Provisions in Human Biomedical Research Act 2015 relating to human tissue regulatory framework in force from 1 November 2019
30 October 2019
With effect from 1 November 2019, the provisions in the Human Biomedical Research Act 2015 (“Act”) relating to the tissue bank regulatory framework will come into force.
The Act includes provisions relating to the operation of tissue banks, duties of tissue banks, declaration of compliance by tissue banks, restrictions on activities relating to human tissue, offence of compelling tissue donation, and restrictions on disclosure of information on tissue donors.
The human tissue regulatory framework subjects tissue banks involved in supplying tissue for transplant into research subjects to stringent requirements for the purposes of protecting the welfare and safety of research subjects and tissue donors. The framework sets out administrative requirements such as notification to Ministry of Health (“MOH”) as a tissue bank and annual declarations of compliance. The framework also sets out operational requirements including those that concern the obtaining and tracking of appropriate consent from donors, the requirements for the removal, supply and export of tissue from a tissue bank and the reporting of serious adverse events and contraventions.
On 1 July 2016, the provisions relating to matters such as administration of the Act, enforcement powers and code of practice and ethics came into force. Subsequently, on 1 January 2017, the provisions in the Act relating to the prohibition of commercial trading of human tissue and the prohibition of advertisements relating to such commercial trading of human tissue came into force, making it an offence to buy or sell, or advertise the buying or selling of, human tissue.
On 1 November 2017, the provisions relating to consent, institutional review boards, regulation of human biomedical research and related amendments to the Mental Capacity Act came into force.
MOH had conducted a public consultation from 17 August 2018 to 28 September 2018 on draft subsidiary legislation relating to the human tissue regulatory framework under the Act. MOH has released its Response to the feedback received from the public consultation.
The commencement of the provisions relating to human tissue is further to the commencement of the Act in phases as set out above. With the commencement of the human tissue provisions on 1 November 2019, all the provisions of the Act will have come into force.
To support this, subsidiary legislation has been issued.
The Human Biomedical Research Act and related subsidiary legislation are available from the Singapore Statutes Online website sso.agc.gov.sg.