Blake Morgan’s Health Sector legal experts have put together a round-up of the latest news within the area.
Welcome to the review of the February edition of Health Sector News, a digest of legal issues hitting the headlines in the health sector.
The health sector, and in particular the NHS, is under enormous strain at the moment as a result of the Covid-19 pandemic. The impact on healthcare services is profound and we have already seen a huge shift in priorities within the health sector with elective surgeries and outpatient appointments being cancelled and we are likely to see many more changes over the coming weeks and months. Indeed the NHS is arguably undergoing one of the most radical and rapid reconfigurations in its history to face the challenge of Covid-19.
Blake Morgan would like to thank all those working on the frontline and offer our continued and unwavering support to all those in the health sector in the face of the pandemic.
Business is continuing as usual at Blake Morgan and we are available to provide any advice and support to the healthcare sector as and when required.
In our next newsletter and intervening updates we will keep you up to date with these changes, including the new emergency legislation which will underpin all this change but in the interim please see below other recent healthcare sector news.
The Immigration Health Surcharge Briefing Paper
The Government has published a briefing paper on their plans to increase the Immigration Health Surcharge after the Brexit transition period.
The Immigration Health Surcharge is paid by non-European Economic Area (EEA) nationals as a contribution towards the costs of their NHS care, and once paid it entitles such persons to receive NHS health care free of charge. The Government doubled the cost of the Surcharge in January 2019 and intends to increase it further to £625 per person per annum.
The Surcharge is payable by non-EEA nationals who are seeking to stay in the UK temporarily, but not those with permanent right to stay in the UK, who are able to use the NHS without payment. The Surcharge is payable when the individual is applying for their visa.
The Government intends to extend the requirement to pay the Surcharge to EEA nationals after 31 December 2020, however it will not apply to such individuals who were resident in the UK before this date. It has not yet been determined the precise requirements of when EEA nationals will need to pay the Surcharge.
Certain people are exempt from the Surcharge such as victims of slavery or trafficking, children taken into care and dependants of those in the armed forces. The Home Office also has a waiver policy where they do not require the fee or allow a reduction where enforcing the Surcharge would be incompatible with the individual’s human rights.
There is however criticism of the effective double taxation of temporary migrants, and of the lack of exemptions for those such as NHS staff and teachers.
The briefing paper can be found here.
Recommendations for the healthcare sector following the Inquiry into the actions of Ian Paterson
The Department of Health and Social Care has published its report following an independent inquiry which was set up as a result of the conviction of the breast surgeon Ian Paterson for malpractice. The Report looks into the effects on the victims, how such failings occurred, and makes recommendations to the Government on how to improve private and public healthcare services across England.
On the basis of evidence gathered from its inquiry the following are recommended:
- That it is clearly explained to those who opt for private healthcare treatment, the differences between how the NHS and private hospitals operate.
- That it is standard practice that consultants write to patients outlining their condition and treatment, in simple language, and copy this to their GP, rather than writing to the GP in technical language with a copy to the patient.
- That there is a single mandatory repository for all consultants in England which sets out their performance data amongst other information, which is accessible and understandable to the public.
- That a short period for reflection is given to patients so that they can consider their diagnosis and treatment options in order for them to give voluntary and informed consent to medical procedures. It is recommended that the GMC monitor this as part of ‘Good Medical Practice’.
- That the Care and Quality Commission urgently assures itself that all hospitals are complying effectively with national guidance on multidisciplinary team meetings in order to ensure patients treatments are being reviewed by other healthcare professionals
- The Government should urgently reform the current regulation of indemnity products for healthcare professionals, and introduce a national safety net to ensure patients are not left without compensation. The Medical Defence Union revoked their cover once Paterson’s actions were decided as criminal leaving his patients without a means of seeking compensation.
Investigating healthcare professionals
- That when an individual is being investigated by a hospital, if there is any perceived risk to patient safety, the individual should be suspended and other providers who employ the individual should be notified.
- That health boards should apologise at the earliest stage of investigation, and not refrain from doing so due to fears about admitting liability
The report does however acknowledge that there were regulations and guidance in place during Ian Paterson’s years of practice and that they were largely disregarded or ignored by him and others, and that no single legislative or regulatory provision would provide a complete solution to ensure patient safety.
The report can be found here.
Update on gender identity development service for children and young people
NHS England has announced that they will conduct a review of gender identity and development services for children and young people during 2020.
An independent group is being established to make recommendations to support a review of the use of puberty suppressants and cross-sex hormones and whether changes are needed to existing clinical policies. NICE will also undertake a review of the latest clinical evidence to help inform the working group’s review and will develop guidance to identify when children and young people should be referred to specialist services.
Dr Hilary Cass OBE, who has been appointed chair of the independent group has stated:
“I look forward to chairing this independent group, bringing together medical and non-medical experts with a range of perspectives, to make evidence-based recommendations about the future use of these drugs.”
To view the announcement please visit here.
PSA renews its accreditation of the Society of Homeopaths despite concerns
The Professional Standards Authority for Health and Social Care (PSA) has renewed the accreditation of the Society of Homeopaths for the next 12 months, despite calls from the NHS that it be revoked and the ongoing judicial review proceedings of its decision to renew accreditation last year.
The PSA has however, made the accreditation subject to a number of conditions:
- The Society must make its position statement clear that registrants must not practice or advertise therapies inconsistent with Society registration, in particular there must be specific reference forbidding the practice of CEASE (Complete Elimination of Autistic Spectrum Expression) therapy and dietary/nutritional supplements.
- The Society must make its position statement clear that registrants do not have the scope to provide advice on vaccination or offer homeopathy as an alternative. Registrants should direct patients to the NHS.
- The Society must provide quarterly reports of its monitoring to ensure within 12 months all registrant websites comply with the updated position statements
- The Society must complete and make available to the public its guidance on adjunctive/supplementary therapies
Leave was granted in October 2019 for judicial review of the PSA’s decision in 2019 to re-grant accreditation to the Society. Judicial review is sought by the charity Good Thinking who argue that the CEASE therapy (a proposed treatment for autism in children which supposes that autism is caused by vaccinations) promoted and offered by the Society is harmful, and that the PSA decision to grant accreditation is irrational and that the PSA has failed to consider the effect of its decision on autistic children.
The case is due to be heard on 18 March 2020.
The PSA’s statement can be viewed here.
Improving care, improving lives: national care review of NHS learning disabilities hospital inpatient provision
The Welsh Government has published a National Care Review report on care and services provided to those who are inpatients in learning disability hospitals in Wales. No immediate safety concerns were found but recommendations were made.
The report’s recommendations are focused at the Welsh Government, healthcare providers and healthcare commissioners, and include the following:
- Should consider establishing a national campaign to support the reduction in the inappropriate use of psychotropic mediation
- Should support Regional Partnership Boards to develop sustainable funding models in order support, transition and improve community services in Wales.
- Should ensure staff are trained to recognise and meet the needs of older persons with learning difficulties
- Should ensure staff are aware of the difference in presentation and needs of male and female patients
- Must ensure that the patient, local care team and carers are involved in the decision to commence or discontinue any psychotropic medication
- Should ensure that all patients subject to detention under the Mental Health Act or Deprivation of Liberty Standards are aware of their rights
- Should ensure that all patients not subject to detention, have the capacity to consent to being an inpatient
- Should ensure that any restrictive intervention involves the minimum degree of force, for the briefest amount of time and with due consideration of the self-respect, dignity, privacy, cultural values and individual needs of the patient
- Should ensure that they have planned learning disability services to take account of an ageing population profile
- Should ensure that staff are trained to recognise and meet the needs of patients with a learning disability that are concurrent with other conditions such as an autistic spectrum disorder, dementia and mental illness
- Should ensure that all care plans and hospital support plans are co-produced with the patient and with the involvement of the care coordinator and the patients’ families.
- Should ensure that no hospital bed is classed as an individual’s home and every endeavour should be made to see community care as the ‘default option’ for all patients.
To view the full report please go to here.
Multidisciplinary Team Working in a General Practice Setting
A new resource, developed in partnership by the Royal College of General Practitioners and the Royal Pharmaceutical Society in Wales, focuses on the dynamic of multidisciplinary (MDT) working in a general practice setting. It aims to support the development of MDT approaches in general practice settings and contribute to the primary care transformation programme in Wales.
The resource is intended to provide an insight into the practical challenges of developing an effective MDT and to help staff integrate into the team, learn and self-reflect as part of team development, and for those recruiting in general practice, or those who want to move into a general practice based role.
The resource can be found here.
Medicines and Medical Devices Bill
The Medicines and Medical Devices Bill was introduced to the House of Commons on 13 February 2020.
The Bill introduces delegated powers to enact regulations in the fields of human and veterinary medicines and medical devices to enable the existing regulatory framework to be updated following the UK’s departure from the EU. It also consolidates the enforcement provisions for medical devices and introduces sanctions, and provides an information gateway to enable the sharing of information held by the Secretary of State.
The Government intends to introduce secondary legislation under the Bill which would increase the range of professionals who can prescribe medicines in low-risk circumstances, introduce new regulations on medical devices, and allow hospitals to use personalised medicine for unique cancers and diseases. The Government has drafted Illustrative Regulations which will accompany the Bill through Parliament.
The Secretary of State may issue compliance notices, requiring a person to comply with medical device provisions, suspension or safety notices, prohibiting a person from supplying etc. a medical device, or information notices, requiring a person to disclose information which the Secretary of State needs to serve the above mentioned notices.
It would be a criminal offence for a person to not comply with a notice under the Bill, which could result in a fine and/or prison, though it would be a defence to show that they took all reasonable steps and exercised all due diligence to avoid committing the offence. The Bill places an obligation on the Secretary of State to prepare and publish guidance on what would constitute an offence and the likely sanctions.
Health Secretary faces legal challenge for failing patients with learning disabilities and autism
The Equality and Human Rights Commission has launched a legal challenge against the Secretary of State for Health and Social Care over the repeated failure to move people with learning disabilities and autism into appropriate accommodation.
It has sent a pre-action letter arguing that the Department of Health and Social Care has breached the European Convention of Human Rights for failing to meet the targets set in the Transforming Care program and Building the Right Support program. The Commission believes there has been a systemic failure to protect the right to a private and family life, and the right to live free from inhuman or degrading treatment or punishment of individuals with learning difficulties and autism.
A statement by the Equality and Human Rights Commission can be found here.
Call for evidence: barriers to research with controlled drugs
The Advisory Council on the Misuse of Drugs has put together a working group to consider barriers to legitimate scientific research with controlled drugs. The Council is seeking to understand whether researchers in practice are finding that the Misuse of Drugs Act is impeding research, in particular in relation to research concerning synthetic cannabinoids, or other compounds which are caught by legislation meant to cover synthetic cannabinoids.
For more information visit here.
Government considers more flexible training for healthcare professionals switching discipline
People who are already working as healthcare professionals could train to become doctors and nurses more quickly following Brexit. The Government will consider how to better recognise the skills and experience of existing healthcare professionals who want to train in a different area of healthcare. Under the potential new system, experience and qualifications will determine the completion of new training, rather than fixed time-frames.
Currently training standards are set by the EU, with healthcare professionals having to complete the full training to re-qualify in another profession, regardless of experience or qualifications, including undertaking a minimum of 5,500 hours of training to become a doctor.
Post Brexit, the Government is looking to introduce a flexible approach which allows other health professionals to re-qualify in another profession based on qualifications and experience of the particular person. The Government hopes that this will help ease the shortage of doctors and nurses and allow people from a wider range of backgrounds to become doctors.
The Health Secretary Matt Hancock has stated: “Without being bound by EU regulations, we can focus on ensuring our workforce has the necessary training which is best suited to them and their experience, without ever compromising on our high standards of care or on patient safety. The plans we are setting out today mean that we can retrain healthcare workers and get them back to the frontline faster. This is good for patients, and good for our NHS.”
To view the Government’s statement please go here.
Improving patient safety by bringing private healthcare and NHS information together into NHS England systems
An NHS Digital consultation concerns the first set of changes under the Acute Data Alignment Programme (ADAPt) which has been initiated between NHS Digital and the Private Healthcare Information Network (PHIN) to explore how data collected by PHIN from UK private healthcare providers could be aligned to NHS England data standards and integrated into relevant NHS quality and safety reporting systems.
The Consultation sets out a number of options for changes to how data is recorded and managed across private and NHS care, and describes a series of pilot projects which will test different data flow scenarios for the sharing of data between the NHS and PHIN.
Currently private healthcare data is not included in national quality and safety reporting systems, however systemic failures recently reported such as in the Inquiry into Ian Paterson’s conduct have raised calls for a single repository of information for private and public consultants across England in order to ensure patient safety. Such a repository would need to be underpinned by common standards on recording and reporting information.
The Health Secretary Matt Hancock has stated: “The recent Paterson Inquiry highlighted the shocking failures that can occur when information is not shared and acted upon in both the NHS and independent sector. We are working tirelessly across the health system to deliver the highest standards of care for patients. Trusted data is absolutely critical to this mission and the ADAPt programme will help improve transparency and raise standards for all.”
The aims of the ADAPt system are to:
- ensure that data describing both privately funded and NHS funded healthcare is visible within all healthcare reporting systems to assist in the monitoring of quality of service delivery;
- promote the completeness of health records for patients whose care encompasses both NHS and private healthcare and therefore supporting NHS Trusts and private providers in delivering safe and effective care to patients;
- improve the information available to members of the public considering private healthcare through the publication of performance measures by PHIN, thereby offering a more robust and sustainable way of achieving greater information transparency of quality and safety in private healthcare;
- identify opportunities for reducing the burden on private providers and NHS Trusts in relation to data collection and reporting.
The Consultation closes on 31 March 2020. To comment on the Consultation visit here.
You can view the consultation document here.
Patients who abuse NHS employees could be barred
The Health Secretary Matt Hancock has warned that patients who are aggressive, abusive or discriminatory towards NHS staff could be refused treatment at hospitals if their treatment is not critical under updated guidelines that cover any bullying, discrimination or harassment, including homophobic, sexist or racist remarks.
A staff survey in England, found that 15% of NHS staff had experienced physical violence from patients or the public in the last year, with this figure rising to 34% amongst ambulance staff.
NHS England has joined forces with the police and the Crown Prosecution Service to approve a joint agreement on offences against emergency workers, which provides a framework to ensure effective investigation and prosecution of perpetrators of violence against NHS staff.
Matt Hancock’s letter can be viewed here.
Government announces Organ Donation (Deemed Consent) Act 2019 to come into force on 20 May 2020
The new law, named Max and Keira’s law, in honour of 12 year old Max Johnson and his heart donor Keira Ball, is due to come into force in England on the 20 May 2020, subject to parliamentary approval.
Antony Clarkson, Director of Organ Donation and Transplantation for NHS Blood and Transplant, said that while a majority of people say they are in favour of donation only approximately 4 in 10 people in England are registered organ donors. The hope is that the Act will address the current shortage of donors which resulted in 408 people dying while on the transplant waiting list in 2019. There are currently over 6,000 people waiting for an organ in the UK.
Currently the organ donation register operates as an ‘opt-in which requires people to pro-actively register as an organ donor. The Act will change this to an opt-out system where all adults in England over the age of 18 will be deemed to be an organ donor unless they have recorded a decision to opt-out or are in one of the excluded groups:
- children under the age of 18;
- people who lack mental capacity to understand the changes for a significant period before their death; and
- people who have not lived in England for at least 12 months before their death.
The hope is the law will also encourage families to discuss organ donation so that family members are aware of each other’s feelings and decisions regarding donation and will prevent decisions having to be made at such a difficult time. Currently, less than half of families give consent for their loved one’s organs to be donated if they are unaware of their wishes.
The NHS have been keen to stress that despite being an opt-out, families will always be consulted before donation goes ahead. However if there are concerns about family members not supporting a decision regarding donation, the Act also has a mechanism for the nomination of up to two representatives to make the final decision on the donors behalf.
Wales already has an opt-out system, after changing their law in December 2015. Jersey introduced the opt-out system in July 2019 and Scotland will also be moving to an opt-out system from autumn 2020.
For more information please visit here.