Article 1 Subject matter and scope
1. 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. 2. This Directive shall apply to the provision of healthcare to patients, regardless of how it is organised, delivered and financed. 4. 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 Member State 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 Member State.
Article 2 Relationship with other Union provisions
This Directive shall apply without prejudice to: (a) Council Directive 89/105/EEC of 21 December 1988 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 ( 18 ); (b) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( 19 ), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 20 ) and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( 21 ); (c) Directive 95/46/EC and Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector ( 22 ); (d) Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services ( 23 ); (e) Directive 2000/31/EC; (f) Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin ( 24 ); (g) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 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 ( 25 ); (h) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 26 ); (i) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components ( 27 ); (j) Regulation (EC) No 859/2003; (k) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells ( 28 ); (l) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ( 29 ); (n) Directive 2005/36/EC; (o) Regulation (EC) No 1082/2006 of the European Parliament and of the Council of 5 July 2006 on a European grouping of territorial cooperation (EGTC) ( 31 ); (p) Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work ( 32 ); (r) Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation ( 35 ); (s) Regulation (EU) No 1231/2010.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’ 1 , the Commission stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a dedicated effort to rationalise and simplify reporting requirements, with the ultimate aim to reduce such requirements by 25%, without undermining the related policy objectives. Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. Streamlining reporting obligations and reducing administrative burden is therefore a priority. In this context, the present proposal aims to simplify initiatives included in headline ambition ‘An Economy that works for the people’, A ‘European Green deal’ and ‘Promoting our European way of life’ in the policy area of the Internal Market, Food safety and Health and impacting respectively the outdoor equipment and the radio equipment industry/sectors as well as sectors related to food treated with ionising radiation and on cross-border healthcare. The proposal aims to rationalise reporting obligations by a combination of measures: – f or Directive 1999/2/EC on foods and food ingredients treated with ionising radiatio n 2 , and for Directive 2000/14/EC on the noise emission of outdoor equipment 3 , this proposal aims to remove reporting obligations that are not necessary; – f or Directive 2014/53/EU on radio equipment 4 , t his proposal aims to reduce the frequency of the reporting obligation of Member States ; – f or Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare 5 , this proposal aims to reduce the frequency of the reporting obligation. With regard to Directive 1999/2/EC, the reporting obligation concerns both Member States and the Commission. Article 7(3) of Directive 1999/2/EC provides that Member States report annually to the Commission the results of official controls they have carried-out in food irradiation facilities and on irradiated food placed on the market. Article 7(4) of that Directive provides that the Commission publishes in the Official Journal of the European Union a report based on the information provided every year by the national supervisory authorities. These reporting obligations have become redundant, as annual reporting obligations for Member States’ competent authorities and the Commission are respectively also laid down in Articles 113 and 114 of Regulation (EU) 2017/625 6 . Those obligations are sufficient to ensure enforcement and facilitate monitoring of the effectiveness of legislation. Therefore, the proposal provides for the deletion of the similar reporting obligations currently laid down in Article 7(3) and (4) of Directive 1999/2/EC. With regard to Directive 2000/14/EC, those reporting requirements concern both companies and public authorities. Indeed, Article 16 of Directive 2000/14/EC provides that manufacturers, or their authorised representatives, shall send to both the authorities of Member States and to the Commission a copy of the EC declaration of conformity for equipment covered by that Directive. The Commission has then the obligation to collect the data and publish the relevant information periodically. According to recital 14 of Directive 2000/14/EC, one of the principal justifications for this reporting obligation was to provide for ‘a basis for informed consumer choice’. However, it appears that this reporting obligation creates an unnecessary administrative burden in this respect, since consumers are already informed of the noise emission level via the mandatory noise marking affixed on all the equipment covered by that Directive. Consumers are also informed on the noise emission of the specific equipment via the instructions for use for machines which are under the scope of both Directive 2006/42/EC 7 on machinery and its successor Regulation (EU) 2023/1230 8 , as those pieces of legislation cover 55 of the 57 equipment categories that fall within the scope of Directive 2000/14/EC. Consequently, it is proposed to delete Article 16 of Directive 2000/14/EC. With regard to Directive 2011/24/EU the reporting obligation concerns the Commission. However, indirectly it also concerns Member States, as the Commission’s reporting relies largely on the Member States’ contributions on how the Directive is being applied at national level. Article 20(1) of Directive 2011/24/EU provides that the Commission shall by 25 October 2015 and subsequently every 3 years thereafter, draw up a report on the operation of the Directive and submit it to the European Parliament and to the Council. The European Reference Networks established under Directive 2011/24/EU are to be evaluated every 5 years in accordance with Article 14(1) of Commission Implementing Decision setting out criteria for establishing and evaluating European Reference Networks 9 . The evaluation of the functioning and operations of all European Reference Networks is a key part of the content of the reports on the operation of Directive 2011/24/EU. Consequently, the current frequency of reporting is disproportionate and does not have added value in the absence of a parallel evaluation of the European Reference Networks. In addition to that, the current reporting period of 3 years is, in practice, insufficient for the Commission and Member States to address all follow-up actions expected. Furthermore, if the two processes (reporting on the operation of the Directive and evaluating the European Reference Networks) were aligned, synergies between the report and the evaluation could be ensured. Therefore, it is proposed to provide for the reporting on the operation of Directive 2011/24/EU to be carried out every 5 years. With regard to Directive 2014/53/EU, the reporting obligation in question concerns Member States. Indeed, Article 47(1) of Directive 2014/53/EU provides that Member States shall submit to the Commission, every two years, a report on the application of the Directive which is to contain a presentation of the market surveillance activities performed by the Member States and whether requirements of that Directive have been attained. The current frequency of that obligation does not match the reporting obligation from the Commission to the European Parliament and to the Council which takes place every five years. In that spirit, it is proposed to reduce the frequency of the reporting obligation of Member States to every five years. 
Revised version (Article 2 Relationship with other Union provisions):
This Directive shall apply without prejudice to: (a) Council Directive 89/105/EEC of 21 December 1988 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 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( 2 ), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 3 ) and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( 4 ); (c) Directive 95/46/EC and Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector ( 5 ); (d) Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services ( 6 ); (e) Directive 2000/31/EC; (f) Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin ( 7 ); (g) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 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 the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 9 ); (i) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 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 the European Parliament and of the Council of 31 March 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 the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ( 12 ); (n) Directive 2005/36/EC; (o) Regulation (EC) No 1082/2006 of the European Parliament and of the Council of 5 July 2006 on a European grouping of territorial cooperation (EGTC) ( 14 ); (p) Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work ( 15 ); (r) Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation ( 18 ); (s) Regulation (EU) No 1231/2010.
Article 3 Definitions
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, dispensation and provision of medicinal products and medical devices; (d) ‘Member State of treatment’ means the Member State on whose territory healthcare is actually provided to the patient. In the case of telemedicine, healthcare is considered to be provided in the Member State where the healthcare provider is established; (e) ‘cross-border healthcare’ means healthcare provided or prescribed in a Member State other than the Member State of affiliation; (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) ‘medical device’ means a medical device as defined by Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC; (l) ‘health technology’ means a medicinal product, a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare; (m) ‘medical records’ means all the documents containing data, assessments and information of any kind on a patient’s situation and clinical development throughout the care process.
Article 4 Responsibilities of the Member State of treatment
3. 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 Member State 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 Member State 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. 4. 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 medical 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. 5. 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 Member State concerned.
Article 5 Responsibilities of the Member State of affiliation
The Member State of affiliation shall ensure that: (a) the cost of cross-border healthcare is reimbursed in accordance with Chapter III; (c) where a patient has received cross-border healthcare and where medical follow-up proves necessary, the same medical 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 medical 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.
Article 6 National contact points for cross-border healthcare
1. Each Member State shall 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 Member State of treatment shall provide them with information concerning healthcare providers, including, on request, information on a specific provider’s 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 Member State, 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 Member State 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.
Article 7 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 Member State 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 Member State of affiliation. 3. It is for the Member State of affiliation to determine, whether at a local, regional or national level, the healthcare for which an insured person is entitled to assumption of costs and the level of assumption of those costs, regardless of where the healthcare is provided. 4. The costs of cross-border healthcare shall be reimbursed or paid directly by the Member State of affiliation up to the level of costs that would have been assumed by the Member State 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 Member State of affiliation may nevertheless decide to reimburse the full cost. The Member State of affiliation may decide to reimburse other related costs, such as accommodation and travel 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 Member State 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 Member State of affiliation. This mechanism shall be based on objective, non-discriminatory criteria known in advance and applied at the relevant (local, regional or national) administrative level. 7. The Member State of affiliation may impose on an insured person seeking reimbursement of the costs of cross-border healthcare, including healthcare received through means of telemedicine, the same conditions, criteria of eligibility and regulatory 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 Member State 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 patient’s entitlement to healthcare. However, no conditions, criteria of eligibility and regulatory and administrative 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 Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources. 8. The Member State of affiliation shall not make the reimbursement of costs of cross-border healthcare subject to prior authorisation except in the cases set out in Article 8. 9. The Member State 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 Member State 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 authorisation 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.
Article 8 Healthcare that may be subject to prior authorisation
1. The Member State 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. 2. Member States shall notify the categories of healthcare referred to in point (a) to the Commission. 3. With regard to requests for prior authorisation made by an insured person with a view to receiving cross-border healthcare, the Member State 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 Member State of affiliation or if the expert’s opinion is inconclusive, the Member State of affiliation may request scientific advice. 5. Without prejudice to points (a) to (c) of paragraph 6, the Member State of affiliation may not refuse to grant prior authorisation 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 medical assessment of the patient’s medical condition, the history and probable course of the patient’s illness, the degree of the patient’s pain and/or the nature of the patient’s disability at the time when the request for authorisation was made or renewed. 7. The Member State 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.
Article 9 Administrative procedures regarding cross-border healthcare
1. The Member State of affiliation shall ensure that administrative procedures regarding the use of cross-border healthcare and reimbursement of costs of healthcare incurred in another Member State 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 medical 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 Member State 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 patient’s clinical case, specifying the medical 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 Member State of affiliation does not apply such mechanisms, it shall ensure that patients receive reimbursement without undue delay.
Article 10 Mutual assistance and cooperation
1. 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 12 December 2007 concerning the implementation of the Internal Market Information System (IMI) as regards the protection of personal data ( 36 ).
Article 11 Recognition of prescriptions issued in another Member State
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 substitution. 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 pharmacist’s right, by virtue of national rules, to refuse, for ethical reasons, to dispense a product that was prescribed in another Member State, where the pharmacist would have the right to refuse to dispense, had the prescription been issued in the Member State of affiliation. The Member State 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 Member State of treatment for medicinal products or medical devices available in the Member State of affiliation and where dispensing is sought in the Member State of affiliation. This paragraph shall also apply to medical devices that are legally placed on the market in the respective Member State. 2. Measures referred in point (a) shall be adopted by the Commission no later than 25 December 2012 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 regulatory 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 medical devices from the recognition of prescriptions provided for under this Article, where necessary in order to safeguard public health. 6. Paragraph 1 shall not apply to medicinal products subject to special medical prescription provided for in Article 71(2) of Directive 2001/83/EC.
Article 12 European reference networks
1. 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 Member State 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. 3. Member States are encouraged to facilitate the development of the European 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 the European reference networks. 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 medical care.
Article 13 Rare diseases
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 the European reference networks; (b) make patients, health professionals and those bodies responsible for the funding of healthcare aware of the possibilities 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 Member State of affiliation.
Article 14 eHealth
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. 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. 3. The Commission shall, in accordance with the regulatory procedure referred to in Article 16(2), adopt the necessary measures for the establishment, management and transparent functioning of this network.
Article 15 Cooperation on health technology assessment
1. 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 network’s activities in accordance with the legislation of the Member State where they are established. That network shall be based on the principle of good governance including transparency, objectivity, independence of expertise, fairness of procedure and appropriate stakeholder consultations. 4. The Commission shall, in accordance with the regulatory procedure referred to in Article 16(2), adopt the necessary measures for the establishment, 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 medical care.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’ 1 , the Commission stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a dedicated effort to rationalise and simplify reporting requirements, with the ultimate aim to reduce such requirements by 25%, without undermining the related policy objectives. Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. Streamlining reporting obligations and reducing administrative burden is therefore a priority. In this context, the present proposal aims to simplify initiatives included in headline ambition ‘An Economy that works for the people’, A ‘European Green deal’ and ‘Promoting our European way of life’ in the policy area of the Internal Market, Food safety and Health and impacting respectively the outdoor equipment and the radio equipment industry/sectors as well as sectors related to food treated with ionising radiation and on cross-border healthcare. The proposal aims to rationalise reporting obligations by a combination of measures: – f or Directive 1999/2/EC on foods and food ingredients treated with ionising radiatio n 2 , and for Directive 2000/14/EC on the noise emission of outdoor equipment 3 , this proposal aims to remove reporting obligations that are not necessary; – f or Directive 2014/53/EU on radio equipment 4 , t his proposal aims to reduce the frequency of the reporting obligation of Member States ; – f or Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare 5 , this proposal aims to reduce the frequency of the reporting obligation. With regard to Directive 1999/2/EC, the reporting obligation concerns both Member States and the Commission. Article 7(3) of Directive 1999/2/EC provides that Member States report annually to the Commission the results of official controls they have carried-out in food irradiation facilities and on irradiated food placed on the market. Article 7(4) of that Directive provides that the Commission publishes in the Official Journal of the European Union a report based on the information provided every year by the national supervisory authorities. These reporting obligations have become redundant, as annual reporting obligations for Member States’ competent authorities and the Commission are respectively also laid down in Articles 113 and 114 of Regulation (EU) 2017/625 6 . Those obligations are sufficient to ensure enforcement and facilitate monitoring of the effectiveness of legislation. Therefore, the proposal provides for the deletion of the similar reporting obligations currently laid down in Article 7(3) and (4) of Directive 1999/2/EC. With regard to Directive 2000/14/EC, those reporting requirements concern both companies and public authorities. Indeed, Article 16 of Directive 2000/14/EC provides that manufacturers, or their authorised representatives, shall send to both the authorities of Member States and to the Commission a copy of the EC declaration of conformity for equipment covered by that Directive. The Commission has then the obligation to collect the data and publish the relevant information periodically. According to recital 14 of Directive 2000/14/EC, one of the principal justifications for this reporting obligation was to provide for ‘a basis for informed consumer choice’. However, it appears that this reporting obligation creates an unnecessary administrative burden in this respect, since consumers are already informed of the noise emission level via the mandatory noise marking affixed on all the equipment covered by that Directive. Consumers are also informed on the noise emission of the specific equipment via the instructions for use for machines which are under the scope of both Directive 2006/42/EC 7 on machinery and its successor Regulation (EU) 2023/1230 8 , as those pieces of legislation cover 55 of the 57 equipment categories that fall within the scope of Directive 2000/14/EC. Consequently, it is proposed to delete Article 16 of Directive 2000/14/EC. With regard to Directive 2011/24/EU the reporting obligation concerns the Commission. However, indirectly it also concerns Member States, as the Commission’s reporting relies largely on the Member States’ contributions on how the Directive is being applied at national level. Article 20(1) of Directive 2011/24/EU provides that the Commission shall by 25 October 2015 and subsequently every 3 years thereafter, draw up a report on the operation of the Directive and submit it to the European Parliament and to the Council. The European Reference Networks established under Directive 2011/24/EU are to be evaluated every 5 years in accordance with Article 14(1) of Commission Implementing Decision setting out criteria for establishing and evaluating European Reference Networks 9 . The evaluation of the functioning and operations of all European Reference Networks is a key part of the content of the reports on the operation of Directive 2011/24/EU. Consequently, the current frequency of reporting is disproportionate and does not have added value in the absence of a parallel evaluation of the European Reference Networks. In addition to that, the current reporting period of 3 years is, in practice, insufficient for the Commission and Member States to address all follow-up actions expected. Furthermore, if the two processes (reporting on the operation of the Directive and evaluating the European Reference Networks) were aligned, synergies between the report and the evaluation could be ensured. Therefore, it is proposed to provide for the reporting on the operation of Directive 2011/24/EU to be carried out every 5 years. With regard to Directive 2014/53/EU, the reporting obligation in question concerns Member States. Indeed, Article 47(1) of Directive 2014/53/EU provides that Member States shall submit to the Commission, every two years, a report on the application of the Directive which is to contain a presentation of the market surveillance activities performed by the Member States and whether requirements of that Directive have been attained. The current frequency of that obligation does not match the reporting obligation from the Commission to the European Parliament and to the Council which takes place every five years. In that spirit, it is proposed to reduce the frequency of the reporting obligation of Member States to every five years.
Article 16 Committee
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 7 of 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.
Article 17 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 24 April 2011. The Commission shall make a report in respect of the delegated powers not later than 6 months before the end of the five-year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European 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 the European 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.
Article 18 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 the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union .
Article 19 Objections to delegated acts
1. The European Parliament or the Council may object to the delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by 2 months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.
Article 20 Reports
1. The Commission shall by 25 October 2015 and subsequently every 3 years thereafter, draw up a report on the operation of this Directive and submit it to the European Parliament and to the Council. 2. The report shall in particular include information on patient flows, financial dimensions of patient mobility, the implementation of Article 7(9) and Article 8, and on the functioning of the European reference networks and national contact points. To this end, the Commission shall conduct an assessment of the systems and practices put in place in the Member States, in the light of the requirements of this Directive and the other Union legislation relating to patient mobility. The Member States shall provide the Commission with assistance and all available information for carrying out the assessment and preparing the reports. 3. Member States and the Commission shall have recourse to the Administrative Commission established pursuant to Article 71 of Regulation (EC) No 883/2004, in order to address the financial consequences of the application of this Directive on the Member States which have opted for reimbursement on the basis of fixed amounts, in cases covered by Articles 20(4) and 27(5) of that Regulation. The Commission shall monitor and regularly report on the effect of Article 3(c)(i) and Article 8 of this Directive. A first report shall be presented by 25 October 2013. On the basis of these reports, the Commission shall, where appropriate, make proposals to alleviate any disproportionalities.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’ 1 , the Commission stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a dedicated effort to rationalise and simplify reporting requirements, with the ultimate aim to reduce such requirements by 25%, without undermining the related policy objectives. Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. Streamlining reporting obligations and reducing administrative burden is therefore a priority. In this context, the present proposal aims to simplify initiatives included in headline ambition ‘An Economy that works for the people’, A ‘European Green deal’ and ‘Promoting our European way of life’ in the policy area of the Internal Market, Food safety and Health and impacting respectively the outdoor equipment and the radio equipment industry/sectors as well as sectors related to food treated with ionising radiation and on cross-border healthcare. The proposal aims to rationalise reporting obligations by a combination of measures: – f or Directive 1999/2/EC on foods and food ingredients treated with ionising radiatio n 2 , and for Directive 2000/14/EC on the noise emission of outdoor equipment 3 , this proposal aims to remove reporting obligations that are not necessary; – f or Directive 2014/53/EU on radio equipment 4 , t his proposal aims to reduce the frequency of the reporting obligation of Member States ; – f or Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare 5 , this proposal aims to reduce the frequency of the reporting obligation. With regard to Directive 1999/2/EC, the reporting obligation concerns both Member States and the Commission. Article 7(3) of Directive 1999/2/EC provides that Member States report annually to the Commission the results of official controls they have carried-out in food irradiation facilities and on irradiated food placed on the market. Article 7(4) of that Directive provides that the Commission publishes in the Official Journal of the European Union a report based on the information provided every year by the national supervisory authorities. These reporting obligations have become redundant, as annual reporting obligations for Member States’ competent authorities and the Commission are respectively also laid down in Articles 113 and 114 of Regulation (EU) 2017/625 6 . Those obligations are sufficient to ensure enforcement and facilitate monitoring of the effectiveness of legislation. Therefore, the proposal provides for the deletion of the similar reporting obligations currently laid down in Article 7(3) and (4) of Directive 1999/2/EC. With regard to Directive 2000/14/EC, those reporting requirements concern both companies and public authorities. Indeed, Article 16 of Directive 2000/14/EC provides that manufacturers, or their authorised representatives, shall send to both the authorities of Member States and to the Commission a copy of the EC declaration of conformity for equipment covered by that Directive. The Commission has then the obligation to collect the data and publish the relevant information periodically. According to recital 14 of Directive 2000/14/EC, one of the principal justifications for this reporting obligation was to provide for ‘a basis for informed consumer choice’. However, it appears that this reporting obligation creates an unnecessary administrative burden in this respect, since consumers are already informed of the noise emission level via the mandatory noise marking affixed on all the equipment covered by that Directive. Consumers are also informed on the noise emission of the specific equipment via the instructions for use for machines which are under the scope of both Directive 2006/42/EC 7 on machinery and its successor Regulation (EU) 2023/1230 8 , as those pieces of legislation cover 55 of the 57 equipment categories that fall within the scope of Directive 2000/14/EC. Consequently, it is proposed to delete Article 16 of Directive 2000/14/EC. With regard to Directive 2011/24/EU the reporting obligation concerns the Commission. However, indirectly it also concerns Member States, as the Commission’s reporting relies largely on the Member States’ contributions on how the Directive is being applied at national level. Article 20(1) of Directive 2011/24/EU provides that the Commission shall by 25 October 2015 and subsequently every 3 years thereafter, draw up a report on the operation of the Directive and submit it to the European Parliament and to the Council. The European Reference Networks established under Directive 2011/24/EU are to be evaluated every 5 years in accordance with Article 14(1) of Commission Implementing Decision setting out criteria for establishing and evaluating European Reference Networks 9 . The evaluation of the functioning and operations of all European Reference Networks is a key part of the content of the reports on the operation of Directive 2011/24/EU. Consequently, the current frequency of reporting is disproportionate and does not have added value in the absence of a parallel evaluation of the European Reference Networks. In addition to that, the current reporting period of 3 years is, in practice, insufficient for the Commission and Member States to address all follow-up actions expected. Furthermore, if the two processes (reporting on the operation of the Directive and evaluating the European Reference Networks) were aligned, synergies between the report and the evaluation could be ensured. Therefore, it is proposed to provide for the reporting on the operation of Directive 2011/24/EU to be carried out every 5 years. With regard to Directive 2014/53/EU, the reporting obligation in question concerns Member States. Indeed, Article 47(1) of Directive 2014/53/EU provides that Member States shall submit to the Commission, every two years, a report on the application of the Directive which is to contain a presentation of the market surveillance activities performed by the Member States and whether requirements of that Directive have been attained. The current frequency of that obligation does not match the reporting obligation from the Commission to the European Parliament and to the Council which takes place every five years. In that spirit, it is proposed to reduce the frequency of the reporting obligation of Member States to every five years. 
Revised version (Article 20 Reports):
1. The Commission shall, by 25 October 2027 and subsequently every 5 years thereafter, draw up a report on the operation of this Directive and submit it to the European Parliament and to the Council. 2. The report shall in particular include information on patient flows, financial dimensions of patient mobility, the implementation of Article 7(9) and Article 8, and on the functioning of the European reference networks and national contact points. To this end, the Commission shall conduct an assessment of the systems and practices put in place in the Member States, in the light of the requirements of this Directive and the other Union legislation relating to patient mobility. The Member States shall provide the Commission with assistance and all available information for carrying out the assessment and preparing the reports. 3. Member States and the Commission shall have recourse to the Administrative Commission established pursuant to Article 71 of Regulation (EC) No 883/2004, in order to address the financial consequences of the application of this Directive on the Member States which have opted for reimbursement on the basis of fixed amounts, in cases covered by Articles 20(4) and 27(5) of that Regulation. The Commission shall monitor and regularly report on the effect of Article 3(c)(i) and Article 8 of this Directive. A first report shall be presented by 25 October 2013. On the basis of these reports, the Commission shall, where appropriate, make proposals to alleviate any disproportionalities.
Article 21 Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 25 October 2013. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. 3. By way of derogation from the first sentence of paragraph 1, France shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive in respect of Mayotte as an outermost region within the meaning of Article 349 TFEU by 30 June 2016.
Article 22 Entry into force
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union .
Article 23 Addressees
This Directive is addressed to the Member States.