It has been established from opinion surveys that approximately 90% of the public and health professionals are in favour of organ and tissue donation for transplantation. The Department of Health has undertaken a comprehensive review of the law governing use of human tissues and has drafted a new Human Tissue Bill, which is currently in Committee stage in the House of Commons. This bill has been written to bring together all the uses of human tissues and organs (with the exception of gametes, embryos, hair and nails) in a statutory regulatory framework. The bill will only apply to England, Northern Ireland and Wales, and separate arrangements are under discussion in Scotland.

One of the main provisions of the new legislation is to change the existing law to require explicit consent for organ or tissue donation. The Bill provides for the same processes to apply to both organ and tissue donation for transplantation and organ or tissue retention for diagnosis of disease. The Society believes that to protect patients the processes of donation and retention need very different regulation. The motives, purpose, circumstances and outcomes of organ or tissue donation are quite distinct from those of organ or tissue retention.

For organ donation and retention the Bill provides that appropriate consent from the patient or a defined qualifying relative is required for lawful organ removal and specifies heavy penalties for failure to comply with the law. This means that where a relative cannot be contacted and consent by the patient cannot be established organ removal will be forbidden. This is quite different from the existing situation where the law allows organ donation where it is believed that there would be no objection by "such reasonable enquiry as may be practical" and will lose some organs that might previously have been donated.

If the potential donor has not given an indication of his or her wishes during life then the qualifying relative has the responsibility of deciding. This places an enormous burden on them at a difficult time. Preliminary results from the current UKT donor audit have shown that up to 50% of relatives now refuse consent for organ donation when approached under these circumstances.

The Society has balloted it's Membership to establish whether there is a view in support of amending the Human Tissue Bill to specifically provide for presumed consent for organ donation where the donors preferences in life were not known (so called "opt out" system) in distinction to the current and proposed "opt in" system where the person is actively required to indicate their consent in life.

There is a strong majority in the Society in favour of changing the existing law and an overall majority in favour of a change to a system of "soft opt out". A "soft opt out" would provide that consent for organ and tissue donation for transplantation (not organ or tissue retention) has been given if the donor did not register their objection to donation in life and the qualifying relative does not object to donation. In the absence of a qualifying relative this duty could be delegated to another designated independent individual. The Society did not generally support the concept of organ removal for transplantation without consultation with relatives as could be lawful in the proposed legislation. In Scotland it is understood that a requirement for consultation with relatives will be included in their legislation.

The Society believes that this change would shift the emphasis in the new legislation away from restriction of organ or tissue donation and would in consequence make donation easier, to the benefit of patients. It would make the important distinction between organ or tissue donation for transplantation and organ or tissue removal for retention. The requirement for lack of objection would introduce the necessary balance in the process to protect potential donors.