General concepts

When we talk about healthcare, about how the Union and the states share competence in this field, we have to look at the Europe we live in, towards the development of functional relationships and the model we are aiming for.

Today, while we are participating in the conference, the entire Union is in the midst of the process of holding elections for the European Parliament. Now, perhaps more than ever before, it seems clear that that we are divided between those who want to take a progressive path, those who want a rapid federalization, and those who believe that only powerful nations can generate an efficient interstate structure. Europe is a Europe of citizens, more so than of political leaders or states. The free movement of workers is perhaps the most important component of the internal market, which generates good service development; and cross-border health services are directly linked to the mobility of citizens within the Union.

Of course, when we talk about national healthcare systems, we find that there are big discrepancies. The infrastructure investment, the specialized facilities, the training and competence of the medical and administrative staffs, the administrative organization, the transparency, but also ensuring cleanliness and disinfection are all factors that differentiate one national system from another.

The report published by the European Commission on 23 November 2018[1] emphasized the fact that the health system in Romania has the lowest expenditure per capita as a share of the GDP in the European Union, being characterized by a low financing and by an inefficient utilization of public resources. Although Romania established a national health strategy, objectives in the field of public health and medical assistance services, it is situated on the last spot in the EU with only 983 euro spent annually per capita, with over 250 euro below Belgium. At the opposite pole is Luxembourg, with 4713 euro, while the EU average is of 2773 euro.

Reorganization of the healthcare services, directing investments towards the disadvantaged areas and the necessity of rethinking the health system represent only a few of the conclusions drawn and which have as a common denominator guaranteeing that the healthcare services in Romania will remain adequate and will offer dedicated care for patients.

Romania has unfortunately succeeded in a historic counter-performance. Although the 2014-2020 multi-annual budget funds were provided for the construction and equipment of 4 regional hospitals, in 2013 the Government promised its completion by 2020, however another government decided, during the course of this year, that these investments are not a priority for Romania, being scheduled for the next period. A decision that I consider erroneous, with a major effect in quality assurance and decongestion of hospitals that are already very over-populated.

European Union law and competences in the medical field

With the establishment of the European Communities and subsequently of the European Union, Member States have entrusted part of their sovereignty to supranational bodies, by transferring certain attributes of national sovereignty.[2]. This transfer of power to the Union and the institutions, irreversible in its purpose, is stipulated even in the first paragraph of the first article of the Treaty on European Union, which states that the Member States confer on the Union powers to achieve their common objectives. Article 2 (1) and (2) of the TFEU defines the concept of competence as the power to legislate and adopt acts with binding legal force.

The delimitation of competences within the Union is regulated by Article 5 TEU, which establishes the principle of conferral: „(2) Under the principle of conferral, the Union shall act only within the limits of the competences conferred upon it by the Member States in the Treaties to attain the objectives set out therein”. Both Article 5 paragraph (2) TEU, as well as Declaration no. 18 on the delimitation of competences, annexed to the Treaties, states that any competence not conferred on the Union by treaties belongs to the Member States, and that the European Union having legal personality will not authorize it in any way to legislate or act outside the competences which they are conferred on the Member States by treaties[3]. In the field of Union competences, Article 5 TEU must be viewed in conjunction with Article 2-6 TFEU, which governs the scope of the Union’s competences. The provisions of Articles 2-6 TFEU replace Article 3 of the Maastricht Treaty, which regulated the „activities of the Community”, currently the primary law highlighting three categories of competences, respectively exclusive competences (Article 3), shared competences (Article 4) and competences to support, coordinate and complete the action of Member States (Article 6). In addition to this, Article 2, (3) and (4), and Article 5 TFEU provide for special competencies of the Union in the areas of the common foreign and security policy, which includes the gradual definition of a common defense policy; in coordinating economic policies; in coordinating employment policies; in coordinating social policies. In the category of special situations, those provided by Article 4 paragraph. (3) and (4) TFEU are also included, namely the fields of research, technological development and space, respectively the fields of development cooperation and humanitarian aid, fields to which the principle of preemption is not applied, provided for in Article 2 (2)[4]. Each area of competence corresponds to a number of areas provided for in the Treaties. Declaration no. 18 on the delimitation of competences, annexed to the Treaty of Lisbon, assigns a dynamic character to the competences exercised within the Union, specifying the possibility of their extension or reduction, by the ordinary procedure of revision of the Treaties, stipulated in Article 48 TEU.

The positioning of the health component as a distinct area of Union law is recent and has developed following the adoption of measures regarding the free movement of goods, persons and services that had a component of protecting the health of citizens. The application of Article 9 and Article 168 (1) TFEU allowed for the development of this sector. “EU health law has also unfolded through many of the directly effective provisions of the TFEU, especially those on free movement of the factors of production, and on free and fair competition, and on the legislation that support those measures. The Court of Justice has found that the EU law on free movement of goods, services, workers, and freedom of establishment, as well as on anti-competitive agreements, and abuse of a dominant position, applies in health context. This means that EU health law has been developed through litigation, as well as through Treaty reform and EU legislation.”[5]

Patient mobility in the European Union has been developed in 3 components: the legislation on workers and their families, the provisions of the primary legislation on the movement of services and, finally, the legislation on the rights of patients.

Regulation 883/2004 provides for the mobility of patients for the following situations: emergency medical treatment, based on the European Health Insurance Card, the medical treatments authorized by the national authorities of the states of origin, respectively for exceptional medical services, if such treatment would be delayed in the state of origin, with serious consequences on the patient’s health.

Article 56 TFEU establishes that restrictions on the freedom to provide services within the Union are prohibited. The Court of Justice has interpreted that these provisions are applicable even if a person wishes to receive services in another state, for a remuneration. Since 1984 the Court has recognized private medical services as being provided under the legal basis of Article 56.[6].

The Charter of the Fundamental rights of the European Union provides the right to social security benefits and social services providing protection in cases such as maternity, illness, industrial accidents, dependency or old age, and in the case of loss of employment, in accordance with the rules laid down by Union law and national laws and practices, the right to social security benefits and social advantages of any person residing and moving legally within the European Union in accordance with European Union law and national laws and practices, the right of access to preventive healthcare and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.

The Directive on patients’ rights

In 2011, Directive 2011/24/EU was adopted, a directive on the application of patients’ rights in cross-border healthcare, by which the establishment of a general framework is provided for, regarding patient rights in relation to: cross-border medical assistance, guaranteeing access, quality and safety of the medical assistance received in a different state within the EU, to promote cooperation in healthcare between Member States.

These provisions are applicable in Romania as well, the way in which a person can benefit from healthcare services within the territory of the EU member states also being regulated in our country.

General considerations on Directive 2011/24/EU

In order to ensure a better transparency in what regards quality and safety standards in the EU, the directive provides mutual assistance and cooperation between member states, especially regarding the  interoperability of eHealth tools and the evaluation of health technologies; facilitates the recognition of prescriptions from other Member States; provides for the development of European reference networks in order to encourage the sharing of knowledge and the most efficient use of resources in highly specialized medical assistance, for example in the diagnosis and treatment of rare diseases.

After the entry into force of the Directive, the prior authorization for the planned cross-border medical assistance tends to become more of an exception than a rule, however the total elimination of prior authorizations can have negative consequence for the sustainable health systems of the member states[7]. For example, for reasons of planning the activity of hospitals, the authorization requirement is maintained for treatments requiring at least a night of hospitalization, being considered a limitation without it or an obstacle in the free movement of patients.

At a national level, contact points were established within member states, which are in a position to offer patients pertinent information regarding cross-border medical assistance and provide help, not legal assistance[8].

The directive does not apply to long-term specialized medical assistance services, organ transplants, human origin tissue or cells, for therapeutic purposes and to public vaccination programmes[9].

At the beginning of 2019, the European Parliament requested that the European Commission analyze the possibility of extending the purpose of the directive where it concerns cross-border medical assistance to include vaccination programmes. The European Parliament requested that all member states correctly transpose the directive to ensure high quality, accessible medical assistance for patients, in full compliance with the implementation deadlines provided by legislation. It was underlined that unfortunately the vast majority of patients are not aware of what their rights are, nor indeed do they know where to get information. The fact is every member state should have at least one information point. This is why they are calling for the setting up of one-stop shops where patients can get all the information they need about healthcare, reimbursement by health funds and all the rest of it. The Parliament reminds the member states that any limitation regarding the application of the directive, such as the prior authorization requests or limitation of reimbursement, should be necessary and proportional but should not give rise to an arbitrary or social discrimination, should not create unjustified obstacles in the path of free movement of patients and of services, and should not create an excessive burden for national public healthcare systems.

Directive 2011/24/EU represents an important step forward for European citizens, who will be able to have more control over the healthcare provided to them, and, at the same time, through patient associations they will be able to promote higher standards of quality and safety in the health field, which will favorably influence healthcare systems in EU member states.

The new directive brought major changes regarding patients’ rights, thus citizens[10] will have the right to choose receiving healthcare in the public health system or in the private system, in their home state or in another EU member state, the cost of their treatment being reimbursed. The decisions regarding treatment options will be made knowingly, the necessary information being accessible to national contact points or directly from the healthcare providers, and the prior authorization for cross-border health assistance will become rather the exception than the rule.

Moreover, the Directive also makes clarifications about: respecting the freedom of every member state to decide upon the type of health assistance they consider adequate; member states remain fully responsible in what regards the organization and supply of health assistance, healthcare and social security benefits, especially in case of illness; the establishment of the obligation to reimburse the costs of cross-border social security benefits limited to the level of health assistance to which the insured person is entitled to according to the legislation of the state they belong to. The Directive does not apply to the long-term healthcare services, considered necessary to permit a person to continue living in a natural and autonomous way, as well as to long-term healthcare services provided by: home healthcare services, in special units of social assistance and in homes (“care homes”).

Directive 2011/24/ EU on the application of patients’ rights in cross-border healthcare provides the establishment of a general framework regarding:

– the right of patients to seek to receive medical treatments in another Member State of the EU and to foster cooperation between national systems;

– The right of patients to reimbursement of the costs of healthcare provided;

– The right of patients to information;

– The right of patients to choose their doctor and the hospital in which to benefit from cross-border healthcare

The full member states of the European Union have had the task of implementing the directives adopted by the Union, any delay of the national authorities being liable to lead to actions of non-fulfillment of the obligation of a member state. The breach of the European right is committed in the situation in which, upon the expiration of the procedural deadline of replying, two months after receiving the motivated opinion, member states have not adopted the domestic legislative measures of transposing them, regardless of if during the litigation procedure they comply, the European Commission establishing punitive penalties, with significant impact on national budgets. Before the expiration of the period, the European Commission granted assistance to all member states, however in spite of the efforts made, the Commission registered 26 procedures regarding the violation of European Law, for late or incomplete notices of the transposition measures[11]. Following the notification of full transposition measures by all Member States when assessing compliance with the transposition of the Directive, The Commission has found the existence of more than 500 national measures due to differences in regional/administrative levels regarding: reimbursement mechanisms, information channels (national contact points, healthcare providers); patient rights and professional liability.

An important aspect pointed out by the European Commission concerns the level of reimbursement for cross-border healthcare, some member states having lower levels of reimbursement, applicable to the health assistance received from private or non-contractual healthcare providers on their territory, comparatively to the reimbursement level within the public healthcare system or of contractual healthcare providers, aspect upon which the Commission is to decide on which path to follow.

The deadline to transpose Directive 2011/12/EU on the application of patients’ rights in cross-border healthcare into domestic legislation was on 25 October 2013, Romania transposing it on 29 January 2014, through GEO no. 2/29/01/2014.

Payments and reimbursements in planned cross-border healthcare[12]

Romanian citizens have the right to medical treatment in other EU countries, through this understanding: specialized consultations, surgical interventions, treatments for certain ailments, under the same conditions and supporting the same costs as citizens of the respective country. In order to have access to this type of healthcare assistance it is necessary to obtain prior authorization, one of the reasons being that there is a risk of destabilizing the national healthcare system by covering high costs, which in some cases can be unjustified, some cases being treatable locally.

The prior authorization can be rejected if: (i)  the patient will be exposed to a patient-safety risk, (ii) the general public will be exposed with reasonable certainty to a substantial safety hazard (iii) this healthcare can be provided on its territory within a time limit which is medically justifiable (iv)  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. There are situations in which the state required to grant specialized hospital treatment or which implies significant costs to refuse to grant the respective types of healthcare.

In Romania, the types of healthcare which are subject to prior authorization, the procedure of obtaining the prior authorization for the reimbursement of the equivalent value of the cross-border healthcare, as well as the reimbursement methodology of the  equivalent value of the cross-border healthcare are regulated by GD no. 304/014 for the approval of the methodological norms regarding cross-border healthcare – normative act elaborated on the basis of Law no. 95/2006 regarding the healthcare reform, republished, with subsequent amendments by which the provisions of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare.

It must be taken into consideration that some types of healthcare included in the authorization system have high levels of reimbursed tariffs in the social health insurance system in our country, under the conditions of the application of Directive 2011/24/EU would generate too great a pressure upon the single national health insurance fund.

These types of healthcare assistance are:

1. the PET-CT in outpatient care
2. hospital healthcare provided under continuous hospitalization (hospitalization longer than 24 hours) for treatment:
3. cardiac defibrillator implant or replacement
4. tumor articular endoprosthesis
5. spinal segment implants
6. coronary bypass with/without invasive cardiac investigation
7. birth

Reimbursement of the amount of cross-border healthcare provided in the territory of a Member State of the European Union and paid for by the insured person is made if healthcare services, medicines and medical devices are among the benefits to which the insured person under the health insurance legislation is entitled and are settled from the single national health insurance fund.

The level at which the reimbursement of the equivalent of cross-border healthcare is made does not exceed the level at which it would have been incurred if that healthcare had been provided on the territory of Romania, but no more than the value paid by the insured. For example, if a Romanian patient performs computerized tomography in Spain for which he pays 1,500 euros, the Romanian state will reimburse them 400 euros, equivalent to the tariff applied in Romania for the same investigation. Therefore, the difference of 1.100 euros will be covered by the Romanian patient from his pocket.

According to the NHIH Order no. 592/2008 modified and completed by NHIH Order no. 575/2009, Romanian patients have to meet a number of conditions to benefit from cross-border healthcare, the most important being obtaining prior authorization by issuing the S2 form by the health insurance house at which the applicants are registered. The application must be accompanied, inter alia, by:

– a medical report drawn up by a physician from a healthcare establishment in a contractual relationship with an insurance house that contains the recommendation for treatment in another EU Member State;

– the medical record with the patient’s diagnosis and the fact that the requested medical service cannot be performed in any of the medical units in Romania within a normal time from a medical point of view, taking into account the patient’s current health condition and the likely evolution of the disease;

– written confirmation from the healthcare unit of the EU Member State showing the availability to provide the medical service during the period indicated by the applicant patient.

Payments and reimbursements for unplanned medical assistance

In the case of an unplanned health care requirement in another Member State, the relevant procedures are governed, in principle, by EC Regulation no. 883/2004. More specifically, medical care that is required from a medical point of view can be obtained through the European Health Insurance Card (EHIC), identical for all EU Member States, demonstrating that the cardholder is covered by social health insurance.

As far as patient’s rights are concerned, they are determined by the benefit package and the reimbursement rates of health insurance in the Member State of treatment. Therefore, the patient has access to healthcare under the same conditions as the citizens of that state with social health insurance. Unplanned cross-border healthcare usually refers to a sudden need for treatment that occurs during a temporary stay abroad, using outpatient emergency medicine or emergency hospitalization.

This kind of medical care does not require prior authorization, but in order to benefit from free medical care and the subsequent reimbursement of costs, it is necessary to have a European Health Insurance Card. An additional recommendation is to conclude an optional medical insurance to cover additional costs or even repatriation.

The benefits are: any kind of medical treatment, the purchase of medicines or medical supplies, provided that they do not exceed the strict medical requirement during their temporary stay. The free of charge benefit, as well as the reimbursement of the costs of emergency medical assistance are conditional on the existence of a contract with the local health insurance system, in the requested country, which recognizes the European Health Insurance Card. If healthcare services were provided by a private physician, it is possible that the reimbursement of the expenses will be only partial. If paid in advance, the card guarantees that the money will either be returned back to that country or, if the refund procedure is not completed, upon return home from the health insurance authority.

According to data published by the European Commission in 2018 in the Report on the implementation of Directive 2011/24/EU, the total number of claims for reimbursement of cross-border healthcare expenditure was relatively low as a proportion of total patient assistance, in all three reporting years.

The C‑268/13[13]

In a dispute pending before the Sibiu Tribunal, the applicant Elena Petru asked the court to order the County Health Insurance House and the National Health Insurance House to reimburse her the costs of the surgery performed in Germany, worth 18,000 euros.

In fact, this proved to the referring court that she suffers from serious vascular diseases and that in 2007 she suffered a myocardial infarction, after which she underwent surgery. In 2009, due to the deterioration of her medical condition, she was admitted to the Cardiovascular Disease Institute of Timișoara and, following the medical investigations to which she was subjected, the decision was made to perform an open heart surgery. Considering that the hospital did not have satisfactory conditions for performing the surgery in complete safety, Ms. Petru decided to perform the operation at a clinic in Germany, the total operating and postoperative costs being approximately 18,000 euros.

During the national procedures, Ms. Petru had submitted to the Health House a request regarding the surgical intervention abroad, on the basis of form E 112. Her reaquest was rejected on the grounds that the report of the attending doctor did not show that the requested medical service, which did part of the basic services package, could not be performed in a reasonable time in medical units in Romania, based on the current medical status of the insured person and on the time evolution of the disease.

In 2011, Ms. Petru brought a civil action in order to oblige the Sibiu County Health Insurance House and the National Health Insurance House to pay the value in RON of the sum of 17,714.70 euros as interest damages. Ms. Petru mentioned, in support of this request, that the conditions of hospitalization in Timișoara were precarious, because the medicines and medical supplies of first necessity were lacking, and the number of beds was insufficient, and that due to the complexity of the surgery and these poor conditions, she decided to leave the hospital and go to a clinic in Germany. The court of first instance rejected its action in a judgment in October 2012, and Ms Petru appealed against it to the Sibiu Tribunal. In support of this appeal, Ms Petru relies on Article 208 (3) of Law no. 95/2006, Article 22 (1) (c) and the second line of paragraph 2 of Regulation no. 1408/71, as well as the Charter of Fundamental Rights of the European Union. The respondents in the main proceedings requested that the appeal be dismissed, claiming that Ms. Petru did not meet the conditions necessary for issuing the E 112 form, since she did not prove the impossibility to benefit in Romania, within a reasonable time, of the medical service in question. They invoke the provisions of Regulations no. 1408/71 and no. 574/72, of Law no. 95/2006 and of Order no. 592/2008, as amended by Order no. 575/2009, as well as article 8 of the Decree no. 729/2009.The referring court stated that the parties to the dispute give a different interpretation to the national and Union law provisions applicable to the dispute before them and that its resolution depends on how the provisions of Article 22 of Regulation no. 1408/71 are interpreted, and ordered the suspension of the trial of the case and to refer the following question to the Court:

“If, in relation to the provisions of the second paragraph of Article 22 (2) of [Regulation no. 1408/71], the impossibility of granting treatment [to an insured person] in the country of residence is interpreted absolutely or [reasonably], respectively if the situation in which, although surgery can be performed in the country of residence in a timely and technically appropriate manner, in the sense that there are the necessary specialists and even the same level of specialized knowledge, however, is the lack of medicines and medical supplies of first necessity equivalent to a situation in which the necessary medical treatment cannot be granted within the meaning of the mentioned article?”

As regards admissibility, the Government considered the action inadmissible, as it is for the national court to define, in the preliminary ruling application, the factual framework in which the questions addressed to the Court fall, emphasizing that, in this case, the referring court did not specify the factual situation in the main proceedings, as established on the basis of the evidence presented, but only took the parties’ statements. However, according to the Sibiu County Health Insurance House and the National Health Insurance House, the facts invoked by Ms. Petru regarding the lack of medicines and medical supplies of first necessity, which are the basis of the preliminary question, are rejected by this evidence, so that the question does not have any utility in resolving the dispute. In addition, the Romanian Government reiterated that the referring court did not explain the reasons why it considers that this answer is necessary for the settlement of the main dispute.

The Court considered that the procedure established by Article 267 TFEU is an instrument of cooperation between the Court and the national courts through which the Court provides the latter with the elements of interpretation of Union law that are necessary for the settlement of disputes to be decided. Within this cooperation, only the national court notified with the resolution of the dispute and who must assume responsibility for the court decision to be delivered has the competence to assess, taking into account the particularities of the case pending, both the necessity of a preliminary ruling in order to be able to make its own judgment and the relevance of the questions it asks the Court.

As regards the reasons which caused the referring court to ask the interpretation of the second paragraph of Article 22 (2) of Regulation no. 1408/71, it is clear from the order for reference that, since the parties to the main proceedings gave a different interpretation of this provision, the said court raises the question whether this applies if the inability to provide the treatment in question in the Member State of residence results from a shortage of medicines and medical supplies of primary necessity, and that this court considers that the solution to be given in the main dispute depends on the answer to be given to this question. Thus, the interpretation requested is not manifestly devoid of any connection with the reality or object of the main dispute, and the issue raised is not hypothetical, but refers to facts discussed by the parties to the main dispute, which must be determined by the referring court. In addition, the Court has the necessary elements to answer the question asked to it in a useful way.

In the light of all the aforementioned elements, the Court finds that the action brought is admissible.

Regarding the substance

By the question referred, the referring court essentially to determine whether the second line  of Article 22 (2) of Regulation no. 1408/71 it must be interpreted as meaning that the authorization required under paragraph 1 (c) (i) of the same article cannot be refused when, because of the lack of essential medicines and medical supplies, the hospital treatment in question cannot be granted in a timely manner in the Member State of residence of the socially insured person. It should be noted that the second paragraph of Article 22 (2) of Regulation no. 1408/71 sets out two conditions, the fulfillment of which obliges the competent institution to issue the prior authorization required under paragraph 1 (c) (i) of the same article. The first condition requires that the treatment in question is one of the benefits provided by the law of the Member State in whose territory the socially insured resides. The second condition requires that the treatment the latter intends to receive in a Member State other than the State of which he is a resident, is that he cannot, given his current state of health and the probable evolution of his disease, be granted within the time frame normally required to obtain the treatment in question in the Member State of which he is a resident. With regard to this second condition, which is referred to in the question referred in the present case, the Court has already held that the requested authorization cannot be refused when identical treatment or with the same degree of effectiveness cannot be obtained in a timely manner in the Member State of which the person concerned is a resident. In this case, the Court stated that, in order to assess whether a treatment having the same degree of efficacy can be obtained in a timely manner in the Member State of residence, the competent institution is obliged to take into account all the circumstances that characterize each particular case, taking due account not only of the patient’s medical situation at the time when the authorization is requested and, if applicable, the degree of suffering or the nature of the latter’s disability, which could, for example, make the exercise of a professional activity impossible or excessively difficult, but also of their background. Among those circumstances which the competent institution is obliged to take into consideration, the lack of essential medicines and medical supplies may be included, in a specific case, as is the case in the main proceedings. Thus, as the Advocate General pointed out in point 25 of his Opinion, the second line of Article 22 (2) of Regulation no. 1408/71 makes no distinction as to why a particular benefit cannot be made in a timely manner. However, this lack of medicines and medical supplies can obviously, as is the case with the lack of specific equipment or specialized skills, make it impossible to provide identical treatment or to have the same degree of effectiveness in a timely manner in the Member State of residence.

However, as pointed out by the Romanian and United Kingdom governments (which intervened in favor of the Romanian government), as well as the European Commission, it follows from the case-law cited in the judgment that this impossibility must be assessed, on the one hand, at the level of all hospitals in the Member State of residence, capable of granting the treatment in question, and, on the other hand, in relation to the time interval in which the latter can be obtained in due time.

Regarding the main cause, the Romanian government observes that Ms. Petru had the right to contact any hospital in Romania that had the necessary equipment to perform the intervention she required. It is also pointed out, together with the respondents in the main proceedings, that the attending doctor’s report indicated that this intervention had to be carried out within a period of three months. Therefore, if the facts invoked by Ms. Petru regarding the lack of medicines and medical supplies of first necessity at the Institute of Cardiovascular Diseases in Timisoara are proved, it is for the referring court to assess whether this intervention could not have been performed in this time in another hospital in Romania. In the light of the foregoing considerations, an answer must be given to the question whether  the second line of Article 22 (2) of Regulation no. 1408/71 must be interpreted as meaning that the authorization requested under paragraph 1 (c) (i) of the same article cannot be refused when the hospital treatment in question cannot be granted in a timely manner in the Member State of residence of the socially insured person due to the lack of medicines and medical supplies of first necessity. This impossibility must be assessed at the level of all the hospitals in this Member State that are able to provide the respective treatment and in relation to the time interval in which the latter can be obtained in a timely manner.

For these reasons, the Court ruled:

The second line of Article 22 (2) of Regulation (EEC) no. 1408/71 of the Council of 14 June 1971 on the application of the social security schemes in relation to the employed workers, with self-employed workers and members of their families moving within the Community, as amended and updated by Regulation (EC) no. 118/97 of the Council of 2 December 1996, as amended by Regulation (EC) no. 592/2008 of the European Parliament and of the Council of 17 June 2008, must be interpreted as meaning that the authorization requested under paragraph 1 (c) (i) of the same article cannot be refused when the hospital treatment in question cannot be granted in due time in the Member State of residence of the social insured person because of a lack of essential medicines and medical supplies. This impossibility must be assessed at the level of all the hospitals in this Member State, able to afford the respective treatment and in relation to the time interval during which the latter can be obtained in a timely manner.

BIBLIOGRAPHY

BOOKS

BURRIS Scott, Berman Micah, Penn Matthew, Holiday Ramanathan Tara, The new public health law, Oxford University Press, 2018

FLEAR L Mark, Governing public health, Hart Publishing, 2018

GÂLEA Ionuț, Tratatele Uniunii Europene.Comentarii și explicații, Ed. CH Beck, București, 2012

Hervey Tamara, EU Health Law, in European Union Law, edited by Catherine Barnard and Steve Peers, Oxford University Press, 2014,

ISPAS Gabriel Liviu, Panc Daniela, Drept institutional al Uniunii Europene, Editura Hamangiu, 2019

ROBERTS Jessica, Weeks Elizabeth, Healthism. Health- Status Discrimination and the Law, Cambridge University Press, 2018

STUDIES

1. BAETEN, Cross – border patient mobility, en The European Union: in search of benefits from the new legal framework, en Journal of Health services research & Policy, 19/2014
2. FRISCHHUT – R. LEVAGGI, Patient mobility in the contest of austerity and an enlarged EU: the European Court of Justice’ s rulling in the Petru case, en Health policy, 119/2015
3. PEETERS, Free Movement of Patients: Directive 2011/24 on the application of patients’ rights, en Cross – border healthcare, en European Journal of public health, 2/2014
4. UCCELLO BARRETTA, Il diritto alla salute nello spazio europeo: la mobilità sanitaria alla luce della direttiva 2011/24/Ue, en www.federalismi.it,19/2014.
5. VAN DE GRODEN, Cross border health care in the EU and the organization of the national health care systems of the Member States: the dynamics resulting from the European Court of Justice’s decisions on free movement and competition law, en Wisconsin international law review, 2008, p. 704 ss.

M.J.  VAN  DEN  BRINK, EU  Citizenship  and  EU  Fundamental  Rights:  Taking  EU  Citizenship  Rights Seriously?, en Legal Issues of Economic Integration, 2/2012,

A.P.  VAN  DER  MEI, Cross border Access to Medical Care: Non Hospital Care and Waiting Lists, en Legal Issues of Economic Integration, 2004,

STUDIES AND REPORTS

European Comission, Patient’s Rights in the European Union, Mapping exercise, 2016, ISBN 978-92-79-66960-6

Report from the Commission to the Council and the European Parliament on the implementation of Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare, Brussels, 21.9.2018, Com.(2018) 651 final

ONLINE RESOURCES

https://ec.europa.eu/health/sites/health/files/cross_border_care/docs/2017_msdata_en.pdf

https://eur-lex.europa.eu/legal-content/RO/TXT/DOC/?uri=CELEX:52018DC0651&from=EN

[1]https://eur-lex.europa.eu/legal-content/RO/TXT/DOC/?uri=CELEX:52018DC0651&from=EN

[2]Gabriel- Liviu Ispas, Daniela Dancă, Drept instituțional al Uniunii Europene, Hamangiu Publishing House, 2019, p. 104-109

[3]Declaration no. 24 on the legal personality of the European Union, annexed to the Treaties of the European Union.

[4]I. Gâlea, Tratatele Uniunii Europene. Comentarii și explicații, ed. CH Beck, 2012., pp. 138-139.

[5]Tamara Hervey, EU Health Law, in European Union Law, edited by Catherine Barnard and Steve Peers, Oxford University Press, 2014, p. 622

[6]Luisi and Carbone, 1984, ECR 377, case C-158/96 Kohll, 1988

[7] https://ec.europa.eu/health/sites/health/files/cross_border_care/docs/2017_msdata_en.pdf, p. 4-6

[8] https://ec.europa.eu/health/sites/health/files/cross_border_care/docs/2017_msdata_en.pdf , p. 10. for exemple, Poland received more than 30000 requests in 2017.

[9] Patient’s Rights in the European Union, Mapping exercise, 2016, ISBN 978-92-79-66960-6, p.146-147

[10] Mark L Flear, Governing public health, Hart Publishing House, 2018, p. 38-44

[11]Report from the Commission to the Council and the European Parliament on the implementation of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, Brussels, 21.9.2018, Com.(2018) 651 final, p.2

[12] “In 2017 twenty-two Member States reported they had received in total 235,541 requests for reimbursement. It should be noted that there are some discrepancies between the total number of reported requests and those for which data on grounds for acceptance or refusal are provided. In some cases the discrepancy was negative (fewer outcomes than requests reported) and in some cases positive (a higher number of outcomes than requests). These discrepancies, though not very significant, indicate that there are still some issues with the recording of cross-border care, as well as a time-lag between request and outcome which will not always be covered within the reporting period (i.e. some requests will still be pending a reimbursement decision).”, https://ec.europa.eu/health/sites/health/files/cross_border_care/docs/2017_msdata_en.pdf, p. 26

[13]http://curia.europa.eu/juris/document/document.jsf?text=&docid=158423&pageIndex=0&doclang=RO&mode=lst&dir=&occ=first&part=1&cid=370150

Gabriel Liviu ISPAS

associate professor and dean,

Law Faculty, Titu Maiorescu University, Bucharest