21 December 2020

'What a year it's been!' With this statement, Sarah Norcross, director of the Progress Educational Trust (PET) opened the charity's annual conference 'Fertility, Genomics and COVID-19' on 9 December which, for the first time in its history, was online via Zoom.

She spoke about how the COVID-19 pandemic has 'affected the lives of all of us', and this was inevitably the unexpected theme of this year's conference. The plus side of holding a virtual conference was that half of this year's speakers were able to attend from overseas, said Norcross, speaking from her kitchen. She added that this year she did not have to worry about the conference catering, or queues for the loos, but rather whether delegates would hear the sound of her husband putting the kettle on.

Norcross also announced the appointment of Professor Dame Lesley Regan as a new patron of PET (which publishes BioNews).

The first session 'The Impact of COVID-19 on the Fertility Sector', chaired by Norcross, heard from three heavyweights and chairs of different organisations.

First to speak was Sally Cheshire, chair of the UK's Human Fertilisation and Embryology Authority (HFEA) and interim chair of the Children and Family Court Advisory and Support Service (CAFCASS).

The UK regulator will reach its 30-year anniversary in 2021, and she examined the role of the HFEA and how it has and will regulate fertility services through the pandemic and beyond. Cheshire said that fertility clinics in the UK shut their doors for the first time in 30 years on 15 April this year, in response to the Government's directive. 'It was the most challenging decision we had to make in 30 years,' she said.

Patient safety was paramount. And with this in mind, clinics stopped new treatments from 23 March, though fertility preservation treatments (eg for patients undergoing chemotherapy) have continued throughout the pandemic. Other issues that the HFEA had to consider with the upheaval caused by COVID-19 and lockdown included the 10-year storage limits for gametes, and patients who were approaching the cut-off age of fertility treatment on the NHS.

At the height of the pandemic in the spring, NHS fertility staff including anaesthetists and nurses, as well as laboratory testing equipment were turned over to help tackle COVID-19. In the private fertility sector, many staff were furloughed and the industry lost millions of pounds. She said there are normally about 6000 IVF cycles worth 30 million in one month alone.

'The worries about whether these businesses would survive were real ones,' Cheshire told delegates. Additionally, staff 'were undergoing what everybody else' was, with sickness and the loss of colleagues and loved-ones to COVID-19.

For patients there were many questions about treatment and waiting lists. Cheshire said that the technical NHS term 'non-emergency' applied to fertility treatments provoked some anger among patients on social media. Patients' worries about the 10-year storage limit for gametes were addressed by the UK government with a two-year extension given to those affected by the pandemic (see BioNews 1040).

The fertility sector was the earliest sector to reopen on 11 May, said Cheshire. Many adjustments have been made, including in the HFEA's own processes such as the video assessments of clinics.

On a different note, she said the HFEA has extended its own strategy to 2024, and are in discussions on changes to the Human Fertilisation and Embryology (HFE) Act. But Cheshire cautioned: 'Warnock two might be a long way off.'

Following on from this, Dr Jane Stewart gave her clinician's perspective on the pandemic. Chair of the British Fertility Society, Dr Stewart made it clear that she was speaking from her experiences as head of the Newcastle Fertility Centre.

She said her Trust already had a pandemic policy in place. So when the Government directive came to close all centres: 'There was no time for panic, we had to start planning.' All elective and non-emergency work was stopped, staff redeployed, and many worked from home.

'Patient communication was an enormous part of it,' she said. 'We didn't always get that right but certainly it was a priority for us.'

Once their clinic reopened, they re-established appointments via phone calls or video-link, and would bring patients in separately for their physical assessments. 'We scrutinised all treatment protocols to reduce the number of visits,' said Dr Stewart.

She welcomed the vaccine news on COVID-19, as 'things beginning to turn a corner'. However, she also noted that a 'big dilemma' would be coming up for fertility patients as there is no data on use of the vaccine in pregnant women, so it is currently not advised in this group.

'Hopefully, there will be some discussion around this,' she said.

Dilemmas were the focus of the next speaker, Julian Savulescu, professor of practical ethics at the University of Oxford and director of the Oxford Uehiro Centre for Practical Ethics. 'IVF, in general, is a playground of ethical issues with many questionable policies and regulatory issues,' he said.

He shared some of his work on ethics and COVID-19, reflecting on how this might be applied to dilemmas in fertility treatment.

'It seems to me that the challenges facing people with infertility are the challenges facing all of us during the pandemic,' said Professor Savulescu.

These include the trade-offs between liberty and wellbeing, in particular, that of the infertile versus the health of the elderly; policies of selective restriction of freedom; and in the allocation of limited resources, how we balance equality versus utility. The comparisons were particularly pertinent in how limited resources such as ventilators, vaccines or IVF are allocated.

The principle of equality or egalitarianism is 'equal treatment for equal need' (one of the NHS's basic principles), which means that factors such as potential length of life gained and the probability and quality of survival would be ignored in allocating resources.

Healthcare decisions based on utility or utilitarianism allocate according to what will bring the greatest benefit. This approach would take into account for example, the quality and predicted length of survival when allocating a ventilator to a COVID-19 patient.

Many governments use QALYs (cost per quality-adjusted life year) which estimate how much benefit is gained for the cost, to make healthcare utilitarian decisions. Professor Savulescu noted that for the UK's pandemic lockdown response, the QALYs were 'enormous'. He said that the prioritisation of IVF inside and outside the pandemic is a massive value assumption depending on how you value the life of a subsequent child (IVF calculations do not typically include QALYs for the child).

While the UK did not use utilitarian decision-making in pandemic allocations, for example NICE and the Intensive Care Society used frailty rather than QALYs to allocate ventilators, such principles guide some IVF allocations. For example, an IVF age-cut off that 'may well' also breach the UK's Equality Act 2010. Likewise, in Australia, BMI limits are placed on IVF.

Professor Savulescu noted contestable ethical issues arising from the pandemic itself. Early on in the pandemic it became apparent that the disease primarily kills the elderly, he said.

Modelling by the US Centres for Disease Control and Prevention in November suggested the chance of someone aged 20-49 dying from COVID-19 lay somewhere between 7 in 100,000 and 2 in 10,000. He said the chances of a person in this age group the IVF patient age group, dying in a car accident are 1 in 10,000.

With such a low risk, the primary reason for stopping IVF during the pandemic is to prevent transmission. 'Then the issue is can we use PPE to prevent transmission?' asked Professor Savulescu.

He wrapped up by saying that patients with infertility have been a low priority whose 'liberty has probably been excessively restricted' and raised questions about them being given greater priority now.

As usual with PET events, the second half of the session was given over to audience questions. Cheshire was asked about the potential to reopen the HFE Act to bring it up to date. She agreed that it would be beneficial to review some areas, but acknowledged that Parliamentary time is likely to be taken up with COVID and Brexit. One of the areas she and Dr Stewart spoke about was the extra level of confidentiality surrounding fertility treatment, meaning that it does not appear on a patient's medical records, and how these restrictions put patients' lives at risks due to hiding information about patient care outside the hospital patient management systems.

PET would like to thank the sponsors of its conference - the Anne McLaren Memorial Trust Fund, the Edwards and Steptoe Research Trust Fund, ESHRE, Wellcome, the European Sperm Bank, Ferring Pharmaceuticals, the London Women's Clinic, Merck, Theramex, Vitrolife and the Institute of Medical Ethics.

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The Impact of COVID-19 on the Fertility Sector - BioNews