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31 August 2006

Dear Colleague

Consultation on the 7th edition of the HFEA Code of Practice

The last edition of the HFEA Code of Practice was published in January 2004.  Since then the ART sector has seen a number of technical advances, clinical innovations and legal developments.  Alongside these, the HFEA has published new guidance, Directions and advice to help centres innovate safely and responsibly, maintain quality of service for service users and encourage the spread of good practice throughout the sector.  Perhaps the most significant challenge now facing providers of fertility treatment in the UK is to prepare for the introduction of the EU Tissues and Cells Directive including the need for each centre to introduce a formal quality management system which will come into effect on 7th April, 2007. 

The introduction of new European requirements and the extension of these to over 100 previously unregulated centres on the one hand, and, on the other, the need to minimise the burden that this places on centres and to streamline the process of regulation call not merely for a new code of practice but for a complete re-thinking of the way in which the Code is delivered, updated and used.

The HFEA is now developing a revised code of practice to help centres meet these challenges.  The new Code will comprise two parts:

(1) the HFEA Standards, which contains specifications that centres are required to show they can meet, including those required for compliance with the new legislation,* and

(2) Guidance on how these specifications should be met (consolidating much of the content of the existing Code of Practice). 

The revised Code will:

• consolidate all extant HFEA guidance from the previous Code of Practice, subsequent Chair's letters and HFEA Standards
• distinguish clearly between mandatory and advisory specifications
• link each standard to the underlying legislation, licence conditions or directions, and to HFEA guidance on how that standard should be met, as well as other sources of advice and information
• provide a framework of guidance on which centres can develop their quality manuals and detailed standard operating procedures (SOPs) as required by the new legislation
• be updatable, so amendments can be seamlessly incorporated into the existing Code rather than communicated through a variety of different documents (Chair's letters, leaflets, Directions, etc.) as at present 
• be available in the way that best suits the user, including online and printed versions.

The revised Code will not, however, introduce any new requirements other than those demanded by the new legislation; where possible, requirements will be simplified in line with better regulation principles.

The second part of the Code, the Guidance section, will shortly be published for consultation and may be accessed from the ´consultations' page of the HFEA website. 

Those who do not have easy access to the website may pre-order a printed copy of the consultation document by telephoning, emailing or writing to: 

telephone: 020 7291 8200
email: code@hfea.gov.uk
website:  www.hfea.gov.uk/consultations
post: Code of Practice
HFEA
21 Bloomsbury Street
London WC1B 3HF

Responses and comments should be sent by email or post to the address given above.  The 7th edition of the Code will be published in March 2007 and brought into force in time for the requirements of the Directive coming into effect in April 2007.

Yours sincerely,

Dame Suzi Leather, DBE,
Chair

Page last updated: 23 August 2012

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