88 Amendments of Marianne THYSSEN related to 2008/0142(COD)
Amendment 43 #
Proposal for a directive
Recital 5
Recital 5
(5) As confirmed by the Court of Justice on several occasions, while recognizing their specific nature, all typescross-border provision of medical care falls within the scope of the Treaty.
Amendment 50 #
Proposal for a directive
Recital 9
Recital 9
(9) This Directive on the application of patients’ rights in cross-border healthcare applies to all types of cross-border 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 which is not strictly medical. It does not apply, for example, to services which are normally provided at residential homes or housing, or assistance provided to elderly people or children by social workers or volunteer carers or professionals other than health professionalsor care for the disabled.
Amendment 51 #
Proposal for a directive
Recital 10
Recital 10
(10) For the purpose of this Directive, the concept of "cross-border healthcare" covers the following modes of supply of healthcare: - Use of healthcare abroad (i.e.: a patient moving toshall mean: - The patient physically visits a healthcare provider in another Member State for treatment)other than that where he has social security affiliation with the intention of seeking health services there; this is what is referred to as 'patient mobility'; - CThe health service itself cross-es border provision of healthcare (i.e.: delivery ofs, virtually or otherwise: the patient does not physically go to another Member State but nonetheless receives health services from the territory of onea Member State into other territory of another); such as telemedicine services, remote diagnosis andhan that where he has social security affiliation, such as telesurgery, a medical consultation, issuing of a prescription, and remote laboratory services; this is what is referred to as 'telemedicine'; - 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); - The purchase of goods connected with health care, such as medical devices and medicines, in a Member State other than that where the purchaser has social security affiliation; this may be, but is not necessarily, accompanied by physical movement of the patient to the latter Member State.
Amendment 58 #
Proposal for a directive
Recital 12
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 types of healthcare. This is necessary 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. These, after all, are values which have been unanimously embraced by the Community institutions and by the health systems of values that are shared by health systems across Europel the Member States. 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),place of establishment and the principle of necessity and proportionality of any restrictions on free movement. However, nothing inThis implies that this Directive by no means requires healthcare providers to accept for planned treatment or to prioritise patients from other Member States to the detriment of oor always to charge them the same price as that which applies to their own patients with similar health needs, such as through increasing wait. Obstacles to freedom of movement may be permitted on compelling public-interest grounds, for example if the inflow of patients undermines or is likely to underminge time for treatmenthe capacity or financial balance of a health system.
Amendment 60 #
Proposal for a directive
Recital 13
Recital 13
(13) Moreover, patients from other Member States should enjoy equal treatment with the nationals of the Member State of treatment and, aAccording to the general principles of equity and non -discrimination, as recognized in Art. 21 of the Charter they, patients from other Member States should in no way be discriminated uponagainst 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.
Amendment 62 #
Proposal for a directive
Recital 5
Recital 5
(5) As confirmed by the Court of Justice on several occasions, while recognizing their specific nature, all typescross-border provision of medical care falls within the scope of the Treaty.
Amendment 64 #
Proposal for a directive
Recital 18
Recital 18
(18) The right to reimbursement of the costs of healthcare provided or goods purchased in connection with health care in another Member State from the statutory social security scheme ofto which patients as insured personsre affiliated 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 and goods includes the freedom for the recipients ofpatients deliberately to receive health care, including persons in need of medical treatment, to go to another Member Sate in order to receive it ther services and deliberately to purchase goods connected with health care in another Member State. The same applies to recipients of healthcare seeking to receive health care provided in another Member State through other means, for example through e-health servicesservices by means of telemedicine from a Member State other than that where they have social security affiliation. 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 and goods. Those provisions prohibit the Member States from introducing or maintaining unjustified restrictions on the exercise of that freedom in the healthcare sector.se freedoms
Amendment 67 #
Proposal for a directive
Recital 21
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 also be able to benefit from the principles of free movement of services and goods in accordance with the Treaty and the provisions of this Directive. Patients should be guaranteed assumption of the costs of that healthcare and those goods at least at the level provided for the same or similar healthcare or goods 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 73 #
Proposal for a directive
Recital 24
Recital 24
(24) The patient should, in any event, not derive a financial advantage from the healthcare provided or goods purchased in another Member State and t. The assumption of costs should be therefore be limited only to the actual costs of healthcare received.
Amendment 74 #
Proposal for a directive
Recital 25
Recital 25
(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 isor 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.
Amendment 76 #
Proposal for a directive
Recital 9
Recital 9
(9) This Directive on the application of patients’ rights in cross-border healthcare applies to all types of cross-border 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 which is not strictly medical. It does not apply, for example, to services which are normally provided at residential homes or housing, or assistance provided to elderly people or children by social workers or volunteer carers or professionals other than health professionalsor care for the disabled.
Amendment 81 #
Proposal for a directive
Recital 10
Recital 10
(10) For the purpose of this Directive, the concept of "cross-border healthcare" covers the following modes of supply of healthcare: - Use of healthcare abroad (i.e.: a patient moving toshall mean: - a situation in which the patient physically visits a healthcare provider in another Member State for treatment)other than that where he has social security affiliation with the intention of seeking health services there; this is what is referred to as 'patient mobility'; - Ca situation in which the health service cross-es border provision of healthcare (i.e.: delivery ofs, virtually or otherwise: the patient does not physically go to another Member State but nonetheless receives health services from the territory of onea Member State into other territory of another); such as telemedicine services, remote diagnosis andhan that where he has social security affiliation, such as telesurgery, a medical consultation, issuing of a prescription, and remote laboratory services; this is what is referred to as 'telemedicine'; - 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). ; and - The purchase of goods connected with health care, such as medical devices and medicines, in a Member State other than that where the purchaser has social security affiliation; this may be, but is not necessarily, accompanied by physical movement of the patient to the latter Member State;
Amendment 91 #
Proposal for a directive
Recital 12
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 types of healthcare. This is necessary 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. These, after all, are values which have been unanimously embraced by the Community institutions and by the health systems of values that are shared by health systems across Europel the Member States. 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),place of establishment and the principle of necessity and proportionality of any restrictions on free movement. However, nothing inThis implies that this Directive by no means requires healthcare providers to accept for planned treatment or to prioritise patients from other Member States to the detriment of oor always to charge them the same price as that which applies to their own patients with similar health needs, such as through increasing waiting time for treatment. Obstacles to freedom of movement may be permitted on compelling public-interest grounds, for example if the inflow of patients undermines or is likely to undermine the capacity or financial balance of a health system.
Amendment 98 #
Proposal for a directive
Recital 13
Recital 13
(13) Moreover, patients from other Member States should enjoy equal treatment with the nationals of the Member State of treatment and, aAccording to the general principles of equity and non discrimination, as recognized in Art.21 of the Charter they, patients from other Member States 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.
Amendment 102 #
Council position
Recital 11
Recital 11
(11) It is clear that the obligation to reimburse costs of cross-border healthcare should be limited to healthcare to which the insured person is entitled according to the legislation of the Member State of affiliation, except where the care relates to rare, life-threatening diseases.
Amendment 104 #
Proposal for a directive
Recital 18
Recital 18
(18) The right to reimbursement of the costs of healthcare provided or goods purchased in connection with health care in another Member State from the statutory social security scheme ofto which patients as insured personsre affiliated 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 and goods includes the freedom for the recipients ofpatients deliberately to receive health care, including persons in need of medical treatment, to go to another Member Sate in order to receive it ther services and deliberately to purchase goods connected with health care in another Member State. The same applies to recipients of healthcare seeking to receive health care provided in another Member State through other means, for example through e-health servicesservices by means of telemedicine from a Member State other than that where they have social security affiliation. 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 and goods. Those provisions prohibit the Member States from introducing or maintaining unjustified restrictions on the exercise of that freedom in the healthcare sectorse freedoms.
Amendment 105 #
Proposal for a directive
Article 1
Article 1
This Directive establishes a general framework for the provision of safe, high quality and efficient cross-border healthcare and is intended to improve the accessibility, quality and efficiency of health systems in the Member States.
Amendment 108 #
Council position
Recital 19
Recital 19
(19) Members States should ensure that all patients are treated equitably on the basis of their healthcare needs rather than on the basis of their Member State of affiliation. In doing so, Member States should respect the principles of free movement of persons within the internal market, non-discrimination, inter alia with regard to nationality and necessity and proportionality of any restrictions on free movement. However, nothing in this Directive should oblige healthcare providers to accept for planned treatment patients from other Member States or to prioritise them to the detriment of other patients, for instance by increasing the waiting time for treatment of other patients. Inflows of patients may create a demand exceeding the capacities existing in a Member State for a given treatment. In such exceptional cases, the Member State should retain the possibility to remedy the situation on the grounds of public health, in accordance with Articles 52 and 62 of the Treaty. However, this limitation should be without prejudice to Member States' obligations under Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems6 . Member States shall ensure that the healthcare providers on their territory apply the same scale of fees for healthcare for patients from other Member States as for domestic patients unless there are urgent public-interest reasons to the contrary.
Amendment 112 #
Proposal for a directive
Recital 21
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 and goods in accordance with the Treaty and the provisions of this Directive. Patients should be guaranteed assumption of the costs of that healthcare and those goods at least at the level provided for the same or similar healthcare or goods 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 116 #
Council position
Recital 31
Recital 31
(31) This Directive does not aim to create an entitlement to reimbursement of the costs of healthcare provided in another Member State, if such healthcare is not among the benefits provided for by the legislation of the Member State of affiliation of the insured person, except in the case of rare, life-threatening diseases. Equally, this Directive should not prevent the Member States from extending their benefits-in-kind scheme to healthcare provided in another Member State. This Directive should recognise that Member States are free to organise their healthcare and social security systems in such a way as to determine entitlement for treatment at a regional or local level.
Amendment 120 #
Proposal for a directive
Recital 24
Recital 24
(24) The patient should, in any event, not derive a financial advantage from the healthcare provided or healthcare-related products purchased in another Member State and tThe assumption of costs should be therefore be limited only to actual costs of healthcare receivto costs actually incurred.
Amendment 123 #
Proposal for a directive
Recital 25
Recital 25
(25) This Directive does not aim either to create entitlement for reimbursement of treatment or purchase of a healthcare- related product in another Member State, if such a treatment or product 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 scheme for benefits- in- kind scheme to healthcareand healthcare products to healthcare or healthcare products provided in another Member State according to its provisions.
Amendment 134 #
Proposal for a directive
Article 3 – paragraph 2
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 into go to another Member State for outpatient care 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.
Amendment 135 #
Proposal for a directive
Article 3 – paragraph 3 – point b a (new)
Article 3 – paragraph 3 – point b a (new)
(ba) Regulation (EEC) No 1408/71
Amendment 146 #
Proposal for a directive
Article 4 – point b
Article 4 – point b
(b) "cross-border healthcare" means healthcare provided in or from 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 establishedhas social security affiliation in accordance with the coordination rules laid down in Regulation (EEC) no 1408/71;
Amendment 153 #
Council position
Article 4 – paragraph 4 – subparagraph 1
Article 4 – paragraph 4 – subparagraph 1
Member States shall ensure that the healthcare providers on their territory apply the same scale of fees for healthcare for patients from other Member States, as for domestic patients in a comparable situation, or that they charge a price calculated accord. If, however, no comparable situation exists or there is no comparable price for domestic patients it may be necessary and proportionate ing to objective, non discriminatory criteria if there is no comparable price for domestic patientshe light of urgent public-interest grounds to apply a different price. Member States may decide to do so on condition that the scale of fees is calculated according to objective, non-discriminatory criteria.
Amendment 154 #
Proposal for a directive
Article 4 - point h
Article 4 - point h
(h) ‘Member State of affiliation’ means the Member State where the patient is an insured personhas social security affiliation in accordance with the coordination rules laid down in Regulation (EEC) No 1408/71;
Amendment 156 #
Proposal for a directive
Article 4 - point i
Article 4 - point i
(i) ‘Member State of treatment’ means the Member State on or from whose territory cross- border healthcare is actually provided;
Amendment 157 #
Proposal for a directive
Article 4 – point i a (new)
Article 4 – point i a (new)
(ia) ‘medical device’ means a medical device as defined by Directive 93/42/EEC or Directive 90/385/EEC or Directive 98/7/EC;
Amendment 158 #
Proposal for a directive
Article 4 – point i b (new)
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 160 #
Proposal for a directive
Article 4 – point l
Article 4 – point l
(l) ‘harm’ means adverse outcomes or injuries stemming from the provision of healthcare, as defined in the national law of the Member States.
Amendment 166 #
Council position
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Subject to the provisions of Articles 8 and 9, the Member State of affiliation shall ensure the costs incurred by an insured person who receives cross-border healthcare are reimbursed, if the healthcare in question is among the benefits to which the insured person is entitled in the Member State of affiliation. Without prejudice to 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 with rare, life-threatening diseases, the treatment for which has been validated by international medical science, should have the right to access healthcare in another Member State and to receive reimbursement.
Amendment 168 #
Proposal for a directive
Article 5 – paragraph 1
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 caregeographical and financial access to good quality care, efficiency and effectiveness, continuity, equity and solidarity, they shall define clear quality and safety standards for healthcare provided on their territory, and ensure that:
Amendment 176 #
Proposal for a directive
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) mechanisms are in place for ensuring that healthcare providers are able to meet such standards, taking into accounthealth care is genuinely provided in accordance with the quality and safety standards referred to in paragraph 1; in doing so, account shall be taken of international medical science and generally recognised good medical practices;
Amendment 178 #
Council position
Article 8 – paragraph 2 – point c
Article 8 – paragraph 2 – point c
(c) involves treatments presenting a particular risk for the patient or the population or which could raise serious and specific concerns relating to the quality or safety of the care with the exception of healthcare which is subject to Union legislation ensuring a minimum level of safety and quality throughout the Union.
Amendment 186 #
Proposal for a directive
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) patients have a means of making complaints and are guaranteed remedies and compensation whenso that they can receive compensation for any harm which they suffer harm arising from the healthcare they receive;
Amendment 189 #
Council position
Article 8 – paragraph 6 a (new)
Article 8 – paragraph 6 a (new)
6a. Patients with rare, life-threatening diseases shall not require prior authorisation for reimbursement of the cost of a treatment for the disease at least up to the level applied by the Member State where the treatment is provided.
Amendment 191 #
Proposal for a directive
Article 5 – paragraph 1 – point f
Article 5 – paragraph 1 – point f
(f) there is a right to continuity of care by means of the forwarding of relevant medical data concerning the patient. In this context the fundamental right to privacy with respect to the processing of personal data ismust be 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;
Amendment 193 #
Proposal for a directive
Article 5 – paragraph 1 – point g
Article 5 – paragraph 1 – point g
(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. Equal treatment shall not prevent Member States from assigning priority to patients from their own Member State if this proves necessary in order to ensure that the impact of cross-border care on waiting times remains reasonable and manageable. Equal treatment shall not prevent Member States from setting a different price for cross-border care if this is necessary in order to take account of the cost of developing care provision and care infrastructure.
Amendment 194 #
Proposal for a directive
Article 5 – paragraph 1 – point g a (new)
Article 5 – paragraph 1 – point g a (new)
(ga) the right to written or electronic medical records, with a view to continuity of care, must be safeguarded;
Amendment 198 #
Proposal for a directive
Article 1
Article 1
This Directive establishes a general framework for the provision of safe, high quality and efficient cross-border healthcarecross-border healthcare and is intended to improve the accessibility, quality and efficiency of health systems in the Member States.
Amendment 213 #
Proposal for a directive – amending act
Article 6 – title
Article 6 – title
Healthcare provided in or from another Member State
Amendment 214 #
Proposal for a directive – amending act
Article 6 – paragraph 1
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 pfrovided inm another Member State, will not bethout physically visiting that Member State or seeking to purchase goods connected with health care there are not prevented from receiving this healthcare provided in another Member Stateor these goods where the treatment or goods in question isare 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 or the same or similar goods been purchased in its territory. This Directive shall not prevent Member States from adopting more favourable rules, for example that the costs of treatment shall be reimbursed at the (higher) rate which applies in the Member State where the treatment has been provided or the goods purchased. This may in particular be the case for treatments which can be provided through the European reference networks referred to in Article 15 of this Directive. In any event, it is for the Member State of affiliation to determine thewhat health care that isservices and goods are paid for regardless of where it is providthey are provided or purchased.
Amendment 222 #
Proposal for a directive – amending act
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The costs of healthcare provided in another Member State shall, to the extent that they are among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled, 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.
Amendment 233 #
Proposal for a directive
Article 3 - paragraph 2
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 into go to another Member State for outpatient care 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.
Amendment 237 #
Proposal for a directive – amending act
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Member State of affiliation may impose on a patient seeking healthcare providedservices or goods connected with health care 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 or the same goods were purchased in its territory, in so far as they are neither discriminatory nor an obstacle to freedom of movement of personto provide goods and services.
Amendment 240 #
Proposal for a directive
Article 3 - paragraph 3 - point (b a) (new)
Article 3 - paragraph 3 - point (b a) (new)
(ba) Regulation (EEC) No 1408/71;
Amendment 241 #
Proposal for a directive – amending act
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4a. The Member State where the treatment is provided shall operate a system which makes it possible to charge the actual cost of treatment to patients who are not affiliated to the social security scheme of that Member State.
Amendment 245 #
Proposal for a directive – amending act
Article 7
Article 7
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 health care 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 251 #
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, hospital care shall mean: (a) healthcare which requires overnight accommodation of the patient in question for at least one night. (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: - healthcare that requires use ofInpatient care and care equated with it shall be covered by the provisions of Regulation (EEC) No 1408/71, and the provisions of Article 6 shall not apply to them. Member States shall define ‘inpatient care’ for the purposes of this Directive. Member States shall draw up a list of treatments for which highly specialised and cost-intexpensive medical infrastructure or medical equipment; or - healthcare involving treatments presenting is required or treatments which entail a particular risk forto the patient or to the populationublic and which are therefore equated with inpatient care.
Amendment 259 #
Proposal for a directive
Article 4 - point (b)
Article 4 - point (b)
(b) "cross-border healthcare" means healthcare provided in or from 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 establishedhas social security affiliation in accordance with the coordination rules laid down in Regulation (EEC) no 1408/71;
Amendment 260 #
Amendment 268 #
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
Amendment 280 #
Proposal for a directive
Article 4 - point (h)
Article 4 - point (h)
(h) "Member State of affiliation" means the Member State where the patient is an insured personhas social security affiliation in accordance with the coordination rules laid down in Regulation (EEC) no 1408/71;
Amendment 284 #
Proposal for a directive
Article 4 - point (i)
Article 4 - point (i)
(i) "Member State of treatment" means the Member State on or from whose territory cross- border healthcare is actually provided;
Amendment 285 #
Proposal for a directive
Article 4 - point (i a) (new)
Article 4 - point (i a) (new)
(ia) “medical device” means a medical device as defined in Directive 93/42/EEC or Directive 90/385/EEC or Directive 98/79/EC.
Amendment 286 #
Proposal for a directive
Article 4 - point (i b) (new)
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 288 #
Proposal for a directive
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The prior authorisation system as referred to in paragraph 1 shall be limited to what is necessary and proportionate to avoid such impact, and shall not constitute a means of arbitrary discrimination.
Amendment 292 #
Proposal for a directive
Article 8 – paragraph 5
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 31.
Amendment 299 #
Proposal for a directive
Article 4 - point (l)
Article 4 - point (l)
(l) "harm" means adverse outcomes or injuries stemming from the provision of healthcare, as defined in the national law of the Member States.
Amendment 315 #
Proposal for a directive
Article 5 – paragraph 1 – introduction
Article 5 – paragraph 1 – introduction
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 caregeographical and financial access to good quality care, efficiency and effectiveness, continuity, equity and solidarity, they shall define clear quality and safety standards for healthcare provided on their territory, and ensure that:
Amendment 322 #
Proposal for a directive
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) mechanisms are in place for ensuring that healthcare providers are able to meet such standards, taking into accounthealth care is genuinely provided in accordance with the quality and safety standards referred to in paragraph 1; in doing so, account shall be taken of international medical science and generally recognised good medical practices;
Amendment 339 #
Proposal for a directive
Article 12 – paragraph 2 – point (a)
Article 12 – paragraph 2 – point (a)
(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, the public or private status of the care provider, the reimbursement procedure and rates, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and conditions applicable;
Amendment 348 #
Proposal for a directive
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) patients have a means of making complaints and are guaranteed remedies and compensation whenso that they can receive compensation for any harm which they suffer harm arising from the healthcare they receive;
Amendment 351 #
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. Member States shall ensure that registers of health care providers can be consulted in the same way by the equivalent competent authorities in other Member States as by the competent authorities in their territory.
Amendment 352 #
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. The Commission shall organise a system for exchanging information on ethical and criminal proceedings against healthcare providers.
Amendment 353 #
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. Member States shall inform the Commission of any failure by other Member States to meet their obligations regarding mutual assistance. If necessary the Commission shall take suitable measures to remedy matters.
Amendment 354 #
Proposal for a directive
Article 5 – paragraph 1 – point f
Article 5 – paragraph 1 – point f
(f) there is a right to continuity of care by means of the forwarding of relevant medical data concerning the patient. In this context the fundamental right to privacy with respect to the processing of personal data ismust be 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;
Amendment 356 #
Proposal for a directive
Article 5 – paragraph 1 – point g
Article 5 – paragraph 1 – point g
(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. Equal treatment shall not prevent Member States from assigning priority to patients from their own Member State if this proves necessary in order to ensure that the impact of cross-border care on waiting times remains reasonable and manageable. Equal treatment shall not prevent Member States from setting a different price for cross-border care if this is necessary in order to take account of the cost of developing care provision and care infrastructure.
Amendment 360 #
Proposal for a directive
Article 5 – paragraph 1 – point g a (new)
Article 5 – paragraph 1 – point g a (new)
(ga) the right to written or electronic medical records, with a view to continuity of care, must be safeguarded;
Amendment 380 #
Proposal for a directive
Article 15 – paragraph 3 – point b a (new)
Article 15 – paragraph 3 – point b a (new)
(ba) measures to ensure the financial affordability and geographical accessibility of European reference networks.
Amendment 383 #
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
Healthcare provided in or from another Member State 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 pfrovided inm another Member State, will not bethout physically visiting that Member State or seeking to purchase goods connected with health care there are not prevented from receiving this healthcare provided in another Member Stateor these goods where the treatment or goods in question isare 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 or the same or similar goods been purchased in its territory. This Directive shall not prevent Member States from adopting more favourable rules, for example that the costs of treatment shall be reimbursed at the (higher) rate which applies in the Member State where the treatment has been provided or the goods purchased. This may in particular be the case for treatments which can be provided through the European reference networks referred to in Article 15 of this Directive. In any event, it is for the Member State of affiliation to determine thewhat health care that isservices and goods are paid for regardless of where it is providthey are provided or purchased.
Amendment 397 #
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The costs of healthcare provided in another Member State shall, to the extent that they are among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled, 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.
Amendment 399 #
Proposal for a directive
Article 20
Article 20
20. 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. To that end and without prejudice to Article 22, the Member States shall communicate to the Commission any measure they have introduced, modified or maintained with a view to implement the procedures laid down in Articles 8 and 9are applying to implement the Directive.
Amendment 409 #
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Member State of affiliation may impose on a patient seeking healthcare providedservices or goods connected with health care 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 or the same goods were purchased in its territory, in so far as they are neither discriminatory nor an obstacle to freedom of movement of personto provide goods and services.
Amendment 424 #
Proposal for a directive
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4a. The Member State where the treatment is provided shall operate a system which makes it possible to charge the actual cost of treatment to patients who are not affiliated to the social security scheme of that Member State.
Amendment 436 #
Proposal for a directive
Article 7
Article 7
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 health care 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 444 #
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, hospital care shall mean: (a) healthcare which requires overnight accommodation of the patient in question for at least one night. (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: - healthcare that requires use ofInpatient care and care equated with it shall be covered by the provisions of Regulation (EEC) No 1408/71, and the provisions of Article 6 shall not apply to them. Member States shall define 'inpatient care' for the purposes of this Directive. Member States shall draw up a list of treatments for which highly specialised and cost-intexpensive medical infrastructure or medical equipment; or - healthcare involving treatments presenting is required or treatments which entail a particular risk forto the patient or to the populationublic and which are therefore equated with inpatient care.
Amendment 458 #
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 469 #
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
Amendment 488 #
Proposal for a directive
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The prior authorisation system referred to in paragraph 1 shall be limited to what is necessary and proportionate to avoid such impact, and shall not constitute a means of arbitrary discrimination.
Amendment 496 #
Proposal for a directive
Article 8 – paragraph 5
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 31.
Amendment 574 #
Proposal for a directive
Article 12 – paragraph 2 – point a
Article 12 – paragraph 2 – point a
(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, the public or private status of healthcare providers, repayment procedures and rates, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and conditions applicable;
Amendment 606 #
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. Member States shall ensure that registers of healthcare providers may be consulted by the relevant authorities of other Member States in the same way as by the equivalent authorities situated in their own territory.
Amendment 607 #
Proposal for a directive
Article 13 – paragraph 2 b (new)
Article 13 – paragraph 2 b (new)
2b. The Commission shall organise a system for exchanges of information concerning ethical and criminal proceedings against healthcare providers.
Amendment 608 #
Proposal for a directive
Article 13 – paragraph 2 c (new)
Article 13 – paragraph 2 c (new)
2c. Member States shall inform the Commission of any failure by other Member States to meet their obligations regarding mutual assistance. If necessary the Commission shall take suitable necessary measures to remedy matters.
Amendment 668 #
Proposal for a directive
Article 15 - paragraph 3 - point b a (new)
Article 15 - paragraph 3 - point b a (new)
(ba) measures to ensure the financial affordability and geographical accessibility of European reference networks.
Amendment 705 #
Proposal for a directive
Article 20 – paragraph 2
Article 20 – paragraph 2
To that end and without prejudice to Article 22, the Member States shall communicate to the Commission any measure they have introduced, modified or mainare takinedg with a view to implement the procedures laid down in Articles 8 and 9. directive.