Cross Border Healthcare & Patient Mobility: Public Consultation on Scotland's Transposition and Implementation of Directive 2011/24 EU on the Application of Patients' Rights in Cross-border Healthcare.

Article 4 - Responsibilities of the Member State of treatment

8.1 Article 4 sets out the responsibilities of Member States where healthcare providers in their territory are providing treatment under the Directive. The Regulations will deal with visiting patients, that is patients who are insured for healthcare in another Member State and are seeking healthcare in Scotland under the provisions of the Directive. In this scenario, as a part of the Member State, Scotland would be responsible for ensuring that healthcare providers meet the following requirements:

• Provide patients with relevant information on treatment options and quality and safety;
• Provide clear invoices and price information;
• Apply fees in a non-discriminatory manner;
• Ensure transparent complaints procedures and procedures to obtain redress;
• Apply adequate systems of professional liability insurance or similar;
• Respect privacy in processing personal information;
• Supply patients with a copy of the record of their medical treatment.

8.2 On the face of it, these are comparatively routine requirements that most patients would expect to be in place for treatment provided in a foreign country. However, it is important to be clear about some specific points.

Scope

8.3 Who is and who is not a "health professional" differs considerably across Europe. As an example osteopaths are a regulated profession in only seven Member States throughout the EU (the UK being one of them). There is little in the way of consistency about who is and who is not regulated throughout Europe.

8.4 The Directive defines "healthcare provider" by reference to the definition of "health professional" and "healthcare" in the Directive. Accordingly, the term "healthcare provider" means natural or legal person (for example a company) legally providing healthcare on the territory of the Member State. "Healthcare" is defined as health services provided by "health professionals" to patients to assess, maintain or restore their state of health, including the prescription, dispensation, and provision of medicinal products and medical devices.

8.5 The definition of "healthcare professional" in the Directive is a doctor of medicine, a nurse, a dental practitioner, a midwife or a pharmacist within the meaning of Directive 2005/36/EC or another professional carrying out activities in the healthcare sector which are restricted to a regulated profession as defined in Directive 2005/36/EC or a person considered to be a health professional, according to the legislation of the Member State of Treatment.

8.6 Therefore, in accordance with our national legislation that regulates health professionals, the requirements on "healthcare providers" will apply to "healthcare" provided in Scotland by any registrant of the following statutory healthcare regulators, whether as an individual or as an employee of a legal entity:

• General Chiropractic Council
• General Dental Council*
• General Medical Council
• General Optical Council
• General Pharmaceutical Council*
• General Osteopathic Council
• Health and Care Professions Council* (also regulates social workers in England)
• Nursing and Midwifery Council

*The regulation of healthcare professionals is reserved to Westminster apart from certain professional groups regulated by the three bodies highlighted above, where regulation began after the introduction of the Scotland Act 1998. In addition, the regulation of any new professional group by any of the regulatory bodies above or the establishment of a new regulatory body will also be a devolved matter.

Consultation question

• Are there any other "health professions" in the UK to which the provisions of the Directive will apply when treatment is provided in Scotland?

Obligations on providers

8.7 The focus of Article 4 then moves to how to ensure that the Article 4(2) obligations on providers (information on treatment options, quality & safety, pricing & invoices, complaints procedures, non-discrimination) are applied across the board - and what happens if these obligations are not properly observed? Here, we believe the requirements of the Directive can be met through the various existing requirements imposed by statutory healthcare regulators, together with existing consumer protection provisions and that it is not necessary to make further provision in the regulations to implement the Directive.

8.8 The purpose of health profession regulation is to protect the public. Regulation ensures that those who practice a health profession are doing so safely. Regulatory bodies have four main functions:

• Establishing standards of competence, ethics and conduct;
• Establishing Standards of training;
• Keeping a register of those who meet the standards;
• Dealing with registrants who fall short of the standards required through fitness to practice action (e.g. placing conditions on their registration or removing them from the register).

8.9 The heath regulators produce a variety of standards, guidance, codes of practice and codes of conduct that govern the way in which their registrants are required to act as regulated professionals. As such, health professionals are bound to comply with the provisions contained in these documents. Failure to do so brings into question their conduct or performance and then the regulatory bodies can take account of whether the standards have been met, when deciding if it would be appropriate to take" fitness to practice" action to protect the public.

Thus, we believe that a good standard of regulatory coverage is in place for cross-border patients seeking healthcare services in Scotland.

Delivering the Article 4 obligations

National Contact Points - Article 4(2)(a)

8.10 Article 4(2) (a) introduces the concept of National Contact Points (NCPs). This sets out that the NCP shall supply patients with "relevant information" on:

• Standards and guidelines on quality and safety in UK and Union legislation;
• Provisions for the supervision and assessment of healthcare professionals;
• Information on which health providers are subject to such standards and any restriction on practice;
• Information on hospital accessibility for persons with a disability.

8.11 What is "Relevant information" is not defined, in either Article 4 or elsewhere in the Directive. The idea behind NCPs is to establish a network of such bodies across the Community to facilitate patient information and access to services. To a large extent, this is an area where Member States will need to co-ordinate their approach, since a degree of uniformity of provision and practice across the Community will be required. Discussions at European level are continuing in this area.

8.12 Our preferred approach to implementation is to re-order the provisions relating to the NCP, which are contained in Articles 4, 6 and 10 of the Directive and to group them together in the domestic Regulations (see also the discussion around Article 6 below). We would then provide detailed guidance on "how" the NCP will go about its business.

Pricing & how much to charge patients - Article 4(2)(b) & (4)

8.13 The Directive requires healthcare providers to give patients clear information on prices and to provide them with clear invoices. Providers cannot seek to charge more simply because the person is an EEA patient seeking treatment under the Directive.

8.14 In terms of how these requirements are met, for secondary NHS care, NHS Boards should recover the full cost of the treatment provided to EEA patient under the Directive, including an element to cover reasonable costs of administration. Member States must have a transparent mechanism for the calculation of costs for cross-border healthcare, which must be based on objective, non-discriminatory, criteria known in advance.

8.15 A number of methods for charging exist in primary care, where services are provided by GP practices, dental practices and community pharmacies and high street optometrists. There is no formal tariff system in primary care, so the current system of patient charging will depend on the treatment or service that is required.

8.16 For GP and out of hour services, if an EEA national is treated as an NHS patient (as they should be unless they specifically ask to be treated privately), then the treatment / consultation is free of charge. However, while NHS prescriptions are free to patients who are ordinarily resident in Scotland, EEA patients should be charged the actual NHS tariff cost of any medication that is dispensed by a community pharmacist.

8.17 While NHS dental patients who are ordinarily resident in Scotland pay 80% of the cost of NHS dental treatment, up to a ceiling of £384, EEA patients should be charged the actual cost of NHS dental treatment with no dispensations.

8.18 Some groups of patients who are ordinarily resident in Scotland are entitled to free NHS sight tests and optical vouchers to help with spectacles or contact lenses. The same principles should be applied in calculating charges for EEA patients.

Independent Providers

8.19 An EEA patient seeking treatment in Scotland may wish to access services in the independent sector, which is not governed by the same charging principles as the NHS. Nevertheless, the Directive obligations on clear pricing apply equally to healthcare provided to a visiting patient by either the public (NHS) or private sector. However, Member States are not obliged to provide more extensive information on accessing private healthcare to visiting patients than it provides for its own resident patients.

8.20 We consider that the obligation on clear information on prices and invoices can be satisfied by domestic consumer protection legislation - in particular, the Consumer Protection from Unfair Trading Regulations 2008. This legislation sets out the rules that apply to consumer protection and the responsibilities on businesses to trade fairly. The Regulations implement the Unfair Commercial Practices Directive (2005/29/EC) in the UK and set a general duty not to trade unfairly, as well as ensuring that traders act honestly and fairly towards their customers. If a trader misleads or otherwise acts unfairly towards consumers, then the trader is likely to be in breach of the Regulations and may face action by enforcement authorities (in the UK, the Office of Fair Trading). Both civil and criminal enforcement is possible under the Regulations.

Non-Discrimination

8.21 Article 4 requires non-discrimination with regard to nationality; in particular, Article 4(2) requires the Member State providing the treatment to ensure that an incoming patient is charged the same prices that apply to a domestic patient in a compatible situation. Healthcare providers must, therefore, apply the same scale of fees for healthcare to EEA patients as for domestic patients. If there is no comparable price for domestic patients, the price must be based on objective, non-discriminatory criteria (Article 4(4)).

8.22 This also means that independent providers who deliver NHS services will only be able to charge the same price as that for resident NHS patients, should an EEA patient seek treatment as if they were an NHS patient. They will only be able to charge the patient on a private basis if the patient has specifically asked to be treated privately.

8.23 Providers cannot routinely refuse EEA patients on the grounds of nationality, but may do so where the delivery of such treatment would cause significant detriment to home patients waiting for similar treatment or where there is insufficient capacity to treat additional patients who are not ordinarily resident in Scotland.

8.24 The Equality Act 2010 prohibits direct or indirect discrimination in the provision of services (whether for payment or not) on the grounds of race. Section 9(1) of the Act sets out that" race" includes colour, nationality and ethnic or national origin.

Transparent complaints procedures - Article 4(2)(c)

8.25 Details of the Scottish NHS Complaints Procedure are available through the Health Rights Information Scotland Website at:

http://www.hris.org.uk/index.aspx?o=1025

Professional liability insurance - Article 4(2)(d)

8.26 Article 4(2)(d) sets out the requirements for systems of professional liability insurance (or similar such arrangement). This means that any healthcare provider or individual health professional, not already covered by vicarious arrangements, must have an appropriate level of indemnity cover and make this known to the incoming patient. This is a policy area that has already been evolving separately in the UK following the 2010 independent review of the requirement to have insurance or indemnity as a condition of registration as a healthcare professional, chaired by Finlay Scott. The UK and Scottish Government has accepted the recommendations of the review and the subsequent work to deliver the commitments in this area will ensure that the requirements of Article 4(2) (d) will be met in full in respect of individual professionals. This work is UK-wide in scope.

Personal data & patient medical records - Article 4(2)(e)&(f)

8.27 The Directive requires the right to privacy with respect to the processing of personal data and that patients are supplied, on request, with a copy of the record of their medical treatment. That is, granting a copy of the record of treatment for the cross-border patient to take away (back to their own Member State for follow up with their own clinicians).

8.28 The Data Protection Act 1998 (as amended) provides safeguards on the protection of personal information and the right for a patient to request a copy of their health records. The right can also be exercised by an authorised representative on the individual's behalf.

8.29 This legislation is UK-wide in scope. Data Protection legislation defines a health record as a record consisting of information about the physical or mental health or condition of an identifiable individual made by or on behalf of a health professional in connection with the care of that individual. A health record can be recorded in computerised or manual form or in a mixture of both.

8.30 A health record may include such things as; hand-written clinical notes, letters to and from other health professionals, laboratory reports, radiographs and other imaging records e.g. X-rays and not just X-ray reports, printouts from monitoring equipment, photographs, videos and tape-recordings of telephone conversations. Data Protection legislation is not confined to health records held for National Health Service purposes. It applies equally to all relevant records relating to living individuals; this includes the private health sector and health professionals' private practice records. The relevant guidance may be accessed here:

http://www.scotland.gov.uk/Publications/2012/01/10143104/0

http://www.hris.org.uk/index.aspx?o=1026

Other General Principles

8.31 Article 4 confirms that the Member State of treatment is not required to provide treatment to anyone where this would undermine significantly the treatment of home patients. Article 4(3) also confirms that where justified by overriding reasons of general interest (such as planning requirements or the wish to control costs) the Member State of treatment may adopt measures controlling access to treatment were this is necessary and appropriate. This could not be an arbitrary decision and would need to be supported by clear evidence on the effects of cross-border healthcare on the home system.

8.32 Member States may provide information in other EU languages if they choose to do so. We propose covering all of these points in guidance.