This month has seen the most widespread changes made to our daily lives in peace time as the UK battles to limit the spread of the coronavirus. It is a challenging time for us all but particularly those working in the health sector and on the frontline who have seen unprecedented demand for services.
To all those working in the healthcare sector, Blake Morgan continues to offer its full support. We are here to provide any advice and assistance as and when required.
The nature of the legislative landscape is changing rapidly at present and whilst we have picked some of the more topical issues from the last month, these are by no means exhaustive.
You can also keep up to date with our latest articles and blogs on legal issues arising during this pandemic by going to our COVID-19 Hub.
Appeal challenging NHS Avastin policy dismissed
The Court of Appeal has dismissed an appeal brought by the pharmaceutical companies Bayer and Novartis, who had sought judicial review of a policy adopted by 12 NHS clinical commissioning groups (“CCGs”). This policy had recommended the use of the drug Avastin as the preferred treatment for the eye disease known as wet age-related macular degeneration (“WAMD”) over the two licenced drugs marketed by the pharmaceutical companies.
Avastin was significantly cheaper than the two licenced drugs, however it was not licensed for WAMD treatment in the UK, only having EU marketing authorisation as a cancer drug. The National Institute for Health and Care Excellence (“NICE”) had concluded that all three drugs were equal in respect of safety and clinical effectiveness in treating WAMD. The annual savings for the NHS through promoting Avestin for WAMD would be in the millions of pounds.
The pharmaceutical companies challenged the policy, relying on section 10 of the Medicines Act 1968 and Article 77(1) of Directive 2001/83/EC (the “Directive”). Section 10 sets out the exemptions to the restriction on manufacturing medicinal products without a licence in domestic law, with the pharmaceutical companies asserting that the CCGs’ policy fell outside of its scope. Article 77(1), implemented by regulation 18 of the Human Medicines Regulations 2012, places a restriction on distributing a medicinal product by way of wholesale dealing except with a licence. The main judgment was given by Underhill LJ, with each ground of the appellants’ challenge being dismissed.
The key authority considered by the court was the CJEU case of Novartis Pharma GmbH v. Apozyt (“Apozyt”), which had introduced an exemption from the requirement under the Directive that Marketing Authorisation had to be obtained for supplying to hospitals compounded Avastin (this being Avastin mixed so as to be tailored to the specific needs of the patient). This exemption would be available if the process for compounding Avastin did not modify the medicinal product, and an individual prescription for its use had already been made prior to the compounding.
The court found that there was no evidence that the compounding process introduced changes to the substance of the drug. They also found that while prior prescriptions were required for the exemption to apply, this did not render the policy unlawful. This was because a system could be adopted that ensured that compounded Avastin was prepared only where prior prescriptions were first in place.
The court determined that section 10 of the Medicines Act 1968 was wide enough to encompass the large scale production of compounded Avastin. Similarly, in respect of Article 77 of the Directive, wholesale distribution was defined as expressly excluding supply to the public. Accordingly, no licence was needed for the policy, and the Apozyt exemption was given full effect.
It was found that it was lawful under the policy for the compounding of Avastin to be carried out by an NHS pharmacy in the hospital in which the patient was being treated. It was also potentially lawful, subject to a prior prescription being in place, for compounded Avastin to be supplied to a hospital by an NHS pharmacy in a different Trust. The Court made no decision on the lawfulness of acquiring compounded Avastin from a commercial compounder, as it did not need to do so in the case and had before it no evidence relating to it. That the policy was wide enough to potentially permit this was no ground for holding the policy to be unlawful.
Finally, the court also found that prescribing Avastin to a patient on the basis of its lower cost, when licensed alternatives were also available, would not constitute a breach of General Medical Council Guidance to clinicians. Even if it had constituted a breach, this alone would still not have made the policy unlawful. In holding the policy lawful and dismissing the appeal, Underhill LJ concluded by stating: “There is nothing inherently illegitimate in prescribing decisions being influenced by cost considerations where the evidence shows no differences in efficacy or safety.”
This decision is likely to have wide ranging implications for commissioners, potentially permitting the NHS to make decisions which could make significant savings to its drugs spend.
£2.9 billion COVID-19 care funding for the vulnerable
Following the Government’s announcement in the Budget of a £5 billion fund relating to COVID-19, a sum of £2.9 billion has been allocated from this in order to assist those patients who are returning home from hospital and who no longer require urgent hospital treatment.
Of this £2.9 billion, £1.3 billion will be utilised for improving hospital discharge processes, to enable patients to return home quickly and safely once they no longer require urgent treatment. This in turn will free up hospital beds for new admissions and reduce pressure on NHS staff, ensuring that they have more capacity to treat people requiring urgent care, including those with COVID-19.
The remaining £1.6 billion of the funding will be provided to local authorities to assist them in responding to the pressures caused by COVID-19 on the services they provide. This includes providing enhanced support for adult social care workers and further assistance for those services that help those classed as the most vulnerable, including homeless people.
For more information please see here.
More than £2.2 million to local authorities to reduce air pollution
Local authorities in England have received more than £2.2 million in funding from the government under the Air Quality Grant. This funding is intended for local authorities to develop schemes that will encourage cleaner transportation and improve air quality outside schools.
The Air Quality Grant was set up in 1997, with more than £64 million having been awarded in total. It supports schemes that reduce harmful omissions, creating healthier environments and reducing the impact on people’s health. The projects that the funding enables local authorities to develop and implement are for the benefit of schools, businesses and residents.
Proposals which will receive funding include projects that:
- reduce harmful emissions outside schools
- encourage the take up of electric taxis
- encourage more active transport through education, awareness, and the creation and improvement of cycling and pedestrian routes; and
- collect further data on the exposure to air pollution by vulnerable groups in order to better design future policies.
For more information please see here.
COVID-19 adult social care guidance
New guidance has been published for councils and care providers by the Department of Health and Social Care and Public Health England, to ensure increased protection for adults receiving social care in the face of the continuing spread of the COVID-19 pandemic.
The guidance covers numerous scenarios which involve providers of home care and care homes, to ensure that the best protection is given to older people and those with pre-existing conditions and care needs who receive support.
People receiving care who develop symptoms of COVID-19 will be isolated to their rooms, although they will still receive the care they require from care staff. To minimise the risk of infection, the staff providing the care will use protective equipment.
People with existing health conditions who are infected by COVID-19 are more susceptible to developing serious complications from the illness. Accordingly, anybody suspected of being infected by COVID-19 or displaying the symptoms of the illness should self-isolate, and should not be permitted to visit care homes or persons receiving home care.
In addition, to ensure that people can be provided with the best possible care while remaining in their communities, the NHS has been instructed to utilise its existing local relationships with care providers. Local Authorities have also been directed to facilitate plans with registered providers in their area for mutual aid and to asses all care and support to prioritise those who are at the highest risk.
For more information please see the Government’s full update here.
Guidance was also issued to care home providers in Wales by letter sent from the Welsh Ministers which can be accessed here and the Minister for Health and Social Services, Vaughan Gething announced an extra £40m to support adult social care services in Wales during the pandemic.
Judge orders dialysis where refusal by patient was a manifestation of his mental disorder
In the High Court case of A Healthcare B NHS Trust v CC  EWHC 574, Mrs Justice Lieven has ordered that the respondent undergo dialysis treatment at times when he does not consent to it, on the grounds that this refusal of consent was a manifestation of his mental disorder.
The respondent, a 34 year old male, had received a psychiatric diagnosis of psychotic depression and a mixed personality disorder with marked dissocial and dependent traits. He had been detained under section 3 of the Mental Health Act 1983 (the “Act”) and at times subsequently refused consent to undergo dialysis treatment.
The respondent had been diagnosed with type 1 diabetes in his youth, but in the following years had failed to comply with the required diabetic treatment. This had resulting in complex physical health issues including most recently renal failure, which ultimately would require a kidney transplant.
It was thought by the respondent’s clinician that his refusal to undergo dialysis was a manifestation of his mental disorder. The respondent’s capacity to make decisions about dialysis was described as fluctuating; when physically well the respondent understood the need for and readily consented to dialysis, consistently expressing a desire to continue living. In contrast, at times when the respondent’s mental health deteriorated he would outright refuse to undergo the treatment.
The respondent’s clinician and the nephrology team that oversaw his dialysis treatment sought clarification from the court that dialysis could be provided to the respondent under section 63 of the Act, as medical treatment within the meaning of section 145(4) of the Act.
Mrs Justice Lieven found:
- Both the respondent’s refusal to consent to dialysis and the physical condition he was presently in were properly described as manifestations of his mental disorder. If he did not have the mental disorder he would likely have cared for himself and never required dialysis. Accordingly, dialysis was treatment for a manifestation of his mental disorder within the scope of section 63 of the Act.
- The respondent’s capacity to consent to dialysis treatment fluctuated, however his consent was not required in order to be treated under section 63 of the Act.
- The decision whether it was in the respondent’s best interests to receive dialysis treatment was a matter for his clinician (having consulted clinicians attending to his physical health), subject to the supervisory jurisdiction of the Court.
- Section 58 of the Act had no applicability, as it was excluded by section 63 of the Act in cases where urgent treatment was immediately necessary to save the patient’s life, to prevent a serious deterioration of his condition, and to alleviate serious suffering.
- Section 63 of the Act could be used as authority to provide medical treatment to the respondent, including by dialysis treatment.
- As section 63 of the Act could be used as authority to provide treatment to the respondent, it was not necessary for the court to use its discretion to make a contingent declaration that it was lawful to give the respondent dialysis treatment whenever he lost his capacity to make a decision regarding receiving the treatment.
The full judgment can be found here.
Emergency changes to be made to the Mental Health Act 1983
Responding to concerns over a potential shortage of psychiatrists available to assess people that may require sectioning and admitting to hospital, the Government is looking to make temporary amendments to the Act.
Short term changes to the Act will likely include reducing the number of the qualified psychiatrists required for carrying out an urgent assessment of whether a person should be sectioned. Under the Act at present, two doctors are needed to carry out an assessment, one of whom must be ‘section 12’ approved. The amendment to the Act will likely reduce this to one doctor.
This amendment would be brought in as a precaution against shortages of staff. There are legitimate concerns that as COVID-19 continues to spread the number of NHS staff self-isolating as a result of displaying symptoms will increase significantly. This could realistically lead to a lack of psychiatrists available to carry out assessments.
Other changes would allow the temporary extension or removal of time limits under the legislation, to permit increased flexibility where services would be less able to respond. This would be done where staff shortages resulting from COVID-19 caused such an adverse effect that it would be necessary to support the continued safe running of services under the Act.
The President of the Royal College of Psychiatrists, Professor Wendy Burn, said: “We’re supportive of this during this time of crisis. This is about keeping patients safe. This is to make sure people who are in danger of harming themselves or someone else are cared for in a safe environment. If people are at risk you have to be able to get them into hospital.”
Wales has already brought in commencement provisions by virtue of the Coronavirus Act 2020 (Commencement No. 1) (Wales) Regulations 2020.
For more information please see here: Government to make emergency changes to Mental Health Act.
Changes to hospital discharge requirements
Following the outbreak of the COVID-19 pandemic, the Department of Health and Social Care has produced new guidance for NHS trusts, acute and community interest companies, and private care providers of community beds and community health services and social care staff in England. The guidance sets out how discharging arrangements and the provision of community support must be changed during the course of the COVID-19 pandemic. This guidance also extends to health and social care commissioners.
Under the new requirements, patients must now be discharged as soon as it is clinically safe for this to be done. Within one hour of the decision to discharge a patient having been made, the patient must be transferred from their ward to a designated discharge area. Once this has been done, the patient should then be discharged from hospital as soon as possible, normally within two hours of the transfer. Arrangements will be made for the patient’s transport home and for assistance to be provided with immediate practical support. Doing this will allow the discharged patient’s bed to be used immediately by a new person admitted with acute symptoms of COVID-19.
For 95% of patients being discharged, assessment and organisation of ongoing care, where needed, will take place once they are back in their own home. For those remaining patients whose care needs are too serious for them to return to their own home, arrangements will be made for a suitable short or long term rehabilitation bed or care home. It has been confirmed by the Government that the cost of this out of hospital support will be fully funded by the NHS.
As the new discharge requirements will need the cooperation and coordination of many people and organisations, a “discharge to assess” model will be introduced in England.
The complete guidance can be found here.
An ethical framework for adult social care
Guidance on ethical considerations for the response to COVID-19 has been published for local authorities and adult social care professionals by the Department of Health and Social Care.
As the COVID-19 pandemic continues to spread, it is recognised that local authorities and adult care professionals will be required to make difficult decisions under extreme pressure, with limited time, information and resources. Such decisions could relate to the organisation and delivery of services, or to individuals, carers and communities.
In response to this, the new framework is intended to ensure that consideration is given to a series of ethical values and principles when organising and delivering social care for adults. Aimed at planners and strategic policy makers at local, regional and national level, the framework will support response planning and the organisation of adult social care as COVID-19 continues to develop. It is also intended to support professionals and others in the health and social care workforce, who are responding to the outbreak and developing policies in line with their own professional codes of conduct and regulations, with these ethical values able to be applied more widely in the social care sector.
The framework will act as a guide for making decisions as to prioritising care needs and redirecting resources, and will ensure that individuals’ needs and the possibility of harm being caused will be the central consideration in the decision-making process. It will also require that records are maintained of every decision made and the justification behind it, to guarantee accountability and to allow others to learn from previous situations as the pandemic spreads.
The ethical values and principles set out in the guidance are:
- Minimising harm
These ethical values and principles set out in the guidance are not exhaustive, and should be used as a starting point. They should be reinforced by leading professional opinion and the information available in each particular case. Furthermore, every decision that will be made must also consider the wellbeing of any individuals involved, the available resources and the public good overall.
The complete guidance can be found here.
For more information regarding the removal of data charges by mobile networks for online NHS coronavirus advice, see here.
Coronavirus (COVID-19) – what you need to do:
- Stay at home
- Only go outside for food, health reasons or work (but only if you cannot work from home)
- If you go out, stay 2 metres (6ft) away from other people at all times
- Wash your hands as soon as you get home
- Do not meet others, even friends or family.
- You can spread the virus even if you don’t have symptoms.
- Stay at home; protect the NHS; save lives.