known as Malaysia’s National University.

  3. IJN is Institut Jantung Negara also known as National Heart Institute.

  4. The Official Portal of ‘Invest in Pahang’, developed by the Pahang State Development Corporation (2012), has a section on Stem Cell within its opportunity section mentioning the project. There is also a write-up on the Czechoslovakian physician by Coker (2018) in OC Weekly Magazine.

  5. NKEA is described as ‘an important driver of economic activities towards Malaysian Economic Growth measured by the National Gross Income (CNI)’.

  6. Alaqah marks the ensoulment stage of an embryo in Islamic belief. Refer to Saniei and Baharvand (2018).

  7. It is based on the justification and opinions of many scholars (theologians, ethicists and philosophers), that any act that leads to the destruction of an embryo after the formation of primitive streak (that occurs after the 14th day) which marks the onset of a sentient-being as unethical. Embryos at blastocyst (prior to the 14th day) stage are not rational beings, and therefore the 14th day rule inspired by Immanuel Kant is a concept of universalisability, which has been adopted by many countries around the world (Potter and Timmons 2012; Cummiskey 1996; Pera 2017).

Abbreviations

ART:

Assisted reproductive technology

ASM:

Academy Science Malaysia

BAC:

Bioethics Advisory Committee

ELSI:

Ethical, legal and social implication

GMP:

Good manufacturing practice

HESC:

Human embryonic stem cell

ISSCR:

International Society for Stem Cell Research

IEC:

Institutional Ethics Committee

IRB:

Institutional review board

IVF:

In vitro fertilization

MOH:

Ministry of Health

MoU:

Memorandum of understanding

MREC:

Medical Research and Ethics Committee

NGOs:

Non-governmental organizations

NKEA:

National Key Economic Area

NMRR:

National Medical Research Registry

NPRA:

National Pharmaceutical Regulatory Agency

NSCERT:

National Stem Cell Research and Ethics Subcommittee

OECD:

Organisation for Economic Co-Operation and Development

PHFS:

Private Healthcare Facilities and Services

SCNT:

Somatic cell nuclear transfer

UK:

United Kingdom

US:

United States of America

USD:

US Dollar

WoS:

Web of Science

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Authors and Affiliations

  1. Department of Science and Technology Studies, Faulty of Science, University of Malaya, Kuala Lumpur, Malaysia

    Nishakanthi Gopalan & Mohd Salim Mohamed

  2. Genovasi University College (GUC), Lot 2A (Gate C) Jalan 13/2, Seksyen 13, 46200, Petaling Jaya, Selangor, Malaysia

    Siti Nurani Mohd Nor

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Gopalan, N., Nor, S.N.M. & Mohamed, M.S. Regulation of Stem Cell Technology in Malaysia: Current Status and Recommendations. Sci Eng Ethics 26, 1–25 (2020). https://doi.org/10.1007/s11948-019-00111-5

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