Activities of Zuzana ROITHOVÁ related to 2008/0142(COD)
Plenary speeches (2)
Patients' rights in cross-border healthcare (debate)
Patients’ rights in cross-border healthcare (debate)
Amendments (25)
Amendment 42 #
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 45 #
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 55 #
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 82 #
Proposal for a directive
Recital 27
Recital 27
(27) This Directive provides also for the right for a patient to receive any medicinal product or medical device authorised for marketing in the Member State where healthcare is provided, even if the medicinal product or medical device is not authorised for marketing in the Member State of affiliation, as it is an indispensable part of obtaining effective treatment in another Member State.
Amendment 85 #
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 therefore constitute an obstacle to the freedom for patients to receive healthcare. In order to overcome that obstacle, it is necessary to provide a Community definition of hospital care. Hospital care generally means care requiring the overnight accommodation of the patient. However, it may be appropriate to submit to the same regime of hospital care also certainy other kinds of healthcare, if that healthcare requires use of highly specialised andighly cost-intensive healthcare (usually highly specialised). It makes sense for Member Sates to set a financial limit for such highly cost- intensive medical infrastructure or medical equipment (e.g. high-technology scanners used for diagnosis) or involving treatments presenting ahealthcare. Establishing a uniform list and definitions for specialised healthcare is not possible in practical terms in the light of progress in medical science and a non-uniform list may also be an unreliable guideline for patients, who must take care to identify when they have the right to receive cross-border healthcare in another Member State without the prior agreement of their health insurance provider. Setting a financial limit on cost-intensive healthcare is something which particular risk for the patient or the population (e.g. treatment of serious infectious diseases). A regularly updated list of such treatments shall be specifically defined by the Commission through the comitology procedure. ents will understand and at the same time takes account of the differences in the financial situation of the health systems of the Member States with regard to the principle of subsidiarity, i.e. their right to decide on the financing and organisation of health and healthcare provision, and at the same time is in accordance with the case-law of the Court of Justice of the European Communities. When planning to receive cross-border healthcare, patients will ask for a preliminary estimate for the treatment, on the basis of which they will or will not ask their health insurance provider for prior authorisation. Member States shall announce the financial limit valid for a period of at least one year and may regularly increase the level.
Amendment 91 #
Proposal for a directive
Recital 32
Recital 32
(32) In any event, if a Member State decided to establish a system of prior authorisation for assumption of costs of hospital or specialisedhighly cost-intensive care provided in another Member States in accordance with the provision of this Directive, the costs of such care provided in another Member State should also be reimbursed by the Member State of affiliation up to the level of costs that would have been assumed had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received. However, when the conditions set out in Article 22(2) of Regulation (EC) No 1408/71 are fulfilled the authorisation should be granted and the benefits provided in accordance with that Regulation. This applies in particular in instances where the authorisation is granted after an administrative or judicial review of the request and that the person concerned has received the treatment in another Member State. In that case Articles 6, 7, 8 and 9 of this Directive shall not apply. This is in line with the case law of the Court of Justice which has specified that patients who received a refusal of authorisation subsequently held to be unfounded, are entitled to have the cost of the treatment obtained in another Member State reimbursed in full according to the provisions of the legislation in the Member State of treatment.
Amendment 97 #
Proposal for a directive
Recital 38 a (new)
Recital 38 a (new)
(38a) The Commission should reinforce reciprocal aid between national bodies responsible for monitoring quality, voluntary certification of activities, quality certifications and cooperation of professional associations and should support the development of codes of conduct of healthcare service providers.
Amendment 113 #
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 for enhanced legal certainty for citizens regarding the reimbursement of the cost of healthcare provided in another Member State.
Amendment 121 #
Proposal for a directive
Article 2
Article 2
1. The objective of this Directive is to establish rules for the movement of patients who decided to seek cross-border healthcare either of their own volition or on the recommendation of their treating physician or their health insurance provider. 2. This Directive shall apply to cross- border provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or private. 3. The purpose of the Directive is to enhance access to cross-border healthcare.
Amendment 125 #
Proposal for a directive
Article 3 – paragraph 1
Article 3 – paragraph 1
1. This Directive shall apply without prejudice to: the Community legislation below; where the provisions of this Directive are at variance with the provisions of another piece of Community legislation which implements specific aspects of healthcare, the provisions of that other Community law shall take precedence and shall apply to the specific situation in question. This shall apply in particular to: -a) Directive 2005/36/EC of the European Parliament and of the Council of 6 July 2005 on the recognition of professional qualifications; -ab) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce);
Amendment 126 #
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. WIn accordance with the case-law of the Court of Justice of the European Communities and when the circumstances under which an authorisation to go to another Member State in order to receive appropriate treatment under Article 22 of Regulation (EC) No 1408/71 must be granted are met, the provisions of that Regulation shall apply and the provisions of Articles 6, 7, 8 and 9 of this Directive shall not apply. Conversely, when an insured person seeks healthcare in another Member State in other circumstances, Articles 6, 7, 8 and 9 of this Directive apply and Article 22 of Council Regulation (EC) No 1408/71 shall not apply. However, whenever the conditions for granting an authorisation set out in Article 22(2) of Regulation (EC) No 1408/71 are fulfilled, the authorisation shall be accorded and the benefits provided in accordance with that Regulation. In that case Articles 6, 7, 8 and 9 of this Directive shall not apply.
Amendment 159 #
Proposal for a directive
Article 4 – point l
Article 4 – point l
(l) ‘harm’ means adverse outcomes or injuriesdemonstrable physical or mental damage stemming from the incorrect provision of healthcare (non lege artis procedure).
Amendment 188 #
Proposal for a directive
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) patients have a means ofit is straightforward for patients to makinge complaints and they are guaranteed remedies and compensation when they suffer harm arising from the healthcare they receive;
Amendment 190 #
Proposal for a directive
Article 5 – paragraph 1 – point e
Article 5 – paragraph 1 – point e
(e) systems of professional liability insurance or a guarantee or similar arrangement, which are equivalent or essentially comparable as regards their purpose and which are appropriate to the nature and the extent of the risk are in place for treatment provided on their territory of all Member States;
Amendment 198 #
Proposal for a directive
Article 5 – paragraph 1 – point g a (new)
Article 5 – paragraph 1 – point g a (new)
Amendment 199 #
Proposal for a directive
Article 5 – paragraph 1 – point g b (new)
Article 5 – paragraph 1 – point g b (new)
(gb) the calculation of the costs of healthcare provided to patients from other Member States corresponds to the actual average costs charged to patients or to their health insurance companies in the Member State of treatment;
Amendment 200 #
Proposal for a directive
Article 5 – paragraph 1 – point g c (new)
Article 5 – paragraph 1 – point g c (new)
(gc) in the case of healthcare provision not covered by public funds, healthcare providers publish price lists for services that would, among other things, make remote access possible, and that these price lists are the same for patients from the Member State as for patients from other Member States;
Amendment 216 #
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 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, including administrative regulations, guidelines and codes of conduct of the medical professions, 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. Healthcare can only be considered as being similar, if it does not contravene the laws, regulations and codes of conduct of the medical professions of the 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 233 #
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 247 #
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, or care other than highly cost-intensive care, provided in another Member State subject to prior authorisation, where the cost of that care, if it had been provided in its territory, would have been paid for by its social security system. In such cases, the Member State of affiliation shall not be entitled to require any other requests or declarations by the patient. Or. cs Justification
Amendment 257 #
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
Amendment 283 #
Proposal for a directive
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The prior authorisation system shall be limited to what is necessary and proportionate to avoid such impact, and shall not constitute a means of arbitrary discrimination or an obstacle to the implementation of the right to free movement of citizens of the Union.
Amendment 376 #
Proposal for a directive
Article 14 – paragraph 4 a (new)
Article 14 – paragraph 4 a (new)
4a. The Member States shall cooperate and shall make every effort necessary to detect counterfeit medicinal products on the EU market.
Amendment 377 #
Proposal for a directive
Article 14 – paragraph 4 a (new)
Article 14 – paragraph 4 a (new)
4a. Article 14 shall also apply to prescriptions for the supply of medical devices authorised in accordance with the laws of the Member State concerned.
Amendment 391 #
Proposal for a directive
Article 17 – paragraph 2 – point b
Article 17 – paragraph 2 – point b
(b) to support provision of objective, reliable, timely, transparent and transferable information on the short- and long-term effectiveness of health technologies and on their possible side- effects and impacts on society, and enable an effective exchange of this information between national authorities or bodies.