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26 February 2010

Dear Colleague

Key changes coming in April 2010

Over the last two years I have tried to keep you up to date with the extensive changes taking place at the HFEA. I am writing today because 6 April will mark the culmination of this work. The final provisions of the HFE Act 2008 are scheduled to be enacted as well as the introduction of a number of key HFEA policies and services.

Listed below is an overview of these changes. Full details can be found in the explanatory documents accompanying my letter.

Parental orders

The new parental orders regulations are due to come into force on 6 April 2010 as are the relevant provisions of the HFE Act 2008.

A new paragraph has been added to the 8th Code of Practice to explain that commissioning couples who are unmarried or in a same sex relationship can now apply to become legal parents of the child by parental order. The mandatory requirements in the code’s Guidance Note 14 have been amended to reflect the new regulations.

Updated General Directions, 8th Code of Practice guidance and consent forms

Since October 2009, following the introduction of the bulk of the HFE Act 2008, we’ve reviewed some of our policies and therefore made some amendments to the Code of Practice, consent forms and General Directions.

We’ve also taken the opportunity to respond to some of the suggestions received from centres about improvements which could be made. Details of these changes, along with those relating to parental orders are set out in:

• Chair’s letter CH(10)03 - Update to General Directions, Code of Practice and consent forms

New maximum multiple births rate

Last month we wrote to you about the new Year 2 maximum multiple birth rate of 20% which comes into force on 6 April. I wish to thank centres and their staff for their efforts to develop and implement their minimisation strategies over the last year; I realise this has been a steep learning curve for us all.

A major focus of the Authority over the next year will be the avoidable health risks associated with multiple embryo transfer in patients who meet the criteria for single embryo transfer.

We listened to what centres told us about the first year of the policy and what patients felt as well. I and the Authority believe the 2nd Year maximum rate will help us build on these achievements by maintaining momentum and giving centres scope to review their minimisation strategies to further reduce their multiple birth rates and improve healthy outcomes.

Donor Sibling Link

In April we’re launching a new service to enable contact between people who share the same sperm, egg or embryo donor. This will be called Donor Sibling Link and initial pre-launch information about what it does and who it is for can be found on our website at http://www.hfea.gov.uk/donor-sibling-link.html

Donor Sibling Link will be only be available to those born as a result of donor-conception treatment in an HFEA licensed clinic after August 1991; who have reached the age of 18 and who wish to share their contact details with their donor-conceived siblings.

This service is being introduced following new requirements in the HFE Act 2008 and is part of a wider role we have of providing different levels of information to donors, donor-conceived people and their parents.

Re-designed compliance cycle

Our change programme has focused on improving the way we inspect and license centres and the improvements we’ve made have been based on the many helpful comments and suggestions we’ve received from centres and their staff. I also want to take this opportunity to thank centres for completing their new self-assessment questionnaires. These results will inform the HFEA’s new risk tool, which from April will be used to help identify key areas of focus for inspections.

April also sees the beginning of a new four-year compliance cycle that is designed to reduce the number of routine inspections of centres with good levels of compliance.

Taken together we believe these changes will better support the efforts of centres in improving their level of compliance and the quality of their services.

Sharing lessons learnt – HFEA centre workshops

I’m committed to supporting the sector in its continuing efforts to learn from experience and share best practice. With this in mind I hope as many centre staff can join us in the programme of clinic workshops taking place in March and May 2010.

There are two workshops in early March - in Manchester and London - on risk management. These are to help centres improve their adverse incident reporting and also to identify issues which the HFEA should take into account.

In late March and May we’re holding four regional workshops to enable centre staff to learn from each other in order to improve the implementation of their multiple births minimisation strategies and to better inform patients about consent to the disclosure of their data for research purposes. The dates for your diaries are Birmingham (23 March), Glasgow (31 March), London (5 May) and Leeds (19 May).

These four workshops are very much centre-led affairs with clinic speakers talking about their experiences of working to the new requirements. The multiple births session will also feature lessons from the first year using analysis of HFEA national data and experts from the sector discussing the latest clinical practice in embryo grading and storage.

Find out details about all the workshops and how to take part in HFEA events. 

HFEA application procedures going on-line

To streamline and improve the licence application process, centres will from April be able to submit their applications to us via the secure clinic portal. This includes applications for new licences, renewals, variations, PGD, PGS and Special Directions.
The content of the forms remains largely unchanged but if you do have any queries after they go live in April about completing the new style forms, currently on our website at www.hfea.gov.uk/177.html, please contact your inspector.

Senior management changes

You may have read that Trish Davies, HFEA Director of Compliance, is stepping down from the end of March. I’m sure that many of you would have met Trish and would echo my thanks for her hard work and professionalism during a period of great change, including the new HFE Act and the European Union’s Tissue and Cells Directive.

Recruitment for Trish’s successor has started and I will update you when we have made a new appointment.

Once all these changes are in place we will have completed what has been an enormous series of changes and developments that began with an Authority decision in January 2008. Can I thank you and your staff for all the hard work I know you have put into more than two years’ of cooperation with us. I am sure we will see the fruits of this over the coming months.

Yours faithfully

Alan Doran CB
Interim Chief Executive

Page last updated: 24 August 2012

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