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

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.