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Trouble in Store?

4 November 2019
By Eleri Williams
Associate at Hill Dickinson
Appeared in BioNews 1022

The Progress Educational Trust (PET) event 'Trouble in Store? How Not to Break the Law when Storing Embryos and Gametes' took place at Hill Dickinson LLP in London on 29 October 2019.

Sarah Norcross, PET's director, introduced the event by asking whether the regulations ought to be made clearer. She noted that the law and regulation governing the storage of embryos and gametes beyond the maximum statutory storage period of ten years is complex and has become problematic for both clinics and patients alike.

The evening's chair was Dr Ippokratis Sarris, director of King's Fertility. He opened proceedings by reminding the audience that many clinics in the UK are facing problematic consent scenarios, where gametes and embryos have remained in storage beyond ten years, and that they would hear from three legal experts in this area about the applicable law and the steps clinics should take where problems do arise.

As the first speaker, I set the scene with an overview of the law and regulations governing storage of embryos and gametes. The relevant regulations are the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009 ('the 2009 Regulations'), which are complex both in their content and in their application. The 2009 Regulations replaced previous regulations from 1991 and 1996 governing the extended storage of gametes and embryos respectively, but these may still apply in limited circumstances.

The law requires there to be written and signed consent in place for the lawful storage and use of all gametes and embryos, subject to a statutory maximum storage period of ten years. The criteria for extending storage under the 2009 Regulations includes the need for effective consent from the gamete provider(s) and a written opinion from the registered medical practitioner on 'premature infertility'.

One of the main problems which clinics face is a failure to obtain a medical practitioner's statement within the 'relevant period' which, for these purposes, is ten years from the initial date of storage (or from the most recent medical practitioner's opinion, if later). Whilst the requirement to have the patient's consent is not time-sensitive (although there should ideally be no gap in consent), the requirement to have the medical practitioner's opinion justifying the extension is.

Finally, I reviewed the circumstances in which the 1991 and 1996 regulations may still be relevant to an extension of storage, and the key distinctions between the requirements under these two sets of Regulations and the 2009 Regulations.

The next speaker was Catherine Drennan, head of legal at the Human Fertilisation and Embryology Authority (HFEA), who gave an overview of their perspective on extension to storage.

She confirmed that the HFEA expects clinics to comply with the statutory requirements and regulations regarding storage, but will aim to strike a fair balance between supporting patients and upholding the HFEA's responsibilities as a regulator where problems with storage occur.

To avoid punishing patients for clinic failings, the HFEA has adopted the position that where there has been a gap in consent to storage but no other errors have occurred, the gametes or embryos may remain in storage - providing it is in accordance with current effective consent. This is possible because the 2009 Regulations do not specify expressly when consent must be provided.

However, the HFEA does not consider that there is scope for interpretation about the timeframe in which the registered medical practitioner's opinion must be obtained, since the 2009 Regulations are explicit on this point. She added that where clinics have failed to use the HFEA pro forma Medical Practitioner's Statement form (or 'MPS'), there may be circumstances where other written evidence from the relevant period exists to satisfy this requirement: for example, a referral letter in the patient's medical records from a registered medical practitioner, confirming premature infertility.

The last speaker was Catherine Dobson, barrister from 39 Essex Chambers. She discussed making an application to court in circumstances where the 2009 Regulations have not been complied with and where the patient or couple are faced with the prospect of their gametes or embryos being removed from storage and allowed to perish.

She outlined the fact that the courts have been willing in the past to find judicial remedies in cases where clinics have not kept records on the forms required by the HFEA. A good example of this is legal parenthood case law, where the HFEA pro forma PP and WP consent forms are missing or incorrectly completed, or where there has been a failure to use the prescribed HFEA form.

In these instances, the court has previously been willing to read down the requirements of statute and regulation, to avoid a disproportionate interference with a patient's Article 8 rights under the European Convention of Human Rights.

She noted that there are, however, limits to the court's intervention, and there is no certainty that the court would be willing to read down the 2009 Regulations in favour of keeping gametes or embryos in storage beyond the maximum statutory storage period, where the requirements under the 2009 Regulations have not been complied with.

All speakers, plus James Lawford Davies from Hill Dickinson, then formed a panel. Two case studies setting out hypothetical problematic storage scenarios were considered, with the audience invited to offer opinions on whether patients' embryos and sperm could continue to be stored.

The audience was then given an opportunity to ask questions. One question covered the fact that there is no definition of 'premature infertility' and what might be covered by this: it was confirmed that, in the HFEA's view, the patient's infertility could not be 'naturally occurring', age-related infertility to comply with the Regulations: it must be premature.

A further question related to the first case study and whether the 1996 Regulations could be relied upon on the basis that the embryos had been put in storage in November 2007, when those Regulations were still in force. In response, it was explained that under the 1996 Regulations two opinions were required on 'premature and complete fertility' and, as such, a single GP letter which made reference to premature infertility would not suffice in satisfying those requirements.

Towards the end of the conference a question was raised about whether the panel thought the law should be changed, to allow storage of gametes and embryos beyond ten years without the need to demonstrate 'premature infertility'. There was a general agreement that the law is too restrictive and is not based on any medical or scientific reasoning, although it was noted that at the time the 2009 Regulations came into force, egg freezing was still in its infancy. Reference was made to social egg freezing and the growing number of woman who are freezing their eggs to use later in life: the need to demonstrate 'premature infertility' to store beyond ten years is clearly detrimental to them and their right to have a family. There appears to be no cogent argument in support of the ten-year storage limit.

Sarah closed the conference, referring to the Progress Educational Trust's recently launched #ExtendTheLimit campaign, calling for an end to the ten-year storage limit and the restriction of reproductive choices that this creates.

PET is grateful to Hill Dickinson for supporting this event. Our next public events will be:

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