Beyond Hopes, Beyond Cures: A Proposed Malaysian Regulatory Framework for Somatic Gene Therapy in Human

Zakiah Samori; Fadilah Abd Rahman

doi:10.61707/btmq4740

Authors

Zakiah Samori Department of Halal Industry Management, Academy of Contemporary Islamic Studies (ACIS), Universiti Teknologi MARA (UiTM), 40450 Shah Alam, Selangor, Malaysia
Fadilah Abd Rahman Head Halal Supply Chain, Malaysia Institute of Transport (MITRANS), Universiti Teknologi MARA (UiTM), Department of Halal Industry Management, Academy of Contemporary Islamic Studies (ACIS), Universiti Teknologi MARA (UiTM), 40450 Shah Alam, Selangor, Malaysia

DOI:

https://doi.org/10.61707/btmq4740

Keywords:

Somatic Gene Therapy (SGT), Gene Therapy Products, Clinical Application, Malaysian Regulatory Framework, Legal Issues

Abstract

After serious side effects 20 years ago, somatic gene therapy (SGT) is gaining traction again. The pipeline for somatic gene therapy has expanded rapidly. Although SGT has shown remarkable efficacy for cancer and genetic diseases, it also carries risks, ethical challenges, and legal concerns. This study intends to (i) present Malaysia's experience with SGT clinical trials (ii) evaluate the adequacy of existing regulatory frameworks and (iii) propose future legislation. The study employs a qualitative approach by utilizing both primary and secondary data. Statutory provisions are referred to for doctrinal legal analysis. Primary data was collected through a purposeful sampling of experts. Interviews were conducted with government representatives, medical experts with experience in SGT, and Shariah experts. The findings indicate that in establishing Malaysian law on SGT, customary beliefs, especially Shariah perspective, must be taken into account, as well as adopting best practices from other developed countries and improving Malaysia's existing law.