Organ Donation

Legislation

Human Tissue Act 2004

Following consultation, the Government has introduced new legislation to regulate the removal, storage and use of Human Organs and Tissue.

The Human Tissue Act 2004 received Royal Assent on 15th November 2004. It:

• Streamlines and updates current law on organs and tissue so that current gaps and anomalies are put right and the system is made fit for the 21st century.
• Provides safeguards and penalties to prevent a recurrence of the distress caused by retention of tissue and organs without proper consent. Tissue or organs cannot be taken or kept without consent other than for a Coroner to establish the cause of death.
• Sets up an overarching authority which will rationalise existing regulation and will introduce regulation of post mortems and the retention of tissue for purposes like education and research.
• Provides for the Human Tissue Authority to issue Codes of practice giving practical guidance on the conduct of activities within its remit
• Will help improve public confidence so that people will be more willing to agree to valuable uses of tissue and organs like research and transplantation.
• Will improve professional confidence so that properly authorised supplies of tissue for research, education and transplantation can be maintained or improved.

A summary of the new legislation is available.

The Act, the Statutory Instrument, and accompanying explanatory notes can be found on the Office of Public Sector Information website.

The Act applies to England, Wales and Northern Ireland and in part to Scotland. The Human Tissue (Scotland) Bill was passed by the Scottish Parliament on 2 February 2006. Having received Royal Assent on 16 March 2006 it was published as the Human Tissue (Scotland) Act 2006.

The substantive provisions of the Act will come into force on days appointed by the Secretary of State by order. This is expected to be by September 2006. However, to comply with the requirements of the EU Tissue and Cells Directive, those establishments that store material for human application will need to be licensed by the Human Tissue Authority from April 2006. Further information can be found on the Human Tissue Authority website.

Until the Human Tissue Act 2004 is fully implemented, and the Human Tissue Authority issues guidance and codes of practice, the Department of Health interim guidance should continue to apply.

The 2004 Act repeals and replaces:

• The Human Tissue Act 1961
• The Anatomy Act 1984 and
• The Human Organ Transplants Act 1989 as they relate to England and Wales.

It also repeals and replaces:

• The Human Tissue Act (Northern Ireland) 1962
• The Human Organ Transplants (Northern Ireland) Order 1989 and
• The Anatomy (Northern Ireland) Order 1992.

The Human Tissue Authority (HTA) has announced new opportunities for transplants which will potentially save or improve the lives of dozens of people a year. These types of transplant will be allowed from 1 September 2006 and will apply across the UK.

Currently, under the the Human Organ Transplants Act 1989, and the accompanying Human Organ Transplants (Unrelated Persons) Regulations, 1989, kidney transplants from living donors can only take place between those who are genetically or emotionally related. The new types of allowed transplant – called paired and altruistic (or ‘stranger’) donation – will help reduce the waiting list for an organ from a deceased donor. The HTA will take over the regulatory role formerly fulfilled by the Unrelated Live Transplant Regulatory Authority (ULTRA).

How to become a donor