The UK's High Court has ruled against the Human Fertilisation and Embryology Authority saying its actions towards two clinics over a licence condition to impose a maximum multiple birth rate were unlawful. The HFEA has now decided to withdraw the condition from all UK fertility clinics' licences.
A national strategy aimed at reducing the multiple birth rate in the UK came into force in 2009. In 2011, as part of an effort to reinforce the policy, the HFEA made it a condition of a fertility clinic's treatment and storage licence not to exceed the multiple birth rate target – currently set at ten percent.
Mr Mohamed Taranissi, person responsible for the Assisted Reproduction and Gynaecology Centre (ARGC) and the Reproductive Genetics Institute (RGI) challenged the HFEA's decision to impose the condition, known as T123. The Sunday Times reports that Mr Taranissi believed the decision on the number of embryos to be transferred to the patient should be a medical one, taking into account the patient's age, medical history and chances of conceiving. If his clinics had reached the multiple birth quota midway through the year, they would then be forced to offer all remaining patients only one embryo if they wished to comply with the condition.
'It is my understanding that many clinics are not able to meet this target, and that it has already had an adverse impact on pregnancy rates', he said in a statement. 'Clinics with a higher percentage of patients who are over 40 and who have had several failed IVF attempts would have fallen foul of the HFEA's ten percent condition even though they are simply providing universally recognised standard treatment by transferring two embryos'.
Although Mr Taranissi emphasised that he shared the goals around reducing multiple births, he called the licence condition 'unworkable' as it failed to allow for a large variation between patients.
An action for judicial review brought by the ARGC and RGI against the HFEA was heard by the High Court in October. It held that the HFEA had no power to impose a licence condition before the appeals process that Mr Taranissi had initiated had been completed.
Mrs Justice Patterson in the High Court said that the condition 'had the potential to interfere with the clinical judgment to be exercised on behalf of ARGC', which should have been a material consideration in the decision to introduce the licence condition.
'It is important to note that Mr Taranissi’s clinics have throughout been supportive of the multiple births policy. Their dispute is whether condition T123 is the proper way to achieve the agreed objective. Their concern is shared by other professionals in the field', Mrs Justice Patterson wrote. 'There appears, therefore, to be an ongoing legitimate debate the resolution of which cannot be determined until the appeal committee convenes and adjudicates'.
The HFEA's policy of multiple births has attracted criticism from Professor Alison Murdoch writing in BioNews 707. 'This licence condition […] does not reflect the complexity of the scientific data, the professional debate, the financial considerations, the legal implications nor the voice of the patients', she said.
In a statement, the HFEA said that from 1 January 2014, it will no longer be a licence condition for clinics to keep their multiple birth rate below the set target. 'We believe strongly in our multiple births policy – as do IVF professionals and patient groups, who have worked hard to reduce the avoidable risk of a multiple pregnancy over the past several years. The policy stands and we will still expect clinics to bring the multiple birth rate down to ten percent – in the interests of IVF mothers and their babies', said Lisa Jardine, Chair of the HFEA. It said it would concentrate on other, existing powers to enforce the policy.
Commenting on the case, James Lawford Davies, of law firm Lawford Davies Denoon which represented the claimants in this case, told BioNews: 'The decision to impose this condition was always an ill-judged regulatory strategy, as evidenced by the large number of clinics which failed to hit the target. I hope the HFEA will now let doctors get on with their jobs rather than interfering with clinical practice through inappropriate sanctions'.
Multiple births policy will be discussed by a panel including Mohamed Taranissi and an HFEA representative at the Progress Educational Trust conference 'Double Take: Twins in Genetics and Fertility Treatment', taking place in London on Wednesday 4 December 2013.