ENG-2012 — Page 193

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Health

medicines. The Chinese Medicine Council of Hong Kong is the statutory body responsible for devising and implementing regulatory measures for Chinese medicines. All proprietary Chinese medicines must be registered before they can be sold, imported or possessed in Hong Kong. As a transitional arrangement, proprietary Chinese medicines manufactured or on sale on 1 March 1999 are eligible for a transitional registration status upon submission of acceptable basic test reports. By the end of 2012, there were 6,680 licensed Chinese medicine traders (including 10 holding Certificate for Manufacturer), and 8,990 proprietary Chinese medicines had obtained transitional registration status, and 306 proprietary Chinese medicines had been issued with 'Certificate of registration of proprietary Chinese medicine!

Since December 2011, registered products must have the relevant registration number affixed. Their labels and package inserts should also comply with the relevant requirements.

Provisions relating to clinical trials and medicinal tests also took effect on 3 December 2010, 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

The Human Organ Transplant Ordinance (HOTO) regulates the transplant of human organs and importation of human organs for transplant purposes, and prohibits commercial dealings in human organs intended for transplant. 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. Applications can be made to the DH for exemption from the HOTO of certain commercial products made from human tissue that have been subjected to processing, enabling patients with a genuine medical need for a transplant to benefit from the use of these products. As at the end of 2012, the DH had received 22 applications for exemption and approved 18 products.

In 2012, the Human Organ Transplant Board received a total of 25 applications for organ transplants between living non-related persons and 12 human 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. Reproductive technology service providers and embryo researchers who wish to conduct relevant activities regulated by the Human Reproductive Technology Ordinance must obtain a licence issued by the Council on Human Reproductive Technology. Up to the end of 2012, the council had issued 50 licences, including 12 treatment licences, 36 artificial insemination-by-husband licences and two research licences.

The ordinance confines the application of reproductive technology procedures to infertile married couples, regulates surrogacy arrangements and the use of embryos and gametes for

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