Select Committee on Science and Technology Fifth Report

8  Legislative and regulatory models

316. In Chapter 3 we discussed some of the reasons why the state has interest in regulating assisted reproduction. However, a key question for this inquiry has been whether assisted reproduction requires special attention and whether any concerns can or should be addressed by generic regulation. A 2004 report by the Better Regulation Task Force states:

"Classic regulation, in the form of prescriptive rules, is the most common response to a policy problem. Sometimes, this is the best and most direct way to protect people from harm, or it may be a necessary element in implementing an EU Directive. In many cases, however, an alternative form of implementing policy - either on its own, or in conjunction with other methods - may be the better approach. It is often best not to intervene at all.".[417]

317. One reason for close regulation is that the state has some interests in assisted reproduction, as we concluded in Chapter 3, in restricting reproductive freedom if there are demonstrable harm or negative impacts on society. A further reason would be to ensure high standards of treatment. In Finland, which has the highest success rates in the world and had the highest use of single embryo transfer in Europe in 2000, there is effectively no regulation in place.[418] It could be concluded that the single most important factor in determining clinical standards is not regulation as such but the self-imposed standards of the profession. To draw conclusions on the effect of deregulation in the UK requires an analysis of the culture of medical practitioners in these countries.

318. In giving evidence to us, Dr Simon Fishel said that regulation should avoid ethics and focus on the safety of the procedures; the appropriateness of the technology; the efficacy of the technology; and the information given to patients.[419] We have accepted that there needs to be some mechanism for having controls to provide safeguards to individuals and society. However, we accept that the distinction between regulating reproductive decision-making and clinical standards is important.

Clinical and technical standards

319. We have identified four approaches to regulation in this area:

a)  The extension of the current regime to ensure that all assisted reproductive technologies (including those currently excluded) are covered;

b)  The separation of the scientific or clinical from the ethical or policy aspects of regulation, with the inspection and quality assurance aspects retained by the regulator but questions of ethics and policy placed under the responsibility of a separately constituted body which would advise Parliament;

c)  Deregulation of certain aspects of the provision of services. The regulator would have no policy function but would have a policing and monitoring role. Reproductive medicine would be subject to the usual controls on medical interventions. Embryo research would not require local ethical review and scientific peer review before it was allowed to proceed;

d)  Complete deregulation.

320. Professor Martin Johnson from Cambridge University has concluded that some sort of regulation is inevitable so that the starting point for any discussion should be a justification of regulation in terms of its objectives and the ethical principle on which they are based and should allow the expression and creativity or doctors and scientists while allowing responsible choice and self-determination by patients. Professor Johnson draws attention to the formal and informal self regulation that already exists in medical practice. While this has advantages, there is a danger that it is viewed with suspicion by the public. We have also heard concerns that self-regulation could be more conservative, perhaps for this reason. Professor Johnson identifies three deficiencies in the way that the professionals currently operate:

a)  They must be more open and honest about how they conduct and disseminate their findings and recommendations;

b)  They must develop better relationships with their members and improve their ethical and attitudinal education;

c)  They must deal better with mavericks in their ranks.

321. He argues that external regulation should be limited to discrete areas and should follow three principles:

a)  There should be a positive culture between the regulator and professionals

b)  The regulator should work to outcome-based objectives

c)  The regulator should avoid excessive bureaucracy.

REGULATION OF OTHER MEDICAL PRACTICE

322. Since the HFE Act was passed, the regulatory environment for medical practice has changed substantially. Large numbers of bodies have been set up by Government to regulate clinical standards, medicines and healthcare products and equipment and the conduct of healthcare professionals. The current vogue is to merge these bodies and the key organisations are described below.

Medicines and Healthcare Products Regulatory Agency

323. From 1 April 2003, the Medicines and Healthcare Products Regulatory Agency (MHRA) replaced the Medical Devices Agency (MDA) and the Medicines Control Agency (MCA). It is an executive agency of the Department of Health which aims to protect and promote public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.

324. The draft technical standards produced by the professional bodies demand that: "All procedures shall be validated for their intended use prior to introduction, and the methods used and results obtained shall be recorded.".[420] This requires a process by which new techniques can be introduced. The MHRA's brief does not currently include medical procedures but we see little fundamental difference between a new drug and a new surgical technique.

Commission for Healthcare Audit and Inspection

325. The Commission for Healthcare Audit and Inspection (the Healthcare Commission) was set up on 1 April 2004 under the Health and Social Care (Community Health and Standards) Act 2003. It replaces the work of the Commission for Health Improvement, takes over the private and voluntary healthcare functions of the National Care Standards Commission and covers the elements of the Audit Commission's work which relate to efficiency, effectiveness and economy of healthcare.

The Inspectorate will:

a)  Encourage improvement in the quality and effectiveness of care, and in the economy and efficiency of its provision;

b)  Inspect the management, provision and quality of health care services and tracking where, and how well, public resources are being used;

c)  Carry out investigations into serious service failures;

d)  Report serious concerns about the quality of public services to the Secretary of State;

e)  Publish annual performance ratings for all NHS organisations and produce annual reports to Parliament on the state of healthcare;

f)  Collaborate with other relevant organisations including the CSCI;

g)  Carry out an independent review function for NHS complaints.

326. Professor Allan Templeton, President of the Royal College of Obstetricians and Gynaecologists told us that abortion regulation could be usefully compared to assisted reproduction. He suggested that its hands-off, more focused approach, informed by a more professional input into the accreditation system standards with a professional inspectorate had merits.[421] Abortion clinics are inspected and registered by the Healthcare Commission on a 4-yearly basis, although they are charged an annual fee, which might typically be around £3-5k. We understand that the Government wishes the Healthcare Commission to pass on the full costs of regulation to healthcare providers and that the figures currently charged reflect about one third of the full costs. While it might be unwise to make too much of the relative costs of regulating abortion and assisted reproduction facilities, a large IVF clinic could face regulatory bills in excess of £100,000.

Relationship of the HFEA with other regulators

327. The HFEA says it is its aim to minimise duplication and to pool efforts and resources wherever practicable. It says it is doing this by:

a)  Working closely with professional bodies and associations linked to assisted reproduction and developing agreed protocols on the conduct of inspections.

b)  Agreeing a memorandum of understanding with the GMC and working towards similar agreements with other regulatory bodies (such as MHRA and CHAI).

c)  Close liaison with the HGC through mutual co-optation of members and exchange of information.

d)  Active involvement in the MRC's development of protocols for the use of stem cells.

328. The extent of overlap with the Healthcare Commission is the most problematic. The HC has published an agreement between the main healthcare inspection, review and audit bodies in England, aimed at reducing the burden of inspection on frontline healthcare staff. The Concordat commits each organisation to a set of principles which aim to support improvement in health services while minimising disruption and duplication, ensure that information is shared appropriately and encourage joint inspections. The HFEA reveals in its 2003-04 Annual Report that it is holding discussions with the HC to eliminate duplication.

Ethical oversight

329. It is important to establish what we mean by ethics in this context. As the Warnock Committee pointed out, medical ethics can be used to describe professionally acceptable practice or the principles upon which these practices are based. The distinction is important since the former could considered to be an element of good medical practice, such as the way consent is achieved or description of the duty of care owed to patients. However, ethics can also be evaluated from the perspective of the principles which underpin the enterprise itself, and we have been concerned to engage with the latter interpretation. Ethical oversight of assisted reproduction and embryo research can take place at several levels. Legislation can set out boundaries, national guidelines can then be set out by the HFEA. The conduct and scope of clinicians' and researchers' work can also attract the attention of local ethics committees, of which there are two forms, for research and for the consideration of clinical cases. Currently, national guidelines are drawn up by the HFEA.

RESEARCH OVERSIGHT

330. A research project involving human embryos has three bureaucratic obstacles it must overcome before it can proceed. It must have an HFEA licence, it must satisfy a local ethics committee and it must have funding. The HFEA has the power to grant research licences for up to three years for individual research projects. All licence applications, renewals and progress reports are evaluated by an HFEA Licence Committee. Research ethics approval must have been sought from a properly constituted research ethics committee (REC) before an application is made. The HFEA then initiates peer reviews which determine whether the application:

a)  Comes within the statutory purposes of the HFE Act;

b)  Requires human embryos to fulfil its aims and objectives;

c)  Requires the numbers and types of embryos described in the application;

d)  Meets the requirements of the HFEA's Code of Practice.

331. In theory, the HFEA Research Licence Committee does not give ethical approval, merely decides whether the proposed research comes within the eight purposes set out in Schedule 2 of the HFE Act and conforms to its provisions in Section 15 on the conditions of research licences and consent (Schedule 3). As the HFEA's Chair, Suzi Leather, put it, "There are ethical dimensions, of course, to the work we do; but essentially we implement the wishes of Parliament. The legislation does not contain any explicit ethical principles".[422] We asked the HFEA for what reasons research licences had been refused. It gave three examples:

a)  Because there was no "research" angle, and the application was effectively about training ICSI or embryo biopsy practitioners (not within the law to grant such a licence, but we have flagged up that we would like to be given power to give such licences).

b)  Because the applicants couldn't demonstrate the required ability to select spermatids reliably.

c)  Because the Committee felt that the proposal was of "poor experimental design".[423]

332. Research ethics committees are well established in the UK and an English network now operates under a central committee called the Central Office for Research Ethics Committees (COREC) (see Box 12).

Box 12: Functions of the Central Office for Research Ethics Committees (COREC)

co-ordinates the development of operational systems for local and multi-centre Research Ethics Committees (LRECs and MRECs), on behalf of the NHS in England;

Maintains an overview of the operation of the research ethics system in England, and alerts the Department of Health and other responsible authorities if the need arises for them to review policy and operational guidance relating to Research Ethics Committees;

Manages the MRECs in England;

Develops and manages a national training programme for REC members and administrators in England;

Maintains close contact with officials in the Department of Health with policy responsibility for wider issues of research ethics and with colleagues from Northern Ireland, Scotland and Wales;

With appropriate advice, develops, implements and maintains operating procedures and standards for RECs that will be consistent across the UK;

Establishes and manages regional Offices of Research Ethics Committees (ORECs) to oversee the activity of LRECs;

Provides advice to the Department of Health on the implications and practicalities of transposing the European Clinical Trials Directive in the UK.

333. Professor Robert Edwards highlighted the importance of RECs during his work: "When IVF started there were hardly any ethical committees in hospital. It was a sort of American invention that was entering our practice, and when I started working with Patrick Steptoe we had to strengthen the ethical committee. It was doing nothing. We had to make it much stronger, and we had to tell someone else to appoint the people otherwise we were biasing it towards ourselves. I think in those days you talked to your colleagues and your friends and your doctors and you decided things were safe and you had to make a lot of decisions by yourself, and this is what we had to do, but at every step we took immense advice from everybody.".[424]

334. Professor Neil McClure from Queen's University Belfast told us that "the whole ethics structure within the United Kingdom has changed so much there is no need any more to have the HFEA regulating basic research projects. They will be very tightly regulated by the local ethics committees and by the research governance societies".[425] Dr Veronica van Heyningen, a geneticist who contributed to our online consultation, also suggested that there was too much oversight: "the levels at which the barriers are drawn should be different for laboratory science and for putting it to practical use and there should be a very rigorous barrier of testing before something is taken from the lab to the clinical side".[426]

335. However, there are a number of concerns about the way RECs operate. There are around 200 in the UK and they are not universally admired, perhaps not surprisingly since they are likely to impose a burden on clinical researchers. There are a number of criticisms that have been levelled at them:

a)  There are major variations in the way they operate.

b)  Delays in approval may inhibit research

c)  Committees are risk averse and fail to recognise the benefits to patients

336. These issues cannot be ducked and in recognition of this, Lord Warner of Brockley, Parliamentary Under Secretary of State (Lords) has asked Michael O'Higgins, a managing partner of PA Consulting Group Ltd, to review the systems that support NHS Research Ethics Committees in England, and make recommendations for further steps to improve their operation, building on changes already under way. It is due to report to Health Ministers by the end of March 2005.[427] We look forward to reading Mr O'Higgins's conclusions.

337. During our visit to Sweden we heard that in January 2004 an Ethics Review of Research Involving Humans Act came into force. It created a new organisation of six independent regional boards for research ethics review, each chaired by a judge, as well as a Central (National) Board for research ethics review. The only requirement on researchers wishing to undertake research using human embryos is that their proposal is accepted by their local committee, and even here the emphasis is on the protection of the donor, since this is not required if the donor cannot be traced. The research ethics committee has to judge whether the project is scientifically sound and defensible in terms of the knowledge it will generate and to make certain that subjects are given enough information about what participation entails and give their consent to participate in a satisfactory manner.

338. If an embryo research project requires external funding it is likely that it will have to go through the scientific peer review process. The major funder in the UK is the Medical Research Council. The MRC's assessment of any research proposal is based on three core criteria:

a)  Importance: how important are the questions, or gaps in knowledge, that are being addressed?

b)  Scientific potential: what are the prospects for good scientific progress?

c)  Resources: are the funds requested essential for the work, and do the importance and scientific potential justify funding on the scale requested?

In addition, MRC Research Boards are asked to identify any ethical issues or risks to human participants, that need further attention.[428] We presented some of the reasons why the HFEA had refused embryo research licences. These are problems that we would expect peer reviewers to pick up. Indeed, it is likely that this exactly what happened, thus in these cases, the HFEA licensing process apparently added nothing to the refusal of the application.

339. It is worth considering whether the combination of scientific peer review and local ethical oversight could fulfil the Warnock Committee's desire that embryos should not be used frivolously for research. An obstacle would be that the research purposes currently in Schedule 2 of the HFE Act are open to interpretation, particularly with regard the use of the term "serious disease" and the extent to which basic research can be licensed. In this respect, the licensing process places compliance with the legislation in the lap of the HFEA. As Suzi Leather put it, "There are very complex issues that our licence committees have to look at. The lawyers would do terribly well if you asked local ethics committees to do our job".[429] This supposes that the law remains the same. A problem with the eight research purposes listed in Schedule 2 is that they are open to interpretation - by lawyers. The issue here is whether legislation needs to specify the purposes for which research on embryos can be undertaken. The aim of Schedule 2(3) is to spell out what Parliament considers to be the ethical use of embryos, yet this should not be beyond the abilities of a properly constituted local ethics committee. The Act, as amended by the 2001 research purposes regulations, effectively says you can do research on embryos if you have a good reason for doing so, provided that they are allowed by the prohibitions in Sections 3 and 4. The MRC's guidance to its review panels makes it quite clear that it will not fund research unless there is a good reason for doing so.

340. Rather than demand that a research project conforms to certain research purposes, legislation could instead specify the processes used by ethical committees with regard to embryo research and the issues they need to consider. It is worth remembering that the vast majority of RECs will never see an embryo research proposal. The HFEA currently lists 30 licensed research projects and some are held by the same institution (the most recent annual report says that there are 24 centres holding research licences, of which 17 also provide treatment and storage). Thus the embryo research community is not large, notwithstanding the growth in embryonic stem cell research.

341. There are, however, advocates of the present system in the scientific community. Professor Alison Murdoch described the current system as the single most important reason why we have taken a lead worldwide in stem cell research and Professor Roger Pederson thinks that "the HFEA works and that it is a huge part of the engine that drives forward stem cell research".[430] Nevertheless, any mechanism that can offer a less bureaucratic approval process is worth further consideration. We recognise that there need to be some prohibitions on research in law, as we set out in Chapter 9, but we think there is much merit in a system of local oversight to provide faster, more proportionate, oversight of research on human embryos.

OVERSIGHT OF TREATMENT

342. Clinical ethics committees (CECs) are less established than their research equivalents. While there has been a rapid growth in recent years, there are currently only 68 in the UK, most of which are in acute trusts. They have three principal functions:

a)  Provide advice to health professionals on individual cases;

b)  Provide ethical input into trust policies and guidelines;

c)  Facilitate ethics education for health professionals within the trust.

Professor Doyal from Queen Mary, University of London says that CECs can play a valuable role in disseminating national guidance, which has been presented in long documents and may not be readily assimilated by busy clinicians. He has considered some of the reasons why CECs are less prevalent than their research counterparts:

d)  Concerns that the collective character of CECs will contaminate the doctor-patient relationship because of its dependence on the trust patients place in their individual clinicians;

e)  Concerns that individual clinicians might abnegate personal responsibility for difficult ethicolegal decisions through becoming overly reliant on CECs;

f)  Concerns that "decision making by committee" may be ineffective; and

g)  Opposition from senior clinicians who resent the idea that they might need ethicolegal support and advice from colleagues who are in different specialisations or have no medical training at all.[431]

343. Many assisted reproduction clinics have their own dedicated ethics committee. While the HFEA provides no guidance in its current Code of Practice on what form CECs should take, Professor Henry Leese, a former member of the Authority, told us that "we would always look at the constitution of the ethics committee. It was one of the questions. 'Do you have a properly formulated ethics committee?'".[432] Anne Slowther and Tony Hope from the Ethox Centre at Oxford, which has been awarded an NHS grant to set up network of CECs, argue that "Ethics support at unit level is valuable despite the existence of a national statutory body (the HFEA)".[433] Professor Doyal says that in assisted reproduction CECs can advise on how best to implement professional and legal guidance on all forms of treatment and genetic screening.

344. It is possible that clinical ethics committees could be valuable in aiding clinical decision-making. However, their national provision is uneven and there would need to be a national framework for committees, setting out their composition and working practices. Professor Len Doyal has concluded that "Provided that CECs work to such principles and their members are trained to do so then there is every reason to believe they can make an extremely positive contribution to improving clinical practice and the general quality of health care". This view, however, is not universally shared, and research is currently under way to evaluate the impact of CECs on the delivery of healthcare services. Funded by the Wellcome Trust, the outcome of this research will not be available until 2007.

345. It would be tempting to seek to combine local research and clinical committees but Dr Slowther and Professor Hope explain that CECs have distinct functions and should therefore remain distinct.[434] While RECs are decision-making bodies, preventing or allowing research, CECs are constituted to help clinicians make decisions. There are merits in the creation of a nationally coordinated network of clinical ethics committees to parallel the arrangement for local research ethics committees. Should the evaluation of these committees demonstrate their value, they should be provided with national guidelines for their conduct in the area of assisted reproduction but their decisions should be directed needs of patients and the families and the concerns of health care professionals.

NATIONAL COMMITTEES

346. The creation of a national bioethics committee is favoured by many with a principled opposition to assisted reproduction, who feel that they have no national forum to express their views since successive Secretaries of State for Health have refused to appoint Authority members who are not sympathetic to the HFEA's aims. Cardinal Cormac Murphy-O'Connor, the head of the Roman Catholic Church in England and Wales, was reported in the Daily Telegraph as saying: "I am hearing from all sides a growing demand for major bioethical decisions to be subject to greater scrutiny by Parliament, and for there to be proper public discussion and awareness of what is at stake." He said that the HFEA was "not an adequate body" for dealing with the implications of many of the latest technological advances. "Many of the HFEA's rulings are causing deep public disquiet. People do not understand the thinking behind them. They see them as contradictory and perplexing". The Cardinal said he would like to see a national bioethics committee of the sort that exists elsewhere in Europe and the United States. He said it could be made up of moral philosophers, theologians and ethicists, as well as scientists and IVF clinicians.[435]

347. CORE argues that the UK should set up such a national bioethics council, with a focus on philosophers, theologians and qualified ethicists rather than scientists: " Such a group, far removed from any possible accusations of conflict of interest, would address the ever-increasing ethical issues arising in the field of reproductive technology and stem cell research, and report its conclusions for the benefit of Westminster and the country at large." CORE cites the President's Council on Bioethics, set up by George W Bush in November 2001, as a model for such a council (see Box 13 for examples of national bioethics committees).

Box 13: National bioethics committees

US President's Council on Bioethics

The Council is composed of not more than 18 members appointed by the President from among individuals who are not officers or employees of the Federal Government. The Council includes members drawn from the fields of science and medicine, law and government, philosophy and theology, and other areas of the humanities and social sciences. Its functions are:

to undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioural science and technology;

to explore specific ethical and policy questions related to these developments;

to provide a forum for a national discussion of bioethical issues;

to facilitate a greater understanding of bioethical issues; and

to explore possibilities for useful international collaboration on bioethical issues.

Unlike the HFEA it has no statutory powers. Since members are appointed directly by the President there have been accusations of political and ideological bias.

French National Consultative Ethics Committee for Health and Life Sciences

French National Consultative Ethics Committee for Health and Life Sciences's mission is to give opinions on ethical problems and societal issues raised by progress in the fields of biology, medicine, and health. The National Consultative Ethics Committee is now an independent authority and is composed as follows: the President, nominated by the President of the Republic, an Honorary President, and 39 members. Five of these members are drawn from the main philosophies and religious faiths and are designated by the President of the Republic. Nineteen members are chosen because of their qualifications, competence, and their interest in ethical issues. Fifteen members are engaged in scientific research. The Committee publishes around five "opinions" a year. Opinions in 2004 include: Composite tissue allotransplantation of the face; the generalised prenatal screening for cystic fibrosis; and Opinion on education in medical ethics.[436]

348. It has emerged that there were discussions as part of the review of arms' length bodies on the creation of a national bioethics committee because some of the functions of arms' length bodies could have been vested in such a committee. The Nuffield Council on Bioethics wrote to Lord Warner at the Department of Health setting out its concerns that it might be asked to form part of a National Bioethics Commission.[437] It argues that national bioethics commissions can often be asked to tackle "short term issues of narrow scope" and "tend to be heavily politicised". The Government ultimately concluded that the current distributed system remains the best option as it provides for specific bioethical issues to be addressed by dedicated groups who are able to concentrate on the relevant field in question.

349. It is not possible to present simple arguments for and against a national bioethics committee. As Sarah Elliston from Glasgow University pointed out, "there are very many different models of a bio-ethics committee and a bio-ethics commission that we could actually follow and each of them would have different implications.".[438] Professor Margaret Brazier from Manchester University, while indicating that she thought a national bioethics committee should be considered by the Government, but that there should be substantial research into how such committees and commissions operate in other jurisdictions where they have been set up. She told us that there were a number of holes into which they can fall:

a)  They can simply be talking shops;

b)  They can be hugely expensive bureaucracies; or

c)  They can become extremely politicised.[439]

350. Professor Brazier's first point can be addressed by clearly defining the role of the committee. If they are simply left to operate detached from practice and regulation then there must be a danger that well meaning reports will be considered as worthy and inconsequential and dutifully filed. Alternatively, if these committees have statutory powers then their output will be highly relevant. If this is the case then it is likely that there will be fewer concerns about cost.

351. The suggestion that appointments are heavily politicised has been an accusation levelled at the US President's Council on Bioethics, which is seen as weighted towards those with a principled opposition to assisted reproduction and "thereby lost all credibility in the medical and bioethics community".[440] This can, however, be overcome by removing the political control over appointments. We have heard that members of the HFEA are no longer appointed by the Secretary of State for Health but by the NHS Appointments Commission.[441] If a bioethics committee were appointed in this way we would consider this sufficient protection against political interference.

352. Professor Donna Dickenson from Birkbeck College argues that even if a national bioethics committee were set up, "an updated regulatory authority, accompanied by a national bioethics committee but not replaced by it, is absolutely essential to deal with the rapid evolution of new reproductive technologies". She points out that in France a new statutory national biomedicine regulatory authority has been set up to work alongside its 20-year-old national ethics committee. [442] This system may have advantages. In the UK, the regulator could be left to deal with technical and quality management issues, the "boring bits", while an ethical committee with teeth sits above it and provides direction on ethical policy issues. This would satisfy the demands of the British Fertility Society that policy be separated from policing. A drawback would be that the role of a wide ranging bioethics committee with executive functions would not sit easily with a number of other regulatory bodies that might fall within its remit, e.g. Gene Therapy Advisory Committee (GTAC), the UK Xenotransplantation Interim Regulatory Authority (UKXIRA) and the Unrelated Live Transplant Regulatory Authority (ULTRA). While this could be addressed by limiting the jurisdiction of the ethics committee, we believe that the Government is correct that smaller advisory committees with specific briefs would be more effective. Nevertheless, we favour the rationalisation of these committees where there is clear overlap and human genetics and embryology fall into this category. We recommend the formation of a single commission to develop policy issues relating to the assisted reproduction, embryo research and human genetics.

LOCAL VS NATIONAL OVERSIGHT

353. Decisions made at a local level have the advantages of speed and proximity to the clinical setting. National deliberation has the advantages of consistency and of being placed in the context of national debate. We have favoured the first approach as long as there is a national forum where ethical issues can be discussed. There are two major drawbacks of local decision-making, however. The first is that judgements will be inconsistent and the second is that the threat of legal challenge will paralyse research and treatment services. Inconsistency is already a concern among clinical researchers.

354. Both of these can be tackled by specifying in law the processes that local committees work by but not including provisions that are open to interpretation. For example, the legislation could demand that research proposals have been peer reviewed but not that the research must be for a particular purpose. In the clinical setting, a local committee could be asked to consider the wider implications of the treatment but would not be asked to make subjective judgements, for example as to what constituted a serious disease. The consistency and transparency of operations. should ensure the confidence of clinicians, patients and the public. A charge that has been levelled at research ethics committees is that they are inconsistent and bureaucratic. However, the Department of Health, COREC and the Association of Research Ethics Committees are working to improve standards. The solution is not necessarily one or the other but their roles would need to be clearly defined. They can have distinct roles or they can be hierarchical whereby difficult cases can be referred upwards for national consideration. Professor Donna Dickenson believes that the later approach can cause difficulties since it can introduce lengthy delays to decisions that need to be taken as soon as possible. Any national policy-making committee should not attempt to interfere with individual clinical decisions. If the value of local clinical ethics committees can be established, they should be given a defined brief that clearly distinguishes their role from the Commission, which should issue guidelines for their operation .

Role of Parliament

355. In our Report Developments in Human Genetics and Embryology in 2002, we took issue with the assertion by Ruth Deech (the outgoing chair) that the HFEA's decision on PGD "protects Members of Parliament from direct involvement in that sort of thing".[443] We argued that Parliament does not need to be protected and democracy is not served by unelected quangos taking decisions on behalf of Parliament.[444] During this inquiry, our view of a strengthened role for Parliament has been widely supported. Professor Kenyon Mason of Edinburgh University argued that "the great deal of thrust really ought to be by parliamentary decisions, if it could be done; but it would be a matter of parliamentary technique rather than anything else.".[445] Dr Sue Avery of ACE said that sex selection and cloning "are not issues to be decided by a committee; they are issues for Parliament" and Ms Philippa Taylor, a contributor to our online consultation, told us that "there are some obvious weaknesses in the HFEA and I would want to see Parliament's role superseding that of the HFEA in difficult cases".[446] The All-Party Parliamentary Pro-Life Group argues that Parliament needs to do more to engage in debate on sensitive bioethical issues: "It is simply not good enough for Parliament to legislate in this field and then wash its hands of the matter for a decade or so".[447]

356. The problem remains of the level and type of intervention. An arms' length body such as the HFEA has certain advantages. It is insulated against political pressures and vagaries and, as Professor Kenyon Mason commented, it can make changes fairly rapidly. Dr Richard Fleming, a contributor to our online consultation, agreed: "There is a comfort zone about having some level of framework within which all of these things operate and I think that is right".[448] Professor Margaret Brazier argued that "It would be entirely impossible for Parliament to intervene at every possible stage. […] it is very difficult, even with hindsight, to identify a particular time and think, "Ah, that is the boundary that never should have been crossed.".[449] The Chair of the HFEA, Suzi Leather, told us that "We have […] a quieter environment, in a sense, for the cutting edge research, embryonic stem cell research, in this country than, for instance, in the United States. I think that some of that can be put down to regulation".[450] We are not convinced that comparisons with the US are useful. We have no separate authority for abortion clinics yet the UK "climate" is considerably cooler than in the US. We are also aware that public support for embryonic stem cell research in the US is similar to that in the UK.[451] We remain convinced that a larger role for our democratically accountable Parliament would give the public greater confidence that the big ethical issues of the day are being given adequate attention.

Role of the public

357. One of our starting points for this inquiry was the change in social attitudes to assisted reproduction. Professor Martin Richards from Cambridge University comments that any novel technology which artificially intervenes in the natural process of human reproduction will usually be resisted initially and only becomes generally accepted when social benefits are demonstrated in practice and familiarity with its use increases. He cites the birth of Louise Brown in 1978 as an obvious example.[452]

358. One reason for caution in using attitude surveys is that views can change rapidly. The HFEA's 1993 consultation on sex selection reported that 93% of the 165 responses opposed sex selection using PGD for non-medical reasons. In the opinion poll commissioned by the HFEA and conducted in January 2003, 69% did not agree with the suggestion that any parent should be able to choose the sex of their child. While only the more recent survey was an opinion poll using recognised methodology, there is a suggestion that attitudes have become more liberal. This is in line with the comments from Professor Martin Richards, a social researcher from Cambridge, who told us that in the same way that IVF had become more socially acceptable, the same would be likely for other reproductive technologies such as sex selection and cloning. Dr Sarah Parry, a social researcher from Edinburgh, told the Committee that in the case of reproductive cloning, it was possible that public attitudes were not as clear cut as one might expect: "The people I have spoken to were able to think it through and came to the conclusion that maybe it would not be such a bad thing".[453]

359. As pollsters are keen to point out, the answers you get to depend on the phrasing of the question, and also the circumstance. We commented above in paragraph 143 that we did not doubt the accuracy of the HFEA's polls on sex selection, but we were interested to hear the Mastertons tell us they were surprised by the results of the public opinion polls conducted by the HFEA as people they met were universally supportive of their stance. We do not doubt the accuracy of their reports but we suspect that family's tragedy has influenced the local response to their campaign. It would not surprise us that faced with abstract questioning on the uses of sex selection, these same people would offer similar views to those elicited for the HFEA. The HFEA has recently allowed the subjects of treatment licences to makes representations should their initial application fail. We will be interested to see what effect this has on their decisions on difficult cases.

360. In our 2003 Report on Developments in Human Genetics and Embryology, we welcomed Suzi Leather's declaration that "[…]". Public consultations are not difficult processes to undertake given experience and good advice. More problematic is how the results are used, and seen to be used. The Christian Medical Fellowship says that "Public consultations must not be just a listening exercise to satisfy the critics […] the HFEA must respect and be seen to take on board the concerns of individuals and groups who invest huge amounts of time and resources in contributing to the debate, and yet often feel marginalised and excluded from the decision-making process".[454] Comment on Reproductive Ethics (CORE) is concerned about the way the HFEA uses public consultation to inform policy. CORE was founded in response to serious dissatisfaction with a 1994 HFEA consultation on donated ovarian tissue, which "having recorded public opinion then virtually ignored it". Its dissatisfaction has increased over the years and was reinforced following the recent consultation on sex selection.[455] Similarly, the Christian charity, CARE, states that "it has never been entirely clear to us what note is taken of consultations and to what extent they do actually influence decision-making within the HFEA or other bodies".[456]

361. The HFEA's consultation on sex selection makes a good case history. As well as disappointing groups such as CORE for having ignored the opinion it elicited, it has been criticised for giving it too much weight. We were aware of these pitfalls in planning our own online consultation and hope we have been able to show how we have used the views put to us to reach our conclusions. At the same time, we made no efforts to quantify the views submitted. We commented above that when the Department sought the HFEA's view on sex selection, it was not necessarily asking for the public's view. We believe that the HFEA would have been well-advised to adopt our approach, for having found that a large majority did not wish to see sex selection for social reasons it would have been very brave to conclude otherwise, unless serious ethical debate was engaged in and principles could be identified which justified proceeding on the basis of these rather than the numbers opposed. The Medical Research Council has suggested that the HFEA should consider setting up a citizens council to help guide it through ethical decision-making. This has the attraction of providing ongoing public input. Surveys and opinion polls provide useful input to policy development, but are essentially anecdotal and represent the views of a self-selecting group of individuals; often activists. Additionally, we would caution about using the weight of response to determine the outcome of any policy review.Role of the regulator

362. It is instructive to look at the roles that the HFEA does or could conceivably have as a regulator:

a)  Development of technical guidelines

b)  Policy development and ethical oversight

c)  Policing the legislation

d)  Licensing/accreditation

e)  Risk assessment

f)  Collating data on clinical practice

g)  Oversight of new technologies

h)  Providing information to patients

i)  Consulting professionals and the public

j)  Advising central Government

k)  Providing a forum for public debate

POLICY AND ADVICE

363. We have discussed above how the combination of the HFEA's advisory role could conflict with its statutory duty to enforce the HFE Act. [457] Similar conflicts arise with HFEA's policy role, according to the British Fertility Society. The BFS wishes to see the separation of the HFEA's policy and regulatory function and its Secretary, Dr Richard Kennedy, suggested to us that the policy function of the HFEA could be merged with the Human Genetics Commission (HGC).[458] We have discussed criticisms of the HFEA from the Lawyers' Christian Fellowship that in making policy the HFEA has strayed beyond its statutory remit.[459] We argued that the HFEA had little choice but to develop a policy function given its brief. This is not the same as concluding that the regulator should be in a position where it has to develop policy. If the regulator was charged with ensuring that technical standards were maintained and that quality management systems were satisfactory then it would have no need to deliberate on, for example, the welfare issues associated with sex selection or PGD. Merely it would check that the processes were in place to ensure that patients were provided with a service that embraced the wider implications of clinical care.

364. Dr Kennedy's view that the HFEA's policy function should be merged with the HGC is shared by Professor Margaret Brazier from Manchester University.[460] The HGC is a well respected advisory body that has made valuable contributions in this area and is currently undertaking a consultation on reproductive decision-making.[461] In the area of PGD in particular there is common ground between the two organisations and the HFEA's Chair is an ex-officio member of the Commission. However, there is an important difference between the HFEA and the HGC. While both may develop policy in similar ways, the HFEA's conclusions become enshrined in its Code of Practice, on which clinics are obliged to comply; the HGC can only recommend, however persuasively. As the HGC is an advisory body, it did not form part of the Department of Health's Review of Arm's Length Bodies in 2004. (The HGC, despite being a joint body of the DoH and the Office of Science and Technology, is not at arm's length, being firmly embedded in the Department.). The Department's basis for its exclusion was because the review "considered primarily those stand-alone national organisations sponsored by the Department of Health undertaking executive functions, which normally have boards, employ staff and publish accounts".[462]

365. It is worth considering whether a statutory policy function is necessary at all. We have declared that the foundation of legislation is to protect as far as possible the reproductive freedom of people wishing to have children. Any declared statutory policy can only erode the freedom of patients to make decisions in consultation with their doctors. Much of the HFEA's policy centres around the welfare of the child provision in Section 13(5), yet we have concluded that this is fundamentally discriminatory and should not be part of any future legislation. There is sufficient overlap between the policy and advisory functions of the HFEA and the Human Genetics Commission to provide a strong case for merger.

POLICING AND ACCREDITATION

366. At present the HFEA's Code of Practice embraces both technical standards and directions to treatment centres on its interpretation of the HFEA. It is debatable whether the HFEA was ever intended to police the Act and impose technical standards. The fact that it has is not a criticism of the Authority. The assisted reproduction subspecialty was embryonic in more ways than one in 1990 and, while the British Fertility Society (BFS) was formed in 1972, the Royal College of Obstetricians and Gynaecologists (RCOG) comments that "there has been a dearth of any clear standards from either the British Fertility Society or the Association of Clinical Embryologists (ACE) against which inspections could take place. Therefore the HFEA had to draw up its own Code of Practice in this vacuum".[463] ACE commented that "there exists no accreditation body for embryology laboratories. The Clinical Pathology Accreditation scheme (CPA) has expanded its portfolio to include andrology, but does not accredit embryology laboratories as the field is considered "too controversial".[464]

367. In 2004, on the instigation of the HFEA, the BFS worked with the ACE, the British Andrological Society, the Royal College of Nursing and the British Infertility Counselling Association to develop Standards for Assisted Conception Units. These standards reflect a desire to move from a system of licensing to an accreditation process. ACE says that the current HFEA inspection process does not amount to accreditation since insufficient time is spent on inspection and inspector training is inadequate and inappropriate.[465] The development of these standards coincides with the 2004 EU Tissue Directive, which will be transposed to UK law by April 2006.[466] The Directive introduces a skeleton framework for inspection and accreditation, incorporating amongst other things the establishment of a register of accredited establishments, guidelines for inspectors, and the requirement of a notification system for adverse incidents. The BFS is concerned about the duplication of regulation, but concludes that implementation of the Directive "gives an opportunity to ensure that we have robust, consistent and effective regulation".[467]

368. The BFS believes that the professional bodies' standards incorporate and should replace the current HFEA Code of Practice. It recommends that inspection should be carried out by professional inspectors with guidance from the professions and patient groups. During this inquiry the RCOG has undertaken to set up a committee under its auspices (to include the Royal College of Pathologists, the college responsible for embryologist accreditation) to draw up professional guidelines ready for the introduction of any new legislation.[468] The professional bodies' model would require them to be responsible in law for maintaining quality standards in compliance with the EU Directive. We supported the introduction of a professional inspectorate in paragraph 238. We see great merits in the professional bodies taking control of the technical and management standards and welcome the offer of the Royal College of Obstetricians to take responsibility under the auspices of the regulator in drawing up and maintaining these standards for centres concerned with the provision of storage or treatment services in compliance with the EU Tissue Directive.

ISO accreditation

369. The international standard for quality measurement is ISO 9001. Its application to assisted reproduction is widespread in Germany and is increasing in the UK, largely since the drug company Serono is funding the compliance by treatment centres. In the UK, ISO accreditation is awarded by BSI, which employs its own inspectors. It has been suggested that ISO accreditation can improve standards of care, including the safety of the procedures and success rates. This route of accreditation offers an alternative to that proposed by the professional bodies. The Department of Health says its has not encouraged or supported clinics to achieve ISO accreditation specifically, although it recognises that the EU Tissue Directive's emphasise on the importance of a 'quality systems' approach is "inspired by and has much in common with relevant ISO accreditation".[469] If the regulator can be assured that external forms of accreditation such as ISO 9001 comply with legislation following the transposition of the EU Directive into UK law, then such accredited facilities should be free to operate without additional scrutiny.

RISK MANAGEMENT

370. The Epalan consultancy, which provides risk management, training and public affairs services to those working in reproductive and genetic technologies, states that risk management in assisted reproduction is of fundamental importance, both for the protection of patients and for progress and the development of good practice in treatment and research. Epalan argues that "no-one has accepted responsibility for risk in ART in the UK […] the HFEA, was never intended to take responsibility for risk management and has consistently maintained that it does not have the resources to conduct the necessary follow-up studies and reviews that constitute an essential part of the process". It compares the HFEA with Canada's Assisted Human Reproduction Agency. Health Canada commissioned a review of all risk in ART (including psychosocial risks) reported in peer reviewed journals around the world. They then used this information to develop a risk management tool which will be used by the regulatory body in policy making, in regulation, and in advising the centres they licence. The tool will be updated so as to assess the risks associated with new reproductive technologies as and when they emerge.[470]

Box 14: Risk management and the Incident Alert System

Epalan believes that "The 'quality control' model proposed by the Directive is also more closely related to risk management and risk assessment so the transition would be easily made.".[471]

In response to the Toft Report on adverse incidents in Leeds, the HFEA announced an Incident Alert System in September 2003 to warn clinics about any incident which could have an adverse effect on patient care and staff safety. It will be the duty of the Person Responsible in each clinic to check their equipment or procedures and take avoiding action so that mistakes are not repeated.

The warning system came in response to a number of incidents involving either equipment failure or human error. It is hoped that the alert system will reduce the risk by enabling clinics to change the way they work. The type of incidents that would trigger an alert include equipment failure such as the freezer malfunction in the Western General Hospital in Edinburgh which led to the destruction of some sperm samples and human error such as the misreading of patient's name labels on sperm samples which happened at Leeds General Infirmary in the twins mix up case.

The HFEA requires Persons Responsible to ensure that any incident is reported to the HFEA without delay. An adverse incident means anything relating to treatment services which is potentially harmful or actually causes harm to any person, embryos, gametes or staff. In an average month about five incidents are reported to the HFEA. Typically these relate to equipment failure or breaches of protocol which cause serious concern but haven't done any actual harm. The Alert will be sent to all 110 licensed centres, HFEA inspectors and professional bodies such as British Fertility Society (BFS) and Association of Clinical Embryologists (ACE).

Role of clinicians

371. Opinion polls conducted by MORI on behalf of the British Medical Association have been tracking public trust in the professions for 20 years. Trust in the medical profession has risen steadily since 1983 from 82% 20 years ago, to 91% in 2003. This is higher than for any other professions that have featured in the polls.[472] Nevertheless, we have heard concerns from within and without the profession. Mr John Ford, a contributor to our e-consultation told us that "I do not know exactly what they are doing and were we to leave it up to them to regulate themselves I think they would decide to do what they wanted to do". It is interesting that he drew a distinction between the medics on the ground, who described as "superb" and those working in the "background".[473]

372. There are concerns from within the profession too. Vivian Nathanson of the BMA told us that "the fact that there is a strong regulatory framework helps to encourage public support for people who would otherwise, perhaps, sit on the fence".[474] Dr Martin Briggs is concerned that doctors do not always have an objective view of patients' quality of life, arguing "our 'expert' view as doctors of patients quality of life is heavily biased through being based mainly on our meeting them at the lowest points in their life i.e. when they are very ill and suffering[…] doctors should not be regarded as having 'expert knowledge' of the day-to-day reality of patient's lives such as to justify 'authoritative pronouncements' on the subjective quality of life of our patients".[475] An interesting feature of the evidence we have received from three medical bodies - the British Fertility Society, the Royal College of Obstetricians and Gynaecologists and the British Medical Association - is that the broader the remit of the body, the more cautious and conservative their views on assisted reproduction.

373. Jayson Whitaker, who sought preimplantation testing to conceive a child who was a tissue match for a sick sibling, told us "I think that, to a certain extent, [clinical decisions] should be left to the patient and the doctor but there does need to be some voice of reason in there. What I am not advocating is carte blanche to go off and have PGD for anything you fancy. There should be some voice of reason but not as regulated as it is at the moment."[476] Mr Tony Gilland, a contributor to our online consultation, told us that that responsibility for decision-making should shift away from the public and the experts to the individuals concerned.[477]

374. The independence of doctors to respond to the problems of their patients is at the heart of the welfare of the child debate. We have heard concerns that there is a danger that doctors, in feeling sympathetic to patients' fertility problems, lose sight of the bigger picture. Dr Alexina McWhinnie and Professor Alastair Bissett-Johnson from Dundee University quote Peter Brinsden, Medical Director at the Bourne Hall Clinic:

"It is impossible for us as caring individuals not to be strongly influenced by a couple's particular needs, and yet there may be a conflict between what we believe may be the best option for them and what is 'right' or 'ethical' to society […] It is possible for us clinicians in particular to become so 'wrapped up' in what we perceive to be best for the couple that we do not see the wider picture'."[478]

Dr McWhinnie and Professor Bissett-Johnson use this to counter arguments for reproductive freedom. In our view this provides a strong argument for the use of clinical ethics committees to provide a broader input into clinical decision-making.[479]

Review of arms length bodies

375. The Department of Health undertook a review of its arms-length bodies including the HFEA. The review is aimed at reforming the arms-length body sector to achieve the objectives of:

a)  maximum devolution of responsibility to front line NHS and social care

b)  improved efficiency across the sector with minimal bureaucratic overhead

c)  closer working across boundaries between health and social care; and

d)  minimised burden of inspection and regulation on health and social care services without reduced effectiveness.

The Secretary of State has decided that, against a baseline year of 2003/04, the parameters for the review should be:

e)  a 50% reduction in the number of arms-length bodies

f)  a saving in expenditure by arms-length bodies of £0.5 billion by 2007/08; and

g)  a reduction in posts of 25% in the same period.

The Department of Health's Report on Reconfiguring the Department of Health's Arm's Length Bodies concluded that the HFEA should be merged with the proposed Human Tissue Authority to form RAFT (Regulatory Authority for Fertility and Tissue).[480] According to the Report, the merger reflects the many similarities between the HFEA and the HTA, both of which are designed to:

h)  be competent authorities under the EU Tissues and Cells directive

i)  regulate ethically sensitive areas

j)  focus on technical matters of safety and quality

k)  set standards

l)  enforce compliance

m)  cover research as well as therapy

n)  cover settings outside healthcare, e.g. sperm banks (HFEA) and university anatomy schools (HTA)

o)  operate UK wide

376. The creation of RAFT requires primary legislation. The aim is to start up RAFT by 1 April 2008, merging HFEA and HTA in the process. In the meantime a minimalist HTA (shadow board by April 2005 and an ENDPB by April 2006) will be set up using HFEA accommodation and corporate services. HTA Chair and members will be recruited for the period 2005-2008. A shadow RAFT will be set up in 2007-08. The merger has not been universally popular. The solicitor James Lawford Davies told the Committee "I think it was a moment of reckless abandonment to suggest that the HFEA and the Human Tissue Authority should be joined together".[481] According to Professor Margaret Brazier, this is "profoundly misguided" and "RAFT will either have to be so large that it cannot function effectively or any expertise in its diverse subject matter will be so dilute as to be useless. Lay representation will become tokenism. The subject matter which the proposed partners in RAFT will address is entirely different".[482] She told the Committee "I think it would be disastrous to merge the two authorities.".[483] Suzi Leather, Chair of the HFEA, wrote to the Department of Health on 7 June expressing the Authority's concern at the review, citing the HFEA's "vital, highly specialised functions in an area of acutely sensitive and highly contested public policy" and setting out 10 reasons for retaining the status quo. If there was to be radical change, she said, "the best option would be to merge the HFEA with the Human Tissue Authority". Ms Leather is now more in favour, describing the merger as "sensible".[484] We have argued for the rationalisation of advisory bodies in the past as they have a habit of springing up to plug holes without proper consideration.[485] Our concern here is that the exercise has more to do with the political need to portray Government as lean and efficient. More specifically, we have concerns that the merger will hamper any progress in reforming the regulation of assisted reproduction and embryo research. The creation of the Regulatory Authority for Fertility and Tissue seems to be the result of political pressure to be seen to be reducing bureaucracy rather than a logical move . Nevertheless, we share the Department's wish to see fewer appendages to central Government and recognise that the merger of the regulatory functions of the HFEA and the HTA has its merits as long as its implementation recognises that there are big differences in the activities they regulate, as well as similarities. However, its activities should be restricted to the oversight of assisted reproduction to technical standards and quality management.

International dimension

377. The Warnock Committee recognised that the problems it faced were not confined to the UK and accepted that there was "an obvious attraction" in pursuing an international approach but noted that "Different countries […] have different cultural, moral and legal traditions, influencing the way a problem is tackled and the ways in which it might be resolved".[486]

HARMONISATION OF LEGISLATION

378. There are two reasons why one might wish to harmonise legislation in assisted reproduction and embryo research on a regional or global basis. First, for practical reasons to ensure common standards and definitions and, second, to develop common ethical standards. At a European level the problem is what competence the EU has to pass such laws. Clearly the Tissue and Cells Directive will have an impact[487] but it is doubtful if that could or should be replicated in relation to, say, treatment services.

International monitoring programmes

379. Sweden has established two permanent and independent systems to monitor assisted reproductive technology outcomes. Furthermore, several national ad hoc research projects have been conducted using information from these two national databases.[488] A World Health Organization conference in 2001 identified the need for more national and international IVF registries. The Medical Research Council says that harmonising international monitoring programmes would provide the "maximum statistical power particularly for the analysis of putative adverse events".[489] In the UK such a registry would require changes to the HFE Act. Section 33 demands that no member or employee of the HFEA disclose any information held on its register. We have recommended that the confidentiality provisions in the HFE Act need to be relaxed. This should be accompanied by efforts to use UK data to inform the international monitoring of the risks of assisted reproduction.

Trade in gametes

380. Professor Donna Dickenson from Birkbeck College, London has drawn our attention to the global trade in oocytes as a result of their shortage for IVF purposes and their value in stem cell research. She states that payments of up to $50,000 per cycle have been reported, with up to 70 oocytes being extracted in some cases. It seems highly likely that poor women in the Third World and in Eastern Europe will be the targets of this trade. Professor Dickenson points out that the HFEA has taken some steps towards attempting to regulate this international trade, for example by overseeing procedures under which ova are imported from Romania, but it is clear that some international oversight will be necessary.

381. We see major advantages in creating international standards in the handling and export of human gametes and embryos to improve the consistency and quality of procedures, protect those at risk of exploitation and improve the monitoring of treatments and risks.

REPRODUCTIVE TOURISM

382. The lack of international legislation means that individuals can and do seek treatment abroad that they cannot in their own country. Cheaper treatment can also provide an incentive to what is often termed reproductive tourism. While the HFEA has control over the import and export of gametes and embryos, it has no powers to prevent patients seeking treatment abroad nor clinicians from assisted patients going overseas. Examples of seeking treatment abroad have been for sex selection (often to Spain or the USA) and preimplantation tissue typing (often to the USA). It has been suggested that the removal of donor anonymity will lead to patients going abroad to seek donated sperm (quite likely to Denmark).[490] PROGAR, a multidisciplinary body under the auspices of the British Association of Social Workers says that "for many people, the biological drive and social pressure to have children will cause them to try to get round any perceived restrictions. People will always devise their own reproductive strategies whatever the prevailing culture's official view." As Jayson Whitaker, who went with his wife to the US for preimplantation tissue-typing put it, "let us be totally honest and totally brutal. If I decide that I want to have a girl next time and you cannot do it in the UK, then I can go to a European country or I can go to an American country or I can go to all sorts of other places and have it done. To me, it does not matter whether I have boys or girls but people may have an overwhelming desire to have one sex or another.".[491] Professor Margaret Brazier from Manchester University told us that "No system of regulation can eliminate or effectively control procreative tourism. One basic question needs to be addressed. The provisions of the HFEA concerning parental status are important in securing the welfare of the child once born. Amendment to the HFE Act should make provision for status rules concerning the recognition of the status of children born after fertility treatment outside the UK."

383. We have heard demands to limit the ability of patients to circumvent UK legislation and regulation. The Christian Medical Fellowship would like to see clinics licensed by the HFEA prevented from importing embryos obtained from abroad using techniques illegal in the UK, nor export embryos created here by techniques that are illegal abroad.[492] A Report commissioned by the Department of Health and published in 1998 also recommended that the export provision of the 1990 Act should be clarified to ensure that gametes obtained unlawfully in the UK could not be exported for treatment in other European countries. Dr David King, a contributor to our online consultation, points out there is a precedent for making it an offence in the UK to either refer people to abroad or to go abroad oneself to do something which would be illegal in the UK.[493] Professor Brazier said that "Extra-territoriality is a very difficult area of criminal jurisdiction. For a very long time we limited our extra-territorial jurisdiction to offences such as homicide and offences against the Crown: sedition and treason. I do not believe that such extensive invasions of personal freedom would be compatible with either the European Union treaties in relation to freedom of movement and freedom of services or the human rights provision.".

384. The Sexual Offences Act 2003 tightened up the regulation of sex offenders. Registered sex offenders must notify their local police before they travel abroad, where the trip exceeds three days. The local Police then decide whether to notify the country concerned on the basis of a risk assessment and knowledge of the individual. Extra-territorial legislation can be used to prosecute UK nationals or residents for sex offences committed against children overseas.[494] However, extraterritorial legislation can only be applied if the behaviour is illegal in the country where it is being committed, thus it could not be used to prevent people from travelling overseas to use cloning technology unless it was illegal in that country. Professor Brazier did argue that there was value in introducing certain common standards in the EU to combat procreative tourism, to harmonise the status of children born as a result of assisted reproduction and to ensure common competency".[495]

385. A paper presented at a recent meeting of the European Society of Human Reproduction and Embryology indicated that the availability of cheaper IVF in some Eastern European countries may lead to an increase in "reproductive tourism".[496] The HFEA has issued a press release warning of the dangers of unregulated clinics. Suzi Leather repeated this warning in giving evidence[…]We are not sure what evidence she has to support this statement other than the notion that regulation necessarily leads to safer practice. The EU Tissue Directive will come into force in 2006 in 25 European nations. Given that the standards this imposes on the handling of gametes in treatment centres is higher than that required by the HFEA, we would see no reason to discourage UK citizens to seek cheaper treatment in these countries. The Department of Health told us that they gave no guidance to patients thinking of seeking treatment abroad but the HFEA has produced a leaflet entitled "Thinking of going abroad for fertility treatment or using donor material from abroad?".[497] It declares that "IVF treatment in the UK is the safest in the world. No other country has this system of independent regulation". We have discussed above the weaknesses in the HFEA's inspection processes and the high standards of treatment in some other European countries. It makes the mistake of believing that tight regulation is good regulation. As we stated in Chapter 5, there are good grounds for concluding that the HFEA's regulation has not been good regulation. We believe that any attempts to curtail reproductive tourism would not be justified by the seriousness of the offence. Moreover, it would be impossible to enforce if the treatment was legal in the country concerned. Nevertheless, anyone considering such a course of action should be aware of any risks involved. It would be inappropriate for the HFEA to encourage patients to go overseas for treatments that were either prohibited or prevented in the UK; however, we consider the HFEA's guidance to be misleading and complacent. We recommend that it provide more detailed guidance on treatment overseas based on evidence not on prejudice.

INTERNATIONAL SCIENCE

386. The issue of reproductive tourism has its parallels in scientific research. The UK has been the beneficiary of the USA's conservative federal stance on embryonic stem cell research. Of course this is a feature in many scientific fields, with researchers moving to countries where they can best undertake the research they wish to do (even if the motive is often financial). This has implications for the development of reproductive technologies. Dr Richard Fleming, a contributor to our online consultation, told us that "Progress is going to happen whether it happens here or not. If it happens in a country where we are not happy with their ethical approach, does that mean we are not going to take any notice of it and is our community not going to benefit from some of this other work?".[498]

International treaties

387. It is extremely difficult to introduce international or harmonised legislation. In some areas, there may be little justification for harmonisation and it is reasonable for national legislation to reflect the traditions of the relevant country, even if it results in the reproductive tourism (see above in paragraphs 383-386). In other areas, there are good reasons for achieving a consensus at a European or global level. This may be to establish fundamental ethical guidelines or to remove legal anomalies that may arise if people seek treatment overseas. It is therefore necessary to consider our legislative proposals in the international context. It was suggested by Josephine Quintavalle during the Committee's launch of its e-consultation on 22 January 2004 that the UK had a responsibility in setting a good example for other countries. It has certainly been suggested that the UK is seen as being highly influential its approach to regulation of assisted reproduction and embryo research, although, as we have discussed above, we suspect this is exaggerated. We recognise there are practical constraints to any regulatory proposals but ultimately the UK Government should do what it thinks is best for the those who receive and deliver these services and for the wider public in the UK. The Centre for Bioethics and Public Policy has drawn our attention to the UK's apparent "international isolation of the UK in permitting the creation of cloned human embryos".[499] However, being in a minority does not necessarily make you wrong. As the BioIndustry Association puts it, "it is essential that the principle of subsidiarity is maintained".[500] It is right that we should learn what we can from the example of others and we should offer what advice we can to other nations. We accept they will do what best reflects their culture and traditions. Charters, declarations and treaties no doubt keep diplomats busy and fulfilled but there are some ethical issues which are the domain of nation states and cultures. We should respect the cultures and desires of others and not seek to impose our own ideas. Such charters can only produce vague, lowest common-denominator agreements that are of questionable clarity and dubious effectiveness. Further attempts should be resisted until legislation and regulation are more widespread and the common threads can be identified.

LEGISLATION AROUND THE WORLD

388. The first IVF legislation in the world was enacted in Victoria, Australia in 1984 and must countries where it is widely practised now have legislation. A noteworthy exception is Finland, which by most measures has the highest quality treatment in the world and 2.3% of live births are as a result of IVF or ICSI in 2000.[501] We have been struck by how little comparative information there is about the approach to legislation and regulation in other countries. We understand that the Progress Educational Trust approached the Department of Health in August 2004 for funding to undertake a comparative study of international approaches to legislation and regulation, but this was refused. However, Progress has been able to assemble some preliminary information, which it has generously agreed to share with us.

389. Whatever the Department's reasons, it is unfortunate that this information is not available. In our 2002 report on Developments in Human Genetics and Embryology we expressed surprise that the House of Lords Stem Cell Research Committee referred to the esteem with which the HFEA was held overseas without any supporting evidence.[502] As Professor Robert Winston comments, "Over the last 15 years, many countries have looked at the British system of regulation and rejected it. Indeed, there is not a single member of the European Union with a precisely similar body.".[503] The HFEA unwittingly concedes this in declaring IVF in the UK as the safest in the world as "No other country has this system of independent regulation".[504] Despite this, the Minister maintained that "we are regarded very highly internationally as a result of the arrangements we have here".[505] From our discussions in Sweden, it seems that the UK system is seen as being rather burdensome. Perhaps the only country where the regulatory model show strong similarities to the UK's is in Canada, where the Assisted Human Reproduction Act 2004, passed after years of deliberation, creates the Assisted Human Reproduction Agency of Canada. A new bioethics law, passed in France in July 2004 created a new agency, which will have a similar remit to the HFEA to regulate embryology and reproduction. The Government claims that our regulation of assisted reproduction is highly regarded with little substance to support this view, which betrays a worrying complacency. We recommend that the Government, as a first step in its review of the HFE Act, conduct a review of regulatory models overseas and their effectiveness in maintaining public confidence, protecting patients and promoting safe and effective treatment. Given that the Progress Educational Trust has made a start, it would be well placed to continue this work, with appropriate funding, on behalf of the Department of Health.

Box 15: Canada's Assisted Human Reproduction Act 2004

The Assisted Human Reproduction Agency of Canada has a Board of Directors, analogous to the Authority but while the Act specifies that a range of backgrounds should be represented, a person is not eligible to be a member of the board of directors if they hold a licence or are an applicant for a licence or a director, officer, shareholder or partner of a licensee or applicant for a licence.[506] Canada has recently established a regulatory body to oversee the area of assisted human reproduction and related research. The Assisted Human Reproduction Agency of Canada will be separate from Health Canada, but will report to Parliament through the Minister of Health. The body is similar to the HFEA and it employs a system of prohibited and controlled activities. There are important differences in the legislation. It is based on a system of risk management and therapeutic cloning is expressly forbidden.

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417   ^{BetterRegulationTaskForce,AlternativestoRegulation,January2004} Back

418   ^{Thisisthelastyearforwhichcomparativedataareavailable.} Back

419   ^Q651 Back

420   ^{February2004,paraE2.2} Back

421   ^Q1165 Back

422   ^Q1270 Back

423   ^Ev431 Back

424   ^Q1057 Back

425   ^Q31 Back

426   ^Q227 Back

427   ^{LordWarner,WrittenMinisterialStatement,17November2004} Back

428   ^{www.mrc.ac.uk} Back

429   ^Q1268 Back

430   ^Q1112 Back

431   ^{LenDoyal,Clinicalethicscommitteesandtheformulationofhealthcarepolicy,JournalofMedicalEthics,2001;27:i44-i49} Back

432   ^{Q 1088} Back

433   ^Ev402 Back

434   ^Ev401 Back

435   ^{Cardinaldemandstougherscrutinyoverfertilityresearch,DailyTelegraph,20December2004} Back

436   ^{www.ccne-ethique.fr} Back

437   ^{ThisprivateletterwassenttotheChairman.TheNuffieldCouncildidnotwishtomakethispublicbutinsteadmadeawrittensubmissiontotheCommittee(Ev394)outliningtheirconcernsonthisissue.} Back

438   ^Q899,Ev394 Back

439   ^Q899 Back

440   ^Ev400 Back

441   ^Q1257 Back

442  ^Ev399 Back

443   ^{HC(2001-02)791} Back

444   ^Asabove Back

445   ^Q851 Back

446  ^Qq47,128 Back

447   ^Ev222 Back

448   ^Q225 Back

449   ^Q851 Back

450   ^Q1241 Back

451   ^{www.pollingreport.com/science.htm;www.mori.com/polls/2003/amrc.shtml} Back

452   ^Ev363 Back

453   ^Q1026 Back

454   ^Ev221 Back

455   ^Ev265 Back

456   ^Ev276 Back

457   ^{Seeparas209-218} Back

458   ^Q40 Back

459   ^Seeparas 219-221 Back

460   ^Q899 Back

461   ^{HumanGeneticsCommission,Choosingthefuture:geneticsandreproductivedecisionmaking,July2004;www.hgc.gov.uk} Back

462   ^Ev427 Back

463   ^Ev369 Back

464   ^Ev244 Back

465  ^Ev244 Back

466   ^{ExistinglicensingcentresintheUKhavebeengivenayear'sgracetocomplywiththeDirectiveandmustcompybyApril2007.} Back

467   ^Ev214 Back

468   ^Ev370 Back

469   ^Ev430 Back

470   ^Ev347 Back

471   ^Ev349 Back

472   ^{www.mori.com/polls/2003/bma.shtml} Back

473   ^Q153 Back

474   ^Q816 Back

475   ^Ev206 Back

476   ^Q589 Back

477   ^Q155 Back

478   ^Ev409 Back

479   ^Ev408 Back

480   ^{DepartmentofHealth,ReconfiguringtheDepartmentofHealth'sArm'sLengthBodies,July2004} Back

481   ^Q891 Back

482   ^Ev367-368 Back

483   ^Q892 Back

484   ^Q1278 Back

485   ^{HC(2001-02)791} Back

486   ^para1.8 Back

487   See paras 84, 89, 236-238, 368-370, 386 Back

488   ^{KarlNygren,TheSwedishexperienceofassistedreproductivetechnologiessurveillance,}In Current Practices and Controversies in Assisted Reproduction, WHO, 2002, Section 6 Back

489   ^Ev436 Back

490   ^Ev435 Back

491   ^Q584 Back

492   ^Ev218 Back

493   ^Q166 Back

494   ^{www.fco.gov.uk} Back

495   ^Q864 Back

496  ^{ESHREEuropeanIVFMonitoringreport,20thannualconferenceoftheEuropeanSocietyofHumanReproductionandEmbryology,July2004} Back

497   ^{Issued12July2004} Back

498   ^Q228 Back

499   ^Ev237 Back

500   ^Ev279 Back

501   ^{AssistedreproductivetechnologyinEurope,2000.ResultsgeneratedfromEuropeanregistersbyESHRE,HumanReproductionVol.19,No.3pp.490-503,2004} Back

502   ^{HC(2001-02)791} Back

503   ^Ev424 Back

504   ^{HFEA,Thinkingofgoingabroadforfertilitytreatmentorusingdonormaterialfromabroad?,July2004} Back

505   ^Q1328 Back

506   ^Clause26 Back

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Prepared 24 March 2005