Please find below the November 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
CMA accepts proposal from medical device supplier to resolve concerns
The Competition Markets Authority (“CMA”) has accepted a proposal from medical device suppliers Stryker Corporation and Wright Medical Group to resolve the CMA’s concerns regarding competition in the UK market.
Both suppliers manufacture orthopaedic products for patients requiring implants in their feet, ankles and hands. The CMA carried out a Phase 1 investigation earlier this year after they became concerned that a £4.2 billion merger between the companies would have a negative impact on vulnerable patients in the UK.
Following the investigation Stryker Corporation has now agreed to sell its global total ankle replacement product and assets to Colfax Corporation in order to satisfy the CMA that their divestment will address the competition concerns.
The merger has also been reviewed by the US Federal Trade Commission which has been working with the CMA and the CMA announced in August 2020 that it had agreed “to extend its consideration of an acceptable divestment package in order to align with the FTC’s timing and ensure that the divestment package would be acceptable in both UK and US jurisdictions.”
For more information please see the Government’s COVID-19 guidance and support.
To see the full CMA decision click here.
CMA launches consultation for draft new consumer law guidance in the IVF sector
The Competition and Markets Authority (“CMA”) has published consumer guidance in the IVF sector after they expressed concerns earlier this year about certain practices in IVF clinics including a lack of price transparency and misleading claims about success rates. The concern was raised that this would mean patients would be unable to compare clinics when seeking treatment. There was also concern that clinics were unaware of their obligations under consumer law.
The draft guidance, published on 3 November 2020, sets out what information must be provided to patients and when, as well as how clinics can ensure their terms of business and practices are fair in accordance with consumer law.
The CMA worked with the Human Fertilisation and Embryology Authority, and other organisations in the IVF sector in order to understand patients’ experiences and how clinics operate.
The consultation will be open for nine weeks closing on 5 January 2021. Once the final guidance has been issued the CMA will also continue to work within the IVF sector including conducting a compliance review and will consider enforcement action if any evidence is found that clinics’ practices or terms are unfair.
For more information please go to here.
To read the draft guidance please see here.
Government releases updated guidance for clinically extremely vulnerable people during COVID
On 4 November 2020, the Department of Health and Social Care released updated guidance for people who are deemed clinically extremely vulnerable as to how keep safe under the most recent COVID-19 restrictions in England, which came into force on 5 November 2020.
The updated guidance sets out the precautions those in the clinically extremely vulnerable group should take, in addition to the new measures. Those included in the clinically extremely vulnerable group include:
- Those with reduced immune systems (for examples due to organ transplants);
- Those with specific cancers, including people undergoing active chemotherapy, those with lung cancer undergoing radical radiotherapy, those with cancers of the blood and bone such as leukaemia and those having immunotherapy or other antibody treatments for cancer or other targeted cancer treatments that can affect the immune system; and
- Those with severe respiratory conditions such as cystic fibrosis.
Those with stage 5 chronic kidney disease and undergoing dialysis and adults with Down’s Syndrome are also being added to the shielding patient list.
For further information and a full clinically extremely vulnerable list please go to here.
Government launches consultation on ban of unhealthy food advertising online
The Department of Health and Social Care and the Department for Digital, Culture, Media and Sport have launched a consultation following proposals that there should be a total ban of online adverts that advertise foods that are high in fat, sugar and salt.
The aim of the proposals is to protect children from developing long-term, unhealthy eating habits and forms part of the Government’s strategy to tackle the obesity crisis and get people healthier.
The proposals are based on evidence that exposure to advertising of high fat, sugar and salt foods can affect children in terms of what and when they eat, both in the short and long-term.
The consultation will run for six weeks from 10 November 2020, and asks for views from industry stakeholders and the wider public.
For more information please go to here on the Government website.
View the Government’s wider obesity strategy here.
British Association of Social Workers launch Test, Safe Access, Promote Rights campaign
The British Association of Social Workers England (“BASW”), in partnership with BASW Cymru, have launched the Test, Safe Access, Promote Rights campaign seeking changes to national guidance that would “allow social workers to have regular and safe access to health and care settings and supported living, so that they may carry out their statutory duties on behalf of public bodies and protect the human rights of citizens in care.”
The campaign seeks to have social workers recognised as Professional Visitors in health and care settings by making changes to the Government and Public Health England guidance relating to visiting arrangements in care homes during times of national restrictions. The current guidance has placed blanket restrictions on visiting in care homes, which has resulted in social workers being denied access to people in those settings.
The campaign focuses on three key elements:
- Test – designation of social workers as Professional Visitors who are tested on a weekly basis and have a negative test result prior to visiting someone in a healthcare or supported living setting;
- Safe Access – Social workers to be given priority access to people living in health care and supported living settings through testing, rigorous infection control and access to PPE; and
- Promoting Rights – Safe access for social workers to health and care and supported living settings to ensure the promotion of rights, strengths and wellbeing of people, families and communities.
For further information about the BASW campaign please see here.
For the current Government guidance on visiting in care homes settings see here.
Ombudsman criticises local authority over treatment of dementia patient
The Local Government and Social Care Ombudsman (“the Ombudsman”) has criticised Hampshire County Council after it failed to meet an elderly dementia patient’s needs when his finances diminished.
The gentleman initially paid for the care he received at his home until spring 2019 when a relative informed the council that his capital had fallen below the £23,250 threshold. However the council failed to carry out a Care Act compliant assessment, as a result of which, the gentleman’s needs for help to maintain his home were not addressed, and he therefore had to pay for the support he required himself.
His needs increased in September 2019 and care workers were needed to spend longer periods with him; this should have triggered a review of his needs by social workers however this was not carried out until June 2020. It was only at this point that the council increased his budget for care and support.
An investigation was carried out by the Ombudsman which found that the council had failed to carry out a compliant assessment and delayed implementing a personal budget, as well as failing to review the gentleman’s needs and either failed to produce or retain a care and support plan for him. They therefore did not identify and meet his eligible need for help.
The council has subsequently agreed to the Ombudsman’s recommendations and pledged to make changes to the way in which assessments of needs are carried out in future. The council has agreed to backdate the gentleman’s personal budget to the date at which they were told his finances had fallen below the threshold, and will also backdate the amount of additional funding he needed. In addition, a payment of £200 in compensation will be made to him, and £250 to his relative for the time and trouble caused by having to make a complaint.
Please see this article in the Local Government Lawyer.
Supreme Court refuses to hear case of transgender man seeking be named as father on birth certificate
The Supreme Court has refused an application by a transgender man, Freddy McConnell, to consider a case that would allow him to be recognised as his child’s “father” or “parent” on the birth certificate.
Mr McConnell was able to biologically get pregnant and gave birth to his child in 2019 and was legally a man when his child was born. When attempting to register the birth he was told by the registrar that the law required that people who physically give birth to be registered as mothers, at which point he initially took legal action against the General Register Office.
He was unsuccessful in this action and appealed the case to the Court of Appeal, claiming that to make him register as his child’s mother on the birth certificate was a breach of his human rights, specifically in relation to privacy and family life, However he was unsuccessful on the basis that people who had given birth were legally mothers and that there was “a material difference between a persons’ gender and their status as a parent”. It was also held that the issue involved interlinked legislation and any legal reform in this area was a matter for Parliament.
The Supreme Court has subsequently refused to hear the challenge stating that his case did not raise “an arguable point of law” which “ought to be considered”.
Organ donation consent rates encouraging since introduction of Max and Keira’s Law
The Organ Donation (Deemed Consent) Act 2020 came into force on 20 May 2020, and introduced an “opt-out” organ donation scheme in England, following those already in place in Wales, Scotland and Jersey. The law considers that people in England are willing to donate organs unless they specifically opt-out of the scheme, are one of the excluded groups, or have told their family they do not wish to donate.
The figures published on 20 November 2020 by NHS Blood and Transplant, have been published to show the positive impact the law has had to date in helping to save lives through organ donation. The figures show that, as of 31 October 2020, 135 people have donated organs after being considered willing to donate as a result of having not opted out of the organ donation scheme, nor having expressed an organ donation decision during their life. These donations accounted for 26% of all donations during the same period.
Of all the families approached about organ donation between 20 May – 31 October, when the criteria for deemed consent applied, the consent rate (percentage of families giving their agreement for organ donation to go ahead) was 71%. In comparison, the consent rate was 91% for patients who had expressed their decision to donate and 52% for patients who had not expressed a decision and were in one of the excluded groups.
For more information please go to the NHS website.
For more information about Max and Keira’s Law please see Blake Morgan’s Healthcare update in May 2020.
Government to extend visas for thousands of healthcare workers free of charge
The Government has announced that visas for over 6,000 vital health professionals and their family dependants will have their visas extended free of charge for a year.
This will include the following:
- biological scientists;
- dental practitioners;
- health professionals;
- medical practitioners;
- medical radiographers;
- occupational therapists;
- social workers;
- speech and language therapists; and
- therapy professionals.
The visas have been extended in order to allow healthcare professionals to be able to continue working through the coronavirus pandemic. This follows the announcements earlier in the year that free visa extensions were being made available for professionals whose visas were due to expire between 31 March and 1 October 2020.
In order to benefit from the extension, an online form must be completed and employers must confirm the employee’s eligibility.
- Coronavirus (COVID-19): advice for UK visa applicants and temporary UK residents
- News story: Thousands more health workers to benefit from visa extensions
- Visa extensions and changes to the application process
COVID-19 related healthcare news
Revised Regulations in England to deal with COVID-19
The restrictions below were correct as of 30 November 2020.
On 5 November 2020 the Health Protection (Coronavirus, Restrictions)(England) (No.4) Regulations 2020 came into force and had the effect of imposing a 28 day lockdown in England, to prevent the spread of COVID-19.
These Regulations introduced social and business restrictions, and revoked the previous three-tier system in place which came into force on 14 October 2020.
The Regulations introduced to following social and movement restrictions:
- A household of one adult and one or more children under the age of 18 may link or “bubble” with another household. Neither household may link with another household except as a “childcare household” and may not have been linked with a another household between 14 September and 5 November 2020;
- A household which includes at least one child aged 13 or under may link with one other household to enable the provision of informal childcare.
- A person may not leave or be outside of a place where they are living, including a garden or outdoor space, without a reasonable excuse which are organised into 12 categories:
- Certain Purposes – this includes buying products from shops permitted to be open for personal use or for vulnerable persons; obtaining money from or depositing in a bank; exercising alone, with members of the household or linked household or as part of providing informal childcare; attending Remembrance Sunday commemoration events; undertaking activities in connections with the purchase, sale, letting or rental of residential property; visiting a linked household; collecting pre-ordered food, drinks and other goods from businesses permitted to take such orders; and visiting water disposal or recycling centres.
- Work, voluntary services, education and training – this includes leaving the home for work or providing voluntary or charitable services where these cannot be done from home; education or training; provision of care or assistance including to a vulnerable person; provide emergency assistance to any person; to fulfil a legal obligation, including attendance at court or satisfying bail conditions; to access critical public services including social services, services provided by the DWP, provided to victims including victims of crime, to attend asylum and immigration interviews; and to access services provided by voluntary or charitable services such as food banks.
- Training or competing as an elite athlete – an elite sports person, their coach or parent (if they are under 18 years) can leave the home to be outside to train or compete.
- Medical Needs – this includes to seek medical assistance, to take medical tests, be vaccinated, access dental, opticians or audiology services, chiropody, chiropractors, osteopaths and other medical health services (including mental health); to donate blood or attend medical trials; to avoid illness or injury or escape risk from harm; to attend a birth; and to visit a hospital, hospice or care home patient or accompany a member of a person’s household to a medical appointment.
- Support and respite – this includes to attend a meeting of a support group consisting of no more than 15 persons that does not take place in a private dwelling and at which physical presence is reasonably necessary; and to provide respite care for a vulnerable person with a disability or a short break in respect of a looked after child within the meaning of s22 of the Children Act 1989.
- Death bed visits – to visit someone that a person reasonably believes is dying if that person is a member of the household, a close family member or friend.
- Attending a funeral – to attend a funeral or memorial service restricted to no more than 30 people; and to visit a burial ground or garden to pay respects to a member of the household, close family member or friend.
- Attending a permitted marriage ceremony or civil partnership – to attend a permitted marriage ceremony, civil partnership or alternative wedding ceremony restricted to no more than 30 people.
- Children – this includes access to and contact between parents and children where the children do not live in the same household as their parents or one of their parents; arrangements for contact between siblings where they do not live in the same household; accessing educational facilities or accompanying a child to those facilities; and childcare, supervised activities for children or informal; childcare for under 13 years but only where necessary for the child’s parent to work, look for work or receive education or training.
- Animal Welfare – this includes to visit a vet for advice about a pet a person owns; and to care for or exercise a pet or other animal a person owns or cares for.
- Returning home from holiday – allows being outside the home in the course of returning from holiday taken immediately before the restrictions come into force.
- Making a prison visit – to visit close family member or friend in criminal justice accommodation.
The Regulations also introduced the following restrictions on indoor and outdoor gatherings:
- Indoor gatherings, including at home, of two or more people are prohibited unless an exception applies;
- Outdoor gatherings (including in a private garden) are prohibited unless an exception applies, however not more than two people can gather in a public outdoor space such as a park;
- Organising or facilitating a gathering of more than 30 people taking place in private dwellings, on vessels or in an outdoor public place are prohibited, except those gatherings organised by a business, charitable or public body;
- Organising or facilitating indoor “rave-type” gatherings of more than 30 people is not permitted.
The exceptions to these restrictions are largely the same as those listed above in relation to leaving the home.
The following businesses are required to close or restrict their activities:
- Businesses providing food or drink for consumption at their premises, including outdoor seating areas including cafes, restaurants, bars social clubs, pubs and workplace canteens, except those in hospitals, prisons and those serving the homeless;
- Entertainment venues such as cinemas, theatres, nightclubs, bingo halls, concert halls, funfairs, theme parks, zoos, safari parks etc;
- Betting and gaming venues;
- Health and beauty businesses including spas, nail and beauty salons, hair salons, tanning salons, massage parlours and tattoo and piercing parlours;
- Indoor sports and recreation venues such as skating rinks, dance studios, gyms, swimming pools, bowling alleys, amusement arcades, soft play areas and indoor leisure centres;
- Outdoor recreation venues including outdoor sports centres, shooting and archery venues, driving ranges, outdoor gyms and waterparks;
- Retail premises including outdoor markets, except those selling livestock or food, and showrooms including outdoor areas;
- Conference venues including conference centres, exhibitions, trade shows private dining and banquet halls;
- Shops and libraries unless expressly permitted to remain open, but can continue to make deliveries or allow collection of items ordered online or by phone, text or post. The businesses permitted to stay open are:
- Food retailers including food markets, supermarkets, corner shops and off-licences;
- Pharmacies, dental services and other medical or health services;
- Hardware stores, building merchants and garden centres;
- Petrol stations, car repair and MOT services, bicycle shops and vehicle hire businesses;
- Banks, building societies, credit unions, savings clubs, cash points, and exchange and transmit money offices;
- Vets and pets shops; and
- Drop off and collection points and storage and distribution facilities.
Holiday accommodation including hotels, bed and breakfasts, holiday homes, campsites and caravan parks, must also close but can remain open to provide accommodation to people such as those who cannot return to their main residence, those who require accommodation whilst moving house, attending a funeral, are self-isolating as required by law, engaged in elite sports, or for education and training purposes.
Individuals can receive a fixed penalty notice which would initially be for £200, reduced to £100 if paid within 14 days. If a person has already received a fixed penalty notice, under the Regulations or other listed COVID-19-related regulations, the penalty doubles on each repeat offence up to a maximum of £6,400. The fixed penalty for breaching the restrictions on businesses is initially £1,000, increasing for subsequent offences to a maximum of £10,000. The fixed penalty for organising a gathering offence is £10,000.
Revised Regulations in Wales to deal with COVID-19
The Health Protection (Coronavirus Restrictions) (No. 4) (Wales) Regulations 2020 came into force on 9 November 2020 following the end of the firebreak lockdown in Wales. These Regulations impose the following on a Wales-wide basis:
- Restrictions on meeting other people. An extended household can be formed with one other household (a “bubble”). Meeting away from people’s homes is limited to four people, not including children under 11, subject to certain exceptions. More than four people may gather if they are part of the same household. Certain organised activities involving up to 15 people indoors and 30 people outdoors are also exceptions to the rule of four.
- A prohibition on people entering and leaving Wales, subject to certain exceptions.
- Requirements on those testing positive for COVID-19 to remain in the place they are living until the end of the last day of their isolation.
- Licensed premises are prohibited from selling alcohol after 10pm.
- Certain businesses are to remain closed.
- Requirements on regulated premises to take steps to minimise the risk of exposure to COVID-19.
- Face coverings are mandatory on public transport, including taxis.
- The imposition of fines and/or enforcement action to ensure compliance with the Regulations.
See the full Regulations here.
Further amendments were also made to existing regulations dealing with isolation requirements to those arriving from certain countries and territories to Wales.
Guidance and information on the new Covid-19 restrictions in Wales can be found on the Welsh Government website here.
On 30 November 2020 the First Minister Mark Drakeford announced that a new set of Regulations will be coming into force from Friday 4 December 2020 which will have an effect on the hospitality sector including pubs, cafes and restaurants which will have to close at 6pm (after which they may operate a takeaway business only) and will not be allowed to serve alcohol.
Further information surrounding the new Regulations will be included in our December 2020 update.
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