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Consultation on the Draft Directive
Context of the proposal
Cross-border healthcare
5. There are already existing arrangements in place for patients to access healthcare in another Member State.
A. The European Health Insurance Card ( EHIC) allows temporary access to emergency healthcare while in the EU. Patients may have to pay for some of this, depending on the arrangements in the host country.
B. Healthcare for groups of people who live and work in another EU Member State, such as pensioners and workers are covered by a EU-wide social security agreement known as Regulation 1408 / 71. This route also allows people with an NHS entitlement to apply to go to another Member State for planned public sector treatment for medical reasons (under the E112 scheme) - for example, if the treatment is not available in their home country or if the treatment cannot be provided without 'undue delay' 2.
6. The main purpose of this draft Directive is to establish a framework to make provision for cross-border healthcare under the freedom to obtain services in the EU. It also proposes some EU wide measures for co-operation in other areas of healthcare.
7. Cross-border healthcare is defined in the draft Directive as, "healthcare provided in a Member State other than that where the patient is an insured person or healthcare provided in a Member State other than that where the healthcare provider resides, is registered or is established."
8. The draft Directive does not modify the existing framework for coordination of social security schemes, of which the two existing arrangements above are part.
9. This draft Directive also does not create changes to the mutual recognition of professional qualifications.
Rationale for the proposed legislation
10. The last decade or so has seen a number of court cases in the European Court of Justice about cross-border healthcare. The European Court of Justice judgments have established that EU citizens should be able to exercise rights to access treatment in other EU states under Article 49 of the EC Treaty, even for citizens accessing tax-funded systems like the NHS. Article 49 prohibits restriction on the freedom of movement of services within the European Union.
11. The effect of the case law 3 has been:
- Recognition that a patient has a right to seek healthcare abroad and be reimbursed for this, subject to certain conditions, under Article 49 of the Treaty.
- Recognition from the Court that Member States are responsible, (under Article 152 of the Treaty) for their health systems and should be able to put in place a system of prior approval for patients who want to access hospital care in another Member State, if they think that such a system is needed to manage the possible outflow of patients.
12. However, the application of the case law has left some ambiguities. For example, what is the exact level of reimbursement a patient should receive? Which country's legislation and healthcare standards should apply when a patient goes overseas for treatment - the 'sending' country, or the Member State where treatment is provided? On what grounds can a Member State refuse to authorise a patient going to another Member State for treatment? In addition, although the "Explanatory Memorandum", is clear that there is no requirement on providers in Member States to accept a patient from another Member State it is not clear on what grounds they can be refused.
13. The European Commission believes that there is some merit in codifying the case law to clarify patients' rights and address these ambiguities. The proposed Directive is specifically about the freedom of patients to "obtain services", not about the freedom of movement of providers.
Content of the Commission's proposal
14. The aim of the draft Directive is to establish "a general framework for the provision of safe, high quality and efficient cross-border healthcare." The scope of the Directive applies to "healthcare regardless of how it is organised, delivered and financed or whether it is public or private". 4
15. As explained in the Commission's Explanatory Memorandum to the draft Directive, the Commission's proposal has three components:
1) Common principles in all EU health systems
The first part of the Directive is to do with measures the Commission considers are necessary for cross-border healthcare to operate effectively, and for patients to have trust in cross-border healthcare.
2) Use of healthcare in another member state
Secondly, the Directive deals with the practicalities of cross-border healthcare, for example, who pays, for what, and how much.
3) Co-operation on healthcare
The third part of the Directive is to do with co-operation at an EU level on health matters which the Commission suggests will benefit healthcare (for example, information sharing, European Reference networks).
16. The following sections of the consultation document set out the main proposals in the draft Directive, what they may mean for the NHS, and the Scottish Government's initial views on the Directive's proposals, which chime with those of the UK Government.
1) Common principles for healthcare
17. The draft Directive clarifies that when a patient chooses to go abroad, the treatment should be provided in accordance with the legislation of the Member State of treatment. This means that if a NHS patient chooses to go to another country for treatment, it will be that country's legislation and standards that apply, not NHS standards.
18. The Commission has stated that it believes that patients should be able to rely on clear principles for quality and safety for healthcare so patients can access cross-border healthcare with confidence.
19. Therefore, Article 5 of the draft Directive acknowledges that it is the responsibility of Member States to manage their respective healthcare systems and proposes that Member States should set healthcare standards which include:
- The monitoring of healthcare providers;
- the need for complaint systems to be in place;
- the need for indemnity insurance for providers; and
- the respect for patient privacy.
20. Article 5.3 proposes that the Commission shall develop guidelines, together with the Member States, in so far as necessary to facilitate the implementation of healthcare standards in Member States.
2) Use of healthcare in another Member State
Entitlement to healthcare
21. The draft Directive states that patients can only seek reimbursement for the same or similar healthcare to which they would be entitled in their home system. It is for the home healthcare system to determine these entitlements. This means that if someone is not entitled to receive a particular treatment from the NHS - for example, some forms of cosmetic surgery or specific drugs - this Directive should not provide any additional rights to patients to have that treatment paid for by the NHS.
Reimbursement of treatment
22. Article 6 in the draft Directive sets out the suggested rules for reimbursement of treatment sought in another Member State. Patients pay for treatment in another Member State upfront and can be reimbursed up to the amount which their home state would have paid, had the patient been treated there. A Member State is not required to cover the full cost of treatment where this is higher. Where the treatment in the other Member State costs less than the cost of the treatment in the home state, the home state is required only to pay the actual cost. The level of reimbursement cannot exceed the actual cost of treatment.
23. Member States can apply the same conditions, administrative requirements and eligibility criteria for patients wishing to travel to another Member State for treatment, as they would require for accessing treatment at home, providing these formalities are not a barrier to freedom of movement. In Scotland, and throughout the UK, this should mean that a patient has to be advised by a General Practitioner ( GP) or other appropriate healthcare professional first (as the 'gatekeeper'), to establish clinical need for further specialist treatment and NHS entitlement.
24. Member States will be required to introduce a mechanism for calculating costs for reimbursement. This mechanism should be based on objective, non-discriminatory criteria which are known in advance.
Prior authorisation for hospital treatment
25. The draft Directive discusses when Member States might be able to require patients to seek approval ('prior authorisation') before accessing healthcare overseas. In Scotland, we would expect that local healthcare commissioners, the NHS Board of the patient's residence, would be responsible for granting this authorisation.
26. The draft Directive allows Member States to put in place a prior authorisation system for hospital care, provided that "the consequent outflow of patients …seriously undermines, or is likely to seriously undermine... the financial balance of the Member State's social security system; and/or the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or maintenance of treatment capacity or medical competence.
27. The prior authorisation scheme must be necessary and proportionate to this goal, and shall not constitute a means of arbitrary discrimination. It must be capable of objective justification. Member States must make information on the prior authorisation system public.
28. Hospital care is defined as care that requires at least one night stay in hospital, or is healthcare included on a list that shall be limited to treatments which a) require "use of highly specialised and cost intensive medical infrastructure or medical equipment," or b) are treatments "presenting a particular risk for the patient or the population." It is unclear how these principles will be put into practice.
29. The Commission proposes that it will be in charge of drawing up this list of treatments.
30. The draft text proposes that patients can access non-hospital care (to which they are entitled in their home state) in another Member State without the requirement of prior authorisation. It is important to note that some healthcare that is in practice delivered in Scotland in a non-hospital setting may still be subject to prior authorisation, if it is on the list referred to in the paragraph above.
31. Member States must also set out time limits within which requests for the use of healthcare in another Member State must be dealt with, taking into account the specific medical condition, the patient's degree of pain, the nature of the patient's disability, and the patient's ability to carry out a professional activity.
Patients coming from other Member States for treatment
32. The case law, and in time the Directive, will apply in all EU Member States and the European Economic Area (because it is based on freedom to obtain services, which applies to EEA and EU countries). This means that patients can choose to come to the UK for treatment as well as UK nationals travelling abroad for treatment. The draft Directive does not allow home systems to discriminate against patients accepted from other Member States.
33. However, the draft Directive also states that nothing requires a system to accept a patient for planned treatment to the detriment of other patients with similar health needs. In this context, our understanding is that providers in receiving Member States are not automatically obliged to accept a patient from another Member State. This would seem to be helpful in protecting limited capacity. On the other hand, if a provider has accepted an overseas patient for treatment and there are two patients who have the same clinical need the Member State of treatment cannot discriminate against the other Member State's patient. The draft Directive is currently unclear about the grounds on which providers can refuse to accept a patient from another Member State.
Patient data to be shared
34. The draft Directive proposes that patients accessing treatment in another Member State should be able to access their medical records subject to data protection provisions.
Information for patients
35. Under the draft Directive Member States need to provide information to patients who are going abroad for treatment and the terms and conditions that apply, including how to seek redress if things go wrong. Information on entitlements to EU treatment should be easily accessible, including electronically, and should include details on access procedures and system of appeals. The Commission may develop a standard EU-wide format covering the above information.
36. National contact points will be responsible for providing information to patients on their entitlements to cross-border treatment and helping them seek appropriate redress in the event of harm. The national contact point should gather information on national bodies operating out-of court settlements and facilitate the development of an international out-of-court settlement scheme for cross-border healthcare disputes.
37. The Commission has proposed that it manage the network of national contact points, outline the type of data to be collected and the nature of the information to be provided to patients.
3) Co-operation on healthcare
EU-wide recognition of prescriptions
38. Article 14 of the Directive deals with EU wide recognition of prescriptions, prohibiting restrictions on recognition of individual prescriptions unless they are "necessary and proportionate to safeguard human health and are non-discriminatory" or are due to "legitimate and justified doubts about the authenticity or content of an individual prescription".
39. Separately to the Directive, the UK Government has already amended legislation to allow, from November 2008, UK pharmacists, at their professional discretion, to dispense a prescription-only medicine in response to a prescription written by a doctor or dentist who legally practices medicine or dentistry in another EEA State or Switzerland. However, the requirements for the prescription are the same as the legal requirements for valid prescriptions in the UK. The changes do not apply to the prescribing of medicines which do not have a Marketing Authorisation (licence) in the UK, nor will they apply to any products or substances regulated under the UK's Misuse of Drugs Act 1971.
40. The draft Article 14 states that the Commission will bring forward measures to facilitate recognition of prescriptions, including a Community prescription template and supporting interoperability of e-Prescriptions.
European Reference Networks
41. The Directive aims to facilitate the development of European reference networks. These networks are the subject of an existing pilot study and aim to share expertise amongst clinicians in the treatment of rare diseases. Membership is open to providers who meet certain criteria (to be specified by the Commission). The aims of the networks will include co-operation among Member States on highly specialised care; concentrating resources for cost-effectiveness; sharing knowledge and training for health professionals; providing quality and safety benchmarks; and helping Member States with insufficient numbers of patients to provide a highly specialised service.
Data Collection required by the Directive
42. The Directive would create various requirements on Member States around data collection and sharing. Article 18 requires that statistical and other data is collected on cross-border healthcare, including the care provided, the patients and providers, the cost and outcomes of the care.
E-health
43. Draft Article 16 provides for the Commission to adopt specific measures to achieve inter-operability of health information and communication systems whenever Member States decide to adopt them.
44. The Commission has proposed that they will be able to specify the necessary standards and terminologies for inter-operability of relevant information and communication technology systems to ensure safe, high-quality and efficient provision of cross-border health services.
Health Technology Assessment Network
45. The EU has proposed that Member states shall facilitate development and functioning of a network connecting their authorities or bodies responsible for health technology assessment.
46. This will be to support cooperation and enable effective exchange between such bodies and support provision of objective, reliable, timely, transparent and transferable information on health technologies.
47. The Commission shall adopt the necessary measures to establish and manage the network and specify the nature and type of the information to be exchanged.
Initial Scottish Government views on the Directive
48. The Scottish Government welcomes the draft Directive as a means of ensuring clarity in how patients' rights are applied to cross-border healthcare. The case law has established that patients have a number of rights under the EC Treaty, and it is important to be clear how, for example, a reimbursement system would work in practice.
49. The draft Directive will be subject to change during negotiations. The Scottish Government's initial views, which chime with those of the UK Government, are set out below.
1) Common principles for healthcare
50. The Scottish Government agrees that where healthcare is provided, it should be safe and high quality. However, the Scottish Government considers that Member States are best placed to manage their healthcare systems and set standards. It considers that the draft Directive is currently not clear on the extent to which Article 5 may provide for EU wide standards. The Scottish Government does not consider that EU wide guidelines on quality, safety etc are necessary to allow for cross-border care.
51. In terms of healthcare standards, healthcare providers in Scotland are already required to meet national standards.
2) Use of healthcare in another Member State
52. The Scottish Government welcomes the draft Directive's provisions which make clear that it is the responsibility of the home state to decide entitlements to healthcare and that Member States can maintain 'gatekeeper' arrangements to ensure that treatment is provided on the basis of clinical need.
53. The Scottish Government agrees that where a patient goes overseas for treatment, he or she should only be entitled to reimbursement for treatment he or she would have been entitled to from the NHS and up to the level to which it would have cost the NHS to provide the treatment.
54. Although the draft Directive makes clear that it is for the home health service to determine what healthcare people are entitled to, we want to make sure that the text allows for local healthcare commissioners, in Scotland the NHS Board of the patient's residence, to continue to set local priorities and offer services to their patients based on local needs.
55. To ensure that the Directive provides a sustainable framework for cross-border healthcare and that Member States can manage their healthcare systems, the Scottish Government believes that prior authorisation systems are a sensible and necessary measure. For hospital care we believe it is important that Member States can establish prior authorisation schemes in order to manage entitlement and the impact of patient mobility on health systems as well as allow patients greater certainty around reimbursement. The Scottish Government notes that the draft Directive does not currently allow Member States to require a system of prior authorisation when patients want to access 'non-hospital care.'
56. Under the Directive, patients will be required to pay the costs of treatment in the EU upfront and then seek reimbursement up to the level that it would have cost the NHS to treat the patient at home. Although some people may be eligible to apply for help with travel costs (if they are eligible for help with healthcare travel costs in Scotland) the Scottish Government recognises that many people may not be able to afford to seek treatment abroad. We would welcome comments about any potential impact on equity the draft Directive may have.
57. In addition, we believe there are some practical issues to be addressed in terms of how the Directive will be applied to the NHS. These include being clear about costing mechanisms as it may prove difficult to establish costings for some services. Arrangements differ in other UK Countries.
58. There may also be some practical difficulties for patients and clinicians needing to rely on patient records that are possibly in a different language.
3) Co-operation on healthcare
59. In general we believe that there may be a role for EU wide co-ordination in some areas of healthcare, but only where this can share expertise and add value to existing domestic policy.
60. The UK Government recently amended Medicines legislation 5 to facilitate the mutual recognition of prescriptions. The draft Directive proposes that the Commission may develop an EU-wide prescription template. We will need to consider if this goes beyond the information required on UK prescriptions. We will also need to consider any measures proposed to facilitate the mutual recognition of prescriptions, such as e-prescriptions, to ensure patient safety is maintained.
61. The UK has been participating in the European Reference Networks pilot project. This presents an opportunity for clinicians to share expertise on the treatment of rare diseases. We support the aim of the reference networks but think their remit should be limited to covering treatment for rare diseases only.
62. Concerning e-health, the Scottish Government already collaborates on e-health initiatives as part of the European eHealth Action Plan. The Government notes that the provisions in the Directive relating to ehealth are potentially quite wide. It will be seeking to clarify the scope of this provision so that costs and benefits can be appropriately assessed.
63. The Scottish Government acknowledges that data collection requirements under the Directive may lead to additional costs for the NHS.
64. Finally, the Scottish Government broadly supports health technology assessment networks as a means of sharing information and good practice but is keen to advocate using existing mechanisms.
Impact assessment
65. The Scottish Government considers that it is very important that the proposed Directive facilitates a sustainable framework for patient mobility. It is difficult to predict the level of cross border healthcare in the future. Patients already have the right to access cross-border healthcare, but the clarification of how this operates through the Directive is likely to lead to an increase in patients accessing cross-border healthcare in the medium to long term.
66. In order to start to assess the potential economic impact that the Directive has, the Department of Health has prepared a UK-wide partial impact assessment to accompany this UK-wide consultation. This is available at: www.dh.gov.uk/en/consultations/index.htm
67. Respondents are invited to comment on the initial impact assessment. We would welcome data on what numbers of patients might be expected to access cross-border healthcare (both incoming and travelling abroad) and the treatments they might require, to help us as develop our thinking in this area further.
Equality Impact Assessment Screening Template
68. The partial impact assessment also includes an equality Impact assessment screening template. After due consideration, the Department of Health has concluded that it should undertake a full Equality Impact Assessment. We agree, and would welcome data and information from stakeholders to inform the development of this.
Working with the NHS
69. The NHS Confederation (through its NHS European Office) is engaging with its members to consider the implications of this Directive for the NHS. Their findings will be considered alongside those from this wider public consultation.
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