35 Amendments of Margrete AUKEN related to 2008/0142(COD)
Amendment 42 #
Proposal for a directive
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The European Parliament rejects the Commission proposal.
Amendment 51 #
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty establishing the European Community, and in particular Article 95 and Article 152 thereof,
Amendment 67 #
Proposal for a directive
Recital 8
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, whilslay down rules for the reimbursement of the costs of healthcare received in another Member State for patients who choose to go to another Member State with the purpose of receiving healthcare there and to enable cooperation between Member States in relation to health technology assessment, centres of reference and e-health, whilst fully respecting national competence to organise and deliver healthcare, in accordance with the principles of universal access, solidarity, affordability, equal territorial accessibility and democratic control. It fully respectings the responsibilities of the Member States forin the field of healthcare in accordance with the Treaty including 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.
Amendment 78 #
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 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)use of healthcare in a Member State other than the Member State of residence by patients who choose to travel to another Member State for the purpose of receiving healthcare there.
Amendment 86 #
Proposal for a directive
Recital 11
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. In view of these common values it is nevertheless 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. It does not impose on Member States to make treatments and services accessible their territory or to reimburse costs for those treatments (received in another Member State) which are not allowed under national laws, regulations and codes of conduct of the medical professions.
Amendment 114 #
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 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. At the same time any significant effect on the financing of the national healthcare systems has to be prevented. 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 131 #
Proposal for a directive
Recital 26
Recital 26
(26) This Directive does not provide either for transfer of social security entitlements between Member States or other coordination of social security schemes. The sole objective of the provisions regarding prior authorisation and reimbursement of healthcare provided in another Member State is to enable freedom to provide healthcare for both patients and healthcare providers and to remove unjustified obstacles to that fundamental freedom within the patient's Member State of affiliation. Consequently the Directive fully respects the differences of national health-care systems and the Member States' responsibilities for organisation and delivery of health services and medical care.
Amendment 148 #
Proposal for a directive
Recital 31
Recital 31
(31) The evidence available indicates that the application of free movement principles regarding use of healthcare in another Member State within the limits of the cover guaranteed by the statutory sickness insurance scheme of the Member State of affiliation will not undermine the health systems of the Member States or financial sustainability of their social security systems. However, the Court of Justice has recognised that it cannot be excluded that thethere is a possible risk of seriously undermining a social security system's financial balance or the objective of maintaining a balanced medical and hospital service open to all may constitute overriding reasons in the general interest capable of justifying a barrier to the principle of freedom to provide services. The Court of Justice has also recognised that the number of hospitals, their geographical distribution, the way in which they are organised and the facilities with which they are provided, and even the nature of the medical services which they are able to offer, are all matters for which planning must be possible. This Directive should provide for a system of prior authorisation for assumption of costs for hospital care received in another Member State, where the following conditions are met : had the treatment been provided on its territory, it would have been assumed by its social security system and the consequent outflow of patients due to the implementation of the directive seriously undermines or is likely to seriously undermine the financial balance of the social security system and/or this outflow of patients seriously undermines, or is likely to seriously undermine 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. As the assessment of the precise impact of an expected outflow of patients requires complex assumptions and calculations, the Directive allows for a system of prior authorisation if there is sufficient reason to expect that the social security system will be seriously undermined. This should also cover cases of already existing systems of prior authorisation which are in conformity with conditions laid down in Article 8.
Amendment 183 #
Proposal for a directive
Recital 45
Recital 45
(45) In particular, power should be conferred on the Commissionit shall be for the Member States’ competent authorities 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.
Amendment 191 #
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 healthcareprovides rules for reimbursement of the costs of healthcare received in another Member State for patients who choose to go to another Member State with the purpose of receiving healthcare there and enables cooperation between Member States in relation to health technology assessment, centres of reference and e-health, in full respect of national competence in organising and delivering healthcare, in accordance with the principles of universal access, solidarity, affordability, equal territorial accessibility and democratic control.
Amendment 219 #
Proposal for a directive
Article 2 - subparagraph 1 a (new)
Article 2 - subparagraph 1 a (new)
In order to guarantee a high level of public health as required by Article 152 of the Treaty, Member States should give precedence to the principles referred to in Article 1, in the event that the provisions of this Directive conflict with those principles.
Amendment 232 #
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) No1408/71 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 healthcareThis 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. Neither does this Directive affect patients’ rights to be granted an authorisation for a treatment in another Member State in owhere ther circumstances, Articles 6, 7, 8 and 9 of this Directive apply andonditions provided for by the regulations on coordination of social security schemes, in particular Article 22 of Council Regulation (EC) No 1408/71 shall not apply. However, whenever the conditions for granting an authorisation set out inof the Council of 14 June 1971 on the application of social security schemes to employed persons and their families moving within the Community and Article 22(2)0 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 of883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems are met. If this Directive covers situations that are also covered by Regulation (EC) No 1408/71 and Regulation (EC) No 883/2004, those regulations apply and this Directive shalldoes not apply.
Amendment 245 #
Proposal for a directive
Article 4 - point (a)
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 organized, delivered and financed at national level or whether it is public or privateto patients to assess, maintain or restore their state of health. For the purpose of Articles 6, 7, 8, 9, 10 and 11 healthcare means treatments that are among the healthcare benefits provided for by the legislation of the Member State of affiliation;
Amendment 263 #
Proposal for a directive
Article 4 - point (d)
Article 4 - point (d)
Amendment 269 #
Proposal for a directive
Article 4 - point (f)
Article 4 - point (f)
(f) for the purpose of this Directive "patient" means any natural person who receives or wishes tointends to travel to another Member State with the purpose of receiveing healthcare in a Member Statthere;
Amendment 294 #
Proposal for a directive
Article 4 - point (l)
Article 4 - point (l)
Amendment 311 #
Proposal for a directive
Article 5 – paragraph 1 – introduction
Article 5 – paragraph 1 – introduction
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, theysafe, high-quality healthcare in accordance with the principles of universal access, solidarity, affordability, equal territorial accessibility and democratic control. The Member States of treatment shall also be responsible for the means of making complaints and for remedies in the case of harm. In the case of harm arising from healthcare received in a cross-border healthcare setting, the system of making complains and the system of compensation of the Member State of treatment shall apply. The Member States of treatment shall define clear quality and safety standards for healthcare provided on their territory, and ensure that:
Amendment 345 #
Proposal for a directive
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) patients have a means of making complaints to an independent body and are guaranteed remedies free of charge and compensation when they suffer harm arising from the healthcare they receive;
Amendment 370 #
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 408 #
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 provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities for receiving healthcare and reimbursement of healthcare costs thereof 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 personsobjective, non-discriminatory and known in advance. Those conditions may include limitations, already in place in some Member States, on treatment with non-contracted providers or providers outside their own region, as long as the treatment needed can be given within a medically acceptable time by contracted providers or providers in their own region.
Amendment 432 #
Proposal for a directive
Article 6 – paragraph 5 a (new)
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 453 #
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 meanand specialised care shall include at least: (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 that requires use of highly specialised and cost-intensive medical infrastructure or medical equipment; or healthcare involving treatments presenting a particular risk for the patient for at least one night. This list shall be limited to: - healthcare that requires use of highly specialised and cost-intensive medical infrastructure or medical equipment; or - healthcare involving trethe population. (ba) healthcare for which planning is necessary in order to maintain universal access, affordability and equal territorial accessibility, to control costs and to prevent any significant wastage of financial, technical and human resources. (bb) healthcare for patmients presenting a particular risk for the patient or the populationsuffering from chronic illnesses who require care and/or medicines which are not supplied through common distribution channels and cannot be self-administered, so that they require administration or supply by hospital units or specialised units.
Amendment 463 #
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
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 scrue competent authorities of the Member State of affiliation shall set up a list of treatments considered as hospital or specialised care and notinfy referred to in Article 19(3)it to the Commission.
Amendment 477 #
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
3. The Member State of affiliation may provide for a system ofrequire prior authorisation for reimbursement by its social security system of the cost of hospital and specialised 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 ther 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: (i): (a) to protect the financial balance of the Member State's social security system; and/or (ii)b) to protect 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 Stateealthcare sector in order to maintain universal access, affordability and equal territorial accessibility, to control costs and to prevent any significant wastage of financial, technical and human resources.
Amendment 481 #
Proposal for a directive
Article 8 – paragraph 3 a (new)
Article 8 – paragraph 3 a (new)
3a. Prior authorisation shall in any event be granted when the patient is in need of medical treatment normally provided for by the social security system of the Member State of affiliation and the treatment cannot be provided in the Member State of affiliation, within a time medically justifiable, as established by Regulation 1408/71 and Regulation 883/2004.
Amendment 482 #
Proposal for a directive
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The requirement of prior authorisation system shall be limited to what is necessary and proportionate to avoid such impactenable the Member State of affiliation to organise and deliver safe high quality healthcare within its territory in accordance with the principles of universal access, solidarity, affordability, equal territorial accessibility and democratic control, and shall not constitute a means of arbitrary discrimination.
Amendment 503 #
Proposal for a directive
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5a. The Member State of treatment may take appropriate measures to address the inflow of patients and to prevent it from undermining, or being likely to undermine, 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 Member State concerned. The Member State of treatment shall refrain from discriminating on the basis of nationality and shall ensure that the measures restricting free movement shall be limited to what is necessary and proportionate. The Member State of treatment shall notify the measures to the Commission.
Amendment 539 #
Proposal for a directive
Article 9 – paragraph 4 a (new)
Article 9 – paragraph 4 a (new)
Amendment 547 #
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
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. In information about cross-border care, a clear distinction shall be made between the rights which patients have by virtue of this Directive and rights arising from resgult of healthcare received in another Member Stateations on the coordination of social security schemes as referred to in Article 3(1)(f).
Amendment 564 #
Proposal for a directive
Article 12 – paragraph 2
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: (a) provide and disseminatmake available 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 particulardefine and share transparent and relevant information with other competent healthcare regulatory bodies with regard to the mobility of health professionals; this 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; (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 healthcaron shall include information that covers sanctions and undertakings arising from criminal behaviour, professional misconduct and sanctions imposed as a result of impaired fitness to practice;
Amendment 665 #
Article 15 - paragraph 3 - point a - subpoint ix a (new)
(ixa) are primarily engaged with treatments of very rare diseases or conditions that are so cost intensive, or require a level of specialisation that is so high, as to make it impossible to provide the care needed in each Member State;
Amendment 669 #
Article 15 - paragraph 3 a (new)
3a. Reference through networks of reference, for treatment in another Member State, should take place where treatment of very rare diseases or conditions is so cost intensive, or requires a level of specialisation that is so high, as to make it impossible to provide the care needed in the individual Member State and thus complement healthcare provision within that state.
Amendment 670 #
Article 15 - paragraph 3 b (new)
3b. For all treatments that do not fulfil the criteria defined in paragraph 3a, Member States have the responsibility to provide treatment as close to home as possible and to guarantee equal territorial accessibility.
Amendment 671 #
Article 15 - paragraph 3 c (new)
Amendment 699 #
Proposal for a directive
Article 18 – paragraph 3 – subparagraph 1 a (new)
Article 18 – paragraph 3 – subparagraph 1 a (new)
The collection of data within the framework of this Article shall be carried out in close cooperation with the collection of data provided for by the Administrative Commission on Social Security for Migrant Workers.