From 6 November 2014 to 18 December 2014, the Ministry of Health (the “MOH”) is conducting a public consultation on a draft Human Biomedical Research Bill (the “draft Bill”) which covers human biomedical research and human tissue collection and banking activities.

Essentially, the draft Bill seeks to:

  • Regulate the conduct of human biomedical research and to further regulate certain restricted human biomedical research.
  • Prohibit certain types of human biomedical research.
  • Regulate tissue banking.
  • Prohibit the commercial trading of human tissues.

According to the MOH press release, the new legislation is expected to be enacted in 2015.

Human biomedical research framework

The key objectives of the human biomedical research framework under the draft Bill are to protect the safety and welfare of human research subjects as well as regulate certain more sensitive types of human biomedical research. The draft Bill sets out the types of human biomedical research, such as those involving human embryos or human eggs, which are considered restricted and hence subject to additional requirements. There are also prohibited types of human biomedical research which would be an offence to conduct. The draft Bill only covers research that uses individually-identifiable data or tissue (including re-identified data or tissue) and sets out various consent requirements relating to adults, minors and dead persons.

The self-accountability framework under the draft Bill is based on the interlocking roles of three main players: the research institution, institutional review board and researcher.

The research institution is the main entity responsible for the conduct of human biomedical research and will appoint an institutional review board to review the human biomedical research of its researchers. A research institution can be established by a public healthcare institution with an existing institutional review board and which is currently conducting human biomedical research, or private clinics/hospitals currently conducting human biomedical research or biotech start-ups, small and medium enterprises and other research organisations. The institutional review board would then review the human biomedical research proposals of researchers from its appointing research institution, assess (among others) the ethics of the study, qualifications of the researcher, and the adequacy of the monitoring system and safety measures put in place to protect the research subjects of the study. The institutional review board also considers the safety and welfare of the research subjects and makes an independent assessment whether to approve (or reject) the human biomedical research proposals. The researcher is the natural person who conducts the human biomedical research.

Human tissues and tissue bank framework

The human tissue framework under the draft Bill seeks to protect the safety and welfare of tissue donors, prohibit commercial trading (including advertisements) of human tissue and ensure human tissue used in biomedical research are obtained only through altruistic donations. Similar to the human biomedical research framework, various consent requirements would be applicable in the use, removal, storage and supply of human tissue. It is generally an offence to compel a person to donate tissue. As tissue banking is one of the activities which will be regulated under the draft Bill, there are provisions on the duties and responsibilities for tissue banks.

Other existing legislation

The current prohibition against the commercial trading of human organs and blood in the Human Organ and Transplant Act and human gametes and embryos in the Human Cloning and OtherProhibited Practices Act will remain despite some overlapping areas since the definition of human tissue in the draft Bill would include organs, blood, gametes and embryos.

Reference materials

The following materials are available from the MOH website