IVF is one of the most regulated practises in the UK. Please read the information below to better understand what regulations Genesis Reproductive Health LLP & you must comply with.

Human Fertilisation and Embryology ACT

The Human Fertilisation and Embryology Act was passed by parliament in 1990 and became law on 1st August 1991. Simultaneously the Department of Health established The Human Fertilisation and Embryology Authority (HFEA) for the regulation of all treatments and research pertaining to human eggs, sperm and embryos. This authority licenses centres, its staff and regularly inspects the centres for compliance with the law and the HFEA Code of Practice. By law every HFEA licensed centre is required to report every treatment cycle and its outcome to the HFEA. This information is analysed periodically and published on the HFEA website (www.hfea.gov.uk) and in a `Patient’s Guide to IVF and DI treatments’ which is available free of charge on request from the HFEA.

HFEA register

The Authority keeps a confidential register of identifying information on all patients, their treatments, donors, recipients and children born after HFEA licensed treatments. This register was set up on 1st August 1991 and contains above information from that date onwards.

From the year 2008, people aged 16+ (if contemplating marriage) or 18, who ask the HFEA, will be told whether or not they were born as a result of HFEA licensed treatment, and if so, whether they are related to the person they want to marry.

The HFEA ‘generally permits donors to preserve their anonymity’. Only information that HFEA could give at the time when treatment was conducted may ever be available unless there was a further change in the law. This includes information about the screening tests performed before donation and their results.

Prior to April 2005, the law did not allow children born with donated gametes or embryos to apply for identifying information from the register about current or past* donors, or of patients and their children. It is a criminal offence for the centres to disclose this information.

*Recipient couples and donors concerned about how a retrospective change in the law might affect their and their child’s legal position should seek more specific independent legal advice.

Legal Parenthood

The law defines the ‘woman who gives birth as the mother and her partner as the father’ irrespective of the source of eggs, sperm or the embryos. This is the case unless the couple are judicially separated or the husband can prove that he did not consent to treatment.

  • When a child is born to an unmarried couple the male partner may not have parental responsibility for that child. In our centre, we provide treatment services to couples in stable relationships where both partners consent to treatment.
  • All partners are advised to provide legal consent in writing for the use of donated sperm/eggs/embryos in the treatment of their partner.
  • If the woman using donated sperm or embryos created with donor sperm is not married and is not in a civil partnership, she will be asked to consent in writing that she agrees to her partner being the legal parent of any child born as a result of this treatment. Her partner will also be asked to consent in writing that he/she agrees to being the legal parent of any child born as a result of this treatment.

*Unmarried couples concerned about how parental responsibility affects their legal rights should seek independent legal advice.

Treatment for lesbian couples and single women is considered on an individual basis after careful consideration of the Welfare of the Future Child/Children.

HFEA (The Human Fertilisation & Embryology Authority)

The Human Fertilisation & Embryology Authority exists to regulate any clinic which carries out assisted conception procedures involving the removal of eggs and sperm from the body and the transfer of any resulting embryos. It is there to make sure that the patient’s best interests are looked after and that the clinic maintains a high standard of practice at all times. Every Reproductive Medicine Unit is registered with the HFEA.

The HFEA produce a range of leaflets about treatments involving eggs and sperm, as well as a detailed patient guide which contains important information about all clinics in the United Kingdom. More details can be obtained by contracting the HFEA at:

The Human Fertilisation and Embryology Authority
21 Bloomsbury Street
London
WC1B 3HP

Welfare of Future Children

The HFE Act states 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 (other children in the household or the family) who may be affected by the birth’.

This applies to every woman whether or not she is resident in or a citizen of the United Kingdom. It is the statutory duty of every centre to have a written procedure for assessing the Welfare of the Future Child and that of any other existing child who may be affected by treatment.

Factors considered in assessment include:

  1. the couple’s commitment to having and bringing up a child
  2. the couple’s ability to provide a stable and supportive environment for the child/children
  3. the couple’s medical history and that of their families, considering factors that may risk the child’s wellbeing
  4. both partner’s health (including their ages) and their ability to provide maternal and paternal nurturing to the child
  5. the couple’s ability to meet the needs of the children in the event of a multiple birth
  6. any risk of harm e.g. that of inherited disorders, transmissible disease, neglect or abuse
  7. any risk a new born may put on the welfare of the existing child with in the family

The HFEA Code of Practice (COP) also advises that views of all those who have been involved with the prospective parents should be taken into account. It is also our statutory duty to identify the person/s who will have the parental responsibility and who will be responsible for the raising of the child.

We have a protocol that has been approved by our local ethics committee. Under specific circumstances, we may also need to contact your general practitioner, other medical specialists, authorities and agencies e.g. social workers, police etc for information. This is to enable the members of the team at The Leeds Centre for Reproductive Medicine or the Clinical Ethics Committee in the Leeds Teaching Hospitals Trust formally Consider the Welfare of the Future Child when appropriate.

Please note that fair and unprejudiced counselling services are available to everybody prior to, during or after the assessment process irrespective of the outcome of such an assessment.

Regulation of egg donation

We suggest you read the leaflet “What you need to know about donating sperm, eggs or embryos” produced by the Human Fertilisation and Embryology Authority, the official government body regulating and licensing IVF units in this country.

1 – Human Fertilisation and Embryology Act

Human Fertilisation and Embryology Act was passed by parliament in 1990 and became law on 1st August 1991. Simultaneously a statutory Human Fertilisation and Embryology Authority (HFEA) were established for the regulation of all treatments and research. It is our statutory obligation to report every treatment cycle and its outcome to the HFEA. This information is analysed annually and published in a `Patient’s Guide to IVF and DI treatments’ which is available free of charge on request from the HFEA.

2 – HFEA register

The Authority keeps a confidential register of identifying information on all patients and their treatments, donors and recipients and children born after all licensed treatments. This register was set up on 1st August 1991 and therefore contains information concerning children conceived from licensed treatments since that date.

From 2008, people aged 16+ (if contemplating marriage) or 18, who ask the HFEA, will be told whether or not they were born as a result of licensed assisted conception treatment, and if so, whether they are related to the person they want to marry.

3 – The Law

Children born following treatment have the right to know of their genetic origins at the age of 18 years or at 16 years, if contemplating marriage.

This means that donors have to provide identifying information which the HFEA may release, on request, to people aged 18 years or more and who has been conceived with gamete or embryo donation.

All recipient couples and donors are advised to explore the implications of these regulations. Counselling services are available to all donors and recipient couples. When in doubt, please seek independent legal advice.

4 – Legal Parenthood

The law defines the legal mother as the woman who gives birth and her partner as the father irrespective of the source of eggs or embryos created with donated eggs unless the husband/partner can prove that he did not consent to treatment. The donor has no parental rights or responsibilities.

Both partners of a recipient couple must provide written consent to the use of donated eggs/embryos in the treatment of their partner.

Under the current law, there is no need for the recipient couple to disclose the use of donor eggs/embryos to the Registrar of Births. Therefore you will not expect to be named at any stage.

Unmarried couples concerned about parental responsibility are advised to seek independent legal advice.

5 – Welfare of Future Children

The law states 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 (other children in the household or the family) who may be affected by the birth’.

This applies to every woman whether or not she is resident in or a citizen of the United Kingdom. It is the statutory duty of every centre to have a written procedure for assessing the welfare of the potential child and that of any other child who may be affected.

FACTORS CONSIDERED IN ASSESSMENT INCLUDE:

  1. the couple’s commitment to having and bringing up a child
  2. ability to provide a stable and supportive environment for the child/children
  3. couple’s medical history and that of their families
  4. both partner’s health (including their ages) and consequent future ability to look after or provide for a child’s needs
  5. ability to meet the needs of the children in the event of a multiple birth
  6. risk of harm e.g. that of inherited disorders, transmissible disease or abuse, multiple birth, neglect or abuse
  7. risk a new born may put on the existing child in the family

It is our statutory duty to identify the person/s who will have the parental responsibility and who will be responsible for the raising of the child. Where necessary, we obtain reports from the general practitioner, other medical specialists, authorities and agencies e.g. social workers, police etc for information to ensure that the child would not be at risk. When treating single women or those in a single sex relationship we ask the couple to identify a father figure to ensure that the child’s/children’s right for both paternal and maternal nurturing will be met.

7 – Donors’ rights

The donor has the right to change her mind up to the point the embryos have been placed in the recipient. Embryos created using donated eggs can only be stored for a patient with the consent of the donor. On the other hand, the donor has no rights once embryos have been transferred to the recipient.

8 – Limitation to the number of pregnancies with each donor

Legally in the UK, eggs or sperm from any one donor can be used to produce a maximum of TEN children or TEN families. In reality, this possibility is extremely unlikely for egg donors. However, donors may set a lower limit should they wish to do so.

9 – Consents

As stated above, we can only advise you with respect to the current law and the changes that we can envisage. You are advised to seek more specific and independent legal advice if you are concerned about how a retrospective change in the law might affect your legal position.

All donors and recipients are asked to sign appropriate consent forms after they have read the information booklets, have discussed the medical/ ethical issues with the doctors/nurses/counsellor, and are satisfied that their questions have been answered fully. Consents are obtained prior to donation.

Your consent advises us of your informed choice. You always reserve the right to change your mind until but not after the embryos have been transferred to the recipient. It is however important that all issues are thoroughly considered beforehand so that sudden and unexpected changes that you may later regret are avoided.

10 – Confidentiality

All information regarding your treatment is strictly confidential and subject to both the HFEAct and the Data Protection Act. We may communicate with your general practitioner, referring consultant and other carers only with your written consent.

Once the information has been disclosed to unlicensed individuals it can no longer be controlled by the HFE Act although it will still be under the Data Protection Act and General Law of Confidentiality. At your GP’s practice, information will be accessible to other GPs and staff. When changing GPs, your medical records will be transferred to your new GP practice without our involvement or written named consent from you.

From time to time your notes may be inspected by HFEA members for audit, by Commission of Health Improvements (CHI), individuals working for Patient Safety Agency (PSA) and National Care Standards Commission.

You have a right to decline consent to communicate with specific people or agencies, in which we may need to consider the reasons for your refusal to consent in our assessments.

We advise you to keep your G.P. informed. They are your primary carers, will also be committed to confidentiality. Sometimes patients request their GP to keep written information regarding egg and sperm donation separate from the practice notes so that this information is not freely available to all the staff in their surgery. You may request them but they may not be obliged to do so.

We request photographic evidence of your identity (e.g. passport) which we will photocopy and along with a photograph of yourself placed in your notes, so that as treatment proceeds we can confirm your identity.

11 – Treatment for single sex couples and single women

Treatment for single sex couples and single women is considered on an individual basis after careful consideration of the Welfare of the Future Child/Children (Next Section).