The Healthcare Law Review: United Kingdom - England & Wales
Healthcare in the UK is dominated by the National Health Service (NHS), a universal healthcare system largely free to citizens at the point of access. The NHS is not a single organisation but a network of national and local organisations all operating under the NHS 'brand'. The organisation of the NHS varies between the four nations of the UK: this chapter will focus on England. While private healthcare is readily available in the UK, the vast majority of people use the NHS either for the entirety of their healthcare or as a gateway before choosing to access private healthcare at the secondary care stage.
In England, healthcare is currently provided distinctly from personal, non-medical ('social') care, with different legislative schemes in place; the NHS is governed by, among others, the National Health Service Act 2006, while social care is provided by local authorities, primarily under the Care Act 2014. This divide is increasingly being questioned by both patients and practitioners, and the covid-19 pandemic has highlighted fragmentation in the sector and strengthened calls for a National Care Service.
Healthcare services are commissioned either at the local level by clinical commissioning groups (CCGs) made up of local general practitioners or, for more specialised commissioning, at a national level by the National Health Service Commissioning Board (known as NHS England). Funding pressures on the NHS have been political priorities and have been reflected in the latest NHS Long Term Plan, published in January 2019. The biggest impact of Brexit is likely to be the availability of healthcare professionals.
There is an increasing role for private healthcare provision, either directly to the NHS (i.e., by running NHS-provided services) or by providing private services directly to patients. In 2018–2019, NHS spending with private sector providers in England was £9.2 billion (7.3 per cent of the total budget). This has been politically contentious but is unlikely to change in the short term and private providers are as closely regulated as the NHS.
The healthcare economy
Approximately 11 per cent of the UK population has some form of private medical cover, although this is rarely comprehensive, and cover is not usually provided for accidents and emergencies. In 2018 the private market for self-paid treatments was an additional £1.2 billion spent largely on elective surgery or physiotherapy, where there may be a wait to receive such treatment on the NHS.
In England, NHS hospital treatment and primary care is free at the point of use to those ordinarily resident in the UK. It is funded through general taxation and national insurance deducted from salaries. There are fixed charges for certain items of NHS care, such as prescription medicines and dental treatment. Exemptions from these charges are available on the basis of age, income or certain medical conditions.
As a current member of the European Union, UK nationals have reciprocal arrangements with European Union states. These arrangements will cease in the event of a no-deal Brexit, although the government has expressed a desire to maintain the current arrangements.
The regulations that set the legal framework for cost recovery from overseas visitors changed in 2017; it is now mandatory to collect payment in advance of services, unless treatment is immediately necessary or urgent.
The role of voluntary or third-sector providers in healthcare in England is limited, given the availability of NHS care, but one particular area of charitable provision is hospice care.
ii The role of health insurance
Some UK citizens opt to have private health insurance, often as a tax-efficient employment benefit, but it is not compulsory. EU nationals living in the UK and not employed are required to have comprehensive sickness insurance, and those eligible for overseas visitor charges may rely on insurance. In addition, those applying for certain types of entry clearance or leave to remain in the UK must pay an Immigration Healthcare Surcharge of £400 a year to use NHS services this is due to rise to £624 from October 2020 and will extend to EU workers once Brexit goes ahead. The fee however is to be waived for healthcare workers, after an announcement during lockdown.
Private health insurance is available in a variety of forms, including access to private specialists and hospitals, or as a rebate for time spent in NHS care.
iii Funding and payment for specific services
Which services are routinely commissioned by NHS England or a CCG is substantially informed by evidence-based guidance and advice issued by the National Institute for Health and Care Excellence (NICE).
NICE has various powers to produce guidance and recommendations to NHS bodies on care pathways and technologies they are expected to provide. NHS bodies are legally obliged to fund treatments recommended by NICE's technology appraisal recommendations; however, other guidelines do not have the same level of authority.
For example, NICE guidelines recommend that three IVF cycles should be offered to women under 40 years of age who have been trying to get pregnant naturally for two years, or who have had 12 cycles of artificial insemination. However, the final decision about who can have NHS-funded IVF in England is made by local CCGs, whose criteria may be stricter than those recommended by NICE. NICE's role is to assess the clinical and financial efficacy of the technology.
The Cancer Drugs Fund (CDF) is another option at the end of the NICE technology appraisal process. The CDF acts as a managed access fund where more information is required to determine clinical effectiveness. A budget impact test also applies for certain technologies over the first three years of a technology's use in the NHS. If the budget impact exceeds £20 million, in any of the first three years, NHS England may engage in commercial discussions with the company to mitigate the impact on the rest of the NHS budget. This has resulted in confidential discounts being agreed for medicines such as Keytruda in 2018 and Luxturna in 2019.
In some cases, further funding is available through Individual Funding Requests (IFRs). Where NHS England's duty to provide health services is not met under NICE technology appraisal recommendations, individuals can request funding for treatment through an IFR. The law surrounding IFRs is discussed in the case of S v. NHS England. One area of increasing IFR applications has been for medicinal cannabis since it became lawful in November 2018.
As set out above, standard charges apply to a number of NHS services.
Primary/family medicine, hospitals and social care
The UK healthcare system is heavily reliant on primary care practitioners (general practitioners, GPs) delivering family medicine and acting as gatekeepers to secondary and tertiary care, which in the NHS is rarely directly accessible, except in emergencies.
GP providers are normally independent businesses, providing services to the NHS under contracts with NHS England. While these are private law contracts negotiated between NHS England and the British Medical Association (acting as the representative of all GPs), many of the provisions are required under the NHS (General Medical Services Contracts) Regulations 2015 or the NHS (Personal Medical Services Agreements) Regulations 2015. Similar arrangements are in place for NHS pharmacy and dental services.
NHS hospitals and secondary services are run by local trusts or foundation trusts, which are independent of CCGs or NHS England. The relationship between them is contractual; trusts and foundation trusts are providers of services commissioned by CCGs and NHS England. Emergency services are almost exclusively available through the NHS because of the high operating costs. However, secondary or hospital care may be provided by either the NHS or private providers. Private secondary care may either take place in separate private hospitals, or private patient units in NHS hospitals. While it is not usually possible for patients using the NHS to see a medical consultant without first being referred by a GP, there is nothing to prevent this in the private sector.
It should be noted that social care is, at present, provided under an entirely separate legislative scheme by local authorities. However, there has been an increasing movement in recent years towards the integration both of different health services and of health and social care. In 2019, the government published the NHS Long Term Plan to focus on funding, staffing and the pressures of a growing and ageing population. A new service model is proposed with every patient having the right to online GP consultations. Expanded community health and social care teams are intended to create genuinely integrated teams, and new integrated care systems are to be in place nationally by 2021.
Healthcare in the UK benefits from a near universal Summary Care Record (SCR) for each patient, which contains basic information and is accessible by a range of NHS bodies. In England (and to some extent the rest of the UK), healthcare records are held at a local level by the patient's GP and the relevant hospital. Of GP practices in England, 98 per cent now use a system that automatically creates an SCR unless a patient has opted out. This can be accessed by professionals, and patients can see who has accessed their records.
The UK's data protection law has been significantly strengthened by the EU General Data Protection Regulation whose principles and approach are expected to be retained post Brexit. Alongside this, NHS Digital provides a data security toolkit for organisations to measure their performance against the National Data Guardian's data security standards, which is required to be completed annually.
The licensing of healthcare providers and professionals
There are a range of healthcare regulators, including separate regulators for healthcare operators and professionals.
Institutional healthcare providers
The key regulator for institutional health providers in England is the Care Quality Commission (CQC). Whether a provider requires CQC regulation is dependent on the activities they provide; carrying out a 'regulated activity' without being CQC registered is a criminal offence subject to a potentially unlimited fine or up to 12 months' imprisonment, as well as lesser regulatory sanctions. The regulated activities are set out in the Regulated Activities Regulations and include:
- the provision of personal care at home;
- residential accommodation with nursing or personal care;
- treatment for a disease, disorder or injury by or under the supervision of a healthcare professional;
- surgical procedures carried out by a healthcare professional;
- diagnostic and screening procedures; and
- medical advice or triage, over the telephone or by email.
To be registered, a new provider must register with CQC, which will assess the suitability of the applicant. All registered providers must have a registered manager responsible for the overall management of the service, who also must be fit for the role. Among others, the following documents may be required:
- safeguarding policy and procedures document;
- buildings regulations document;
- registered manager's supporting evidence; and
- governance document.
CQC anticipates that it will provide a decision within 10 weeks of an application. Registration can be either unconditional or with conditions. Appeals against a decision on registration are made to the First Tier Tribunal. When assessing an application, CQC will focus on:
- compliance with the fundamental standards, including person-centred care, dignity and respect, consent, and safe care and treatment;
- management and safeguarding; and
- whether the provider's directors are of good character and have the necessary competence and qualifications.
Once registered, providers are required to share information with CQC and notify it of changes in registered details or certain adverse incidents. CQC also operates a regime of both announced and unannounced inspections of providers. CQC has wide-ranging enforcement powers to place conditions on registration or to suspend or even cancel registration where there have been breaches of its requirements.
Following the failure in 2011 of Southern Cross, one of the largest care providers in England at the time, CQC also has limited market oversight powers in relation to the largest care providers.
Healthcare professionals in England are usually required to be registered with one of the eight different regulators, including the General Medical Council and the General Dental Council. Some regulators operate on a UK-wide basis, while others only operate in certain nations. A new profession of nursing associates has been regulated in England only since early 2019. These regulators are overseen by the Professional Standards Authority for Health and Social Care (PSA). The PSA also accredits voluntary registers for health and care professionals (such as psychotherapists or complementary healthcare practitioners) where there is no legal requirement for registration. Not all individuals involved in front-line care are regulated, including 'healthcare assistants', who may provide a wide range of services to patients under the direction of a registered healthcare professional.
Where a profession is regulated by a statutory regulator, registration is compulsory under the applicable legislation. Each regulator details its requirements for initial registration (i.e., qualifications, experience and good character), continued registration (i.e., standards and continuing professional development) and disciplinary procedures to address serious concerns about a registrant. The requirements for registration typically vary according to whether an applicant is coming from the UK, the EU or overseas. The long-standing mutual recognition of EU qualified healthcare professionals may be lost in the absence of a comprehensive trade agreement after Brexit. As regulators are typically involved in setting the requirements of UK qualifications leading to registration, an overseas applicant will normally need to demonstrate how their qualifications and training meet the requirements of a UK qualification. This may be done either by their overseas registration, qualification or further training being recognised by the UK regulator, by the applicant undergoing testing, or by a period of supervised practice in the UK. Following a Law Commission review and subsequent consultation about reform of professional regulation in the UK, the government responded on 9 July 2019 proposing some amendments. The government announced on 18 July 2019 that the General Medical Council will become the regulator for physician associates and anaesthesia associates.
As a result of the UK's domestic implementation of Directive 2011/24/EC on the application of patients' rights in cross-border healthcare, all the professional regulators require registrants to have indemnity or insurance arrangements providing appropriate cover for their practice. This will usually be provided by their employer. In medical negligence claims the primary defendant will be the NHS trust or the private corporate provider, rather than the individual practitioner. The practitioner's employer (or hospital with whom they have a relationship) would usually be deemed to have vicarious liability for any negligence, subject to the nature of the relationship between the practitioner and the institution and the connection between the wrongdoing and the relationship.
The cornerstone of medical negligence case law in the UK is the concept of consent – patients are required to be fully informed of the risks of treatment before continuing. As a result, patients are normally required to sign consent forms setting out the risks of treatment before any but the most common procedures are carried out.
ii Notable cases
The most significant recent case is the Supreme Court decision in Montgomery v. Lanarkshire Health Board, which revisited a patient's right to information about the risks of a procedure in light of societal changes in the doctor–patient relationship. The judgment noted that patients are 'now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession' (paragraph 75) as the duty of doctors is 'to take reasonable care to ensure that a patient is aware of material risks of injury that are inherent in treatment . . . a duty of care to avoid exposing a person to a risk of injury which she would otherwise have avoided'.
Much controversy was generated by the case of Dr Hadiza Bawa-Garba, a trainee paediatrician who was found guilty of gross negligence manslaughter in November 2015, following the death of a child after delays in diagnosing septic shock. Dr Bawa-Garba had recently returned to practice following an extended period of maternity leave and the incident occurred towards the end of a 12-hour shift. The case led to a review into gross negligence manslaughter and culpable homicide.
Ownership of healthcare businesses
As discussed above, the Regulated Activities Regulations require directors of registered providers to comply with a range of requirements. These include that the directors:
- are of good character;
- have the qualifications, competence, skills and experience necessary;
- have not been responsible for or contributed to any serious misconduct or mismanagement while carrying out a regulated activity; and
- have not been convicted of an offence or erased from a register of health professionals.
There is no prohibition on international or non-national businesses being CQC-registered; however, they must have registered premises in the UK from which the service is provided.
The Competition and Markets Authority's concerns that features of the privately funded healthcare market in the UK prevented, restricted or distorted competition resulted in the Private Healthcare Markets Investigation Order (2014). Among wider prohibitions, the Order restricts the circumstances in which a clinician can refer a patient to a private hospital where that clinician has a financial interest in:
- that hospital;
- the hospital operator or owner; or
- the equipment used at that hospital.
To avoid sanction, the referring clinician must comply with certain conditions, including a 5 per cent limit on shares in the private hospital and various prohibitions on referral incentives.
At present, the UK government is keen to welcome new investment in the UK healthcare space, which is particularly evident in 2017's Life Sciences: Industrial Strategy.
Commissioning and procurement
Since the reforms of the Health and Social Care Act 2012, provision of NHS services has been on a provider–commissioner basis. Services are commissioned by either NHS England or CCGs, depending on the nature of the service and how commonly it is required (routine services are commissioned on a local basis by the CCG, whereas complex, rare procedures are commissioned by NHS England). The services are commissioned from NHS providers or by private companies by means of the NHS Standard Contract, the terms of which are mandated each year by NHS England. The exact services to be commissioned will be based on recommendations by NICE and the available funding.
Procurement of services by NHS bodies is subject to transparent competitive tendering under the 'light-touch regime' in the Public Contracts Regulations 2015 (PCR 2015). In addition, procurement of healthcare services by CCGs and NHS England is subject to a specific procurement regime under the National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013, which is overseen by NHS Improvement. Regimes may overlap in some instances.
For the procurement of supplies (rather than services), competitive tendering under the PCR 2015 is normally required. There is a general trend for NHS procurement of supplies (from sophisticated medical equipment to non-medical supplies) to be aggregated into larger 'hubs' to secure economies of scale. There is also a move towards greater clinical and price standardisation of medical supplies across the NHS and centralised contracting for some higher-value products. Patented pharmaceuticals are generally procured directly from the originating manufacturer. Prices of drugs are (indirectly) controlled through a voluntary scheme agreed between the Department of Health and Social Care and the Association of British Pharmaceutical Industries (ABPI).
Marketing and promotion of services
The presence of the NHS limits the role of marketing in UK healthcare, and the NHS logo is a widely recognised symbol. Private healthcare services can be marketed and promoted, provided this is in accordance with the codes provided by the regulator, the Advertising Standards Authority (ASA).
The professional regulators also provide guidance on the marketing of services, obliging professionals to ensure advertising, promotional material or other information is accurate and not misleading and does not exploit patients' vulnerability or lack of knowledge. All CQC-registered services are required to display on each of their premises and websites the rating given at the most recent CQC inspection.
The ASA's advertising codes prohibit misleading, harmful or offensive advertising and require that advertising must be legal, decent, truthful, deal fairly with consumers and not be misleading or offensive. The ASA may make public rulings and impose sanctions. The advertising of medicinal products is regulated by Part 14 of the Human Medicines Regulations 2012. It is an offence to advertise a medicinal product unless it has a UK or EU marketing authorisation and there are separate requirements for marketing to the public and prescribers. Prescription-only medicines cannot be advertised. Therefore, the promotion of services that specify a treatment with a product that is not authorised in the UK or by the EU, or for a use that is not on label or that is a prescription-only medicine will breach these strictly enforced laws. Commercial practices are also regulated by the Competition and Markets Authority and local trading standards offices, who enforce the Consumer Protection from Unfair Trading Regulations 2008 and the Business Protection from Misleading Advertisements 2008, both of which prohibit misleading, unfair and aggressive commercial practices.
The Association of British Healthcare Industries and the ABPI also publish codes of practice that regulate the medical devices and the pharmaceutical industries' interactions with healthcare professionals, including all marketing and training activities. The codes are binding only on the corporate members of those associations, but are widely considered to reflect industry best practice; compliance with them (as well as NHS policies and codes) is often required contractually.
The Bribery Act 2010 applies to all market participants. It establishes general bribery offences, which apply to individuals who offer or receive an advantage with the intention to induce or reward improper performance of any function or activity. Improper performance is performance in breach of an expectation of good faith, impartiality or trust associated with that function or activity. There are also corporate offences of failure to prevent bribery and bribing a foreign public official. A body corporate may be prosecuted for failure to prevent bribery anywhere in the world.
Future outlook and new opportunities
It is likely that healthcare systems globally will have been permanently changed by the 2020 covid-19 pandemic. In England many observed that as the NHS prepared for and delivered care in the pandemic long-held assumptions were shattered. Change was achieved at never expected rates; new Nightingale hospitals were established in multiple conference centres; agreements were reached with the private sector for services, facilities and staff, medicines and equipment such as ventilators were fast-tracked through regulatory processes to reach the front line and unprecedented clinical trials were undertaken, making full advantage of the 'nation' health service.
Technological change was achieved at unprecedented pace. Whereas in 2015 at Care Quality Commission survey of GPs found none of the 319 practices offered video consultation and only 18 offered consultation by email, by April 2020 GPs were only seeing 7 per cent of patients face to face and by 11 May there have been 79,000 outpatient video consultation by hospital-based doctors. Patients and practitioners alike have had their expectations altered and a new online, technology-based service seems certain to stay. There will be lessons to be learned from the mandated use of such technology as to which patients and prescriptions are high risk and from there new priorities for providers, commissioners and regulators of healthcare services.
As indicated above, the failure of integration with care services was starkly revealed and in the reflections on the pandemic we anticipate care providers and care homes to be given a higher priority and representation at the highest level.
The NHS also had to prioritise during the crisis and only as the country begins to unlock is the true cost of delayed care being assessed. There are predictions that, given that resuming services will still have to abide by ongoing social distancing and other precautions, the number of people waiting for NHS treatment could double by the end of 2020 to 10 million. In the past, waiting times have impacted on insurance and self-paid treatment, which might be expected to increase going forward if the NHS service is as challenged as predicted.
As well as an anticipated inquiry into the handling of the covid-19 crisis, the Department of Health and Social Care has a number of major inquiries ongoing, including into the use of infected blood, and into the safety of certain medicines and medical devices. Each of these could generate recommendations on the delivery of services and the role of various NHS bodies.
The UK continues to lead the world in its genomics work. The Department of Health set up Genomics England in 2013, which sequenced its 100,000th genome in December 2018 from NHS patients with rare diseases and common cancers, creating a unique platform for research and delivery of personalised care. The NHS offers genetic screening of new cancer patients to provide personalised treatment, and full genome analysis for children with rare diseases from 2020. The potential impact of Brexit has yet to be fully realised, but it is now clear that there will be no extension to transition period and as such the UK will leave the EU on 31 December 2020. The extent of any trade agreement is still unknown, but issues such as workforce mobility, EU requirements for healthcare practitioners to have indemnity cover, marketing authorisations for new drugs and devices and procurement rules, are all likely to be under scrutiny in the negotiations.
English healthcare is delivered in an environment dominated by the NHS. However, there are opportunities for new providers to enter the marketplace to deliver services for or alongside the NHS. Innovation and new approaches are being driven by the need for cost efficiencies and a desire for greater integration of care, in an environment that wants to embrace new technology.