Human Fertilisation and Embryology Authority/Human Tissue Authority

Baroness Warwick of Undercliffe Excerpts

Tuesday 1st February 2011 Grand Committee

[Baroness Warwick of Undercliffe]

My Lords, in congratulating my noble friend on the timeliness of this debate, I must declare my interest as chair of the Human Tissue Authority.

As my noble friend said, the authority was set up as a result of the organ retention scandals at Alder Hey and Bristol. The retention of children's organs—including in some cases their hearts—without the consent or knowledge of their parents, rightly created outrage. It resulted in a crisis of public confidence. At the time, David and Hazel Thewlis, representatives of those affected, said:

“The Human Tissue Act has provided a new foundation for the people of this country ... consent was the cornerstone of the Act, and this must colour all of the work of the Human Tissue Authority”.

The authority has put informed consent at the centre of everything it does, and by doing so it has ensured the safe and ethical use of human tissue. I can confidently say that it has turned around the crisis in public confidence. However, it would be misguided to be complacent. The improvement is by no means universal or fully embedded. The reasons why we were set up have not gone away.

I am not hidebound or precious about which bodies should do the work, nor are my authority members. What we are concerned about is ensuring that the advances we have made are not lost, particularly the hard-won confidence of the public in the proper use of organs and tissue. We believe that the current proposals to transfer our functions to three or possibly four different organisations risk undermining the progress that has been made.

Paula O’Leary, of the Alder Hey parents’ support group PITY II, said recently:

“We fought hard for 10 years … who is to say this is not going to start up all over again?”.

Roger Goss from Patient Concern said:

“Dividing would be diluting. That would be going back down the hill in terms of protecting patients' rights to exercise informed consent”.

The best way of making sure that does not happen is to maintain a clear focus on the safe and ethical use of human tissues and organs across all our sectors. To do that, we need to keep our functions together. That way, we maintain a consistently rigorous approach to consent, and guarantee an individual’s right to decide, in life and in death, what happens to their bodies and the bodies of their loved ones.

The HTA is a small organisation with a broad remit. Our activities are interdependent. There are pathologist researchers, and researchers treating patients with tissue. Researchers study organs to improve the success of transplants. They are all regulated by the HTA and the ethical issues are common to all the sectors that we regulate. The gift of organs and tissues is a special one, giving rise to special ethical considerations. During the passage of the Human Tissue Act, consent was described as the golden thread through all our activities. That is why there is a single set of core standards across all the sectors that we regulate under the Act.

We are a lean organisation. The money that we get from the Department of Health is £1 million a year, about one-sixth of our total cost. We have to earn the rest. What we do makes a difference. Last year, we approved 1,100 organ donations from living people. Since we began regulating, these numbers have increased year by year. We work to give more people the gift of life offered by organ transplants. When tissue is used in medical treatments—such as the use of bone marrow stem cells in cancer treatments, or skin for burns victims—people can be confident that they are safe and good quality and have been donated with consent. If stem cells are collected from umbilical cord blood for potential future use, we safeguard the safety of mother and child and the quality of the cells. Our regulation of mortuaries means that individuals and their families can have confidence that their loved ones are treated with dignity and respect. In research, too, people can know that tissue will be kept only with their consent or the consent of their family, so they can be confident that their wishes will be respected.

I have no quarrel with the Government’s intention to simplify the regulatory landscape. My plea is simply that we do not jeopardise the gains that the HTA has made by spreading its functions across a number of disparate organisations and losing the coherent overall approach that has been so successful in promoting public and professional confidence in the safe and ethical use of tissues and organs.