Consent is key as new Human Tissue Act comes into force

New legislation which came into force on 1 September 2006 means that establishments must be licensed by the HTA in order to operate lawfully.

Issue date: 31 August 2006

For the first time, from 1 September 2006, post mortem services, anatomy schools, establishments storing tissue for research, and sites displaying human tissue, such as museums, must be licensed by the Human Tissue Authority (HTA) in order to operate lawfully. An HTA licence will ensure that these establishments meet the consent and other standards relating to the taking, storage and use of human tissue.

Consent is the cornerstone of the new legislation – the Human Tissue Act 2004 (HT Act). The HT Act requires that consent must be given for body parts, organs and tissue from the living or deceased to be removed, stored or used for certain specified purposes. The new legislation heralds a number of changes for both professionals and patients.

Introducing the new legislation, Rosie Winterton, Health Minister, said: "The Human Tissue Act coming fully into force on 1 September is a huge milestone. The Human Tissue Authority has played a key role in bringing activities involving the use of human organs and tissues into a regulatory framework that builds on best practice, in many cases for the first time. I am sure that both professionals and the public will have confidence in the knowledge that these activities will be carried out in a system that promotes high professional standards and provides proper protection for the rights of individuals and families."

Baroness Hayman, Chair of the HTA, said: “From 1 September, the changes that are already taking place around the obtaining of consent will be put on a statutory footing. The Authority is clear in its desire to implement the Act in a way that will give the public confidence that their wishes will be respected and professionals the confidence that they are working within a clear regulatory framework. I believe this confidence is essential if vital work in medicine and research is to continue and flourish.”

Adrian McNeil, Chief Executive of the HTA, said: “We have worked extensively with representatives from both professional and patient groups to develop a robust, yet proportionate, regulatory framework and licensing standards. We will continue to work in partnership with our stakeholders to make sure that regulation has the positive effect that the HTA is aiming for and to encourage and promote best practice across the sectors we regulate.”

A year on from its establishment, the HTA will hold its first report-back event on 7 September at the Royal College of Pathologists in London. This will look back at the work done over the last year to set up the new regulatory authority and will also take a brief look forward to its plans for the future.

Living-donor transplants

From 1 September, the HTA will approve all organ transplants from living donors using local Independent Assessors who are accredited by the HTA to recommend approval of a donation. The HTA will also consider approving donations made in two new ways – paired (or pooled) donation6 and non-directed altruistic donation7. These ways of finding suitable organ donors – made for the first time in the UK – may improve or save the lives of dozens of people a year.

For the first time, the HT Act makes trafficking in human material for transplantation an offence and liable to a fine and/or imprisonment.

Deceased organ donation

From 1 September, the HT Act permits cold perfusion of non-heart beating donors – a technique used to preserve organs following death – until the wishes of the deceased can be established.

In addition, the wishes of the deceased legally take precedence over those of the family – relatives will no longer have the legal right to overrule a person’s wish to donate organs or tissue. A person can record their wishes to donate by joining the NHS Organ Donor Register or carrying a donor card. They can also express their wish to donate verbally in discussion with relatives, close friends or clinical staff. If no record of consent exists, or no discussion has taken place, consent to donate can be obtained from a person nominated by the deceased, or their family.

DNA testing

From 1 September, a new offence of DNA ‘theft’ comes into force across the UK. This has implications for a number of areas including paternity testing. Anyone considering carrying out a paternity test or requiring another person to do so should make sure that the correct consent has been given or they could be breaking the law.

ENDS

Additional information is available in the briefing notes on living-donor transplants and deceased donation. A series of quotes about the HTA is also available.

For further information contact the HTA on 020 7211 3417 or email daisy.thomas@hta.gov.uk

Notes to editors

1. The HTA was established on 1 April 2005 to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of ‘Scheduled Purposes’ – such as research, transplantation, and education and training – set out in the Human Tissue Act 2004 (HT Act).

2. The HT Act covers England, Wales and Northern Ireland. There is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA will perform certain tasks on behalf of the Scottish Executive (approval of living donation of organs and licensing of establishments storing tissue for human application).

3. The HTA is responsible for licensing a number of activities under the HT Act. These licensable activities are:

• Anatomical examination
• Post mortem examination
• Removal of material from deceased persons in certain circumstances
• Storage of post mortem material
• Storage of anatomical specimens
• Storage of material from a living person (for research)
• Public display of a body or material from a deceased person.

Establishments storing tissue for human application are regulated under the EU Tissues and Cells Directive and fell to be licensed from 7 April 2006.  All other activities described above must be licensed by the HTA from 1 September 2006.

4. The HT Act does not cover the removal of tissue from the living, for example for diagnosis or treatment. This is a matter for Common Law.

5. The HTA is also responsible for approving transplantation of solid organs and bone marrow from living donors. Independent Assessors (IAs) have been accredited to work on the HTA’s behalf to assess applications for all live transplants of solid organs. They will act as representatives of the HTA and as advocates for the donor. Accredited Assessors will act in a similar capacity to IAs to assess donation of bone marrow by children who are non-Gillick competent and adults who lack capacity.

6. Paired donation is where a donor and recipient whose blood groups or tissue types are mismatched (or incompatible) are paired with another donor and recipient in the same situation. If more than two donors and two recipients are involved in the swap this is called pooled donation. 

7. Non-directed altruistic donation is where a living person who has never met the recipient wishes to become a donor. If a person is assessed to be a suitable altruistic donor, their name will be matched to a suitable anonymous person by UK Transplant.

8. Subscribe to the HTA’s e-newsletter ‘Current issue’ to keep up-to-date with the work of the HTA