prop · H003150 · 2013-04-11 00:00:00 — Where the patient is entitled to cross-border healthcare under both this Directive and Regulation (EC) No 883/2004, and the application of that Regulation is more advantageous to the patient, the patients attention should be drawn to this by the of affiliation. (3) OJ L 344, 29.12.2010, p. (4) OJ L 124, 20.5.2003, p. (32)Patients should, in any event, not derive a financial advantage from the healthcare provided in another and the assumption of costs should be therefore limited only to the actual costs of healthcare received. (33)This Directive does not aim to create an entitlement to reimbursement of the costs of healthcare provided in another , if such healthcare is not among the benefits provided for by the legislation of the of affiliation of the insured person. Equally, this Directive should not prevent the Member States from extending their benefits-in-kind scheme to healthcare provided in another . This Directive should recognise that Member States are free to organise their healthcare and social security systems in such a way as to determine entitlement for treatment at a regional or local level. (34)Member States of affiliation should give patients the right to receive at least the same benefits in another as those provided for by the legislation of the of affiliation. If the list of benefits does not specify precisely the treatment method applied but defines types of treatment, the of affiliation should not refuse prior authorisation or reimbursement on the grounds that the treatment method is not available in its territory, but should assess if the cross- border treatment sought or received corresponds to benefits provided for in its legislation. The fact that the obligation to reimburse cross-border healthcare under this Directive is limited to such healthcare that is among the benefits to which the patient is entitled within its of affiliation does not preclude Member States from reimbursing the cost of cross-border healthcare beyond those limits. Member States are free, for example, to reimburse extra costs, such as accom modation and costs, or extra costs incurred by persons with disabilities even where those costs are not reimbursed in the case of healthcare provided in their territory. (35)This Directive should not provide either for the transfer of social security entitlements between Member States or other coordination of social security systems. The sole objective of the provisions regarding prior authorisation and reimbursement of healthcare provided in another should be to enable freedom to provide healthcare for patients and to remove unjustified obstacles to that fundamental freedom within the patients of affiliation. Consequently this Directive should fully respect the differences in national healthcare systems and the Member States responsi bilities for the organisation and delivery of health services and care. (36)This Directive should provide for the right for a patient to receive any medicinal product authorised for in the of affiliation, as it is an indis pensable part of obtaining effective treatment in another . Nothing should oblige a of affiliation to reimburse an insured person for a medicinal product prescribed in the of treatment, where that medicinal product is not among the benefits provided to that insured person by the statutory social security system or national health system in the of affiliation. (37)Member States may maintain general conditions, criteria for eligibility and regulatory and administrative formalities for receipt of healthcare and reimbursement of healthcare costs, such as the requirement to consult a general practitioner before consulting a specialist or before receiving hospital care, also in relation to patients seeking healthcare in another , provided that such conditions are necessary, propor tionate to the aim, not discretionary or discriminatory. 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. It is thus appropriate to require that these general conditions, criteria and formalities should be applied in an objective, transparent and non-discrimi natory way and should be known in advance, based primarily on considerations, and that they should not impose any additional burden on patients seeking healthcare in another in comparison with patients being treated in their of affiliation, and that decisions should be made as quickly as possible. This should be without prejudice to the rights of the Member States to lay down criteria or conditions for prior authorisation in the case of patients seeking healthcare in their of affiliation. (38)In the light of the case-law of the Court of , making the assumption by the statutory social security system or national health system of costs of healthcare provided in another subject to prior auth orisation is a restriction to the free movement of services. Therefore, as a general rule, the of affiliation should not make the assumption of the costs of healthcare provided in another subject to prior authorisation, where the costs of that care, if it had been provided in its territory, would have been borne by its statutory social security system or national health system. (39)Patient flows between Member States are limited and expected to remain so, as the vast majority of patients in the Union receive healthcare in their own country and prefer to do so. However, in certain circumstances patients may seek some forms of healthcare in another . Examples include highly specialised care or healthcare provided in frontier areas where the nearest appropriate facility is on the other side of the border. Furthermore, some patients wish to be treated abroad in order to be close to their family members who are residing in another , or in order to have access to a different method of treatment than that provided in the of affiliation or because they believe that they will receive better quality healthcare in another . (40)According to the case-law of the Court of , Member States may make the assumption of costs by the national system of hospital care provided in another subject to prior authorisation. The Court of has judged that this requirement is both necessary and reasonable, since the number of hospitals, their geographical distribution, the way in which they are organised and the facilities with which they are equipped, and even the nature of the services which they are able to offer, are all matters for which planning, generally designed to satisfy various needs, must be possible. The Court of has found that such planning seeks to ensure that there is sufficient and permanent access to a balanced range of high-quality hospital treatment in the concerned. In addition, it assists in meeting a to control costs and to prevent, as far as possible, any wastage of financial, technical and human resources. According to the Court of , such wastage would be all the more damaging because it is generally recognised that the hospital care sector generates considerable costs and must satisfy increasing needs, while the financial resources made available for healthcare are not unlimited, whatever mode of funding is applied. (41)The same reasoning applies to healthcare not provided in a hospital but subjected to similar planning needs in the of treatment. This may be healthcare which requires planning because it involves use of highly specialised and cost-intensive infra structure or equipment. In light of technological progress, the development of new methods of treatment and the different policies of the Member States regarding the roles of hospitals in their healthcare systems, the question of whether this kind of healthcare is delivered within hospital or ambulatory care facilities is not the decisive factor for deciding whether it requires planning or not. (42)Given that the Member States are responsible for laying down rules as regards the management, requirements, quality and safety standards and organisation and delivery of healthcare and that the planning necessities differ from one to another, it should therefore be for the Member States to decide whether there is a need to introduce a system of prior authori sation, and if so, to identify the healthcare requiring prior authorisation in the context of their system in accordance with the criteria defined by this Directive and in the light of the case-law of the Court of . The information concerning this healthcare should be made publicly available in advance. (43)The criteria attached to the grant of prior authorisation should be justified in the light of the overriding reasons of general interest capable of justifying obstacles to the free movement of healthcare, 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 identified several potential considerations: the risk of seriously undermining the financial balance of a social security system, the objective of maintaining on grounds of public health a balanced and hospital service open to all and the objective of maintaining treatment capacity or competence on national territory, essential for the public health, and even the survival of the population. It is also important to take into consideration the general principle of ensuring the safety of the patient, in a sector well known for information asymmetry, when managing a prior authorisation system. Conversely, the refusal to grant prior authorisation may not be based on the ground that there are waiting lists on national territory intended to enable the supply of hospital care to be planned and managed on the basis of predetermined general clinical priorities, without carrying out an objective assessment. (44)According to the case-law of the Court of , the criteria for granting or refusing prior auth orisation should be limited to what is necessary and proportionate in the light of these overriding reasons in the general interest. It should be noted that the impact on national health systems caused by patient mobility might vary between Member States or between regions within a , depending on factors such as geographical location, language barriers, location of hospitals in border regions or the size of the population and healthcare budget. It should therefore be for Member States to set such criteria for refusing prior authorisation that are necessary and proportionate in that specific context, also taking into account which healthcare falls within the scope of the prior authori sation system, since certain treatments of a highly specialised nature will be more easily affected even by a limited patient outflow than others. Consequently, Member States should be able to set up different criteria for different regions or other relevant adminis trative levels for the organisation of healthcare, or indeed for different treatments, as long as the system is trans parent and easily accessible and the criteria are made public in advance. (45)Where the patient is entitled to healthcare and that healthcare cannot be provided within a time limit which is medically justifiable, the of affiliation should in principle be obliged to grant prior authorisation. However, in certain circumstances, cross- border healthcare may expose the patient or the general public to a risk which overrides the interest of the patient to receive the cross-border healthcare sought. instances, the of affiliation should be able to refuse the request for prior authorisation, in which case the of affiliation should direct the patient towards alternative solutions. (46)In any event, if a decides to establish a system of prior authorisation for assumption of costs of hospital or specialised care provided in another in accordance with the provision of this Directive, the costs of such care provided in another should also be reimbursed by the of affiliation up to the level of costs that would have been assumed had the same healthcare been provided in the of affiliation, without exceeding the actual costs of healthcare received. However, when the conditions set out in Regulation (EEC) No 1408/71 or Regulation (EC) No 883/2004 are fulfilled, the auth orisation should be granted and the benefits provided in accordance with Regulation (EC) No 883/2004 unless otherwise requested by the patient. This should apply in particular in instances where the authorisation is granted after an administrative or judicial review of the request and the person concerned has received the treatment in another . In that event, Articles 7 and 8 of this Directive should not apply. This is in line with the case-law of the Court of which has specified that patients who were refused prior authorisation on grounds that were subsequently held to be unfounded, are entitled to have the cost of the treatment obtained in another reimbursed in full according to the provisions of the legislation in the of treatment. (47)Procedures regarding cross-border healthcare established by the Member States should give patients guarantees of objectivity, non-discrimination and transparency, in such a way as to ensure that decisions by national authorities are made in a timely and with due care and regard for both those overall principles and the individual circumstances of each case. This should also apply to the actual reimbursement of costs of healthcare incurred in another after the patient has received treatment. It is appropriate that, under normal circum stances, patients be entitled to receive decisions regarding cross-border healthcare within a reasonable period of time. However, that period should be shortened where warranted by the urgency of the treatment in question. (48)Appropriate information on all essential aspects of cross- border healthcare is necessary in order to enable patients to exercise their rights on cross-border healthcare in practice. For cross-border healthcare, one of the mechanisms for providing such information is to establish national contact points within each . Information that has to be provided compulsorily to patients should be specified. However, the national contact points may provide more information voluntarily and also with the support of the Commission. Information should be provided by national contact points to patients in any of the official languages of the in which the contact points are situated. Information may be provided in any other language. (49)The Member States should decide on the form and number of their national contact points. Such national contact points may also be incorporated in, or build on, activities of existing information centres provided that it is clearly indicated that they are also national contact points for cross-border healthcare. National contact points should be established in an efficient and trans parent way and they should be able to consult with patient organisations, healthcare insurers and healthcare providers. The national contact points should have appropriate facilities to provide information on the main aspects of cross-border healthcare. The Commission should work together with the Member States in order to facilitate cooperation regarding national contact points for cross-border healthcare, including making relevant information available at Union level. The existence of national contact points should not preclude Member States from establishing other linked contact points at regional or local level, reflecting the specific organisation of their healthcare system. (50)Member States should facilitate cooperation between healthcare providers, purchasers and regulators of different Member States at national, regional or local level in order to ensure safe, high-quality and efficient cross-border healthcare. This could be of particular importance in border regions, where cross-border provision of services may be the most efficient way of organising health services for the local population, but where achieving such cross-border provision on a sustained basis requires cooperation between the health systems of different Member States. Such cooperation may concern joint planning, mutual recognition or adap tation of procedures or standards, interoperability of respective national information and communication tech nology (hereinafter ICT) systems, practical mechanisms to ensure continuity of care or practical facilitating of cross-border provision of healthcare by health profes sionals on a temporary or occasional basis. Directive 2005/36/EC of Parliament and of the Council of on the recognition of professional qualifications (1) stipulates that free provision of services of a temporary or occasional nature, including services provided by health profes sionals, in another is not, subject to specific provisions of Union law, to be restricted for (1) OJ L 255, 30.9.2005, p. any reason relating to professional qualifications. This Directive should be without prejudice to Directive 2005/36/EC. (51)The Commission should encourage cooperation between Member States in the areas set out in Chapter IV of this Directive and may, in accordance with Article 168(2) TFEU, take, in close contact with the Member States, any useful initiative to facilitate and promote such coop eration. In that context, the Commission should encourage cooperation in cross-border healthcare provision at regional and local level, particularly by iden tifying major obstacles to collaboration between healthcare providers in border regions, and by making recommendations and disseminating information and best practices on how to overcome such obstacles. (52)The of affiliation may need to receive confirmation that the cross-border healthcare will be, or has been, delivered by a legally practising health professional. It is therefore appropriate to ensure that information on the right to practise contained in the national or local registers of health professionals, if estab in the of treatment, are, upon request, made available to the authorities of the of affiliation. (53)Where medicinal products are authorised within a and have been prescribed in that by a member of a regulated health profession within the meaning of Directive 2005/36/EC for an individual named patient, it should, in principle, be possible for such prescriptions to be medically recognised and for the medicinal products to be dispensed in another in which the medicinal products are authorised. The removal of regu latory and administrative barriers to such recognition should be without prejudice to the need for appropriate agreement of the patients treating physician or phar macist in every individual case, if this is warranted by protection of human health and is necessary and propor tionate to that objective. The recognition of prescriptions from other Member States should not affect any profes sional or ethical duty that would require pharmacists to refuse to dispense the prescription. Such recog nition should also be without prejudice to the decision of the of affiliation regarding the inclusion of such medicinal products among the benefits covered by the social security system of affiliation. It should further be noted that the reimbursement of medicinal products is not affected by the rules on mutual recognition of prescriptions, but covered by the general rules on reim bursement of cross-border healthcare in Chapter III of this Directive. The implementation of the principle of recognition should be facilitated by the adoption of measures necessary for safeguarding the safety of a patient, and avoiding the misuse or confusion of medicinal products. These measures should include the adoption of a non-exhaustive list of elements to be included in prescriptions. Nothing should prevent Member States from having further elements in their prescriptions, as long as this does not prevent prescriptions from other Member States that contain the common list of elements from being recognised. The recognition of prescriptions should also apply for devices that are legally placed on the market in the where the device will be dispensed. (54)The Commission should support the continued devel opment of European reference networks between healthcare providers and centres of expertise in the Member States. European reference networks can improve the access to diagnosis and the provision of high-quality healthcare to all patients who have conditions requiring a particular concentration of resources or expertise, and could also be focal points for training and research, information dissemi nation and evaluation, especially for rare diseases. This Directive should therefore give incentives to Member States to reinforce the continued development of European reference networks. European reference networks are based on the voluntary participation of their members, but the Commission should develop criteria and conditions that the networks should be required to fulfil in order to receive support from the Commission. (55)Rare diseases are those that meet a prevalence threshold of not more than five affected persons per 10 000, in line with Regulation (EC) No 141/2000 of Parliament and of the Council of on orphan medicinal products (1), and they are all serious, chronic and often life threatening. Some patients affected by rare diseases face difficulties in their quest for a diagnosis and treatment to improve their quality of life and to increase their life expectancy, difficulties which were also recognised by the Council Recommendation of 8 2009 on an action in the field of rare diseases (2). (56)Technological developments in cross-border provision of healthcare through the use of ICTs may result in the movement of healthcare and give rise to possible addi tional risks to health protection. Widely different and incompatible formats and standards are used for provision of healthcare using ICTs throughout the Union, creating both obstacles to this mode of cross- border healthcare provision and possible risks to health protection. It is therefore necessary for Member States to aim at interoperability of ICT systems. The deployment of health ICT systems, however, is entirely a national competence. This Directive therefore should recognise the importance of the work on interoperability and respect the division of competences by providing for the Commission and Member States to work together on developing measures which are not legally binding but provide additional tools that are available to Member States to facilitate greater interoperability of (1) OJ L 18, 22.1.2000, p. (2) OJ C 151, , p. ICT systems in the healthcare field and to support patient access to eHealth applications, whenever Member States decide to introduce them. (57)The interoperability of eHealth solutions should be achieved whilst respecting national regulations on the provision of healthcare services adopted in order to protect the patient, including legislation on Internet pharmacies, in particular national bans on mail order of prescription-only medicinal products to the extent that they are compatible with the case-law of the Court of and Directive 97/7/EC of Parliament and of 1997 on the protection of consumers in respect of distance contracts (1) and Directive 2000/31/EC of Parliament and of 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (2).