Statement on Chief Medical Officer's announcement

HTA position statement on Chief Medical Officer’s comments on presumed consent

Issue date: 24 July 2007

The underlying principle of the Human Tissue Act 2004 (HT Act) is that consent must be obtained to use human organs and tissue for transplantation, whether from the living or after death. Provisions for consent have only just been established in the HT Act, which has been in force for less than a year. The HTA believes that now is not the right time to make changes to the legislation.

The HTA believes that a system of presumed consent for organ transplantation might undermine current provisions in the HT Act for fully informed consent for other purposes, such as body donation for medical science or removal of tissue at autopsies. Any change to legislation would require wide-ranging consultation.

Adrian McNeil, Chief Executive of the Human Tissue Authority, said: “the option of presumed consent was debated extensively during the passage of the Human Tissue Act through Parliament. It was decided that the opt-in system should remain. As long as the Act is in force, the HTA will continue to support the requirement to obtain fully informed consent. Any change in the law is a matter for the Government to decide.”

In the case of deceased donation for organ transplantation, consent must be obtained from the person before they died or from the family after death, if the deceased person has not made their wishes known before death.

The HT Act and the establishment of the HTA has the potential to increase the numbers of organs available for transplant by making the wishes of the deceased take precedence over those of the family, and by introducing new forms of living organ donation – namely paired and altruistic.

Notes to Editors

• 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).
• The HT Act covers England, Wales and Northern Ireland. There is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA performs certain tasks on behalf of the Scottish Executive (approval of living donation of organs and licensing of establishments storing tissue for human application). As the regulator under the HT Act, the HTA is responsible for licensing a number of activities and carrying out inspections to ensure licence conditions are being met.
• Establishments storing tissue for human application are regulated under the EU Tissues and Cells Directive (EUTCD) and required a licence from 7 April 2006.  All other activities required a licence from 1 September 2006.
• The HTA is also responsible for approving transplantation of solid organs and bone marrow from living donors.
• Sir Liam Donaldson’s report

For further information please contact:

Heath Jeffries
Head of Media
Human Tissue Authority
Finlaison House
15-17 Furnival Street
London EC4A 1AB
Tel 020 7211 3400 (general) 020 7211 3439 (direct)
Mobile 07917 551741
Email heath.jeffries@hta.gov.uk
Web www.hta.gov.uk