13 January 2014
ByAppeared in BioNews 737
First up was Nick Jones, director of compliance and information at the HFEA. He opened his presentation, 'Still One at a Time', emphasising the HFEA's continuing commitment to decrease the multiple birth rates (MBR) of UK fertility clinics and to promote SET.
In 2006, one in four babies born after IVF were multiple births, said Jones. That's now down to 17 percent. The decline was due, he said, to staff at clinics evaluating and adapting their practices.
He described the range of policy and strategic techniques employed by the HFEA to promote good practice, including the Report and National Strategy in 2009 written by an expert group the HFEA consults with.
The HFEA also released professional guidelines for national reporting and evaluation written with the Association of Clinical Embryologists in 2008. Then in 2011 they made targets for MBR a condition of clinics' treatment licences.
Referring to that decision, Jones said that the HFEA was acting within its powers, despite the outcome of the challenge. The HFEA believes, he continued, that its continuing efforts to encourage best practice will allow the reduced levels of MBR to be maintained.
Rachel Cutting, person responsible and principal embryologist at Sheffield Teaching Hospital began her talk by emphasising the worldwide acceptance of SET as 'the right thing to do'.
Proper implementation of SET could save both money and lives, she said. A quarter of IVF twins are born, she said, at extremely low birth weights and the extra care these babies need is expensive. She used Canada as an example of a country where a policy of SET had resulted in a decline in neonatal deaths.
Cutting's own clinic in Sheffield recently conducted a study of patient responsiveness to SET. They found that 99.6 percent of patients questioned understood the information they received on SET and supported it. But only two thirds went on to choose SET as part of their course of IVF.
Cutting supports the approach of the HFEA, and its decision not to enforce a rigid policy. It allows, she said, for clinical input and flexibility over factors such as age, cost, previous attempts, and embryo viability and number - factors which might mean that SET is not the most appropriate course of action for every patient.
James Lawford Davies, solicitor at Lawford Davies Denoon, discussed the recent challenge to the HFEA, in which the firm acted for the claimant, in his talk '"Orthodoxy Is Unconsciousness": Challenging Regulatory Overreach'.
He began by giving an overview of licence conditions and the law. Each clinic must have an IVF licence which sets out conditions for practice. The Person Responsible at the clinic ensures that the conditions are complied with. Failure to do so can lead to the licence being revoked and the clinic being closed down.
In May 2011, the HFEA introduced the T123 condition into all treatment licences, which states that each clinic 'must not exceed the maximum multiple birth rate specified by Directions'. The position was inflexible, but Lawford Davies argued that if a clinic disagreed with a condition, it should be able to apply to an appeals committee for a reconsideration.
Ultimately, the High Court ruled against the HFEA's handling of the clinics in this case. The condition has since been withdrawn. In November, the HFEA announced that it had removed T123 from all licences with effect from the first day of this year.
Lawford Davies criticised the tone of the HFEA in the robust enforcement of its targets. The sector was already complying well with the targets, he said. Like Cutting, he argued that there are cases where SET is not suitable for the patient, and the clinic must use on its clinical judgment.
Mohamed Taranissi, founder and medical director of the Assisted Reproduction and Gynaecology Centre, followed Lawford Davies, arguing that a system demanding strict compliance with the HFEA's targets was not necessary.
No-one in the sector, he said, opposed the need to reduce MBR and, in fact, the numbers had already been decreasing before the HFEA intervened. Evidence, he said, that clinicians were already responsible enough. The HFEA's targets, he claimed, would have meant that 60 clinics risked having their licences revoked.
While this should give rise to some important questions, he conceded, the targets should never have been a condition of the licence. He emphasised existing HFEA policy which states that 'not all patients are eligible for SET and every individual must be treated individually'.
The presentations were followed by questions from the floor. Jennie Bristow of the British Pregnancy Advice Service asked 'Where is patient choice in all of this? For example, what if a couple wanted twins. Could two embryos be put in?'
Cutting replied by drawing on her experience at the Sheffield Teaching Hospital clinic, where she said that couples were able to make that decision, following counselling and advice. Jones also replied and admitted that the policy can create difficult scenarios sometimes. He said that while the HFEA was committed to reducing MBR, it would also look to draw on clinical experience.
The next question came from NHS commissioner Peter Taylor who, in his work, had resisted a policy requiring every IVF couple to undergo SET. He asked 'What is the ultimate penalty for clinics that fail targets for MBR?'
Jones replied that on a practical level, it is possible that an inspector might report and sanction any unsuitable practices involving MBR. This is, however, a last resort and inspectors would always discuss it with the clinic first.
The last question came from Stuart Lavery who asked Lawford Davies 'Did you win your case on a technical point of law or because the court ruled against T123 as a licensing condition?'
Lawford Davies replied that although the case was won on a technicality, it would be belittling to call it that.
Taranissi argued that the HFEA needed to provide clearer guidance on when SET is unsuitable, in light of factors such as age and previous attempts.
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