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LEGISLATION RELATING TO ORGAN AND TISSUE DONATION AND TRANSPLANTATION: ANALYSIS OF CONSULTATION RESPONSES
CHAPTER 1: BACKGROUND TO THE CONSULTATION
THE CONSULTATION
The consultation on the Legislation Relating to Organ and Tissue Donation and Transplantation was launched by the Health Minister on 18 March 2004. Over 100 copies of the consultation paper were distributed to a wide range of people and organisations in the public, private and voluntary sectors
1.
The consultation paper set out specific questions which highlighted proposed changes to the Human Tissue Act 1961 in Scotland. The exercise followed the consultations dealing with legislation on hospital post-mortem examinations (published on 24 November 2003) and the Anatomy Act 1984 (published on 28 January 2004) each of which is the subject of a separate analysis report
2.
The initial consultation period ran from 18 March 2004 until 11 June 2004 although a small number of responses were received after this date and have been included in this analysis. A press release helped publicise the consultation paper which was made available on the Scottish Executive website. In announcing the consultation the Minister said:
"
We know that 90 per cent of the population supports organ donation and transplantation. We need to build on that support by putting in place a modern piece of legislation to replace the Human Tissue Act 1961.
The proposals in this consultation build on the work of two expert groups and are consistent with proposals for new legislation in the rest of the UK.
One of the key proposals for new legislation is aimed at respecting the wishes expressed by an adult individual while still alive. We believe that by strengthening the system for "opting in" in this way, we will increase the number of organs becoming available for transplantation.
For live donor transplants, the main change proposed is the extension of independent scrutiny to all live transplants, not just those between unrelated individuals. This will ensure that the donor really wants to undergo the operation, understands the risks of the procedure and has not been offered any financial inducement.
This is a very important piece of work and we are anxious to canvas views from as wide a range of people as possible"
The consultation paper comprised a 17 page document along with a covering letter. The document was divided into 3 main sections:
Views were invited on issues highlighted in the first two of these sections. The proposals contained in the consultation paper built on the Scottish Transplant Group's Organ Donation Strategy and the reports of the Review Group on Retention of Organs at Post Mortem. They also took account of parallel consideration in the rest of the UK of the law relating to human organs and tissue.
Altogether 62 responses to the consultation were received and are included in this analysis of responses
3. The responses will inform the preparation of advice to Ministers on the comments received on the proposal to replace in Scotland the Human Tissue Act 1961.
CONTEXT
The consultation concerned new legislation aimed at addressing the country's severe shortage of organs for transplantation. It included consideration of ways to help patients needing transplants and ways of improving safeguards for donors. The existing legislation is contained in the Human Tissue Act 1961 and the Human Organ Transplants Act 1989.
The proposals take account of parallel consideration in the rest of the UK of the law relating to organ and tissue donation and transplantation in order to ensure broad consistency of approach. The Human Tissue Bill, which contains details of the legislation proposed for the rest of the UK, can be found at
www.doh.gov.uk/tissue
The shortage of organs in the UK has led to a growing emphasis on donation from the living, particularly kidneys, for which the waiting list is the longest. The consultation addresses retrieval from people who are still alive as well as from people who have died. (It should be noted that for the purposes of this consultation, blood, and any products derived from blood, were excluded from its scope.)
On transplantation of organs and tissue from people who have died, the proposals for new legislation were aimed at respecting the wishes of the adult individual who has died, and included:
That carrying a card or registering should be seen as a form of authorisation
That where people expressed an objection to their organs being retrieved, this would be respected
That where people had not expressed any wishes, the legislation would provide for authorisation from those who were closest in life to the deceased
That in the case of children, organ donation could take place only if the parents had given their authorisation
That the new legislation would continue the penalties for trafficking in organs, currently contained in the Human Organ Transplants Act 1989
In relation to donation from the living, such transplants are currently subject to independent scrutiny where the potential donor and recipient are not related. The main change proposed by the consultation paper regarding transplantation from a living donor is that independent scrutiny would be extended to all live transplants, to make sure that family members do not exert undue influence on the donor.
In addition, no-one under the age of 16 would be allowed to authorise the donation of their own organs, and parents would not be able to authorise the removal of an organ from a living child under the age of 16 years.
Full written responses to the consultation have been made publicly available on the Scottish Executive website unless the respondent has specifically requested otherwise.
The remainder of the report presents the "story" of the consultation, - the consultation process (
Chapter 2), the approach to analysis of responses (
Chapter 3), and the findings of the analysis (
Chapters 4-7).
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