Health Sector News – Review of April 2020

Blake Morgan’s Health Sector legal experts have put together a round-up of the latest news within the area.

Welcome to the review of the April edition of Health Sector News, a digest of legal issues hitting the headlines in the health sector.

To all those working in the healthcare sector, Blake Morgan continues to offer its full support. We are here to provide any advice and assistance as and when required.

The nature of the legislative landscape is changing rapidly at present and there are also differences in the laws and guidance which apply in England and in Wales. We have set out some of the most topical issues from last month, but these are by no means exhaustive.

You can also keep up to date with our latest articles and blogs on legal issues arising during this pandemic by going to the dedicated COVID-19 insights section.

COVID-19 related healthcare news

The Health Protection (Coronavirus Restrictions) (England) (Amendment) Regulations 2020

On 26 March 2020, the Health Protection (Coronavirus, Restrictions) (England) Regulations 2020 came into force, detailing Regulations on social distancing and business and venues closures. These Regulations set out that a review of these Regulations must take place every 21 days to ensure they are both necessary and proportionate. The Government completed the first review as required on 16 April 2020 and determined that no change would be made to the existing restrictions and that they would remain in place for at least three more weeks.

A statement from the Department of Health and Social Care can be found here.

The Health Protection (Coronavirus Restrictions) (Wales) (Amendment) Regulations 2020

On 7 April 2020, the above Regulations came into force to make amendments to the original Regulations. Regulation 5 makes provision relating to providers of holiday accommodation to cease carrying on their business. Amendments were also made to insert a requirement on persons responsible for work being carried out at any place to take all reasonable measures to ensure that a distance of 2metres is maintained between persons on the premises.

A further set of amendments were made on 24 April 2020 via The Health Protection (Coronavirus Restrictions) (Wales) (Amendment) (No. 2) Regulations 2020 in which the Welsh Government changed the core requirement for people not to leave the place where they live to a requirement not to leave or remain away from that place, meaning that people who leave their home with a reasonable excuse cannot remain outside to do other things.

Changes to the Care Act 2014 – England

The government has published guidance to local authorities on temporary changes made to the Care Act 2014, as a result of coronavirus pandemic. The guidance sets out how local authorities can use the provisions created under the Coronavirus Act 2020 (known as Care Act easements) with the stated aim of  prioritisation of  care and support to those most in need.

The Coronavirus Act 2020 allows for key duties to be suspended under the Care Act 2014 to enable the prioritisation of resources if necessary, if local authorities are unable to meet existing statutory duties in full, for example should resource demand increase significantly, or staff resources decrease.

The key provisions fall into four categories:

1. Local authorities will not have to carry out detailed assessments of people’s care and support needs in compliance with pre-amendment Care Act requirements, although they will still have to respond as soon as possible so as not to jeopardise human rights;
2. Local authorities will not have to carry out financial assessments in compliance with pre-amendment Care Act requirements, however they will have powers to charge people retrospectively for care and support received;
3. Local authorities will not have to prepare or review care and support plans in line with pre-amendment Care Act provisions, however will still be expected to carry out proportionate, person-centred care planning which provides sufficient information; and
4. The duties on local authorities to meet eligible care and support needs or the needs of a carer are replaced with a power to meet needs, but are still expected to take all reasonable steps to continue to meet needs now. In the event they are unable to do so, the powers enable them to prioritise the most pressing needs.

The easements took effect from the 31 March 2020 but should only be exercised by local authorities where necessary in order to maintain high levels of services. They should also continue to comply with pre-amendment provisions and other statutory guidance for as long and as far as possible. It has been stressed that these provisions are temporary. , Before the easements are applied, there must be a decision made by a local authority Director of Adult Social Care that ‘…the workforce is significantly depleted, or demand on social care increased, to an extent that it is no longer reasonably practicable for it to comply with its Care Act duties (as they stand prior to amendment by the Coronavirus Act)’ and that ‘…to continue to try to do so is likely to result in urgent or acute needs not being met, potentially risking life’

The detailed guidance also sets out a number of other safeguards and protections, the duties that are remaining in place, the principles governing the use of the powers, and the steps local authorities should take before exercising the easements. Any decision to rely on the new provisions must be made carefully, in consultation with other relevant bodies and people, and in a staged manner so that changes are only made incrementally, following a decision that they are truly necessary.

Local authority duties under the Mental Capacity Act 2005 (MCA 2005) including Deprivation of Liberty Safeguards (DoLS) and under the Equality Act 2010 (including the Public Sector Equality Duty) are unaffected and are potentially relevant to use of the Care Act easements

The full guidance for local authorities can be found here. 

Changes to the Social Services and Wellbeing (Wales) Act 2014 (“the Act”)

Wales has issued guidance enabling local authorities in Wales enabling them to make temporary changes to the Act for adult services. The guidance sets out how local authorities can use the modifications to the Act created under the Coronavirus Act 2020 (“the 2020 Act”), to ensure the best possible care for some of the most vulnerable people in our society during this exceptional period. It applies only in relation to adult social care and should only be exercised as a last resort where this is in order to maintain the highest possible level of services. Local authorities are to comply with the Act for as long and as far as possible.

A local authority should only take a decision to begin exercising its modified duties when:

• the workforce is depleted, or demand on social care increased, to an extent that it is no longer reasonably practicable for it to comply with its 2014 Act duties (as they stand prior to modification by the 2020 Act)
• where to continue to try to do so is likely to result in needs not being met, potentially risking life.

Any changes resulting from such a decision should be proportionate to the circumstances in a particular local authority. Local authorities must maintain a record of the decision with evidence that was used in the decision-making process.

In summary, there are four operating stages:

• Stage 1 – Business as usual – local authorities are to continue in this stage for as long as is feasible;
• Stage 2 – Applying flexibilities in the Act – to enable some service types to be changed, restricted or cancelled in the short term within that service type;
• Stage 3 – Streamlining services using the modifications – to allow local authorities to cease formal assessments, the application of eligibility criteria and the preparation and review of care plans under the Act.
• Stage 4 – Prioritisation using the modifications – to allow local authorities to make decisions about changing support for people, they should consider and allocate capacity across the whole of adult social care or all of social care.

The guidance on adult social care can be found here.

Guidance in relation to children’s services in Wales, issued on 21 April 2020, can be found here. The guidance makes clear that its application should be made by local authorities on a case-by-case basis, ensuring the best outcome for children is central to planning and decision making. Recording and evidencing why and how decisions have been reached remains a key responsibility when applying this guidance.

Regulations suspended to fast-track PPE Supplies

It was announced on 28 March by Business Secretary Alok Sharma that several new measures are being introduced to allow essential personal protective equipment (“PPE”) and hand sanitiser to reach NHS staff more quickly. These measures include:

• Asking the Health and Safety Executive (“HSE”) and Local Authorities to fast-track PPE through product safety assessment processes and prioritise this activity over other market surveillance activity;
• Allow PPE equipment which lacks the CE mark onto the market provided the products meet essential safety requirements; and
• Providing new guidance for local authorities and ports and enforcement officers on the import and safety testing of hand sanitizer.

Additionally HMRC has confirmed that manufacturers of hand sanitizers and gels will have applications for denatured alcohol fast-tracked.

The rationale behind the decision is that by reducing the amount of red tape, new suppliers and businesses that produce ingredients for safe hand sanitizer and PPE will be able to bring their products to the market much quicker.

Companies, such as the Brewdog Distillery, who do not normally produce such products, have already offered their services and have begun production at their premises in response to the national shortage, and are providing it free to charities and frontline workers.

Alok Sharma said “The government is doing everything in its power to save lives and protect livelihoods during these unprecedented times. Applying a common-sense approach to regulation will ensure products are safe and reach the market without any unnecessary delay, getting vital protective equipment such as face masks to frontline staff as quickly as possible. Today’s measures will also reduce the burden on business, giving bosses much-needed breathing space to keep their workers employed and their companies going.”

For more information please go to the Government website.

First in the UK: Antibody Transfusion for COVID-19 patients

The University Hospital of Wales has become the first hospital in the UK to use potentially ground-breaking antibody transfusion to treat coronavirus patients.

The treatment uses blood plasma taken from patients who have already recovered from Covid-19, which is then transfused into patients currently suffering to help them fight the virus more quickly.

Public Health Wales is inviting those who are eligible, via letter, to donate blood to the scheme. Dr Gill Richardson, senior professional advisor to the Chief Medical Officer, said “Convalescent plasma is plasma that is collected from patients who have recovered from the disease, in this case Covid-19. Plasma from patients who have recovered from the virus will contain antibodies that a patient’s immune system has produced to fight the virus. This can be transfused to patients whose immune systems are struggling to develop their own antibodies.”

“In the absence of any current vaccine or anti-viral therapy, it has significant potential to aid the recovery of patients.”

Health Minister Vaughan Gething said “It’s brilliant to see Wales is playing a leading role on this project which has the potential to significantly improve patient recovery and save lives. We will be capturing all outcomes and feeding into the UK and worldwide learning on the use of this technology.”

Collection of the plasma will take place no sooner than 28 days after recovery from people who have fully recovered and are free from the virus. This will then be matched using the established safe blood donor selection criteria, and processed by the Welsh Blood Service.

The first use of this treatment will take place on patients in the University Hospital of Wales.

NHS faces billions in crisis claims

The Medical Defence Union (MDU) has warned the Government that the NHS could be faced with billions of pounds of medical negligence claims if it does not grant some form of legal immunity to medics during the pandemic.

As well as recalling retired doctors and fast-tracking medical students before they have finished training, many treatments and surgeries are being delayed to cope with the influx of coronavirus patients and the MDU is calling for a debate over the need for emergency legislation.

Whilst there is an acceptance that doctors should be accountable for their actions, with medical staff taking difficult decisions about patient care in challenging conditions, the MDU wants them to be able to work without fear they will be unfairly judged in the years to come.

Other healthcare news

Royal College of Physicians clarifies its position on euthanasia

On the 21 March 2019 the Royal College of Physicians (“RCP”) adopted a position of neutrality in respect of assisted dying following a survey of its members and fellows in which 6885 of their member responded.  43.4% opposed a change in the law of assisted dying, 31.6% were in support and 25% thought the RCP should be neutral on the issue.

The current position in England, Wales and Northern Ireland is that assisting in a suicide is illegal and carries a sentence of up to 14 years in prison for those convicted of the crime. There have been several attempts at amending the law in recent years, most notably the Assisted Dying Bills proposed by Lord Falconer in 2014 and Rob Marris in 2015, neither of which were successful.

The RCP defined neutrality as neither supporting nor opposing a change to the current law in order to represent the breadth of views across their membership. However this has been interpreted by some as either that the RCP is indifferent to a change or that they support assisted dying. To rectify this the RCP has clarified that it does not support a change in the law at the present time.

The RCP has reiterated the following points in relation to the survey and its position:

• The RCP has an important role in informing the societal debate on this issue, and is keen to do so;
• Whilst the ultimate decision on assisted dying rests with society through Parliament, professional and clinical issues pose significant challenges to the success of any future legislation;
• There remain many shortcomings in the provision of palliative care, and physicians of all shades of opinion in the current debate share a commitment to the improvement of care at the end of life;
• There is a plurality of views within the RCP membership on the issue of assisted dying;
• Whilst a significant minority of its fellows and members support a change in the law, a greater number remain opposed;
• The majority of doctors would be unwilling to participate actively in assisted dying if the law were changed to permit it, with only 25% indicating a willingness to do so.

For more information in relation the RCP’s position please see here.

Maternity scandal inquiry grows by hundreds of cases

An independent investigation has written to a further 400 families as the number of cases under investigation reach 1,170. The inquiry covers fatalities and other serious outcomes in a 40-year period up to the end of 2018.

Donna Ockenden, a maternity specialist commissioned to lead the review has been clear that the review is not historical and will make a difference to maternity care going forward.

In April 2020, the Trust concerned, Shrewsbury and Telford Hospitals Trust, was rated inadequate for the second time in a row by the Care Quality Commission.

You can read more about the review at the Donna Ockenden website.

Recent case law

Court of Protection rules that the ability to die surrounded by loved ones is a fundamental right

VE v (1) AO (By her litigation friend, the Official Solicitor), (2) The Royal Borough of Greenwich, (3) South East London CCG [2020] EWCOP

The Court of Protection has ruled that it was in the best interests of an elderly woman, AO, diagnosed with terminal cancer to be allowed to leave the care home where she resided (TO) to die surrounded by her family. The application was made under s.21A Mental Capacity Act 2005 (MCA) as a challenge to the legality of AO’s deprivation of liberty at TO. The real question for the court was, however, whether or not it was in AO’s best interests to continue to reside at TO or to move to live with VE and her family. Any decision as to deprivation of liberty would inevitably follow the best interests assessment as to where she lived. All parties agreed that AO did not have capacity to litigate or to decide where she lived. Mrs Justice Lieven ruled, that the right to die with one’s loved ones was covered by article 8 of the European Convention on Human Rights, the right to a private and family life.

“The ability to die with one’s family and loved ones seems to me to be one of the most fundamental parts of any right to private or family life,”

AO had terminal cancer and was going to die within a relatively short time. It was not argued that the court should not allow AO to leave TO because of the risk of Covid 19, or that any possible public interest in not allowing her to move outweighed her best interests, or her article 8 rights.

Mrs Justice Lieven stated that: “At the time I made my decision it was not clear whether or not any of the other residents at TO had Covid 19, and it was not being said that AO had Covid 19, but this is a possibility given some accounts of her current symptoms. This is important because this judgment is solely about what is in AO’s best interests in circumstances where she had terminal cancer and her family wanted her to die at home with them.”

Mrs Justice Lieven applied Section 4 MCA which deals with the assessment of best interests. She reached the conclusion that it was in AO best interests for AO to move to live with her family. This accorded with the history of her relationship with her family and her background and known values. It also accorded with the views of her family.

In making this decision the court considered the Health Protection (Coronavirus Restrictions) Regulations 2020 (SI 2020/350) in order to ensure that in allowing a family member to collect AO from the care home was not inadvertently allowing a breach of these Regulations.

Regulation 6(1) prohibits any person from leaving home without a reasonable excuse. Regulation 6(2) lists, apparently non-exhaustively, matters that would amount to a “reasonable excuse”. At regulation 6(2)(d) these include providing care or assistance to a vulnerable person.

The Court of Protection concluded that , for a family member to collect AO from TO was providing assistance to a vulnerable person and would in any event also accord with the order of the court.

A full copy of the judgment can be found here.

First Skype hearing takes place in Court of Protection in life-support case

A Clinical Commissioning Group v AF, 2020 EWCOP 16 

The first Court of Protection case held entirely remotely via Skype took place between the 17 and 20 March with Mostyn J presiding.

The case involved a woman’s application to withdraw life support from her mentally incapacitated father who had suffered a severe stroke. Evidence was presented by the applicant that her father had expressed to her several times prior to his stroke that he would not wish to be kept alive if he was ‘just a body in a bed’ and had spoken about the indignity of being in such a situation. He had also allegedly expressed a wish to die after having his stroke and had refused food via a nasogastric tube several times.

The Court rejected the application, however the focus has been on the way in which the hearing was conducted.

The coronavirus pandemic made the original listing in the court in Nottingham impossible due to the risk to the participants, therefore the hearing was agreed to take place via Skype. The hearing consisted of 17 continuously active participants, 11 witnesses and two journalists. Participants were generally in their own homes and located all over the country.

The hearing proceeded without any issues save for some files of recording becoming corrupted as a result of their size. There was also a slight issue with audio lag, the result of which was that judge or counsel would think that someone had finished speaking when they had not causing the witness being questioned to experience an interruption.

Despite this and despite all parties having agreed to the Skype hearing, not all parties considered the approach ideal. Academic Celia Kitzinger, in support of the applicant, said “what we found in practice was that a preoccupation with the technology distracted people’s attention from the substantive content of the case’. She also stated that it was easy to forget that the applicant remained in the virtual courtroom throughout the hearing. The applicant herself stated she felt it was a “second rate hearing” and that the technology lost her the opportunity to influence the court and left her unable to get her message across as she would have done in person. She said “it felt like a stop gap to ensure a box was ticked”.

Notwithstanding these criticisms Mostyn J commented that “in the national crisis, it must be expected that hearings will be conducted remotely in this way as a matter of routine practice”.

For more information regarding court hearings during the coronavirus pandemic please go to the COVID-19 guidance on the Government website.

Judge orders mental health patient to vacate bed for COVID-19 cases

A mental health patient (“MB”) at the University College London Hospitals has been ordered by the court to be discharged after occupying a room for over a year.

MB had been diagnosed with a functional neurological disorder and psychological conditions including PTSD and possible borderline personality disorder and Asperger’s syndrome, and requires help with most aspects of personal care. Discussions relating to her care had been ongoing for over a year with the hospital stating she had been fit for discharge to a specially adapted local authority accommodation since May 2019. However she had twice refused to cooperate when they attempted to discharge her.

The hospital made an urgent claim for possession of the patient’s room to the High Court stating that the need for the room was urgently needed for other patients because of the Covid-19 pandemic. One doctor in evidence stated that all patients who are medically fit for discharge are discharged home into other care arrangements as per the government’s guidance.

However MB’s lawyer argued that she did want to be discharged but was concerned that the care package in place was inadequate given her complex needs and that she was at risk of self-harm or suicide.

In his ruling in the hospital’s favour Justice Chamberlain stated “it is contrary to MB’s interests to remain in the hospital, where she at increased risk of contracting Covid-19” and said that although it was distressing for MB it was safe for her to be discharged into the adapted accommodation with 24 hour care provided seven days a week.

Court of Appeal rules parents must register and vaccinate son

Parents who appealed a High Court ruling regarding the registration of their son’s birth have lost in the Court of Appeal.

The baby’s parents decided not want to register the birth in accordance with the Birth and Deaths Registration Act 1953 and they refused to have their son vaccinated as they did not want him to become “a creature of the state” and were concerned vaccines would make him ill.  As the 42 day birth registration period passed, Tower Hamlets Council (the Council) stepped in in a bid to become the child’s ‘institutional parent’ in order to get him registered and vaccinated.

The High Court, in June 2019, ruled that the Council had the right to step in as the child’s institutional parent to register the birth. Additionally, the child was the subject to a care order while his parents were subject to residential assessment. The court ruled the parents did not have their child’s best interests at heart and concluded that vaccinations were in his best interests and the parental objections were “tenuous and tendentious”.

The parents appealed the High Court ruling to the Court of Appeal where the Council’s powers under section 33(3) of the Children’s Act 1989 to consent to vaccination for children under care orders were assessed.

The court rejected the parents’ appeal and have reserved their judgment with their reasoning in the case to be set out in due course.

Counsel for the local authority described the decision as “an important marker on an issue that generates considerable public debate” which could have potential ramifications for parents that refuse to vaccinate their children.

For a full copy of the judgment please visit here.

Supreme Court rules NHS to pay for US surrogacy costs

Supreme Court rules NHS to pay for US surrogacy costs [2020] UKSC 14

A woman, identified as XX, has been successful in her Supreme Court case to have the NHS pay for surrogacy treatment she plans to have in the US through commercial agreements as a result of previous negligence by the Trust.

XX was successful in an earlier clinical negligence claim against Whittington Hospital NHS Trust after they admitted to negligently failing to detect signs of cervical cancer. This ultimately resulted in XX being left infertile at the age of 29 following treatment for invasive malignancy. She was awarded damages but her application for costs towards surrogacy treatments in California was denied as the commercial agreement under which the surrogacy would be bound are not legal in the UK.

Her representatives argued that she should be granted the costs of the treatment as the practice is legal and binding in California and that “the civil courts should no longer have any role in censuring a woman’s reproductive choice”.

The judgment was delivered via video-link with a majority of three to two in favour of XX. Lady Hale gave the majority decision and said “The courts have bent over backwards to recognise the relationships created by surrogacy, including 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 no longer contrary to public policy to award damages for the costs of a foreign commercial surrogacy. However, that does not mean that such damages, still less damages such as are claimed in this case, will always be awarded. There are some important limiting factors.

“The proposed programme of treatments must be reasonable. There may be good reasons to think that, but for the negligence, the claimant would have had the number of children now proposed, but there may not”.

In his dissenting judgment Lord Carnwath said: “The fact that the laws of other jurisdictions and other systems may reflect different policy choices seems to me beside the point. It would in my view be contrary to the principle of consistency between civil and criminal law for the civil courts to award damages on the basis of conduct which, if undertaken in this country, would offend its criminal law”.

You can view a full copy of the judgment here.