What are the Criteria for Exemption?

Criteria for Exemption

The criteria for exemption of a regulated product from the application of the Human Organ Transplant Ordinance (Cap. 465) ("the Ordinance") are stipulated under section 7A(3) of the Ordinance. The Director of Health ("the Director") may, on application, exempt a regulated product from the application of the Ordinance if he is satisfied -

1. that using the product for transplant purposes is safe and has no adverse impact on public health;
2. either that the donor of the tissues concerned has given his consent to the removal of the tissues for the purpose of producing the product without coercion or the offer of inducement, or that the tissues are removed for the therapy of the donor;
3. that no payment has been made, or is intended to be made to that donor for his supplying the tissues from his body;
4. that all applicable laws of the place where the tissues were obtained or processed have been complied with in obtaining and processing the tissues; and
5. that the circumstances and manner in which the tissues are obtained and processed are not affected by any matter that the Director may consider to be objectionable.

Compliance with the Exemption Criteria

When considering an application for exemption of a regulated product, the Director will consider, inter alia, whether adequate measures have been taken to address the potential health risks of the product to recipients and the public (see the Table below), and whether the product has been approved for marketing by regulatory authorities in other jurisdictions.

	Risks of regulated products	Measures to address the risks 1
(a)	The risk of transmitting diseases from donors to recipients (in particular, infectious diseases such as HIV, hepatitis B, hepatitis C, prion diseases, syphilis and HTLV-I/II)	Proper donor screening and testing
(b)	The risk of microbial contamination and cross-contamination of products during processing and storage	Compliance with Good Tissue Practice (GTP) or equivalent in tissue procurement and tissue processing
(c)	For products that are derived from substantial processing of human organs or tissues, or that are intended for non-homologous 2 use, the safety, quality and efficacy of products for transplant	Non-clinical and clinical studies to substantiate the safety and, where appropriate, efficacy of the product; and Compliance with Good Manufacturing Practice (GMP) in product manufacturing
(d)	For (a) to (c) above	Implementation of a track and trace system that allows tracking of individual products from donors to end users 3 , or preferably to recipients, and tracing from end users or recipients to donors; and A system in place to identify, investigate and report serious adverse events and reactions

Footnotes

1. The safety requirements of regulated products are set out with reference to the regulatory requirements for human tissue products in overseas jurisdictions including the United States ("US"), the European Union ("EU"), Canada and Australia.

2. "Homologous use" means the product performing the same basic functions in the recipient as in the donor, while "non-homologous use" means the product performing different basic functions.

3. End users refer to registered medical practitioners under the Medical Registration Ordinance (Cap. 161), registered dentists under the Dentists Registration Ordinance (Cap. 156), and healthcare institutions.