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Home > Publications > Selected cases— Parliamentary > Selected Cases and Summaries of Completed Investigations: April 2001 to September 2001 > Case No. C.431/01
Selected Cases and Summaries of Completed Investigations
PCA 6th Report – Session 2001-2002
Chapter 1
Mishandling of a request to review policy on pre-implantation genetic diagnosis
In October 1999 Mr Masterton wrote to the Human Fertilisation and Embryology Authority seeking a review of their policy not to allow fertility treatment centres to use pre-implantation genetic diagnosis (PGD) to select the sex of embryos for social reasons, explaining that he and his wife had lost their only daughter, and their general practitioner and a psychologist considered that the use of PGD to ensure another female child was necessary on medical grounds. In December the Authority told Mr Masterton that they would be able to consider the case in principle and give a general indication of their view, but it would require a specific application from a treatment centre to enable the treatment to be carried out. Following further correspondence, and having obtained legal advice, in January 2000 the Authority told Mr Masterton that, if the matter needed to be referred to the next meeting of the full Authority membership (which was scheduled for 27 January), it would only be to determine how the matter should proceed. On 27 January, acting on legal advice, the Authority membership decided that the appropriate route was for Mr and Mrs Masterton to seek the support of a licensed PGD treatment centre, who would make their case for a variation of their licence in an application to one of the Authority’s statutory licence committees. The Ombudsman found that the Authority’s view of the extent to which it would be appropriate for their general policy on the use of PGD, and the circumstances of Mr and Mrs Masterton’s case, to be addressed at the meeting on 27 January 2000 had become more sharply focused, and as a result had changed significantly, in the course of consideration during their correspondence with Mr Masterton and their lawyers; their responses to Mr Masterton had changed accordingly. As a result, Mr Masterton had initially been given good reason to believe that his wish that the Authority would re-examine their policy and make a pronouncement in the light of his case would be granted. The Ombudsman criticised the Authority for having failed to consider their position more thoroughly at the outset, and given undertakings from which on further reflection they justifiably considered it necessary to retreat. The Chief Executive offered her apologies to Mr Masterton for having unnecessarily (albeit in good faith) raised expectations which were later disappointed.
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Full text
4.1 Mr Masterton complained of mishandling by the Human Fertilisation and Embryology Authority (the Authority) in dealing with his request that they review their policy on pre-implantation genetic diagnosis (PGD).
4.2 My investigation began in August 2000 once the Ombudsman had received comments from the Chief Executive of the Authority. I have not put into this report every detail investigated by the Ombudsman’s staff, but I am satisfied that no matter of significance has been overlooked.
Background
4.3 The Human Fertilisation and Embryology Act 1990 forbids the use of specified fertility treatments except under licence by the Authority. Section 9 of the Act requires the Authority to maintain licence committees to discharge their functions relating to the grant, variation, suspension and revocation of licences. The composition and procedure of licence committees is prescribed by the Human Fertilisation and Embryology Authority (Licence Committees and Appeals) Regulations 1991; insofar as it is not provided for in those Regulations or in the Act, the Authority may regulate their own procedures. The Authority have 21 members, under a Chairman, who decide policy and sit on licence committees; an executive, under a Chief Executive, is responsible for implementing policy and licensing decisions, and conducting the Authority’s day to day activities.
4.4 Section 13 of the Act specifies the conditions of licences for treatment. Those include taking account of the welfare of any child who may be born as a result of the treatment, and providing the opportunity for the couple concerned to receive proper counselling about the implications of taking the proposed steps. Section 20 provides a right of appeal to the Authority against refusal, variation or revocation of a licence. Section 25 requires the Authority to maintain and publish a code of practice giving guidance about the proper conduct of activities carried on in pursuance of a licence. Failure to observe the code does not of itself render a person liable to proceedings; but licence committees must take account of any relevant provision of the code in considering whether there has been a failure to comply with the conditions of a licence. The code and any revision to it must be approved by the Secretary of State and laid before Parliament. Paragraph 1 of Schedule 2 to the Act includes among the activities which may be authorised by a licence the creation of embryos in vitro, and practices designed to determine the suitability of embryos for use in treatment. A licence cannot authorise any activity unless it appears to the Authority to be necessary or desirable for the purpose of providing treatment services.
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4.5 The Authority have stated that the object of the code of practice is wider than securing the safety or efficacy of particular clinical or scientific practices. It is concerned with areas of practice that raise fundamental ethical and social questions. It is regularly reviewed and amended in the light of experience, and to keep abreast of the latest developments in clinical practice and public concerns. It is currently in its fourth edition. The Authority have discretion to consider making exceptions to the code in particular cases and applications can be made accordingly. Such cases are considered by licence committees upon application by a licensed treatment centre.
4.6 In 1998 the Authority established a joint working group with the Advisory Committee on Genetic Testing, whose remit was to prepare a consultation document on the issues surrounding PGD. That consultation document was issued in November 1999. It explained that PGD was a two-stage process in which in vitro fertilisation was used to create embryos, which were then tested for a particular genetic disorder or to establish their sex (where the disorder was sex-linked). Embryos which did not carry the genetic disorder or were not of the potentially affected sex could then be transferred to the uterus in the hope that a normal pregnancy would develop. The Authority had licensed PGD for certain severe or life-threatening disorders at a limited number of treatment centres. Following a public consultation in 1993, the Authority had rejected the use of PGD for sex selection for social reasons. (Accordingly, the code of practice says: “Centres should not select the sex of embryos for social reasons.”) The November 1999 document aimed to consult on whether there were any uses of PGD which should not be permitted, or which should only be permitted under certain circumstances. It proposed that, subject to appropriate clinical considerations, the current practice of licensing clinics to perform PGD for a limited number of specific serious inherited conditions should continue. Responses were invited by 31 March 2000.
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Jurisdiction
4.7 Under section 12(3) of the Parliamentary Commissioner Act 1967 the Ombudsman is precluded from questioning the merits of discretionary decisions taken without maladministration.
Investigation
4.8 A Summary of the key events leading to Mr Masterton’s complaint follows:
4.9 On 20 October 1999 Mr Masterton wrote to the Authority. He asked their advice on how best to make an appeal to them regarding what he described as their blanket policy of allowing gender selection by PGD on medical grounds only. He explained that he and his wife had lost their only daughter, and their general practitioner and a psychologist considered that the use of PGD to ensure another female child was necessary on medical grounds to prevent a serious adverse psychological effect upon his wife. They had approached treatment centres, but been told that these could not provide PGD because the Authority would view the use as a social one. Mr Masterton sought the opportunity to present the Authority with all the facts of his case, and medical evidence, either in writing or in person. On 22 October the Chief Executive replied that if Mr Masterton would send her all the information he wished to submit for their consideration, she would ensure that his case was considered by the members at a future Authority meeting. Following further correspondence, on 8 December the Chief Executive wrote to Mr Masterton saying that the Authority were considering the matter not as an appeal, which had a particular meaning under the Act (paragraph 4.4), but as a request for the Authority to reconsider their current policy position, taking into account the special circumstances of his case. Until they received his papers, they could not decide how best to proceed, or whether any other material would be required. It might be that the Chairman would be able to deal with the matter alone, or together with only a small number of other members; alternatively, it might require consideration by the full Authority. In any event, while the Authority would be able to consider the case in principle and give a general indication of their view, it would require a specific application from a licensed treatment centre to enable the treatment to be carried out.
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4.10 On 16 December Mr Masterton wrote to the Authority asking to be told the deadline by which his papers should be submitted for consideration by the next full meeting of the members of the Authority, which was scheduled for 27 January 2000. He also asked whether he could presume that the Authority had no objection to his attending the meeting. Having obtained legal advice, on 23 December the Deputy Chief Executive replied that on receipt of Mr Masterton’s papers the Authority would be able to establish the most appropriate way to proceed; for it to be possible for the Authority to consider the matter at the meeting on 27 January, he should provide the papers by 12 January. He asked Mr Masterton to set out why he thought it would be insufficient for the Authority to consider written representations, adding that in any event it would not be possible for the Authority to consider oral representations at the meeting on 27 January.
4.11 On 4 January 2000 Mr Masterton wrote to the Authority asking whether a decision on his case would be made on or before 27 January. He repeated his desire that his case should be put to the full Authority and that he should be allowed to make oral representations on that date. Having obtained further legal advice, on 5 January the Deputy Chief Executive replied that until the Authority received details of Mr Masterton’s submission it was not possible to say exactly how they would proceed, or how or when the matter would be determined. The final determination of his request would lie with a licence committee. If the matter needed to be referred to the meeting on 27 January, it would only be in order to determine how the matter should proceed. Detailed consideration would not be possible on that date. For that reason, it would not be necessary or appropriate for Mr Masterton to attend. They would notify him in writing of how the matter was to proceed no later than 28 January.
4.12 On 7 January Mr Masterton sent the Authority a detailed submission in support of his application “for a modification of your present policy that the use of PGD will only be permitted in circumstances where there is a ‘medical’ reason for undertaking the procedure”. He reiterated his desire to present his arguments orally at the meeting on 27 January. On 12 January Mr Masterton wrote to the Authority seeking confirmation that his application would be considered at or before the full Authority meeting on 27 January, and that 21 copies of his application would be presented in their entirety to the full Authority, if they reached that stage. Following further discussion, on 14 January the Deputy Chief Executive wrote to Mr Masterton, confirming that his file, as submitted, would receive consideration at or before the meeting on 27 January, although that would not in any event constitute final determination of his request for treatment. He could assure Mr Masterton that the file, as submitted, would receive proper consideration, but could not make specific assurances about possible stages that had yet to be reached.
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4.13 On 27 January the members of the Authority met. In accordance with legal advice obtained by the Chief Executive on 17 January, the Chairman advised the members that the Authority had received a submission from a couple seeking to undergo PGD for the purpose of sex selection on the basis of exceptional circumstances. She explained that the couple had submitted a file in support of that proposal, which she as Chairman had seen. She had been advised that the appropriate route for the case would be for the couple to seek the support of a licensed PGD treatment centre, who would make their case for variation of their licence in an application to a licence committee. On the basis that members would sit on a licence committee to hear such an application, it would not be appropriate for the full details as submitted by the couple to be put before the Authority. The members agreed. On 28 January the Deputy Chief Executive wrote to Mr Masterton conveying that decision. He listed the addresses of five treatment centres in the UK that had been licensed to use PGD, and suggested that Mr Masterton contact one of them.
4.14 Mr Masterton objected to the creation of an additional hurdle in the process of his application, saying that he believed from conversations he had had with many treatment centres that an application for variation of a licence of the kind suggested would be a waste of time. He said that he had not been applying for variation of a licence, but to have the Authority’s policy on the use of PGD modified, and had been led to believe that his application would be submitted in full to, and decided upon by, the full meeting of the Authority on 27 January. In response, the Authority maintained their position that the appropriate course was an application by Mr and Mrs Masterton to a treatment centre. Any licensed treatment centre could apply to the Authority to use PGD, although the five already authorised to do so had demonstrated that they had the relevant technical expertise. The Authority were always prepared to consider making exceptions to their policy. The proposed way forward avoided the possibility of the Authority making an exception but there being no licensed treatment centre willing to offer treatment. It might be prejudicial to such an application for members of the Authority to be given detailed information in advance. The Authority denied that they had misled Mr Masterton.
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The Authority’s comments on the complaint to the Ombudsman
4.15 Annex A to this report gives an edited extract from the Chief Executive’s comments on Mr Masterton’s complaint.
Findings
4.16 Mr Masterton’s letter to the Authority of 20 October 1999, while expressed in terms of an appeal against what Mr Masterton understood to be the Authority’s policy on the use of PGD, raised three issues: the acceptability of the Authority’s general policy on the use of PGD as conveyed by the code of practice and implemented in the licences granted (paragraph 4.6); whether Mr and Mrs Masterton’s grounds for wishing to use PGD (being, in Mr Masterton’s argument, based at least to a significant extent on medical rather than social reasons) fell within the scope of the existing code of practice, albeit not within the scope of those licences which had been granted; and, if it did not, whether an exception should be made to the code of practice, having regard to the particular circumstances of Mr and Mrs Masterton’s case. The second and third of those issues were of the sort that the Act provided for licence committees to consider (paragraphs 4.3 and 4.4); in that respect, I find no fault with the Authority’s decision that Mr and Mrs Masterton should apply to a treatment centre, who might in turn apply to a licence committee, for authority to use PGD in their case. I note that the Authority’s letters to Mr Masterton of 28 January and 10 February 2000 made clear that a licence committee could make an exception to the Authority’s general policy in the light of the circumstances of the case. That seems to me to have addressed, as far as the Authority might reasonably have been expected to in the context of their current general policy, Mr Masterton’s concern that applying to a treatment centre would be a waste of time as long as that policy remained unchanged.
4.17 Nevertheless, Mr and Mrs Masterton’s hope of a successful application would have been increased if the Authority had agreed to introduce a less restrictive general policy on the use of PGD. Mr Masterton was entitled to ask them to do so. How to respond to that request was a matter for the Authority’s discretion. In the event, Mr Masterton asked that his case for a change in the Authority’s policy be considered in full by the meeting of the Authority’s members on 27 January 2000; ultimately, the Authority declined to do so. The Ombudsman cannot question the merits of that discretionary decision unless it was taken with maladministration (paragraph 4.7). Mr Masterton has alleged two instances of maladministration affecting the taking of the decision: first, that his submission was not shown to the members; and secondly, that he was not allowed to attend the meeting. I consider each in turn.
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4.18 Regarding the handling by the Authority of Mr Masterton’s submission, the Authority took legal advice on that point on 17 January 2000. I see that as having been a wise precaution. I do not consider it appropriate to disclose in this report the advice received by the Authority; but having read it I consider that the terms in which the Chairman put the matter to the meeting on 27 January 2000 fairly and accurately represented the advice and the facts to which it related. Mr Masterton subsequently queried the basis of the legal advice. I accept that the question of whether sight by the Authority members of Mr Masterton’s submission might have prejudiced a future decision of a licence committee is debatable; but I cannot say that the advice in question was so obviously wrong or unreasonable as to be classifiable as maladministrative in itself, and I recognise that in addressing the issue of possible prejudice it was the Authority’s intention to be fair to Mr Masterton. Accordingly I find no fault with the Authority for having chosen to follow the legal advice they received.
4.19 Regarding Mr Masterton’s request to attend the meeting, the Authority’s response to that was guided by legal advice obtained on 23 December 1999 and 5 January 2000. In view of the need to have regard to the principles of natural justice, the Authority were right to consult their lawyers on the point. I have read the advice they received. Although again I do not consider it appropriate to disclose it here, I am satisfied that, by inviting Mr Masterton, in their letter of 23 December 1999, to set out why he thought it would be insufficient for the Authority merely to consider written representations, the Authority acted in accordance with the advice they received on that date. The Authority referred Mr Masterton’s response of 4 January 2000 to their lawyers; the Authority’s decision, conveyed to Mr Masterton on 5 January, that it would not be necessary or appropriate for him to attend the meeting, was consistent with the advice they received on that date and on 23 December. Mr Masterton found that incompatible with the European Convention on Human Rights, but I see nothing maladministrative in the Authority’s exercise of their judgment in the context of the advice they received.
4.20 In sum, I consider that Mr Masterton’s requests regarding presentation of his submission and personal attendance at the meeting of 27 January 2000 raised issues that were properly referred by the Authority for legal advice; that, in the context of that advice, the Authority were entitled to choose to proceed as they did; and that they did so effectively. I therefore do not see the facts that Mr Masterton’s submission was not shown to the Authority’s members, and that he was not permitted to attend the meeting, as being attributable to maladministration by the Authority.
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4.21 My investigation has uncovered no other elements of maladministration potentially affecting the Authority’s decision not to review their general policy on the use of PGD in the light of Mr and Mrs Masterton’s case at the meeting on 27 January 2000. Indeed, in view of the fact that the public consultation period on the subject did not end until 31 March 2000 (paragraph 4.6), it would probably have been premature for them to do so. I therefore have no grounds on which to criticise the decision sent to Mr Masterton on 28 January 2000.
4.22 The questions remain as to whether that decision should have been conveyed to Mr Masterton earlier, and whether in the meantime the Authority misled Mr Masterton as to the likely outcome, or the procedure by which it would be reached. On the former point, I note that the matter was decided within slightly more than three months of Mr Masterton’s first letter on the subject. It was dealt with throughout at a senior level in the Authority, and the replies to Mr Masterton’s letters were almost always extremely prompt. That in itself would count for little if the decision made and conveyed in January 2000 was one that could reasonably have been expected to have been made and conveyed the previous October. However, the case was one that the Authority might reasonably feel obliged to refer to their full membership simply to endorse their recommendation for its handling, even if they did not propose that that forum should address the substantive issues. I therefore do not criticise the Authority for the fact that a decision was not conveyed to Mr Masterton until after the full membership had met (and I note the promptness with which it was then conveyed).
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4.23 Did the Authority mislead Mr Masterton as to what he could expect from the meeting on 27 January 2000? The Chief Executive’s letter of 22 October 1999 said that she would ensure that Mr and Mrs Masterton’s case was considered by the members at a future Authority meeting; it was, even if that consideration was not of the substantive nature that Mr Masterton was seeking. I regard the Authority’s first, quick response to Mr Masterton’s approach as having been so brief and broadly worded that it cannot in itself be criticised for being actively misleading. However, the Chief Executive’s more detailed letter of 8 December 1999 said that the Authority were considering the matter as a request to reconsider their current policy position, taking into account the special circumstances of the case. The Chief Executive told Mr Masterton in that letter that the Authority could not decide how best to proceed until they had received his papers, and that the Chairman might deal with the matter alone, or together with only a small number of other members. She also reminded Mr Masterton that an application from a treatment centre would be needed to enable the treatment to be carried out. Nevertheless, she did say that the Authority would be able to consider the case in principle and give a general indication of their view. That strongly implied that the Chief Executive expected the substantive issues raised by Mr Masterton’s letter of 20 October 1999 to be addressed, and a view expressed, albeit not necessarily by the full membership of the Authority, before the submission of an application from a treatment centre. That impression was reinforced by the Chief Executive’s letter of 10 December 1999, which said that in considering Mr Masterton’s submission the Authority would be examining a question of policy, which a licensee could then take into account when considering his future request for treatment.
4.24 I consider therefore that the Chief Executive’s letters of 8 and 10 December did mislead Mr Masterton about what was, in the event, to be considered at the meeting on 27 January 2000. I am satisfied, however, that there was no intention on the part of the Authority so to mislead him. The content of the advice that the Authority obtained from their lawyers on 23 December 1999 suggests that at that stage the Authority had not ruled out substantive consideration at the meeting on 27 January 2000 of their general policy on the use of PGD, and of the possibility of making an exception to it in Mr and Mrs Masterton’s case. However, that advice also referred to the difficulty of making any decision that extended the circumstances in which PGD might generally be used while a consultation process on the subject was still under way (paragraph 4.6). The further advice obtained by the Authority on 5 January 2000, partly in response to Mr Masterton’s question on 4 January as to whether a decision on his case would be made on or before 27 January, emphasised what were seen as the benefits of the licence committee route for determination of Mr and Mrs Masterton’s case. It was after that that the Authority told Mr Masterton for the first time, in the Deputy Chief Executive’s letter of 5 January 2000, that if the matter needed to be referred to the meeting on 27 January, it would only be in order to determine how it would proceed.
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4.25 In sum, the Authority’s papers indicate that their view of the extent to which it would be appropriate for their general policy on the use of PGD, and the circumstances of Mr and Mrs Masterton’s case, to be addressed at the meeting on 27 January 2000 became more sharply focused, and as a result changed significantly, in the course of consideration during their correspondence with Mr Masterton and their lawyers; their responses to Mr Masterton changed accordingly. Had Mr and Mrs Masterton’s case been of a routine nature, I would regard the time taken by the Authority to reach a considered view as to how the matter should be put to the meeting as unacceptable; it was in large measure due to Mr Masterton’s persistence that the point was determined at the time it was. The Deputy Chief Executive’s point, in his note of a telephone discussion with Mr Masterton on 28 January 2000, that an individual seeking to apply directly to the Authority was a fairly novel situation, for which there was no established procedure, offers some mitigation. Nevertheless, in view of their own uncertainty, the Authority should at least have been more careful than they initially were about what they led Mr Masterton to expect. Instead, they presented to Mr Masterton an option that they had not thought through, with the result that from 8 December 1999 to 5 January 2000 Mr Masterton was given good reason to believe that his wish that the Authority would re-examine their policy and make a pronouncement in the light of his case would be granted. I do not regard that as having significantly altered the course of events, or led to any trouble or expense on Mr Masterton’s part that he would otherwise have avoided, because after 5 January 2000, when the position had been made clear to him, he continued to press his case as before. However, I considered that an apology was due from the Chief Executive to Mr and Mrs Masterton, for the Authority’s having unnecessarily (albeit in good faith) raised expectations which were later disappointed, by failing to consider their position more thoroughly at the outset, and giving undertakings from which on further reflection they justifiably considered it necessary to retreat. When I put that to the acting Chief Executive, he replied that he accepted that the Authority had, inadvertently and in good faith, raised Mr Masterton’s expectations, and that an apology for that would be appropriate.
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4.26 I turn finally to the question of whether the Authority misled Mr Masterton on any of the procedural points involved. The situation was sufficiently open to misunderstanding to make reliance by either party upon telephone discussions alone risky, in view of which Mr Masterton was understandably insistent upon written confirmation. For that reason, while I have, for the sake of completeness, described the records of telephone discussions kept by the Authority, I see no value in debating precisely what was said or meant on those occasions. I have considered what the Authority said in their letters to Mr Masterton prior to the meeting on 27 January 2000. Apart from the flaw described in paragraphs 4.23 to 4.25 above, I find nothing misleading in them. In particular, the Deputy Chief Executive’s letter of 14 January 2000 went no further than to say that Mr Masterton’s file, as submitted, would receive proper consideration at or before the meeting on 27 January. I regard the facts that the file was seen before the meeting by the Chairman, and that its existence was disclosed to the other members at the meeting in the context of the Chairman’s proposal for its handling, as having fulfilled the Deputy Chief Executive’s commitment; the Authority’s legal advice was that more detailed consideration at that stage would be inappropriate. I conclude that the Authority were sufficiently cautious in the terms in which they replied to Mr Masterton’s queries on procedural points to have avoided making any promises in that respect that they could not keep.
Conclusion
4.27 Mr Masterton’s request that the Authority review their policy on the use of PGD was mishandled insofar as, finding themselves unable easily to reach a considered view at the outset as to how best to deal with it, the Authority initially expressed their intentions in terms which led Mr Masterton to expect a resolution that in the event, with the benefit of closer consideration and legal advice, the Authority legitimately decided they could not provide. The new Chief Executive of the Authority will be writing to Mr Masterton to apologise for that. I regard that as a suitable response to Mr Masterton’s complaint.
Annex A
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