Human Tissue Review Cabinet Papers

Human Tissue Review Cabinet Papers

Date of publication: March 2006

In 2004, the Ministry of Health published a discussion document on the review of the regulation of human tissue and tissue-based therapies (Human Tissue Review). The discussion document formed the basis of public consultation, which was undertaken in April - June 2004. In September 2004, following an analysis of submissions and feedback obtained from consultation meetings, the Summary of Submissions document was released.

In June 2005, Cabinet considered policy proposals for new Human Tissue legislation contained in the suite of three Cabinet papers and the regulatory impact statement attached below. The policy proposals took into consideration feedback from the public consultation process, evidence from scientific literature, international experience, cost/benefit implications, legal implications, feasibility of implementation and other policy/regulatory developments.

The new Human Tissue legislation is currently being drafted. The aim is to introduce the Bill to the House and refer to Select Committee in 2006. Public submissions are usually sought as part of the Select Committee’s consideration of draft legislation.

Ministry of Health officials are undertaking a full scoping exercise to size and cost the establishment and operation of a national organ donor consent register. To assist the scoping project an advisory group of health sector and DHB representatives, chaired by the Ministry of Health will shortly be established.

Review of the Regulation of Human Tissue and Tissue-Based Therapies: Paper One: Overview and Principles for Human Tissue Legislation
Paper One is an overview paper which provides the rationale for the proposed new regulatory framework for the collection, use, retention and disposal of human tissue, including the proposed scope and structure of new legislation. It also proposes the inclusion of a set of overarching principles in new Human Tissue legislation to guide its interpretation and implementation.

Review of the Regulation of Human Tissue and Tissue-Based Therapies: Paper One: Overview and Principles for Human Tissue Legislation (Word, 89 KB)
Review of the Regulation of Human Tissue and Tissue-Based Therapies: Paper One: Overview and Principles for Human Tissue Legislation (PDF, 133 kB)

Review of the Regulation of Human Tissue and Tissue-Based Therapies: Paper Two: Consent Framework for Organ/Tissue Donation from Deceased People
Paper Two sets out options for a consent framework for organ/tissue donation from deceased people and includes proposals for who can give consent, what requires consent, and how that consent should be recorded.

Review of the Regulation of Human Tissue and Tissue-Based Therapies: Paper Two: Consent Framework for Organ/Tissue Donation from Deceased People (Word, 281 kB)
Review of the Regulation of Human Tissue and Tissue-Based Therapies: Paper Two: Consent Framework for Organ/Tissue Donation from Deceased People (PDF, 191 kB)

Review of the Regulation of Human Tissue and Tissue-Based Therapies: Paper Three: Additional Matters Relating to the Therapeutic and Non-Therapeutic Use of Human Tissue
Paper Three sets out proposals for a new regulatory framework for the oversight and management of the therapeutic and non-therapeutic uses of human tissue and proposes that human tissue-based therapeutic products be regulated under the trans-Tasman Joint Therapeutic Products Agency and regulatory scheme and the non-therapeutic use of tissue through new Human Tissue legislation. It also addresses the import and export of human tissue, requirements in relation to the sale and purchase of human tissue, and a mechanism to control activities that raise ethical, cultural and spiritual implications and/or health and safety issues.

Review of the Regulation of Human Tissue and Tissue-Based Therapies: Paper Three: Additional Matters Relating to the Therapeutic and Non-Therapeutic Use of Human Tissue (Word, 169 kB)
Review of the Regulation of Human Tissue and Tissue-Based Therapies: Paper Three: Additional Matters Relating to the Therapeutic and Non-Therapeutic Use of Human Tissue (PDF, 150 kB)