I OVERVIEW

Healthcare in the United Kingdom is dominated by the National Health Service (NHS), which was set up in 19462 to provide universal healthcare, 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 United Kingdom: 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, with many attempts at improving integration at a local level, in particular to keep patients out of hospital. Integrated care has tended to be successful in spite of the legislation, rather than because of it.

Healthcare services are commissioned either at the local level by clinical commissioning groups (CCGs) made up of local general practitioners3 or, for more specialised commissioning, on a national level by the National Health Service Commissioning Board4 (known as NHS England). Funding pressures in the NHS and the consequential priorities and choices have been political priorities. The biggest impact of Brexit is likely to be on the availability of healthcare professionals.

All healthcare providers are regulated by the Care Quality Commission (CQC).5 In addition, most individual healthcare professionals must be registered with the regulator for their individual profession.

There is an increasing role for private healthcare provision, either directly to the NHS (i.e., by running specific NHS-provided services) or by providing privately available services directly to patients. A recent answer to a Parliamentary question indicated that NHS spending with private sector providers in England was just over £9 billion in the 2016–2017 financial year, representing 7.7 per cent of the Department of Health's revenue budget.6 While this has been politically contentious,7 this does not seem likely to change in the short term, and private providers are as closely regulated as the NHS.

II THE HEALTHCARE ECONOMY

i General

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 emergency. In addition, some people choose to receive private treatment for specific activities, such as elective surgery or physiotherapy, where there may be a wait to receive such services on the NHS.

In England, NHS hospital treatment and primary care is free at the point of use to those ordinarily resident in the United Kingdom.8 It is funded through general taxation and national insurance deducted from salary. There are fixed, statutory charges for certain items of NHS care, such as prescription medicines and devices, dental treatment and optical treatment.9 There are a range of exemptions from these charges available on the basis of age, income or certain medical conditions. These charges and exemptions are set by the Department of Health, but are subject to parliamentary approval.

As a current member of the European Union, UK nationals are entitled to healthcare when visiting any EU member state as if they were a national of that state,10 and this is reciprocated for EU nationals in the UK. It is uncertain whether such provisions will remain after Brexit.

As of 21 August 2017, those exempt from charges for NHS services are no longer able to receive NHS medical, surgical or obstetric services provided for the diagnosis or treatment of infertility. The regulations that set the legal framework for cost recovery from chargeable overseas visitors changed in October 2017;11 it is now mandatory to collect payment, in full and in advance of providing any services, unless doing so would prevent or delay the provision of immediately necessary or urgent services to the patient. The new regulations also extended the scope of the rules to include private and voluntary providers supplying NHS services.

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,12 however in December 2017 the government announced that EU citizens who apply for post-Brexit settled status in the UK will not be required to have such insurance.13 In addition, those applying for certain types of entry clearance or leave to remain in the UK must pay a compulsory surcharge of £150–£200 a year to use NHS services.14

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. The private healthcare market has come under close scrutiny in recent years from a competition perspective. In 2014, the Competition and Markets Authority published its final report into the UK private healthcare market.15

iii Funding and payment for specific services

NHS services are commissioned at a local or national level by either the local CCG or NHS England; what services are routinely commissioned 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.16 NHS bodies are legally obliged to fund medicines and treatments recommended by NICE's technology appraisal recommendations,17 however, other forms of guidelines do not have the same level of authority.18

For example, NICE guidelines (as opposed to technology appraisal recommendations) recommended that IVF should be offered to women under 43 years of age who have been trying to get pregnant through regular unprotected sex for two years, or who have had 12 cycles of artificial insemination, with three cycles offered to women under 40 and one for those aged 40–42. 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. Another example is the very limited availability of acupuncture on the NHS in the absence of NICE recommendations.

NICE's role is to assess the clinical and financial efficacy of the technology. In addition, the Cancer Drugs Fund (CDF) is a third option at the end of the NICE technology appraisal process. The CDF acts as a managed access fund for cancer drugs where it is considered that more information is required to determine clinical effectiveness. In April 2017 a controversial budget impact test for certain technologies was introduced to assess the financial impact of a technology over the first three years of its 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. These discussions are designed to mitigate the impact that funding the technology would have on the rest of the NHS.

In some cases, further funding is available through Individual Funding Requests (IFRs). Where NHS England's duty to provide health services under Section 1H(3) of the 2006 Act is not met under NICE technology appraisal recommendations, individuals can request funding for treatments that have not been recommended through an IFR. What is considered to be an exceptional circumstance, and the law surrounding IFRs, is discussed in the case of S v. NHS England [2016] EWHC 1395 (Admin).

As set out above, standard charges apply to a number of NHS services. In England they are set out in Regulations.19

III 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.20

GP providers are normally run as independent businesses, providing services to the NHS under the General Medical Services (GMS), Personal Medical Services (PMS) or Alternative Provider Medical Services (APMS) contracts with NHS England. While these are private law contracts negotiated between NHS England and the British Medical Association (acting as the representatives of all GPs), many of the provisions are required under the National Health Service (General Medical Services Contracts) Regulations 200421 or the National Health Service (Personal Medical Services Agreements) Regulations 2015, respectively.

NHS hospitals and secondary services are run by local trusts or foundation trusts. While these are still NHS bodies, they are independent of CCGs or NHS England. The relationship 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, as a result of the large costs of operating in this area. However, secondary or hospital care may be provided by either the NHS or by private providers. Private secondary care may either take place in physically separate private hospitals, or, alternatively, in private patient units (PPUs) located in NHS hospitals; under Section 44 of the National Health Service Act 2006, NHS Foundation Trusts may provide private healthcare 'only to the extent that its exercise does not to any significant extent interfere with the performance by the NHS foundation trust of its functions'. While it is not usually possible for patients using the NHS to see a medical consultant without first being referred for secondary care 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.22 However, there has been an increasing movement in recent years towards the integration of both different health services and of health and social care,23 albeit while retaining separate legal systems for each. This is being provided through Sustainability and Transformation Partnerships24 across England, and explicit integration agreements in some areas. A recent development has been the government's proposal to introduce 'Accountable Care Organisations', which would be commissioned by CCGs to take responsibility for the healthcare of a population. However, this has been controversial and faced two legal challenges, both of which were defeated.

Healthcare in the UK now benefits from a near universal Summary Care Record 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 with the patient's GP and the relevant hospital. Attempts to create a universal digital healthcare record for every NHS user (known as 'care.data') ran into significant controversy in 2014 as a result of inadequate attempts to inform patients of the use of their data, and concerns that some data could be sold to pharmaceutical or insurance companies. The government previously announced a plan to launch a digital service allowing people to see who had accessed their Summary Care Record by December 2018, but no further information has been released.

The UK's data protection law (which regards information about a person's health to be a special category of personal data25) has been significantly strengthened by the introduction of the new Data Protection Act and EU General Data Protection Regulation in 2018, which came into force on 25 May 2018. Alongside this, NHS Digital has launched a new data security toolkit to measure and publish their performance against the National Data Guardian's data security standards, which is required to be completed annually.

IV THE LICENSING OF HEALTHCARE PROVIDERS AND PROFESSIONALS

i Regulators

There are a range of healthcare regulators in the UK, some of which operate on a UK-wide basis. There are separate regulators for healthcare operators and healthcare professionals.

ii Institutional healthcare providers

The key regulator for institutional health providers in England is the CQC.26 Whether a provider requires regulation by the CQC is dependent on what activities they are providing; carrying out a 'regulated activity' without being registered with the CQC is a criminal offence subject to a potentially unlimited fine or up to 12 months' imprisonment,27 as well as lesser regulatory sanctions. The regulated activities are set out in the Regulated Activities Regulations28 and include:

a the provision of personal care at home;

b residential accommodation together with nursing or personal care;

c treatment for a disease, disorder or injury by or under the supervision of a healthcare professional;

d surgical procedures carried out by a healthcare professional;

e diagnostic and screening procedures; and

f medical advice or triage, over the telephone or by email.

In order to be registered, a new provider must register with the CQC,29 which will assess the suitability of the applicant to provide the regulated activities. In addition, all registered providers must have a registered manager responsible for the overall management of the service, who also must be considered fit for the role. 30Among others, the following documents may be required:

a safeguarding policy and procedures document;

b building regulation document;

c registered manager's supporting evidence; and

d governance document.

The CQC anticipates that, once an application is sent to them, a notice of decision will be provided in approximately 10 weeks. Registration can be granted either unconditionally or with conditions. Appeals against a decision on registration are made to the First Tier Tribunal.31 When assessing an application, the CQC will focus on:

a compliance with the fundamental standards, including person-centred care, dignity and respect, consent, and safe care and treatment;

b management and safeguarding; and

c 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 the CQC, in particular to notify it of any changes in registered details, or of certain adverse incidents. In addition, the CQC operates a regime of both announced and unannounced inspections of providers, which will be assessed against key lines of enquiry. The 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.32

As a result of a failure in 2011 of Southern Cross, one of the largest care providers in England, the CQC also has limited market oversight powers in relation to certain care providers deemed 'too big to fail'.33

iii Healthcare professionals

Healthcare professionals in England are usually required to be registered with one of the eight different regulators, including the General Medical Council (GMC),34 the Nursing and Midwifery Council (NMC),35 the General Dental Council (which regulates the wider dental team)36 and the General Pharmaceutical Council.37 Some of these operate on a UK-wide basis, while others only operate in certain nations. In particular, a new profession of nursing associates is being created in England only. Nursing associates will be regulated by the NMC from early 2019. These regulators are overseen by the Professional Standards Authority for Health and Social Care (PSA).38 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, and operate under the direction of a registered healthcare professional.

Where a profession is regulated by one of the above regulators, registration is compulsory under the provisions of their respective legislation. Each regulator sets out its requirements for initial registration (i.e., qualifications, experience and good character), continued registration (i.e., standards to be complied with and continuing professional development) and disciplinary procedures to address serious concerns about a regulator's fitness to practise. The requirements for registration with a regulator typically vary according to whether an applicant is coming from the UK, the EU or overseas. As regulators are typically involved in setting the requirements of UK qualifications leading to registrant, an overseas applicant will normally need to demonstrate how their qualifications and training meet the requirements of an applicant with 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. There was a consultation in late 201739 about reform of the regulation of professionals in the UK.40 There is an expectation of a government response in autumn 2018 but at present, no indication has yet been given for when legislation might be submitted to parliament.

V NEGLIGENCE LIABILITY

i Overview

As a result of the UK's implementation of Directive 2011/24/EC on the application of patients' rights in cross-border healthcare, all of the professional regulators require their registrants to have indemnity or insurance arrangements providing appropriate cover for their practice.41 In the vast majority of circumstances, this will be provided by their employer. In most claims for medical negligence, the primary defendant will be the NHS Trust (represented by the NHS Litigation Authority, also known as NHS Resolution) 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 occurring, subject to the nature of the relationship between the practitioner and the institution and the connection between the wrongdoing and the relationship, although this is currently the subject of legal debate.

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 (or have them signed on their behalf) 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 of Montgomery v. Lanarkshire Health Board 42 (while this is a Scottish case, most of its principles will apply throughout the UK), which revisited a patient's right to information about the risks of a procedure in light of perceived societal changes in the doctor–patient relationship. The judgment noted that, rather than the previously paternalistic approach towards patients, they are 'now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession' (Paragraph 75). This has been formulated as 'a duty on the part of doctors 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'.43 The test of materiality is 'whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it' (Paragraph 87).

Much controversy has been 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 only recently returned to practice following an extended period of maternity leave and the errors were made towards the end of a 12-hour shift. In addition to her criminal conviction, in June 2017 the Medical Practitioners Tribunal suspended her from the GMC's register of medical practitioners for one year, however the GMC appealed this and in January 2018 the High Court instead erased her name from the register. This decision was then overturned by the Court of Appeal, which reinstated the original one-year suspension. The matter has also sparked a review into such cases and further changes to the law are being considered.

VI OWNERSHIP OF HEALTHCARE BUSINESSES

As discussed above, the Regulated Activities Regulations require directors of registered providers to comply with a range of requirements, although these requirements are currently under review. These include that the directors:44

a are of good character;

b have the qualifications, competence, skills and experience necessary;

c have not been responsible for or contributed to any serious misconduct or mismanagement while carrying out a regulated activity; and

d have not been convicted of an offence or erased from a register of health professionals.

There is no prohibition on internationally owned or non-national businesses being CQC-registered, however, there must be a registered premises in the UK from which the service is provided.

Between April 2012 and April 2014, the Competition and Markets Authority concluded that features of the privately funded healthcare market in the UK prevented, restricted or distorted competition. As a result, the Private Healthcare Markets Investigation Order (2014) was brought into force. Among wider prohibitions, the Order restricts the circumstances where a clinician can refer a patient to a private hospital where that clinician has, directly or indirectly, a financial interest in:

a that hospital;

b the hospital operator that owns or operates that hospital; or

c the diagnostic equipment or 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 very keen to welcome new investment in the UK healthcare space, which is particularly seen in 2017's Life Sciences Industrial Strategy.45

VII COMMISSIONING AND PROCUREMENT

Since the reforms of the Health and Social Care Act 2012, provision of services within the NHS has been based on a provider–commissioner basis. Services are commissioned by either NHS England or CCGs, supported by local Commissioning Support Units, depending on the nature of the service and how commonly those services are required (routine services would be commissioned on a local basis by the CCG, whereas complex, rare procedures would be commissioned by NHS England). The commissioned services may be provided by NHS providers or by private companies. The exact services to be commissioned will be based on recommendations by NICE and the available funding. The commissioning of health services is done by means of the NHS Standard Contract,46 which sets out the standard terms to be expected for the commissioning of all health services except primary care. The terms of the contract are mandated each year by NHS England.

Since 18 April 2016, procurement of healthcare services by all publicly funded or controlled NHS bodies is subject to open and 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 its own specific procurement regime under the National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013, which is overseen by NHS Improvement. These two procurement regimes may overlap in some instances.

For the procurement of supplies (as opposed to services), competitive tendering under the PCR 2015 is normally required. There is a general trend for NHS procurement of supplies (ranging from sophisticated medical equipment to non-medical supplies) to be aggregated into larger 'hubs' in order to secure economies of scale in purchasing. For similar reasons, there is 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 the Pharmaceutical Price Regulation Scheme, a voluntary scheme agreed between the Department of Health and the Association of British Pharmaceutical Industries (ABPI).

VIII MARKETING AND PROMOTION OF SERVICES

The vast majority of health services being provided by the NHS limits the role of marketing in UK healthcare. The NHS logo is a widely recognised symbol, and the NHS provides branding guidelines for this logo. Private healthcare services such as dentistry, fertility, walk-in primary care and sight testing 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 in mandatory codes or standards on the marketing of services, placing an obligation on 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 each of their websites the rating given at the last CQC inspection47.

The ASA's advertising codes prohibit misleading, harmful or offensive advertising and require that all advertising must be legal, decent, truthful, deal fairly with consumers and not be misleading or offensive. The ASA may make publicly available rulings and impose sanctions. The advertising of medicinal products is regulated by Part 14 of the Human Medicines Regulations 2012. This strictly controls the circumstances when a product may be advertised and the content of any such advertisement. 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 at all. Therefore, the promotion of health 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 of traders 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, which regulate the medical devices and the pharmaceutical industries' interactions with healthcare professionals, including all marketing and training activities. Even though these codes are binding only on the corporate members of those associations, they are widely considered to reflect industry best practice, and compliance with them (as well as various NHS policies and codes, such as its Managing Conflicts of Interest in the NHS) 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 a financial or other advantage with the intention to induce or reward improper performance of any function or activity (including activity performed as part of a public duty or commercial operations). Improper performance is understood as 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, and the foreign public official offence may apply to interactions with healthcare professionals in countries where those professionals are also public officials.

IX FUTURE OUTLOOK AND NEW OPPORTUNITIES

Since 2008, there has been a continuous pressure on NHS budgets, leading to increased innovation in order to drive cost efficiencies. The focus on innovation has also led to a greater role for localism in the NHS, with the introduction of vanguard sites to pilot new ways of providing services, and Sustainability and Transformation Plans.

There is an increasing number of online services being promoted, many of which have been welcomed in terms of speed of access, increased access for those in remote areas and potentially lower-cost services. Many of these are private services, although some have gone on to partner with NHS organisations. However, there is concern to ensure patient safety in these settings, with the CQC subjecting such providers to close inspection and guidance from bodies such as the professional regulators and new guidance from the Royal College of General Practitioners for patients.48

The Department of Health currently has a number of major inquiries ongoing in relation to English patients: into the use of infected blood;49 following the conviction of surgeon Ian Paterson for unlawful wounding during unnecessary breast surgery;50 and an independent review of apparent failures in breast cancer screening. Each of these has the potential to generate recommendations on the delivery of certain 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 by June 2018 had sequenced over 60,670 genomes51 from NHS patients with rare diseases and common cancers, creating a unique platform for research and delivery of personalised care; from October 2018, the NHS is intending to conduct genetic screening of new cancer patients to gather personalised medicine. In addition, 2018 saw the first licences to allow mitochondrial donation in embryos that will be transferred for pregnancies in the coming months.

The potential impact of Brexit has yet to be fully realised, but issues such as workforce mobility and those healthcare-related issues determined by EU law, such as the requirement of healthcare practitioners to have indemnity cover, marketing authorisations for new drugs and procurement rules, are all likely to be under scrutiny in the negotiations.

X CONCLUSIONS

English healthcare is largely delivered in a unique environment dominated by the NHS. However, the service is undergoing great change, with 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, a desire for greater integration of care and in an environment that wants to embrace new technology and personalised medicine.


Footnotes

1 Holly Bontoft is an associate and Sarah Ellson is a partner at Fieldfisher LLP. Our thanks go to our colleagues Alison Dennis, Sonal Patel, Nicholas Pimlott and Debbie Nicholson.

2 National Health Service Act 1946.

3 Section 1I, National Health Service Act 2006.

4 Section 1H, National Health Service Act 2006.

5 Section 1, Health and Social Care Act 2008.

8 Regulation 3(1), National Health Service (Charges to Overseas Visitors) Regulations 2015/328.

9 Section 172 ,National Health Service Act 2006, National Health Service (Dental Charges) Regulations 2005 (as amended) and National Health Service (Charges for Drugs and Appliances) Regulations 2015.

10 Directive 2011/24/EU, Regulation (EC) No. 883/2004.

11 The National Health Service (Charges to Overseas Visitors) Regulations 2015 were amended by the National Health Service (Charges to Overseas Visitors) (Amendment) Regulations 2017.

12 Immigration (European Economic Area) www.gov.uk/cma-cases/private-healthcare-market-investigation#final-reportRegulations 2016.

14 The Immigration (Health Charge) Order 2015/792.

16 See, in particular, Regulations 5 and 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013.

17 Regulation 7(6) National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013.

18 The obligations to comply with different types of NICE guidance, guidelines and recommendations were most recently explored in R (Rose) v. Thanet CCG [2014] EWHC 1182 (Admin), which confirmed that, while CCGs and other health bodies are required to comply with technology appraisal recommendations, other forms of NICE guidance should be seen as 'relevant considerations' (paragraphs 22 to 27).

19 National Health Service (Charges for Drugs and Appliances) Regulations 2015 and the National Health Service (Dental Charges) Regulations 2005 (as amended).

20 This position is slowly beginning to change, with the recent introduction in some areas of allowing patients to self-refer to NHS physiotherapy services in certain situations.

21 S.I. 2004/291.

22 See generally the Care Act 2014, and specifically Section 18(1) of the Act.

23 Both the Secretary of State for Health and local authorities have a duty to promote integration of health and social care services under Section 13N of the National Health Service Act 2006 and Section 3 of the Care Act 2014 respectively.

25 Section 2(e), Data Protection Act 1998.

26 Section 1, Health and Social Care Act 2008.

27 Section 10(1) and (4), Health and Social Care Act 2008.

28 Schedule 1, Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

29 Section 11, Health and Social Care Act 2008.

30 Known as the 'fit and proper person test', this is currently subject to an independent review by Tom Kark QC.

31 Section 32, Health and Social Care Act 2008.

32 Sections 17 and 18, Health and Social Care Act 2008 and the Care Quality Commission (Registration) Regulations 2009.

33 Sections 54 to 56, Care Act 2014 and the Care and Support (Market Oversight Criteria) Regulations 2015.

34 Medical Act 1983.

35 Nursing and Midwifery Order 2001 2002/253.

36 Dentists Act 1984.

37 Opticians Act 1989.

38 National Health Service Reform and Health Care Professions Act 2002.

41 For example, Section 44C, Medical Act 1983 and Article 12A, Nursing and Midwifery Order 2001.

42 (Scotland) [2015] UKSC 11.

43 Montgomery v. Lanarkshire Health Board (Scotland) [2015] UKSC 11, paragraph 82.

44 Regulation 5, The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

47 Under Regulation 20A of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.