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European Standing Committee C Debates

Quality and Safety of Human Tissues and Cells

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European Standing Committee C

Wednesday 12 November 2003

[Mr. David Amess in the Chair]

Quality and Safety of Human Tissues and Cells

[Relevant Document: EU Document No. 10122/03.]

2.10 pm

The Parliamentary Under-Secretary of State for Health (Miss Melanie Johnson): The proposal in European Union document No. 10122/03 provides an important opportunity to introduce a harmonised regulatory framework to ensure the quality and safety of tissues and cells intended for transplantation and other human applications. Once adopted, it will introduce safety standards across the EU facilitating the safer and easier exchange of tissues and cells between member states, and secure public health protection for the tens of thousands of people who receive human tissue and cell treatments every year in the UK.

Human tissues and cells from both living and deceased donors are transplanted in an increasing range and number of procedures. A few years ago, it was estimated that some 10,000 patients per year benefit from NHS treatments involving human tissue transplants. That is now thought to be a considerable underestimate of the usage of tissues and cells. The British Association for Tissue Banking recently estimated that bone alone is used in 7,500 operations a year. In addition, more than 2,000 corneal transplants, about 2,000 bone marrow transplants and approximately 35,000 in vitro fertilisation cycles are undertaken each year, all of which would fall within the directive's scope. Other tissues and cells that may be transplanted include skin, heart valves, tendons, cartilage and stem cells.

We already have systems in place in the UK to improve the safety and quality of tissue and cell transplantation. In April 2001, UK health departments launched a voluntary accreditation scheme for all tissue banks that store and process human tissue for therapeutic use within the NHS. Under that scheme, the Medicines and Health-Care Products Regulatory Agency is inspecting applicant tissue banks against the UK code of practice. The voluntary code of practice requires tissue banks to have appropriate facilities and to undertake staff training. It also sets out high standards for donor screening, process control and record keeping.

The main benefit of the Commission's proposal would be to enable the UK's voluntary scheme to be put on a statutory basis. The directive would require all establishments dealing with tissues and cells for human applications to be regulated and so meet high standards of quality and safety. That 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 that by requiring a

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competent authority or authorities in each member state to inspect and to accredit tissue establishments.

In many respects, the provisions in the proposal will consolidate existing UK guidance. However, in a small number of areas, the directive will introduce new requirements. For example, the proposal will for the first time regulate imports of tissues and cells from outside the EU and ensure that such tissues, together with those supplied from within the EU, are of a high standard and can be traced.

Perhaps the most significant point is the proposed inclusion of mature gametes, sperms, eggs and embryos within the scope of the directive. The European Scrutiny Committee has, rightly, identified that as an area that needs careful consideration.

The Human Fertilisation and Embryology Authority already regulates infertility clinics in the UK. However, few, if any, other member states have so effective a system of regulation and some have no system at all, hence the desire of the EU to ensure that they are included. The HFEA has begun work with infertility clinics and professional bodies such as the Association of Clinical Embryologists and the British Fertility Society to devise appropriate standards for accreditation of laboratory practice in infertility units. To date, feedback from UK licence clinics and professional bodies has broadly welcomed the directive as a means of further raising and maintaining standards and best practice.

Nevertheless, there is undoubtedly some anxiety in the infertility treatment sector about what the precise standards will be, whether they will require capital investment and whether the implementation time scale will allow for incorporation into expenditure planning cycles. I fully understand those anxieties and concerns.

The eventual impact on infertility clinics will depend on the final text of the directive and what it requires of them. Much remains for negotiation. The HFEA and the bodies representing infertility clinics are working to reach agreement among professionals on the appropriate accreditation standards, and that work will be fed into further development of the directive and its detailed annexes.

The Government's role is to ensure that appropriately high standards of quality and safety are achieved. That is in the best interests of patients. However, those standards must be proportionate and relevant. It is likely that additional investment by clinics will be needed to meet the standards finally agreed.

It is not unusual for regulatory impact assessments to change as draft directives change throughout the period of their negotiation. Work is continuing to quantify the possible additional costs that are imposed by the directive. The final costs of implementation will depend on the technical standards developed in a series of detailed annexes that will be agreed under the comitology procedure after adoption of the directive. It is expected that the standards will be in line with current international practice and comparable with the UK code of practice. We estimate that the extra cost will be between £9 million and £15 million for set-up

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costs, with annual recurring costs in the region of £1 million to £2 million.

It is important to update the Committee on the current status of the directive. A common position was agreed on 22 July and the proposal is progressing through second reading. On 4 November, the European Parliament's environment, public health and consumer policy committee adopted several amendments that will be discussed by the Council and by the European Parliament during its 15 to 18 December plenary session.

People must have confidence in their health services. They have a right to expect high levels of protection in terms of safety and quality, and such protection involves cost. The directive will put our voluntary accreditation scheme for tissue banks on a statutory footing with 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.

The additional costs are reasonable and justified, and we therefore give the directive our general support as it is an important element in ensuring the continued supply of the high-quality tissues and cells that NHS patients and other patients in the UK need and expect. I hope that the Committee supports the motion.

The Chairman: We now have until 10 minutes past 3 for questions to the Minister. I remind hon. Members that questions should be brief and asked one at a time.

Tim Loughton (East Worthing and Shoreham): I am afraid that I have several questions, and I will ask them one at a time. I will see how it goes and perhaps roll the questions into the debating period after one hour.

The directive is very technical, and it might be useful if the Minister were to give more detail about where we are and what might happen. We welcome any improvements in the standards of human tissues. As she rightly says, if anything, the UK is ahead of the game already. We do not want to incur great extra costs and extra regulation. We are already achieving quality—most would agree on that.

Will the Minister confirm what could happen to the directive? The main point of contention, I agree, is the treatment of mature gametes and the effect that that will have on IVF treatment centres and payment for donations of sperm. Is it likely that, if the European Parliament insists on including gametes in the directive, and if only voluntary donations are to be accepted, the measure will go to the Council of Ministers, at which stage the UK Government can object and involve the courts, pleading article 152 of the Maastricht treaty on the basis that it is an ethical matter, rather than a standards matter, which would be in the competence of the European Parliament and Commission? In that case, the UK could effectively get an opt-out and the fears that we are addressing would not be relevant to the UK. Am I wrong in thinking that that could happen?

Miss Johnson: On the way in which the negotiations have been conducted to date, the proposal dates from

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June 2002. Negotiations have been going on for some time. At the end of my statement, I outlined the immediate process that will take place over the rest of this year. We do not anticipate that the directive is likely to be agreed until the spring or summer of 2004, at which point a number of technical annexes will be subject to an awful lot more discussion because they will not have been resolved as part of the directive agreement. Implementation is unlikely before 2006 at the earliest.

It is important to emphasise that the precise requirements that clinics will have to meet are yet to be decided—that relates to the hon. Gentleman's point about infertility clinics and gametes. The requirements will be determined through the comitology process and there will be a separate annexe as a result of those discussions. We are working closely with the professional bodies to ensure that negotiations lead to realistic and proportionate requirements.

The clinics have been consulted and the feedback from the licensed clinics and professional bodies in the infertility treatment sector is that they broadly welcome the directive as a means further to raise and maintain standards and best clinical practice. However, there is undoubtedly anxiety in the treatment sector, which the Government share, about what the precise standards for clinics will be, whether they will require capital investment and whether the time scale allowed for implementation will allow for incorporation into expenditure planning cycles. At the moment, we can discuss only the common position texts that we have. The UK Government will continue to resist all the amendments that are outside the scope of article 152.


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Prepared 12 November 2003