Please find below the September 2020 review edition of our Healthcare update, bringing you some of the most topical legal news stories from the last month.
Blake Morgan continues to offer its full support to all those working in the healthcare sector and is happy to provide any advice and assistance as and when required.
Please do also keep up to date with our latest articles and blogs on legal issues arising by going to BM Insights section.
COVID-19 related healthcare news
Please see the Appendix at the bottom of this newsletter for Regulations issued in England and Wales in September to deal with COVID-19.
Other Health and Social Care News
NHS Trust fined for lack of candour in first prosecution of its kind
The University Hospitals Plymouth Trust has been fined and ordered to pay legal costs amounting to £12,565 following a landmark case brought by the Care Quality Commission (“CQC”).
The case involved the way in which the Trust handled the death of 91 year old Elsie Woodfield at Derriford Hospital following an endoscopy in December 2017. She suffered a perforated oesophagus during the procedure causing it to be abandoned and passed away a few hours later.
The CQC claimed the Trust failed to inform Ms Woodfield’s family that her death may have been the result of the mistake made during the procedure, stating that they failed to share details of what happened during the procedure and that they failed to apologise within a reasonable time frame. The Trust pled guilty to not being open with the family about the circumstances of her death and were prosecuted in the first criminal prosecution of its kind.
Christian Concern loses Court of Appeal challenge
The group Christian Concern has lost their case at the Court of Appeal against the Department for Health and Social Care (“DHSC”).
The appeal follows a High Court decision in which it was held that a change in regulations allowing women to have medical abortions at home following a phone or video consultation during the Covid-19 pandemic, was lawful.
Christian Concern brought the action against the DHSC claiming that the government’s decision to introduce the regulations went beyond the powers available under the Abortion Act 1967 and that allowing woman to have abortions at home went against the purpose of the Act to prevent “backstreet abortions”. It was argued that the change had “serious and life-changing consequences for the women involved”.
DHSC, in opposition, argued that changes in the rules fell within its scope and power.
Under previous rules only the second drug required when undergoing a medical abortion could be taken at home, after the first being administered at a hospital or clinic with a doctor. The rules were amended in March 2020 as a result of the outbreak of Covid-19 to allow women to take both the first and second drugs at home for an early medical abortion.
At the Court of Appeal ruling, Lady Justice Nicola Davies rejected Christian Concerns’ claims stating that the decision to change the rules was within the scope of the 1967 Act and its’ purpose was to protect women’s health. She went on to say that there was evidence from health professionals that vulnerable woman were turning to online providers outside the regulated healthcare system and that “the purpose of the 2020 approval was to address a specific and acute medical need, in the context of a public health emergency” to “ensure the continuance of the protection of the health of women in the context of the 1967 Act”. It was also added that the registered medical practitioner remains in charge throughout the procedure and the changes are “time limited”.
Christian Concern has stated they will be taking the proceedings to the Supreme Court following the Court of Appeal ruling.
PI Arbitration service set to shut if there are no new cases
Andrew Ritchie QC, who pioneered a personal injury and medical negligence arbitration service has warned that it could close by Christmas if there are no new cases.
The Personal Injury claims Arbitration Service (“PIcARBS”) has been running for five years however has only dealt with two cases in that time, generating a total of £4000 in income, compared to £35,000 of expenses. The service was launched in response to the decision by the Ministry of Justice to increase court fees to £10,000 for personal injury cases valued at or over £200,000. It offers digital filing and Mr Ritchie stated it is efficient and cheap in order to compete for large disputes.
Second reading of the Medicines and Medical Devices Bill 2019-2021
The second reading in the House of Lords of the Medicines and Medical Devices Bill 2019-2021 took place on 2 September 2020, following introduction in the House of Commons in February 2020.
The Bill seeks to address the regulatory gap that will be left after the transition period of the UK’s exit from the EU ends. The current legal framework for medicines and medical devices in the UK derives from EU Directives and have been implemented in UK law through section 2(2) of the European Communities Act 1972 (“ECA”), which has been used to create a body of regulations including the Human Medicines Regulations 2012 and the Medical Devices Regulations 2002. However when the transition period ends the ECA will no longer be available in the UK to amend the regulations and there is no other general power to update the regulations except through the introduction of primary legislation.
The new Bill will therefore plug the gap by introducing regulation-making delegated powers covering human medicines, clinical trials of human medicines, veterinary medicines and medical devices, in order to enable existing regulatory frameworks to be updated at the end of the Brexit transition period. The powers introduced are designed to be targeted delegated powers that can only be exercised in relation to a restricted number of matters in relation to key pieces of legislation within each of its first three parts:
- The Human Medicines Regulations 2012;
- Medicines for Human Use (Clinical Trials) Regulations 2004;
- Medicines (Products for Human Use) Regulations 2016;
- Medicines Act 1968 (in limited areas specific to the provision related to pharmacies);
- Veterinary Medicines Regulations 2013; and
- Medical Devices Regulations (MDR) 2002.
Part four of the bill creates a duty to consult before any changes to regulations are made and sets out exceptions to this duty and the use of affirmative action. In addition the Bill will provide the Secretary of State with the power to impose civil sanctions for breaches of the medical devices regime, as opposed to a criminal prosecution.
The Bill will apply to England, Wales, Scotland and Northern Ireland.
For further information on the Bill please see here.
Emergency approval to be given to any Covid-19 vaccine
The UK Government are introducing plans to give any “new and effective” Covid vaccines emergency approval for use in the UK.
The law change will allow the Medicines and Healthcare Products Regulatory Agency (“MHRA”) to grant temporary approval for a vaccine from October 2020 before it has been licenced by European authorities, contrary to the normal procedure. While the European Medicines Agency will fast-track any efficient vaccine, the language requirements in the new law are thought to make approval by the MHRA quicker.
The proposed legislation will also involve protection for companies who manufacture, supply and administer the vaccine from civil action should an individual suffer a rare side-effect that could not have been detected during trials.
A three week consultation was launched and ran until the 18 September 2020.
For further information in relation to the consultation please see here.
Permission to appeal over stroke services refused
The Court of Appeal has refused permission for Medway Council in Kent to appeal a High Court ruling in relation to the actions of a joint committee of clinical commissioning groups (“CCG”), when dealing with health inequalities when deciding locations of three hyper acute stroke units.
Following a review of stroke services and a public consultation, in December 2019 the joint committee established three hyper acute stroke units at Darent Valley Hospital, Maidstone Hospital and William Harvey Hospital, and decided that the stroke unit at the Queen Elizabeth the Queen Mother Hospital will close. In addition the reconfiguration of services did not include a hyper acute unit at Medway Maritime Hospital.
The council advanced eight grounds of challenge, two of which were accepted by the High Court in February 2020, being that the CCG had misunderstood or failed to discharge the health inequality under section 14T of the National Health Service Act 2006 and that the consultation was unlawful. However the court went on to dismiss the claim finding that the joint committee had acted lawfully when dealing with health inequalities.
The council thereafter sought permission to appeal the decision however this has been refused by the Court of Appeal with Lord Justice Phillips ruling that there were no permissible grounds for appeal against the judicial review ruling made by the High Court.
A referral has now been made by the council to the Secretary of State for consideration for an independent review of the process.
Concerns raised over NICE pregnancy alcohol intake proposals
Concerns have been raised over the National Institute for Health and Care Excellence (“NICE”) proposals to include all pregnant women’s alcohol intake on their children’s medical records.
Following consultation of the proposed guidelines in England and Wales, NICE have proposed introducing guidelines that would result in all alcohol intake by expectant mothers, including before they are aware of their pregnancy, being permanently attached to their children’s medical records in an attempt to better treat foetal alcohol spectrum disorder (“FASD”). NICE have stated this is necessary in order to obtain accurate information in order to identify children who may be at risk of FASD, and would be particularly relevant in the case of children adopted or taken into care.
However both the British Pregnancy Advisory Service (“BPAS”) and the Royal College of Obstetricians and Gynaecologists (“RCOG”) have voiced that the proposals are concerning. BPAS has stated there is “no compelling research” that shows unborn children are harmed by low levels of drinking and that the plans are “unjustified and disproportionate”.
There are also concerns surrounding confidentiality if the information is available in children’s medical records with a spokesperson for BPAS stating “women do not lose their right to medical confidentiality simply because they are pregnant”. The charity Birthrights also stated they have serious concerns surrounding NICE’s apparent failure to recognise the need for informed consent to screening and the transfer of information to children’s medical records.
In addition, data protection lawyers have warned that sharing details from mother’s records to a child’s could be “illegal and incompatible” with the GDPR.
Following the raising of concerns NICE extended their consultation period until the 18 September 2020.
New GMC decision making and consent guidance to come into force
The General Medical Council have published their updated Decision Making and Consent Guidance which is due to come into force in November. The guidance is designed to assist doctors to “practise shared decision making and help their patients to make healthcare decisions that are right for them”.
In order to make obtaining patient’s consent easier and less time-consuming the guidance introduces the following new features:
- A focus on taking a proportionate approach, acknowledging that not every paragraph of the guidance will be relevant;
- Seven key principles which summarise the guidance;
- A new section to help doctors find out what is important to patients so they can share relevant information to make decisions between them as to viable options; and
- Suggestions for how other members of the healthcare team can support good decision making.
The seven key principles are:
- All patients have the right to be involved in decisions about their treatment and care and be supported to make informed decisions if they are able;
- Decision making in an ongoing process focused on meaningful dialogue – the exchange of relevant information specific to the individual patient;
- All patients have the right to be listened to, and to be given the information they need to make a decision and the time and support they need to understand it;
- Doctors must try to find out what matters to patients so they can share relevant information about the benefits and harms of proposed options and reasonable alternatives, including the option to take no action;
- Doctors must start from the presumption that all adult patients have capacity to make decisions about their treatment and care. A patient can only be judged to lack capacity to make a specific decision at a specific time, and only after assessment in line with legal requirements;
- The choice of treatment or care for patients who lack capacity must be of overall benefit to them, and decisions should be made in consultation with those who are close to them or advocating for them; and
- Patients whose right to consent is affected by law should be supported to be involved in the decision-making process, and to exercise choice if possible.
The new guidance will come into force on 9 November 2020.
To read the guidance in full please see here.
Welsh Government launches consultation on provision of autism services
On 21 September 2020 the Welsh Government launched their consultation seeking views on the Code of Practice on the Delivery of Autism Services under the Social Services and Well-being (Wales) Act 2014 and the NHS (Wales) Act 2006.
The Code of Practice has been developed in response to feedback from people with autism and their families or carers who would like clarity of the services they can expect to receive in Wales. It will set out duties for local authorities and health bodies in relation to the range and quality of services available to people in their local areas, and is envisaged to reinforce the current legal frameworks already in place.
The Code will be applicable to: people with autism, including those with other co-existing conditions; providers of social care and health support to autistic people and their families/carers; practitioners in social care and health who work with autistic people and their families; commissioners and people with a strategic role in assessing and planning local services for autistic people and their families; practitioners in other related services providing support to autistic people and their families; and service providers and practitioners providing services to autistic people with other co-existing conditions.
The consultation will remain open for response until 14 December 2020.
For more information please see the full consultation briefing.
Revised Regulations in England to deal with Covid-19
On 10 September 2020 the Heath Protection (Coronavirus, Restrictions)(Bolton) Regulations 2020 came into force and had the effect of requiring the following businesses to either remain closed or not open in the affected local areas:
- Nightclubs, dancehalls and discotheques;
- Sexual entertainment venues and hostess bars;
- Indoor skating rinks;
- Bowling alleys;
- Indoor play areas, including soft play areas; and
- Exhibition halls and conference centres.
It was also advised that indoor performances should not reopen or restart.
Hospitality venues, including restaurants, cafes, bars and pubs, must only provide takeaway food and drinks or offer delivery services.
Businesses were also told they must close between the hours of 10pm and 5am and that takeaway is not permitted during this time. This excludes cinemas, theatres and concert halls who remain open after 10pm in order to conclude a performance that began before 10pm.
Failure to fulfil the obligations set out in the restrictions can result in businesses being fined by the local authority as follows:
- £1,000 for the first offence;
- £2,000 for the second offence;
- £3,000 for the third offence; and
- £10,000 for the fourth and all subsequent offences.
For individuals living in Bolton the restrictions introduced that you must not: host people in either the house or garden unless they are in your support or childcare bubble; or meet people you do not live with in either the home or garden unless in a support or childcare bubble. Failure to comply can result in fines of £200 for a first offence (lowered to £100 if paid within 14 days); £400 for a second offence; then doubling for each further offence to a maximum of £6,400. Fines have also been introduced for those who host gatherings of more than 30 people up to £10,000.
On 14 September 2020 the Heath Protection (Coronavirus, Restrictions)(No.2)(England)(Amendment) (No.4) Regulations 2020 were brought into force and had the effect of prohibiting the gathering of people both indoors and outdoors in groups of more than six (including children) unless they are members of the same household or another specified exception applies:
- Where the gathering is of people from the same household or are members of two linked households;
- Weddings or civil partnership ceremonies, or receptions, however a maximum number of 30 people applies;
- A “significant event gathering” limited to 30 people, defined as a gathering for the purpose of a ceremony to celebrate a milestone according to religion or belief, or a funeral;
- Gatherings that are reasonably necessary for a specified purpose including for work, voluntary or charitable purposes, provision of education purposes, provision of emergency services or assistance to vulnerable persons;
- Gatherings that take place outdoors for the purpose of physical activity and the person organising has appropriate authorisation from the local authority to do so;
- Where the gathering is for an elite sportsperson and their coach for the purposes of competition or training; and
- Where the gathering is to fulfil a legal obligation.
The Regulations do not apply to those in “protected areas” in Leicester, Blackburn with Darwen and Bradford, the North of England and Bolton who have separate, more restrictive local measures and regulations already in place.
On 17 September 2020 the Health Protection (Coronavirus, Collection of Contact Details etc and Related Requirements) Regulations 2020 came into force and had the effect of introducing a legal requirement for the collection of data for contact tracing and introduced a requirement for relevant premises to display an official QR code.
Hospitality, leisure and community premises must collect data from customers, staff and volunteers for contact tracing purposes, including restaurants, cafes, bars, museums, sports centres, libraries, villages halls and close contact services such as hairdressers.
The data to be collected includes:
- Telephone number/email or postal address);
- Date and time of entry; and
- Number of people in group.
There are exceptions for those unable to provide details such as those under the age of 16 years, or those who have physical or mental disabilities.
Data does not need to be collected where the individual has scanned the official QR code, if there is one on display, which can be scanned using the NHS Covid-19 App.
Data collected must be retained for 21 days, shared with NHS Test and Trace or public health officials if requested, and then destroyed as soon as reasonably practical unless there is another lawful basis to retain it.
On 18 September 2020 the Health Protection (Coronavirus, Restrictions) (Obligations of Hospitality Undertakings) (England) Regulations 2020 came into force and had the effect of requiring hospitality business to enforce the “rule of six”.
Hospitality businesses are defined to include pubs, restaurants, cafes and other businesses that provide food or drink for consumption on their premises to enforce the restriction whereby people are prohibited from gathering in groups of more than six unless they are members of the same household. In particular businesses should take the following measures:
- Not to accept bookings for groups of more than six people and not to admit persons in groups of more than six unless one of the exemptions applies (see above);
- Maintain appropriate distance between tables, being two metres or one metre if other measures such as protective screens are in place; and
- Customers from two separate groups do not mingle with each other whilst on the premises.
Business who fail to comply with these restrictions can be issued with an initial fine of £1,000, increasing to a maximum of £4,000 for subsequent offences.
On 22 September 2020 Prime Minister Boris Johnson announced the following further measures to be introduced in England to control the spread of Covid-19:
- With immediate effect the advice is that office workers should work from home over the winter if they are able to do so effectively.
- From the 24 September 2020 businesses selling food and drink, including cafes, restaurants, bars, and pubs, social clubs, casinos, bowling alleys, amusement arcades and bingo halls must close between the hours of 10pm and 5am, including takeaway services. Delivery services may continue after 10pm. Staff in hospitality and retail are also required to wear face coverings.
- From 28 September 2020 compliance with Covid-19 Secure requirements becomes a legal obligation for a range of leisure and entertainment venues, services provided in community centres and close contact services, with fines of up to £10,000 for repeated breaches.
- Also from the 28 September 2020 wedding and civil partnership ceremonies will be restricted to a maximum of 15 people (reduced from 30).
On 28 September 2020 the Health Protection (Coronavirus, Restrictions) (Self-Isolation)(England) Regulations 2020 came into force and had the effect of making it a legal requirement to self-isolate and introduces penalties for individuals and employers.
The Regulations require that anyone who tests positive for Covid-19 or has been officially notified by the NHS Test and Trace system that they have been in contact with someone who is, to self-isolate for a period of 10 or 14 days respectively. Self-isolating workers must notify employers that they are required to self-isolate as soon as reasonably practicable, as but no later than their next working day. Where employers are aware of the worker’s need to self-isolate they must not knowingly allow them to come into work.
Anyone who unreasonably fails to self-isolate can be fined anywhere between £1,000 to £10,000 for repeat offences or serious breaches. This also applies to employers who knowingly allow workers to come to work.
Also on 28 September 2020 the Health Protection (Coronavirus, Restrictions) (Obligations of Undertakings) (England) (Amendment) Regulations 2020 came into force and made the following changes:
- Pubs, cafes, restaurants and bars are required to take measures to prevent singing and dancing, except in limited circumstances such as couples dancing at their own wedding.
- Music above 85 A-weighted decibels at source should not be played with the exception of live music.
- Those responsible for running a business in an area where face coverings must legally be worn are required to display notices about the requirement to wear a face covering. Preventing or attempting to prevent persons from wearing face coverings is not permitted. Failure to comply with this measure can result in fines of up to £10,000.
- Fines imposed under different sets of regulations may be taken into account when assessing total numbers of fines imposed to date.
On 19 September the following countries were removed from the travel corridor exempt list, which means those arriving in England from these countries after 4am will be required to self-isolate:
On 26 September 2020, the following countries were removed from the travel corridor exempt list:
Revised Regulations in Wales to deal with Covid-19
On 14 September 2020 the Health Protection (Coronavirus, Restrictions)(No.2) (Wales) (Amendment)(No.9) Regulations came into force and had the effect of restricting all indoor gatherings of members of extended households to six people, not including children under the age of 11 years.
Indoor gatherings may not, without a “reasonable excuse”, consist of more than six members of an extended household (which can consist of up to four households). Reasonable excuse is limited to the following:
- Work or provide voluntary or charitable services;
- To obtain medical assistance;
- Access childcare, supervised activities for children and educational services;
- Enable an elite athlete to train or compete;
- Attend a marriage or civil partnership ceremony, or a funeral. There is a 30-person limit on such gatherings;
- Fulfil a legal obligation, including attending court or to participate in legal proceedings; and
- Exercise with others in a gym, swimming pool or other indoor leisure centre. Such gatherings must not exceed 30 people.
Also coming into force on the 14 September was the requirement for people to wear face coverings in relevant indoor premises, including indoor public areas or premises that have been allowed to reopen, indoor areas in bus stations, trains stations, airports and seaports. There are exceptions from this requirement for the following people:
- For children under the age of 11.
- Where the person is in a place that sells food and drink for consumption on those premises.
- Where there is a “reasonable excuse”, for example, if a person is unable to wear a face covering due to a medical condition, or is undertaking an activity where wearing a face covering may be a risk to health, or where the person removes a face covering to take medication.
On 24 September 2020 the Health Protection (Coronavirus Restrictions) (No.2) (Wales) (Amendments) (No.12) came into force and had the effect of restricting opening hours of premises licensed for the sale of alcohol for consumption on the premises and requires that customers on such premises must be seated and wear masks unless seated.
The Regulations provide that:
- In premises licensed for the sale of alcohol for consumption on the premises, food or drink may only be served to customers who are seated and customers must be seated when consuming the food or drink.
- Premises licensed for the sale of alcohol, whether for consumption on or off the premises, may not serve or supply alcohol after 10pm and may not serve or supply alcohol again before 6am the following morning. Licensed premises must close at or before 10:20pm.
- The exemption is removed in relation to the requirement to wear a face covering in applicable premises where food or drink is sold, replacing it with a reasonable excuse for customers not to wear a face covering while seated.
Throughout September the following counties were placed in local lockdowns by way of relevant Health Protection Regulations:
- Blaenau Gwent County Borough – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 11) (Blaenau Gwent, Bridgend, Merthyr Tydfil and Newport etc.) Regulations 2020;
- Bridgend County – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 11) (Blaenau Gwent, Bridgend, Merthyr Tydfil and Newport etc.) Regulations 2020;
- Caerphilly County – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 8) (Caerphilly) Regulations 2020;
- Cardiff County – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 14) (Cardiff and Swansea) Regulations 2020;
- Conwy County Borough – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales)(Amendment) (No. 16) (Conwy, Denbighshire, Flintshire and Wrexham) Regulations 2020;
- Denbighshire County – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales)(Amendment) (No. 16) (Conwy, Denbighshire, Flintshire and Wrexham) Regulations 2020;
- Flintshire County – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales)(Amendment) (No. 16) (Conwy, Denbighshire, Flintshire and Wrexham) Regulations 2020;
- Llanelli – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 13) (Llanelli etc.) Regulations 2020;
- Merthyr Tydfil County Borough – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 11) (Blaenau Gwent, Bridgend, Merthyr Tydfil and Newport etc.) Regulations 2020;
- Newport City – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 11) (Blaenau Gwent, Bridgend, Merthyr Tydfil and Newport etc.) Regulations 2020;
- Rhondda Cynon Taff – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 10) (Rhondda Cynon Taf) Regulations 2020;
- Swansea County – The Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 14) (Cardiff and Swansea) Regulations 2020;
- Torfaen County Borough Council – Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 15) (Neath Port Talbot, Torfaen and Vale of Glamorgan) Regulations 2020;
- Vale of Glamorgan – Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 15) (Neath Port Talbot, Torfaen and Vale of Glamorgan) Regulations 2020; and
- Neath Port Talbot – Health Protection (Coronavirus Restrictions) (No. 2) (Wales) (Amendment) (No. 15) (Neath Port Talbot, Torfaen and Vale of Glamorgan) Regulations 2020.
The local lockdowns consist of the following main restrictions:
- People are not allowed to enter or leave the defined county areas without a reasonable excuse;
- People are no longer able to form, or be in, an extended household or bubble;
- Indoor meetings with anyone not within your household is prohibited unless there is a good reason, such as to care for a vulnerable person;
- Licensed premises must stop serving alcohol at 10pm; and
- People who are able to work from home, must do so wherever possible.
Reasonable excuse includes going to work (where working from home is not possible), accessing public services not in the area, having medical treatment, and going to school.
The restrictions do not affect the ability to meet in a gathering of up to 30 people outdoors, however this is limited to those who live in the local area, and in line with social distancing guidelines. Visitors are also still permitted in gardens and may enter a household to reach the garden if necessary.
Those who are found to be in breach of the Regulations can be issued with fixed penalty notices or prosecuted and fined.
Local lockdown restrictions are to be reviewed every two weeks by the Welsh Government, increasing to every week if restrictions are required to stay in place longer than estimated.
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