Human Tissues and Tissue-Based Products

Discussion paper on new regulatory system in New Zealand

The New Zealand Ministry of Health (MoH) is reviewing its legislation on the use of human tissues for both therapeutic and non-therapeutic purposes, with the intention of consolidating and updating regulation in this area¹. Currently, the regulation of human-tissue related issues in New Zealand is spread across a number of different acts and regulations, with some matters not well covered and other parts of the legislation out of date. The MoH is also looking to prepare for new tissue-based therapies that are, or soon will be, available, such as stem cell therapies.

To this end, the MoH has issued a consultation document outlining key policy issues that require consideration in developing a new regulatory framework. The framework is likely to include both legislative and non-legislative measures, including:

• a new Human Tissue Act - to regulate the collection and use of tissue from deceased persons for therapeutic and non-therapeutic purposes;
• amendments to the therapeutic products regulation - to ensure (possibly through the addition of a new section) the safety of tissue-based therapeutic products (standards would also be developed under the Health and Disability Services (Safety) Act);
• use of the provisions of the Health and Disability Services (Safety) Act - which provides a framework for setting safety standards in the health and disability sector;
• use of the provisions of the Health Act 1965 relating to ‘controlled human substances’ - to recognise particular entities as being authorised to collect human substances and possibly to prevent trade in controlled human substances; and
• other regulations, guidelines or codes of practice.

Proposed timelines

Comments on the discussion paper must be submitted to Human Tissue Review, Sector Policy Directorate, Ministry of Health, PO Box 5013, Wellington, New Zealand, by 4 June 2004, with the aim of having the legislation in place by June 2005. Comments should cover the proposed legislation, as well as privacy and the use of genetic information (specimens in particular), the use of foetal tissue, and controls on xenotransplantation.

Following the consultation, the MoH will provide advice to the minister of health and the government on a proposed approach to governing the human tissue area.

Trans-Tasman arrangement

The discussion document comes amid preparations to establish a joint Trans-Tasman agency and system of regulation for therapeutic products, to replace the separate agencies and regulatory systems in New Zealand and Australia (see article in the international section of the Worldwide Update). As such, it is envisaged that the New Zealand regime for the safety of tissue-based therapeutic products could come under the jurisdiction of the joint therapeutics agency. Australia issued a similar discussion paper on the regulation of human tissues and biological therapies in March 2003².

References

1. Review of the Regulation of Human Tissue and Tissue-based Therapies: Discussion Document, March 2004, posted 5 April 2004, www.moh.govt.nz

2. The Regulatory Affairs Journal - Devices, 2003, 11(3), 159-160