prop · H003150 · 2013-04-11 00:00:00 — 9.The of affiliation may limit the application of the rules on reimbursement for cross-border healthcare based on 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. 10.Notwithstanding paragraph 9, Member States shall ensure that the cross-border healthcare for which a prior auth orisation has been granted is reimbursed in accordance with the authorisation. 11.The decision to limit the application of this Article pursuant to paragraph 9 shall be restricted to what is necessary and proportionate, and may not constitute a means of arbitrary discrimination or an unjustified obstacle to the free movement of goods, persons or services. Member States shall notify the Commission of any decisions to limit reimbursement on the grounds stated in paragraph 9. Healthcare that may be subject to prior authorisation The of affiliation may provide for a system of prior authorisation for reimbursement of costs of cross- border healthcare, in accordance with this Article and Article 9. The system of prior authorisation, including the criteria and the application of those criteria, and individual decisions of refusal to grant prior authorisation, shall be restricted to what is necessary and proportionate to the objective to be achieved, and may not constitute a means of arbitrary discrimination or an unjustified obstacle to the free movement of patients. Healthcare that may be subject to prior authorisation shall be limited to healthcare which: (a)is made subject to 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 and: (i)involves overnight hospital accommodation of the patient in question for at least one night; or (ii)requires use of highly specialised and cost-intensive infrastructure or equipment; (b)involves treatments presenting a particular risk for the patient or the population; or (c)is provided by a healthcare provider that, on a case-by-case basis, could give rise to serious and specific concerns relating to the quality or safety of the care, with the exception of healthcare which is subject to Union legislation ensuring a minimum level of safety and quality throughout the Union. Member States shall notify the categories of healthcare referred to in point (a) to the Commission. With regard to requests for prior authorisation made by an insured person with a view to receiving cross-border healthcare, the of affiliation shall ascertain whether the conditions laid down in Regulation (EC) No 883/2004 have been met. Where those conditions are met, the prior authorisation shall be granted pursuant to that Regulation unless the patient requests otherwise. 4.When a patient affected, or suspected of being affected, by a rare disease applies for prior authorisation, a clinical evaluation may be carried out by experts in that field. If no experts can be found within the of affiliation or if the experts opinion is inconclusive, the of affiliation may request scientific advice. 5.Without prejudice to points (a) to (c) of paragraph 6, the of affiliation may not refuse to grant prior auth orisation when the patient is entitled to the healthcare in question in accordance with Article 7, and when this healthcare cannot be provided on its territory within a time limit which is medically justifiable, based on an objective assessment of the patients condition, the history and probable course of the patients illness, the degree of the patients pain and/or the nature of the patients disability at the time when the request for authorisation was made or renewed. 6.The of affiliation may refuse to grant prior authorisation for the following reasons: (a)the patient will, according to a clinical evaluation, be exposed with reasonable certainty to a patient-safety risk that cannot be regarded as acceptable, taking into account the potential benefit for the patient of the sought cross- border healthcare; (b)the general public will be exposed with reasonable certainty to a substantial safety hazard as a result of the cross-border healthcare in question; (c)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, including provisions on supervision, whether these standards and guidelines are laid down by laws and regulations or through accreditation systems established by the of treatment; (d)this healthcare can be provided on its territory within a time limit which is medically justifiable, taking into account the current state of health and the probable course of the illness of each patient concerned. 7.The of affiliation shall make publicly available which healthcare is subject to prior authorisation for the purposes of this Directive, as well as all relevant information on the system of prior authorisation. Administrative procedures regarding cross-border healthcare 1.The of affiliation shall ensure that adminis trative procedures regarding the use of cross-border healthcare and reimbursement of costs of healthcare incurred in another are based on objective, non-discriminatory criteria which are necessary and proportionate to the objective to be achieved. 2.Any administrative procedure of the kind referred to in paragraph 1 shall be easily accessible and information relating to such a procedure shall be made publicly available at the appropriate level. Such a procedure shall be capable of ensuring that requests are dealt with objectively and impartially. 3.Member States shall set out reasonable periods of time within which requests for cross-border healthcare must be dealt with and make them public in advance. When considering a request for cross-border healthcare, Member States shall take into account: (a)the specific condition; (b)the urgency and individual circumstances. 4.Member States shall ensure that individual decisions regarding the use of cross-border healthcare and reimbursement of costs of healthcare incurred in another are properly reasoned and subject, on a case-by-case basis, to review and are capable of being challenged in judicial proceedings, which include provision for interim measures. 5.This Directive is without prejudice to Member States right to offer patients a voluntary system of prior notification whereby, in return for such notification, the patient receives a written confirmation of the amount to be reimbursed on the basis of an estimate. This estimate shall take into account the patients clinical case, specifying the procedures likely to apply. Member States may choose to apply the mechanisms of financial compensation between the competent institutions as provided for by Regulation (EC) No 883/2004. Where a of affiliation does not apply such mechanisms, it shall ensure that patients receive reimbursement without undue delay. Mutual assistance and cooperation Member States shall render such mutual assistance as is necessary for the implementation of this Directive, including cooperation on standards and guidelines on quality and safety and the exchange of information, especially between their national contact points in accordance with Article 6, including on provisions on supervision and mutual assistance to clarify the content of invoices. 2.Member States shall facilitate cooperation in cross-border healthcare provision at regional and local level as well as through ICT and other forms of cross-border cooperation. 3.The Commission shall encourage Member States, particularly neighbouring countries, to conclude agreements among themselves. The Commission shall also encourage the Member States to cooperate in cross-border healthcare provision in border regions. 4.Member States of treatment shall ensure that information on the right to practise of health professionals listed in national or local registers established on their territory is, upon request, made available to the authorities of other Member States, for the purpose of cross-border healthcare, in accordance with Chapters II and III and with national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC, and the principle of presumption of innocence. The exchange of information shall take place via the Internal Market Information system established pursuant to Commission Decision 2008/49/EC of concerning the implemen tation of the () as regards the protection of personal data (1). Recognition of prescriptions issued in another Member State If a medicinal product is authorised to be marketed on their territory, in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004, Member States shall ensure that prescriptions issued for such a product in another for a named patient can be dispensed on their territory in compliance with their national legislation in force, and that any restrictions on recognition of individual prescriptions are prohibited unless such restrictions are: (a)limited to what is necessary and proportionate to safeguard human health, and non-discriminatory; or (b)based on legitimate and justified doubts about the auth enticity, content or comprehensibility of an individual prescription. (1) OJ L 13, , p. The recognition of such prescriptions shall not affect national rules governing prescribing and dispensing, if those rules are compatible with Union law, including generic or other substi tution. The recognition of prescriptions shall not affect the rules on reimbursement of medicinal products. Reimbursement of costs of medicinal products is covered by Chapter III of this Directive. In particular, the recognition of prescriptions shall not affect a pharmacists right, by virtue of national rules, to refuse, for ethical reasons, to dispense a product that was prescribed in another , where the pharmacist would have the right to refuse to dispense, had the prescription been issued in the of affiliation. The of affiliation shall take all necessary measures, in addition to the recognition of the prescription, in order to ensure continuity of treatment in cases where a prescription is issued in the of treatment for medicinal products or devices available in the of affiliation and where dispensing is sought in the of affiliation. This paragraph shall also apply to devices that are legally placed on the market in the respective . In order to facilitate implementation of paragraph 1, the Commission shall adopt: (a)measures enabling a health professional to verify the auth enticity of the prescription and whether the prescription was issued in another by a member of a regulated health profession who is legally entitled to do so through developing a non-exhaustive list of elements to be included in the prescriptions and which must be clearly identifiable in all prescription formats, including elements to facilitate, if needed, contact between the prescribing party and the dispensing party in order to contribute to a complete under standing of the treatment, in due respect of data protection; (b)guidelines supporting the Member States in developing the interoperability of ePrescriptions; (c)measures to facilitate the correct identification of medicinal products or devices prescribed in one and dispensed in another, including measures to address patient safety concerns in relation to their substitution in cross border healthcare where the legislation of the dispensing permits such substitution. The Commission shall consider, inter alia, using the International Non-proprietary Name and the dosage of medicinal products; (d)measures to facilitate the comprehensibility of the information to patients concerning the prescription and the instructions included on the use of the product, including an indication of substance and dosage. Measures referred in point (a) shall be adopted by the Commission no later than and measures in points (c) and (d) shall be adopted by the Commission no later than 25 October 2012. 3.The measures and guidelines referred to in points (a) to (d) of paragraph 2 shall be adopted in accordance with the regu latory procedure referred to in Article 16(2). 4.In adopting measures or guidelines under paragraph 2, the Commission shall have regard to the proportionality of any costs of compliance with, as well as the likely benefits of, the measures or guidelines. 5.For the purpose of paragraph 1, the Commission shall also adopt, by means of delegated acts in accordance with Article 17 and subject to the conditions of Articles 18 and 19 and no later than 25 October 2012 measures to exclude specific categories of medicinal products or devices from the recognition of prescriptions provided for under this Article, where necessary in order to safeguard public health. Paragraph 1 shall not apply to medicinal products subject to special prescription provided for in Article 71(2) of Directive 2001/83/EC. The Commission shall support Member States in the development of European reference networks between healthcare providers and centres of expertise in the Member States, in particular in the area of rare diseases. The networks shall be based on voluntary participation by its members, which shall participate and contribute to the networks activities in accordance with the legislation of the where the members are established and shall at all times be open to new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria referred to in paragraph 4. European reference networks shall have at least three of the following objectives: (a)to help realise the potential of European cooperation regarding highly specialised healthcare for patients and for healthcare systems by exploiting innovations in science and health technologies; (b)to contribute to the pooling of knowledge regarding sickness prevention; (c)to facilitate improvements in diagnosis and the delivery of high-quality, accessible and cost-effective healthcare for all patients with a condition requiring a particular concentration of expertise in domains where expertise is rare; (d)to maximise the cost-effective use of resources by concen trating them where appropriate; (e)to reinforce research, epidemiological surveillance like registries and provide training for health professionals; (f)to facilitate mobility of expertise, virtually or physically, and to develop, share and spread information, knowledge and best practice and to developments of the diagnosis and treatment of rare diseases, within and outside the networks; (g)to encourage the development of quality and safety benchmarks and to help develop and spread best practice within and outside the network; (h)to help Member States with an insufficient number of patients with a particular condition or lacking tech nology or expertise to provide highly specialised services of high quality. Member States are encouraged to facilitate the devel opment of reference networks: (a)by connecting appropriate healthcare providers and centres of expertise throughout their national territory and ensuring the dissemination of information towards appropriate healthcare providers and centres of expertise throughout their national territory; (b)by fostering the participation of healthcare providers and centres of expertise in reference networks. 4.For the purposes of paragraph 1, the Commission shall: (a)adopt a list of specific criteria and conditions that reference networks must fulfil and the conditions and criteria required from healthcare providers wishing to join reference network. These criteria and conditions shall ensure, inter alia, that European reference networks: (i)have knowledge and expertise to diagnose, follow-up and manage patients with evidence of good outcomes, as far as applicable; (ii)follow a multi-disciplinary approach; (iii)offer a high level of expertise and have the capacity to produce good practice guidelines and to implement outcome measures and quality control; (iv)make a contribution to research; (v)organise teaching and training activities; and (vi)collaborate closely with other centres of expertise and networks at national and international level; (b)develop and publish criteria for establishing and evaluating European reference networks; (c)facilitate the exchange of information and expertise in relation to the of European reference networks and their evaluation. 5.The Commission shall adopt the measures referred to in paragraph 4(a) by means of delegated acts in accordance with Article 17 and subject to the conditions of Articles 18 and 19. The measures referred to in points (b) and (c) of paragraph 4 shall be adopted in accordance with the regulatory procedure referred to in Article 16(2). 6.Measures adopted pursuant to this Article shall not harmonise any laws or regulations of the Member States and shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and care. The Commission shall support Member States in cooperating in the development of diagnosis and treatment capacity in particular by aiming to: (a) make health professionals aware of the tools available to them at Union level to assist them in the correct diagnosis of rare diseases, in particular the Orphanet database, and reference networks; (b)make patients, health professionals and those bodies responsible for the funding of healthcare aware of the possi bilities offered by Regulation (EC) No 883/2004 for referral of patients with rare diseases to other Member States even for diagnosis and treatments which are not available in the of affiliation. 1.The Union shall support and facilitate cooperation and the exchange of information among Member States working within a voluntary network connecting national authorities responsible for eHealth designated by the Member States. 2.The objectives of the eHealth network shall be to: (a)work towards delivering sustainable economic and social benefits of European eHealth systems and services and inter operable applications, with a view to achieving a high level of trust and security, enhancing continuity of care and ensuring access to safe and high-quality healthcare; (b)draw up guidelines on: (i)a non-exhaustive list of data that are to be included in patients summaries and that can be shared between health professionals to enable continuity of care and patient safety across borders; and (ii)effective methods for enabling the use of information for public health and research; (c)support Member States in developing common identifi cation and authentication measures to facilitate transfer ability of data in cross-border healthcare. The objectives referred to in points (b) and (c) shall be pursued in due observance of the principles of data protection as set out, in particular, in Directives 95/46/EC and 2002/58/EC. The Commission shall, in accordance with the regulatory procedure referred to in Article 16(2), adopt the necessary measures for the , management and transparent functioning of this network. Cooperation on health technology assessment The Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States. The Member States shall communicate their names and contact details to the Commission. The members of such a health technology assessment network shall participate in, and contribute to, the networks activities in accordance with the legislation of the where they are established. That network shall be based on the The objectives of the health technology assessment network shall be to: (a)support cooperation between national authorities or bodies; (b)support Member States in the provision of objective, reliable, timely, transparent, comparable and transferable information on the relative efficacy as well as on the short- and long-term effectiveness, when applicable, of health technologies and to enable an effective exchange of this information between the national authorities or bodies; (c)support the analysis of the nature and type of information that can be exchanged; (d)avoid duplication of assessments. 3.In order to fulfil the objectives set out in paragraph 2, the network on health technology assessment may receive Union aid. Aid may be granted in order to: (a)contribute to the financing of administrative and technical support; (b)support collaboration between Member States in developing and sharing methodologies for health technology assessment including relative effectiveness assessment; (c)contribute to the financing of the provision of transferable scientific information for use in national reporting and case studies commissioned by the network; (d)facilitate cooperation between the network and other relevant institutions and bodies of the Union; (e)facilitate the consultation of stakeholders on the work of the network. 4.The Commission shall, in accordance with the regulatory procedure referred to in Article 16(2), adopt the necessary measures for the , management and transparent functioning of this network. 5.Arrangements for granting the aid, the conditions to which it may be subject and the amount of the aid, shall be adopted in accordance with the regulatory procedure referred to in Article 16(2). Only those authorities and bodies in the network designated as beneficiaries by the participating Member States shall be eligible for Union aid. 6.The appropriations required for measures provided for in this Article shall be decided each year as part of the budgetary procedure. 7.Measures adopted pursuant to this Article shall not interfere with Member States competences in deciding on the implementation of health technology assessment conclusions and shall not harmonise any laws or regulations of the Member States and shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and care. IMPLEMENTING AND FINAL PROVISIONS 1.The Commission shall be assisted by a Committee, consisting of representatives of the Member States and chaired by the Commission representative. 2.Where reference is made to this paragraph, Articles 5 and 7of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 3 months. Exercise of the delegation 1.The powers to adopt delegated acts referred to in Articles 11(5) and 12(5) shall be conferred on the Commission for a period of 5 years from . The Commission shall make a report in respect of the delegated powers not later than 6months before the end of the five-year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless Parliament or the Council revokes it in accordance with Article 18. 2.As soon as it adopts a delegated act, the Commission shall notify it simultaneously to Parliament and to the Council. 3.The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 18 and 19. Revocation of the delegation 1.The delegation of power referred to in Articles 11(5) and 12(5) may be revoked at any time by Parliament or by the Council. 2.The institution which has commenced an internal procedure for deciding whether to revoke the delegation of