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Posthumous use of Gametes and the Protection of Future Families

A Scottish court has recently ruled that a woman was able to use her deceased husband’s sperm for IVF. The couple were pursuing fertility treatment when he died from cancer. Her late husband had stored his sperm before he died in the hope of starting a family. However, he had only given consent to intrauterine insemination and not IVF. Despite this, the Court were able to use the wording in his will and ruled this as appropriate consent for IVF treatment, which stated:

“I direct my executors to ensure that my donation of sperm will be, for as long as possible, and for as long as she may wish, available to [my wife].”

In her judgement, Lord Justice Clerk Lady Dorrian stated that the specific wording of the will and the fact the couple were undergoing fertility treatment was enough to express his wish for future use of his stored gametes.

In the UK, in the ground breaking case of Y v A Healthcare NHS Trust & The HFEA & Z of 2018, the Court of Protection authorised the posthumous use of a husband’s sperm for fertility treatment, following a catastrophic accident causing brain injury which limited his capacity to consent. In this case, the husband and wife were in the early stages of fertility treatment and although they had discussed that his sperm could be used in fertility treatment in the event of his death, he had not legally consented to this before the accident. The Court of Protection ruled that it was in the husband’s best interests for the sperm to be retrieved and stored for use in posthumous treatment under the Mental Health Act 2005.

Under Schedule 3, the Human Fertilisation and Embryology Act 1990 requires consent to be given in writing and signed by the person giving it before any fertility treatment can go ahead. This is a particularly rigid piece of legislation which does not account for unexpected situations where an individual has not had the chance to properly consent to treatment. Furthermore, those wishing to use the gametes posthumously are unable to rely on the Human Tissue Authority as sperm and eggs are not within its remit under the Human Tissue Act 2004. It seems the Act requires updating so that the law could account for any wishes specified in a will, or any sufficient evidence that shows the individual was undergoing or had planned to undergo fertility treatment. This would allow for flexibility within in the Act for those still wishing to create a family.

Although this case is a step forward in recognising the wishes of those wanting to continue to start a family, the wording of the Act should be more flexible to allow for these situations so that those involved do not have to part take in stressful and time consuming court processes. This case highlights the importance of being proactive with future fertility planning and this is particularly important in the current climate, due to the growing rate of COVID-19 as unexpected deaths are unfortunately becoming more and more imminent.

Do Not Resuscitate Orders: A New System of Consent?

During the coronavirus pandemic, it has come to light that do not resuscitate orders (DNROs) have been applied in a blanket manner to vulnerable and elderly patients. These have been implemented without discussion or consultation with the patient or their families. Whilst decisions for DNROs are often made in the patient’s best interest, practice is ambiguous on a number of points. Patients and their families should be at the heart of these discussions and instead, paternalism is at the forefront. Should a system of informed consent be implemented to ensure that patient’s wishes are given appropriate attention?

Kate Masters is currently taking legal action due to the Government’s failure to provide national guidance on DNROs, which has contributed to poor healthcare decisions during the pandemic. In 2014, her father had brought a successful judicial review claim in relation to his wife’s Article 8 Human Rights in response to an imposed DNRO. This case established the legal duty to consult with patients if a DNR order is placed in their records.

In response to recent legal action, the Government have stated that they will publish guidance for both patients and families on DNRs for the first time on the NHS website, as well as information for medical staff when making these decisions. Although this will help in clarifying DNR guidance, it seems the importance of these decisions in law have been misplaced.

In the USA, a doctor can only write a DNRO after consulting with the patient, a proxy or their family. In the UK, DNR decisions ultimately rest with medical practitioners and are administered in the best interest of the patient. Unlike the USA, the law in the UK does not require the consent of the patient for a DNR order.

Making DNR decisions without clear consent of the family of the patient is a breach of human rights. Article 8 of the Human Rights Act protects the right to private and family life and covers DNR decision-making. Both the patient and their family should have the right to involvement in these discussions and be the sole decision makers on these matters.

Article 14 of the Human Rights Act protects non-discrimination. For doctors to be making decisions regarding a patient’s quality of life seems excessively paternalistic and almost runs along the same lines as assisted suicide which is illegal in the UK. Doctors are able to make these decision based on whether a certain condition or disability is worth living, which takes away autonomy from the patient in making decisions regarding their own life.

Circumstances such as coronavirus where pandemic medicine is used highlights the growing problems with the current law. The law does not go far enough in ensuring that autonomy in decisions about one’s own body are protected. The majority of medical decisions require patients to give informed consent where they receive explanation from a clinician. It seems misconceived not to require the same consent for important end of life decisions. Where the inevitable outcome of a decision means that an individual will die, it is only ethical if an individual or a proxy for that individual consents to that decision.

Embryo and Gamete Freezing: Does the 10 Year Limit Restrict Reproductive Choice?

The current storage period for embryos and gametes is limited to 10 years, at which point patients must choose whether to undergo fertility treatment or to have their frozen eggs, sperm or embryos destroyed. After announcing fertility clinic closures due to COVID-19, the Government recently applied a two-year temporary extension to the 10-year statutory limit. However, there is increasing support for a permanent change.

The Human Fertilisation and Embryology Act 1990, as amended, limits the storage of embryos and gametes for fertility treatment to no more than 10 years, unless a medical practitioner has given a written opinion that the person to be treated has or will develop premature fertility (e.g. through cancer treatment or gender reassignment), in which case storage can be extended up to 55 years.

In February 2020, the Department of Health and Social Care launched a public consultation on gamete and embryo storage limits. The Human Fertilisation and Embryology Authority in their response, stated that they were in favour of a change in legislation:

“The current 10-year statutory storage limit and 2009 Statutory Storage Period for Embryos and Gametes Regulations are too restrictive and negatively impact on a persons’ reproductive choice.”

They have confirmed that they would support regulation that allows patients to store their gametes and embryos for a maximum of 55 years, with an initial 10-year period, provided they meet certain conditions. They have suggested that patients provide fertility clinics with new written consent to storage every 10 years and confirm that they are storing because they intend to use the gametes or embryos in their own treatment or in their partner’s treatment (including surrogacy arrangements).

The optimum time for a women to freeze her eggs is before the age of 35, when the quality and number of eggs starts to decline. However, the current legislation leaves women at a disadvantage, as depending on when a woman elects to freeze her eggs, she may need to store them for longer than the current 10-year period.

Egg freezing was originally used for women looking to preserve their fertility prior to cancer treatment, which would leave their fertility at risk. However, women are now wishing to freeze their eggs at a young age to preserve their fertility for many different reasons. For example, not having met the right partner, pursing other commitments such as a career or caring responsibilities, or not being financially ready. It seems arbitrary to maintain the 10-year limit on storage, as the legislation is based on whether a person is likely to become or is prematurely infertile, when in fact there are a number of reasons why an individual may want to store their gametes or embryos. The demands of modern living are making it increasingly difficult for individuals to start a family and the current legislation does not provide enough time for people to do so.

Further, when the legislation was introduced, eggs, sperm and embryos could not be stored effectively for long periods, which allowed clinics to destroy samples that could not be used. Since then, freezing methods have been developed much further and gametes and embryos are far more likely to maintain their quality when fertilized using vitrification techniques.

The 10-year limit is almost forcing men and women to either delay their freezing, which could decrease the chance of achieving a health pregnancy, or alternatively, they face the prospect of having to decide whether to destroy their frozen gametes or embryos, or feel pressured into having a child before they are ready. Changing this legislation would provide the flexibility for individuals to make their own decisions, without having to sacrifice careers or relationships.

The temporary measure to extend storage by two years will hopefully bring about positive change to this area and eventually replace the outdated legislation. One issue that may arise is the increase in geriatric pregnancies, which often have negative health risks to both the mother and baby. Therefore, it may be the case that the extension of storage will need to be reviewed on a case-by-case basis after the initial 10-year period.

It is clear that the law needs to change as the current legislation does not provide enough autonomy for those wanting to preserve their fertility, and individuals should be allowed to make these decisions without being restricted by outdated UK law.

(The Progress Educational Trust recently created a petition to extend the limit on social egg freezing. You can sign this petition here.)

COVID-19 Vaccine: Safety vs Autonomy

The COVID-19 pandemic is responsible for the deaths of thousands of people and there is currently no effective cure or vaccine. There has been a £25m research response to the pandemic, which is funding approximately 27 research projects with the aim to develop an effective vaccine or treatment, as well as improve the understanding of the disease. Whilst the research is already underway, it is unclear how the government is going to navigate the implementation of a new vaccine.

The Public Health (Control of Disease) Act 1984 gives the government powers to prevent, control or mitigate the spread of an infection or contamination. However, it explicitly states that these regulations cannot require an individual to undertake medical treatment, including vaccinations. Under the Coronavirus Act 2020 there are regulations to prevent the spread of disease in other ways, such as requiring people self isolate should they have any symptoms.

Speaking to reporters the Health Secretary stated:

“The question of whether it’s mandatory is not one that we’ve addressed yet. We are still some time off a vaccine being available. But I would hope, given the scale of this crisis, and given the overwhelming need for us to get through this and to get the country back on its feet, and the very positive impact that a vaccine would have, that everybody would have the vaccine.”

The most successful vaccine programmes tend to be via consent and it is unlikely that the Government will implement a mandatory vaccine. The Government’s own guidelines on vaccinations states that individuals “must be given enough information to enable them to make a decision before they can give consent.” However, this is a unique situation and as we have seen in recent months the Government have passed a variety of emergency legislation in order to control the pandemic. Requiring individuals to be vaccinated may be the most efficient way to control public health, however this would ultimately obstruct an individual’s right to make decisions about their own health care and medical treatment. This would be morally onerous, especially for those who resist or refuse vaccinations on the basis of religious, political or health reasons. The Government will need to make efforts to educate the general public about the effects of the vaccine if they want to ensure as many people consent to take it as possible.

Due to the accelerated scale that the vaccine is being developed, people may not want to be vaccinated due to the potential safety risks. Traditionally, it can take many years to develop a safe vaccine. However, the Government have reported that because of the accelerated framework for research and testing, a vaccine could be available within 12-18 months. It will be crucial for scientists to balance the aims of creating a vaccine as quick as possible to prevent further spread of the disease, whilst also ensuring the safety of civilians. Vaccines are generally very safe, however it is inevitable that there will be some adverse reactions if a vaccine is given to a large population. Couple that with the speed that that the vaccine is being developed at, it is likely that there may be scope for litigation following its release.

If the vaccine does cause adverse effects, there may be scope for individuals to be awarded vaccine injury compensation under the Vaccine Damage Payments Act 1979. This is a statutory scheme and it is not necessary to demonstrate negligence in order to qualify. The individual must have suffered severe or 60% disablement in order to claim compensation through the scheme. This legislation was originally put in place after the whooping cough (pertussis) vaccine scare and aimed to provide support for children who had been severely disabled as a result of a vaccination. However, this was overturned in 2017 when the decision to exclude adults from the scope of compensation was challenged. It is unclear whether the Government will allow for awards under this scheme for the vaccine, especially if it is released to the entire population, however it may be a useful tool to reassure the public that they will be supported by this legislation, should any adverse effects occur.

When deciding on the appropriate methods to deal with the release of a vaccine, the Government will need to consider how to best prevent the spread of disease across the country, whilst also protecting people’s rights to make an informed choice about how their body is treated. It seems the Government are attempting to create a quick prevention, but they need to ensure that there are no dangerous shortcuts to immunisation, whilst also upholding public trust and confidence. This will be difficult to achieve as it is likely one will fall short of the other. The Government ultimately need to refine its aims and place a strong focus on patient safety and education about the vaccine, which will ultimately lead to a higher rate of those consenting to be immunised.

Organ Donation and Presumed Consent: The Power of Family Veto

Upon death in the UK, the deceased’s money and property are protected, however their body is not. This raises difficult ethical questions about the power of autonomy after death. Does self-determination weigh appropriately against family veto under the new organ donation laws in England?

The Organ Donation (Deemed Consent) Act 2019 Regulations 2020 came into force on 20 May 2020, introducing a new ‘opt-out’ system, meaning that consent for organ donation will be presumed after death unless stated otherwise. The previous system required individuals to ‘opt-in’ by joining the NHS organ donation register if they wished to donate their organs. The Organ Donation (Deemed Consent) Bill received Royal Assent on 15 March 2019 and makes amendments to the Human Tissue Act 2004. The new bill will bring England in line with Wales who adopted a similar system in 2015 and now have the highest consent rate in the UK.

The ‘opt-out’ system has been introduced as a way to increase the number of organ transplants each year, with the hope that this will spark further conversations about organ donation. This new legislation is known as ‘Max and Keira’s Law’, after Max Johnson, aged nine received a heart transplant from Keria Ball, also aged nine, who passed away when her organs were donated after she died in a car crash in 2017. The aim of the new law is to save lives without having to sign up to a register. Individuals under 18, those that lack the mental capacity to understand the new arrangements and those who have lived in England for less than 12 months will be exempt. A further exception applies if family members can demonstrate that the individual did not want to be a donor.

Previously, if the intention of the deceased regarding organ donation was unknown, family members would be consulted to discuss the decision. In the majority of organ donation refusals, an individual’s views were not known or recorded, and it was often the case that family members then refused organ donation on this basis. As the new law is operating under a ‘soft opt-out’ system, families will continue to be consulted on these decisions as a safeguard. Whilst this allows scope for religious and personal views and ensures organ donation does not go ahead against the wishes of the deceased, families still have an entitlement to withhold organs.

The fact that consent to donation can be overruled by relatives raises difficult ethical questions surrounding autonomy. The difficultly with presumed consent is that the only evidence of an expression of interest is silence. This means that it may actually be easier to allow for a family refusal under the new system due to the absence of opting in. If a patient had not discussed their decision with their family, the family may have concerns about whether that individual wanted to donate. It may also be presented that the individual was unaware that the system has changed and they would have to opt-out if they did not want to donate. Consequently, it may be easier for families to overrule an individual’s consent in an ‘opt-out’ rather than ‘opt-in’ system, as in the latter, evidence of a wish to donate is stronger evidence than presumed consent.

The new legislation creates an almost hybrid like system, where in fact presumed consent is not always conclusive and individuals must continue to actively ‘opt-in’ on the NHS organ donation website, or write their wishes into a will to provide stronger evidence for their decision. Whilst there is no doubt that the new system will enable hundreds of extra transplants each year, it is possible that even more lives could be saved without the caveat that family members have the final say. It may be the case that once the system is well established, a more definitive approach will be adopted to ensure freedom of choice is protected for those wanting to donate, without the fear that family members may override their decision. This could in turn reduce the shortage of organs further and save even more lives.

Families are far more likely to attempt to overrule silent consent that is simply presumed and it is therefore important now more than ever for individuals to share their wishes with their relatives so that they are informed about their decision regarding organ donation.

You can register your decision about organ donation on the NHS organ donation website.

COVID-19: Does the ‘Bolam’ test still set the standard?

The outbreak of COVID-19 has changed the scope of our National Health Service during the Government’s efforts to combat coronavirus. Hospital staff are under immense pressure, risking their lives and many are working in unfamiliar roles during these abnormal circumstances. The Government has guaranteed an indemnity for healthcare professionals as part of their response to coronavirus, although this does not omit liability for any claims brought against them. The Medical Defence Union has proposed instead that emergency legislation should be implemented which would grant the NHS immunity against any clinical negligence claims. One of the main challenges for the courts in relation to the standard of care in clinical negligence claims will be finding the right balance between the interests of society and the copious pressures that continue to burden the NHS.

All patients are owed a duty of care in law. In order to succeed in a claim for negligence, the claimant must prove that there was a breach of that duty, that the breach caused harm to the claimant and that damage or other losses resulted from that harm. The ‘standard of care’ in medicine is well established in the decision of Bolam v Friern Hospital Management Committee [1957] 1 WLR 582, otherwise known as the ‘Bolam’ test. The Bolam test sets out the the standard of care for professionals in medicine as a comparative exercise, by judging clinicians in accordance with the standards of a responsible body of healthcare professionals in that field at the time. The Bolam test has since been modified through developments in case law. However, the test for breach of duty still remains and continues to require expert evidence to identify a breach and ultimately determine best practice. The question stands as to whether the Bolam test can still be applied in unprecedented circumstances, such as COVID-19.

We are currently in a unique situation which no clinician would have ever experienced, making it difficult to identify ‘best practice’. It seems problematic to hold healthcare workers to the same standard when COVID-19 wards are completely novel and made up of staff from a variety of specialisms. Additionally, the impact of COVID-19 has had consequential affects on the NHS, making the circumstances that staff are working far from normal. The time pressures staff are facing, as well as the increase in workload could easily create room for the ‘standard of care’ to slip. Further, patients with progressive conditions that are non-coronavirus related could also experience delays in diagnosis and have limited availability to staff and medical resources due to the current circumstances.

The G eneral Medical Council recently published guidance for clinicians on practice during the pandemic:

“Doctors should continue to follow our guidance as far as is practical in the circumstances. It is likely that as the situation develops, some doctors will need to depart from established procedures to care for patients. We expect doctors will behave responsibly, reasonably and will be able to explain their decisions and actions if they’re called on to do so. But we understand that this is a challenging time.”

Whilst this guidance is reassuring for clinicians, it is still unclear what approach the courts will take. Previous case law suggests it is likely that the present context will significantly contribute to the court’s findings during this period.

Mulholland v Medway NHS Foundation Trust [2015] EWHC 268 (QB) offers a contextual approach to clinical negligence claims in relation to a misdiagnosis in A&E. It was emphasised in this case that the standard of care was “formed within context” and “in a manner reflecting reality”.

More recently in Morrison v Liverpool Women’s NHS Foundation Trust [2020] EWHC 91 (QB), it was stated: “Of course, in the clinical context a balance has to be struck between the needs of any given patient and any other competing professional demands placed upon the clinicians involved.”

It will be important for the courts to consider the particular circumstances and pressures that hospital staff are facing when imposing a standard of care on healthcare workers. However, it remains important for clinicians now more than ever to take accurate records of situations in which they may have to depart from traditional practices. Whilst Bolam has been the basis of the courts’ approach to clinical negligence claims for the past 60 years, it will prove difficult for the court to determine breaches of duty as it is more likely that instead the the pandemic will allow a bigger scope for error of judgement. It therefore seems reasonable to depart from the Bolam test during these difficult and unprecedented times.

UK Surrogacy: Should civil courts still have a central role in a women’s reproductive choices?

Recently, the UK Supreme Court awarded damages for a commercial surrogacy arrangement which took place in California, after a woman pursued the NHS for negligence. This case not only depicts the personal struggles of infertility, but also demonstrates that surrogacy law in the UK is no longer fit for purpose.

California has one of the most liberal laws on surrogacy in the United States and it is legal to enter into a commercial surrogacy arrangement. This is typically where a single person, or a couple will enter into a paid arrangement with a surrogate to carry their baby. In California, the intended parents of the child can obtain a pre-birth court order to confirm legal parenthood of the intended parents.

In the UK, surrogacy is governed by the Surrogacy Arrangements Act 1985, the Human Fertilisation and Embryology Act 1990 and 2008. These regulations make clear that surrogacy arrangements are not legally binding and it is illegal to enter into a paid surrogacy arrangement, with the exception of any expenses incurred by the surrogate. The legislation sets out that the birth mother will always be the legal mother of the child. Legal parenthood status can only be changed by parental order issued by the court, which cannot be done for at least six weeks after birth. This has caused wide spread support for a change to UK surrogacy law and recommendations have been made to clarify this area of the law by the Law Commission who are currently embarking on a three-year review of UK surrogacy legislation.

In XX v Whittington Hospital NHS Trust UKSC 2019/0013, a delay in diagnosis of cervical cancer led to the claimant, aged 29, developing invasive malignancy which caused infertility. The London hospital treating the claimant had erroneously reported the results of her cervical smear tests and biopsies between 2008-2012. The delay in diagnosis expedited the cancer, giving rise to irreparable damage to her uterus and ovaries, causing premature menopause. The cancer was far too advanced for surgery to have taken place, which could have preserved the claimant’s fertility. Instead, she harvested and froze eight of her eggs before chemotherapy treatment, with a preference for commercial surrogacy taking place in California.

The UK Courts initially refused the cost of commercial surrogacy to be included in a payment for damages, due to the illegality of commercial surrogacy in the UK. However, in a majority ruling of three to two, the Supreme Court found in favour of the claimant and ruled that as long as the surrogacy arrangement had a chance of success, damages for reasonable costs may be awarded. The court also added the caveat that it must be reasonable to seek an overseas surrogacy arrangement, rather than a UK based surrogacy agreement. These criteria must be met, as long as the foreign country has a well-established system that safeguards the interests of the surrogate, intended parents and resulting child.

Lady Hale, when giving the majority decision, stated:

“It is no longer contrary to public policy to award damages for the costs of a foreign commercial surrogacy…. The government now supports surrogacy as a valid way of creating family relationships, although there are no plans to allow commercial surrogacy agencies to operate here”

It is important to recognise that whilst the courts have acknowledged foreign commercial surrogacy as a means of damages in clinical negligence claims and there seems to have been a ‘victory’ of sorts in this case, the catastrophic battle that the claimant endured over a period of ten years in order to create a family is far from victorious. This highlights the problems imbedded within the current law and demonstrates that surrogacy law in the UK is outdated and no longer suitable for society. Lady Hale herself described UK surrogacy law as “fragmented and in some ways obscure”. With the laws dating back to the 1980s, it is widely accepted that there is a clear need for legal reforms to bring the law in line with social trends and medical advances.

The uncertainty surrounding legal parenthood embellished within UK surrogacy law may attract potential parents to enter into foreign surrogacy arrangements. This would ensure formality and flexibility in and confirmation of legal parenthood; elements that are missing from the UK framework. Parental orders are one of the main areas that will be addressed in the Law Commission’s review and there is much support for a reform to allow for the intended parents to be the legal parents immediately after birth. This would provide reassurance to intended parents from the outset and allow individuals to regain autonomy over their reproductive choices.