Cheshire and Merseyside Specialised Services Commissioning Team Addendum to the Cheshire and Merseyside Fertility Policy May 07 Outstanding Clinical Issues Below are a number of issues that are not directly addressed in the current policy and which require clarification. 1. Definition of a Cycle The current wording in the policy has been interpreted differently by units and commissioners. Clarity is required as the new policy marks a change from the previous situation in which embryo transfer was the point at which a cycle was counted for the purposed of accounting. A cycle of IVF/ICSI will be counted for the purposes of NHS funded treatment if: Ova have been harvested Maximal stimulation dosage has been used. This upper limit is 225mg of gonadotrophin Thus, clinicians will be able to titrate the dose of follicular stimulation up to the maximum without utilising the NHS allocation of funding. However, once that maximal level has been reached, each cycle of maximal stimulation will count for the purposes of NHS treatment 2. Ovum/embryo donation NHS funding will be available for women with premature menopause. Premature menopause is defined as amenorrhea of at least 12 months duration with FSH in the menopausal range, under the age of 40. The cause may be either spontaneous, as a result of other morbidity (e.g. Turner’s syndrome), congenital abnormality or iatrogenic (e.g. following surgery) NHS funding for ovum/embryo donation will not normally be available for women outside these groups who do not respond to maximal doses of follicular stimulation. 3. Stimulated Intrauterine Insemination The possibility of multiple births arising from this intervention is an important consideration. If ovarian stimulation is used in IUI, the cycle should be abandoned if more than 2 follicles of 14mm diameter develop. There should be Cheshire and Merseyside Fertility Working Group 2 a contractual target aimed at decreasing the multiple birth rate to between 510%. 4. Sperm retrieval In general male fertility problems will not require biopsy to confirm diagnosis and formulate a management plan. However, if a biopsy is to be taken, the appropriate management of sperm retrieved at this procedure is outline below: Men who, with their partner, will be eligible for NHS funded fertility treatment – NHS funds all investigation and treatment Men in whom biopsy is clinically essential but who, with their partner, will not be eligible for NHS fertility treatment – NHS funded biopsy and retrieval, patient funds subsequent costs of testing storage and subsequent use. Vasectomised men – costs of surgical sperm retrieval, testing storage and subsequent use of sperm to be borne by the patient. 5. Storage of ovarian tissue The techniques involved in storage of ovarian tissue, the subsequent thawing and use are considered to be experimental at present. Thus, they will not be routinely offered by the NHS. The NHS will fund clinically necessary freezing and storage of ova under the same criteria as that for the storage, use and disposal of sperm. 6. Egg sharing This is a system by which women undergoing self funded follicular stimulation for IVF agree to give some of the eggs they produce to another woman in need of egg donation in exchange for a reduction in the price they pay for their IVF. In general this should not affect patients receiving NHS treatment, however, women waiting for NHS funded egg donation would not be able to use to obtain ova in this way. It is distinct from egg donation by women about to undergo sterilization and from donation of eggs or embryos by women undergoing fertility treatment who are donating without any commercial considerations. Cheshire and Merseyside Fertility Working Group 3 7. Surrogacy Current legal advice is for PCTs not to fund surrogacy arrangements. The rationale underpinning this is contained in the attached advice received from Hill Dickenson. (Appendix 1). This should be used by PCTs in conjunction with the existing points for consideration contained in the guidance on exceptional case consideration. Cheshire and Merseyside Fertility Working Group 4 Appendix 1 Legal Advice from Hill Dickenson Hill Dickinson LLP Pearl Assurnce House 2 Derby Square Liaverpool L2 9XL Tel: +44 (0)151 236 5400 Fax: +44 (0)151 236 2175 DX 14129 Liverpool www.hilldickinson.com E-Mail claire.odonnell@cmssct.nhs.uk Re: Date: 21 February 2007 Surrogacy Arrangements Thank you for your patience in waiting for me to come back to you with a more detailed response on the issue of surrogacy arrangements involving infertile couples and, in particular, the situation where a couple have secured the surrogate themselves but are requesting that the PCT fund the IVF treatment within that arrangement. As previously discussed, I advise against PCTs becoming involved in surrogacy arrangements. The surrogacy review carried out by Professor Margaret Brazier for the Department of Health in 1998 makes the following observations on the involvement of clinicians in brokering surrogacy arrangements:3.26 What medical practitioners do not involve themselves in, however, is the process by which commissioning couples find a surrogate. Doctors may often now be willing to advise generally on surrogacy arrangements and assist in establishing a pregnancy. They do not (and might well fall foul of the 1985 Act if they did) assist couples to establish a surrogacy arrangement. A couple seeking medical assistance to establish a pregnancy must either have found their own prospective surrogate independently, or have obtained assistance from one of the non profit-making organisations set up to support commissioning couples and surrogates, such as COTS and SPC. We understand that some clinics will refer patients contemplating surrogacy to such organisations. Professor Brazier’s report did not envisage any change to the above position. The reference to a possible breach of the Surrogacy Arrangements Act 1985 may refer to the potential commission of an offence under Section 3 which prohibits any form of “advertising” that “any person is or may be willing… to negotiate or facilitate the making of a surrogacy arrangement.” Cheshire and Merseyside Fertility Working Group 5 The funding of treatment in respect of surrogacy arrangements raises numerous legal and ethical issues, particularly as the legal position on surrogacy is presently unclear. I would therefore advise that, to be on the safe side, PCTs should go beyond simply observing the prohibition on “brokering” surrogacy arrangements and decline to provide any form of fertility treatment to those in surrogacy arrangements. I believe this conclusion is supported by a number of arguments which I have set out below. National Health Service Act 1977 There is some doubt as to the statutory basis upon which a NHS body can provide IVF to those in surrogacy arrangements given that the person in whom any resulting embryo is implanted, the surrogate, is not herself suffering from an illness or disability and also may not follow through on the arrangement. The National Health Service Act 1977 empowers the Secretary of State, acting through NHS bodies, to secure the effective provision of services for the prevention, diagnosis and treatment of illness. The precise wording of the legislation only appears to envisage treatment provided direct to the person suffering from an illness or disability. The Act also grants NHS bodies a general power to “do any other thing whatsoever which is calculated to facilitate, or is conducive or incidental to, the discharge of” its duties. It is debatable whether this clause is so wide as to encompass the provision of treatment to a healthy third party in order to “treat” the commissioning couple’s infertility. Ethical and Legal Implications I have set out below a list of the risks which have apparently been considered by other NHS bodies when determining whether to fund fertility treatment for those in surrogacy arrangements. Although if one of these risks materialise the PCT may not itself be a party to any resulting legal proceedings, the PCT may nevertheless wish to consider the public reaction if the NHS has been seen to assist in the creation of what are exceptionally complex and emotive disputes. If, as is recommended by BMA guidance, the surrogate has a partner, there may be issues as to the parentage of any child. The surrogate may change her mind in the course of the pregnancy and seek to have a termination. The surrogate may refuse to give the child to the commissioning couple after birth. The Courts have in the past affirmed the surrogate mother’s right to retain parental responsibility over the child as the Surrogacy Arrangements Act 1985 specifically makes any agreement between the commissioning couple and the surrogate unenforceable before the Courts. There have however been occasions when it has been held to be in the best interests of the child to be handed over to the commissioning couple. The commissioning parents may change their mind and the surrogate may herself decline to care for the child resulting in an “unwanted baby.” This situation may arise when tests in the course of the pregnancy demonstrate that the child is suffering from a genetic or congenital defect. Cheshire and Merseyside Fertility Working Group 6 The surrogate mother may become disabled or die as a result of the pregnancy. Issues then arise as to who is to provide for the continuing care of the mother or her dependants. There may be disputes as to the extent of the surrogate mother’s continuing involvement with the child throughout its life. The surrogate mother or the child’s biological siblings may experience ongoing emotional issues arising from the arrangement. NICE Guidance & General Government Attitude to Surrogacy Clinical Guidelines to NHS Bodies on “Assessment and Treatment for People with Fertility Problems” published by NICE in February 2004 offer guidance as to how scare resources should be allocated in the provision of fertility treatment. It is specifically stated that surrogacy is outside the remit of the guidance. It is therefore arguable that instead of providing surrogacy services PCTs should perhaps use their resources to facilitate the provision of services prescribed by the NICE guidelines to a wider section of the population. A brief search of the Internet also provided evidence that the majority of NHS bodies do not fund surrogacy-related IVF treatment. The failure to implement the changes to the current law on surrogacy recommended by the Brazier Report does seem to be symptomatic of a wider reluctance on the part of government to involve itself in this issue. The Surrogacy Arrangements Act 1985 was introduced following the “Baby Cotton” case where a surrogate mother entered into an arrangement with a commissioning couple via a profit-making intermediary. The rationale behind the Act appears to be that surrogacy is “tolerated” and not promoted, in contrast with other fertility treatments. It is therefore doubtful whether or not public money should be used to facilitate such arrangements. This view is further supported by the Brazier Report which states at Paragraph 3.26:Couples who wish to utilise full surrogacy where they are the genetic parents of the child can obtain assistance in establishing a pregnancy via IVF at a licensed clinic. Couples who seek partial surrogacy but with the reassurance of medical supervision can also do so. In both cases that ability to seek professional involvement is likely to be dependent on ability to pay. There have been to our knowledge at least two instances of health authorities being asked to pay for surrogacy services, but generally such services are confined to the private sector. Given the fact that the Brazier Report made no recommendations on the wider availability of surrogacy services it may be presumed the intention was that the status quo would continue. Cost Implications I attach a copy of the Aberdeen Royal Hospitals NHS Trust guidance on “Management of Requests for Surrogacy Treatment.” Although this relates to a Scottish NHS Trust, the relevant legislation, the Surrogacy Arrangements Act 1985 and the Human Fertilisation and Embryology Act 1990, are applicable across the UK and the guidance given is therefore relevant. Cheshire and Merseyside Fertility Working Group 7 As can be seen from the guidance all those involved must undergo an exhaustive programme of counselling. This includes not only an evaluation of the participants prior to commencement of treatment, throughout the pregnancy and childbirth but also ongoing emotional support into the future. Such measures would presumably entail a significant cost implication for the PCT’s. Provision of Ante-Natal and Maternity Services to Surrogate Mothers Notwithstanding the above advice ante-natal and maternity services must be provided to women who act as surrogates and who approach anging Conceptions of Motherhood: The Practice of Surrogacy in Britain (1996) states thattheir PCT after conception. The BMA’s report entitled Ch:Once a surrogate pregnancy has been established, the practitioner’s ethical obligations to the surrogate mother and child are no different from those owed to any other pregnant woman except that additional support may be required. The duty of the health care team is to provide the appropriate level of support and guidance both during and after the pregnancy. The Royal College of Midwives has also published guidance dealing with this specific issue and the difficulties that may arise. For the reasons outlined above I would advise against the PCTs funding IVF treatment for surrogate mothers. The Human Fertilisation and Embryology Act and other associated fertility issues are currently under review by the government and it may be that this issue should be revisited once the legal position becomes clearer. Kind regards. Yours sincerely Sharon Wilson (Miss) Partner HILL DICKINSON LLP Cheshire and Merseyside Fertility Working Group 8