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Online Consultation on Draft Subsidiary Legislation for Human Biomedical Research Act - Tissue Banking Regulations

28 Sep 2018

ONLINE CONSULTATION ON DRAFT SUBSIDIARY LEGISLATION FOR HUMAN BIOMEDICAL RESEARCH ACT

        The Ministry of Health (MOH) is holding an online consultation from 17 August to 28 September 2018 on the draft subsidiary legislation relating to the human tissue regulatory framework under the Human Biomedical Research Act (HBRA).


Human Biomedical Research Act

2      The HBRA was passed by Parliament on 18 August 2015, and is being brought into operation gradually in phases. The provisions relating to the prohibition against commercial trading of human tissue were brought into operation on 1 January 2017 and the research regulatory framework was brought into force on 1 November 2017.

3      For the next phase, the human tissue regulatory framework is targeted to be brought into force in the first half of 2019. The human tissue regulatory framework will: 

  • Prescribe administrative and operational requirements for any person conducting tissue banking activities for research; and
  • Subject tissue banks that are involved in the supply of tissue for transplant into research subjects to additional stringent requirements to protect the safety and welfare of tissue donors and research subjects.


Proposed Subsidiary Legislation

4      The Tissue Banking Regulations will specify the technical details and elaborate on the various requirements and controls on the handling of human tissue in research. These include matters such as notifying MOH as a Tissue Bank, annual declaration of compliance, obtaining and tracking of appropriate consent from donors, requirements for the removal, supply and export of tissue from a tissue bank and reporting of serious adverse events and contraventions.

5      In particular, the proposed set of subsidiary legislation include the following: (click on links below)

        (a) Regulations relating to human tissue activities and tissue banks
        (b) Exemptions relating to human tissue activities and tissue banks


Stakeholder Consultation Sessions Held on August 28 and September 12

6      The presentation slides relating to the draft regulations are available here.   


Feedback Sought

7      MOH invites interested parties to submit written comments on the draft subsidiary legislation. For your convenience, you can use the e-feedback form here. Alternatively, you can also share your views and comments by sending an email to MOH at hbr_enquiries@moh.gov.sg.