Human Fertilisation and Embryology Authority/Human Tissue Authority

Baroness Thornton Excerpts

Tuesday 1st February 2011 Grand Committee

Asked By

[Baroness Thornton]

To ask Her Majesty’s Government how they will maintain public confidence and patient safety following the abolition of the Human Fertilisation and Embryology Authority and the Human Tissue Authority.

[Baroness Thornton]

My Lords, it seems appropriate that we are having a short debate on the proposed abolition of the HFEA and the HTA, as one might say that it is a sort of warm-up for the debates that we will be having when the Public Bodies Bill restarts its Committee stage, which I hope will be soon.

This morning, the British Heart Foundation announced that it is spending £50 million on stem cell research in the hope that one day it will be as easy to recover from a heart attack as it is to repair a broken bone. A year ago, the groundbreaking partnership was announced between the Multiple Sclerosis Society and the UK Stem Cell Foundation to pump-prime and speed up stem cell research. This perhaps reflects science’s fast-moving progress in relation to stem cell research and the wonders that it might bring to medicine over the next few years. Right now, the HFEA is conducting a consultation on the ethics of sperm and egg donation. This issue is often in the media, which is unsurprising given what donation involves—that is, making children who may not be genetically related to their parent or parents.

As medical science advances, there seem to be more, not fewer, ethical issues to address in this area. To underline this point, not long ago—in fact, in March last year—the noble Earl the Minister and I were dealing with the regulations arising out of the Human Fertilisation and Embryology Act 2008 relating to the disclosure of information for research purposes and parental orders regarding the adoption of children born of surrogate mothers, among other matters. These are both highly sensitive and important issues concerning ethical and safeguarding matters and both rest in the hands of an HFEA accountable to the Minister and to Parliament.

In preparing for this debate, I used as my starting point what both organisations do and I tried to work out how these functions might be undertaken in the new regime that the noble Earl kindly outlined to some of us not long ago. The HTA licenses and inspects organisations that store and use human tissue for purposes such as research, patient treatment, post-mortem examinations, teaching and public exhibitions. It also approves organ and bone marrow donations from living people. Its work covers anatomy, stem cells, cord blood, public display—that is, the public display of human body parts in various forms—post-mortems, coroners and transplants. It is clear to me that the HTA covers a wide but related range of competencies, as well as the ones that were behind the organisation being established with such care some years ago.

The ethical issues that arise all the time as a result of the advances in science throw up new and sometimes very complex issues. Public indignation at the cavalier use of body parts for research without the knowledge or consent of patients and their families was huge and many in your Lordships’ House will recall the thought and time that were given to creating a regulatory framework that would command public confidence. The Bill was given more than 100 hours of direct parliamentary scrutiny in both Houses, not counting pre-legislative scrutiny or investigation by Select Committees. I fail to see what has changed that can allow any slackening off of the responsibility that the HTA bears for the uses of human tissue.

The HFEA is the UK’s independent regulator of treatment using eggs and sperm and of treatment and research involving human embryos. It sets standards for and issues licences to centres; provides authoritative information for the public, particularly for people seeking treatment, donor-conceived people and donors; and, very importantly, determines the policy framework for fertility issues, which are sometimes ethically and clinically complex. The Human Fertilisation and Embryology Act 2008 includes provisions for research on different types of embryos and changes the definition of legal parenthood for cases involving assisted reproduction. More than 200 hours were spent scrutinising this and previous legislation in both Houses, not counting the need for Select Committees and pre-legislative scrutiny. I make this point to emphasise that Parliament took its time to get these things right. It seems to me that, if Parliament is going to change the HFEA and the HTA, it needs to take time to do that also.

The Government argue that the HFEA’s licensing function could be moved and that its very sensitive records should become a responsibility elsewhere. I remind noble Lords that, on every occasion that Parliament has discussed human fertility since the 1980s, it has agreed that human embryos have a unique status and that their use for treatment and research requires special oversight.

Some say that IVF treatment has become so common that its regulation should be normalised in some way. I point out that, although public opinion has indeed moved, there are still powerful forces wishing to stop or limit the use of assisted conception and there are still the unscrupulous who would wish to profit from, for example, the longing of parents to have a baby. In addition, there is a very real danger that important research will be frustrated by people who have strong and hostile views should the responsibility for ethical review be removed from the responsible but supportive environment fostered by the HFEA.

The HFEA plays an important role in actively improving standards by, for example, being responsible for several consultations on issues of best practice, such as the ones to which I have referred. Reducing multiple pregnancies by limiting the number of embryos transferred has been and remains an important part of its work. My question is whether the Care Quality Commission will take on the important role of ensuring that clinics’ results are not achieved regardless of the perinatal mortality associated with multiple pregnancy.

The Human Fertilisation and Embryology Act is the focus for interactions between doctors, nurses and scientists. I suppose that these interactions could take place elsewhere. However, all the disciplines have vested interests and I point out, with the greatest respect, that organisations such as the Royal College of Obstetricians and Gynaecologists, the Royal College of Nursing, the Association of Clinical Embryologists and the British Fertility Society do not have the same impartial image enjoyed by the HFEA. The public have learnt to trust the HFEA and, indeed, the HTA. These bodies act as a bulwark between the sensational headlines in the less responsible press and those who are working in the field. Who would take on that role if either of these bodies was abolished? Would Andrew Lansley, or indeed the noble Earl, be prepared to act as that bulwark?

UK legislation on these matters is the envy and the blueprint for the world. In Australia, for example, the states of Victoria, South Australia and Western Australia have legislated to establish statutory oversight bodies. In 2000, the Singapore Cabinet appointed a bioethics advisory committee to examine the ethical, legal and social issues arising from biomedical research and development. Again, that is not a government department but a stand-alone, arm’s-length body.

I am not opposed to change and improvement and I am not opposed to these proposals for the sake of it. I support change to make organisations more effective—for example, by sharing back-office functions or other facilities, by changing regulatory functions or by testing to see whether functions could be performed more effectively elsewhere. It might be that the proposals that the Government have suggested so far for the HTA and the HFEA will provide efficient regulation of some of their functions through the CQC and possibly through the still-to-be-created academy of medical science. However, none of the proposals answers the question that is the subject of this debate: where would the ethical and safeguarding issues that are at the heart of the work of both these bodies sit?

I am aware that the Government have said that there is no intention to revisit the ethical and safeguarding provisions in the HFE Act or the principles of consent underpinning the HTA, but they have so far failed to address how the ethical and safeguarding functions might satisfactorily be carried out were these organisations not to exist. I cannot see the CQC or an academy of science being an appropriate body. That leaves us the Secretary of State and the Government, which is where we came in all those years ago with Alder Hey and the challenges posed by the new embryo and fertility advances of the 1980s. I suggest that public confidence in this area is best established through the independence of the bodies that regulate—the HTA and the HFEA—and that the Government need to rethink their proposals.