Regulation of fertility treatment in the UK: information for patients
Fertility treatment: the regulatory system
Fertility treatment in the UK is closely regulated by law. Certain activities involving embryos are criminal offences. These include allowing an embryo to develop outside the body for more than 14 days and putting an animal, hybrid or genetically modified embryo in a woman. Most other activities involving human eggs, sperm or embryos are allowed only if you have a licence from the Human Fertilisation and Embryology Authority (HFEA), including:
- Providing fertility treatment involving embryos, eggs or sperm
- Storing or distributing human eggs or sperm
- Creating an embryo through IVF
- Testing an embryo
- Conducting research involving embryos.
The licensing system sets rules about what is permitted, and all activities are regulated and inspected by the HFEA. The HFEA also enforces EU laws, which ensure quality and safety standards across Europe.
The Human Fertilisation and Embryology Authority
The HFEA was set up in 1991 and oversees all fertility treatment and research involving human embryos in the UK. The HFEA comprises members (the majority of whom are clinicians, researchers or other fertility/embryology professionals) and a lay chair. Its functions include:
- Granting licences to fertility clinics, storage facilities and research projects
- Ensuring that the conditions of the licences are complied with through an ongoing inspection and enforcement system
- Giving support and guidance to licence-holders, patients and donors
- Publishing a code of practice and ensuring that licence-holders comply with it
- Advising the government on developments in fertility and embryology matters
- Keeping the Register of Information.
The HFEA Register of Information
The Register of Information contains details of all fertility treatments carried out in the UK since 1 August 1991. If you are having (or have had) fertility treatment in a licensed clinic in the UK, the Register records details about you, your treatment, any donor that you have used and any child born if your treatment is successful.
The register is particularly important for families of donor-conceived children, because they have certain legal rights to access information about their genetic heritage in later life (find out more).
Information on the Register of Information is protected by strict confidentiality laws which go beyond normal medical confidentiality and make it a criminal offence for information to be disclosed, except in very particular circumstances.
The HFEA welfare of the child assessment
The Human Fertilisation and Embryology Act 1990 (as amended) imposes on fertility clinics a duty, before offering treatment, to ‘consider the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting) and of any other child affected by the birth’.
Guidance on the welfare of the child assessment is given to fertility clinics by the HFEA Code of Practice. Generally speaking, the guidance instructs clinics to take a risk-based approach to the assessment. There is a presumption that you should be treated unless there is real evidence of potential risk to your prospective child.
Until 1 October 2009, fertility clinics had a duty to consider the child's need for 'a father' rather than 'supportive parenting'. The decision to change the wording of the law provoked a great deal of controversy while the Human Fertilisation and Embryology Act 2008 was going through Parliament, with some vocal critics arguing that the change undermined traditional family values and devalued the role of men in parenting. However, the new duty to consider the need for 'supportive parenting' brings fertility law into line with other anti-discrimination and equality laws which make it unlawful to discriminate on the grounds of sexuality. There is no longer any suggestion in the law that single and lesbian women need to satisfy a higher standard of suitability for fertility treatment than heterosexual couples.
HFEA requirements for counselling and information
The law requires counselling to be offered to patients and donors (although uptake is not mandatory) and ‘proper information’ to be given, before fertility treatment is provided.
How we can help
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