Health Sector News – review of December 2020

Please find below the December 2020 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 the dedicated BM Insights section.

Readers may also be aware that the Welsh NHS Confederation also produces some very interesting articles and news items, which can be found here.

Other Healthcare related news

Psychedelic drug approved for clinical trial to treat depression

The Medicines and Healthcare products Regulatory Agency (“MHRA”) has approved an initial clinical trial to test the drug dimethyltriptamine (“DMT”) for the treatment of depression.

The drug, known for its hallucinogenic effects, will initially be trialled by being given to healthy individuals, and a second trial is then expected where DMT will be given in conjunction with psychotherapy. The trial is being run by the company Small Pharma together with Imperial College London. The initial trial is anticipated to begin in January, subject to the approval of the Home Office as DMT is a controlled drug. The trial will begin with 32 healthy volunteers who have never taken any form of psychedelic drug, before moving on to 36 volunteers who suffer with clinical depression.

For further information about the clinical trial please see here.

High Court permits legal challenge to closure of A&E department

The High Court has granted permission for a legal challenge over a decision to close the A&E department at Grantham and District Hospital, to be replaced with an urgent care centre until 31 March 2021.

The claimant, Jayne Dawson, has brought the challenge on the basis that the plans made by United Lincolnshire Hospitals NHS Trust to downgrade services at the hospital, including the closure of the A&E department, were made without appropriate public consultation or engagement. It is believed that the closure of the department will have an adverse effect on those who rely on the service provided at the hospital, as the nearest A&E department is now over twenty miles away, and that the Trust has acted unlawfully by not taking into consideration the needs of patients who need to use their local hospital and failing to involve them prior to making the decision.

The Trust’s other plans include to immediately implement proposals to convert the hospital to a “Green Site” in order to carry out planned cancer and urgent surgery in a Covid-safe environment.

The Trust has stated that the changes are temporary and have been made in response to a national health emergency:

“Unfortunately, the nature of emergency care means that we do not know the COVID status of the patients that we are seeing, and therefore admitting emergency patients to the hospital would compromise the green site status.

“Hence the requirement to cease medical admissions and make the move to temporarily change the A&E to an Urgent Treatment Centre (UTC) with no admissions. In addition, we do not have the level of diagnostics at Grantham to support separate blue and green diagnostic pathways or have them situated in such a way as to enable segregation of the different patient and staff groups. As a result we would not be able to support an A&E service with medical admissions.”

A hearing is expected to take place in January 2021.

For more information on the legal challenge please see here.

Landmark change to criteria for blood donation

On 14 December 2020 the Health Secretary Matt Hancock announced that homosexual men in long term relationships will be able to donate blood in England.  The press release from the UK government states that this change will also be implemented in each of the devolved administrations and will mean that the UK becomes one of the first countries in the world to adopt a more individualised risk-based approach to donor selection criteria.

The recommendations of the Advisory Committee for the Safety of Blood Tissues and Organs (“SaBTO”) are that donors who have had one sexual partner and who have been with their sexual partner for more than 3 months, will be eligible to donate regardless of their gender, the gender of their partner, or the type of sex they have.

In a further step being implemented under the new selection process, the press release confirms that all donors will complete the same donor health check prior to donation, regardless of gender or sexuality, recognising that all donors, including heterosexual men and women, have potential to carry infections.

The changes are expected to come into force in the summer of 2021.

For further information on blood donation please see here.

Local authority rules out judicial review over placement in Tier 3

Stratford-on-Avon District Council has made the decision to hold off on bringing a judicial review challenge they previously planned, over the decision to place the area into Tier 3 local COVID-19 restrictions.

The council had previously argued that none of the metrics for the district warranted it being placed in the highest tier, and that the decision appeared “arbitrary and irrational”. The area was particularly reliant on the hospitality industry, it added.

The decision to hold off on the challenge was made after the Government Legal Department (“GLD”) responded to the Council’s pre-action letter which stated that:

“The government stood by the original decision to assess areas at upper tier local authority level and the rationale for including the district in a wider cluster with Coventry and Solihull and the whole of Warwickshire” and “the decision had been taken on the grounds of the serious and imminent threat to public health, and to do so at a lower level would have ‘resulted in a ‘patchwork quilt’ which was confusing for the public and led to a lack of compliance.”

The Council stated that whilst it was not the response they were hoping for, they accepted the Government had to make a decision on the appropriate geography to make its assessment and that in their letter the Government shared new information with the Council of which they were not aware when the initial decision to bring a challenge was made.

Coroner makes landmark ruling in death of nine year old girl

Coroner Phillip Barlow has made legal history with his ruling that air pollution was a cause of the death of nine year old Ella Kissi-Debrah in February 2013.

In his ruling Mr Barlow stated that Ella’s death was caused by acute respiratory failure, severe asthma and exposure to air pollution, stating that she was exposed to “nitrogen dioxide and particulate matter (PM) pollution in excess of World Health Organization guidelines, the principal source of which were traffic emissions.”

He also stated the failure to reduce pollution levels in Lewisham, where she lived, to below legal limits possibly contributed to her death, as did the failure to provide her mother with information as to how air pollution exacerbates asthma.

He found that air pollution both induced and exacerbated Ella’s particular form of severe asthma.

The ruling is the first of its kind in the UK and is likely to increase pressure on the Government to reduce air pollution levels.

For further information on the ruling please see here.

Royal Pharmaceutical Society meet with Government to discuss medicine law changes

The Royal Pharmaceutical Society (“RPS”), along with GP and community pharmacy leaders, have met with the Department of Health and Social Care to discuss changes they feel are required to the law surrounding prescriptions.

RPS want medicines legislation changed to allow pharmacists to make small changes to prescriptions when a particular medicine is out of stock without the need for the patient to go back to the original prescriber. This would mean allowing pharmacists to amend prescriptions to provide a different quantity, strength, formulation or generic version of the same drug. This practice is already  common in hospital and general practice and such a legislative change would not involve a change of the patient’s treatment.

For more information on the RPS meeting please see here.

COVID-19 vaccines approved and begin roll-out in the UK

Both the Pfizer/BioNTech and Oxford Astra-Zeneca vaccines have been judged as safe and approved for use in the UK in the fight against COVID-19 under Regulation 174 Human Medicines Regulations 2012.

The Pfizer vaccine was the first to receive approval at the beginning of December 2020 and the first dose was administered to Margaret Keenan, 91 at Coventry University Hospital. She has since become the first person in the world to receive the vaccine’s required second dose.

The UK regulator Medicines and Healthcare products Regulatory Authority (“MHRA”) has stated the Pfizer vaccine offers up to 95% protection from COVID-19. The vaccine, at present, requires an initial injection which offers up to 75% protection, with a booster to be administered to offer the higher protection. There are some logistical issues with being able to administer the vaccine in more local settings as it needs to be stored at -70 degrees celcius in order to be effective

The Oxford Astra-Zeneca vaccine was approved for use in the UK on 30 December 2020 with the first dose given to 82 year old Brian Pinker, at Churchill Hospital, Oxford on 4 January 2021. Like the Pfizer vaccine, the Oxford vaccine also requires two doses, offering between 70-90% protection (where the doses are perfected) and has been shown to provide a strong immune response in older people.

Unlike the Pfizer vaccine however, this is easier to distribute as it does need to be stored in such cold temperatures.

There are also several other vaccines still undergoing trial and development including Moderna, Sputnik V and Jassens vaccines.

As a result of the roll-out of the approved vaccines the Government has, based on the recommendations of the Joint Committee on Vaccination and Immunisation,  published a priority list, setting out who will be receiving the vaccine first:

1. residents in a care home for older adults and their carers
2. all those 80 years of age and over and frontline health and social care workers
3. all those 75 years of age and over
4. all those 70 years of age and over and clinically extremely vulnerable individuals
5. all those 65 years of age and over
6. all individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality
7. all those 60 years of age and over
8. all those 55 years of age and over
9. all those 50 years of age and over

Read more on the Joint Committee on Vaccination and Immunisation: advice on priority groups for COVID-19 vaccination, 30 December 2020 here and news on the Pfizer/BioNTech vaccine being judged safe for use in UK here.

COVID-19 related healthcare news

Revised Regulations in England to deal with COVID-19

The restrictions below were correct as of 31 December 2020.

On 2 December 2020 the Health Protection (Coronavirus, Restrictions) (Local Authority Enforcement Powers and Amendment) (England) Regulations 2020 (SI 2020/1375) (Enforcement Regulations) came into force.

The Regulations create additional enforcement tools for local authorities to deal with COVID-19 in relation to business premises and are made under Part 2A of the Public Health (Control of Disease) Act 1984.

The Regulations introduces the following, which can be imposed by local authorities:

• Coronavirus Improvement Notices (CIN);
• Coronavirus Immediate Restriction Notices (CIRN); and
• Coronavirus Restriction Notices (CRN).

A local authority designated officer may issue a CIN where they are of the opinion that:

• There has been a contravention of one or more of the relevant statutory provisions.
• The requirement(s) of the CIN are necessary and proportionate to ensure that the contravention(s) are ended or remedied.

A CIN may not be issued in relation to premises which form part of “essential infrastructure”.

A local authority designated officer may issue a CIRN where they are of the opinion that there has been a contravention of one or more of the relevant statutory provisions in circumstances that make it likely that the contravention(s) will continue or be repeated and that contravention(s) involves or would involve a risk of exposure to COVID-19. Any requirement(s) of a CIRN must be necessary and proportionate for the purpose of minimising the risk of exposure to COVID-19.

It is not possible to issue a CIRN in relation to premises which form part of “essential infrastructure”. CIRNs are intended for use where rapid action is required to close premises without issuing a CIN first.

A CIRN must require either or both of the following:

• The closure of the premises, or part of the premises.
• That the CIRN recipient must end or remedy the contravention or, as the case may be, that that person must ensure that the contravention will not be repeated or continued (or both).

Any requirement set out in a CIRN will take effect at the end of a period specified in the notice, or if no such period is specified, will take effect immediately

A CIRN will have effect for 48 hours.

A local authority designated officer may issue a CRN where a person has been issued with a CIN but they have failed to comply with the notice and the non-compliance involves a risk of exposure to coronavirus.

It is not possible to issue a CRN in relation to premises which form part of “essential infrastructure”.

A CRN must require either or both of the following:

• The closure of the premises, or part of the premises.
• That the CRN recipient must end or remedy the contravention specified in the CIN.

Any requirement in a CRN must be necessary and proportionate for the purpose of minimising the risk of exposure to COVID-19.

Any requirement set out in a CRN will take effect at the end of a period specified in the notice, or if no such period is specified, will take effect immediately.

A CRN will have effect for seven days from the day that it was issued.

On 20 December 2020, the Health Protection (Coronavirus, Restrictions) (All Tiers and Obligations of Undertakings) (England) (Amendment) Regulations 2020 (SI 2020/1611) (Amending Regulations) came into force.

The main effect of the Amending Regulations is the introduction of an additional tier of more severe restrictions (Tier 4), where the previous Restrictions introduced a 3 tier system of local restrictions.

The Regulations have the effect of:

• All 32 London boroughs and the City of London and some local authority areas in the east and south east of England have been moved from Tier 3 to Tier 4. The implications for businesses and venues in Tier 4 are that:
• A wide range of shops and venues must close, including non-essential retail shops, community centres, libraries, entertainment venues, leisure venues, businesses providing personal care services (like hairdressers and nail bars) and holiday accommodation. There are limited exceptions to when these venues can stay open.
• Hospitality businesses are restricted to delivery, click and collect, drive through and takeaway services only. There are exceptions for certain venues to provide table service, like a workplace or school canteen.
• Essential retail shops like food retailers, pharmacies, banks and post offices can remain open.

The Amending Regulations also impose requirements on businesses in Tiers 3 and 4 to take account of the gathering restrictions in their tier when accepting bookings or admitting people into their premises.

The Amending Regulations also include:

• A general “stay at home” message for Tier 4 (including a legal requirement to work from home where possible);
• A general prohibition on Christmas gathering arrangements for all tiers and rules on gatherings (including for weddings and funerals) for Tier 4.

The Amending Regulations must be reviewed by the Secretary of State at least every 28 days and the allocation of areas into Tiers 2, 3 and 4 must be reviewed every 14 days. The All Tiers Regulations cease to have effect on 2 February 2021 when they will expire.

The Health Protection (Coronavirus, Restrictions) (All Tiers) (England) (Amendment) (No. 4) Regulations 2020 came into force on 31 December 2020.

These Regulations amend Schedule 4 to the Health Protection (Coronavirus, Restrictions) (All Tiers) (England) Regulations 2020 so as to make changes to the areas that are subject to Tier 1, Tier 2, Tier 3 and Tier 4 restrictions for the purposes of those Regulations and also make minor amendments correcting errors in those Regulations.

Revised Regulations in Wales to deal with COVID-19

The restrictions below were correct as of 31 December 2020.

On 4 December 2020, the Health Protection (Coronavirus Restrictions and Functions of Local Authorities) (Amendment) (Wales) Regulations (SI 2020/1409) (Regulations) came into force.

The Regulation have the effect of the following:

• Funfairs, amusement and theme parks, museums, galleries and visitor centres may open if not indoors.
• Indoor entertainment premises, venues and visitor attractions including bingo halls, bowling alleys, amusement arcades and indoor play areas, casinos, cinemas and skating rinks must close, save that they can carry out remote sales.
• Bars, cafes, canteens, restaurants and pubs must be closed to customers between 6.00 pm and 6.00 am. There are exceptions including in relation to workplace canteens, educational establishments, holiday or travel accommodation and for wedding or civil partnership receptions booked before the Regulations came into force. Off-premises sales outside these hours are still permitted.
• Alcohol may not be sold for consumption in, and may not be consumed in, bars, cafes, canteens, restaurants and public houses. There are exceptions relating to in-room consumption by residents in holiday or travel accommodation. Alcohol may not be sold anywhere between 10.00 pm and 6.00 am.
• Shops and certain other premises open to the general public must take specified measures to reduce the risk of the spread of COVID-19, including requiring two-metre social distancing, re-organising internal lay-outs and requiring customers to remain seated while consuming food and drink.

The Regulations also provide for the Health Protection (Coronavirus Restrictions) (Functions of Local Authorities etc) (Wales) Regulations 2020 (SI 2020/1011) to expire on 19 February 2020 instead of 8 January 2020, to align with the expiry date of the (No. 4) Regulations 2020 and require a local authority, when deciding whether to give an event direction, to have regard to whether the event may result in the contravention of Regulation 6 of the No. 4 Regulations by allowing there to be more than 15 people in attendance (if the event is held indoors) or 30 people (if held outdoors).

On 14 December 2020, the Health Protection (Coronavirus Restrictions) (No 4) (Wales) (Amendment) Regulations 2020 (SI 2020/1522) (Regulations) came into force. The Regulations amend the Health Protection (Coronavirus Restrictions) (No 4) (Wales) Regulations 2020 (SI 2020/1219) (Principal Regulations) and have the following effects:

• Requirement that all cinemas, funfairs, amusement parks, theme parks, museums, galleries and visitor attractions to be closed, whether indoors or outdoors.
• Clarifies that trampoline parks and centres and indoor skate parks and centres must be closed.
• Despite the requirements on certain business premises to be closed, allow drive-in cinemas and theatres to open subject to the requirement in the Principal Regulations for all reasonable measures to be taken on business premises to minimise the risk of exposure to COVID-19.

On 20 December 2020, the Health Protection (Coronavirus Restrictions) (No 5) (Wales) Regulations 2020 (SI 2020/1609) (as amended by the Health Protection (Coronavirus Restrictions) (No 5) (Wales) (Amendment) Regulations 2020 (SI 2020/1610)) (Regulations) came into force.

The Regulations have the following effects:

• Introduction of a new system of four alert levels in Wales with areas in Alert Level 4 being subject to the strictest restrictions.
• Imposition of restrictions on gatherings and the movement of people as well as on the operation of businesses at all alert levels.
• As of 20 December 2020 the whole of Wales is designated as Alert Level 4, where there are strict limitations on gatherings and travel in and out of Wales and most premises are required to close.
• There is also a general requirement to stay at home unless a specified exemption applies.
• The previous relaxation of restrictions for a five day period over Christmas is rescinded. Instead two households are allowed to mix on Christmas day only, with Alert level 4 restrictions resuming on 26 December 2020.

The Regulations also set out the Alert Level 4 restrictions on the following businesses:

• All non-essential retail must close, with a list of exceptions, including: bike shops, hardware shops, shops selling building supplies and equipment, plant and tool hire, newsagents, off-licences and licenced shops selling alcohol, laundrettes and dry cleaners and post offices.
• Providers of funeral services such as funeral directors and funeral homes conducting funerals may remain open, subject to guidelines.
• Restaurants, bars and public houses, including within hotels and members’ clubs, cafes and canteens must remain closed but food delivery and takeaway can continue and businesses which only provided food for consumption on their premises can now provide takeaway food as a new activity supported by a new permitted development right.
• Hotels, hostels, B&Bs, campsites and boarding houses for commercial use as well as camp sites and parks for commercial use must remain closed, with limited exceptions.
• Community centres, youth centres and similar must remain closed unless providing essential voluntary services.
• Premises for assembly and leisure, such as libraries and museums, must remain closed as must most premises for recreation, including swimming pools, indoor fitness studios, gyms, spas or other indoor leisure centres or facilities.

The restrictions will expire on 31 March 2021, but will be reviewed on 7 January 2021, with further specified periods of review thereafter.

This newsletter has been co-prepared by Joanne Thompson and Rachael Thomas.