Submitted by: Adrienne Wong
Potential Systemic Burdens in EU Cross-Border Healthcare:
Examining the Implications of the Reimbursement Provisions of Directive 2011/24/EU Within Less-Developed EU Countries
Introduction
In facilitating the furtherance of the internal market and the cooperation between Member States within the European Union (EU), Directive 2011/24/EU outlines the parameters of cross-border healthcare for patients, including treatment costs, prescriptions, and delivery of medications and medical devices.[1] The Directive was largely a response to two issues: first, on Regulation no. 883/2004/EC on the coordination of social security systems, but which focused primarily for the freedom of movement for workers, and second, a series of case law from the Court of Justice of the European Union (CJEU) that highlighted patients’ rights.[2] In this sense, the Directive’s purposes are not only for the progress of high-quality patient care, autonomy, and efficiency; its main objective is to enhance national control over cross-border health by emphasising the freedom of movement of citizens.[3] Therefore, the Directive incorporates regimes on social security coordination that collaborates with Regulation 883/2004/EC to advance patients’ rights on cross-border movement for healthcare.
The European Commission has identified four aspects of Directive 2011/24/EU that may be potential barriers to cross-border mobility: this includes frameworks relevant to prior authorisation rules, administrative requirements, charging of incoming patients, and systems of reimbursement.[4] This paper will focus on the Directive’s reimbursement scheme since one of the main drivers of the Directive’s implementation was to offer greater clarity regarding citizens’ entitlements to healthcare mobility and legal certainty for reimbursement of these costs.[5] Specifically, there has been some concern in relation to the reimbursement scheme’s application for poorer EU countries and whether any non-anticipated adverse effects may result from its provisions. This paper argues that while the implementation of Directive 2011/24/EU advocates for individual patients’ rights to cross-border healthcare, its reimbursement provisions may result in potential economic burdens on the healthcare and legal systems of less developed EU countries. The scope of the Directive and its relationship with Regulation 883/2004/EC (with reference to Regulation 1408/71/EEC) will first be discussed followed by an examination of the Directive’s reimbursement framework in detail. A case study of the Directive’s implementation in Romania will be explored to illustrate any possible stresses to its national healthcare system.
Cross-Border Healthcare Mobility Instruments
The timeline of the EU’s efforts to achieve further healthcare harmonisation can be traced through a series of major cases. Arguably, the first pivotal moment was in Luisi and Carbone[6] where it was stated that the freedom to provide services should also include the freedom of recipients of those services to travel to another Member State to receive them, thereby extending the Court’s perception of protection for recipients’ rights.[7] In Decker[8] and Kohll,[9] it was held that social security could not be excluded from the freedom of movement principles even though Member States retained competences to regulate their country’s own social security systems.[10] It also held that the prior authorisation rules were incompatible with freedom of movement to the extent of non-hospital treatment and that competent Member States must reimburse the patient under the same terms as if the treatment was obtained within its jurisdiction.[11] Further, the prior authorisation condition by reason of quality of health services and the preservation of the financial balance of the medical system cannot be used to justify refusal for reimbursement as this had already been harmonised at the EU level.[12] These cases demonstrated the gradual recognition of citizens’ rights to receive health services abroad.
There are two primary routes to access cross-border healthcare today: Regulation 883/2004/EC and Directive 2011/24/EU.
Prior to Regulation 883/2004/EC, cross-border mobility was governed largely by Regulation 1408/71/EEC which was limited only to employed or self-employed citizens.[13] Both Regulations were established to complement the freedom of movement of persons, specifically workers. While Regulation 1408/71/EEC is still in force, the new Regulation 883/2004/EC extends to all EU nationals covered by a social security scheme and clarifies the coordination of social security systems across Member States, specifically on the criteria for obtaining cross-border healthcare and prior authorisation measures needed before travel.
First, the scope of Regulation 883/2004/EC covers sickness benefits from public or contracted providers regulated by statutory law, thus, non-contracted or purely private providers not affiliated with the social security system are excluded.[14] Second, insured persons must seek prior authorisation from the competent institution for any planned healthcare travel.[15] This authorisation will be granted if the treatment concerned is i) among the basket of services or benefits provided by the patient’s affiliated Member State and ii) if the treatment cannot be administered within a medically justifiable time in consideration of the patient’s state of health.[16] Where healthcare is unplanned, such as accidents while abroad, prior authorisation is not required. Third, in the case of planned healthcare and where authorisation has been granted, the cost of the medical treatment abroad is borne by the competent state (the patient’s Member State of residence) where the costs are refunded directly to the institution of the Member State where the treatment was sought.[17] This reimbursement cost is calculated based on the domestic cost of the treatment in the Member State offering the service; even if the cost of the treatment is higher than the competent state, the competent state still bears its full cost.[18] Where healthcare is unplanned, the costs are reimbursed between both Member States once a request is made by the institution from the Member State of which treatment was given.[19]
Both Regulations have provided a strong foundation for cross-border healthcare mobility; however, the rules regarding prior authorisation have posed some issues in relation to its reimbursement criteria. Since cross-border treatment costs are borne in full by the competent state, this may create hesitancy for states to authorise its citizens for healthcare abroad – especially where the treatment costs are higher.[20] The consequences of the prior authorisation and reimbursement frameworks became most realised in Watts[21] where there was a lack of clarity within the application of Regulation 1408/71/EEC and Article 49 TEC (now Article 56 TFEU) in relation to uncertainties of waiting lists as grounds for refusal for prior authorisation and subsequent reimbursement claims after treatment abroad.[22] It was held that the prior authorisation rule in this context infringed Article 49 TEC and that the National Health Service (NHS) must reimburse the cross-border treatment costs since the NHS could not provide the claimant’s treatment within a medically acceptable time in consideration of her worsening health; further, that Article 49 TEC still applied even when the claimant paid for treatment abroad first before seeking reimbursement.[23]
Directive 2011/24/EU was proposed to address the Regulations’ relationship with case law complications and specifically resolve the issues surrounding reimbursement refusal as a result of prior authorisation rejections based on the Regulations’ provisions. Implemented in early 2011 and adopted by all Member States by late 2013, the Directive, without prejudice to the Regulations, and with special regard to Articles 114 and 168 TFEU, introduced clearer coordination for prior authorisation and reimbursement systems.[24] In a sense, the Directive is arguably less restrictive than the Regulations. First, the Directive allows for private healthcare providers.[25] Second, while prior authorisation is mandatory in the Regulations, it is an exception in the Directive route, applicable only to treatments that requires long-term care, access to organs for organ transplantation, or public vaccination programs.[26] Third, patients are usually expected to pay treatment costs upfront to a cross-border healthcare provider and have the costs subsequently reimbursed by their Member State of affiliation.[27] However, while the Regulation covers the patient’s treatment costs in full, the Directive only covers the costs up to the amount that would have been covered by the patient’s Member State of affiliation.[28]
The development of the above provisions continues to emphasise the unity of the Regulation and the Directive. As both mechanisms cannot be used concurrently, patients will have to evaluate which instrument would be of better benefit. At first glance, it may seem that Regulation 883/2004/EC would be more favourable since treatment costs are fully refunded by the competent state. However, the Directive route avoids most necessary prior authorisation procedures before travel, provides a larger range of healthcare provider coverage, and clarifies reimbursement schemes which were at the centre of Regulation-related case law complications. As the Directive can be considered less restrictive in some sense, the Courts still recognise that there may be potential risks with an influx of uncontrolled and unlimited cross-border mobility and reimbursement claims.[29] Has the Directive clarified or complicated reimbursement procedures – and are there any effects or burdens on healthcare systems of Member States, in particular, poorer states, as a result of the Directive’s reimbursement criteria? The Directive’s reimbursement scheme will be further discussed in detail in the following section.
Reimbursement Under Directive 2011/24/EU
Entitlement to reimbursement from cross-border healthcare costs through the Directive is subject to the basket of care provision in the patient’s affiliated Member State, without prejudice to Regulation 883/2004/EC and with regard to Articles 8 and 9 of the Directive which outline exceptions needed for prior authorisation and administrative procedures.[30] In detail: first, reimbursement by the Member State of affiliation is only applicable if the treatment sought abroad is among the benefits that are also available in the patient’s home country. Second, Regulation 883/2004/EC, with reference to Article 22(2) of Regulation 1408/71/EEC states that national authorities must evaluate whether a certain cross-border treatment method corresponds to an equivalent benefit provided by the home state.[31] In contrast, if the treatment sought is determined not to correspond with the home Member State’s benefits, the national authority has no obligation to grant authorisation for the treatment abroad as provided by the Regulation’s provisions, nor is there an obligation to reimburse the treatment under the Directive either.[32] Third, Member States may refuse reimbursement subject to the list of healthcare exceptions as listed in Article 8 of the Directive which may require prior authorisation.[33] Where a patient is entitled to a particular healthcare treatment and where the treatment cannot be administered to the patient in their home country within a medically justifiable time based on the medical assessment of the patient’s condition, the home Member State may not refuse to grant prior authorisation.[34] The cross-border costs reimbursed is equal to the level of costs that would have been incurred had the treatment been sought within the patient’s home country. In the absence of comparable costs for domestic patients, the reimbursement amount is calculated based on an objective and non-discriminatory criterion in accordance with the relevant local, regional, or national reimbursement levels for the type of treatment sought.[35]
The above frameworks have offered clearer legal certainty, however, there is an additional provision that should be noted. Article 7(4) of the Directive further states that if the incurred cross-border healthcare costs exceed the level of costs of treatment that would have otherwise been provided within its territory, the Member State of affiliation may still nonetheless decide to reimburse the full cost and/or other associated costs such as travel, accommodation, or additional costs for patients with disabilities, granted there is documentation for the relevant costs.[36]
It has been argued that since the Directive provides more clarity, transparency, and somewhat ‘less restrictive’ measures than that of the Regulations, patients, in theory, should no longer need to face lengthy and costly court cases in order to obtain reimbursement.[37] However, because Article 7(4) implies that full or additional reimbursement is available on a discretionary basis from national authorities, it may arguably encourage more patients to pursue the Directive route and claim further reimbursement – thereby potentially resulting in more court cases as patients seek to claim why they should be entitled to additional reimbursement for their cross-border healthcare. The attractiveness of the Directive’s provisions, absent of stricter implementation, may cause more challenges if patients and interest groups flood to make use of it.[38]
Analysis in the past has shown that a large number of healthcare movement in the EU were patients from less developed countries travelling to major medical centres in wealthier and highly developed countries for treatment.[39] As the popularity of cross-border mobility has risen since the implementation of the Regulations and the Directive, it can be deduced that this pattern of mobility has also become more frequent. However, some scholars have asked whether patients from less developed countries should be able to receive cross-border treatment if their home country, due to, for instance, a financial crisis, is unable to provide certain healthcare services to them.[40] If the poorer countries are not able to provide certain types of treatment to patients within their home country, how can they be expected to provide payment or reimbursement for treatments abroad, especially where the treatment costs are higher than their own?[41] However, restricting the flow from these poorer EU countries would disadvantage the patients who need cross-border healthcare the most. The main question that should be asked is whether the Directive effects positive steps toward patients’ rights to cross-border healthcare or whether it burdens the healthcare and legal systems of poorer EU countries as a result of reimbursement and litigation costs.
Case Study: Implementation of Directive 2011/24/EU in Romania
Romania was chosen as a representative comparator jurisdiction for this analysis as the most recent Eurobarometer study on healthcare mobility established that Romania was among the top eight Member States whose citizens had sought treatment in another EU country; it also found that Romania was among the top thirteen Member States where knowledge about the rights to receive cross-border healthcare was a priority.[42] Directive 2011/24/EU was adopted in Romania by Law no. 95/2006 on health reform which outlines the method of reimbursement through health insurance houses and the procedure for challenges against reimbursement levels or rejections by the state.[43]
Several concerns have been raised. It has been argued that the Directive imposes pressure on the Romanian state, particularly in the following areas: reimbursement of costs, prior authorisation procedures, healthcare quality standards and malpractice systems, and coherence between reform measures and principles for the functioning of the healthcare system as provided by the Directive.[44] The first two issues will be discussed more extensively but it is important to note that difficult economic conditions have great effect on healthcare standards and coherency which impact the reimbursement and prior authorisation mechanisms for less developed countries. In the Romanian context, financial crisis reduced the availability of treatments for its domestic citizens, leading to 67 hospital closures (approximately 15% of the country’s public hospitals) in 2011.[45] Since these structural and prolonged deficiencies in hospital facilities may continue, this could render certain services, even services within the basket of benefits covered in the state’s healthcare system, may be unavailable.[46] This leaves little option for patients but to seek these unavailable treatments abroad; this only reemphasises the challenges for less developed Member States to reimburse these costs while struggling with its own healthcare system deficiencies simultaneously.
In Petru,[47] the claimant, who suffered from serious cardiovascular illnesses, travelled to Germany from Romania for her surgical procedure; although she had been scheduled for surgery in a Romanian institution, Ms Petru believed that the hospital infrastructure was inadequate and unreliable. Prior to her travel, she submitted a request for cost coverage, but it was denied on the grounds that there was no suggestion that the surgery, which was within the basket of services in Romania, could not be provided in a medically reasonable time.[48] Her initial proceedings were dismissed but she relied on Article 22(2) of Regulation 1408/71/EEC and Law no 95/2006 in her appeal.[49] The CJEU held that the competent institution must have regard to all circumstances of a specific case, not only including the patient’s condition, progress of illness, but also the adequacy and ability to carry out the medical treatment.[50] Therefore, the Court held that Article 22(2) of Regulation 1408/71/EEC must be interpreted in light of Article 22(1)(c)(i) in that prior authorisation must not be refused where it is due to lack of medication, basic medical supplies, and infrastructure of the hospital institution which cannot be provided in a reasonable time in the patient’s Member State of residence.[51]
The judgment was significant in demonstrating the prioritisation of individual patient rights to cross-border healthcare; however, this also poses some concerns on the stability of an ‘economically-distressed’ state. Given that the main dispute in Petru was regarding the inadequacy of healthcare infrastructure, this stresses the questions around the sustainability of particularly low-income countries that already face general shortages of basic healthcare resources, in addition to, the struggles of providing reimbursement costs for its citizens’ cross-border healthcare.[52] Of course, Member States, particularly less developed ones, cannot afford a mass migration of patients abroad, therefore this systemic deficiency dilemma may likely curtail patient mobility to protect national healthcare systems in the long run.[53]
It is also important to note that Petru was concerned with the Regulation’s provisions instead of Directive 2011/24/EU. This was partially because the Directive had not been implemented by all Member States at the time; but primarily, it was because the Directive requires upfront payment whereas the Regulation did not.[54] This highlights another issue where citizens may have unequal access to cross-border healthcare in which it seems to suggest that perhaps the cross-border instruments may be more beneficial for wealthier citizens from poorer EU countries who are able to travel abroad more easily and provide any relevant upfront costs for their healthcare before claiming reimbursement. The Directive has aimed to address this issue by either generously consider paying the costs of the treatment abroad directly, for example, via a voucher system, or allow the application of reimbursement between institutions as provided in the Regulations.[55] However, it has been suggested that this does not seem effective as reimbursement under the Directive generally does not cover the full cost of cross-border treatment as compared to the Regulations.[56] Studies have found that problems relating to reimbursement are critical operational indicators which have shown signs of negatively affecting the efficiency of the Directive.[57] In the Romanian context, it has been determined that the Directive places its citizens in an inferior position in relation to other EU citizens from Member States with financially favourable healthcare systems.[58] This demonstrates that the Directive is mostly ineffective for poor citizens where healthcare abroad is intensely costly and where healthcare at home is inadequate or insufficient. As it stands, the Directive seems to only make economic inequality more prominent.[59] This reiterates that the Directive seems to be mostly useful for wealthier patients or wealthier Member States. Therefore, this disproportionate access to the Directive’s benefits will be felt most by vulnerable populations who may be in need of crucial cross-border healthcare and support.
However, the Petru outcome does shed some hope on the future of cross-border healthcare and may initiate more opportunities for patients from less developed health systems. Indeed, majority of patients from these poorer countries have been prevented from benefitting from the Directive route due to the insufficient reimbursement levels or the inability to provide upfront payment for expensive cross-border treatments.[60] Despite this, Petru may encourage and broaden the possibilities of patients to seek healthcare abroad precisely because of the low levels or lack of healthcare resources in their domestic jurisdiction.[61] In addition, as discussed earlier regarding Article 7(4) of the Directive which notes the possibility for a full or additional discretionary reimbursement by the Member State of affiliation, this may open more doors for patients to seek or file to courts for increased cross-border healthcare coverage.[62] This would thus render the reimbursement claims akin to that of the Regulations’ full reimbursement levels while also allowing patients to enjoy the ‘less restrictive’ nature of the Directive. This hypothesis seems unlikely; however, as the recognition of patients’ rights to seek treatment abroad has become pushed to the forefront over years of major case law, courts in the future may decide to arrange more patient-favourable and patient-focused outcomes to preserve their rights, especially those from vulnerable and less developed societies, to seek critical cross-border healthcare.
While this perspective may illustrate a positive expectation for individual patients, this again repeats the issue of the dangers of large departures of patients from domestic institutions in pursuance of treatments abroad. This could be harmful at the systemic level as reimbursement claims could further financially burden the healthcare and legal systems of less developed and poorer Member States.
Effectiveness of Directive 2011/24/EU
While the Regulations and the Directive have been in place for many years, the actual increase in patient mobility for healthcare has remained marginal. Although the levels of travel were generally low, after the implementation of the Directive, it did increase by 11% between 2007 and 2014.[63] It was discovered that those who sought healthcare abroad tended to be younger and relatively educated individuals, and who were likely wealthier from smaller countries.[64] Another study found that between 2015 and 2018, cross-border mobility only slightly increased as well, likely due to the improvement of access to information on the rights to cross-border healthcare for citizens and the coordination between European institutions and individual Member States.[65]
Some speculations for this low trend of travel have suggested that such reasons could include the late implementation of the Directive by some Member States, the general unfamiliarity of reimbursement rights, specific barriers limiting cross-border movement such as administrative obstacles, and insufficient disseminated information to citizens.[66] However, it was revealed that in 2015, requests for reimbursement between Member State institutions under the usage of Regulation 883/2004/EC was approximately 2 million requests, while those under the Directive amounted to just over 180,000 requests.[67]
This demonstrates that reliance on Regulation 883/2004/EC was more common than the Directive’s provisions, likely, as discussed in the previous section, because the Regulation offers a higher level of cost coverage and because upfront payments are not required. As healthcare professionals are required to inform and ensure that citizens are advised which cross-border mobility route is more suitable for their reimbursement claims, it is likely that the benefits of full coverage under the Regulation has deterred citizens from pursuing the Directive’s provisions.[68] It is clearer now through this analysis that there are administrative barriers, access inequalities, and issues concerning lower levels of reimbursement under the Directive route.
Conclusion
This paper has aimed to investigate the impact of Directive 2011/24/EU on less developed EU countries by highlighting the particular arrangements of reimbursement schemes under each cross-border mobility instrument, examining the Directive’s reimbursement provisions in detail and its potential effects on poorer countries, and understanding the effectiveness and travel trends of the Directive on cross-border movement.
There are three concerns. First, while the Directive offers a ‘less restrictive’ route than Regulation 883/2004/EC, it seems that its requirement for upfront costs and its reimbursement provisions would mainly benefit wealthier populations and countries leading to unequal access for vulnerable individuals, particularly those from poorer countries. Second, although major case law has recognised and prioritised individual patients’ rights for cross-border movement, an exodus of patients from less developed countries seeking treatments abroad would be detrimental for its healthcare and legal systems. This could place a further strain on low-income countries that are already struggling with financial difficulties in their healthcare systems, such as inadequate resources and infrastructure, while also facing cross-border healthcare reimbursement claims. Third, reliance by patients on the Directive for cross-border mobility has been indicatively low compared to usage under Regulation 883/2004/EC. This is likely because the Regulation offers a more favourable and accessible reimbursement route.
It can be argued that this increased attention on cross-border healthcare rights as a result of the Directive’s implementation and major case law has also had the side effect of promoting the Regulation as well.[69] Since the Regulation offers a better administrative framework and cost coverage from the patients’ perspective, it is therefore a more beneficial route for patients from poorer EU countries as the Directive restricts and limits their reimbursement claims.[70]
Perhaps a potential solution to coordinate enhanced equity across all Member States without perpetuating economic inequalities of poorer countries is an equalisation payment system. Funds allocated specifically for healthcare distributed to each Member State may help balance some economic difficulties, improve healthcare infrastructure, and allow countries to cover treatment costs, i.e. on a case by case basis, for patients who cannot afford upfront payments, or provide more adequate reimbursement. This would need further research; however, future analysis should focus more carefully on the Directive’s economic impact to health systems, particularly any inequalities within less developed EU countries, in conjunction with advocating for further individual patients’ rights on cross-border healthcare mobility.
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[1] Directive 2011/24/EU of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare OJ 2011 L 88/45; European Commission, Cross-Border Healthcare <https://ec.europa.eu/health/ cross_border_care/overview_en> accessed 27 April 2020. [2] Regulation (EC) No 883/2004 of the European Parliament and of the Council on the coordination of social security systems OJ 2004 L 166, as implemented by Regulation (EC) No 987/2009; See Treaty on the Functioning of the European Union 1957 (TFEU), art. 48. [3] Tamara Hervey, ‘EU Health Law’ in Catherine Barnard and Steve Peers (eds), European Union Law (2nd edn, Oxford University Press 2017) 635. [4] Ivo Belet, ‘European Parliament: Report on the Implementation of the Cross-Border Healthcare Directive’ (2018) CEPHFS 1, 4. [5] Frans Pennings, ‘The Cross-Border Health Care Directive: More Free Movement for Citizens and More Coherent EU Law?’ (2011) 13 EJSS 424; Directive 2011/24/EU, recitals 9, 27. [6] Joined Cases C-286/82 and C-26/83 Luisi and Carbone v Ministero del Tesoro [1984] ECR 377; See also Case C-120/95 Decker v Caisse de Maladie des Employes Prives [1998] ECR I-1831 and Case C-158/96 Kohll v Union des Caisses de Maladie [1998] ECR I-1931. [7] Johan van de Gronden et al., Health Care and EU Law (TMC Asser Press 2011) 81. [8] Case C-120/95 Decker v Caisse de Maladie des Employes Prives [1998] ECR I-1831. [9] Case C-158/96 Kohll v Union des Caisses de Maladie [1998] ECR I-1931. [10] van de Gronden et al. (n 7) 83. [11] Ibid. 82. [12] Ibid.; See also Case C-368/98 Vanbraekel [2001] ECR I-5363, Case C-157/99 Geraets-Smits and Peerbooms [2001] ECR I-05473, Case C-385/99 Muller-Faure and van Riet [2003] ECR I-04509, and Case C-326/00 IKA v Ioannidis [2003] ECR I-01703. [13] Pennings (n 5) 426; Regulation 883/2004; Regulation (EEC) No 1408/71 of the Council on the application of social security schemes to employed persons and their families moving within the Community OJ 1971 L 149. [14] Ibid.; Dolores Bermejo, ‘Cross-border Healthcare in the EU: Interaction Between Directive 2011/24/EU and the Regulations on Social Security Coordination (2014) 15 ERAF 359, 366. [15] Regulation 883/2004/EC, art. 20(1). [16] Ibid., art. 20(2). [17] Pennings (n 5) 428. [18] Ibid.; Regulation 883/2004/EC, art. 35. [19] European Commission, Commission Report on the Operation of Directive 2011/24/EU on the Application of Patients’ Rights on Cross-Border Healthcare (2018) <https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri =CELEX:52018DC0651&from=EN> accessed 28 April 2020. [20] Pennings (n 5) 428. [21] Case C-372/04 R (Watts) v Bedford Primary Care Trust [2006] ECR I-4325. [22] Regulation 1408/71/EEC, art. 22(1)(c); Treaty Establishing the European Community (TEC), art. 49. [23] Case C-372/04 R (Watts) v Bedford Primary Care Trust [2006] ECR I-4325, at [123], [142]-[143]; Compare also with Case C-173/09 Elchinov [2011] All ER (EC) 767. [24] Directive 2011/24/EU; TFEU, art. 114, 168. [25] Walter Ried and Frauke Rau, ‘Cross-Border Health Care in the European Union: Evaluation of Different Financing Arrangements (2017) 9 EMPS 8, 11; Directive 2011/24/EU, art. 3(g). [26] Directive 2011/24/EU, art. 1(3). [27] Bermejo (n 14) 374. [28] Hiroshi Aiura, ‘Effect of Cross-Border Health Care on Quality and Progressivity of Financing’ (2019) 31 RURDS 29; Belet (n 4) 3. [29] Pennings (n 5) 450. [30] Directive 2011/24/EU, art. 7(1). [31] Regulation 883/2004/EC; Regulation 1408/71/EEC, art. 22(2); Hervey (n 3) 636; Case C-173/09 Elchinov [2011] All ER (EC) 767, at [62]. [32] Hervey (n 3) 636. [33] Directive 2011/24/EU, art. 8, 9. [34] Directive 2011/24/EU, art. 8(5). [35] Directive 2011/24/EU, art. 7(6); See Case C-372/04 R (Watts) v Bedford Primary Care Trust [2006] ECR I-4325. [36] Directive 2011/24/EU, art. 7(4); Brindusa Marian, ‘Considerations Regarding Directive 2011/24/EU on the Application of Patient’s Rights in Cross-Border Healthcare in EU Member States’ (2018) 8 TJ 681, 684. [37] Bermejo (n 14) 363. [38] Scott Greer, ‘Avoiding Another Directive: The Unstable Politics of European Union Cross-Border Health Care Law’ (2013) 8 HEPL 415, 416. [39] Lorena Androutsou and Theodore Metaxas, ‘Measuring the Efficiency of Medical Tourism Industry in EU Member States’ (2019) 26 JTA 115, 118; Michael Horowitz et al., ‘Medical Tourism: Globalization of the Healthcare Marketplace’ (2007) 9 MGM 33. [40] Markus Frischhut and Nick Fahy, ‘Patient Mobility in Times of Austerity: A Legal and Policy Analysis of the Petru Case’ (2016) 23 EJHL 36, 42. [41] Ibid. [42] European Commission, Special Eurobarometer 425, ‘Report: Patients’ Rights in Cross-Border Healthcare in the European Union’ (2015) TNSOS 1, 8, 48. [43] Law no. 95/2006 on health reform, art. 901-922 (Romania); Marian (n 36) 685-686. [44] Viorel Rotila, ‘The Impact of Directive 2011/24/EU on the Romanian Health System’ (2013) CCDSS 1, 114. [45] Eurofound, ‘Access to Healthcare in Times of Crisis’ (2014) 1, 12; Frischhut and Fahy (n 40) 37. [46] Frischhut and Fahy (n 40) 44. [47] Case C-268/13 Petru v Casa Judeteana de Asigurari de Sanatate Sibiu [2015] All ER (EC) 571. [48] Ibid., at [11] [49] Ibid, at [14]; Regulation 1408/71/EEC, art. 22(2); Law no. 95/2006, art. 208(3) (Romania). [50] Case C-268 Petru [2015] All ER (EC) 571, at [32] and [36]. [51] Ibid., at [37]; Regulation 1408/71/EEC, art. 22(2), 22(1)(c)(i). [52] Andre den Exter, ‘The Patient Mobility Saga Continues – The Ruling of court of Justice of European Union in the Case of Elena Petru’ (2014) 55 CMJ 441, 442. [53] Ibid.; See also questions referred for preliminary ruling regarding justifications for full reimbursement claims in Case C-538/19 (Pending). [54] Frischhut and Fahy (n 40) 41. [55] Bermejo (n 14) 374. [56] Ibid. [57] Mustapha Ibrahim et al., ‘Estimating Efficiency of Directive 2011/24/EU Cross-Border Healthcare in Member States’ (2018) 7 JCER 1, 6. [58] Rotila (n 44) 115. [59] Ibid. [60] Frischhut and Fahy (n 40) 53. [61] Ibid. [62] Directive 2011/24/EU, art. 7(4). [63] Andre Peralta-Santos and Julian Perelman, ‘Who Wants to Cross Borders in the EU for Healthcare? An Analysis of the Eurobarometer Data in 2007 and 2014’ (2018) 28 EJPH 879. [64] Ibid., 883. [65] European Commission (n 19) 15. [66] Belet (n 4) 13. [67] Ibid., 7. [68] European Commission (n 19) 8. [69] Frischhut and Fahy (n 40) 52. [70] Ibid.