prop · H003150 · 2013-04-11 00:00:00 — e)underlätta samråd med berörda parter om nätverkets arbete. 4.Kommissionen ska i enlighet med det föreskrivande för farande som avses i artikel 16.2 anta de åtgärder som krävs för att inrätta och förvalta detta nätverk och för att det ska drivas med insyn. 5.Reglerna för att bevilja stödet, de villkor som det kan vara förenat med och beloppet ska beslutas i enlighet med det fö reskrivande förfarande som avses i artikel 16.2. Endast de myn digheter och organ i nätverket som utsetts till stödmottagare av de deltagande medlemsstaterna ska vara berättigade till unions stöd. 6.Vilka anslag som fordras för åtgärderna i den här artikeln ska beslutas som en del av budgetförfarandet. 7.Åtgärder som antas enligt den här artikeln ska inte in kräkta på medlemsstaternas befogenheter i beslut som rör ge nomförandet av resultat av utvärderingar av medicinsk teknik, ska inte medföra någon harmonisering av lagar och andra för fattningar i medlemsstaterna och ska fullständigt respektera medlemsstaternas ansvar för att organisera och tillhandahålla hälso- och sjukvård. 1.Kommissionen ska biträdas av en kommitté som ska bestå av företrädare för medlemsstaterna och ha kommissionens fö reträdare som ordförande. 2.När det hänvisas till denna punkt ska artiklarna 5 och 7 i beslut /468/EG tillämpas, med beaktande av bestämmel serna i artikel 8 i det beslutet. Den tid som avses i artikel 5.6 i beslut /468/EG ska vara . 1.Befogenheter att anta de delegerade akter som avses i artiklarna 11.5 och 12.5 ska ges till kommissionen för en pe riod . Kommissionen ska utarbeta en rapport om de delegerade befogenheterna senast perioden löpt ut. Delegeringen av befogenheter ska automatiskt förlängas med perioder av samma längd, om den inte återkallas av eller rådet i enlighet med artikel 18. 2.Så snart kommissionen antar en delegerad akt ska kom missionen delge och rådet denna. 3.Befogenheterna att anta delegerade akter ges till kommis sionen med förbehåll för de villkor som anges i artiklarna 18 och 19. Den delegering av befogenhet som avses i artiklarna 11.5 och 12.5 får när som helst återkallas av eller rådet. 2.Den institution som har inlett ett internt förfarande för att besluta huruvida en delegering av befogenhet ska återkallas ska sträva efter att underrätta den andra institutionen och kommis sionen inom en rimlig tid innan det slutliga beslutet fattas, och ange vilka delegerade befogenheter som kan komma att återkal las samt skälen för detta. 3.Beslutet om återkallande innebär att delegeringen av de befogenheter som anges i beslutet upphör att gälla. Det får verkan eller vid ett senare, i beslutet angivet, datum. Det påverkar inte giltigheten av delegerade akter som redan trätt Det ska offentliggöras i Europeiska unionens officiella tid ning. Invändning mot delegerade akter eller rådet får invända mot en delege rad akt från delgivningsdagen. På eller rådets initiativ får förlängas . Om varken eller rådet vid utgången av den period som avses i punkt 1 har invänt mot den delegerade akten ska den offentliggöras i Europeiska unionens officiella tidning och träda i kraft den dag som anges i den. Den delegerade akten får offentliggöras i Europeiska unionens officiella tidning och träda i kraft före utgången av om både och rådet har meddelat kommis sionen att de inte tänker invända. Om eller rådet invänder mot en dele gerad akt inom den period som avses i punkt 1 ska den inte träda i kraft. Den institution som invänder mot den delegerade akten ska ange skälen för detta. 1.Kommissionen ska och där efter utarbeta en rapport om tillämpningen av detta direktiv och sända den till och rådet. 2.Rapporten ska i synnerhet innehålla information om pa tientflöden, den finansiella dimensionen av patientrörlighet, till lämpningen av artiklarna 7.9 och 8 och hur de europeiska referensnätverken och de nationella kontaktpunkterna fungerar. I detta syfte ska kommissionen göra en utvärdering av de sy stem och förfaranden som införts i medlemsstaterna, mot bak grund av kraven i detta direktiv och annan unionslagstiftning om patientrörlighet. Medlemsstaterna ska ge kommissionen den hjälp och all den tillgängliga information som krävs för att göra utvärderingarna och utarbeta rapporterna. Medlemsstaterna och kommissionen kan utnyttja den ad ministrativa kommissionen, inrättad enligt artikel 71 i förord ning (EG) nr 883/2004, för att hantera de finansiella kon sekvenserna av tillämpningen av det här direktivet för de med lemsstater som har valt kostnadsersättning på grundval av fasta belopp, i fall som omfattas av artiklarna 20.4 och 27.5 i den förordningen. Kommissionen ska övervaka och regelbundet rapportera om effekterna av artiklarna 3 c i och 8 i det här direktivet. Den första rapporten bör läggas fram . På grundval av dessa rapporter ska kommissionen, när så är lämpligt, komma med förslag för att mildra eventuella snedvrid ningar. Medlemsstaterna ska sätta i kraft de lagar och andra för fattningar som är nödvändiga för att följa detta direktiv . De ska genast underrätta kommissionen om detta. När en medlemsstat antar dessa bestämmelser ska de innehålla en hänvisning till detta direktiv eller åtföljas av en sådan hänvis ning när de offentliggörs. Närmare föreskrifter om hur hänvis ningen ska göras ska varje medlemsstat själv utfärda. Medlemsstaterna ska till kommissionen överlämna texten till de centrala bestämmelser i nationell lagstiftning som de antar inom det område som omfattas av detta direktiv. Detta direktiv träder i kraft den tjugonde dagen efter det att det har offentliggjorts i Europeiska unionens officiella tidning. Detta direktiv riktar sig till medlemsstaterna. DIRECTIVE 2011/24/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the application of patients rights in cross-border healthcare THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of Union, and in particular Articles 114 and 168 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of Economic and (1), Having regard to the opinion of (2), Acting in accordance with the ordinary legislative procedure (3), Article 114(3) TFEU explicitly requires that, in achieving harmonisation, a high level of protection of human health is to be guaranteed taking account in particular of any new development based on scientific facts. (3)The health systems in the Union are a central component of the Unions high levels of social protection, and contribute to social cohesion and social as well as to sustainable development. They are also part of the wider framework of services of general interest. (4)Notwithstanding the possibility for patients to receive cross-border healthcare under this Directive, Member States retain responsibility for providing safe, high quality, efficient and quantitatively adequate healthcare to citizens on their territory. Furthermore, the trans position of this Directive into national legislation and its application should not result in patients being encouraged to receive treatment outside their of affiliation. (1)According to Article 168(1) of the Treaty on the Func tioning of Union (TFEU), a high level of human health protection is to be ensured in the defi nition and implementation of all Union policies and activities. This implies that a high level of human health protection is to be ensured also when the Union adopts acts under other Treaty provisions. (2)Article 114 TFEU is the appropriate legal basis since the majority of the provisions of this Directive aim to improve the functioning of the internal market and the free movement of goods, persons and services. Given that the conditions for recourse to Article 114 TFEU as a legal basis are fulfilled, Union legislation has to rely on this legal basis even when public health protection is a decisive factor in the choices made. In this respect, (1) OJ C 175, 28.7.2009, p. (2) OJ C 120, 28.5.2009, p. (3) Position of Parliament of (OJ C 184 E, , p. 368), position of the Council at first reading of (OJ C 275 E, 12.10.2010, p. 1), position of Parliament of 19 January 2011 (not yet published in the ) and decision of 2011. and competitive pressures to manage health systems, must be taken in the national context. (6)As confirmed by the Court of of Union (hereinafter the Court of ) on several occasions, while recognising their specific nature, all types of care fall within the scope of the TFEU. (4) OJ C 146, 22.6.2006, p. (7)This Directive respects and is without prejudice to the freedom of each to decide what type of healthcare it considers appropriate. No provision of this Directive should be interpreted in such a way as to undermine the fundamental ethical choices of Member States. (8)Some issues relating to cross-border healthcare, in particular reimbursement of healthcare provided in a other than that in which the recipient of the care is resident, have already been addressed by the Court of . This Directive is intended to achieve a more general, and also effective, application of principles developed by the Court of on a case-by-case basis. (9)In the Council Conclusions, the Council recognised the particular value of an initiative on cross-border healthcare ensuring clarity for Union citizens about their rights and entitlements when they move from one to another, in order to ensure legal certainty. (10)This Directive aims to establish rules for facilitating access to safe and high-quality cross-border healthcare in the Union and to ensure patient mobility in accordance with the principles established by the Court of and to promote cooperation on healthcare between Member States, whilst fully respecting the responsibilities of the Member States for the definition of social security benefits relating to health and for the organisation and delivery of healthcare and care and social security benefits, in particular for sickness. (11)This Directive should apply to individual patients who decide to seek healthcare in a other than the of affiliation. As confirmed by the Court of , neither its special nature nor the way in which it is organised or financed removes healthcare from the ambit of the fundamental principle of the freedom to provide services. However, the of affiliation may choose to limit the reim bursement of cross-border healthcare for reasons relating to the quality and safety of the healthcare provided, where this can be justified by overriding reasons of general interest relating to public health. The of affiliation may also take further measures on other grounds where this can be justified by such overriding reasons of general interest. Indeed, the Court of has laid down that public health protection is among the overriding reasons of general interest that can justify restrictions to the freedom of movement envisaged in the Treaties. (12)The concept of overriding reasons of general interest to which reference is made in certain provisions of this Directive has been developed by the Court of in its case-law in relation to Articles 49 and 56 TFEU and may continue to evolve. The Court of has held on a number of occasions that overriding reasons of general interest are capable of justifying an obstacle to the freedom to provide services such as planning requirements relating to the aim of ensuring sufficient and permanent access to a balanced range of high- quality treatment in the concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources. The Court of has likewise acknowledged that the objective of maintaining a balanced and hospital service open to all may also fall within one of the dero gations, on grounds of public health, provided for in Article 52 TFEU, in so far as it contributes to the attainment of a high level of health protection. freedom to provide and hospital services in so far as the maintenance of treatment capacity or competence on national territory is essential for public health. (13)It is clear that the obligation to reimburse costs of cross- border healthcare should be limited to healthcare to which the insured person is entitled according to the legislation of the of affiliation. (14)This Directive should not apply to services the primary purpose of which is to support people in need of assistance in carrying out routine, everyday tasks. specifically, this Directive should not apply to those long- term care services deemed necessary in order to enable the person in need of care to live as full and self- determined a life as possible. Thus, this Directive should not apply, for example, to long-term care services provided by home care services, in assisted living facilities and in residential homes or housing (nursing homes). (15)Given their specificity, access to and the allocation of organs for the purpose of organ transplants should fall outside the scope of this Directive. (16)For the purpose of reimbursing the costs of cross-border healthcare, this Directive should cover not only the situation where the patient is provided with healthcare in a other than the of affiliation, but also the prescription, dispensation and provision of medicinal products and devices where these are provided in the context of a health service. The definition of cross-border healthcare should cover both the situation in which a patient purchases such medicinal products and devices in a other than the of affiliation and the situation in which the patient purchases such medicinal products and devices in another than that in which the prescription was issued. (17)This Directive should not affect Member States rules concerning the sale of medicinal products and devices over the Internet. (18)This Directive should not give any person an entitlement to enter, stay or reside in a in order to receive healthcare in that State. Where the stay of a person on the territory of a is not in accordance with the legislation of that concerning the right to enter or stay on its territory, such person should not be regarded as an insured person according to the definition in this Directive. Member States should continue to be able to specify in their national legislation who is considered as an insured person for the purposes of their public healthcare scheme and social security legislation as long as the patients rights set out in this Directive are secured. (19)When a patient receives cross-border healthcare, it is essential for the patient to know in advance which rules will be applicable. The rules applicable to cross- border healthcare should be those set out in the legis lation of the of treatment, given that, in accordance with Article 168(7) TFEU, the organisation and delivery of health services and care is the responsibility of the Member States. This should help the patient in making an informed choice, and should avoid misapprehension and misunderstanding. It should also establish a high level of trust between the patient and the healthcare provider. (20)In order to help patients to make an informed choice when they seek to receive healthcare in another , Member States of treatment should ensure that patients from other Member States receive on request the relevant information on safety and quality standards enforced on its territory as well as on which healthcare providers are subject to these standards. Furthermore, healthcare providers should provide patients on request with information on specific aspects of the healthcare services they offer and on the treatment options. To the extent that healthcare providers already provide patients resident in the of treatment with relevant information on those specific aspects, this Directive should not oblige healthcare providers to provide more extensive information to patients from other Member States. Nothing should prevent the of treatment from also obliging other actors than the healthcare providers, such as insurance providers or public authorities, to provide the with regard to the organisation of its healthcare system. (21)In its Conclusions the Council recognised that there is a set of common values and principles that are shared across the Union about how health systems respond to the needs of the population and patients that they serve. The overarching values of universality, access to good quality care, equity, and solidarity have been widely acknowledged in the work of various Union institutions. Therefore, Member States should also ensure that these values are respected with regard to patients and citizens from other Member States, and that all patients are treated equitably on the basis of their healthcare needs rather than on the basis of their of affiliation. In doing so, Member States should respect the principles of free movement of persons within the internal market, non-discrimination, inter alia, with regard to nationality and necessity and proportionality of any restrictions on free movement. However, nothing in this Directive should oblige healthcare providers to accept for planned treatment patients from other Member States or to prioritise them to the detriment of other patients, for instance by increasing the waiting time for treatment of other patients. Inflows of patients may create a demand exceeding the capacities existing in a for a given treatment. In such exceptional cases, the should retain the possibility to remedy the situation on the grounds of public health, in accordance with Articles 52 and 62 TFEU. However, this limitation should be without prejudice to Member States obligations under Regulation (EC) No 883/2004 of Parliament and of the Council of on the coordination of social security systems (1). (22)Systematic and continuous efforts should be made to ensure that quality and safety standards are improved in line with the Council Conclusions and taking into account advances in international science and generally recognised good practices as well as taking into account new health technologies. (23)Ensuring clear common obligations in respect of the provision of mechanisms for responding to harm arising from healthcare is essential to prevent lack of confidence in those mechanisms being an obstacle to taking up cross-border healthcare. Systems for addressing harm in the of treatment should be without prejudice to the possibility for Member States to extend the coverage of their domestic systems to patients from their country seeking healthcare abroad, where this is more appropriate for the patient. (24)Member States should ensure that mechanisms for the protection of patients and for seeking remedies in the event of harm are in place for healthcare provided on their territory and that they are appropriate to the nature and extent of the risk. However, it should be for the to determine the nature and modalities of such a mechanism. (1) OJ L 166, 30.4.2004, p. (25)The right to the protection of personal data is a funda mental right recognised by Article 8 of the Charter of Fundamental Rights of Union. Ensuring continuity of cross-border healthcare depends on transfer of personal data concerning patients health. These personal data should be able to flow from one to another, but at the same time the fundamental rights of the individuals should be safe guarded. Directive 95/46/EC of Parliament and of 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (1) establishes the right for individuals to have access to their personal data concerning their health, for example the data in their records containing such information as diagnosis, examination results, assessments by treating physicians and any treatment or interventions provided. Those provisions should also apply in the context of cross-border healthcare covered by this Directive. (26)The right to reimbursement of the costs of healthcare provided in another by the statutory social security system of patients as insured persons has been recognised by the Court of in several judgements. The Court of has held that the Treaty provisions on the freedom to provide services include the freedom for the recipients of healthcare, including persons in need of treatment, to go to another in order to receive it there. The same should apply to recipients of healthcare seeking to receive healthcare provided in another through other means, for example through eHealth services. (27)In accordance with the principles established by the Court of , and without endangering the financial balance of Member States healthcare and social security systems, greater legal certainty as regards the reim bursement of healthcare costs should be provided for patients and for health professionals, healthcare providers and social security institutions. (28)This Directive should not affect an insured persons rights in respect of the assumption of costs of healthcare which becomes necessary on grounds during a temporary stay in another according to Regulation (EC) No 883/2004. In addition, this Directive should not affect an insured persons right to be granted an authorisation for treatment in another where the conditions provided for by Union regulations on the coordination of social security systems are met, in particular by Regulation (EC) No 883/2004 or Council Regulation (EEC) No 1408/71 of 14 1971 on the application of social security schemes to employed persons, to self- employed persons and to members of their families moving within the Community (2), which are applicable (1) OJ L 281, 23.11.1995, p. (2) OJ L 149, , p. by virtue of Regulation (EU) No 1231/2010 of Parliament and of the Council of extending Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009 to nationals of third countries who are not already covered by these Regulations solely on the ground of their nationality (3) and Council Regulation (EC) No 859/2003 of 14 2003 extending the provisions of Regulation (EEC) No 1408/71 and Regulation (EEC) No 574/72 to nationals of third countries who are not already covered by those provisions solely on the ground of their nationality (4). (29)It is appropriate to require that also patients who seek healthcare in another in other circum stances than those provided for in Regulation (EC) No 883/2004 should be able to benefit from the prin ciples of free movement of patients, services and goods in accordance with the TFEU and with this Directive. Patients should enjoy a guarantee of assumption of the costs of that healthcare at least at the level as would be provided for the same healthcare, had it been provided in the of affiliation. This should fully respect the responsibility of the Member States to determine the extent of the sickness cover available to their citizens and prevent any significant effect on the financing of the national healthcare systems. (30)For patients, therefore, the two systems should be coherent; either this Directive applies or the Union regu lations on the coordination of social security systems apply. (31)Patients should not be deprived of the more beneficial rights guaranteed by the Union Regulations on the coor dination of social security systems when the conditions are met. Therefore, any patient who requests an auth orisation to receive treatment appropriate to his condition in another should always be granted this authorisation under the conditions provided for in the Unions regulations when the treatment in question is among the benefits provided for by the legislation in the where the patient resides and when the patient cannot be given such treatment within a time limit that is medically justifiable, taking account of his current state of health and the probable course of the condition. However, if a patient instead explicitly requests to seek treatment under the terms of this Directive, the benefits which apply to reimbursement should be limited to those which apply under this Directive.