The Ministry of Health has stated that the first substantive portion of the Human Biomedical Research Act (HBRA) will be brought into force on January 1, 2017: the ban on commercial trading of human tissue. While occurring within the HBRA, this ban applies to all tissue, including that acquired for therapeutic purposes. You can view the official notification on the MOH website, and contact email@example.com for questions.
There are two important clarifications within the law, as stated in the announcement:
- Substantially manipulated tissue (including stem cell lines) are exempt. Further clarification of substantially manipulated tissue is laid out in the First Schedule of the HBRA.
- The HBRA allows reimbursement for “reasonable costs and expenses” in the collection, preservation, assessment and transportation of the tissue. To avoid doubt, when tissue is paid for in this manner, purchasers should obtain an itemised price breakdown that shows how the price was derived from such reasonable costs and expenses.
At this time, there are no anticipated regulations concerning tissue sales that will be released before the provisions come into force. If this changes, we will send out a further note of clarification. (Notably, this does not supersede existing prohibitions on commercial organ trading for transplant purposes, which are delineated in the Human Organ Transplant Act.)
Given how soon the ban comes into force, it is advisable that clinicians and researchers who use human tissue from third parties make arrangements to comply with the HBRA. Anyone buying and selling of human tissue without qualifying for one of the law’s exemptions may be liable for a prison sentence of up to 10 years and a fine of $100,000.