Joint committee on the Human Tissue and Embryos (Draft) Bill

Joint committee on the Human Tissue and Embryos (Draft) Bill First Report

Chapter 5: part 1 of the draft bill—the regulatory authority for tissue and embryos

57. The merger of the Human Fertilisation and Embryology Authority (HFEA), the Human Tissue Authority (HTA) and some functions of the Medicines and Healthcare Products Regulatory Agency (MHRA) to form the Regulatory Authority for Tissue and Embryos (RATE) was first proposed by the Department of Health's review of arm's length bodies in 2004. The provisions covering RATE are set out in Part 1 of, and Schedule 1 to, the draft Bill, and include: the designation of RATE as the competent authority for the implementation of the EU Tissue Directive[41]; the appointment of the Chair of RATE (by the Secretary of State) and a board, of which at least half of the members must be lay members; and the appointment of at least three Expert Advisory Panels (EAPs) to advise RATE (on reproductive medicine and embryo research; anatomy and pathology; and blood and transplantation).

58. On 1 January 2007, Shirley Harrison was appointed Joint Chair of the HFEA and the HTA to "oversee the work of both Authorities until—pending legislation—the new Regulatory Authority for Tissue and Embryos (RATE) is established."[42] Shirley Harrison had been a member of the HTA since 2005, and its interim Chair since 2006 and, as she told the Committee, the merger had been in mind since the HTA's inception in 2005. (Q 155) In evidence to the committee, the HFEA and the HTA both argued that it was their responsibility "to plan on the basis that RATE is likely to go ahead" and that they were already working together to streamline regulation in this area. (Ev11(a) and Ev12(a))

RATE

59. We have heard a number of explanations of the proposal to set up RATE. The introduction to the draft Bill states that "The Government is committed to establishing RATE as part of its wider review of arms-length bodies",[43] something which the Chief Medical Officer, Sir Liam Donaldson, confirmed. (Q 226)

60. Sir Liam also told us that the EU Tissue Directive pushed in the direction of a merger of the two authorities. He noted synergies between the two, including the relationship between stem cells and potential transplantation of tissues and (potentially) organs, and in terms of the potential of science to draw the work of the two authorities together. (Q 226)This was echoed by the Minister who said that "Currently, we have the HTA, the HFEA and the MHRA as the competent authorities. If we were starting from ground zero … one would not necessarily think that creating three organisations would be the best way forward." She also saw overlaps, such as hospitals conducting "work in relation to tissue as well as in relation to IVF, so there are opportunities there for possibly joint inspections", and the elimination of duplication. (Q 489)

61. The Minister also claimed that RATE would provide added flexibility (through the EAP model), increased efficiency and potential cost savings, although she "would not put cost in and of itself above, for example, whether we can be more effective in terms of how we regulate."[44] (Q 487) Shirley Harrison acknowledged that some 'back office functions' were being "done together already". (Q 161)

62. When asked, the Minister denied that RATE was, in effect, 'gold-plating' the EU Tissue Directive, since it "arose out of looking across government at arm's length organisations". However, she acknowledged that "It just so happens that at the same time, alongside that, the EU Directive also clearly indicates that that might be a better model in terms of dealing with that expansive piece of legislation." (Q 511)

63. We note that in putting forward the case for RATE, the Government presented no research on or assessment of the impact of the current regulatory model before proposals were made to reform it.

64. We received many strong opinions on the formation of RATE. A small minority of witnesses were either neutral about the proposal or saw some potential benefits, largely in terms of efficiency gains and synergies in existing work. However, we were struck by the large majority of witnesses who either expressed concern or were opposed outright to the merger going ahead. We explore this in more detail below.

RATE: EFFICIENCY OR MORE BUREAUCRACY?

65. The Institute of Biomedical Science concluded that "The amalgamation of the HFEA and HTA into a single authority will be helpful" to "avoid some areas of duplication and … any potentially conflicting activities or regulations." (Ev34)[45] Both the HFEA and the HTA cited synergies in their work, such as "the regulation of embryonic stem cells", where "currently the HFEA regulates the creation of the embryos to make cell lines, whilst the HTA regulates activities, like their storage, associated with patient treatment." However, the HFEA also told us that it had written to the Department of Health in June 2004 outlining the risks of a merger, including: the loss of a dedicated organisation for embryos which in the public's eye merits separate attention from healthcare in general; loss of expertise from one dedicated organisation; risk of less focussed public accountability; and a loss of reputation and 'brand image'. Yet the HFEA also recognised that "if a radical change to the HFEA was inevitable" a merger with the HTA carried "least risk". (Ev11(a) and Ev12(a))

66. However, against this, we had overwhelming evidence against establishing RATE. The Royal College of Obstetricians and Gynaecologists, the British Medical Association (BMA), the Royal Society, the Association of Medical Research Charities (AMRC), the Academy of Medical Sciences, Cancer Research UK, Infertility Network UK, the Royal College of Nursing, the British Fertility Society, the Wellcome Trust, the Medical Research Council (MRC), and the Royal College of Pathologists all expressed profound reservations about the proposed model.[46]

67. Professor Sir Ian Kennedy, Emeritus Professor of Health Law, Ethics and Policy, School of Public Policy, University College London, and Chairman of the Healthcare Commission, pointed out that "tidiness is not necessarily synonymous with effectiveness; amalgamating them is on its face tidy but it may not be effective." He added that "in all such amalgamations history tells us that very often you go back to ground zero" and that "such mergers or amalgamations really lose you two years of expertise and administrative skills as you catch up." (Q 744) Charles Kingsland, Consultant Gynaecologist and Clinical Director of the Hewitt Centre in Liverpool, said that "all I can see is added expense, added bureaucracy, with no benefit to my patients." (Q 428) Professor Martin Bobrow, Chair of the Academy of Medical Sciences working party on inter-species embryos, thought that "The analysis that puts the two together … is very superficial" (Q 919), whilst Simon Denegri, Chief Executive of the Association of Medical Research Charities, said that "The business case behind it does not feel very strong." (Q 920) Dr Tony Calland, Chairman of the Medical Ethics Committee at the BMA said "we do not necessarily feel that if these two bodies were to work effectively RATE would be either cheaper, or, in fact, more effective or less bureaucratic". (Q 63)

RATE: BRINGING TISSUE AND EMBRYOS TOGETHER

68. Several witnesses expressed concern that RATE would bring together the regulation of what they saw as two quite different things. For example, Professor Bobrow claimed that "The HTA is essentially concerned entirely with the policing of consent, important but quite trivial in a deep philosophical sense. The HFEA with its remit to look at all aspects of embryology deals with a much wider, more complex range of issues." (Q 919)

69. In oral evidence, we discussed these concerns. Charles Kingsland agreed that there is a "significant difference" between the two and he could not "be persuaded that [embryos] go along with tissue". (Q 436) Dr Gillian Lockwood, Medical Director of Midland Fertility Services, spoke for many when she said that the moral status of the embryo "does appear to be unique":

"You only have to talk to patients who have frozen embryos before and after their treatment cycle to appreciate what a subtle change happens … At the point that they have already had a successful baby from their fresh transfer, and they come back two or three years later to use their frozen embryos, those are not just a little bundle of cells any more; that is a brother or sister for their existing IVF baby. As long as that is the mindset that patients have, and I think to a large extent society has, we cannot be quite so cavalier about what exactly it is we are looking at down the microscope." (Q 433)[47]

70. Dr Mark Hamilton, Chair of the British Fertility Society, and Dr Dave Morroll, Chair of the Association of Clinical Embryologists, agreed but suggested there might be a distinction between embryos to be used for treatment and embryos used for research purposes. (QQ 379-381) Dr Simon Fishel, Managing Director of the CARE Fertility Group, argued from a different perspective that tissue and embryos were not of equivalent status since "Tissue is a more elevated structure, a more complex structure, than four cells as a product of conception". (QQ 430-1)

71. In her letter of 27 June to the Chairman, the Minister claimed that "we take the view that RATE would be established, primarily, to regulate tissue, albeit a range of tissue in various forms."[48] This curious approach stands at odds not only with the majority of the evidence we have heard, but also with the Government's own approach expressed elsewhere.

72. In addition, we also explored the concerns of some witnesses who felt that the name 'RATE' itself implies something of a moral equivalence between embryos and other human tissue. For example, the Christian Medical Fellowship, in common with the Church of England Mission and Public Affairs Council, felt that "it is a fundamental mistake of principle to conflate 'human tissue'—about which ethical concerns are relatively limited and widely agreed—with human embryos, each of whom is a unique being, an embryonic human, worthy of far greater degrees of respect than currently enjoyed, and worthy, we believe, of real protection in law." (Ev26)[49] However, Shirley Harrison told us that "there is something to be said for it doing what it says on the tin and making it clear what it is regulating". (QQ 171-172) Similarly, the Minister confirmed that "we really just wanted to find something so that it was easy for people to see what was on the front of the can", and said that the Government "were not applying any sort of moral priority to at which point the word came in the title". (Q 504)

HFEA REPUTATION: DOMESTICALLY AND INTERNATIONALLY

73. Some witnesses felt strongly that the HFEA's professional reputation may be lost in any merger. For example, Dr Stephen Minger, Director of the Stem Cell Biology Laboratory, Wolfson Centre for Age-Related Diseases at King's College London, told us "I have always held this up as the model regulatory environment for doing embryonic stem cell research and embryo research in general. My concern would be that by merging the two entities together you lose that special status of the HFEA, it becomes a watered-down, less tightly regulated and less respectable organisation. It is fair to say that the HFEA is very highly regarded in this country by the general public and certainly by the scientific community, maybe less so by the reproductive medical community." (Q 598)[50]

74. Both Shirley Harrison and the Minister sought to give examples demonstrating the HFEA's international reputation. (QQ 146, 485) As we have seen in paragraph 65, the HFEA had already expressed concern to Government that this reputation could be lost if a merger took place.[51] In answer to this charge, the Minister acknowledged that "Nobody wants to jeopardise a good reputation for the sake of a restructuring but I think there are very good sound reasons strategically and operationally for this change to happen."(Q 497)

75. Others were worried that a switch to RATE could undermine public confidence in this country. Mark Henderson, Science Editor of The Times¸ pointed out that the name recognition of the HFEA "should not be underestimated", because "people know what it is" and that "it may perhaps be a little foolish to jettison that." (Q 300)[52] Infertility Network UK also warned that the sector "might not benefit from the exclusivity it currently experiences by having more than one regulatory body purely devoted to it." (Ev58, p2)

BREADTH OF FUNCTIONS

76. There was also a strong feeling amongst witnesses that there would be a loss of specialist expertise under RATE, particularly because RATE would have such a wide remit. Both the HFEA and the HTA were particularly conscious of their stakeholders' concerns in this respect. (Ev11(a), para 15, Ev12(a)) Infertility Network UK, the British Association of Counselling and Psychotherapy, and the Royal College of Pathologists all told us that they were worried that their area of work would be "lost" in the new expanded Authority. (QQ 708, 362, 63) The joint submission by the Wellcome Trust and the MRC acknowledged that "RATE will regulate a wide range of sectors, including anatomy, pathology, transplantation, blood transfusion, post mortem research, museums and galleries, fertility treatment, and embryo research"—"highly technical" issues which "raise a uniquely difficult and diverse combination of ethical, scientific and public policy issues." (Ev09, p2)

77. Likewise, the Royal College of Obstetricians and Gynaecologists reminded us that an HFEA membership of 20 had been criticised for not having sufficient breadth of specialist knowledge. (Ev08, para 1.1) For the BMA, "The fundamental problem" was that RATE "will not have expertise in the areas it is regulating", and may therefore lack credibility amongst the public, patients, Parliament, or those being regulated. (Ev07, pp1-2)

78. Others argued that the HFEA and the HTA struggled to manage their existing remits. Dr Stephen Minger argued that "The HFEA has been under-resourced for years and over-burdened and in ten years it has expanded", (Q 608) whilst Professor Sir Richard Gardner, Edward Penley Abraham Research Professor of the Royal Society in the University of Oxford, told us that some of his colleagues working on human embryology complain that the HFEA can be rather slow in deliberating about licenses. (Q 740)

79. Greater concern was expressed about the HTA's current remit. Cancer Research UK told us that "the HTA is currently overwhelmed by the variety and quantity of its workload", and that two of its own license applications were "only now being reviewed, some 10 months later." (Ev94) The Wellcome Trust and MRC claimed that the HTA "rations its resources according to the relative risks of the various activities and sectors it regulates." This has meant that "Most of the organisations seeking licences for research or display since September 2006 still operate on the basis of deemed licences rather than full HTA licences." (Ev09) The Royal College of Pathologists, one of the HTA's key stakeholders, affirmed that the HTA had "struggled to cope with a workload spanning mortuaries, transplantation of solid organs, transplantation of cells, biomedical research, NHS diagnostic laboratories, anatomy training of medical students, genetic tests and the storage and disposal of diverse human material, from urine to products of conception. We believe that the remit of the HTA has proved to be considerably more complex than was envisaged by those who established it." (Ev06, pp1-2)

80. The Royal Society felt that RATE would not be able to cope with its workload without an unwieldy "over reliance upon sub-committees, expert advisory panels and working groups."(Ev59). Meanwhile, the Wellcome Trust and the MRC pointed out that the models and culture of regulation were very different, in that the HFEA "licenses research on an individual project basis, whereas the HTA licenses the storage of tissue for research on the basis of premises." They asserted that this would make the "transition process particularly challenging", and would reduce the scope for cost savings. (Ev09, p3)

81. We have already seen the Department of Health, and the HFEA and HTA, draw attention to potential synergies between the authorities. The Minister also expressed the hope that RATE would create opportunities to "streamline … some of the licensed processes." (Q 487) Yet for the majority of witnesses who commented, any potential gains were at best neutralised, or at worst heavily outweighed, by the potential drawbacks.

82. There was however one area where some witnesses were willing to accept that synergies could be made—through the merger of 'back office' functions. But even here the evidence was mixed. Professor Peter Braude, Head of the Department for Women's Health, King's College London, and Chairman of the Scientific Advisory committee of the Royal College of Obstetricians and Gynaecologists, pointed out that back office savings "are probably already taking place. You already have a joint chair, you already have sharing of personnel and various other aspects, they could share premises and there could be interchangeable ideas—why push them together in such a complex, massive body which is going to be more expensive". (Q 63)[53]

RATE's constitution and the Expert Advisory Panel (EAP) model

83. The Minister argued that the EAP model "potentially has an opportunity to be better than what we currently have, which is effectively a board of a limited size, of a limited number of people on it at any one time who bring their own expertise to it. They are doing a good job, I am sure, but we think there is added value to the process through the model we are suggesting." (Q 496)

84. The Minister, together with Gareth Jones, Director of Scientific Development at the Department of Health, said that the model would provide RATE with flexibility—both in terms of the panels that it set up, and in terms of those who were invited to join them. Gareth Jones said that the model that seemed to work elsewhere was to separate out the expert advice from decision-making. (QQ 498-499)

85. Other witnesses were less convinced. The Royal College of Obstetricians and Gynaecologists argued that there would be "two 'expert advisory bodies' reporting to [RATE]; all but in name being the HFEA and the HTA but without any executive function." They feared that RATE would be "nothing more than an overburdened rubberstamping authority having neither the expertise to fully understand some of the background to the decisions reached by each expert committee, nor the breadth to cover the gigantic range of specialist areas it must cover". (Ev08, para 1.2.1) The BMA, the Royal Society and the Royal College of Pathologists agreed with much of this. (Ev07, para 3, Ev59, p2, Ev06, para 7)

THE DRAFT FULL REGULATORY IMPACT ASSESSMENT: COSTS AND SAVINGS

86. We also gave some consideration to the costs and possible savings under RATE, as set out in the Government's Draft Full Regulatory Impact Assessment (RIA).

87. The RIA claimed that "The estimated saving is approximately £700,000 per annum. These savings represent around 10% of operating costs of the HTA and HFEA, which is a useful guide in terms of merged organisations and potential savings."[54] However, we had concerns about how robust these assessments were. In oral evidence, Gareth Jones said this was "a rough estimate" and "I would not want to be held to that". (Q 522) The Wellcome Trust and MRC noted that it would take more than eight years for the savings to offset the costs of the merger. (Ev09)

88. The Minister told us that "the savings have not been independently verified as this is a calculation based on previous mergers and recognising that some of the savings made will be used to improve the effectiveness of the new organisation, for example in setting up and servicing Expert Advisory Panels."[55] This implies that the level of savings would be in inverse proportion to the number of EAPs set up. Shirley Harrison told us that "It may be that RATE decides that it needs lots and lots of committees, in which case there may be a larger burden of bureaucracy and more cost." (Q 192)

89. We found the evidence on the transition costs of RATE also lacked robustness and precision. The RIA estimated transitional costs to be in the range £2m to £6m "depending mainly upon issues of shared accommodation and ultimate location of RATE."[56] The Minister told us that "the £2m-£6m figure does significantly depend on the ultimate location of RATE … In terms of transition costs being at the higher or lower end of the scale, broadly speaking, the more that changes from the existing set up of the HTA and HFEA, the higher the transitional costs."[57] The Wellcome Trust and MRC, and the HTA sought confirmation that the costs of the transfer would not be met through licensing income. (Ev09, Ev11(a), p4) This supports our conclusion in paragraph 92 that greater savings, consistency, efficiency and co-operation might be achieved both within and between the two organisations without the creation of RATE.

AN ALTERNATIVE TO RATE?

90. The Draft Full Regulatory Impact Assessment also set out other options, including "Option 4: Update the 1990 Act but retain the HTA and HFEA." This commanded more support amongst witnesses than the proposal to establish RATE.[58] The BMA felt that Option 4 had been "dismissed without good reason" and should be given "serious consideration", through the sharing of back office functions, greater consistency in decision making, closer liaison and communication, and more flexibility in the HFEA's licensing system, "without the need to merge the two bodies." (Ev07, p2) In the light of this evidence, we wrote to the Minister on 19 June asking "What level of consideration was given to option 4 … and what are the reasons for its rejection."[59] We were surprised and disappointed by the reply which rehearsed the reasons for RATE rather than giving proper consideration to the alternative.[60]

91. Despite some reservations about the scope of their respective activities and the standard of their regulation, the overwhelming consensus from the evidence we received was that a merger of the two regulators to form RATE would place the positive features of their work at considerable risk. We remain unconvinced by the Government's arguments that a merger will bring benefits, in terms of savings, synergies, more effective implementation of the EU Tissue Directive, or a more streamlined regulatory process.

92. We have found the evidence against establishing RATE overwhelming and convincing and we recommend that the Government abandons the proposals in Part 1 of the draft Bill. We consider that the regulatory oversight provided by the HFEA and the HTA is better than the oversight that could be provided by RATE and we recommend that the HFEA and the HTA (as well as the MHRA) should be retained as separate authorities. However we note the lack of research undertaken as to the workings of the current regulatory structure, and improvements that could be made. We recognise that greater savings, consistency, efficiency and co-operation might be achieved both within and between the two organisations. We recommend that the Government, in consultation with the HFEA, HTA and their stakeholders, look at ways to achieve such improvements.

REGULATING RESEARCH AND TREATMENT

93. Some witnesses saw the draft Bill as an opportunity to revisit the regulatory approach of the 1990 Act, both in terms of the level of regulation of research and treatment and the relationship between the two.

(1) The relationship between research and treatment

94. Alison Murdoch, Professor of Reproductive Medicine at Newcastle Fertility Centre, argued for a separation of the regulation of research and treatment on the grounds of an internal conflict of interests. She claimed that the HFEA's recent consultation, Donation Egg Sharing for Research, Safeguarding Donors 2006 implied that the Authority gives preference to donation for treatment over research, and that "Such a conflict would not arise if the regulation of research and treatment were distinct." (Ev17)

95. From a different perspective, Comment on Reproductive Ethics (CORE), in common with the Lawyers' Christian Fellowship, argued that a "Conflict of interest is inevitable" because the interests of researchers are in direct competition with best practice for fertility patients—"As fertility treatment moves in the direction of less the research industry clamours for more; more eggs, more embryos in particular." (Ev79, pp2-3, Ev52, p5) However, Shirley Harrison told us she did not see any problem with the HFEA's dual role so long as there is a "proper division of responsibilities and accountability" within its governance framework. (Q 146)

96. Professor Sir Ian Kennedy too felt that to separate the regulation of research and treatment was "an attraction too far because it suggests that you can draw a very clear line between those two activities and that is really rather difficult" since "you are constantly going to be worried about where those borders lie". (Q 752) Others, including Neva Haites, Professor in Medical Genetics at the University of Aberdeen and Chair of the HFEA Scientific and Clinical Advances Group, emphasised the merits of keeping a "very careful eye" on clinics as they introduce new techniques like ICSI and metabolomics. (Q 599)[61]

(2) The regulation of research

97. Others argued that the regulatory burden placed on researchers could be eased. For example, Dr Mark Hamilton claimed that there were already robust research regulatory mechanisms in place, for instance through research ethics committees, and that "To piggyback on top of that a need for the regulator, currently HFEA, to be involved in the research assessment process seems to be an unnecessary duplication of effort, and I think the regulator's role should merely be to determine that the research is conducted within the confines of what is the law." (Q 382)[62]

98. Not everyone agreed. Both Professor Colin Blakemore, Chief Executive Officer of the Medical Research Council, and Roger Brownsword, Professor of Law at King's College London, were concerned about handing the whole process over to local review via research ethics committees because of the "divergence of practice around the country". (QQ 7-8) Professor Martin Bobrow argued that the case for regulation remained because "there is a view that embryos should be treated differently from other constructs." (Q 927)

(3) Regulation of treatment

99. There was a range of opinion on whether there was still a need for close regulation of treatment including the requirement to keep records. A number of witnesses, such as Hugh Whittall, Director of the Nuffield Council on Bioethics, agreed that IVF treatment was now "more or less routine". (Q 5)[63] Dr Gillian Lockwood agreed that, in the early days of IVF, the public were concerned that "frightening things were going on", but "Now we know that is not the case, and a lot of the information that we have to collect and send on to the HFEA is of no value at all to patients or to science or to clinicians." (Q 428) She and other clinicians like Simon Fishel were concerned at the "quite remarkable" regulatory burden on staff. (Q 450) Simon Fishel was in favour of a regulatory structure, but he did call for the regulatory process to be streamlined, so that the HFEA only dealt with issues like outcome statistics, personnel review, data on incidents and alerts, public and patient complaints, the maintenance of the register, and "trimmed down" licensing. (Ev85)[64]

100. However, Dr Mark Hamilton argued that there remained value in regulation in terms of "reassuring the public" and "the element of security that it gives those providing the service that they can say we have been inspected by the regulatory authority and we have reached a certain standard that has been approved by the inspection process". (Q 375) Angela McNab, Chief Executive of the HFEA, warned that a regulator was still required in a sector dominated by private practice, in order to provide "a very clear system for good, professional, evidence-based standards, for ensuring that those are checked, are validated and that where patients have concerns that there is a very clear mechanism for addressing those". (Q 174) Sir Liam Donaldson told us that "to deregulate in this field would be a bit of a disaster, and the reason I say that is that I think we have a duty to the welfare of patients." (Q 230)

101. Others questioned whether IVF could really be considered 'routine'. Professor Sir Richard Gardner pointed out that "Clinical practice in this area does not gradually become routine" since "people are forever looking at new ways to assess the developing embryos". (Q 753) He also argued that adverse prenatal experiences may first affect people later in life, and that there was therefore an ongoing case for keeping records. (QQ 755-756)[65]

102. Several witnesses also touched on the regulatory overlap between the HFEA and other regulators outside the field of embryology. Dr Gillian Lockwood told us about the degree of overlap with other regulators, such as the Healthcare Commission "to look after the patient side of things" and the British Standards Institute "which manages our ISO accreditation and the quality management system which is part of the EU Tissue Directive". (Q 453)[66] Professor Sir Ian Kennedy, Chairman of the Healthcare Commission, confirmed that "there is duplication", and acknowledged that "we are from time to time tripping over each other." (QQ 761-762)[67] Charles Kingsland agreed that, from the point of view of treatment, the HFEA had been superseded by other regulatory bodies within the NHS, (Q 459) but Professor Sir Richard Gardner was keen to see the HFEA retain its regulatory role. (Q 754) Dr Dave Morroll pointed out to the Committee that the laboratory elements of assisted conception would have to be inspected in any case to ensure they complied with the technical elements of the EU Tissue Directive. (Q 373)

103. The Minister said the Government "still feel there is a role for regulation" of IVF, both because it creates a "confident atmosphere" for treatment to take place, and because "To dismantle that could potentially undermine the confidence of the public in this particular area." (QQ 485, 512-521) She did however concede that "there are ways to look at a lighter touch approach and to see where, potentially, in the future, some aspects of regulation may not be necessary", for instance to deal with concerns about time delays, or organisations that have demonstrated their quality and have suffered no complaints against them. She argued that this "could be revised as part of the practice of regulation that we currently have", although the Committee pointed out that, under the draft Bill, the fundamental requirement for a treatment licence could not be relaxed. (QQ 512, 514)

(4) The overall regulatory structure

104. In respect of both research and treatment, others, such as the Church and Society Council of the Church of Scotland, and the Lawyers Christian Fellowship, argued that strict regulation "continues to be essential" under a "strong independent regulatory authority". (Ev52, p5, Ev97, p3)

CONCLUSION

105. We have listened carefully to arguments about the regulatory structure, in both the research and treatment fields. We would not wish to see the Government or the regulator involved when responsibility can reasonably and safely be devolved, either to researchers or clinicians. Yet we acknowledge that the special status of the embryo means regulation of both research and treatment continues to be appropriate and desirable. In addition, we recognise that regulation of IVF treatment provides assurance and protection to patients. In accordance with our recommendation about a framework of permissive regulations, we recommend that the draft Bill should be amended to give the regulator statutory power to define areas of exemption from the current regulatory remit where appropriate. We also support calls for a lighter touch and, where it would be appropriate, we urge the regulators to investigate ways in which the unnecessary duplication of regulation can be eliminated. We have considered claims that the regulation of treatment and research should be separated, but we are persuaded by the evidence we have received that the relationship between the two fields is so close and interdependent as to make this impracticable.

Reform of the Human Tissue Act 2004

106. Early in our inquiry, the Royal College of Pathologists put to us a strong case for revisions to the Human Tissue Act 2004 (the 2004 Act) on the basis that the Act was drafted in a way that put unnecessary and unintended burdens on the stakeholders. (Ev06) They told us that "The 2004 Act was drafted with post mortem samples in mind. But the Act defines human tissue as anything containing human cells (with certain specific exceptions). Consequently, legislation designed to protect the hearts and brains of the deceased also applies to urine, faeces, saliva and pus from living patients, since all of these contain human cells." This means that the Act applies to almost all specimens from the living which pass through NHS laboratories—approximately 200,000,000 samples each year. In contrast, fewer than 150,000 post mortem examinations take place each year. A number of witnesses, including Lord Patel, Professor Martin Bobrow and Cancer Research UK agreed that the Act created unnecessary burdens. (QQ 931-932, Ev94).

107. In particular, the Royal College drew our attention to a number of specific problems they found with the operation of the 2004 Act (see Ev06). They also told us that when they made representations to the Department of Health for amendments to the 2004 Act, they were "told, in effect, that no such problems existed, and that no such changes could be expected." (Ev06) Dr Suzannah Lishman, Assistant Registrar, Royal College of Pathologists, was concerned that "the amendments to the Act that were suggested have been completely ignored and that this draft Bill completely ignores everything to do with the Human Tissue Act and concentrates on the embryology side of things." (Q 66)

108. The HTA argued that, though it may be too early to make judgements on its regulatory work, the draft Bill provided an opportunity to "identify parts of the current Human Tissue Act which may benefit from change or clarification." While the HTA's members concluded that its understanding of the current legislation needed to mature before it could recommend specific changes, the HTA did suggest the Authority should have some flexibility in defining "relevant material", and that "an element of discretion" should be allowed in order to extend the list of 'qualifying relationships' in section 27 of the Act. (Ev11(a), p5)

109. The regulation of tissue is a devolved matter in Scotland. The Scottish Parliament passed the Human Tissue (Scotland) Act 2006, which legislated only in respect of tissue removed after death. In addition, the Act provides that tissue blocks and slides become the property of the hospital, which would then be free to conduct any ethically approved research in the future. Both these policies reflected the recommendation of the Independent Committee of Inquiry into the Retention of Organs at Post-Mortem.[68] The Act also provided for post-mortem samples to be kept in perpetuity in a case of Sudden Infant Death Syndrome. Baroness Kennedy's report[69] on the investigation of unexpected death in infancy had come to a similar conclusion. Yet all of these practices are illegal in England and Wales under the 2004 Human Tissue Act.

110. The Royal College of Pathologists said that to legislate only in respect of tissue removed after death was "logical", given the very different attitudes to the body of the deceased, as compared to the organs, tumours or faeces of living patients, and called on the Westminster Parliament to follow suit. (Ev 06) They told us that other possible (but less effective) reforms might be to redefine 'relevant material' so as to exclude blood, urine, faeces etc, or, as a minimum remedy, to give the HTA or the Secretary of State power to alter the range of material covered under the 2004 Act.

111. Professor Neva Haites, from the University of Aberdeen, who has direct experience of the Scottish Act claimed that in Scotland "we have a much less bureaucratic process" that is "working very effectively" with the confidence of researchers and pathologists. (Q 596) She added that research using spare tissue after surgery "has virtually come to a standstill in England because of an inability to know how to actually use the current rules, whereas in Scotland providing you have full consent and ethical committee approval there is no issue." (Q 611)

112. In addition, concern was also expressed about HTA storage licences. The Royal College of Pathologists said that the size of these fees had come as an "unwelcome surprise" for many hospitals, faced with a choice of paying for storage or destroying samples, thereby creating "a financial stimulus to the destruction of appropriately consented samples". Lord Patel agreed that it would be "a tragedy" if specimens were lost in this way. (Q 931)

113. In response to concerns about the 2004 Act, the Minister told us that, since these issues were only aired recently, "we are not convinced of the need for further amendments." In the context of the Scottish approach to the retention of tissue samples and Sudden Infant Death Syndrome tissue sampling, she said that "unless there is a criminal prosecution, to keep these tissues indefinitely does not seem to be an appropriate thing to do, and certainly not without the permission of the families concerned." (QQ 506-507) We disagree with both statements. However, Sir Liam Donaldson assured us this could be looked at if there was a strong and persuasive case for amending the law, and both he and the Minister said that the Government would be prepared to listen to any recommendations that the Committee made. (QQ 272-274, 506)

114. Whilst we did not receive a large quantity of evidence on this issue, what we did receive we found very persuasive. The majority of witnesses who did express an opinion agreed that the 2004 Human Tissue Act needs to be revised. We are also mindful of the Royal College of Pathologists' concerns that issues in relation to the Human Tissue Authority could get lost amidst all the other proposals in the draft Bill. The Government's argument that it is too soon to amend the Act does not stand up to scrutiny. If the law needs amending, as the Committee believes it does, it should be done as quickly as possible. The Committee also notes the weight of evidence suggesting that the Human Tissue (Scotland) Act has achieved a far better result, in particular in terms of legislating only for tissue removed after death, the retention of tissue blocks and slides, and the retention of post-mortem samples in a case of Sudden Infant Death Syndrome. We reject the Government's conclusion that it is too soon to amend legislation as it applies to England and Wales. In consultation with the Human Tissue Authority and its stakeholders, we recommend that the Government use the opportunity presented by the draft Bill to make necessary amendments to the Human Tissue Act 2004.

Embryo transfer in treatment

115. We heard evidence from a number of witnesses about the problems of multiple embryo transfer during fertility treatment. There was a large degree of consensus on this issue, and the British Fertility Society's submission was typical:

"Good clinical practice should be encouraged subject to guidance from appropriate professional bodies … If outcome data suggest to the regulator through the inspection process that clinical or laboratory practice is suboptimal then those providing services should be called to account." (Ev23)[70]

116. The Royal College of Nursing referred to the Multiple Births and Single Embryo Transfer (MBSET) stakeholders consensus statement, which said that "The only way to reduce multiple birth rates after IVF is to transfer only one embryo to those women at most risk of having twins." (Ev38, para 11.1) The National Infertility Awareness Campaign, also a signatory to the consensus statement, argued that "inadequate implementation of the NICE Guideline to Fertility (2004)" whereby patients are entitled to three full cycles of IVF treatment, meant that patients were unwilling to risk Single Embryo Transfer "in what could be their only state funded IVF cycle". (Ev57) Dr Gillian Lockwood told the Committee that "until we are in a situation where we can hand on heart say that the chance of getting pregnant at all is the same … it will be terribly difficult to persuade couples … to have just one transferred." (Q 478)

117. Whilst noting widespread concern about this issue, we acknowledge the weight of evidence that the draft Bill is not an appropriate vehicle with which to seek to solve the problem. This should be left to clinicians working under appropriate guidelines from the regulator.

Paying for the regulator

118. Aside from the cost and potential savings of the proposal to create RATE (paragraphs 86 to 89), the Committee heard views on a range of funding questions, including; the question of whether the regulator should be funded by licence fees, grant-in-aid, or a combination of both; the financial burden placed on researchers, clinics and patients; and whether there was any evidence of a conflict of interest or cross-subsidy.

PAYING FOR REGULATION

119. The Minister told us that that it remained Government policy "that where we are regulating, the cost of regulation should pay for itself through the form of fees. At the present time we obviously provide grant in aid for advice and information, so that those areas of the role of the organisation are distinct." (Q 522) The HFEA told us that they saw no reason why this model should not continue. (Ev12(a))[71] However, the Christian Medical Fellowship felt that an increase in funding by grant-in-aid was needed to avoid a conflict of interest, whereby the regulator has "a positive incentive to issue licences for fees in order to maintain its own existence." (Ev26, p4)

120. Others favoured an increase in funding by grant-in-aid from the point of view of fairness to patients. Dr Mark Hamilton, echoing the comments of Dr Simon Fishel and Hugh Whittall, as well as Sheila Pike from Sheffield Teaching Hospitals NHS Trust, and Kate Grieve from University Hospitals Coventry and Warwickshire NHS Trust, told the Committee that "infertility is not a lifestyle choice. Patients who have infertility have a medical condition; they do not wish to have it and the consequences of that condition have far-reaching medical, psychological and social consequences. It seems unfair to me that the infertile are singled out in this way to pay substantial amounts of money for the purpose of the regulation of treatment which they very much deserve." (Q 386)[72] While we note that a number of witnesses called for an increase in funding by grant-in-aid, we do not in this report seek to challenge's the Government's position that the cost of regulation should be met by a mixture of licence fees and grant-in-aid.

121. We also received some evidence expressing concern at the overall funding balance within RATE and the risks of cross-subsidy and conflicts of interest within RATE, particularly the potential for "one sector underwriting the regulatory activities of another." (Ev23, p4)[73] We note these concerns, but given our recommendation against RATE we have not covered these issues in our Report in depth. We did hear evidence about research licence and treatment fees charged by the regulator which are as relevant to the current structure as they are to RATE and we deal with these below.

RESEARCH LICENCE FEES

122. Several witnesses expressed concern about the requirement for and the cost of HFEA licence fees to undertake research in this area and the imbalance this created with other areas of research. For example, Professor Alison Murdoch told us she thought the requirement for an HFEA licence was unreasonable, and caused "harmful delay and cost." (Ev17, p4) Professor Peter Braude and Professor Sir Ian Kennedy admitted that research licence fees were "anomalous" in comparison to other biomedical research. (QQ 89, 747) Professor Braude further told us that the fee "would get passed to the Medical Research Council or whoever is funding it but usually charities or own accounts for research and it seems to be an inhibitor to doing it, I am not sure why we have to." (Q 91) Professor Blakemore added that "the cost in the end has to be borne by a purse, a public purse, a charity purse or whatever, and I do not think it would be unreasonable to ask the Government to be covering these costs of running these services well and separately through researchers." (Q 23)

123. However, the Biotechnology and Biological Sciences Research Council, in common with Mark Henderson, Science Editor of The Times, told us that "Government funded research grant application mechanisms now permit the costs of licences to be included in the grant proposal and so if a project was successful, the majority of the cost of a licence could be met through that research grant." (Ev39, p2, QQ 308, 610) Hugh Whittall felt that the charging of a fee (whether for research or treatment) was appropriate as a barrier to entry, and to provide a "measure of entitlement" for those paying fees. (Q 20) We recommend that Research Council grants should include the cost of research licences.

TREATMENT FEES

124. We also heard much evidence on HFEA fees charged for IVF treatment. Dr Mark Hamilton, Dr Gillian Lockwood, Dr Simon Fishel and Infertility Network UK told us that patients and clinicians perceive the £104 fee as a "very regressive" "straightforward fertility tax", which "given the current lack of NHS funding for fertility treatment", most patients "have no choice but to pay." (QQ 365, 440, 448 and Ev58, p3) Dr Lockwood told us that her own clinic pays £150,000 "fertility tax" per year. (Q 440)

125. We were particularly interested to know whether there was any evidence of patients being exploited through additional or inflated fees [in the private or public sectors]. Charles Kingsland, an NHS consultant, told us that "there are an awful lot of treatments that are in theory beneficial but have never stood the rigour of scientific evaluation … These are the treatments that can be very expensive and whereas they may not do any harm to the patient … they may not be doing any good either. What we have in this particular area of medicine are patients who are very vulnerable and can be influenced by non-evidence-based medicine." (Q 445) Sheila Pike and Kate Grieve claimed that "The policy of leaving treatment fees to be decided in relation to market forces has led to unjustifiably high prices for IVF in some centres and is contributing to the disturbing phenomenon of fertility tourism." (Ev22, p1) However, Dr Simon Fishel, who currently works in the private sector, said that he knew of no evidence of exploitation. (Q 442)

126. The HFEA told us "We would like to see an explicit provision in the Bill requiring assisted conception clinics to provide patients with fully costed treatment plans and to have in place a proper patient complaint system. At present, the HFEA is limited in what it can do to protect patients who may be at risk of exploitation by some private sector clinics. Explicit requirements on clinics coupled with a clear function for the regulator relating to safeguarding the interest of patients, could make it easier for these concerns to be addressed." (Ev12(a), Appendix A)

127. We support the HFEA's general approach in this area. We are concerned by some of the comments we have heard about fees and unproven treatments and we recommend that the draft Bill is amended to meet the HFEA's suggestion that assisted conception clinics should provide patients with fully costed treatment plans. We recommend that the HFEA works with the Royal Colleges and other appropriate professional bodies to protect patients from any risk of exploitation.

NICE GUIDELINES

128. We have also heard from witnesses concerned about funding issues in fertility treatment beyond the regulator, particularly suggesting that Primary Care Trusts either were not implementing NICE guidance[74] or were implementing them inconsistently. Dr Mark Hamilton complained about the "scandal which is the national failure to implement the NICE guidance around the management of the infertile which, one is led to believe, is purely a matter of resource allocation." (Q 365) Dr Tony Calland told us that "there is, in reality, very much a postcode lottery about the availability of IVF services." He said that patients may not have NICE guidelines implemented in their area and noted that "it does not work in the patients' interests." (Q 89) Charles Kingsland, an NHS consultant, claimed that in the NHS at least, the cost to the NHS of IVF treatment is likely to be between £2,600 and £3,300 for a cycle of treatment which is "relatively cheap if you compare it with other well-established medical conditions." (Q 442)

129. We are concerned by the evidence we have heard that NICE guidance is not being implemented consistently across much of the country, thereby delivering unequal access to the public provision of fertility treatment services in England and Wales. We recommend that the Government takes steps to ensure that Primary Care Trusts and Foundation Trusts implement NICE guidance which sets out minimum levels of treatment.

41 EU 2004/23/EC Back

42 HFEA/ HTA press release, 20 December 2006 Back

43 Cm 7087, introduction, page viii Back

44 See also QQ496-502 Back

45 See also Ev39 Back

46 See Ev06, Ev07, Ev08, Ev09, Ev23, Ev38, Ev58, Ev59, Ev70, Ev84 and Ev94 Back

47 See also Q825 and Q710 Back

48 Letter from the Minister to the Chairman, 27 June 2007, see Appendix 8 Back

49 See also Ev68, p1 Back

50 See also Q757 Back

51 June 2004 HFEA letter to the Department of Health Back

52 See also Q602 and Q711 Back