1. TAIEX Workshop on the Cross- Border Healthcare Directive Ankara, Turkey, 27-28 April 2015 Topic 3: Reimbursement of Costs of Cross-Border Healthcare Professor Tamara Hervey, Jean Monnet Professor of EU Law and Head of School, School of Law, University of Sheffield, UK t.hervey@sheffield.ac.uk t.hervey@sheffield.ac.uk

2. Outline 1.The ‘general principle’ 2.Regulation 883/2004 and Article 56 TFEU 1.Undue delay 2.Amount of reimbursement 3.Prior authorisation 4.The ‘basket of care’ 5.Conclusions

3. The ‘general principle’ Article 7 General principles for reimbursement of costs 1. Without prejudice to Regulation (EC) No 883/2004 and subject to the provisions of Articles 8 and 9, the Member State of affiliation shall ensure the costs incurred by an insured person who receives cross-border healthcare are reimbursed, if the healthcare in question is among the benefits to which the insured person is entitled in the Member State of affiliation.

4. Reimbursement of costs Same basis as entitlement within the MS Assessment by health professional or administrator If assessments are ‘obstacles’ to free movement, must be objectively justified Justifications by ‘planification’, ensure sufficient access to healthcare, control costs, avoid waste of resources

5. Reimbursement of costs Only up to the level of costs that would have been paid in the home MS Only for actual healthcare, not associated costs, unless MS chooses otherwise

6. Subject to 3 key exceptions It applies “without prejudice to Regulation 883/2004/EC” (the relationship with Regulation 883/2004) It is subject to the provisions on prior authorization in Directive 2011/24/EU, Articles 8 and 9 (the prior authorization rules) It applies only to circumstances where “the healthcare in question is among the benefits to which the insured person is entitled in the Member State of affiliation” (the “basket of care”)

7. Relationship with Regulation 883/2004 and Article 56 TFEU Regulation 883/2004 (ex Regulation 1408/71/EEC) oldest part of EU law on mobile patients Free movement of workers and self-employed in practice Coordination of social security entitlements between MS Broad personal scope and material scope

8. Regulation 883/2004 Based on non-discrimination, aggregation of benefit rights, exportability of benefits, ‘single state’ rule for affiliation Generally applies to person moving not as a patient, but as a worker, self-employed person, family member, or travelling for pleasure Right to healthcare for workers and self- employed as if insured in MS of residence Right to emergency healthcare during a stay in a MS

9. Regulation 883/2004 Rights where travel to another MS for the purpose of receiving healthcare/medical treatment MS may authorise treatment – retain control MS must authorise treatment (Article 20 (2)): (a) the treatment in question is covered by the home Member State’s health care system and (b) where the patient cannot be given such treatment within a medically justifiable time- limit, taking into account his or her current state of health and the probable course of his illness

10. Article 56 TFEU Prohibits ‘restrictions’ on freedom to provide services Includes freedom to receive services Very broad definition of ‘restriction’ – in line with its aim Any measures which make provision of services between MS more difficult than within one MS

11. Article 56 TFEU Non-contentious (generally) for private healthcare Since 1990s, also applies to healthcare reimbursed by national health (insurance) system Surprising, because ‘remuneration’ needed National health (insurance) systems organised on solidarity – assumed no ‘remuneration’ But CJEU held otherwise in Kohll case

12. Article 56 TFEU It follows that application of the prior authorisation rules under Regulation 883/2004/EC may in itself be a ‘restriction’ in the sense of Article 56 TFEU, wherever such a system of prior authorisation ‘prevents or deters’ patients from seeking health care from providers in other Member States

13. Reg 883/2004 & Article 56 CJEU stresses interconnected Also stressed in Directive 2011/24/EU Article 56 does not invalidate Regulation – rather they must be interpreted consistently CJEU has considered: – the question of what counts as ‘undue delay’ so as to require an authorization to receive cross-border care; – the amount of reimbursement to which a patient is entitled; – the question of when an authorization system is justified; and – the ‘basket of care’ that is covered by a health system.

14. ‘Undue delay’ Inizan and Watts – ‘within the time normally necessary for obtaining the treatment in question’ from the Regulation interpreted as ‘without undue delay’ in cases involving Article 56 TFEU Must be individual assessment of the patient General rules about waiting times not sufficient

15. Directive 2011/24, Article 8 Healthcare that may be subject to prior authorisation 5. Without prejudice to points (a) to (c) of paragraph 6, the Member State of affiliation may not refuse to grant prior authorisation when the patient is entitled to the healthcare in question in accordance with Article 7, and when this healthcare cannot be provided on its territory within a time limit which is medically justifiable, based on an objective medical assessment of the patient’s medical condition, the history and probable course of the patient’s illness, the degree of the patient’s pain and/or the nature of the patient’s disability at the time when the request for authorisation was made or renewed. 6. The Member State of affiliation may refuse to grant prior authorisation for the following reasons: … (d) this healthcare can be provided on its territory within a time limit which is medically justifiable, taking into account the current state of health and the probable course of the illness of each patient concerned

16. Amount of reimbursement Vanbraekel - where the application of the prior authorisation rules under Regulation 1408/71/EEC results in a lower level of cover where treatment is received in another Member State to that in which the patient is insured, this constitutes a restriction in the sense of Article 56 TFEU – implies patients could make a profit Commission v Spain (Emergency hospital care) – rule in Vanbraekel applies only to scheduled treatment, not emergency treatment

17. Directive 2011/24, Article 7 General principles for reimbursement of costs 4. The costs of cross-border healthcare shall be reimbursed or paid directly by the Member State of affiliation up to the level of costs that would have been assumed by the Member State of affiliation, had this healthcare been provided in its territory without exceeding the actual costs of healthcare received.

18. Prior authorisation Article 8 – MS may have a system of prior authorisation of cross-border health care There is a list of types of health care that may be subject to prior authorisation The list is inspired by the CJEU’s rulings The list goes further than the CJEU’s rulings

19. May be subject to prior authorisation Health care that is “made subject to planning requirements relating to the object of ensuring sufficient and permanent access to a balanced range of high-quality treatment in the Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources and: (i) involves overnight hospital accommodation of the patient in question for at least one night; or (ii) requires use of highly specialised and cost-intensive medical infrastructure or medical equipment;”

20. May be subject to prior authorisation Health care that “involves treatments presenting a particular risk for the patient or the population”, or Health care that is “provided by a healthcare provider that, on a case-by-case basis, could give rise to serious and specific concerns relating to the quality or safety of the care, with the exception of healthcare which is subject to Union legislation ensuring a minimum level of safety and quality throughout the Union”.

21. MS must authorise cross-border health care when the patient is entitled to the healthcare in question in accordance with Article 7, and when this healthcare cannot be provided on its territory within a time-limit which is medically justifiable, based on an objective medical assessment of the patient's medical condition, the history and probable course of the patient's illness, the degree of the patient's pain and/or the nature of the patient’s disability at the time when the request for authorisation was made or renewed”.

22. MS need not authorise this healthcare is to be provided by a healthcare provider that raises serious and specific concerns relating to the respect of standards and guidelines on quality of care and patient safety, including provisions on supervision, whether these standards and guidelines are laid down by laws and regulations or through accreditation systems established by the Member State of treatment;

23. MS need not authorise “the patient will, according to a clinical evaluation, be exposed with reasonable certainty to a patient-safety risk that cannot be regarded as acceptable, taking into account the potential benefit for the patient of the sought cross-border healthcare; the general public will be exposed with reasonable certainty to a substantial safety hazard as a result of the cross-border healthcare in question;

24. MS need not authorise this healthcare can be provided on its territory within a time-limit which is medically justifiable, taking into account the current state of health and the probable course of the illness of each patient concerned.

25. National authorities must Consider whether a treatment method/healthcare provided in another MS ‘corresponds to benefits provided for’ by the home MS If it does, authorisation must be given under the Regulation If it does not, no obligation to authorise under the Regulation And no obligation to reimburse under the Directive either

26. ‘Basket of care’ Case law on basket of care states nothing in EU law requires MS to extend their reimbursable ‘basket of care’ But - Elchinov – a general rule excluding, in all cases, payment for hospital treatment given in another Member State without prior authorisation breaches Article 56 TFEU and is not justified

27. ‘Basket of care’ Elchinov para 62 “where the list of medical benefits reimbursed does not expressly and precisely specify the treatment method applied but defines types of treatment, on the one hand, … it is for the competent institution of the Member State of residence of the insured person to assess, applying the usual principles of interpretation and on the basis of objective and non-discriminatory criteria, taking into consideration all the relevant medical factors and the available scientific data, whether that treatment method corresponds to benefits provided for by the legislation of that Member State. It also follows, on the other hand, that, if such is the case, an application for prior authorisation cannot be refused on the ground that such a treatment method is not available in the Member State of residence of the insured person, since such a ground, if it were accepted, would imply a restriction on the scope of the second subparagraph of Article 22(2) of Regulation No 1408/71”

28. ‘Basket of care’ Similarly – Petru - authorisation under Regulation 1408/71 must be given where lack of medication and basic medical supplies and infrastructure means that the treatment concerned cannot be provided ‘in good time’. This assessment must be by reference to all hospitals in the home Member State.

29. ‘Basket of care’ Petru, para 36 “the second subparagraph of Article 22(2) of Regulation No 1408/71 must be interpreted as meaning that the authorisation necessary under Article 22(1)(c)(i) of that regulation cannot be refused where it is because of a lack of medication and basic medical supplies and infrastructure that the hospital treatment concerned cannot be provided in good time in the insured person’s Member State of residence. The question whether that is impossible must be determined by reference to all the hospital establishments in that Member State that are capable of providing the treatment in question and by reference to the period within which the treatment could be obtained in good time”

30. ‘Basket of care’ Where treatment abroad is more medically advanced than in the home Member State, according to the internationally accepted views of the medical profession “The state may no longer justify prioritizing its own offer of treatment” (Rindal v Norway, EFTA Court, [83]) but must interpret its list of types of treatment appropriately, taking into account “the available scientific data” (Elchinov EU:C:2010:581, [62]) not simply refuse to authorise treatment on the basis that that particular treatment is not available in the home Member State. Moreover, lack of medical infrastructure, medication and basic medical supplies can be a reason that authorization must be given, because ‘the same or equally effective treatment cannot be given in good time’ (Petru EU:C:2014:2271, [33]) in the home Member State.

31. Directive 2011/24 Article 7 General principles for reimbursement of costs 1. Without prejudice to Regulation (EC) No 883/2004 and subject to the provisions of Articles 8 and 9, the Member State of affiliation shall ensure the costs incurred by an insured person who receives cross-border healthcare are reimbursed, if the healthcare in question is among the benefits to which the insured person is entitled in the Member State of affiliation.

32. ‘Basket of care’ Patients’ Rights Directive different approach But Elchinov and Rindal are consistent with the Patients’ Rights Directive in the sense that the list of types of treatment is to be determined by the Member State concerned. It is simply that the interpretation of the list is subject to EU law on free movement. Thus the home Member State controls the “basket” of health care entitlements The desire of a patient to consume health care services available in another Member State, but not the home Member State, has not been translated into a right embodied in EU legislation to do so, or an obligation on the Member States to pay for such treatment where desired.

33. Conclusions Directive consolidates and extends case law under Article 56 TFEU Directive clarifies the relationship between that case law and Regulation 883/2004/EC. Directive in the language of entitlements of patients But substantive content is about national health systems Detail is on exceptions to patients’ rights In understanding the rules on reimbursement of costs of cross-border health care, and implementing them, it is essential to take this into account

34. A blank slide

35. TAIEX Workshop on the Cross- Border Healthcare Directive Ankara, Turkey, 27-28 April 2015 Topic 6: Cooperation on Health Technology Assessment Professor Tamara Hervey, Jean Monnet Professor of EU Law and Head of School, School of Law, University of Sheffield, UK t.hervey@sheffield.ac.uk t.hervey@sheffield.ac.uk

36. Health technology assessment Article 15 Cooperation on health technology assessment 1. The Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States. The Member States shall communicate their names and contact details to the Commission. The members of such a health technology assessment network shall participate in, and contribute to, the network’s activities in accordance with the legislation of the Member State where they are established. That network shall be based on the principle of good governance including transparency, objectivity, independence of expertise, fairness of procedure and appropriate stakeholder consultations.

37. Objectives of the network Cooperation Provide comparable information on effectiveness of health technologies Information analysis Avoid duplication of assessments Network receives aid National competence remains

38. Attempt at ‘EU added value’ Individual assessments at national level Competing objectives balanced – Patient access to new technologies – Patient demand – Reward innovation – Cost-effectiveness to health systems – Fiscal prudence within the Eurozone – Financial sustainability of health systems – Relative efficacy Not ‘scientific’ – many ‘political’ elements Only technologies recognised for reimbursement will succeed Single market in pharmaceuticals and medical devices But no harmonised procedure for coverage within national health systems – which is what matters in practice

39. Other legislation Transparency of Pharmaceuticals Pricing Directive – applies only to pharmaceuticals, not to medical devices or equipment – does not directly affect how national health systems set pharmaceuticals prices – does not directly affect HTA – only seeks to ensure transparency – procedure not substance

40. Other legislative proposals Proposed amendment to Transparency Directive – attempted to reduce overlap between the marketing authorisation procedure (at which equivalence or similarity of assessments is already determined) and the procedure for national health (insurance) system pricing and reimbursement rules. – permitted Member States to continue to use data on equivalence or similarity as part of the health technology assessment process – withdrawn in March 2015

41. Coordination, not harmonisation Source: Finn Børlum Kristensen, Development of European HTA: from Vision to EUnetHTA Michael 2012;9: 147–156 http://www.dnms.no/index.php?seks_id=149347&a=1&treeRoot=147800

42. Barriers differences in the extent and scope of health technology assessment analysis differences in reporting the results need for glossary of common terms need for ‘toolkit’ (a ‘series of checklists and resources that identify or clarify the relevance, reliability, and transferability of data and information from existing reports’) to achieve comparability of health technology assessments new information infrastructures must also be agreed and designed

43. Benefits the EU has many health technology assessment agencies, each producing their own health technology assessment reports multiple reports are produced on the same health technology if these reports could be used in different contexts, across different Member States, there would be a significant saving in time and resources

44. Indirect effects sharing of information or practice envisaged under the Directive could result in significant challenges for national health technology assessment procedures particularly if such procedures currently lack full transparency availability of comparable data on health technology assessment across the EU provides political capital for patients’ rights groups may affect discussions about which novel health technologies are available within national health care systems