Code of Practice

 

Access the Code of Practice

To order a hard copy of the Code of Practice email code@hfea.gov.uk

More about the Code of Practice

 

About the Code

The HFEA has a statutory duty under the HFE Act to produce a Code of Practice that gives guidance to fertility clinics about the proper conduct of HFEA-licensed activities.  The 7th edition of the Code came into force on the 5th July 2007.

The 7th edition of the Code is made up of two parts; standards and guidance:

The Standards
The Standards contain a set of agreed, common specifications for relevant aspects of an assisted conception service or research project involving the use of human embryos. Conformity to standards will be mandatory insofar as they express a legal requirement or a condition of licence. Evidence of conformity with these standards will be sought during an HFEA inspection and will be considered by HFEA licence committees in considering whether to grant, renew, vary or revoke a licence.

The guidance
The guidance gives further information concerning the manner in which licensable activities are expected to be carried out and the functions and responsibilities of licensees discharged. The guidance is intended to assist licensees to meet the criteria set out in legislation and specified in the HFEA Standards, and thereby to ensure good practice in the provision of treatment services or the conduct of research.

Requirements
The effect of the new European legislation being laid over the licensing scheme which already existed in the UK is that requirements from two distinct sources with slightly different inspirations now coexist in domestic law. In the majority of cases (e.g. all IVF treatment and insemination services) both schemes will apply. In the case of human embryo research, however, only certain requirements ? broadly those of the HFE Act prior to the implementation of the European legislation ? will apply. In other cases (e.g. insemination services using only the woman´s husband´s or partner´s sperm) the new requirements will apply but some of the original 1990 Act requirements will not apply (although they should nevertheless be regarded as good practice).This complex situation is reflected in the Code in relation to each standard through the use of the following classification:

  • Requirement scheme A: where the standard relates to a requirement that derives from domestic legislation independently of the incorporation of the European legislation
  • Requirement scheme B: where the standard relates to a requirement that derives from the incorporated European legislation
  • Requirement schemes A and B: where the standard relates to a requirement that is common to both schemes

The consequences of failing to comply with a Requirement include, in some cases, criminal penalties, and revocation or variation of a licence. However, a failure to comply with any provision of the Code of Practice (the Standards or Guidance) may be taken into account by the HFEA in deciding whether to renew, vary or revoke a licence.

How to use the Code

The new edition of the Code contains links to the underlying legislation and licence conditions by which the requirements are enforced.  It also includes extensive cross references between the Standards and guidance, and links to relevant professional guidance.

 

Updating the Code

Updates will be made to the Code 3-4 times a year.  The online Code will be automatically updated, and replacement pages for the hard copy with instructions of where they should be included will be sent out.

Last updated: 29 May 2007