Human Fertilisation and Embryology Authority/Human Tissue Authority

Earl Howe Excerpts

Tuesday 1st February 2011 Grand Committee

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

I start by expressing my thanks to the noble Baroness, Lady Thornton, for tabling this debate, and to all speakers for raising their concerns on this very important set of issues. Let me say immediately that the need to maintain public confidence in every part of the NHS is absolutely vital, particularly in areas as delicate as embryology and human tissue.

I can offer your Lordships absolute reassurance today that our plans do not represent any threat to patient safety, nor to the safeguards held within the legislative framework of provisions within the Human Fertilisation and Embryology Act and the Human Tissue Act.

The Department of Health carried out its review of arm’s-length bodies and published its recommendation in July 2010. We recognise the important role that the Human Fertilisation and Embryology Authority and the Human Tissue Authority have played in the regulation of their respective areas over the years. We thank them sincerely for it. Our recommendations in respect of these bodies took account of the complexities and sensitivities attached to the particular areas in which they operate.

We are not rushing. We have allowed for the full length of the planned Parliament to take these changes to their conclusion. That is far longer than any other change proposed within the department’s review, a decision that reflects both the importance of the two bodies and a recognition that we need to consult fully on, and settle, the detail of all the changes. However, we are clear that a more joined-up system needs to be formed.

With the establishment of the Care Quality Commission, and the Academy of Medical Sciences’ recommendation for a new health research agency, new alternative structures have become available to ensure a more cohesive system for both healthcare and health research regulation that will benefit patients, health professionals and researchers. It is therefore our intention that the healthcare-related licensing functions of the HFEA and HTA will transfer to the CQC.

The CQC already regulates a wide range of NHS and independent healthcare providers. It registers them and ensures that they are meeting essential standards of safety and quality. It takes action if services drop below these essential standards and acts quickly if people’s rights or safety are at risk. It undertakes investigations where there are concerns about quality, seeks the views of people who use services and informs people about the quality of those services. Noble Lords will recognise that this is similar to the roles undertaken by the HFEA and HTA, on a smaller scale, in respect of the regulation of infertility treatment and activities involving the use of human tissue.

We estimate that about 80 per cent of the centres currently licensed by the HFEA are either regulated by the CQC or in premises that it regulates. The CQC also covers 60 per cent of the centres licensed by the HTA. It therefore seems wasteful, and indeed unsustainable, to continue to have these regulatory systems running in parallel. It makes sense to streamline, and ultimately to trust the CQC with the responsibility. There is no reason why the CQC should not be able to fulfil that responsibility as effectively as do the HFEA and HTA now.

The noble Baroness, Lady Thornton, asked about the multiple birth policy. That is an issue that concerns the safety of patients and their children, and it would fit very well into the CQC’s remit.

Noble Lords will be aware of the Academy of Medical Sciences’ report on the regulation and governance of medical research. The report has made recommendations for simplifying the complex framework of regulation. In particular, it suggests the introduction of a new health research agency. The report has been embraced by a wide range of groups and experts. It recognises that there are significant benefits in bringing all medical research regulation, including embryo research, within the remit of a single medical research regulatory authority. The Government welcome the report and are considering their response.

The noble Lord, Lord Alton, referred to Lisa Jardine’s comments about the threat to the status of the embryo. I emphasise that the intention is to co-ordinate health research regulation better so that the system is streamlined without changing or compromising the safeguards. Current quality and ethical safeguards for research involving the use of a human embryo, for example, must be necessary for the research to be approved, and will remain very firmly in place. It is worth reflecting that, although the statutory requirement that the use of embryos is necessary and that the research is necessary or desirable will remain in place, a research regulatory authority with a broad outlook across medical research would be well positioned to make that assessment.

The noble Baroness, Lady Thornton, asked who would be the keeper of ethical safeguards. I would say simply that the ethical safeguards are laid out in legislation, as agreed by Parliament.

The noble Baroness, Lady Deech, suggested that those in favour of the Government’s proposals think that they will not be regulated at all. I have not gained that impression. The letters from professional bodies—the British Fertility Society, the Royal College of Obstetricians and Gynaecologists and leading clinicians—show clearly that they understand that regulation and legislative provisions will remain firmly in place.

There are three key points that I want to make at this juncture. First—I say this especially to my noble friend Lord Willis—my department is planning to undertake a public consultation exercise this summer about where HFEA and HTA functions are best transferred. We regard this as a key part of the process. We will consult on any subsequent use of powers agreed in the Public Bodies Bill to effect those transfers. Effectively, therefore, there will be two consultations.

The noble Lord, Lord Alton, understandably said that he would like to see the colour of the Government’s money before reaching a view on these issues. As yet, no final decisions have been reached on exactly which functions will go to the CQC, the potential health research agency, the Health and Social Care Information Centre or elsewhere. The exact detail of how the powers in the Public Bodies Bill might be used will be considered further and in detailed discussion with the HFEA, HTA, CQC and key stakeholders and in public consultation.

Secondly, our plans are about streamlining the functions of the regulatory bodies concerned. I regard that as the precursor to the lighter touch referred to by the noble Lord, Lord Alton. The lighter touch itself will revolve around the design of systems, which will ensure that the burden of bureaucracy is lessened overall for the NHS and other organisations. The CQC and the HFEA will play a leading role in the development of an efficient approach.

I stress again that, despite what some commentators have said, there is no intention to revisit the ethical provisions and safeguards in the HFE Act, the principles set out in the Warnock report, or the principles of consent underpinning the Human Tissue Act. The proposed powers in the Public Bodies Bill could not be used to do any of those things. The noble Baroness, Lady Thornton, asked what had changed regarding the principles that were debated at length in both Houses of Parliament. The answer is: nothing. The HFE Act provisions that recognise the special status of the human embryo will remain in place, entirely as they are now, as will the provisions in the Human Tissue Act that ensure that donors’ and families’ rights and safety are protected.

The noble Baroness, Lady Thornton, said that she did not have a closed mind to some sort of reorganisation of functions, and I am hope I am right in detecting the same message from the noble Baronesses, Lady Deech and Lady Warwick, and my noble friend Lord Willis. That is welcome. All would say, as I have explained on previous occasions, is that if we cannot secure a place for the HFEA and HTA with the Public Bodies Bill then we will have to look to a future health Bill to support the transfer of functions, however we decide that that transfer should be conducted. However, to move into primary legislation would mean that the safeguards enshrined within the HFEA and HTA Acts would then be open to parliamentary scrutiny and vulnerable to amendment. I know that very few noble Lords would relish that scenario.

Thirdly, we envisage that our proposals should offer benefits to patients, healthcare professionals and researchers. We want the streamlining of regulation and reduction in the number of regulators to mean a less burdensome and bureaucratic system, both for the NHS and for the independent sector. We will work with the HFEA and HTA to try to ensure that those with the necessary expertise will follow their functions to the new arrangements so that it is not lost.

We have received significant numbers of representations from professional bodies and clinicians who are directly regulated by the HFEA, expressing support for the Government’s proposal to include the HFEA in the Public Bodies Bill. Many also expressed concern about the HFEA’s current approach to regulation. I have placed these in the Library.

My noble friend Lady Williams asked about legitimate public concerns about patient safety. I point out that the EU tissues and cell directive sets out robust provisions for safety and quality, covering assisted reproduction and the human application of tissue and cells. The role of competent authority to regulate against the requirements of the directive and standards for quality and safety will remain in place to ensure that patient safety remains a key consideration.

The noble Lord, Lord Alton, asked where the Government saw the information functions going. We will have to consult on that issue carefully with all the bodies concerned. We will give due regard to the sensitivity and confidentiality of the nature of the information currently held by the HFEA and HTA, and we envisage that it will be a key area on which we will consult.

My noble and learned friend Lord Mackay and my noble friend Lord Willis referred to the proposal two or three years ago to form RATE. This is a completely different proposal; RATE simply involved replacing the HFEA and HTA with a single organisation that would undertake all the functions of the two bodies in their entirety. The proposal was rejected because the benefits of doing so for embryo research, for example, were not apparent. The current proposal to indentify where individual functions might best be placed is a different approach and has more potential obvious benefits, such as more streamlining and cohesion.

My noble friend Lady Williams asked why the Government did not set up a national bioethics committee. The consideration of specific ethical issues by bodies such as Nuffield and parliamentary scrutiny committees remains the preferred approach.