On 25th July 1978 something rather remarkable happened. A baby girl was born to two doting parents. Now some days short of her 40th birthday there is nothing to indicate that she is one of the most extraordinary human beings of all time. Louise wasn’t just another baby girl in the maternity wing at Oldham General Hospital – her parents, Lesley and John Brown had battled for nearly a decade to conceive a child and then – when investigations revealed that Lesley’s fallopian tubes were blocked – nearly gave up the struggle.   But having fought against the odds for so long, their luck changed when they met Patrick Steptoe and Robert Edwards in 1976.   Steptoe and Edwards were carrying out research into artificial insemination. In 1977 they fertilised Lesley Brown’s eggs in a petri dish and then implanted her with a two and a half day old embryo.

The rest is history. Louise was the first human to be conceived using in vitro fertilisation. IVF gradually became widely available and recent estimates suggest that approximately 6 million people have been conceived worldwide with IVF in the last 40 years.

It was inevitable that this radical medical advance would bring its share of ethical dilemmas for doctors, parliament and the courts. The Warnock Report of 1984 led to the Human Fertilisation and Embryology Act 1990 (“the Act”) and the creation of the Human Fertilisation and Embryology Authority (“HFEA”) to implement its provisions.   For obvious reasons, the Act focuses on the necessary elements of consent. This is, after all, a process specifically intended to lead to the creation of human life from the gametes of two other people. But despite that focus there have been some notable failures. In 2006 in a survey of 45 fertility clinics, one in four admitted that they did not check identity at all.   37% reported that they had either experienced or suspected identity fraud[1]. In October 2017, Mr Justice Jay gave judgment in a claim arising out of a woman’s deliberate and calculated forgery of her former partner’s signature that resulted in the non-consensual live birth of a baby.

The provisions relating to consent are set out in Schedule 3 of the Act. In summary, a consent under the Schedule “must be in writing” and “must be signed by the person giving it”. That explicit requirement is subject only to the following caveat: where a person is unable to sign because of illness injury or physical disability, a consent will be valid if it is signed by a person “at the direction of the person unable to sign, in the presence of the person unable to sign and in the presence of at least one witness who attests the signature”.

This strict requirement for written consent has caused difficulties in some notable cases. In February 1995, Stephen Blood was admitted to hospital suffering from meningitis. He and his wife Diane had been trying to conceive for several months without success. He lapsed into a coma and his wife asked the hospital to extract and store sperm by electro-ejaculation for use in future treatment. Following discussion with the HFEA and given the real prospect of Mr Blood’s early death, the Hospital agreed. The Court of Appeal subsequently found this extraction – absent any written consent on his behalf - to have been unlawful. Despite that adverse finding, the effect of the breach was to assist Mrs Blood’s case. She argued successfully that she should be allowed to export her husband’s gametes for treatment in another EU member state (Belgium). The Court of Appeal agreed that on the unusual facts of the case she should be allowed to do so and noted in closing that “in future it will not be possible for this problem to arise because under English law Mr Blood’s sperm should not have been preserved as he had not given his written consent.”

Thereafter, the HFEA has – quite properly – required that consent in writing be obtained before any treatment is carried out. To do otherwise is unlawful.

In the years since the Court handed down the decision in the Blood case, there have been a number of challenges to the Act’s strict requirements on the issue of consent. Invariably these challenges arise out of personal tragedy, confounding the hopes of a couple to conceive a child.   Usually, they fail.

Last week saw another challenge arising out of desperate personal circumstances. Mr and Mrs P had been married for many years. They had been in a relationship for some years before they married. From their first meeting they had discussed their joint wish to have a child. Following enduring difficulties with natural conception they attended their GP who referred them to the local hospital. They were given an appointment with a consultant and specialist in fertility treatment. Prior to the appointment, both husband and wife underwent testing. They completed a battery of forms sent by the hospital. They attended the clinic and discussed the future treatment. There was only one more test to be carried out and this was done days later.   The results were entirely reassuring. Then tragedy struck. The husband suffered a catastrophic and irreversible brain injury. As subsequent enquiries revealed, the forms sent by the hospital had not included – and he had not therefore signed - the MT (male treatment) consent form provided by the HFEA or any alternative version of it.

Time was of the essence. P was in a very poor condition, his treating clinicians advised that his heart could fail at any time; without written consent it would be unlawful to store his sperm. Early investigations had focussed on the documents that had been sent prior to the clinic appointment in the hope that one of these might have been the MT form. As investigations progressed that hope dwindled and with it the prospects of establishing that he had provided the requisite consent. In those circumstances it would be unlawful to store and use his sperm for future treatment.

Could the Mental Capacity Act 2005 (“MCA”) provide a solution? The first question was whether the Court could appoint a Deputy to sign the consent on his behalf. This was canvassed with the HFEA’s advisors who, understandably, had concerns that in future any welfare Deputy could simply purport to sign a consent on the patient’s behalf thereby avoiding the express requirements of Schedule 3 of the MCA.

After much discussion between the parties’ advisors and consideration of both the MCA and the HFEA, an alternative solution was reached. Under s16(2)(a) MCA, Mrs P sought a direction from the Court of Protection that a named person should sign the consent on behalf of P authorising storage and use. The consent still had to comply with the requirements of Schedule 3, s1 (being signed in P’s presence and with a witness) but the HFEA was content that if this was done at the Court’s direction, the consent would be valid and it would therefore be lawful for P’s sperm to be extracted and stored.

On 12th July 2018, Gwynneth Knowles J made the declarations and directions sought. That evening the consents were signed and sperm was extracted. P died the following day.   It was the first time that the MCA has been used in conjunction with the HFE Act in this way. But this humane solution to a desperate and heart rending situation would never have been reached without the cooperation of all concerned. From the outset the staff at the hospital where P was admitted had been wholly supportive and offered to do everything they could to assist. So too, the Official Solicitor, who agreed to act at very short notice, instructed Counsel who was able to read into the papers quickly, and supported the application to retrieve and store P’s sperm. In the absence of an opportunity to carry out wider investigation, the Official Solicitor was neutral on the question of posthumous use, taking the reasonable view that his mandate expired on death.

Advisors for the HFEA and P’s wife as well as the Official Solicitor’s representative investigated the crossover between the HFE Act and the MCA and worked to provide the detailed series of declarations and the direction that would allow lawful written consent to be provided despite P’s incapacity. A workable solution for an unthinkable problem.

Stephen Blood had lapsed into a coma in February 1995. The Court of Appeal handed down judgment in the case brought by his wife two years later in February 1997.   It is testament to a legal system that can respond, medically and legally, to the extraordinary challenges that are continually being posed in cases like this, that Mrs P’s application was determined in hours rather than years.  

On a hot summer’s day in July 2018, only days short of Louise Brown’s 40th birthday, something remarkable happened.

Serjeants’ Inn represented parties as follows:

Michael Mylonas QC acted for the Applicant wife instructed by Ayesha Vardag, (Director), Louisa Ghaevert, (Director) and Katherine Res Pritchard, (Senior Associate) of Vardags.

Sophia Roper was instructed by the Official Solicitor.

Claire Watson acted for the Trust, instructed by the in house legal team.

 

[1] http://news.bbc.co.uk/1/hi/health/5098696.stm