Guidelines

Import and export of human biological materials for research

Prohibition against trading of human tissues

Effective 1 Jan 2017, HBRA prohibits commercial trading (i.e. buying and selling) of human tissue, as well as advertisements relating to such trading. This prohibition upholds the principle that human tissue should be obtained only through altruistic donations.

This may affect you if you make use of human tissue in the course of your work. If you have previously made arrangements to obtain and/or supply human tissue, whether for use in therapy or research, please ensure that your arrangements are not in contravention of the prohibitions in the HBRA. Further information can be found on MOH's website. A guide is available here.

Note that HBRA Section 32(6) and HOTA Section 14(4) have provisions for the purchase of human blood products and plasma fractions for research.  


What about Tissue Products and Tissue Derivatives? 

These are usually made from human biological material and would have already undergone substantial manipulation and processing. Where these are not considered to be human tissue, they can be bought and sold on a commercial basis. This would include cell lines. 


How to obtain human tissues lawfully?

While the HBRA prohibits commercial trading of human tissue, it allows for payment to reimburse the reasonable costs and expenses incurred in the process of collecting and supplying human tissue – including the removal of tissue from the donor, and the subsequent transportation, preparation, preservation, quality control and storage of the tissue. The payment must not be for the purchase or sale of the tissue itself.

In this regard, obtaining tissue from sources that are part of a tissue sharing network or exchange programme, whether local or international, and paying only reasonable costs and expenses in relation to such sourcing, would generally be permitted. In contrast, sourcing for tissue from foreign commercial suppliers or tissue banks that routinely charge a price for selling the tissue itself, should be done cautiously.

When making arrangements to obtain human tissue, it is advisable to clarify the arrangements with the supplier providing the human tissue to ensure that the supply of the tissue is on a cost-recovery basis. These arrangements and transactions with the supplier should be documented accordingly.


Export / Transfer of human biological materials (HBM)

Export of HBM is only allowable if the research subject had given explicit consent to allow for the export of his/her HBM. In contrast to health information, this is regardless of whether the tissues are individually identifiable or not.