(Codecision procedure: first reading)

The European Parliament ,

–   having regard to the Commission proposal to the European Parliament and the Council (COM(2008)0414),

–   having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0257/2008),

–   having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–   having regard to Rules 51 and 35 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Employment and Social Affairs, the Committee on the Internal Market and Consumer Protection, the Committee on Economic and Monetary Affairs, the Committee on Committee on Industry, Research and Energy, Committee on Legal Affairs and the Committee on Women's Rights and Gender Equality (A6-0233/2009),

1.  Approves the Commission proposal as amended;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council and Commission.

Text proposed by the Commission   Amendment Amendment 1 Proposal for a directive Recital 2 (2)  Given that the conditions for recourse to Article 95 of the Treaty as a legal basis are fulfilled, the Community legislature shall rely on this legal basis even when public health protection is a decisive factor in the choices made; in this respect Article 95(3) of the Treaty explicitly requires that, in achieving harmonisation, a high level of protection of human health should be guaranteed taking account in particular of any new development based on scientific facts. (2)  Given that the conditions for recourse to Article 95 of the Treaty as a legal basis are fulfilled, the Community legislature shall rely on this legal basis even when public health protection is a decisive factor in the choices made; in this respect Article 95(3) of the Treaty explicitly requires that a high level of protection of human health should be guaranteed taking account in particular of any new development based on scientific facts. Amendment 2 Proposal for a directive Recital 2 a (new) (2a)  The European Parliament adopted on 9 June 2005, by 554 votes to 12, a resolution on patient mobility and healthcare developments in the European Union 1 , in which it called for legal certainty and clarity on rights and procedures for patients, health professionals and Member States. 1 OJ C 124 E, 25.5.2006, p. 543. Amendment 4 Proposal for a directive Recital 5 a (new) (5a)  This Directive respects and does not prejudice the freedom of each Member State to decide what type of healthcare it considers appropriate. No provision of this Directive should be interpreted in such a way as to undermine the fundamental ethical choices of Member States. Amendment 5 Proposal for a directive Recital 6 (6)  Some issues related to cross-border healthcare, in particular reimbursement of healthcare provided in a Member State other than that in which the recipient of the care is resident, have been already addressed by the Court of Justice. As healthcare was excluded from the scope of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market it is important to address these issues in a specific Community legal instrument in order to achieve a more general and effective application of principles developed by the Court of Justice on a case by case basis. (6)  Some issues related to cross-border healthcare, in particular reimbursement of healthcare provided in a Member State other than that in which the recipient of the care is resident, have been already addressed by the Court of Justice. It is important to address these issues in a specific Community legal instrument in order to achieve a more general and effective application of principles developed by the Court of Justice on a case by case basis. Amendment 6 Proposal for a directive Recital 8 (8)  This directive aims to establish a general framework for provision of safe, high quality and efficient cross-border healthcare in the Community and to ensure patients mobility and freedom to provide healthcare and high level of protection of health, whilst fully respecting the responsibilities of the Member States for the definition of social security benefits related to health and the organisation and delivery of healthcare and medical care and social security benefits in particular for sickness. (8)  This Directive aims to establish a general framework for provision of safe, high quality and efficient cross-border healthcare in the Community in relation to patients mobility as well as a to a high level of protection of health, whilst fully respecting the responsibilities of the Member States for the definition of social security benefits related to health and for the organisation and delivery of healthcare and medical care as well as of social security benefits in particular for sickness. Amendment 7 Proposal for a directive Recital 9 (9)  This Directive on the application of patients" rights in cross-border healthcare applies to all types of healthcare. As confirmed by the Court of Justice, neither their special nature nor the way in which they are organised or financed removes them from the ambit of the fundamental principle of freedom of movement. As regards long-term care, the Directive does not apply to assistance and support for families or individuals who are, over an extended period of time, in a particular state of need. It does not apply, for example, to residential homes or housing, or assistance provided to elderly people or children by social workers or volunteer carers or professionals other than health professionals. (9)  This Directive on the application of patients" rights in cross-border healthcare applies to all types of healthcare. As confirmed by the Court of Justice, neither their special nature nor the way in which they are organised or financed removes them from the ambit of the fundamental principle of freedom of movement. As regards long-term care, this Directive does not apply to assistance and support for families or individuals who are, over an extended period of time, in particular need of nursing, support or care in so far as this involves specific expert treatment or help provided by a social security system, including above all such long-term care services as are considered necessary in order to provide the person in need of care with as full and independent a life as possible. This Directive does not apply, for example, to residential homes or housing, or assistance provided to elderly people or children by social workers or volunteer carers or professionals other than health professionals. Amendment 8 Proposal for a directive Recital 9 a (new) (9a)  This Directive does not apply to organ transplantations. Due to their specific nature, they will be regulated by a separate directive. Amendment 9 Proposal for a directive Recital 10 (10)  For the purpose of this Directive, the concept of "cross-border healthcare" covers the following modes of supply of healthcare: (10)  For the purpose of this Directive, the concept of "cross-border healthcare" only covers the use of healthcare in a Member State other than that where the patient is an insured person. This is what is referred to as 'patient mobility' ; –  Use of healthcare abroad (i.e.: a patient moving to a healthcare provider in another Member State for treatment); this is what is referred to as 'patient mobility'; –  Cross-border provision of healthcare (i.e.: delivery of service from the territory of one Member State into the territory of another); such as telemedicine services, remote diagnosis and prescription, laboratory services; –  Permanent presence of a healthcare provider (i.e.: establishment of a healthcare provider in another Member State); and –  Temporary presence of persons (i.e.: mobility of health professionals, for example moving temporarily to the Member State of the patient to provide services). Amendment 10 Proposal for a directive Recital 11 (11)  As recognised by the Member States in the Council Conclusions on Common values and principles in European Union Health Systems there is a set of operating principles that are shared by health systems throughout the Community. These operating principles include quality, safety, care that is based on evidence and ethics, patient involvement, redress, the fundamental right to privacy with respect to the processing of personal data, and confidentiality. Patients, professionals and authorities responsible for health systems must be able to rely on these shared principles being respected and structures provided for their implementation throughout the Community. It is therefore appropriate to require that it is the authorities of the Member State on whose territory the healthcare is provided, who are responsible for ensuring compliance with those operating principles. This is necessary to ensure the confidence of patients in cross-border healthcare, which is itself necessary for achieving patients' mobility and free movement of provision of healthcare in the internal market as well as a high level of health protection. (11)  As recognised by the Member States in the Council Conclusions on Common values and principles in European Union Health Systems there is a set of operating principles that are shared by health systems throughout the Community. These operating principles include quality, safety, care that is based on evidence and ethics, patient involvement, redress, the fundamental right to privacy with respect to the processing of personal data, and confidentiality. Patients, professionals and authorities responsible for health systems must be able to rely on these shared principles being respected and structures provided for their implementation throughout the Community. It is therefore appropriate to require that it is the authorities of the Member State on whose territory the healthcare is provided, who are responsible for ensuring compliance with those operating principles. This is necessary to ensure the confidence of patients in cross-border healthcare, which is itself necessary for achieving patients' mobility as well as a high level of health protection. Notwithstanding those common values it is accepted that Member States take different decisions on ethical grounds as regards the availability of certain treatments and the concrete access conditions. This Directive is without prejudice to ethical diversity. Amendment 11 Proposal for a directive Recital 12 (12)  Given that it is impossible to know in advance whether a given healthcare provider will supply healthcare to a patient coming from another Member State or a patient from their own Member State, it is necessary that the requirements to ensure that healthcare is provided according to common principles and clear quality and safety standards are applicable to all type of healthcare in order to ensure the freedom to provide and obtain cross border healthcare which is the aim of the directive. Member States' authorities have to respect the shared overarching values of universality, access to good quality care, equity and solidarity, which have been already widely recognised by the Community institutions and by all the Member States as constituting a set of values that are shared by health systems across Europe. Members States also have to ensure that these values are respected with regard to patients and citizens from other Member States, and that all patients are treated equitably on the basis of their healthcare need rather than their Member State of social security affiliation. In doing so, Member States must respect the principles of freedom of movement within the internal market, non-discrimination inter alia with regard to nationality (or in the case of legal persons, with regard to the Member State in which they are established), necessity and proportionality of any restrictions on free movement. However, nothing in this Directive requires healthcare providers to accept for planned treatment or to prioritise patients from other Member States to the detriment of other patients with similar health needs, such as through increasing waiting time for treatment. (12)  Given that it is impossible to know in advance whether a given healthcare provider will supply healthcare to a patient coming from another Member State or a patient from their own Member State, it is necessary that the requirements to ensure that healthcare is provided according to common principles and clear quality and safety standards are applicable to all type of healthcare in order to ensure the freedom to provide and obtain cross border healthcare which is the aim of the directive. Member States' authorities have to respect the shared overarching values of universality, access to good quality care, equity and solidarity, which have been already widely recognised by the Community institutions and by all the Member States as constituting a set of values that are shared by health systems across Europe. Members States also have to ensure that these values are respected with regard to patients and citizens from other Member States, and that all patients are treated equitably on the basis of their healthcare need rather than their Member State of social security affiliation. In doing so, Member States must respect the principles of freedom of movement of individuals within the internal market, non-discrimination inter alia with regard to nationality, necessity and proportionality of any restrictions on free movement. However, nothing in this Directive requires healthcare providers to accept for planned treatment or to prioritise patients from other Member States to the detriment of other patients with similar health needs, such as through increasing waiting time for treatment. In order to enable patients to make an informed choice when they seek to receive healthcare in another Member State, Member States should ensure that patients receive on request the relevant information on health and quality standards enforced in the Member State of treatment as well as on the characteristics of healthcare provided by a specific healthcare provider. Such information should also be made available in formats accessible to persons with disabilities. Amendment 136 Proposal for a directive Recital 13 (13)  Moreover, patients from other Member States should enjoy equal treatment with the nationals of the Member State of treatment and, according to the general principles of equity and non discrimination, as recognized in Art.21 of the Charter they should in no way be discriminated upon on the basis of their sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation. Member States may differentiate in the treatment accorded to different groups of patients only where they can demonstrate that this is justified by legitimate medical grounds, such as in case of specific measures for women or for certain ages groups (e.g. free of charge vaccination for children or elderly people). Furthermore, as this Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, it has to be implemented and applied with due respect for the rights to equality before the law and the principle of non-discrimination in accordance with the general principles of law, as enshrined in Articles 20 and 21 of the Charter. This Directive applies without prejudice to Directive 2000/43/EC of the Council of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin, and other Directives giving effect to Article 13 of the EC Treaty. In the light of this, the Directive provides that patients shall enjoy equal treatment with the nationals of the Member State of treatment, including the benefit from the protection against discrimination provided for according to Community law as well as from the legislation of the Member State of treatment. (13)  Moreover, patients from other Member States should enjoy equal treatment with the nationals of the Member State of treatment and, according to the general principles of equity and non discrimination, as recognized in Art.21 of the Charter they should in no way be discriminated upon on the basis of their sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation. Member States may differentiate in the treatment accorded to different groups of patients only where they can demonstrate that this is justified by legitimate medical grounds, such as in case of specific measures for women or for certain ages groups (e.g. free of charge vaccination for children or elderly people). Furthermore, as this Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, it has to be implemented and applied with due respect for the rights to equality before the law and the principle of non-discrimination in accordance with the general principles of law, as enshrined in Articles 20 and 21 of the Charter. This Directive applies without prejudice to Directive 2000/43/EC of the Council of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin, Council Directive 2004/113/EC of 13 December 2004 implementing the principle of equal treatment between men and women in the access to and supply of goods and services 1 , Council Directive 2000/78/EC of 27 November 2000 establishing a general framework for equal treatment in employment and occupation 2 , and the proposed directive on implementing the principle of equal treatment between persons irrespective of religion or belief, disability, age or sexual orientation (COM(2008)0426) giving effect to Article 13 of the EC Treaty. In the light of this, the Directive provides that patients shall enjoy equal treatment with the nationals of the Member State of treatment, including the benefit from the protection against discrimination provided for according to Community law as well as from the legislation of the Member State of treatment. 1 OJ L 373, 21.12.2004, p. 37. 2 OJ L 303, 2.12.2000, p. 16. Amendment 12 Proposal for a directive Recital 13 a (new) (13a)  Member States should ensure that in the application of this Directive patients are not encouraged against their will to receive treatment outside of their Member State of affiliation. Amendment 13 Proposal for a directive Recital 13 b (new) (13b)  It is also important to put in place measures to ensure that women have equitable access to public health schemes and care that is specific to them, particularly gynaecological and reproductive healthcare. Amendment 14 Proposal for a directive Recital 14 a (new) (14a)  Systematic and continuous efforts should be made to ensure that quality and safety standards are improved, in line with the Council Conclusions of 1-2 June 2006 on Common values and principles in European Union Health Systems and taking into account advances in international medical science and generally recognised good medical practices as well as taking into account new health technology; Amendment 15 Proposal for a directive Recital 15 (15)  Research suggests that harm arises from healthcare in around 10% of cases. Ensuring clear common obligations to deal with circumstances of responding to harm arising from healthcare is therefore essential to avoid lack of confidence in those mechanisms acting as an obstacle to taking up cross-border healthcare. Coverage for harm and compensation by the systems of the country of treatment should be without prejudice to the possibility for Member States to extend the coverage of their domestic systems to patients from their country seeking healthcare abroad, where this is more appropriate to the patient, in particular in the case of patients for whom use of healthcare in another Member State is necessary. (15)  Research suggests that harm arises from healthcare in around 10% of cases. Ensuring that Member States of treatment have systems in place (including provision of aftercare) to deal with alleged harm arising from healthcare as defined by the Member State of treatment is therefore essential to avoid lack of confidence in those mechanisms acting as an obstacle to taking up cross-border healthcare. Coverage for harm and compensation by the systems of the country of treatment should be without prejudice to the possibility for Member States to extend the coverage of their domestic systems to patients from their country seeking healthcare abroad, where this is more appropriate to the patient, in particular in the case of patients for whom use of healthcare in another Member State is necessary. Amendment 16 Proposal for a directive Recital 17 (17)  The right to the protection of personal data is a fundamental right recognised by Article 8 of the Charter of Fundamental Rights of the European Union. Ensuring continuity of cross-border healthcare depends on transfer of personal data concerning patient's health. These personal data should be able to flow freely from one Member State to another, but in the same time the fundamental rights of the individuals should be safeguarded. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data establishes the right for individuals to have access to their personal data concerning their health, for example in the patient's medical records containing such matters as diagnosis, examination results, assessments by treating physicians and any treatment or interventions provided. These provisions also apply in the context of cross-border healthcare covered by this Directive. (17)  The right to the protection of personal data is a fundamental right recognised by Article 8 of the Charter of Fundamental Rights of the European Union. Ensuring continuity of cross-border healthcare depends on transfer of personal data concerning patient's health. These personal data should be able to flow freely from one Member State to another, but in the same time the fundamental rights of the individuals should be safeguarded. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data establishes the right for individuals to have access to their personal data concerning their health, for example in the patient's medical records containing such matters as diagnosis, examination results, assessments by treating physicians and any treatment or interventions provided. These provisions also apply in the context of cross-border healthcare covered by this Directive. The patient should be able to stop the release of his data at any point and receive confirmation that his data have been deleted. Amendment 17 Proposal for a directive Recital 18 (18)  The right to reimbursement of the costs of healthcare provided in another Member State from the statutory social security scheme of patients as insured persons was recognised by the Court of Justice in several judgements. The Court of Justice has held that the Treaty provisions on the freedom to provide services include the freedom for the recipients of healthcare, including persons in need of medical treatment, to go to another Member Sate in order to receive it there. The same applies to recipients of healthcare seeking to receive healthcare provided in another Member State through other means, for example through e-health services. Whilst Community law does not detract from the power of the Member States to organise their healthcare and social security systems, Member States must when exercising that power comply with Community law, in particular with the Treaty provisions on the freedom to provide services. Those provisions prohibit the Member States from introducing or maintaining unjustified restrictions on the exercise of that freedom in the healthcare sector . (18)  The right to reimbursement of the costs of healthcare provided in another Member State from the statutory social security scheme of patients as insured persons was recognised by the Court of Justice in several judgements. The Court of Justice has held that the Treaty provisions include the freedom for the recipients of healthcare, including persons in need of medical treatment, to go to another Member Sate in order to receive it there. Community law does not detract from the power of the Member States to organise their healthcare and social security systems. Amendment 18 Proposal for a directive Recital 21 (21)   It is appropriate to require that also patients who go for healthcare to another Member State in other circumstances than those envisaged for coordination of social security schemes established by the Regulation (EC) No. 1408/71 should be able to benefit from the principles of free movement of services in accordance with the Treaty and the provisions of this Directive. Patients should be guaranteed assumption of the costs of that healthcare at least at the level provided for the same or similar healthcare had they been provided in the Member State of affiliation. This fully respects responsibility of the Member States to determine the extent of the sickness cover available to their citizens and prevents any significant effect on the financing of the national healthcare systems. Member States may nevertheless provide in their national legislation for reimbursement of the costs of the treatment at the tariffs in force in the Member State of treatment if this is more beneficial for the patient. This may be the case in particular for any treatment provided through European reference networks as mentioned in Article 15 of this Directive. (21)  Patients should be guaranteed assumption of the costs of healthcare and goods connected with healthcare provided in another Member State at least at the level provided for treatment which is the same or equally effective, had they been provided or purchased in the Member State of affiliation. This fully respects responsibility of the Member States to determine the extent of the sickness cover available to their citizens and prevents any significant effect on the financing of the national healthcare systems. Member States may nevertheless provide in their national legislation for reimbursement of the costs of the treatment at the tariffs in force in the Member State of treatment if this is more beneficial for the patient. This may be the case in particular for any treatment provided through European reference networks as mentioned in Article 15 of this Directive. Amendment 19 Proposal for a directive Recital 24 (24)  The patient should, in any event, not derive a financial advantage from the healthcare provided in another Member State and the assumption of costs should be therefore limited only to actual costs of healthcare received . (24)  The patient should, in any event, not derive a financial advantage from the healthcare provided or goods purchased in another Member State. The assumption of costs should therefore be limited only to the actual costs. Member States may decide to cover other related costs, such as therapeutic treatment, provided that the total cost does not exceed the amount payable in the Member States of affiliation. Amendment 20 Proposal for a directive Recital 25 (25)  This Directive does not aim either to create entitlement for reimbursement of treatment in another Member State, if such a treatment is not among the benefits provided for by the legislation of the patient's Member State of affiliation. Equally this Directive does not prevent the Member States from extending their benefits in kind scheme to healthcare provided in another Member State according to its provisions. (25)  This Directive does not aim either to create entitlement for reimbursement of treatment or of the cost of purchasing goods in another Member State, if such a treatment or such goods are not among the benefits provided for by the legislation of the patient's Member State of affiliation. Equally this Directive does not prevent the Member States from extending their benefits in kind scheme to healthcare and goods provided in another Member State according to its provisions. This Directive recognises that entitlement to treatment is not always determined nationally by Member States and that Member States may organise their own healthcare and social security systems to provide for entitlement to treatment to be determined at a regional or local level . Amendment 21 Proposal for a directive Recital 25 a (new) (25a)  If there are several methods available for treating a certain disease or injury, the patient should have the right to reimbursement for all methods of treatment that are sufficiently tried and tested by international medical science, even if they are not available in the patient's Member State of affiliation. Amendment 22 Proposal for a directive Recital 27 (27)  This Directive provides also for the right for a patient to receive any medicinal product authorised for marketing in the Member State where healthcare is provided , even if the medicinal product is not authorised for marketing in the Member State of affiliation, as it is an indispensable part of obtaining effective treatment in another Member State. (27)  This Directive provides also for the right for a patient to receive any medicinal product or medical device authorised for marketing in the Member State of treatment , even if the medicinal product or medical device is not authorised for marketing in the Member State of affiliation, as it is an indispensable part of obtaining this specific effective treatment for the patient in another Member State. Amendment 23 Proposal for a directive Recital 30 (30)  There is no definition of what constitutes hospital care throughout the different health systems of the Community, and different interpretations could therefore constitute an obstacle to the freedom for patients to receive healthcare. In order to overcome that obstacle, it is necessary to provide a Community definition of hospital care. Hospital care generally means care requiring the overnight accommodation of the patient. However, it may be appropriate to submit to the same regime of hospital care also certain other kinds of healthcare, if that healthcare requires use of highly specialised and cost-intensive medical infrastructure or medical equipment (e.g. high-technology scanners used for diagnosis) or involving treatments presenting a particular risk for the patient or the population (e.g. treatment of serious infectious diseases). A regularly updated list of such treatments shall be specifically defined by the Commission through the comitology procedure. (30)  There is no definition of what constitutes hospital care throughout the different health systems of the Community, and different interpretations could therefore constitute an obstacle to the freedom for patients to receive healthcare. In order to overcome that obstacle, it is necessary to provide a Community definition of hospital care. Hospital care generally means care requiring the overnight accommodation of the patient. However, it may be appropriate to submit to the same regime of hospital care also certain other kinds of healthcare, if that healthcare requires use of highly specialised and cost-intensive medical infrastructure or medical equipment (e.g. high-technology scanners used for diagnosis) or involving treatments presenting a particular risk for the patient or the population (e.g. treatment of serious infectious diseases). Amendment 24 Proposal for a directive Recital 32 (32)  In any event, if a Member State decided to establish a system of prior authorisation for assumption of costs of hospital or specialised care provided in another Member States in accordance with the provision of this Directive, the costs of such care provided in another Member State should also be reimbursed by the Member State of affiliation up to the level of costs that would have been assumed had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received. However, when the conditions set out in Article 22(2) of Regulation (EC) No 1408/71 are fulfilled the authorisation should be granted and the benefits provided in accordance with that Regulation. This applies in particular in instances where the authorisation is granted after an administrative or judicial review of the request and that the person concerned has received the treatment in another Member State. In that case Articles 6, 7, 8 and 9 of this Directive shall not apply. This is in line with the case law of the Court of Justice which has specified that patients who received a refusal of authorisation subsequently held to be unfounded, are entitled to have the cost of the treatment obtained in another Member State reimbursed in full according to the provisions of the legislation in the Member State of treatment. (32)  In any event, if a Member State decided to establish a system of prior authorisation for assumption of costs of hospital or specialised care provided in another Member States in accordance with the provision of this Directive, the costs of such care provided in another Member State should also be reimbursed by the Member State of affiliation up to the level of costs that would have been assumed had treatment which is the same or equally effective for the patient been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received. However, when the conditions set out in Article 22(2) of Regulation (EEC ) No 1408/71 are fulfilled the authorisation should be granted and the benefits provided in accordance with that Regulation. This applies in particular in instances where the authorisation is granted after an administrative or judicial review of the request and that the person concerned has received the treatment in another Member State. In that case Articles 6, 7, 8 and 9 of this Directive shall not apply. This is in line with the case law of the Court of Justice which has specified that patients who received a refusal of authorisation subsequently held to be unfounded, are entitled to have the cost of the treatment obtained in another Member State reimbursed in full according to the provisions of the legislation in the Member State of treatment. Amendment 25 Proposal for a directive Recital 32 a (new) (32a)  Prior authorisation should only be refused in the context of a fair and transparent procedure. The rules laid down by the Member States for submitting an authorisation request and the possible reasons for refusal should be made known in advance. Refusals should be limited to what is necessary, and should be proportionate to the objectives of setting up a prior authorisation system. Amendment 145 Proposal for a directive Recital 32 b (new) (32b)  Patients with a life-threatening condition who are on a waiting list for medical treatment in their home country and who are in urgent need of care may not be subject to prior authorisation, as this procedure could prevent patients from having timely treatment in another Member State. Amendment 27 Proposal for a directive Recital 34 (34)  Appropriate information on all essential aspects of cross-border healthcare is necessary in order to enable patients to exercise their rights to cross-border healthcare in practice. For cross-border healthcare the most efficient mechanism for providing such information is to establish central contact points within each Member State to which patients can refer, and which can provide information on cross-border healthcare taking into account also the context of the health system in that Member State. Since questions about aspects of cross-border healthcare will also require liaison between authorities in different Member States, these central contact points should also constitute a network through which such questions can be most efficiently addressed. These contact points should cooperate with each other and should enable patients to make informed choices about cross-border healthcare. They should also provide information about options available in case of problems with cross-border healthcare, in particular about out-of-court schemes for settling cross-border disputes. (34)  Appropriate information on all essential aspects of cross-border healthcare is necessary in order to enable patients to exercise their rights to cross-border healthcare in practice. For cross-border healthcare the most efficient mechanism for providing such information is to establish central contact points within each Member State to which patients can refer, and which can provide information on cross-border healthcare taking into account also the context of the health system in that Member State. Since questions about aspects of cross-border healthcare will also require liaison between authorities in different Member States, these central contact points should also constitute a network through which such questions can be most efficiently addressed. These contact points should cooperate with each other and should enable patients to make informed choices about cross border healthcare. They should also provide information about options available in case of problems with cross-border healthcare, in particular about out of court schemes for settling cross border disputes. In developing arrangements for the provision of information on cross-border healthcare, the Member States should give consideration to the need to provide information in accessible formats and to potential sources of additional assistance for vulnerable patients, disabled people and people with complex needs. Amendment 28 Proposal for a directive Recital 35 (35)  When healthcare is received by a patient in a Member state, which is not the country where he is insured, it is essential for the patient to know in advance which rules shall be applicable. An equivalent level of clarity is needed in case where healthcare providers temporarily move to another Member State to provide their medical services there or when healthcare is provided cross-border. In those cases, the rules applicable to healthcare are those provided by the legislation of the Member State of treatment in accordance with the general principles set out in Art.5, given that in accordance with Art. 152(5) of the Treaty the organisation and delivery of health services and medical care is of responsibility of Member States. This will help the patient in making an informed choice, and will avoid misapprehension and misunderstanding. It will also establish a high level of trust between the patient and the healthcare provider. (35)  When healthcare is received by a patient in a Member state, which is not the country where he is insured, it is essential for the patient to know in advance which rules shall be applicable. An equivalent level of clarity is needed when healthcare is provided cross-border, such as telemedicine . In those cases, the rules applicable to healthcare are those provided by the legislation of the Member State of treatment in accordance with the general principles set out in Art.5, given that in accordance with Art. 152(5) of the Treaty the organisation and delivery of health services and medical care is of responsibility of Member States. This will help the patient in making an informed choice, and will avoid misapprehension and misunderstanding. It will also establish a high level of trust between the patient and the healthcare provider. Amendment 29 Proposal for a directive Recital 36 (36)  The Member States should decide on the form of those national contact points as well as the number of them. The national contact points may be also 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. The national contact points should have appropriate facilities to provide information on the main aspects of cross-border healthcare and to provide practical assistance to patients if needed. 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 Community level, such as through the European Health Portal. 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. (36)  The Member States should decide on the form of those national contact points as well as the number of them. The national contact points may be also 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. The national contact points should have appropriate facilities to provide information on the main aspects of cross-border healthcare and to provide practical assistance to patients if needed. The Member States should ensure the participation of bodies representing health professionals in these activities. 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. The national contact points should be able to provide patients with relevant information on cross-border healthcare and to assist them. This should not include legal advice. Amendment 30 Proposal for a directive Recital 37 (37)  Realising the potential of the internal market for cross-border healthcare requires cooperation between providers, purchasers and regulators of different Member States at national, regional or local level in order to ensure safe, high quality and efficient care across borders. This is particularly the case for cooperation in border regions, where cross-border provision of services may be the most efficient way of organising health services for the local populations, 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 adaptation of procedures or standards, interoperability of respective national information and communication technology systems, practical mechanisms to ensure continuity of care or practical facilitating of cross-border provision of healthcare by health professionals on a temporary or occasional basis. Directive 2005/36/EC on the recognition of professional qualifications stipulates that free provision of services of a temporary or occasional nature, including services provided by health professionals, in another Member State should not, subject to specific provisions of Community law, be restricted for any reason relating to professional qualifications. This Directive should be without prejudice to those provisions of Directive 2005/36/EC. (37)  Cooperation is required between providers, purchasers and regulators of different Member States at national, regional or local level in order to ensure safe, high quality and efficient care across borders. This is particularly the case for cooperation in border regions, where cross-border provision of healthcare may be the most efficient way of organising healthcare for the local populations, 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 adaptation of procedures or standards, interoperability of respective national information and communication technology systems, practical mechanisms to ensure continuity of care or practical facilitating of cross-border provision of healthcare by health professionals on a temporary or occasional basis. Amendment 31 Proposal for a directive Recital 39 (39)  Where medicinal products are authorised within the patient's Member State in accordance with 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 and have been prescribed in another Member State for an individual named patient, it should be in principle possible for such prescriptions to be medically recognised and used in the patient's own Member State. The removal of regulatory and administrative barriers to such recognition is without prejudice to the need for appropriate agreement of the patients' treating physician or pharmacist in every individual case, if this is warranted by protection of human health and is necessary and proportionate to that objective. Such medical recognition should also be without prejudice to the decision of the Member State of affiliation regarding the inclusion of such medicinal products within the benefits covered by the social security system of affiliation. The implementation of the principle of recognition will be facilitated by the adoption of measures necessary for safeguarding the safety of a patient, and avoiding the misuse or confusion of medicinal products. (39)  Where medicinal products are authorised within the patient's Member State in accordance with 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, including the future legislation on falsified medicinal products (Directive XXXX/XX/EC) and pharmacovigilance (Directive ZZZZ/ZZ/EC), and have been prescribed in another Member State for an individual named patient, it should be in principle possible for such prescriptions to be recognised medically or in pharmacies and used in the patient's own Member State. The removal of regulatory and administrative barriers to such recognition is without prejudice to the need for appropriate agreement of the patients' treating physician or pharmacist in every individual case, if this is warranted by protection of human health and is necessary and proportionate to that objective. Such medical recognition should also be without prejudice to the decision of the Member State of affiliation regarding the inclusion of such medicinal products within the benefits covered by the social security system of affiliation and without prejudice to the validity of national pricing and payment rules . The implementation of the principle of recognition will be facilitated by the adoption of measures necessary for safeguarding the safety of a patient, and avoiding the misuse or confusion of medicinal products. Amendment 32 Proposal for a directive Recital 41 a (new) (41a)  The interoperability of e-health solutions should be achieved whilst respecting national regulations on the provision of health 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 in accordance with the case-law of the Court of Justice and Directive 97/7/EC of the European Parliament and of the Council of 20 May 2007 on the protection of consumers in respect of distance contracts 1 . 1 OJ L 144, 4.6.1997, p. 19. Amendment 33 Proposal for a directive Recital 43 (43)  The constant progress of medical science and health technologies presents both opportunities and challenges to the health systems of the Member States. Cooperation in the evaluation of new health technologies can support Member States through economies of scale and avoiding duplication of effort, and provide a better basis of evidence for optimal use of new technologies to ensure safe, high-quality and efficient healthcare. This will also contribute to the internal market by maximising the speed and scale of diffusion of innovations in medical science and health technologies. Such cooperation requires sustained structures involving all the relevant authorities of all the Member States, building on existing pilot projects. (43)  The constant progress of medical science and health technologies presents both opportunities and challenges to the health systems of the Member States. However, the assessment of health technologies and the possible restriction of access to new technologies by certain decisions by administrative bodies raise a number of fundamental social issues which require contributions from a wide range of stakeholders and the establishment of a viable governance model. Accordingly any cooperation should involve not only the competent authorities of all the Member States but also all the stakeholders concerned, including health professionals and representatives of patients and industry. Moreover, this cooperation should be based on viable principles of good governance such as transparency, openness, objectivity and the impartiality of procedures. Amendment 34 Proposal for a directive Recital 45 (45)  In particular, power should be conferred on the Commission to adopt the following measures: a list of treatments, other than those requiring overnight accommodation, to be subject to the same regime as hospital care; accompanying measures to exclude specific categories of medicinal products or substances from the recognition of prescriptions issued in another Member State provided for in this Directive; a list of specific criteria and conditions that European reference networks must fulfil; the procedure for establishing European reference networks. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, or to supplement this Directive by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. deleted Amendment 35 Proposal for a directive Recital 46 a (new) (46a)  The Member State of affiliation and the Member State of treatment should by prior bilateral cooperation and in consultation with the patient ensure that appropriate aftercare and support is made available in either Member State following the authorised medical treatment and that clear information is available to patients about aftercare options and costs. To do this, Member States should adopt measures to ensure that: (a) the necessary medical and social care data are transferred with due regard to patient confidentiality; and (b) medical and social care professionals in both countries are able to consult each other to ensure the highest quality treatment and aftercare (including social support) for the patient. Amendment 36 Proposal for a directive Recital 46 b (new) (46b)  By facilitating the freedom of movement for patients within the European Union, this Directive is likely to lead to competition between healthcare providers. Such competition is likely to contribute to an increase in the quality of the healthcare for all and to the establishment of centres of excellence. Amendment 37 Proposal for a directive Article 1 This Directive establishes a general framework for the provision of safe, high quality and efficient cross-border healthcare. This Directive lays down rules for access to safe and high-quality healthcare in another Member State and establishes cooperation mechanisms on healthcare between Member States, whilst fully respecting national competencies in the organisation and delivery of healthcare. In the application of this Directive, Member States shall take into account the principles of good quality care and equity. Amendment 38 Proposal for a directive Article 2 This Directive shall apply to provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or private. This Directive shall apply to provision of cross-border healthcare regardless of how it is organised, delivered and financed or whether it is public or private. It shall be without prejudice to the existing framework on the coordination of social security systems as laid down in Regulation (EEC) No 1408/71 and its successor Regulation (EC) No 883/2004 . This Directive shall not apply to health services whose main focus is in the field of long-term care, including services provided over an extended period of time whose purpose is to support people in need of assistance in carrying out routine, everyday tasks. This Directive shall also not apply to organ transplantation. Amendment 39 Proposal for a directive Article 3 - paragraph 1 - points - a a and - a b (new) (-aa) Directive 2005/36/EC on the recognition of professional qualifications; (-ab) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market; Amendment 137 Proposal for a directive Article 3 – paragraph 1 - point e a (new) (ea)  Council Directive 2004/113/EC of 13 December 2004 implementing the principle of equal treatment between men and women in the access to and supply of goods and services; Amendment 138 Proposal for a directive Article 3 – paragraph 1 - point e b (new) (eb)  Council Directive 2000/78/EC establishing a general framework for equal treatment in employment and occupation; Amendment 139 Proposal for a directive Article 3 – paragraph 1 - point e c (new) (ec)  Commission proposal for a Council directive on implementing the principle of equal treatment between persons irrespective of religion or belief, disability, age or sexual orientation (COM(2008)0426); Amendment 40 Proposal for a directive Article 3 - paragraph 1 - point g a (new) (ga)  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 1 ; 1 OJ L 33, 8.2.2003, p. 30. Amendment 41 Proposal for a directive Article 3 - paragraph 1 - point g b (new) (gb)  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 1 ; 1 OJ L 102, 7.4.2004, p. 48. Amendment 42 Proposal for a directive Article 3 - paragraph 1 - point g c (new) (gc)  Council Directive 92/49/EEC of 18 June 1992 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance 1 , as regards the implementing powers conferred on the Commission . 1 OJ L 228, 11.8.1992, p.1. Amendments 117 and 128 Proposal for a directive Article 3 – paragraph 2 2.  When the circumstances under which an authorisation to go to another Member State in order to receive appropriate treatment under Article 22 of Regulation (EC) No 1408/71 must be granted are met, the provisions of that Regulation shall apply and the provisions of Articles 6, 7, 8 and 9 of this Directive shall not apply. Conversely, when an insured person seeks healthcare in another Member State in other circumstances, Articles 6, 7, 8 and 9 of this Directive apply and Article 22 of Council Regulation (EC) No 1408/71 shall not apply. However, whenever the conditions for granting an authorisation set out in Article 22(2) of Regulation (EC) No 1408/71 are fulfilled, the authorisation shall be accorded and the benefits provided in accordance with that Regulation. In that case Articles 6, 7, 8 and 9 of this Directive shall not apply. 2.   This Directive does not address the assumption of costs of healthcare which become necessary on medical grounds during a temporary stay of insured persons in another Member State. Nor does this Directive affect patients' rights to be granted an authorisation for treatment in another Member State where the conditions provided for by the regulations on coordination of social security schemes, in particular Article 22 of Regulation (EEC) No 1408/71 and Article 20 of Regulation (EC) No 883/2004, are met. Amendment 44 Proposal for a directive Article 3 - paragraph 3 3.  If the provisions of this Directive conflict with a provision of another Community act governing specific aspects of healthcare, the provision of the other Community act shall prevail and shall apply to those specific situations concerned. These include: deleted (a)  Directive 2005/36/EC on the recognition of professional qualifications; (b)  Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market. Amendment 45 Proposal for a directive Article 4 – point a (a) "healthcare" means a health service provided by or under the supervision of a health professional in exercise of his profession, and regardless of the ways in which it is organised, delivered and financed at national level or whether it is public or private; (a) "healthcare" means health services or goods, such as pharmaceuticals and medical devices provided or prescribed by health professionals to patients to assess, maintain or restore their state of health or prevent them from becoming ill, regardless of the ways in which they are organised, delivered and financed at national level or whether care is public or private; Amendment 141 Proposal for a directive Article 4 – point a a (new) (aa) "health data" means any information which relates to the physical or mental health of an individual, or to the provision of health services to the individual, which may include: information about the registration of the individual for the provision of health services; information about payments or eligibility for healthcare with respect to the individual; a number, symbol or particular assigned to an individual to uniquely identify that individual for health purposes; any information about the individual collected in the course of the provision of health services to the individual; information derived from the testing or examination of a body part or bodily substance; and identification of a person (healthcare professional) as provider of healthcare to the individual; Amendment 46 Proposal for a directive Article 4 - point b (b) "cross-border healthcare" means healthcare provided in a Member State other than that where the patient is an insured person or healthcare provided in a Member State other than that where the healthcare provider resides, is registered or is established ; (b) "cross-border healthcare" means healthcare provided in a Member State other than that where the patient is an insured person; Amendment 47 Proposal for a directive Article 4 - point c (c) "use of healthcare in another Member State" means healthcare provided in the Member State other than that where the patient is an insured person; deleted Amendment 48 Proposal for a directive Article 4 - point d (d) "health professional" means a doctor of medicine or a nurse responsible for general care or a dental practitioner or a midwife or a pharmacist within the meaning of Directive 2005/36/EC or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC; (d) "health professional" means a medical practitioner or a nurse responsible for general care or a dental practitioner or a midwife or a pharmacist within the meaning of Directive 2005/36/EC or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC, or a person legally exercising healthcare activities in the Member State of treatment; Amendment 49 Proposal for a directive Article 4 - point e e) "healthcare provider" means any natural or legal person legally providing healthcare on the territory of a Member State; e) "healthcare provider" means any health professional in the sense defined in (d) above or legal person legally providing healthcare on the territory of a Member State; Amendment 51 Proposal for a directive Article 4 - point g (g) "insured person" means: (g) "insured person" means a person who is insured under the provisions of the definition in Article 1(c) of Regulation (EC) No 883/2004, or as defined in the policy conditions of private sickness insurance schemes; (i) until the date of application of Regulation (EC) No 883/2004: a person who is insured in accordance with the provisions of Articles 1, 2 and 4 of Regulation (EC) No 1408/71, (ii) as from the date of application of Regulation (EC) No 883/2004: a person who is an insured person within the meaning of Article 1(c) of Regulation (EC) No 883/2004; Amendment 52 Proposal for a directive Article 4 - point h (h)  "Member State of affiliation" means the Member State where the patient is an insured person; (h)  "Member State of affiliation" means the Member State where the patient is an insured person or the Member State where the patient resides if this Member State is not the same as the former . Amendment 53 Proposition de directive Article 4 – point h, subparagraph 2(new) Where, due to the application of Regulation (EEC) No 1408/71 and Regulation (EC) No 883/2004 respectively, the health insurance body in the Member State of residence of the patient is responsible for the provision of benefits in accordance with the legislation of that state, then that Member State is regarded as the Member State of affiliation for the purposes of this Directive; Amendment 54 Proposal for a directive Article 4 - point i a (new) (ia) "medical device" means a medical device as defined in Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC; Amendment 55 Proposal for a directive Article 4 - point i b (new) (ib) "goods used in connection with health care" means goods which are used to preserve or improve a person's health, such as medical devices and medicines; Amendment 56 Proposal for a directive Article 4 - point k a (new) (ka) "health technology" means a medicinal product or a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare; Amendment 57 Proposal for a directive Article 4 - point l (l) "harm" means adverse outcomes or injuries stemming from the provision of healthcare. (l) "harm" is defined in cross-border healthcare by reference to the existing legal framework of the Member State of treatment and understanding of what constitutes harm may vary from Member State to Member State. Amendment 58 Proposal for a directive Article 4 - point l a (new) (la)  "Patient's medical records" or "medical history" means all the documents containing data, assessments and information of any kind on a patient's situation and clinical development throughout the care process. Amendments 59 and 140 Proposal for a directive Article 5 – paragraph 1 1.  The Member States of treatment shall be responsible for the organisation and the delivery of healthcare. In such a context and taking into account principles of universality, access to good quality care, equity and solidarity, they shall define clear quality and safety standards for healthcare provided on their territory, and ensure that: 1.  The Member States of treatment shall be responsible for the organisation and the delivery of healthcare. In such a context and taking into account principles of universality, access to good quality care, equity and solidarity, they shall define clear quality standards for healthcare provided on their territory, and ensure compliance with existing EU legislation on safety standards , and that: (a) mechanisms are in place for ensuring that healthcare providers are able to meet such standards, taking into account international medical science and generally recognised good medical practices; (a) when healthcare is provided in a Member State other than that where the patient is an insured person, such healthcare is provided in accordance with the legislation of the Member State of treatment; (b) the application of such standards by healthcare providers in practice is regularly monitored and corrective action is taken when appropriate standards are not met, taking into account progress in medical science and health technology; (b) healthcare referred to in point (a) is provided in accordance with standards and guidelines on quality defined by the Member State of treatment; (ba) patients and healthcare providers from other Member States are provided with information by the national contact point of the Member State of treatment, inter alia by electronic means, on quality standards and guidelines, including provisions on supervision, and on availability, quality and safety, treatment options, prices, outcomes of the healthcare provided, accessibility for persons with disabilities and details of the healthcare provider's registration status and insurance cover or other means of personal or collective protection with regard to their professional liability; (c) healthcare providers provide all relevant information to enable patients to make an informed choice, in particular on availability, prices and outcomes of the healthcare provided and details of their insurance cover or other means of personal or collective protection with regard to professional liability ; (c) healthcare providers provide all relevant information to enable patients to make an informed choice; (d) patients have a means of making complaints and are guaranteed remedies and compensation when they suffer harm arising from the healthcare they receive; (d) patients have the means of making complaints and the right to seek compensation when they suffer harm arising from the healthcare they receive and there are mechanisms in place to guarantee remedies ; (e) systems of professional liability insurance or a guarantee or similar arrangement, which are equivalent or essentially comparable as regards their purpose and which are appropriate to the nature and the extent of the risk are in place for treatment provided on their territory; (e) systems of professional liability insurance or a guarantee or similar arrangement, which are appropriate to the nature and the extent of the risk are in place for treatment provided on their territory; (f) the fundamental right to privacy with respect to the processing of personal data is protected in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC; (f) the fundamental right to privacy with respect to the processing of personal data is protected in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC; (g) patients from other Member States shall enjoy equal treatment with the nationals of the Member State of treatment, including the protection against discrimination provided for according to Community law and national legislation in force in the Member State of treatment. (g) patients from other Member States shall enjoy equal treatment with the nationals of the Member State of treatment, including the protection against direct or indirect discrimination on the grounds of racial or ethnic origin, sex, religion or belief, disability, age, or sexual orientation provided for according to Community law and national legislation in force in the Member State of treatment. However, this Directive shall not oblige healthcare providers in a Member State either to provide healthcare to an insured person from another Member State or to prioritise the provision of healthcare to an insured person from another Member State to the detriment of a person who has similar health needs and is an insured person of the Member State of treatment. (ga) patients who have received treatment are entitled to a written or electronic record of such treatment and of any medical advice for the continuity of their care; 1a.  The public authorities in the Member State of treatment shall monitor regularly the accessibility, quality and financial state of their healthcare systems on the basis of the data collected under Article 18. Amendment 60 Proposal for a Directive Article 5 - paragraph 1b and 1c (new) 1b.  In order to maximise patient safety the Member States of treatment and affiliation shall ensure that: (a) patients have a means of making complaints, and are guaranteed remedies and compensation when they suffer harm arising from the healthcare they receive; (b) the quality and safety standards of the Member State of treatment are made public in a language and format that is clear and accessible to all citizens; (c) there is a right to continuity of care, notably by means of the forwarding of relevant medical data concerning the patient with due respect to the provisions of paragraph 1 - point (e) and pursuant to Article 13 and patients who have received treatment are entitled to a written or electronic record of such treatment and of any medical advice for the continuity of their care; (d) in the event of complications resulting from healthcare provided abroad or if a particular medical follow-up proves necessary, the Member State of affiliation guarantees to provide healthcare equivalent to that received on its territory; (e) they immediately and proactively inform each other about health providers or health professionals when regulatory action is taken against their registration or their right to provide services; 1c.  The Commission shall in accordance with the regulatory procedure referred to in Article 19(2), adopt measures necessary for achieving a common security level of health data at national level, taking into account existing technical standards in this field. Amendment 61 Proposal for a directive Article 5 – paragraph 2 2.  Any measures taken by Member States, when implementing this Article, shall respect the provisions of Directive 2005/36/EC on the recognition of professional qualifications and Directive 2000/31/EC on certain legal aspects of information society services, in particular electronic commerce. deleted Amendment 62 Proposal for a directive Article 5 – paragraph 3 3.  In so far as it is necessary to facilitate the provision of cross-border healthcare and taking as a basis a high level of protection of health, the Commission, in cooperation with the Member States, shall develop guidelines to facilitate the implementation of paragraph 1. 3.  In so far as it is necessary to facilitate the provision of cross-border healthcare and taking as a basis a high level of protection of health, the Commission, in cooperation with the Member States, may develop guidelines to facilitate the implementation of paragraph 1. Amendment 63 Proposal for a directive Article 5 – paragraph 3 a (new) 3a.  For the purposes of this Article, Member States shall have a transparent mechanism for the calculation of costs that are to be charged for the healthcare provided. This calculation mechanism shall be based on objective, non-discriminatory criteria known in advance and it shall be applied at the relevant administrative level in cases where the Member State of treatment has a decentralised healthcare system. Amendment 64 Proposal for a directive Article 5 – paragraph 3 b (new) 3b.  In view of the great importance, particularly to patients, of safeguarding the quality and safety of cross-border care, the organisations involved in drawing up standards and guidelines as referred to in paragraphs 1 and 3 shall at the minimum include patients' organisations (particularly those of a cross-border nature). Amendment 65 Proposal for a directive Article 6 – title Article 6 Article 6 Healthcare provided in another Member State Responsibilities of authorities of the Member State of affiliation Amendment 66 Proposal for a directive Article 6 – paragraph 1 1.  Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled. The Member State of affiliation shall reimburse the costs to the insured person, which would have been paid for by its statutory social security system had the same or similar healthcare been provided in its territory. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided. 1.  Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation, administrative regulations, guidelines and codes of conduct of the medical professions, of the Member State of affiliation to which the insured person is entitled. Without prejudice to Regulation (EEC) No 1408/71 and, as from its date of application, Regulation (EC) No 883/2004, the Member State of affiliation shall reimburse the costs to the Member State of treatment or the insured person, which would have been paid for by its statutory social security system had equally effective healthcare been provided in its territory. If a Member State of affiliation rejects the reimbursement of this treatment, that Member State shall have to give a medical justification for its decision. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided. Patients affected by rare diseases should have the right to access healthcare in another Member State and to get reimbursement even if the treatment in question is not among the benefits provided for by the legislation of the Member State of affiliation. Amendment 68 Proposal for a directive Article 6 – paragraph 2 2.  The costs of healthcare provided in another Member State shall be reimbursed by the Member State of affiliation in accordance with the provisions of this Directive up to the level of costs that would have been assumed had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received. 2.  The costs of healthcare provided in another Member State shall be reimbursed or paid directly by the Member State of affiliation in accordance with the provisions of this Directive up to the level of costs that would have been assumed in respect of the same medical condition under the same conditions as laid down in paragraph 1 in the Member State of affiliation, without exceeding the actual costs of healthcare received. Member States may decide to cover other related costs, such as therapeutic treatment and accommodation and travel costs. 2a.  The extra costs which persons with disabilities might incur when receiving healthcare in another Member State due to one or more disabilities shall be reimbursed by the Member State of affiliation in accordance with national legislation and on the condition that sufficient documentation setting out these costs exists. Amendment 69 Proposal for a directive Article 6 – paragraph 3 3.  The Member State of affiliation may impose on a patient seeking healthcare provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities for receiving healthcare and reimbursement of healthcare costs as it would impose if the same or similar healthcare was provided in its territory, in so far as they are neither discriminatory nor an obstacle to freedom of movement of persons . 3.  The Member State of affiliation may impose on a patient seeking healthcare provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities, whether set at a local, national or regional level, for receiving healthcare and assumption of healthcare costs as it would impose if that healthcare was provided in its territory, in so far as they are neither discriminatory nor an obstacle to freedom of movement of patients and goods, such as pharmaceuticals and medical devices, and are known in advance. This may include a requirement that the insured person is assessed for the purposes of applying those conditions, criteria or formalities by a health professional or healthcare administrators providing services for the statutory social security system of the Member State of affiliation, where such an assessment would also be required for accessing health services in the Member State of affiliation . Amendment 70 Proposal for a directive Article 6 – paragraph 4 4.  Member States shall have a mechanism for calculation of costs that are to be reimbursed to the insured person by the statutory social security system for healthcare provided in another Member State. This mechanism shall be based on objective, non-discriminatory criteria known in advance and the costs reimbursed according to this mechanism shall be not less than what would have been assumed had the same or similar healthcare been provided in the territory of the Member State of affiliation. 4.  For the purposes of this Article, Member States shall have a transparent mechanism for the calculation of costs that are to be assumed by the statutory social security system or other statutory public system for healthcare provided in another Member State. This mechanism shall be based on objective, non-discriminatory criteria known in advance and the costs reimbursed according to this mechanism shall be not less than what would have been assumed had that healthcare been provided in the territory of the Member State of affiliation. The mechanism shall be applied at the relevant administrative level in cases where the Member State of affiliation has a decentralised healthcare system . Amendment 71 Proposal for a directive Article 6 – paragraph 5 5.  Patients travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State shall be guaranteed access to their medical records, in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC. 5.  Patients receiving healthcare in a Member State other than their Member State of affiliation or seeking to receive healthcare provided in another Member State shall be guaranteed access to their medical records, in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC. If the medical records are held in electronic form, patients shall have a guaranteed right to obtain a copy of, or a right of remote access to, those records. Data shall be transmitted only with the express consent in writing of the patient or the patient's relatives. Amendment 72 Proposal for a directive Article 6 – paragraph 5 a (new) 5a.  The provisions of this Chapter shall not affect the conclusion of cross-border contractual arrangements for planned healthcare. Amendment 73 Proposal for a directive Article 7 The Member State of affiliation shall not make the reimbursement of the costs of non-hospital care provided in another Member State subject to prior authorisation, where the cost of that care, if it had been provided in its territory, would have been paid for by its social security system. The Member State of affiliation shall not make the reimbursement of the costs of non-hospital care provided in another Member State or the purchase of goods connected with healthcare which are purchased in another Member State subject to prior authorisation, where the cost of that care, if it had been provided in its territory , or of those goods, if they had been purchased in its territory , would have been paid for by its social security system. Amendment 74 Proposal for a directive Article 8 – title Hospital and specialised care Hospital care Amendment 75 Proposal for a directive Article 8 – paragraphs 1 and 2 1.  For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, hospital care shall mean : 1.  For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, the definition of hospital care, as established by the Member State of affiliation, shall be limited to : (a) healthcare which requires overnight accommodation of the patient in question for at least one night. (a) healthcare which requires overnight accommodation of the patient in question for at least one night; or (b) healthcare, included in a specific list, that does not require overnight accommodation of the patient for at least one night. This list shall be limited to: (b) healthcare which is highly specialised and/or requires use of cost-intensive medical infrastructure or medical equipment; or - healthcare that requires use of highly specialised and cost-intensive medical infrastructure or medical equipment; or (ba) healthcare involving treatments presenting a particular risk for the patient or the population. - healthcare involving treatments presenting a particular risk for the patient or the population. 2.  This list shall be set up and may be regularly updated by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). Amendment 76 Proposal for a directive Article 8 – paragraph 3 3.  The Member State of affiliation may provide for a system of prior authorisation for reimbursement by its social security system of the cost of hospital care provided in another Member State where the following conditions are met: 3.  The Member State of affiliation may provide for a system of prior authorisation for reimbursement by its social security system of the cost of hospital care provided in another Member State where the following conditions are met: (a) had the healthcare been provided in its territory, it would have been assumed by the Member State's social security system; and (a) had the healthcare been provided in its territory, it would have been assumed by the Member State's social security system; and (b) the purpose of the system is to address the consequent outflow of patients due to the implementation of the present Article and to prevent it from seriously undermining, or being likely to seriously undermine: (b) the absence of prior authorisation could seriously undermine or be likely to undermine: (i) the financial balance of the Member State's social security system; and/or (i) the financial balance of the Member State's social security system; and/or (ii) the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member State. (ii) the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member State. Such a system shall be without prejudice to Regulation (EEC) No 1408/71 and, as from its date of application, Regulation (EC) No 883/2004. Amendment 77, 149 and 157 Proposal for a directive Article 8 – paragraph 4 4.  The prior authorisation system shall be limited to what is necessary and proportionate to avoid such impact , and shall not constitute a means of arbitrary discrimination. 4.  The prior authorisation system shall apply without prejudice to Article 3(2) and shall be limited to what is necessary and proportionate, shall be based on clear and transparent criteria , and shall not constitute a means of arbitrary discrimination or an obstacle to freedom of movement of patients. Amendment 78 Proposal for a directive Article 8 – paragraph 4 a (new) 4a.  Where prior authorisation has been sought and given, the Member State of affiliation shall ensure that patients are expected only to pay upfront any costs that they would be expected to pay in this manner had their care been provided in the health system of their Member State of affiliation. Member States shall seek to transfer funds directly between the funders and the providers of care for any other costs. Amendment 79 Proposal for a directive Article 8 – paragraph 4 b (new) 4b.  Prior authorisation application systems must be made available at a local/regional level and must be accessible and transparent to patients. The rules for application and refusal of prior authorisation must be available in advance of an application so that the application can be made in a fair and transparent way. Amendment 80 Proposal for a directive Article 8 – paragraph 4 c (new) 4c.  Patients seeking to receive healthcare provided in another Member State shall be guaranteed the right to apply for prior authorisation in the Member State of affiliation. Amendment 81 Proposal for a directive Article 8 – paragraph 5 5.  The Member State shall make publicly available all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 3. 5.  The Member State shall make publicly available all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 3, including appeal procedures in the event of a refusal to give authorisation . Amendment 82 Proposal for a directive Article 8 – paragraph 5 a (new) 5a.  With regard to any request for authorisation made by an insured person with a view to receiving healthcare in another Member State, the Member State of affiliation shall ascertain whether the conditions laid down in Regulation (EC) No 883/2004 have been met, and, if so, shall grant prior authorisation pursuant to that Regulation. Amendment 83 Proposal for a directive Article 8 – paragraph 5 b (new) 5b.  Patients with rare diseases shall not be subject to prior authorisation. Amendment 84 Proposal for a directive Article 9 – paragraph 2 2.  Any such procedural systems shall be easily accessible and capable of ensuring that requests are dealt with objectively and impartially within time limits set out and made public in advance by the Member States. 2.  Any such procedural systems shall be easily accessible and capable of ensuring that requests are dealt with objectively and impartially within reasonable time limits set out and made public in advance by the Member States. Amendment 85 Proposal for a directive Article 9 – paragraph 3 3.  Member States shall specify in advance and in a transparent way the criteria for refusal of the prior authorisation referred to in Article 8(3). deleted Amendment 86 Proposal for a directive Article 9 – paragraph 3 a (new) 3a.  Member States of affiliation shall ensure that patients who have received prior authorisation for the use of healthcare abroad will only be required to make upfront or top-up payments to the healthcare systems and/or providers in the Member State of treatment, to the extent that such payments would be required in the Member State of affiliation itself. Amendment 87 Proposal for a directive Article 9 – paragraph 4 4.  Member States shall, when setting out the time limits within which requests for the use of healthcare in another Member State must be dealt with, take into account: 4.  Member States shall, when setting out the time limits within which requests for the use of healthcare in another Member State must be dealt with and, when considering these requests , take into account: (a) the specific medical condition, (a) the specific medical condition, (aa) individual circumstances, (b) the patient's degree of pain, (b) the patient's degree of pain, (c) the nature of the patient's disability, and (c) the nature of the patient's disability, and (d) the patient's ability to carry out a professional activity. (d) the patient's ability to carry out a professional activity. Amendment 88 Proposal for a directive Article 9 – paragraph 4 a (new) 4a.  Prior authorisation application systems shall be made available at the level appropriate for the administration of the Member State's health service and must be accessible and transparent to patients. The rules for application and refusal of prior authorisation must be available in advance of an application so that the application can be made in a fair and transparent way. Amendment 89 Proposal for a directive Article 9 – paragraph 5 5.  Member States shall ensure that any administrative decisions regarding the use of healthcare in another Member State are subject to administrative review and also capable of being challenged in judicial proceedings, which include provision for interim measures. 5.  Member States shall ensure that any administrative or medical decisions regarding the use of healthcare in another Member State are subject, on a case-by-case basis, to a medical opinion or an administrative review and also capable of being challenged in judicial proceedings, which include provision for interim measures. Amendment 90 Proposal for a directive Article 9 – paragraph 5 a (new) 5a.  The Commission shall conduct a feasibility study into the establishment of a clearing house to facilitate the reimbursement of costs under this Directive across borders, healthcare systems and currency zones within two years of the entry into force of this Directive and shall report back to the European Parliament and the Council and, if appropriate, present a legislative proposal. Amendment 91 Proposal for a directive Article 9 a (new) Article 9a Prior notification Member States may offer patients a voluntary system of prior notification whereby, in return for such notification, the patient shall receive a written confirmation of the maximum amount that will be paid. That written confirmation can then be taken to the hospital of treatment and reimbursement would then be made directly to that hospital by the Member State of affiliation. Amendment 92 Proposal for a directive Article 9 b (new) Article 9b European Patients Ombudsman The Commission shall present a legislative proposal to establish a European Patients Ombudsman within 18 months after the entry into force of this Directive. The European Patients Ombudsman shall consider, and if appropriate, mediate on patient complaints with regard to prior authorisation, reimbursement of costs or harm. The European Patients Ombudsman shall only be engaged once all the complaint options within the relevant Member State have been exhausted. Amendment 93 Proposal for a directive Article 10 – paragraphs 1 and 2 1.  The Member States of affiliation shall ensure that there are mechanisms in place to provide patients on request with information on receiving healthcare in another Member State, and the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received in another Member State. 1.  The Member States of affiliation shall ensure that there are easily accessible mechanisms in place, including by electronic means, promptly to provide patients on request with information on receiving healthcare in another Member State, and shall include information on patients' entitlements, on procedures for accessing those entitlements and on systems of appeal and redress if the patient is deprived of such entitlements, and the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received in another Member State. This information shall be published in formats accessible to persons with disabilities. Member States shall consult stakeholders, including patients' organisations, to ensure information is clear and accessible. In information about cross-border healthcare, a clear distinction shall be made between the rights which patients have by virtue of this Directive and rights arising from regulations on coordination of social security schemes as referred to in Article 3(1)(f) . 2.  The information referred to in paragraph 1 shall be made easily accessible, including by electronic means, and shall include information on patients' entitlements, on procedures for accessing those entitlements and on systems of appeal and redress if the patient is deprived of such entitlements. Amendment 94 Proposal for a directive Article 10 – paragraph 2 a (new) 2a.  In addition to the information outlined in paragraph 1, information on health professionals and healthcare providers shall be made easily available via electronic means by the Member State in which the health professionals and healthcare providers are registered, and shall include the name, registration number and practice address of the healthcare professional, and any restrictions on their practice . Amendment 95 Proposal for a directive Article 10 – paragraph 3 3.  The Commission may, in accordance with the procedure referred to in Article 19(2), develop a standard Community format for the prior information referred to in paragraph 1. deleted Amendment 96 Proposal for a directive Article 11 – paragraph 1 1.  When healthcare is provided in a Member State other than that where the patient is an insured person, or in a Member State other than that where the healthcare provider resides, is registered or established, such healthcare service is provided according to the legislation of the Member State of treatment in accordance with Art.5. 1.  When healthcare is provided in a Member State other than that where the patient is an insured person, such healthcare service is provided according to the legislation of the Member State of treatment in accordance with Art.5. Amendment 97 Proposal for a directive Article 12 – paragraph 1 1.  Member States shall designate national contact points for cross-border healthcare and communicate their names and contact details to the Commission. 1.  Member States shall designate national contact points for cross-border healthcare and communicate their names and contact details to the Commission. Member States shall ensure that patient organisations, sickness funds and healthcare providers are encompassed by national contact points. The national contact points shall be established in an efficient and transparent way. Information about the existence of the national contact points shall be disseminated across Member States, so that patients have easy access to the information. Amendment 98 Proposal for a directive Article 12 – paragraph 1 a (new) 1a.  The national contact points for cross-border health care may also be incorporated into existing information centres in the Member States. Amendment 99 Proposal for a directive Article 12 – paragraph 2 2.  The national contact point in the Member State of affiliation shall, in close cooperation with other competent national authorities, and with national contact points in other Member States, in particular in the Member State of treatment, and with the Commission : 2.  The national contact point in the Member State of affiliation shall provide and disseminate information to patients and health professionals, on a website if appropriate, on receiving healthcare in another Member State, and on the terms and conditions which apply , in particular on patients' rights related to cross-border healthcare as laid down in Article 6 . The national contact point shall help patients to protect their rights and seek appropriate redress in the event of harm caused by the use of healthcare in another Member State; (a) provide and disseminate information to patients in particular on their rights related to cross-border healthcare and the guarantees of quality and safety, protection of personal data, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and conditions applicable ; (b) help patients to protect their rights and seek appropriate redress in the event of harm caused by the use of healthcare in another Member State; the national contact point shall in particular inform patients about the options available to settle any dispute, help to identify the appropriate out-of-court settlement scheme for the specific case and help patients to monitor their dispute where necessary; 2a.  The national contact point in the Member State of treatment shall provide and disseminate information to patients, on a website if appropriate, on issues referred to in Article 5(1)(ba) and on the protection of personal data, the level of accessibility to healthcare facilities for people with disabilities, procedures for complaints and means of redress available for healthcare received in the Member State of treatment. It shall in particular inform patients and health professionals, where necessary, about the means by which professionals and providers are regulated and the means by which regulatory action can be taken, the options available to settle any dispute, and help to identify the appropriate out-of-court settlement scheme for the specific case. (c) gather detailed information on national bodies operating out-of-court settlement of disputes and facilitate co-operation with those bodies; (d) facilitate the development of international out-of-court settlement scheme for disputes arising from cross-border healthcare; 2b.  The national contact point in a Member State shall cooperate closely with other competent authorities, with national contact points in other Member States, with patients' organisations and with the Commission. 2c.  The national contact points shall provide the information referred to in paragraphs 2 and 2a in formats easily accessible for people with disabilities. Amendment 100 Proposal for a directive Article 13 - paragraphs 2a, 2b and 2c (new) 2a.  Member States, particularly neighbouring countries, may conclude agreements with one another concerning the continuation or potential further development of cooperation arrangements. 2b.  Member States shall guarantee that registers in which health professionals are listed can be consulted by relevant authorities of other Member States. 2c.  Member States shall immediately and proactively exchange information about disciplinary and criminal findings against health professionals where they impact upon their registration or their right to provide services . Amendments 101 and 144 Proposal for a directive Article 14 - paragraphs 1, 2 and 3 1.  If a medicinal product is authorised to be marketed on their territory in accordance with Article 6(1) of Directive 2001/83/EC, Member States shall ensure that prescriptions issued by an authorised person in another Member State for a named patient can be used in their territory and that any restrictions on recognition of individual prescriptions are prohibited unless they: 1.  If a medicinal product is authorised to be marketed on their territory in accordance with Article 6(1) of Directive 2001/83/EC, Member States shall ensure that prescriptions issued by an authorised person in another Member State for a named patient in respect of that medicinal product can be used in their territory and that any restrictions on recognition of individual prescriptions are prohibited unless they: (a) are limited to what is necessary and proportionate to safeguard human health and are non-discriminatory or (a) are limited to what is necessary and proportionate to safeguard human health and are non-discriminatory or (b) are based on legitimate and justified doubts about the authenticity or content of an individual prescription. (b) are based on legitimate and justified doubts about the authenticity or content of an individual prescription, or the status of the prescriber. The recognition of such prescription shall not affect: (i) national rules governing prescribing and dispensing, including generic substitution; (ii) national rules governing the reimbursement of Community cross-border prescriptions; (iii) any professional or ethical duty that would require the pharmacist to refuse to dispense had the prescription been issued in the Member State of affiliation. 2.  For facilitating the implementation of paragraph 1, the Commission shall adopt: 2.  For facilitating the implementation of paragraph 1, the Commission shall adopt: (a) measures enabling a pharmacist or other health professional to verify the authenticity of the prescription and whether the prescription was issued in another Member State by an authorised person through developing a Community prescription template, and supporting interoperability of ePrescriptions; (a) measures enabling a pharmacist or other health professional to verify the authenticity of the prescription and whether the prescription was issued in another Member State by an authorised person through developing a Community prescription template, and supporting interoperability of ePrescriptions; data protection safeguards shall be taken into account and incorporated from the initial stage of this development process ; (b) measures to ensure that medicinal products prescribed in one Member State and dispensed in another are correctly identified and that the information to patients concerning the product is comprehensible; (b) measures to ensure that medicinal products prescribed in one Member State and dispensed in another are correctly identified and that the information to patients concerning the product is comprehensible, including clarity as to different names used for the same medicinal product; (ba) measures to ensure, if needed, contact between the prescribing party and the dispensing party in order to ensure complete understanding of the treatment, whilst maintaining confidentiality of patient's data . (c) measures to exclude specific categories of medicinal products from the recognition of prescriptions provided for under this article where necessary in order to safeguard public health. 2a.  Where a prescription is issued in the Member State of treatment for medicinal products which are not normally available on prescription in the Member State of affiliation, it shall be for the latter to decide whether to authorise exceptionally or to provide an alternative medicinal product deemed to be as effective. 3.  The measures referred to in points (a) and (b) of paragraph 2 shall be adopted in accordance with the regulatory procedure referred to in Article 19(2). The measures referred to in point (c) of paragraph 2, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). 3.  The measures referred to in points (a), (b) and (ba) of paragraph 2 shall be adopted in accordance with the regulatory procedure referred to in Article 19(2). Amendment 102 Proposal for a directive Article 15 - paragraph 1 1.  Member States shall facilitate the development of the European reference networks of healthcare providers. Those networks shall at all times be open for new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria. 1.  Member States shall facilitate the development of the European reference networks of healthcare providers, in particular in the area of rare diseases, which shall draw on the health cooperation experience acquired within the European groupings of territorial cooperation (EGTCs) . Those networks shall at all times be open for new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria. Amendment 103 Proposal for a directive Article 15 - paragraph 2 - point b a (new) (ba) to contribute to the pooling of knowledge regarding sickness prevention and the treatment of major commonly occurring disorders; Amendment 104 Proposal for a directive Article 15 - paragraph 2 - point f a (new) (fa) to implement instruments which enable the best possible use to be made of existing healthcare resources in the event of serious accidents, particularly in cross- border areas . Amendment 105 Proposition de directive Article 15 - paragraph 3 - introductory part 3.  The Commission shall adopt: 3.  The Commission, in collaboration with relevant experts and stakeholders, shall adopt: Amendment 106 Proposition de directive Article 15 - paragraph 3 - point a - introductory part (a) a list of specific criteria and conditions that the European reference networks must fulfil, including the conditions and criteria required from healthcare providers wishing to join the European reference networks, in order to ensure, in particular, that the European reference networks: (a) a list of specific criteria and conditions that the European reference networks must fulfil, including also a list of rarer disease areas to be covered and the conditions and criteria required from healthcare providers wishing to join the European reference networks, in order to ensure, in particular, that the European reference networks: Amendment 107 Proposal for a directive Article 15 – paragraph 3 – point a – point ix a (new) (ixa) have appropriate and effective relationships with technology providers. Amendment 108 Proposal for a directive Article 15 a (new) Article 15a Trial areas The Commission, in cooperation with the Member States, may designate border regions as trial areas in which innovative cross-border healthcare initiatives can be tested, analysed and evaluated. Amendment 109 Proposal for a directive Article 16 The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt specific measures necessary for achieving the interoperability of information and communication technology systems in the healthcare field, applicable whenever Member States decide to introduce them. Those measures shall reflect developments in health technologies and medical science and respect the fundamental right to the protection of personal data in accordance with the applicable law . They shall specify in particular the necessary standards and terminologies for inter-operability of relevant information and communication technology systems to ensure safe, high-quality and efficient provision of cross-border health services. The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt specific measures necessary for achieving the interoperability of information and communication technology systems in the healthcare field, applicable whenever Member States decide to introduce them. Those measures shall conform to the applicable data protection laws in each Member State and shall also reflect developments in health technologies and medical science, including telemedicine and telepsychiatry, and respect the fundamental right to the protection of personal data. They shall specify in particular the necessary standards and terminologies for inter-operability of relevant information and communication technology systems to ensure safe, high-quality and efficient provision of cross-border health services. Amendment 110 Proposal for a directive Article 16 – paragraph 1 a (new) The Member States shall ensure that the use of e-Health and other telemedicine services: (a) adhere to the same professional medical quality and safety standards as those in use for non-electronic healthcare provision; (b) offer adequate protection to patients, notably through the introduction of appropriate regulatory requirements for practitioners similar to those in use for non-electronic healthcare provision. Amendment 135 Proposal for a directive Article 17 Cooperation on management of new health technologies Cooperation on management of health technologies 1.  Member States shall facilitate development and functioning of a network connecting the national authorities or bodies responsible for health technology assessment. 1.  The European Commission shall, in consultation with the European Parliament, facilitate the establishment of a network connecting the national authorities or bodies responsible for health technology assessment. This network shall be based on the principles of good governance including transparency, objectiveness, fairness of procedures, and broad and full stakeholder participation of all relevant groups, including - but not limited to - health professionals, patients" representatives, social partners, scientists and industry, whilst respecting Member States' competence in the area of health technology assessment. 2.  The objective of the health technology assessment network shall be: 2.  The objective of the health technology assessment network shall be: (a) to support cooperation between national authorities or bodies; (a) to support cooperation between national authorities or bodies; (aa) to find sustainable ways to balance the objectives of access to medicines, reward for innovation and management of healthcare budgets; (b) to support provision of objective, reliable, timely, transparent and transferable information on the short- and long-term effectiveness of health technologies and enable an effective exchange of this information between national authorities or bodies. (b) to support provision of objective, reliable, timely, transparent and transferable information on the short- and long-term effectiveness of health technologies and enable an effective exchange of this information between national authorities or bodies; (ba) to analyse the nature and type of information that can be exchanged. 3.  Member States shall designate the authorities or bodies participating in the network as referred to in paragraph 1 and communicate to the Commission names and contact details of those authorities or bodies. 3.  Member States shall designate the authorities or bodies participating in the network as referred to in paragraph 1 and communicate to the Commission names and contact details of those authorities or bodies. 4.  The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt the necessary measures for the establishment and the management of this network and specifying the nature and type of the information to be exchanged . 4.  The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt the necessary measures for the establishment, the management and the transparent functioning of this network. 4a.  The Commission shall only allow such authorities to join the network which fulfil the principles of good governance as defined in paragraph 1. Amendment 112 Proposal for a directive Article 18 – paragraph 1 1.  Member States shall collect statistical and other additional data needed for monitoring purposes on the provision of cross-border healthcare, the care provided, its providers and patients, the cost and the outcomes. They shall collect such data as part of their general systems for collecting healthcare data, in accordance with national and Community law for the production of statistics and on the protection of personal data. 1.  Member States shall collect statistical data needed for monitoring purposes on the provision of cross-border healthcare, the care provided, its providers and patients, the cost and the outcomes. They shall collect such data as part of their general systems for collecting healthcare data, in accordance with national and Community law for the production of statistics and on the protection of personal data, and specifically Article 8(4) of Directive 95/46/EC . Amendment 113 Proposal for a directive Article 19 – paragraph 1 1.  The Commission shall be assisted by a Committee, consisting of representatives of the Member States and chaired by the Commission representative. 1.  The Commission shall be assisted by a Committee, consisting of representatives of the Member States and chaired by the Commission representative. In this process, the Commission shall ensure the consultation of experts from the relevant patient and professional groups in an appropriate manner, especially in the context of the implementation of this Directive, and shall provide a reasoned report on these consultations. Amendment 143 Proposal for a directive Article 19 – paragraph 2 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 of that Decision. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 3 months. 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 of that Decision. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 3 months. Where implementing measures relate to the processing of personal data the European Data Protection Supervisor shall be consulted. Amendment 115 Proposal for a directive Article 20 – paragraph 1 The Commission shall within five years after the date referred to in Article 22(1) draw up a report on the operation of this Directive and submit it to the European Parliament and to the Council. The Commission shall within five years after the date referred to in Article 22(1) draw up a report on the operation of this Directive, including statistics on patient outflows and inflows resulting from this Directive, and submit it to the European Parliament and to the Council.