02 December 2013
Dear Colleague
Removal of the licence condition relating to multiple births
At the HFEA’s recent board meeting on 13 November, we agreed that we would remove the condition relating to multiple births (T123) from all centres’ licences, effective from 1 January 2014. I am now writing formally to announce this change.
Why have we taken this step?
Since the licence condition was introduced in October 2011, we have been subject to a challenge from one Person Responsible, who has disputed its appropriateness. The issue remains unresolved. Nevertheless, we have spent a considerable amount of money and staff time defending the challenge, and we faced the prospect of having to spend considerably more before the appropriateness of T123 could be settled. The result is that, two years on from when it was first introduced, the condition does not appear on two clinics’ licences. My Authority members and I believe that this is not fair to the rest of you, who have continually called for there to be a level playing field.
It is vitally important not to read this move as a lack of commitment on our part to reducing the incidence of multiple births following IVF. The policy remains and we are fully committed to it. We continue to have Code of Practice guidance expecting centres to meet the 10% target. We continue to have General Directions requiring centres to have a multiple births minimisation strategy which is audited and reviewed for effectiveness. And we will continue to support you in meeting the target through our ongoing monitoring of your performance; by publishing patient information about multiple births and eSET on the One at a Time website; and by working with professional and patient organisations through our multiple births stakeholder group.
The policy and our collaborative approach is working. As a sector, you have risen to the challenge, reducing the overall multiple birth rate from 24% in 2009 to 16.9% in 2012 and meeting the year-on-year targets that we have set. And, crucially, this has been achieved without significantly impacting upon success rates. Details of our work on this issue over the past few years can be found on our multiple births and single embryo transfer review page.
The annex to this letter shows the multiple live birth rate for each clinic for the year 3, 15% target period. You will see that a large majority of clinics met the target. Unsurprisingly, a number of clinics have found it harder to reach this target (12 clinics were statistically significantly above 15%). However, the outcomes from the latter part of this period are unverified, so this picture may change.
What should you do?
I know that the reduction from 24% to 16.9% has not been easy and that reducing your multiple birth rate to 10% will, for some of you, be a real challenge. But I am confident that, in the interest of IVF mothers and their babies, you will continue to strive towards what is accepted as the ideal outcome of IVF: the birth of a single, healthy baby.
In the early New Year, we will be meeting with the multiple births stakeholder group to discuss how best to maintain the momentum on multiple births and to support you in reaching the 10% target. If you have ideas or comments to make that might inform those discussions, please contact Hannah Verdin.
What will happen next?
As far as the licence condition is concerned, T123 will, in effect, cease to apply from 1 January 2014. We will not be issuing new licences to each centre. Rather, we will remove it from any licence which is renewed after that date. As a result, the condition will continue to appear on the majority of licences for some time. Whilst we will not measure compliance against the licence condition, we expect centres to reach the 10% target and will be inspecting against the requirements which remain.
If you have questions regarding inspection or your clinic’s performance regarding multiple births, please contact your Inspector.
Yours sincerely
Professor Lisa Jardine CBE
Chair, Human Fertilisation and Embryology Authority
Annex A
Year 3 (15% target period) performance
Page last updated: 04 December 2013