38 Amendments of Anja WEISGERBER related to 2008/0142(COD)
Amendment 41 #
Proposal for a directive
Recital 3
Recital 3
(3) This Directive respects the fundamental rights and observes the general principles of law as recognised in particular by the Charter of Fundamental Rights of the European Union. The right of access to healthcare and the right to benefit from medical treatment under conditions established by national law and practices are recognised by Article 35 of the Charter of Fundamental Rights of the European Union.. Specifically, this Directive has to be implemented and applied with due respect for the rights to private and family life, protection of personal data, equality before the law and the principle of non- discrimination, the fundamental ethical choices of Member States and the right to an effective remedy and to a fair trial, in accordance with the general principles of law, as enshrined in Articles 7, 8, 20, 21, 47 of the Charter.
Amendment 44 #
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
(5a) This Directive respects and does not prejudice the freedom of each Member State to decide what type of health care it considers appropriate. No provision of this Directive shall be interpreted in a way as to undermine the fundamental ethical choices of Member States, in particular as regards the protection of the right to life of every human being.
Amendment 56 #
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 the 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 according to national laws, regulations and codes of conduct of the medical professions.
Amendment 60 #
Proposal for a directive
Recital 3
Recital 3
(3) This Directive respects the fundamental rights and observes the general principles of law as recognised in particular by the Charter of Fundamental Rights of the European Union. The right of access to healthcare and the right to benefit from medical treatment under conditions established by national law and practices are recognised by Article 35 of the Charter of Fundamental Rights of the European Union. Specifically, this Directive has to be implemented and applied with due respect for the rights to private and family life, protection of personal data, equality before the law and the principle of non- discrimination, the fundamental ethical choices of Member States and the right to an effective remedy and to a fair trial, in accordance with the general principles of law, as enshrined in Articles 7, 8, 20, 21, 47 of the Charter.
Amendment 65 #
Proposal for a directive
Recital 5 a (new)
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, in particular as regards the protection of the right to life of every human being.
Amendment 87 #
Proposal for a directive
Recital 30
Recital 30
(30) There is no definition of what constitutes hospital care throughout the different health systems of the Community, and different interpretations could. It is the refore 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 caresponsibility of the Member States to adopt these definitions. 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 procedureThe definition can also apply to healthcare treatment that, under the concepts of provision in the Member State of insurance, provides for a planned infrastructure on other grounds.
Amendment 87 #
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 89 #
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 the 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 8The Member States may provide for a system of prior authorisation for hospital and specialised care and decide on the care sectors in which they consider it necessary to plan needs.
Amendment 95 #
Proposal for a directive
Recital 36
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 contact point should not provide legal advice in individual cases. 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. Consequently, the contact points may be based within the competent professional organisations entrusted with this task by the Member States, as well as in the administrative authorities.
Amendment 102 #
Proposal for a directive
Recital 45
Recital 45
Amendment 140 #
Council position
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) "healthcare" means health services provided to patients by health professionals to patients to assess, maintain or restore theibelonging to the regulated health professions if these activities are performed in a Member sState of health, including the prescription, dispensation and provision of medicinal products and medical deviceswhere the services are provided by members of a regulated health profession under the appropriate professional title;
Amendment 141 #
Proposal for a directive
Recital 30
Recital 30
(30) There is no definition of what constitutes hospital care throughout the different health systems of the Community, and different interpretations could. It is the refore 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 caresponsibility of the Member States to adopt these definitions. 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 procedureThe definition can also apply to the same healthcare treatment that, under the concepts of provision in the Member State of insurance, provides for a planned infrastructure on other grounds.
Amendment 147 #
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 the 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 8The Member States may provide for a system of prior authorisation for hospital and specialised care and decide on the care sectors in which they consider it necessary to plan needs.
Amendment 174 #
Proposal for a directive
Recital 40
Recital 40
(40) European reference networks should provide healthcare to all patients who have conditions requiring a particular concentration of resources or expertise, in order to provide affordable, high quality and cost-effective care and could also be focal points for medical training and research, information dissemination and evaluation. The mechanism for identification and development of the European refMember States shall facilitate the development of the European reference networks of healthcare providers in the form of voluntary groupings with the aim of exchanging scientific experience networks should be established with the aim to organise at European level equal access to high level shared expertise in a given medical fieldin order to improve healthcare possibilities for all patients as well as for health professionalswith rarer illnesses, based on the open coordination method.
Amendment 181 #
Proposal for a directive
Recital 45
Recital 45
Amendment 234 #
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 provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities including codes of conduct of the medical professions 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 not neither discriminatory nor an obstacle to freedom of movement of persons.
Amendment 254 #
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) healthealthcare which, in accordance with the rules of the Member State of affiliation concerned, is the subject of appropriate care and needs planning to ensure efficient, economic and universal medical care, included in a specific list, that does not that State, shall be deemed to be hospital and specialised care. In addition to healthcare which requires overnight accommodation of the patient in question for at least one night. This list shall be limited to: – healthcare that requires or the use of highly specialised and cost-intensive medical infrastructure or medical equipment; or – healthcarewhich involvinges treatments presenting a particular risk for the patient or the population, such care may also include healthcare which, in accordance with the care approach of the Member State of affiliation concerned, requires a planned infrastructure for other reasons.
Amendment 262 #
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 269 #
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
3. The Member State of affiliation may provide for a system ofset prior authorisation as a condition 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 (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) 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 concernedof the cost of hospital or specialised care, as defined by itself pursuant to paragraph 1, which is provided in another Member State.
Amendment 281 #
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 person; if the institution of the place of residence is the competent institution pursuant to the second subparagraph of Article 22(3) of Regulation (EEC) No 1408/71 or Article 20(4) or Article 27(5) of Regulation (EEC) No 883/2004, the State of residence shall be deemed to be the Member State of affiliation;
Amendment 305 #
Proposal for a directive
Article 5
Article 5
Amendment 387 #
Proposal for a directive
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 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 for treatment carried out generally and lege artis in the Member State of treatment on the basis of the given diagnosis at the level thadt the same or similar healthcare been provided in its territorycosts would have been reimbursed to the insured person for treatment carried out generally and lege artis in his Member State of affiliation. 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.
Amendment 413 #
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 including codes of conduct of the medical professions 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 neitherot discriminatory nor an obstacle to freedom of movement of persons.
Amendment 447 #
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) healthealthcare which, in accordance with the rules of the Member State of affiliation concerned, is the subject of appropriate care and needs planning to ensure efficient, economic and universal medical care, included in a specific list, that does not that State, shall be deemed to be hospital and specialised care. In addition to healthcare which requires overnight accommodation of the patient in question for at least one night. This list shall be limited to: - healthcare that requires or the use of highly specialised and cost-intensive medical infrastructure or medical equipment; or - healthcarewhich involvinges treatments presenting a particular risk for the patient or the population, such care may also include healthcare which, in accordance with the care approach of the Member State of affiliation concerned, requires a planned infrastructure for other reasons.
Amendment 470 #
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
3. The Member State of affiliation may provide for a system ofset prior authorisation as a condition 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 (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) 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 concernedof the cost of hospital or specialised care, as defined by itself pursuant to paragraph 1, which is provided in another Member State.
Amendment 572 #
Proposal for a directive
Article 12 – paragraph 2 – point a
Article 12 – paragraph 2 – point a
(a) provide and disseminate objective information of a general nature to patients in particular on their rights related to cross- border healthcare, and the guarantees ofinformation about 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. No recommendations concerning the service providers (rankings) should be supplied;
Amendment 615 #
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. If a medicinal product is authorised to be marketed on theirits territory in accordance with Article 6(1) of Directive 2001/83/EC, a Member States shall ensure that prescriptions for this medicinal product issued by an authorised person in another Member State for a named patient can after recognition by a doctor be used in theirits 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 (b) are based on legitimate and justified doubts about the authenticity or content of an individual prescription or about the authority of the prescriber. Costs will be reimbursed according to the conditions applying in the Member State of affiliation.
Amendment 620 #
Proposal for a directive
Article 14 – paragraph 1 – subparagraph 1 a (new)
Article 14 – paragraph 1 – subparagraph 1 a (new)
The recognition of such a prescription shall not affect the application of the following national regulations: (i) rules governing the dispensing of medicinal products, including generic substitution, (ii) rules relating to pricing and reimbursement, (iii) professional or ethical rules which would require the pharmacist to refuse to dispense had the prescription been issued in his own Member State.
Amendment 633 #
Proposal for a directive
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(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; prescriptions issued in accordance with this EU template shall be written in International Nonproprietary Names (INN).
Amendment 635 #
Proposal for a directive
Article 14 – paragraph 2 – point ba (new)
Article 14 – paragraph 2 – point ba (new)
(ba) measures to facilitate the establishment of contacts between the prescriber and the dispenser, so as to clarify any doubts concerning the prescription.
Amendment 639 #
Proposal for a directive
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c
Amendment 646 #
Proposal for a directive
Article 15 - paragraph 1
Article 15 - paragraph 1
1. Reference networks are voluntary associations for the exchange of scientific experience with the aim of improving the possibilities for healthcare provision for patients with rare diseases and are based on the open coordination method. Reference networks present an opportunity to demonstrate Europe's excellence in medical research and treatment. 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.
Amendment 651 #
Proposal for a directive
Article 15 - paragraph 2
Article 15 - paragraph 2
Amendment 656 #
Proposal for a directive
Article 15 - paragraph 3
Article 15 - paragraph 3
Amendment 672 #
Proposal for a directive
Article 15 - paragraph 4
Article 15 - paragraph 4
Amendment 691 #
Proposal for a directive
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
1a. The network shall act on the basis of an operational framework based on the principles of good governance. These principles include inter alia transparency of procedures, a formal right of appeal, objectiveness, impartiality and the full involvement of all relevant stakeholders.
Amendment 696 #
Proposal for a directive
Article 17 – paragraph 4
Article 17 – paragraph 4
4. The Commission shall, in accordance with the procedure referred to in Article 19(23), 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.
Amendment 698 #
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. Member States shall transmit the data referred to in paragraph 1 to the Commission for statistical purposes at least annually, except for data that are already collected pursuant to Directive 2005/36/EC.