Assisted conception and the law in the United Kingdom

Along with advances in technology comes the need for government guidelines and laws to ensure that those technologies are used safely and responsibly. This article covers the development of the rules in the United Kingdom that govern assisted conception, and the implications of these rules for day to day clinical practice.

Human Fertilisation and Embryology Act 1990

The Human Fertilisation and Embryology Act was passed in 1990 in response to the report of the Committee of Inquiry into Human Fertilisation and Embryology (the Warnock report), which examined three main public concerns. These were:

• Creation of human embryos outside the body and their use in treatment

• Use of human embryos in research

• Use of donated gametes and embryos.

The act established the Human Fertilisation and Embryology Authority (HFEA), and its licensing and inspection procedures, as the main mechanism for regulating these activities.

Figure 1.

Baroness Mary Warnock chaired the Committee of Inquiry into Human Fertilisation and Embryology 1982-4

Functions of the HFEA

The HFEA is a statutory non-departmental public body and is accountable to the secretary of state for health. Established in 1991, it is the first statutory body of its type in the world. It has 18 members who are appointed by the secretary of state, including a lay chairperson and a deputy chairperson. At least one third, but not more than half, of its membership may be registered medical practitioners or those who have been involved with assisted conception or its research funding.

Table 1.

Assisted conception treatments that require an HFEA licence^*

• In vitro fertilisation

• Intracytoplasmic sperm injection

• Preimplantation genetic diagnosis

• Sperm donation

• Egg donation

• Embryo donation

• Surrogacy

^*Other assisted conception treatments, such as intrauterine insemination and gamete intrafallopian transfer, do not need a licence if own gametes are used as no embryo is created in vitro

Licensing

Three types of licences can be granted by the HFEA.

A treatment licence allows the unit to pursue treatments that fall under the act.

A storage licence allows cryopreservation and storage of gametes and embryos.

A research licence is needed to perform any research that uses human embryos in vitro.

Table 2.

Research using human embryos in vitro permitted under an HFEA research licence

• To promote advances in the treatment of infertility

• To increase knowledge about the causes of congenital disease

• To increase knowledge about the causes of miscarriage

• To develop more effective techniques of contraception

• To develop methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation

• To increase knowledge about the development of embryos*

• To increase knowledge about serious disease*

• To enable any such knowledge to be applied in developing treatments for serious disease*

• To enable any such knowledge to be applied in developing treatments for serious disease*

^*Added in 2001 after the parliamentary debate on use of embryos for the creation of stem cells (Human Fertilisation and Embryology (Research Purposes) Regulations)

To practise assisted conception, the centre will be inspected and, if the facilities and staff are deemed suitable, a treatment licence will be granted to the "person responsible." This person will be the named individual under whose supervision the licensed activities will be carried out. In the United Kingdom certain activities are prohibited and a breach of the act is considered a criminal offence. The renewable licence is granted for up to three years, but is subject to annual reports and inspections.

Table 3.

Activities prohibited in the act

• Keeping or using an embryo in vitro after the appearance of the primitive streak or 14 days of development, whichever is the earlier

• Placing an embryo in a non-human animal

• Replacing the nucleus of an embryo with a nucleus taken from the cells of another person or another embryo (cloning)

• Altering the genetic structure of any cell while it forms part of an embryo

The register

The act requires the HFEA to keep a register of all treatment cycles and of all children born as a result of in vitro fertilisation technology or by the use of donated eggs or sperm. The register ensures that later on such children may learn something of the circumstances of their conception. The act states that when children reach 18 years they may request to know whether they were born as a result of a treatment that required an HFEA licence, including donor insemination. If contemplating marriage, the child may ask whether they could be related to the individual that they intend to marry. In these circumstances, the request may be made by a minor of marriageable age, and so the first such requests for information may be expected in 2007 (16 years after the establishment of the HFEA). Under current legislation the identity of donors will not be revealed.

Figure 2.

Suzi Leather chairs the HFEA

Implications of the act for practice

The HFEA publishes and revises regularly its code of practice in which is set out what are considered "suitable practices" in the context of activities that require licences under the act. The act is unusual in clinical practice in five principal ways.

Table 5.

Other functions of the HFEA

• To publicise the services provided by the HFEA or provided in the pursuance of licences. This is done through the HFEA's annual report and website (www.hfea.gov.uk)

• To provide advice and information to those to whom licences apply and to those who are receiving treatment, providing gametes or embryos, or who may wish to do so (guides and leaflets for patients)

• To keep under review information about embryos and about the provision of treatment services, and (when asked) to advise the secretary of state on such matters

Consent

The act requires that control of the use of gametes, whether for in vitro fertilisation, storage, donation, or research should lie with the provider of those gametes (but without the notion of ownership). Consent forms are used to specify the fate of embryos and gametes in assisted conception.

It is this requirement for written consent that was at the heart of the dispute in the case of Diane Blood. While he lay in a coma, Diane Blood wanted some of her husband's sperm removed to be cryopreserved for her later use to have a child. Removal and storage of the sperm and its use without written consent would have been a criminal offence in the United Kingdom. After a protracted court case Diane Blood was allowed to take the sperm abroad for use.

Table 4.

Activities that consent must specify

• The precise use of the gametes in treatment

• Whether gametes may be used to fertilise an egg in vitro and whose eggs may be fertilised

• Into whom those embryos may be placed

• What is to be done with any embryos not transferred (they could be frozen, destroyed, or used for research)

• Whether any embryos or gametes may be cryopreserved, and if so then the length of time for which they may be stored

• The precise use of those cryopreserved gametes or embryos including their use after the death of the donors involved

Figure 3.

Lorraine Hadley and Natallie Evans separated from their partners with whom they had had IVF treatment and embryos frozen. The men withdrew their consent, however, and the embryos must now be destroyed. The High Court in London upheld the ruling that effective consent must be given by both the man and the woman to allow continued storage of their embryos

Confidentiality

Because of the sensitive and personal nature of the treatments involved, specific criminal sanctions exist for a breach of confidentiality. It is unusual for confidentiality to be enforced so strictly, and even more so that criminal sanctions can be brought if broken. In practice, assisted conception unit case notes are kept securely and separately from routine hospital notes. They are accessible only to those members of the unit named on the treatment licence, or when needed, to other licensed individuals. An amendment to the act in 1992 allowed information about the treatment to be given to a third party only with the patient's explicit written consent and strictly on a "need to know" basis.

Counselling

Before providing or receiving gametes for use, donation, or fertilisation, the act requires that a person must have "a suitable opportunity to receive proper counselling on the implications of taking the proposed steps," and that that their consent should not be effective unless such counselling has been offered. All reproductive medicine units should provide access to an appropriately trained fertility counsellor, although the patients do not have to accept the offer of counselling to receive treatment. Counselling for people having treatment in which donor gametes are to be used is strongly advised.

Table 6.

Additional information a centre requires when providing treatment with donor gametes

• A child's potential need to know about his or her origins and whether the prospective parents are prepared for the question if it arises as the child is growing up

• The possible attitudes of other members of the family towards the child and the child's status in the family

• The implication for the welfare of the child if the donor is personally known in the child's family and social circle

• Any possibility known to the centre of a dispute about the legal fatherhood of the child

General practitioners may find that, because of the strict confidentiality of the Human Fertilisation and Embryology Act, summaries and information about the assisted conception treatment that their patient is having may not be forthcoming if that is their patient's wish. Sometimes letters from the unit will be sent to the patient for them to release to their doctor as they see fit

Information

The act also requires that no person should provide gametes for in vitro fertilisation, storage, or donation without first being given appropriate information about treatment. All assisted conception units are therefore obliged to have written information available (including up to date success rates expressed as "live birth per treatment cycle started"), which can be requested by prospective patients or their doctors. The HFEA patients' guides also have information about these success rates, including multiple pregnancy rates and services offered at the 110 units that hold treatment licences in the United Kingdom. The patients' guides and other publications can be obtained free from the HFEA, Paxton House, 30 Artillery Lane, London E1 7LS.

Figure 4.

Patients' guides available from the HFEA

Welfare of the child

The welfare of the child is probably the most controversial part of the act. It requires that "a woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for a father) and of any other child who may be affected by the birth." The latter refers to any existing children in the family

Table 7.

Information to be taken into account when assessing welfare of the child issues

• The couple's commitment to having and bringing up a child or children

• The couple's ability to provide a stable and supportive environment for any child produced as result of treatment

• The couple's medical histories and the histories of their families

• The couple's health and consequent future ability to look after or provide for a child's needs

• The couple's ages and their likely future ability to look after or provide for a child's needs

• The couple's ability to meet the needs of any child, including children in multiple births

• Any risk of harm to the child or children who may be born, including the risk of inherited disorders, transmissible diseases, or problems of neglect or abuse

• The effect of a new baby or babies on any existing child of the family

Thus, each licensed unit is obliged to have clear written procedures for assessing the welfare of the potential child and of any other child who may be affected. However, this condition applies only to centres that hold a treatment licence. It has been argued that this requirement is unfair because it does not apply to natural procreation, nor does it apply to fertility treatments offered outside licensed assisted conception units.

Nevertheless all assisted conception units should ask the couple's general practitioner for information about any factors that may be relevant to the couple's suitability as parents of the child. Permission from the patient is usually included in the letter of request from the unit.

Some units may provide helpful checklists to ensure that they ask about specific issues that are deemed relevant. These issues include whether the couple live together, whether any of their children have been put on the "at risk" register or taken into care, and whether either partner has a drug dependence, a history of violence, or a criminal record. After assessment, if a unit decides that it cannot treat the couple, the couple concerned must be told, and they may then appeal against this decision or seek treatment at another unit.

Providing information about a patient's suitability to be a parent may be regarded as intrusive and hence the general practitioner should ensure that he or she has specific permission from the patient

Legal parents of children from donated gametes or surrogacy

The woman's husband will be the legal father of a child born using donated sperm unless they are judicially separated or he can prove that he did not consent to the treatment. Where a woman is being treated together with a male partner who is not her husband and uses donated sperm, and if her legal husband does not consent to the treatment, then that male partner will be the legal father of any resulting child. Consent forms will normally reflect this intent.

Table 8.

Transfer of legal parentage to a commissioning couple in a surrogacy arrangement

• The child must be genetically related to at least one member of the commissioning couple

• The surrogate parents must have consented to the making of the parental order for transfer no earlier than six weeks after the birth of the child

• The commissioning couple must have applied for a parental order within six months of the child's birth

• The commissioning couple must be married to each other and both be over 18 years

• No money other than expenses must have been paid in respect of the surrogacy arrangement unless authorised by a court

• The child must be living with the commissioning couple

• The commissioning couple must be domiciled in the United Kingdom, the Channel Islands, or the Isle of Man

When a woman receives donated oocytes, she, as the "birth mother" is the legal mother of the child, and her partner or husband is the legal father.

Table 9.

Regulations in the United States

• No federal law exists to govern the practice of assisted conception in the United States except for the requirement of the 1992 Fertility Clinic Success Rate and Certification Act for each in vitro fertilisation or intracytoplasmic sperm injection programme to report annually its pregnancy success rates to the United States Centers for Disease Control and Prevention (CDC)

• These data are analysed and published as the Assisted Reproductive Technology Report by the CDC in conjunction with the Society of Assisted Reproductive Technology (SART)

• The report can be found at www.cdc.gov/reproductivehealth/ART00/index.htm

• Minimum standard practice guidelines are issued by the American Society of Reproductive Medicine, which are updated periodically (www.asrm.org)

Surrogacy is a special case, and the child has to be adopted formally even though it is genetically derived from one or both parents. The birth mother and her partner are the legal parents of a child born as a result of a surrogacy arrangement until legal parentage is transferred to the commissioning couple. The surrogate mother must therefore register the baby to whom she has given birth in the normal way. Her husband or partner should normally be registered as the father. Surrogacy arrangements between the commissioning couple and the surrogate mother are not legally enforceable under UK law, even when the child results from an embryo created from the gametes of the commissioning couple.