Health Sector News – review of October 2020
Please find below the October 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 visiting our 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.
COVID-19 related healthcare news
Other Health and Social Care News
In our September briefing we discussed the UK Government’s plans to introduce emergency approval for COVID-19 vaccines. If you would like a more detailed discussion of the consultation process and the legislation please read the following articles, authored by solicitor Gemma Casey, who specialises in professional regulatory, health and safety and business regulatory and compliance:
CMA rules care home provider broke the law for charging additional fees
The Competition and Markets Authority (“CMA”) has ruled that provider Care UK broke consumer protection law and NHS rules after charging users an “unfair additional fee towards essential care”.
In evidence the CMA submitted a sample of an agreement the provider asked some residents of one of their premium care homes to sign. In this agreement the provider stated that NHS Clinical Commissioning Group funding was insufficient to cover the additional costs of the available room at the home (which offered enhanced facilities compared to their standard homes), and under normal circumstances that person would not be admitted. However they would be admitted if they agreed to pay the “shortfall”.
In their ruling, the CMA stated that requiring someone to pay a shortfall fee as a condition of providing continuing healthcare (“CHC”) was contrary to the Enterprise Act 2002, the National Framework for Continuing Healthcare and the NHS-funded Nursing Care framework.
The framework states that NHS funding should always cover assessed health and social care needs and purchasing additional services should be voluntary and care home providers should not make the private purchase of these services a condition of receiving NHS-funded provision. Examples of additional privately funded provisions include hairdressing, beauty treatments and entertainment.
Care UK said the additional fee included “spacious ensuite rooms, on-site facilities such as cafes and cinemas, a wide range of lifestyle activities and a premium dining experience”, and went on to say that residents always had a choice of a more modest, fully-funded home as an alternative and the CMA’s ruling to stop them “offering families an option of placing their loved ones in a premium home by making personal contributions in addition to NHS funding is a backwards step in terms of consumer choice”.
Following the ruling Care UK will pay more than £1 million in refunds and compensation to more than 160 residents at over 20 premium homes by the end of November 2020. They have also signed an agreement to cease charging the additional fee altogether, however Care UK disagree that they have breached any rules.
For further information please see here.
Government announces Immigration Health Surcharge reimbursement criteria
On 1 October 2020 the UK Government launched guidance as to who is eligible for reimbursement of the Immigration Health Surcharge (“IHS”).
In May 2020, it was announced that the IHS, which was first introduced in 2015 designed to raise income for the UK Government’s devolved health administrations, was to exempt health and care workers from 4 August 2020, with exemptions being able to be backdated to 31 March 2020.
The exemption applies to any non-EEA nationals applying for a health and care visa to work in a health or social care setting in an eligible occupation. Additionally those individuals who enter the UK on a different visa but go on to meet the eligibility criteria, will be reimbursed for any IHS they have already paid in respect of any 6 month period from 31 March 2020 where they were working in a relevant health or social care context. It will also apply to EEA nationals following the end on free movement on 1 January 2020, and extends to eligible family members.
The guidance released applies to those who are eligible for reimbursement as a result of entering the country on a different visa to the health and care visa. The intention behind the guidance is to provide support to potential applicants and sets out a review process should an applicant disagree with a reimbursement decision.
In summary:
- Anyone holding a relevant visa (such as a dependant of a UK national, a Tier 4 student visa, or someone on Tier 5 mobility scheme) who has worked in health and social care continuously for at least 6 months commencing on or after 31 March 2020 and has paid IHS may be eligible for reimbursement.
- Applicants must have paid IHS for the period covered by their claim.
- Applicants will need to apply for reimbursements on a 6-monthly basis when they have worked for an average of at least 16 hours per week over the full 6 months.
- Any period of work completed before the 31 March 2020 cannot be claimed for.
- An applicant is entitled to reimbursement so long as they are not on a Tier 2 (General) visa.
- Applicants must provide the evidence required to demonstrate they have completed the eligible hours (average 16 hours per week calculated over 6 month period) of eligible work.
- Eligible work is defined as providing a service which is related to the delivery of health or social care or where the applicant is employed or engaged to do work by:
- A recognised health or care provider such as a NHS Trust;
- An employer who is registered with an appropriate health or social care services regulator such as care homes registered with the Care Quality Commission, or a pharmacy regulated by the General Pharmaceutical Council; and
- An employer delivering services that directly support health and social care services such as facilities management services within a hospital, as long as the work takes place in a health or social care setting.
- Dependants of an applicant who have also paid IHS will also be able to claim reimbursement including a husband, wife or partner; a child under 18 years of age; and a child over 18 years of age if they are living in the UK as a dependant.
- Required evidence can include:
- The applicant’s IHS number (and those of any dependants);
- Payslips covering the 6 month period of the claim which should include the name of the employer, their job role and the number of hours worked during the period;
- Details of dependants also being claimed for; and
- A supporting letter from the employer outlining the sector of work and the applicant’s role.
For more information and to read the full guidance please go to the Immigration health surcharge: guidance for reimbursement 2020.
CMA to investigate supply of bi-polar drug
The Competition and Markets Authority (“CMA”) has launched an investigation into suspected anti-competitive practices in the supply of a drug used to treat bi-polar disorder.
The investigation centres around whether pharmaceutical company Essential Pharma has abused a dominant market position in relation to medicines for treating bi-polar disorder sold under the brand names “Priadel” and “Camcolit”. The company is proposing to withdraw Priadel from supply to UK patients which would result in thousands of patients having to switch to an alternative, being the more expensive drug Camcolit.
The proposal has prompted concern from medical bodies and charities who have said that switching medication can be a difficult process for patients and can lead to heart complications, as well as the concern over the significantly increased costs.
The CMA has been asked to impose interim measures using section 35 of the Competition Act 1998 to pause the withdrawal of Priadel by the Department of Health and Social Care, while the investigation is ongoing. Since the investigation has been opened, Essential Pharma has stated that it will continue to supply the drug to facilitate discussions on pricing.
The investigation is ongoing and a decision has not yet been made.
For further information please see here.
Coronavirus Act 2020 provisions that weaken Mental Health Act to be dropped following Law Society recommendation
The Government has confirmed that provisions known as “easements” contained in the Coronavirus Act 2020 which were seen as weakening the Mental Health Act 1983 (“MHA”) will be removed.
The easements in question would have:
- Allowed for an application to detain a person under sections 2 or 3 of the MHA to be based on the recommendation of one doctor rather than two, in a situation where seeking a second recommendation was “impractical or would involve undesirable delay”; and
- Allowed provisions to extend time limits under the MHA:
- doctors and nurses to detains patients already in hospital from 72 to 120 hours and from 6 to 12 hours; and
- police to detain a person in a place of safety from 24 to 36 hours.
In September 2020 the Law Society published their report “Law under lockdown; the impact of COVID-19 measures on access to justice and vulnerable people”. The report sets out a number of concerns and recommendations surrounding various provisions contained within the Coronavirus Act 2020 and their impact in relation to vulnerable people and their access to justice including in mental health settings, those detained in prison, and those in immigration detention centres.
For the full Law Society report please see here.
COVID-19 Clinical Negligence Protocol 2020 (England)
Action against Medical Accidents (“AvMA”) has published the Clinical Negligence protocol which came into effect on 14 August 2020 and has been signed by NHS Resolution, the Society of Clinical Injury Lawyers, and AvMA.
The protocol has been modelled on the best practice approach to litigation agreed between the Association of Personal Injury Lawyers and the Forum of Insurance Lawyers, and agreed by the Association of British Insurers as well as other signatories, as a result of the difficulties that have arisen due to the coronavirus pandemic.
Difficulties have arisen as clinical negligence claims rely on evidence provided by medical experts in order identify to breach of duty and causation, as well as determine to quantum issues. Due to the pandemic many medical experts have been called to the frontline creating a shortage of available experts from whom both claimant and defendant solicitors can commission reports. In addition, in both the NHS and private sector, in many cases internal investigations into complaints or incident reports have been suspended, with NHS Resolution stating in May 2020 that “as a matter of principle they will not be approaching front line or redeployed staff where it could disrupt patient care or have an adverse impact on staff”.
The protocol provides for the suspension of any unexpired limitation period in all clinical negligence cases until 3 months after the end of the protocol (with proper notice) and is intended to encourage “positive behaviours” from both claimant and defendant lawyers and organisations and to provide consistency of practice in England. It is also hoped that the protocol will reduce costs spent on issuing proceedings and applications to extend or stay proceedings.
The protocol is not mandatory and signatories may give notice of their intention to leave the scheme by way of notice to the rest of the membership and will remain bound by the protocol for a period of four weeks after notice has been given.
To read AvMA’s statement please see here.
The full COVID-19 Clinical Negligence Protocol 2020 can be found here.
Appeal to European Court of Human Rights in relation to “buffer zone” around abortion clinic
Two individuals have appealed to the European Court of Human Rights following the imposition of a Public Spaces Protection Order (“PSPO”) around an abortion clinic in Ealing, London.
The PSPO was introduced by the London Borough of Ealing in April 2018 and prohibits protests, prayer vigils, and ‘pavement counselling’ outside the Marie Stopes clinic. The claimants previously lost their claim at the Court of Appeal (Dulgheriu v LB of Ealing [2019] EWCA Civ 1490) and were refused permission to appeal to the Supreme Court.
The claimants allege that the PSPO constitutes an unlawful interference with their rights under Articles 9, 10 and 11 of the European Convention on Human Rights (freedom of thought conscience and religion, freedom of expression and freedom of assembly and association respectively).
For further information see this Court of Appeal judgment.
DBS checks during COVID-19 – additional guidance published
The Disclosure and Barring Service (“DBS”) has published additional guidance in relation to enhanced DBS checks and emergency checks of the Barred Lists which were introduced as a result of the current pandemic.
The new legislation introduced in the Coronavirus Act 2020 in March 2020, allows an organisation to apply for a free-of-charge DBS check and fast-track emergency Barred List checks in specific circumstances where employees or volunteers are needed to help with the response to COVID-19. The fast-track service first became available on 30 March 2020.
The service is only available where the role would normally meet the eligibility criteria for an enhanced DBS certificate with a check of the Barred List. These circumstances are:
- Any health or social care professional who is registered, or is registering temporarily, to assist with the delivery of treatment or care in an emergency, involving the loss of human life or human illness. This includes a nurse, nurse associate, midwife, medical practitioner, social worker, pharmacist and pharmacy technician; and
- The appointment of staff to provide a health or social care service in connection with or as a consequence of care or treatment of a person who has, or is suspected to have, COVID-19. This relates to staff appointed to additional positions required to maintain healthcare or social care services, such as extra ambulance drivers, additional cleaners and additional staff in Nightingale hospitals.
The intention of the legislation is to focus on providing a pathway for essential workers to get the checks they need so they can commence work as quickly as possible; it does not cover roles in education, leisure or commercial sectors.
To read the full guidance please see here.
Legal challenge brought by woman with Down’s Syndrome over abortion law
A woman with Down’s syndrome, Heidi Crowter, has mounted a legal challenge in the High Court in relation to current abortion law which she claims in discriminatory.
The current law contained within the Abortion Act 1967 (as amended by the Human Fertilisation and Embryology Act 1990) allows for the legal termination of a pregnancy up to full-term in certain circumstances, including where the foetus has Down’s syndrome, where:
- it is performed by a registered medical practitioner;
- it is authorised by two doctors; and
- those acting are acting in good faith.
In contrast, the usual legal limit for termination is 24 weeks gestation.
Ms Crowter has launched the judicial review in conjunction with Marie Lea-Wilson, whose son has Down’s Syndrome, on the grounds of “unfair treatment” against disabled people.
The case is expected to go to trial early next year. See more information read the Telegraph article.
Revised Regulations in England to deal with COVID-19
The restrictions below were correct as of 31 October 2020.
On 14 October 2020:
- the Health Protection (Coronavirus, Local COVID-19 Alert Level)(Medium)(England) Regulations 2020;
- the Health Protection (Coronavirus, Local COVID-19 Alert Level)(High)(England) Regulations 2020; and
- the Health Protection (Coronavirus, Local COVID-19 Alert Level)(Very High)(England) Regulations 2020
came into force and had the effect of imposing a 3 tier system of restrictions at local level in England in an attempt to contain the spread of coronavirus.
The Regulations will apply until the end of a 28 day period starting on 12 October 2020 unless extended via a resolution by both Houses of Parliament. In any event they will expire after six months from coming into force and must be reviewed every 28 days with the first review being no later than 11 November 2020.
The regulations each set out restrictions at the three alert levels of medium, high and very high, and revoke previous measures in those areas containing similar restrictions, giving legislative effect to the three tier alert level (Local Alert Level). They impose different levels of restrictions by geographical area.
Those determined to be at Local Alert Area Medium (Tier 1) are subject to “current national measures” consisting of existing national measures and represents the minimum level of restrictions in place across England. All geographical areas are automatically designated to be at Medium Level unless specifically designated otherwise.
The restrictions contained in Local Alert Level Medium include:
- The prohibition of gathering of groups of more than six individuals unless everyone is from the same household or an exemption applies. Exemptions includes:
- A household where there is only one adult in the home and one other household of any size to link together to form a support bubble;
- A gathering which is reasonably necessary for work or voluntary purposes, education and training, formal childcare or supervision, providing care to a vulnerable person and support groups; and
- Some specific life events such as wedding ceremonies and receptions with a 15 person limit, and funerals with a 30 person limit.
- Requirement of the closure of all hospitality and leisure venues including takeaways from 10pm to 5am and table service is mandatory in all venues;
- Requirement that nightclubs, dance halls. Discotheques, sexual entertainment venues, hostess bars and any other venue open at night, has a dance floor and provides music whether live or recorded, are closed.
In respect of enforcement and fines the Regulations create offices punishable by fines and provide for fixed penalty notices. In addition:
- A constable, Police community support officer or a person designated by a local authority can enforce the Regulations;
- Business restriction offences are punishable by a first fixed penalty of £1000 increasing to £2000 form a second repeat office, increasing for each further repeat office to a maximum of £10,000.
Those determined to be at Local Alert Area High (Tier 2) are subject to further restrictions than those in Local Area Level Medium which serve to further restrict social contact and primarily target household-to-household transmission.
The restrictions contained in Local Alert Level High include:
- All meetings in outdoor public spaces, outside COVID-secure retail and hospitality venues and outdoor private dwellings (gardens) are to be limited to six people;
- All meetings in indoor COVID-secure retail and hospitality venues and indoor private dwelling must be limited to one household, unless exemptions apply; and
- A person living in an area designated Alert Level High must limit their meeting in indoor COVID-secure retail and hospitality venues and indoor private dwellings to one household.
The exemptions as set out in Alert Level Medium areas still apply.
The Regulations also require the following business restrictions and closures:
- Closure of all hospitality and leisure venues, including takeaways, from 10pm to 5am and table service in such venues is mandatory; and
- Complete closure to the general public of all nightclubs, dancehalls discotheques etc.
The enforcement and offices contained in the Regulations remain broadly the same as contained in the Alert Level Medium areas.
Those determined to be at Local Alert Area (Very High) (Tier 3) are subject to further restrictions that those in Medium and High areas, comprising stricter restrictions on social contact and businesses and venues.
The restrictions contained in Local Alert Very High include:
- Meetings in indoor venues and private gardens must be limited to a single household unless exemptions apply;,
- Meetings at outdoor venues must be limited to a single household unless certain exemptions apply and unless the setting meets certain conditions where groups of six can continue to meet. These include:
- That a place is a public outdoor place but no entry fee is charged;
- an outdoor sports ground or sports facility;
- botanical gardens; and
- gardens or grounds of a castle stately home or historic house.
- The exemptions to the stricter gathering limits include:
- A single-adult household and one other household to form a support bubble;
- A household with at least one child aged 13 or under may link with another household for the purpose of providing childcare;
- Where a gathering is reasonably necessary for work or voluntary purposes or to provide care to a vulnerable person;
- Certain specific life events may take places such as weddings subject to 15 person limit and funerals subject to a 30 person limit. Wedding receptions will not be permitted as they involve more social interaction.
The Regulations require businesses and venues to follow the restrictions imposed at Local Alert Levels Medium and High and impose the following additional restrictions:
- Hospitality venues that serve alcohol for consumption on the premises must close unless the alcohol is served alongside a main course meal
- Respective local authorities may decide that more stringent measures are necessary.
- Certain areas have required the closure of casino, indoor gyms, fitness and dance studios and other sports facilities; betting shops and adult gaming centres.
- There are exemptions for elite sport and dance and supervised activities for children and disabled sport.
The enforcement and offices contained in the Regulations remain broadly the same as contained in the Alert Level Medium areas.
On 31 October 2020 the Prime Minister Boris Johnson announced that England is to go into a second national lockdown in an effort to prevent a “medical and moral disaster” for the NHS. The lockdown begins on Thursday 5 November 2020.
The Health Protection (Coronavirus, Restrictions) (England) (No.4) Regulations 2020 will come into force on 5 November 2020 and have the effect of:
- All non-essential businesses including pubs, restaurants gyms and non-essential shops are to close for 4 weeks from 5 November 2020 (takeaways and click and collect shopping can remain open);
- Schools, colleges and universities can remain open;
- People are to stay at home unless they have a reasonable excuse:
- To leave including work (where work cannot be done at home);
- Education;
- To buy goods or services from essential businesses or services that remain open for those in the same household, vulnerable persons or persons in the same household with a vulnerable person;
- To obtain money from or deposit money;
- Exercise alone, with one or more members of their household or a linked household or in a public outdoor place with one other person who is not a member of their household or their linked household;
- To visit a public outdoor place for the purpose of outdoor recreation alone, with one or more members of their household or a linked household or in a public outdoor place with one other person who is not a member of their household or their linked household;
- To attend a place of worship;
- To attend an event commemorating Remembrance Sunday;
- To undertake the following in connection with the purchase, sale, letting or rental of a residential property: visiting estate or letting agents, developer sales offices or show homes; viewing residential properties to look for property to buy or rent; preparing a residential property to move in; moving house; and visiting a residential property to undertake activities required for the rental or sale of that property;
- To visit a member of a household which is a linked household;
- To collect food, drink or other goods which have been ordered from a business to access goods and services which are provided as permitted by the Regulations;
- To visit a waste disposal or recycling centre;
- For medical reasons including to seek medical assistance; to donate blood or attend medical trials; to attend a person giving birth; and to seek medical assistance or avoid injury or illness.
- For food and other essential shopping;
- Providing care for a vulnerable person;
- To attend a funeral or commemorative event celebrating the life of a person who has died;
- To attend marriage ceremony, civil partnership or alternative wedding ceremony.
- Meetings indoors or in private gardens is prohibited;
- Construction sites and manufacturing workplaces can remain open;
- People are still allowed to form support bubbles;
- Children can move between homes if their parents are separated; and
- Shielding will not resume but the clinically vulnerable are asked to be “especially careful”.
After 2 December 2020 the restrictions will be eased and regions will return to a tiered system.
Revised Regulations in Wales to deal with COVID-19
The restrictions below were correct as of 31 October 2020.
On 3 October 2020 the Health Protection (Coronavirus Restrictions) (No 2) (Wales) (Amendments) (No 17) Regulations 2020 came into force and had the effect of allowing a household comprised of no more than one adult and another household to form an extended household temporarily. The household formed may be formed whether or not it had previously formed an extended household before its area became a local health protection area.
The Regulations also permitted skating rinks to open, but only if measures were taken to minimise the risk of exposure to coronavirus on the premises in accordance with regulation 12 of the Principal Regulations.
On 21 October 2020 the Health Protection (Coronavirus Restrictions) (No 3) (Wales) Regulations 2020 came into force and implementing “firebreak” measures in Wales that will apply from 6pm 23 October 2020 to 8 November 2020 (known as the firebreak period):
- Non-essential businesses and venues in Wales to close including:
- Retail business such as shopping centres, arcades, homeware stores, car dealerships and garden centres;
- Business premises that sell food and drink such as restaurants, cafes and pubs that do not offer take-away options;
- Close contact services such as hairdressers, nail and beauty salons, tattoo parlours and tanning salons;
- Entertainment venues such as cinemas, theatres, nightclubs, dancehalls, casinos or other venues where live or recorded music is provided to members of the public;
- Sporting and leisure venues such as indoor gyms, skating rinks, swimming pools, funfairs, amusement parks and theme parks;
- Indoor play areas and bowling alleys;
- Visitor economy-type venues such as museums, art galleries, visitor attractions and holiday businesses;
- Visitors for conferences, including venues used for weddings (other than places of worship and registry offices);
- Recycling centres;
- Libraries; and
- Estate or letting agents, developer sales offices and show homes.
- Requirement for people to stay home where possible and ban people from meeting anyone from another household;
- Requiring people to wear face coverings in certain indoor places and on public transport.
Some businesses are able to remain open during the firebreak including:
- Businesses and premises that sell food and drink but for consumption off the premises (takeaway). Workplace canteens can remain open where there is no practical alternative for staff.
- Hotels and holiday accommodation where the venue is required to stay open for use by the Welsh Government or where a person staying in that venue is unable to return to their main residence when the regulations come into force;
- Places of worship where the purpose of opening is for funerals, marriage or civil partnership ceremonies or to provide essential voluntary services or to provide public services as requested by the Welsh Government;
- Food retailers such as supermarkets, convenience stores, food markets and corner shops, and cafes, hospital canteens, schools canteens and student accommodation that provides for consumption of food and drink off-site;
- Libraries at educational establishments;
- Banks and post-offices;
- Pharmacies, chemists, dentists, opticians and other medical or health services;
- Building supplies and hardware stores;
- Mechanics, bicycle shops and petrol stations;
- Laundrettes and dry cleaners;
- Vets, pet shops and agricultural and aqua-cultural supplies shops; and
- Funeral directors.
The Regulations require any business and premises that can remain open to take steps to minimise the risk of exposure to coronavirus including:
- Taking all reasonable measures to ensure that a two-metre distance is maintained between persons who are on the premises and also people waiting outside to enter the premises;
- Any other reasonable measures to limit close face-to-face interaction and maintaining hygiene such as changing the layout of premises; controlling use of entrances, passageways, stairs and lifts; installing barriers or screens; and providing or requiring PPE; and
- Providing information to those entering or working at the premises about how to minimise exposure.
Business premises must also collect contact information from each person at the premises (or one of them if from the same household) and retain it for 21 days for track and trace purposes.
The Regulations also contain provisions to restrict movement within Wales including:
- Requirement to stay at home unless there is a reasonable excuse to leave the house such as:
- Going out to buy food or medicine;
- To work or provide voluntary or charitable services where it is not reasonably practicable to do so from home;
- To provide or receive medical assistance;
- To provide or receive assistance such as childcare
- To exercise either alone or with members from your household;
- To attend a marriage or civil partnership ceremony, or funeral;
- For the purpose of accessing or receiving educational services; and
- To perform a legal obligation, such as attending court or to participate in legal proceedings.
- People who live outside Wales must have a reasonable excuse for travelling into Wales.
- In the limited circumstances where people can leave their homes these individuals are subject to additional restrictions that prohibit them from gathering with anyone who is not part of their household unless there is a reasonable excuse to gather.
In relation to schools and further education the Regulations limit the circumstances in which a pupil or student has a reasonable excuse to attend school or further education which are:
- A pupil in Year 9 or above may not attend school in Wales unless to take an exam or to attend a special school, pupil referral unit or a special educational needs school; and
- No student can attend the premises of a further education institution in Wales unless it is to take an exam.
In relation to enforcement and offences under the Regulations the following came into effect:
- The police and local authority have the power to enforce the restrictions on individuals’ movement and gathering and can order people to return home and direct an illegal gathering to disperse;
- Local authorities have the power to deal with business closure requirements and are able to close businesses and premises not permitted to open and can issue improvement notices to those that can open but fail to take the necessary preventative measures;
- A person who breaches the restrictions commits an office punishable on summary conviction by an unlimited fine;
- For offences punishable by way of fixed penalty notices the starting notice is £60, increased to £120 for a second office and continues to doubles for repeated offices up to a maximum of £1,920;
- There is a separate criminal office for organising an unlicensed music event punishable by conviction and unlimited fine or by fixed penalty notice set at £10,000.
The Regulations revoke almost all previous regulations that relate to COVID-19 in Wales including those applicable at national and local levels. The full list of those regulations that have been revoked or amended can be found at regulation 34 and 35.
This newsletter has been co-prepared by Joanne Thompson and Rachael Thomas.
Tags: coronavirus, Coronavirus general, newsletter
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