Exemption of Regulated Products under the Human Organ Transplant Ordinance (Cap. 465)
In Hong Kong, the Human Organ Transplant Ordinance (Cap. 465) (“the Ordinance”) was enacted in 1995. It aims to prohibit commercial dealings in human organs intended for transplanting, to restrict the transplanting of human organs between living persons and the transplanting of imported human organs, and for supplementary purposes connected with those matters.
With the advances in medical technology, certain products made from human tissues (such as skin and bone derived products) are now available overseas for transplanting purposes. As these products fall within the definition of "organ" 1 in section 2 of the Ordinance, commercial dealings of these products are prohibited in Hong Kong. To allow registered medical practitioners and registered dentists in Hong Kong the opportunity to use these products for transplant without contravening the Ordinance, amendment has been made to the Ordinance to provide for the Director of Health ("the Director") a mechanism to exempt these products (namely "regulated products") from the provision of commercial dealings and other sections of the Ordinance as appropriate. However, the principles enshrined in the Ordinance that donation of human organs/tissues for making of these products is on a voluntary basis are upheld. A product which falls within the definition of "organ" 1 and has been subjected to "processing" as stipulated in the Ordinance will be regarded as "regulated product". The Director may, on application, exempt a regulated product from the application of the whole or any part(s) of the Ordinance. The amended Ordinance has come into operation on 1 September 2011.
Examples of regulated products include skin and bone derived products. The scope of regulated products does not include autologous therapeutic products. In addition, tissue products that are unprocessed or only subjected to preparation or preservation steps are excluded.
Commercialisation of regulated products will be allowed if exemption has been granted under Part 7 of the Ordinance.
Use of Regulated Products by Registered Medical Practitioners or Registered Dentists for Transplant Purposes
Before using any regulated products for transplant purposes, registered medical practitioners and registered dentists have the responsibilities to ensure that the regulated products have been exempted by the Director. The list of the exempted products and information on the exemptions granted, revoked, varied or suspended are available in the Register of Exemptions. Interested parties may check with the register to ascertain whether the regulated products of interest have already been exempted. Registered medical practitioners and registered dentists should report any serious adverse event2 or serious adverse reaction3 to the Department of Health ("the DH") and/or relevant regulatory authority. For instance, such event or reaction related to drug products should be reported to the Drug Office of the DH whereas those pertaining to medical devices should be reported to the Medical Device Division of the DH. Same for any interventions, proper informed consents in the transplant of regulated products should be obtained from the recipients and the recipients should understand the transplant procedures, the risks involved and their entitlements to withdraw consent to the transplant.
Subsequent to the review of the system of information collection and with the agreement of the Human Organ Transplant Board (“the HOTB”), it is decided that the approved regulated products will also be exempted from the application of Section 6 (Information about transplant operations) of the Ordinance. As such, with immediate effect, for transplants using an exempted regulated product, registered medical practitioners are not required to supply to the HOTB the information as specified in the prescribed Form 2 of the Human Organ Transplant Regulation (Cap. 465A) (“the Regulation”).
Please note that registered medical practitioners and registered dentists should keep good utilisation record of the exempted regulated product(s), to allow tracing individual recipients of a particular batch of regulated products if needed.
The changes in the requirements to supply information about transplant operations apply only to regulated products that are exempted from the Ordinance. For other transplant operations, the requirements under section 6 of the Ordinance for provision of information to the HOTB by medical practitioners, as specified in the Schedule of the Regulation should be observed.
Application for Exemption of Regulated Products
Pursuant to section 7B of the Ordinance, a person may apply for an exemption in respect of a regulated product. Please click the links below for details.
- Which Products are considered Regulated Products
- What are the Criteria for Exemption
- How to Apply
- Determination of Application for Exemption
- Revocation, Variation or Suspension of Exemption
- Register of Exemptions
- Appeal against a Decision of the Director in relation to the Exemption
- Other Relevant Legislation
- Safety Alert and Recall of Exempted Regulated Product
- Frequently Asked Questions
- Guidelines and Forms for Download
- Useful Links
For enquiries, please contact us at:
Health Technology and Advisory Division
Department of Health
21/F, Wu Chung House
213 Queen's Road East, Wanchai, Hong Kong
|Tel:||(852) 2961 8944|
|Fax:||(852) 2127 7329|
- The decision of the Director to exempt a regulated product and inclusion of such product into the register of exemptions must not be regarded as an official advice, recommendation or warranty, or a substitute for advice or opinions from appropriate health professionals on using such product for patient treatment.
- Neither the DH nor any of its employees or agents shall in any circumstances whatsoever be liable or responsible for any loss or damage whatsoever arising out of or in connection with the use of any exempted regulated products, the use of any of the information contained in or retrieved from the register of exemptions, or any errors or omissions in such register.
- Under paragraph (a)(iii) of the definition of “organ” in section 2 of the Ordinance, "organ" means any structured arrangement of tissues forming part of any human bodily part which consists of a structured arrangement of tissues; and if wholly removed, cannot be regenerated by the body; or any structured arrangement of tissues forming part of any human bodily part specified in the Schedule (i.e. blood, including cord blood, and bone marrow).
- Serious adverse event means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of exempted regulated products (or the starting human materials as appropriate) which might lead to the transmission of a communicable disease, death or life-threatening, disabling or incapacitating conditions to patients, or might result in or prolong hospitalisation or morbidity.
- Serious adverse reaction means any unintended response, including a communicable disease, in the recipient associated with the human application of exempted regulated products that is fatal, life-threatening, disabling, incapacitating or results in or prolongs hospitalisation or morbidity.