Specialised Services Commissioning Team

advertisement
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
Download