prop · H003150 · 2013-04-11 00:00:00 — (58)The progress of science and health tech nologies presents both opportunities and challenges to the health systems of the Member States. Cooperation in the evaluation of new health technologies can support Member States through economies of scale and avoid duplication of effort, and provide a better evidence base for optimal use of new technologies to ensure safe, high-quality and efficient healthcare. Such cooperation requires sustained structures involving all the relevant authorities of the Member States, on existing pilot projects and consultation of a wide range of stake holders. This Directive should therefore provide a basis for continued Union support for such cooperation. (59)According to Article 291 TFEU, rules and general prin ciples concerning mechanisms for the control by Member States of the Commissions exercise of imple menting powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legis lative procedure. Pending the adoption of that new Regu lation, Council Decision 1999/468/EC of 28 1999 laying down the procedures for the exercise of imple menting powers conferred on the Commission (3) continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable. (60)The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of measures that would exclude specific categories of medicinal products or devices from the recognition of prescriptions, as provided for in this Directive. In order to identify the reference networks which should benefit from support by the Commission, the Commission should also be (1) OJ L 144, , p. (2) OJ L 178, , p. (3) OJ L 184, , p. empowered to adopt delegated acts in respect of the criteria and conditions that European reference networks have to fulfil. (61)It is of particular importance that, when empowered to adopt delegated acts in accordance with Article 290 TFEU, the Commission carry out appropriate consul tations during its preparatory work, including at expert level. (62)In accordance with point 34 of the Interinstitutional Agreement on better law-making (4), Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public. (63) Data Protection Supervisor has also delivered his opinion on the proposal for this Directive (5). (64)Since the objective of this Directive, namely providing rules for facilitating the access to safe and high quality cross-border healthcare in the Union, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, Subject matter and scope This Directive provides rules for facilitating the access to safe and high-quality cross-border healthcare and promotes cooperation on healthcare between Member States, in full respect of national competencies in organising and delivering healthcare. This Directive also aims at clarifying its relationship with the existing framework on the coordination of social security systems, Regulation (EC) No 883/2004, with a view to application of patients rights. (4) OJ C 321, 31.12.2003, p. (5) OJ C 128, , p. 2.This Directive shall apply to the provision of healthcare to patients, regardless of how it is organised, delivered and financed. 3.This Directive shall not apply to: (a)services in the field of long-term care the purpose of which is to support people in need of assistance in carrying out routine, everyday tasks; (b)allocation of and access to organs for the purpose of organ transplants; (c)with the exception of Chapter IV, public vaccination programmes against infectious diseases which are exclusively aimed at protecting the health of the population on the territory of a and which are subject to specific planning and implementation measures. This Directive shall not affect laws and regulations in Member States relating to the organisation and financing of healthcare in situations not related to cross-border healthcare. In particular, nothing in this Directive obliges a to reimburse costs of healthcare provided by healthcare providers established on its own territory if those providers are not part of the social security system or public health system of that . Relationship with other Union provisions This Directive shall apply without prejudice to: (a)Council Directive 89/105/EEC of relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (1); (b)Council Directive 90/385/EEC of 20 1990 on the approximation of the laws of the Member States relating to implantable devices (2), Council Directive 93/42/EEC of 14 1993 concerning devices (3) and Directive 98/79/EC of Parliament and of 1998 on in vitro diagnostic devices (4); (c)Directive 95/46/EC and Directive 2002/58/EC of Parliament and of 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (5); (d)Directive 96/71/EC of Parliament and of the Council of concerning the posting of workers in the framework of the provision of services (6); (e)Directive 2000/31/EC; (1) OJ L 40, , p. (2) OJ L 189, 20.7.1990, p. (3) OJ L 169, , p. (4) OJ L 331, 7.12.1998, p. (5) OJ L 201, 31.7.2002, p. (6) OJ L 18, 21.1.1997, p. (f)Council Directive 2000/43/EC of 29 2000 imple menting the principle of equal treatment between persons irrespective of racial or ethnic origin (7); (g)Directive 2001/20/EC of Parliament and of the Council of on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (8); (h)Directive 2001/83/EC of Parliament and of the Council of on the Community code relating to medicinal products for human use (9); (i)Directive 2002/98/EC of Parliament and of 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (10); (j)Regulation (EC) No 859/2003; (k)Directive 2004/23/EC of Parliament and of 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (11); (l)Regulation (EC) No 726/2004 of Parliament and of 2004 laying down Community procedures for the authorisation and super vision of medicinal products for human and veterinary use and establishing a (12); (m)Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009 of Parliament and of the Council of laying down the procedure for implementing Regulation (EC) No 883/2004 on the coordination of social security systems (13); (n)Directive 2005/36/EC; (o)Regulation (EC) No 1082/2006 of Parliament and of 2006 on a European grouping of territorial cooperation (EGTC) (14); (7) OJ L 180, , p. (8) OJ L 121, , p. (9) OJ L 311, 28.11.2001, p. (10) OJ L 33, , p. (11) OJ L 102, , p. (12) OJ L 136, 30.4.2004, p. (13) OJ L 284, 30.10.2009, p. (14) OJ L 210, 31.7.2006, p. (p)Regulation (EC) No 1338/2008 of Parliament and of the Council of on Community statistics on public health and health and safety at work (1); (q)Regulation (EC) No 593/2008 of Parliament and of 2008 on the law applicable to contractual obligations (I) (2), Regulation (EC) No 864/2007 of Parliament and of 2007 on the law applicable to non- contractual obligations (II) (3) and other Union rules on private international law, in particular rules related to court jurisdiction and the applicable law; (r)Directive 2010/53/EU of Parliament and of 2010 on standards of quality and safety of human organs intended for transplantation (4); (s)Regulation (EU) No 1231/2010. For the purposes of this Directive, the following definitions shall apply: (a)healthcare means health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispen sation and provision of medicinal products and devices; (b)insured person means: (i)persons, including members of their families and their survivors, who are covered by Article 2 of Regulation (EC) No 883/2004 and who are insured persons within the meaning of Article 1(c) of that Regulation; and (ii)nationals of a third country who are covered by Regu lation (EC) No 859/2003 or Regulation (EU) No 1231/2010, or who satisfy the conditions of the legis lation of the of affiliation for entitlement to benefits; (c)of affiliation means: (i)for persons referred to in point (b)(i), the that is competent to grant to the insured person a prior authorisation to receive appropriate treatment outside the of according to Regulations (EC) No 883/2004 and (EC) No 987/2009; (1) OJ L 354, 31.12.2008, p. (2) OJ L 177, , p. (3) OJ L 199, 31.7.2007, p. (4) OJ L 207, , p. (ii)for persons referred to in point (b)(ii), the that is competent to grant to the insured person a prior authorisation to receive appropriate treatment in another according to Regulation (EC) No 859/2003 or Regulation (EU) No 1231/2010. If no is competent according to those Regulations, the of affiliation shall be the where the person is insured or has the rights to sickness benefits according to the legis lation of that Member State; (d)of treatment means the on whose territory healthcare is actually provided to the patient. In the case of telemedicine, healthcare is considered to be provided in the where the healthcare provider is established; (e)cross-border healthcare means healthcare provided or prescribed in a other than the of affiliation; (f)health professional means a doctor of medicine, a nurse responsible for general care, a dental practitioner, a midwife or a pharmacist within the meaning of Directive 2005/36/EC, or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC, or a person considered to be a health professional according to the legislation of the of treatment; (g)healthcare provider means any natural or legal person or any other entity legally providing healthcare on the territory of a Member State; (h)patient means any natural person who seeks to receive or receives healthcare in a Member State; (i)medicinal product means a medicinal product as defined by Directive 2001/83/EC; (j)device means a device as defined by Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC; (k)prescription means a prescription for a medicinal product or for a device issued by a member of a regulated health profession within the meaning of Article 3(1)(a) of Directive 2005/36/EC who is legally entitled to do so in the in which the prescription is issued; (l)health technology means a medicinal product, a device or and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare; (m)records means all the documents containing data, assessments and information of any kind on a patients situation and clinical development throughout the care process. RESPONSIBILITIES OF MEMBER STATES WITH REGARD TO Responsibilities of the of treatment Taking into account the principles of universality, access to good quality care, equity and solidarity, cross-border healthcare shall be provided in accordance with: (a)the legislation of the of treatment; (b)standards and guidelines on quality and safety laid down by the of treatment; and (c)Union legislation on safety standards. 2.The of treatment shall ensure that: (a)patients receive from the national contact point referred to in Article 6, upon request, relevant information on the standards and guidelines referred to in paragraph 1(b) of this Article, including provisions on supervision and assessment of healthcare providers, information on which healthcare providers are subject to these standards and guidelines and information on the accessibility of hospitals for persons with disabilities; (b)healthcare providers provide relevant information to help individual patients to make an informed choice, including on treatment options, on the availability, quality and safety of the healthcare they provide in the of treatment and that they also provide clear invoices and clear information on prices, as well as on their authorisation or registration status, their insurance cover or other means of personal or collective protection with regard to profes sional liability. To the extent that healthcare providers already provide patients resident in the of treatment with relevant information on these subjects, this Directive does not oblige healthcare providers to provide more extensive information to patients from other Member States; (c)there are transparent complaints procedures and mechanisms in place for patients, in order for them to seek remedies in accordance with the legislation of the of treatment if they suffer harm arising from the healthcare they receive; (d)systems of professional liability insurance, or a guarantee or similar arrangement that is equivalent or essentially comparable as regards its purpose and which is appropriate to the nature and the extent of the risk, are in place for treatment provided on its territory; (e)the fundamental right to privacy with respect to the processing of personal data is protected in conformity with national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC; (f)in order to ensure continuity of care, patients who have received treatment are entitled to a written or electronic record of such treatment, and access to at least a copy of this record in conformity with and subject to national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC. The principle of non-discrimination with regard to nationality shall be applied to patients from other Member States. This shall be without prejudice to the possibility for the of treatment, where it is justified by overriding reasons of general interest, 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, to adopt measures regarding access to treatment aimed at fulfilling its fundamental responsibility to ensure sufficient and permanent access to healthcare within its territory. Such measures shall be limited to what is necessary and proportionate and may not constitute a means of arbitrary discrimination and shall be made publicly available in advance. Member States shall ensure that the healthcare providers on their territory apply the same scale of fees for healthcare for patients from other Member States, as for domestic patients in a comparable situation, or that they charge a price calculated according to objective, non-discriminatory criteria if there is no comparable price for domestic patients. This paragraph shall be without prejudice to national legislation which allows healthcare providers to set their own prices, provided that they do not discriminate against patients from other Member States. This Directive shall not affect laws and regulations in Member States on the use of languages. Member States may choose to deliver information in other languages than those which are official languages in the concerned. Responsibilities of the of affiliation The of affiliation shall ensure that: (a)the cost of cross-border healthcare is reimbursed in accordance with Chapter III; (b)there are mechanisms in place to provide patients on request with information on their rights and entitlements in that relating to receiving cross-border healthcare, in particular as regards the terms and conditions for reimbursement of costs in accordance with Article 7(6) and procedures for accessing and determining those entitlements and for appeal and redress if patients consider that their rights have not been respected, in accordance with Article 9. In information about cross- border healthcare, a clear distinction shall be made between the rights which patients have by virtue of this Directive and rights arising from Regulation (EC) No 883/2004; (c)where a patient has received cross-border healthcare and where follow-up proves necessary, the same follow-up is available as would have been if that healthcare had been provided on its territory; (d)patients who seek to receive or do receive cross-border healthcare have remote access to or have at least a copy of their records, in conformity with, and subject to, national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC. National contact points for cross-border healthcare Each designate one or more national contact points for cross-border healthcare and communicate their names and contact details to the Commission. The Commission and the Member States shall make this information publicly available. Member States shall ensure that the national contact points consult with patient organisations, healthcare providers and healthcare insurers. 2.National contact points shall facilitate the exchange of information referred to in paragraph 3 and shall cooperate closely with each other and with the Commission. National contact points shall provide patients on request with contact details of national contact points in other Member States. 3.In order to enable patients to make use of their rights in relation to cross-border healthcare, national contact points in the of treatment shall provide them with information concerning healthcare providers, including, on request, information on a specific providers right to provide services or any restrictions on its practice, information referred to in Article 4(2)(a), as well as information on patients rights, complaints procedures and mechanisms for seeking remedies, according to the legislation of that , as well as the legal and administrative options available to settle disputes, including in the event of harm arising from cross-border healthcare. 4.National contact points in the of affiliation shall provide patients and health professionals with the information referred to in Article 5(b). 5.The information referred to in this Article shall be easily accessible and shall be made available by electronic means and in formats accessible to people with disabilities, as appropriate. REIMBURSEMENT OF COSTS OF CROSS-BORDER General principles for reimbursement of costs 1.Without prejudice to Regulation (EC) No 883/2004 and subject to the provisions of Articles 8 and 9, the of affiliation shall ensure the costs incurred by an insured person who receives cross-border healthcare are reimbursed, if the healthcare in question is among the benefits to which the insured person is entitled in the of affiliation. 2.By way of derogation from paragraph 1: (a)if a is listed in to Regulation (EC) No 883/2004 and in compliance with that Regulation has recognised the rights to sickness benefits for pensioners and the members of their families, being resident in a different , it shall provide them healthcare under this Directive at its own expense when they stay on its territory, in accordance with its legislation, as though the persons concerned were residents in the listed in that ; (b)if the healthcare provided in accordance with this Directive is not subject to prior authorisation, is not provided in accordance with Chapter 1 of Title III of the Regulation (EC) No 883/2004, and is provided in the territory of the that according to that Regulation and Regu lation (EC) No 987/2009 is, in the end, responsible for reimbursement of the costs, the costs shall be assumed by that . That may assume the costs of the healthcare in accordance with the terms, conditions, criteria for eligibility and regulatory and admin istrative formalities that it has established, provided that these are compatible with the TFEU. 3.It is for the of affiliation to determine, costs and the level of assumption of those costs, regardless of where the healthcare is provided. The costs of cross-border healthcare shall be reimbursed or paid directly by the of affiliation up to the level of costs that would have been assumed by the of affiliation, had this healthcare been provided in its territory without exceeding the actual costs of healthcare received. Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory the of affiliation may nevertheless decide to reimburse the full cost. The of affiliation may decide to reimburse other related costs, such as accommodation and costs, or extra costs which persons with disabilities might incur due to one or more disabilities when receiving cross-border healthcare, in accordance with national legislation and on the condition that there be sufficient documentation setting out these costs. 5.Member States may adopt provisions in accordance with the TFEU aimed at ensuring that patients enjoy the same rights when receiving cross-border healthcare as they would have enjoyed if they had received healthcare in a comparable situation in the of affiliation. 6.For the purposes of paragraph 4, Member States shall have a transparent mechanism for calculation of costs of cross-border healthcare that are to be reimbursed to the insured person by the of affiliation. This mechanism shall be based on objective, non-discriminatory criteria known in advance and applied at the relevant (local, regional or national) adminis trative level. The of affiliation may impose on an insured person seeking reimbursement of the costs of cross-border healthcare, including healthcare received through means of tele medicine, the same conditions, criteria of eligibility and regu latory and administrative formalities, whether set at a local, regional or national level, as it would impose if this healthcare were provided in its territory. This may include an assessment by a health professional or healthcare administrator providing services for the statutory social security system or national health system of the of affiliation, such as the general practitioner or primary care practitioner with whom the patient is registered, if this is necessary for determining the individual patients entitlement to healthcare. However, no conditions, criteria of eligibility and regulatory and adminis trative formalities imposed according to this paragraph may be discriminatory or constitute an obstacle to the free movement of patients, services or goods, unless it is objectively justified by planning requirements relating to the object 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. 8.The of affiliation shall not make the reim bursement of costs of cross-border healthcare subject to prior authorisation except in the cases set out in Article 8.