“No more than three eggs or embryos should be placed in a woman in any one cycle, regardless of the procedure used.”
“The Authority’s principal task is to regulate, by means of a licensing system, any research or treatment which involves the creation, keeping and use of human embryos outside the body, or the storage or donation of human eggs and sperm. It must also maintain a Code of Practice giving guidance about the proper conduct of the licensed activities. The Act also allows the Authority to give guidance on any procedure involving the placing of eggs and sperm in a woman.”
“ Prohibitions in connection with embryos (1) No person shall (a) bring about the creation of an embryo, or (b) keep or use an embryo except in pursuance of a licence ………”
“ Licences for treatment (1) A licence under this paragraph may authorise any of the following in the course of providing treatment services— (a) bringing about the creation of embryos in vitro , (b) keeping embryos, (c) using gametes, (d) practices designed to secure that embryos are in a suitable condition to be placed in a woman or to determine whether embryos are suitable for that purpose, (e) placing any embryo in a woman, (f) …. (g) such other practices as may be specified in, or determined in accordance with, regulations. (2) Subject to the provisions of this Act, a licence under this paragraph may be granted subject to such conditions as may be specified in the licence and may authorise the performance of any of the activities referred to in sub-paragraph (1) above in such manner as may be so specified. (3) A licence under this paragraph cannot authorise any activity unless it appears to the Authority to be necessary or desirable for the purpose of providing treatment services. (4) A licence under this paragraph cannot authorise altering the genetic structure of any cell while it forms part of an embryo. (5) A licence under this paragraph shall be granted for such period not exceeding five years as may be specified in the licence.”
“The Authority shall: (a) keep under review information about embryos and any subsequent development of embryos and about the provision of treatment services and activities governed by this Act, and advise the Secretary of State, if he asks it to do so, about those matters, (b) publicise the services provided to the public by the Authority or provided in pursuance of licences, (c) provide, to such extent as it considers appropriate, advice and information for persons to whom licences apply or who are receiving treatment services or providing gametes or embryos for use for the purposes of activities governed by this Act, or may wish to do so, and (d) perform such other functions as may be specified in regulations.”
“My client takes the view, as a medical professional, and as an expert in the field, with the statistics to prove his expertise, that the risk of any of these women having a multiple birth is non-existent, given the previous history. He wants to transfer more than 3 embryos to each of these patients simply in order to give them a reasonable chance of conceiving or carrying a foetus beyond the first three months at all . He takes the view that to do so is the minimum required by way of suitable fertility practice for these individuals, and is prepared to act on his professional judgment. We are aware of the spirit of collaboration and co-operation now existing between the HFEA and my client’s Centre. Would the HFEA be willing to acknowledge that transfer of more than 3 embryos in an individual case would be considered appropriate if it were credibly asserted that there was evidence which would convince a responsible body of fertility specialist opinion that such transfer was medically essential .”
“DOB:17/6/1954 .... Para 0+1, 1 st trimester miscarriage in 1984. History of bilateral tubal block and unsuccessful tubal surgery in 1995. Hysteroscopy in 1998 revealed an initially normal uterine cavity. Starting in 1996, she has had seven unsuccessful IVF/ICSI treatments (of which three were unsuccessful frozen embryos replacement cycles) coupled with AH and prolonged embryo culture. Her last frozen embryo replacement cycle was in January 2000. She has always responded adequately to ovarian stimulation in the past and produced good quality embryos; hence the frozen embryos replacement cycles. Her gonadotrophic assessment in the early follicular phase has always been in the normal range including the last assessment in June 2000. She is currently undergoing controlled ovarian hyper-stimulation with 300 iu of HMG (to which she has responded adequately) and is scheduled for embryo transfer on Thursday/Friday 13/14 July 2000 Taking into account the above history the chance of a high order multiple pregnancy in this particular case is negligible. (After all this patient has had a total of 21 embryos replaced during the course of her previous treatments without even getting pregnant once!). It is also ironic that should her tubes been patent, GIFT procedure with the replacement of an unlimited number of eggs would have been an accepted medical practice in her case It is my strong belief that the replacement of more than three embryos in this particular case is not just medically essential and professionally sound, but is the minimum required in the discharge of my professional responsibility towards this patient. ”
“We confirm that the live birth rate of 1.2% (referred to in paragraph 6 of our letter) relates to cycles between 1 8.91 and 31.3.98 involving transfer of fresh embryos create from patients’ own eggs. As our letter confirms, the multiple birth rate (referred to in paragraph 5) is based on the same data. Whilst numbers achieving pregnancy at age 46 and above are very small, this was the largest data set available. Of the numbers achieving pregnancy at age 46 and above, the triplet birth rate was 20% (1/5). The Licence Committee did not consider the risk of multiple pregnancy (including the risk of higher order multiple pregnancy) to be negligible.”
“We refer to our letters of 28 July and 7 August. In those letters we mentioned certain UK data relating to cycles between 1.8.91 and 31.3.98. The Licence Committee has reconsidered the questions raised by you in correspondence without reference to that data. The Licence Committee considered other available evidence, including that derived from the four publications referred to in the attached annex and in addition to the guidelines of the RCOG and BFS. The Licence Committee acknowledges that the numbers of cases are limited but what published evidence there is indicates there is still a risk of multiple pregnancy (including higher order births). It would, therefore, be prudent, given the case that you have described, not to replace more than three embryos in any one treatment cycle. On the evidence available, the Licence Committee remains of the view that it would be an unsuitable practice to transfer more than three embryos.”
“The information states clearly that frozen embryos were used on three occasions and our client has confirmed that fresh embryos were used for the eighth treatment. Consequently it is implicit that the cycles for the treatment during which fresh embryos were used were in fact stimulated, and this is further indicated by the statement that the patient “ has always responded adequately to ovarian stimulation in the past and produced good quality embryos ”
“The Authority did not agree that in this patient’s case the transfer of more than 3 embryos in one treatment cycle would significantly increase the chances of a live birth without a more than negligible increase in the risk of a higher order multiple pregnancy. Accordingly, the Members did not feel that this case could be regarded as an exception justifying departure from the guidance in the Code of Practice. The Members recognise that one factor might affect future decisions in that the state of the clinical evidence (and therefore the evaluation of the risk) might change.”
“(1) fettering its discretion in treating its own Code of Practice as “authoritative” and refusing to depart from that guidance despite the existence of exceptional circumstances; (2) taking into account irrelevant factors and not taking into account relevant considerations in making its decision; and (3) failing to give any rational or proportionate reasons for its decision, and thereby inviting the inference that it has acted irrationally.”
“However, wherever the boundaries of judicial review are drawn for these purposes, it remains fundamental to the arguability of the claimant’s case that there be features demonstrated which arguably take the decision out of the range of available decisions. Even with a more intrusive approach, the court would be bound to allow substantial room for the application of expert and scientific judgment by the bodies specifically entrusted to provide guidance in these sensitive medical and ethical areas. Fundamental to leading counsel’s submissions is the contention that, whilst the balancing exercise carried out by the Authority reflected the correct approach to be adopted, the inputs to the analysis of harm and benefit which would flow from the use of 5 rather than 3 embryos in one cycle, arguably involved such a significant degree of misunderstanding of the relevant scientific considerations as to enable the decision to be described as one falling outside the range of available decisions, even on the basis of a more limited available range.”
“25. The debate, to my mind demonstrated three points. First the Authority had a clear answer to the statistical point that had been raised by leading counsel, both as to the figures which it actually used and as to the fact that those statistics did not arguably contradict the fundamental approach it adopted, namely the risk of multiple births from pregnancy should it occur was greater with a patient who had good eggs if more than three were transplanted. Secondly, the Authority considered the specific medical circumstances and age of the second claimant, rather than applying its policy guideline without considering what was appropriate for a woman with her characteristics of age and egg producing capabilities. Thirdly, however intrusive a level of scrutiny by the court might be appropriate, the court could not be the adjudicator between two views of an academic paper or its relationship to the United States National Vital Statistics Reports referred to in paragraph 10 of the letter, or the Schieve paper. Certainly [leading counsel] had not demonstrated that it was clearly arguable that there was a serious misunderstanding by the Authority of that academic paper falling outside the scope of appreciation available to a specialist and an expert body.”
“27. As to whether two successive cyclical treatments with three eggs as opposed to five eggs in one cycle would achieve better prospects of pregnancy without a greater risk of multiple births, the Authority was entitled to reach the view it did in paragraphs 6 and 7 of its reasoned decision letter. There may of course be two reasonable views possible but to suggest that the absence of success so far for (Mrs H) showed the Authority’s view to be outside the range available to an expert body, again simply impermissibly invites the court to have a range of medical views deployed before it and to decide between them for itself.”
“30. I do not consider that any of the other points raised by [the clinic] in paragraph 13 of [its] skeleton argument raise an arguable point on rationality, within even the narrow limits applicable because of the potential engagement of Articles 8 and 12 of the Human Rights Convention. They all come back to or depend upon the statistical issues discussed above. I do not consider that the decision letter shows any fettering of the Authority’s view such that the appropriate or proportionate application of the guidelines to this particular patient was ignored. On the contrary, the relevant personal medical information was sought, and a conclusion was reached in the light of the significance of the production, even at her age, of a large number of good quality embryos with little artificial stimulation. 31. It may be that the circumstances in which the Authority give different advice as to appropriate practice are indeed very limited, but it may also be that in comparison with other opinions, for example the United States appears to favour no more than two embryos being transferred, United Kingdom guidance is already drawn more generously in the first place. 32. I have taken some time to set out my reasons in some detail, notwithstanding that this is but an application for permission, because (Mrs H)’s circumstances do warrant anxious and indeed sympathetic scrutiny. It is my judgment, however, that the submissions placed before this court on behalf of both parties, by which I mean the claimants and defendant, have shown this to be a case in which there is no arguable point, and that the asserted errors are not errors at all but at the best differences of expert view, the resolution of which is for the Authority and not for the court.”
“The false impression of low multiple pregnancies in older patients comes from the low pregnancy rate in general in this age group. Therefore, we conclude that women over the age of 35 should not be treated differently than their younger counterparts with regard to the number of embryos transferred, unless there is an individual indication to transfer more There is nothing in the text of the paper to suggest that 40 is a “cut off point”
“The Authority has considered carefully, whether, in this case, the transfer of more than three embryos would be likely to significantly enhance the chance of this patient becoming pregnant, and whether any such benefit is outweighed by a greater risk of a multiple pregnancy. The Authority has assessed both the general state of clinical knowledge and the available statistics and the facts of this case.”
“7. The Authority also considered the US data for the years 1995 to 1998 and the additional data and information provided by Dr Schieve concerning cycles between 1996 and 1998, involving women aged 46 or over. 8. The Authority recognises that the available data relating to patients over the age of 46 is very limited. The revised UK data confirms that there have been no live births in the UK for any patient aged 46 or over. Furthermore, apart from the data for 1995, (which indicates a success rate of patients aged 47 or over was zero), the US data for the years 1996 to 1998 confirms that very few women aged 47 or over have treatment using their own eggs. 9. The data information from Dr Schieve confirms that between 1996 and 1998 there were 394 procedures involving women aged 46 or over using their own eggs. Amongst these there were a total of 14 procedures (3.6%) that resulted in a live birth of which 6 (43%) were multiple births. The Authority recognises that this data involves very small numbers and cannot be broken down into further categories. The Members also took into account the points made in your letter dated27 June 2001 . Nevertheless, the data indicate a multiple birth rate of 43% for procedures involving the use of patient’s own eggs. 10. The Authority is anxious to avoid multiple pregnancies, not just births. This is in line with the guidelines of the Royal College of Obstetricians and Gynaecologists and the British Fertility Societies. The Authority noted that 1998 US data refers to there being “almost twice as many triplet pregnancies as triplet births”