User guide to the Code

What is the purpose of the Code?

The Human Fertilisation and Embryology Act (the Act) covers the use and storage of sperm, eggs and embryos for human application, as well as all research involving the use of live human and admixed embryos.

One of the ways we help licensed centres comply with the Act is by publishing the Code. We have a duty under the Act to maintain a code that gives guidance about licensed activities and the people who carry them out.

The guidance in the Code also serves as a useful reference for patients, donors, donor-conceived people, researchers and those working in the fertility sector.

How is the Code structured?

The Code consists of:

  • regulatory principles for licensed centres
  • a glossary, and
  • guidance notes. Regulatory principles for licensed centres

The Act requires the HFEA to maintain a statement of the general principles that we consider should be followed in carrying out activities covered by the Act. The principles:

  • summarise the key behaviours and outcomes we expect licensed centres to demonstrate, and
  • communicate the areas of compliance we regard as important.
  • The principles inform every part of the Code. Each guidance note is linked to one or more of the principles and they should be read together.

Glossary

The glossary explains key terms used in the Code.

Guidance notes

The guidance notes are the core of the Code. Each of the 32 notes covers one subject area, to make it easier to find what you are looking for.

The guidance notes contain the following:


 

References to the regulatory principles for licensed centres

Each guidance note refers to one or more of these principles

Mandatory Requirements Mandatory requirements

These sections include relevant quotes from the Act, HFEA licence conditions, and references to HFEA Directions.

Important: the Code does not provide a complete guide to the Act and other mandatory requirements. Nor is it a substitute for reading the Act.  

The person responsible is expected to be familiar with all mandatory requirements that affect their centre.

 HFEA interpretation of mandatory requirements

The HFEA has provided an interpretation of the law where we feel centres may find it helpful, especially where the law is very complex. 

Please note that our interpretations are intended only to aid understanding and are not definitive.

HFEA guidance

This best-practice guidance is intended to help centres comply with the Act.

LegislationOther legislation, professional guidelines and information

This section lists other useful information, including links to relevant websites.

How does the index work?

The index will help you find the relevant guidance, licence conditions and HFEA interpretation of mandatory requirements. The extracts from the Act are not indexed.

Each paragraph of guidance is numbered to indicate the guidance note in which it belongs, and where it appears in that note (eg, paragraph 2.5 is the fifth paragraph in guidance note 2 – Staff).

The interpretation boxes are identified by a number and letter in the top right-hand corner. The number relates to the relevant guidance note, and the letter to the order of the interpretation box within that note (eg, 14B is the second interpretation box in guidance note 14 – Surrogacy).  

The licence conditions are identified by a letter and a number denoting the licence condition, followed by, in brackets, the guidance note in which that licence condition appears (eg, T48(31) is licence condition T48, which appears in guidance note 31 – Record keeping and document control)

Compliance and enforcement

The HFEA has a duty to promote compliance with:

  • the Act, and
  • the Code of Practice.

The Code and the regulatory principles will inform the inspection process. If the HFEA becomes aware that a centre has not complied with the legislation or the Code, we may take action in line with the Compliance and Enforcement Policy.

The HFEA will take into account a centre’s failure to observe any provision in the Code in the circumstances set out in section 25(6)(a) and (b) of the Act.

 

Code of Practice version: 8