• Mitochondria public consultation 2012
• National Donation Strategy Group
• Multiple births after IVF
• Past reviews
  • Genetic testing
  • Embryo research
  • Fees and regulation
    • Are you ready?
    • 7th Code of Practice
    • Standards for Assisted Conception Centres
    • Modernisation of regulation and the new fee strategy
    • Annual fees for licensed centres (EUTCD)
    • Research fees
    • Public attitudes to regulation
  • Risks of treatment
  • Clinical safety
  • Donation

Background

The HFEA has a statutory duty under the Human Fertilisation and Embryology Act 1990 to produce a Code of Practice which provides guidance to fertility clinics about the proper conduct of activities licensed by the HFEA.

The HFEA developed a completely re-designed 7th edition of the Code of Practice to help centres prepare for the introduction of the EU Tissues and Cells Directive (EUTCD). This also helps centres meet the technical advances, clinical innovations and legal developments of the wider fertility sector.

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Consultation process

The HFEA consulted with a wide range of stakeholders on both the draft standards and the guidance which would form the 7th edition of the Code of Practice.

The consultation ran from September to December 2006 and focused on four key areas:

• the specific content of the draft ‘standards’
• the specific content of the draft ‘guidance’
• the overall arrangement of the code (standards & guidance) and proposals for delivery
• the anticipated impact of the revised code.

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Consultation outcome

At its January 2007 meeting The Authority considered the draft 7th edition of the code of practice and its amendments, arising out of the consultation.

The Authority approved the content (subject to anticipated amendments and delegated final approval to the Regulation Committee) and the revised structure, comprising of following two parts:

1. Standards, which contained specifications that centres were required to show that they could meet, including those required for compliance with the new legislation.
2. Guidance on how those specifications should be met (consolidating much of the content of the existing Code of Practice).

In conjunction with the Code, the HFEA produced ‘The Standards for Assisted Conception Centres’, to assist clinics in meeting the technical requirements of the EUTCD (Directive 2004/23/EC) which came into force on 7th April 2006.

The Code was approved by the Secretary of State for Health, laid before Parliament and came into force on the 5 July 2007.

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Further information

As a result of the Human Fertilisation and Embryology Act 1990 (as amended) the HFEA has produced and consulted upon a new 8th edition of the Code of Practice and on a number of revised patient consent forms.

The Code and consent forms come into force on 1 October 2009. Please see here for further information: http://www.hfea.gov.uk/523.html

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Supporting documents

• Seventh Edition - R.4 (1.3 Mb)
  Until 30 September 2009
• Seventh Edition - R.3 (1.3 Mb)
  Until 1 October 2008
• Seventh Edition - R.2 (1.4 Mb)
  Until 16 June 2008
• Seventh Edition - R.1 (1 Mb)
  Until 9 December 2007

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Page last updated: 13 January 2012

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