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The mandatory registration requirement and the labelling and package insert. requirements of pCm commenced on December 3, 2010 and December 1, 2011 respectively. All pCm must be registered before they can be imported or sold in Hong Kong. Products which have obtained registration status must also be affixed with the relevant registration number. Their labels and package inserts should also comply with the relevant requirements. The import, sale or possession of unregistered pCm is an offence. Provisions relating to clinical trials and medicinal tests also took effect on the aforementioned date, which stipulate that an application for a certificate for clinical trial and medicinal test can be made to the Chinese Medicine Board for the purpose of conducting a clinical trial or medicinal test of any proprietary Chinese medicine.
Human Organ Transplantation
Under the Human Organ Transplant Ordinance (HOTO), transplant of human organs and importation of human organs for transplant purposes are regulated, and commercial dealings in human organs intended for transplant are prohibited. Approval from the statutory Human Organ Transplant Board is required for transplantation of human organs between living persons who are not genetically related or a couple whose marriage has subsisted for not more than three years. The board also collects certain information about transplant operations in prescribed statutory forms. An exemption mechanism provided under the HOTO came into effect in September 2011, allowing certain commercial products made from human tissues that have been subjected to processing to be exempted from the HOTO through applications to the DH, so that patients with genuine medical need for a transplant could benefit from the use of these products. As at the end of 2011, the DH had received 18 applications for exemption, the processing of which is under
way.
In 2011, the Human Organ Transplant Board received a total of 25 applications for organ transplants between living non-related persons. During the same year, no organs were imported into Hong Kong for transplant purposes.
Human Reproductive Technology
Human reproductive technology activities are regulated to ensure the procedures are conducted in a safe and informed manner, and to safeguard the welfare of children born through the technology. The Human Reproductive Technology Ordinance2 and its regulations came into full effect on August 1, 2007. Reproductive technology service providers and embryo researchers who wish to conduct relevant activities as regulated by the ordinance must obtain a licence issued by the Council on Human Reproductive Technology. Up to December 31, 2011, the council had issued a total of 52 licences, including 13 treatment licences, 36 artificial insemination-by-husband licences and three research licences.
The ordinance confines the application of reproductive technology procedures to infertile married couples, regulates surrogacy arrangements and the use of
2
Except section 33(4) (a) of the Ordinance.