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Human Fertilisation and Embryology (Quality and Safety) Regulations 2007

Volume 692: debated on Monday 14 May 2007

rose to move, That the draft regulations laid before the House on 25 April be approved.

The noble Lord said: My Lords, the regulations provide an important opportunity to introduce a harmonised regulatory framework in the UK to ensure the quality and safety of tissues and cells intended for transplantation and other human applications. They will contribute to the introduction of safety standards throughout the European Union, facilitating safer and easier exchange of tissues and cells and securing public health protection for tens of thousands of people receiving human tissue and cell treatments every year in the United Kingdom.

Human tissue and cells from both living and deceased donors are transplanted in an increasing range and number of procedures. One estimate undertaken a few years ago concluded that some 10,000 patients per year benefit from NHS treatments involving a human tissue transplant. This is now thought to be a considerable underestimate of current usage of tissues and cells. The British Association for Tissue Banking has estimated that bone alone is used in 7,500 operations a year. In 2005-06, a total of 3,819 corneas were donated and 2,622 grafts were carried out. Annually, there are some 2,000 bone marrow transplants, approximately 38,000 IVF cycles and 7,000 donor insemination procedures, all of which fall within the regulations’ scope. Other tissues that may be transplanted include skin, heart valves, tendons and cartilage.

The UK already has or has had systems in place to improve the safety and quality of tissue and cell transplantation. For example, in April 2001 the UK health departments launched a voluntary accreditation scheme for all tissue banks that stored and processed human tissue for therapeutic use within the NHS. Under this scheme, the MHRA inspected applicant tissue banks against the UK Code of Practice for Tissue Banks. The voluntary code of practice required tissue banks to have appropriate facilities and to undertake staff training; it also set out high standards for donor screening, process control and record keeping. Similar standards are reflected in the regulations before the House.

For over 15 years the Human Fertilisation and Embryology Authority has regulated the fertility sector in line with the Human Fertilisation and Embryology Act 1990. The authority is the UK’s independent regulator and oversees safe and appropriate practice in fertility treatment, tissue storage and embryo research. The HFEA licences and monitors centres carrying out IVF, donor insemination, storage and human embryo research and provides a range of detailed information and guidance for patients, professionals and Government.

The Human Tissue Authority was set up to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of scheduled purposes, such as transplantation. The Human Tissue Act 2004 covers England, Wales and Northern Ireland. There is separate legislation in Scotland—the Human Tissue (Scotland) Act 2006—but the HTA performs certain tasks on behalf of the Scottish Executive, such as approval of living donation and licensing of establishments storing tissue for human application. Since 2006 the Human Tissue Authority has licensed those establishments storing human tissue and cells for human application.

The main benefit of the regulations is that they will require all establishments dealing with tissues and cells for human applications to be regulated and so ensure that they meet high standards of quality and safety. This will maximise the benefits and minimise the risks for patients arising from infected, contaminated or poor quality tissues and cells. It is proposed to do this by requiring the two competent authorities to regulate establishments carrying out procurement processing, storage, testing and distribution of human tissues and cells intended for human applications such as transplantation.

In many respects, the provisions within the regulations will build upon existing legislation and guidance, but in a small number of areas the regulations will require new provisions to be introduced. For example, all human tissues and cells intended for transplantation in the EU will be traceable and have to meet the same high standards. Currently, apart from the assisted reproductive sector, there are no controls on the importation—or exportation—of human tissues or cells. NHS or independent sector clinicians can import tissues and cells from anywhere, controlled only by their own ethical duty to patients. The regulations will regulate imports and exports of tissues and cells imported from outside the EU and ensure that such tissues, together with those supplied from within the EU, will be of a high standard and traceable.

Infertility clinics in the UK are already regulated by the HFEA. However, few, if any, other member states have so effective a system of regulation in this area. Some member states had no system of regulation at all. Infertility clinics in the UK are licensed and regularly inspected by the HFEA to ensure that they operate appropriate practices to safeguard patient safety. In several areas the HFEA has already implemented measures that are similar to or serve the same purpose as the regulations—for example, the need for a system to report adverse events or reactions and dissemination of lessons to other establishments. Another similarity is the need for a “person responsible” at each licensed centre. The HFEA and the bodies representing infertility clinics have worked together during the negotiation of the directive to agree appropriate practice standards. I place on record much government gratitude to the HFEA and those bodies.

Since April 2006, tissue and cell establishments storing human tissue and cells for human application have been required to be licensed by the Human Tissue Authority under the Human Tissue Act 2004. To date, some 150 establishments and 118 satellites have been licensed. In addition, to enable establishments to prepare for the implementation of these regulations, the HTA has made it a condition of the licence that establishments meet the requirements of the first two directives by April 2007 and work towards meeting the requirements of the third directive as reflected in the regulations before the House.

The regulations set out the requirement for a uniquely identifiable coding and labelling system for human tissues and cells, which will underpin both the traceability and quality control of tissues and cells. An EU-wide coding system is being developed to ensure that tissues and donors, the tissue banks they originate from, as well as processes or storage requirements, can be instantly identified no matter where in the EU they originate from or are used. The regulations also require the introduction of a monitoring system for adverse incidents and reactions to transplanted tissues and cells and the establishment of a system to monitor serious adverse events and reactions. Such a scheme is already in place for blood and blood products and for the fertility sector through the HFEA. The HTA has developed an online system for notification of serious adverse events and reactions, which is now operational.

Gametes and embryos are within the scope of the directive and are therefore included within the regulations. The regulations also extend the remit of the HFEA to cover a range of treatments using a couple’s own sperm. Feedback from UK-licensed clinics and professional bodies to date has indicated a broad welcome for the regulations as a means to further raise and maintain standards and best practice.

The final costs of implementing the regulations are set out in the regulatory impact assessment. They are divided into administrative and policy costs. Many establishments have already introduced the measures necessary to comply with the regulations and we do not anticipate a significant impact on business in either the public or private sector.

The regulations impose clear standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of all human tissue and cells used for any human application, including fertility procedures across the European Union. We believe that the regulations are proportionate and should be supported. I beg to move.

Moved, That the draft regulations laid before the House on 25 April be approved. 16th Report from the Statutory Instruments Committee.—(Lord Hunt of Kings Heath.)

My Lords, these regulations have been billed as being “of medium controversy” but the extent and nature of that controversy seems fairly modest. As the Minister explained, we are dealing here with the implementation of a European directive. The UK has a legal obligation to implement that directive and failure to do so would render us liable to infraction proceedings. To that extent, we must view these regulations as being necessary—on the assumption, of course, that they faithfully reflect the content of the directive without unwelcome gold-plating.

In a purely domestic context, much of the benefit of the regulations is already enshrined in UK law. However, their wider benefits are clear. Over the years ahead, as new treatments are developed, especially in the area of stem cells, we are likely to see greater traffic in human tissues taking place between different countries. There is therefore every advantage in having common procedures governing the safety and quality of tissues across the EU. As an aside, I should be particularly interested to know from the Minister whether the implementation of the directive among member states will do anything, albeit indirectly, to help women and couples who look outside the UK to receive IVF and other fertility treatments.

I was quite struck by the following sentence in the regulatory impact assessment. It said:

“The introduction of quality management systems is likely to encourage the creation of a ‘safety culture’, which will help establishments to prevent, analyse, and learn from errors, in keeping with the recommendations of the Department of Health report, An organisation with a memory”.

To what extent is it the Government’s perception that a safety culture does not currently exist in relevant establishments? How serious a concern is this in relation to fertility clinics in the UK and in tissue banks? If it is a concern, why have the Government not acted more swiftly to deal with it? The document referred to, An Organisation with a Memory, was published as far back as 2001.

The regulations also create a single regulatory framework for reproductive and non-reproductive tissue banking, which paves the way for the merger of the HFEA and the Human Tissue Authority. That merger will, we understand, be the subject of primary legislation in due course, and this is not the moment to anticipate our debates on that issue. However, in giving the regulations our approval, as I am sure we shall do, it should not be assumed that all of us in this Chamber view the creation of RATE, the proposed new regulator, as being necessarily well conceived. My noble friend Lord Jenkin of Roding, who is not in his place, has on a number of occasions voiced his disquiet over the rationale underpinning this merger and I have a great deal of sympathy with what he has said on that subject. So we will be ratifying these regulations very much on a “without prejudice” basis.

In the immediate term, the issue that concerns me most is the regulatory impact of these instruments and their cost to business. We have available a very helpful regulatory impact assessment, which there is no need to go into in detail; but the compliance cost table shows that the implementation of the directive is likely to cost in aggregate between £16.22 million and £17.98 million upfront, with annual recurring costs of between £3.92 million and £11.18 million. Set against predicted annual benefits of £9 million, those costs look fairly hefty, and one wonders whether every effort has been made by the department to minimise them. I wonder also whether the Minister shares my concern that the monetary values assigned to the potential costs and benefits of the directive are unsatisfactorily vague. We are told that the consultation on the regulations has been extensive, and I am sure it has been, but it seems extraordinary that the annual recurring costs of implementing quality management systems should be incapable of more accurate estimates. The range of figures that we have are between £2.74 million and £9.59 million, which indicates to me that no one really has a clue what the costs will be.

We are also told that most fertility clinics face few additional costs as a result of the regulations. But on the face of it this seems surprising in view of the inevitable increase in paperwork arising from some of the new controls. Can the Minister comment on this point, and can he can say to what extent establishments will be subject to new administrative burdens and whether these have been costed in? Bearing in mind that 80 per cent of fertility clinics are classified as being small firms, additional administrative burdens will be proportionately more serious for most of them than might be first thought. I hope the Government will aim to achieve the lightest touch in regulation, consistent with the aims of the directive.

My Lords, we on these Benches welcome these regulations. As the noble Earl, Lord Howe, said—the Minister also alluded to this—we in this country already have a very highly established regulatory framework for these matters, much more so than in other parts of the European Union. It is in our interests to make sure that we maintain these high standards, which have contributed to making this country one of the premier places in the world to which scientists come in order to develop this particular type of work, not least because they find the regulatory framework here far more conducive to ethical development than they do in, for example, the United States of America.

We on these Benches are delighted that in that respect, this European directive underpins and strengthens the position domestically. Also, it must reassure those individuals who will begin to secure tissues from abroad that they will be subject to exactly the same kinds of standards that one would expect here.

I speak as somebody who is on record as being in favour of doing anything that we can—I feel strongly about this because of personal experience—to develop and increase the number of organ and tissue donations, such as corneas for people whose sight has deteriorated. I believe that the regulations set out a framework that will enhance that.

I want to take one stage further the argument proposed by the noble Earl, Lord Howe, about the comparative financial burden on British firms. I accept his point that most of them are small or medium-sized enterprises. However, those firms must be in a far better position than their counterparts in other European countries, because they already have to meet many of the standards in the regulations. How long do the Government expect it to take before the directive is implemented fully across all member states?

I have two questions for the Minister; he may not be able to answer them now, but I would be quite happy if he were to write to me. The first is about storage of traceability data, which are to be kept for 30 years. Why was that figure laid down in the regulations? I ask that not least because we know that the period of fertility for people is getting longer, so I wonder whether the figure has been determined recently.

Secondly, I note the point about screening of donors for HIV, hepatitis B and C, syphilis and chlamydia, but this sentence worries me:

“Donors who, or whose sexual partners, come from high incident areas must also be screened for HTLV antibodies”.

Why only people who have been in high-risk areas? Everything we know about such diseases shows that one has to be exposed only once to have a higher than average possibility of contracting the disease.

Those are just two technical questions, but on the whole we welcome the regulations.

My Lords, I welcome the general comments of the noble Earl, Lord Howe, and the noble Baroness, Lady Barker. I certainly agree with their general view that the regulatory standards in this country are high, which means that the implementation of the directive in the UK is pretty straightforward. I also very much agree with the noble Baroness that the strength of our regulatory system makes this the place for many scientists to come to do crucial work. That was one of the strong factors in the debate on embryonic stem cell research that enabled this House to allow the change in the regulations to be made. We should ever be mindful that high-quality research and science go hand in hand with strong, proportionate regulation.

The noble Baroness, Lady Barker, asked me when the legislation was due in. It was actually in force on 7 April 2006. The UK, because we had legislation already in place, was given a derogation for one year. There has been a slight delay in producing the regulations and bringing them before Parliament because of the work necessary to consult and the detailed work that entailed from that consultation. The implementation enforcement date in this country is 5 July of this year. I am advised that there is a low risk of infraction proceedings. The date for Europe was 7 April 2006.

I understand the comments made by both the noble Earl and the noble Baroness about not wishing for gold-plating of these regulations. My understanding is that there has not been gold-plating; establishments will only be required to meet the requirements of the directive. The noble Baroness, Lady Barker, answered the question posed by the noble Earl, Lord Howe: would this give comfort to women and couples who go to other countries in the EU? The answer must be yes, because the current situation, where many countries do not have any regulation at all, is unsatisfactory. Of course, there are issues about consistency—it is sometimes argued that some countries are better than others in ensuring that directives are implemented. In general, the regulations should give some comfort.

As far as the safety culture is concerned, the noble Earl should not read into that comment that we believe that there is not a safety culture in the regulated establishments, more that we believe that there is strong regulation and a safety culture. Those remarks relate not just to the establishments covered by these regulations but more generally in healthcare. An Organisation with a Memory, which led to the establishment of the National Patient Safety Agency, is about ensuring that we get as much information as possible about safety incidents, including near misses, and learn from those errors. As a result, we can redesign our approach to clinical care; sometimes it is about the use of medicines, sometimes procedure and sometimes training. The comments reflect a general desire to make healthcare in this country as safe as possible and to learn the lessons of experience. That applies to this sector as much as other parts of the healthcare industry.

I noted the comments of noble Earl, Lord Howe, on the establishment of RATE. We have already realised that RATE does not commend itself to other noble Lords. No doubt when we come back with primary legislation we will have a jolly good debate about it. The Government’s view is that bringing the two organisations together will enable us to bring together the strength of both of them and enhance regulation.

I understand the issues raised about fees and the concern that they will lead to burdens on many establishments. First, it would be fair to say that the RIA gives a broad outline of the potential additional costs to them. Those costs were derived from information collected from regulators and tissue establishments during financial year 2005-06. I agree with the comments made by both noble Lords that these are approximations, and we will learn from experience. I also accept that there is a need to keep the costs to regulated establishments down as much as possible—proportionate to the issue of safety. I have no doubt that a very careful eye will be kept to ensure that costs are kept as low as possible. It is worth making the point that many of the establishments that will be regulated for the first time are actually NHS establishments. It will fall in the end to the National Health Service to pay the additional costs. Some other establishments will also now fall to be regulated, but we expect them to be minimal in number.

I understand that so far 31 NHS bodies have applied to be regulated and we expect another 15 to do so. Interestingly, 11 organisations, including eight NHS bodies, have decided not to be regulated for one reason or another, but I accept the issue of cost.

I should be grateful if I could write to the noble Baroness on the question of HTLV.

I understand that the 30-year period for storage of data was brought about through negotiation. If the noble Baroness presses me to give a rational reason why that period was decided on, I am afraid that I cannot give one. I imagine that it was thought to be a reasonable length of time, although I understand her point about longevity. I am afraid that that is the best answer that we have in relation to that matter.

On Question, Motion agreed to.