Activities of Dagmar ROTH-BEHRENDT related to 2008/0142(COD)
Plenary speeches (2)
Patients' rights in cross-border healthcare (debate)
Patients’ rights in cross-border healthcare (debate)
Amendments (32)
Amendment 110 #
Council position
Recital 20
Recital 20
(20) Systematic and continuous efforts should be made to ensure that quality and safety standards are improved, in line with the Council Conclusions and taking into account advances in international medical science and generally recognised good medical practices as well as taking into account new health technology.
Amendment 115 #
Council position
Recital 27
Recital 27
(27) It is appropriate to require that also patients who seek healthcare in another Member State in other circumstances than those provided for in Regulation (EC) No 883/2004 should be able to benefit from the principles of free movement of serpatients and goods such as medicinal products and medical devices in accordance with the Treaty and with this Directive. Patients should enjoy a guarantee of assumption of the costs of that healthcare and goods connected with healthcare provided in a Member State other than their Member State of affiliation at least at the level as would be provided for the same healthcarreatment which is the same or equally effective, had ithey been provided or purchased in the Member State of affiliation. This should fully respect the responsibility of the Member States to determine the extent of the sickness cover available to their citizens and prevent 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. That may be the case in particular for any treatment provided through European reference networks. Or.en (EP position recital 27)
Amendment 144 #
Council position
Article 4 – paragraph 2 – point a
Article 4 – paragraph 2 – point a
(a) patients receive from the national contact point upon request relevant information, inter alia via electronic means, on the standards and guidelines referred to in paragraph 1, including provisions on supervision and assessment of healthcare providers, and information on which healthcare providers are subject to these standards and guidelines;
Amendment 148 #
Council position
Article 4 – paragraph 2 – point c
Article 4 – paragraph 2 – point c
(c) there are complaints procedures and mechanisms in place for patients to s, in order to guaranteek remedies and compensation in accordance with the legislation of the Member State of treatment if they suffer harm arising from the healthcare they receive;
Amendment 152 #
Council position
Article 4 – paragraph 3 – subparagraph 2 a (new)
Article 4 – paragraph 3 – subparagraph 2 a (new)
Amendment 156 #
Council position
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) there are easily accessible mechanisms in place to provide patients on request with information, inter alia via electronic means, on their rights and entitlements in that Member State relating to receiving cross-border healthcare, in particular as regards procedures for accessing and determining those entitlements, conditions for reimbursement of costs and systems of appeal and redress if the patients considers that their rights have not been respected; and the terms and conditions that would apply, inter alia whenever harm is caused as a result of healthcare received in another Member State. That information shall be published in a format accessible to persons with disabilities. Member States shall consult stakeholders, including patients' organisations, to ensure information is clear and accessible. In information about cross-border healthcare, a clear distinction shall be made between the rights which patients have by virtue of this Directive and rights arising from Regulation (EC) No 883/2004.
Amendment 158 #
Council position
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) patients who seek to receive or do receive cross-border healthcare have access to at least a copy of their medical records, in conformity with, and subject to, national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC. Data shall be transmitted only with the express written consent of the patient or the patient's relatives. Or.en (EP position Art 6(6))
Amendment 160 #
Council position
Article 6 – paragraph 3
Article 6 – paragraph 3
3. National contact points in the Member State of treatment shall provide patients with information, inter alia via electronic means, concerning healthcare providers, including on request information on a specific provider's right to provide services or any restrictions on its practice, information referred to in Article 4(2)(a), and information on the protection of personal data, the level of accessibility to healthcare facilities for people with disabilities, as well as information on patients' rights, complaints procedures and mechanisms for seeking remedies, according to the legislation of that Member State. , as well as the options available to settle any dispute, and help to identify the appropriate out-of-court settlement scheme for the specific case. Or.en (EP position Article 14(4))
Amendment 163 #
Council position
Article 6 – paragraph 4 – subparagraph 1 a (new)
Article 6 – paragraph 4 – subparagraph 1 a (new)
Amendment 164 #
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 provided for by the legislation, administrative regulations and guidelines 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 on 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. Without prejudice to Regulation (EC) No 883/2004, patients affected by rare diseases shall have the right to access healthcare in another Member State and to receive reimbursement for methods of treatment that are sufficiently tried and tested by international medical science even if the treatment in question is not among the benefits provided for by the legislation, administrative regulations and guidelines of the Member State of affiliation. Such treatment shall be subject to prior authorisation. Or.en (EP position Article 6(2) and 6(3))
Amendment 179 #
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 199 #
Council position
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Article 11 – paragraph 1 – subparagraph 1 – introductory part
If a medicinal product is authorised to be marketed on their territory in accordance with Article 6(1) of Directive 2001/83/EC, Member States shall ensure that prescriptions issued for such a product in another Member State for a named patient can be dispensed on their territory in compliance with their national legislation in force, and that any restrictions on recognition of individual prescriptions are prohibited unless such restrictions are:
Amendment 210 #
Proposal for a directive
Article 2
Article 2
This Directive shall apply to provision of cross-border healthcare regardless of how it is organised, delivered and financed or whether it is public or private.
Amendment 226 #
Council position
Article 20 – paragraph 1 – subparagraph 1
Article 20 – paragraph 1 – subparagraph 1
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by….** They shall forthwith inform the Commission thereof. ** OJ: 3 years from the date of entry into force of OJ: 1 year from the date of entry into force of this Directive.
Amendment 247 #
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, ands and goods provided or prescribed by health professionals to patients to assess, maintain or restore their state of health or prevent them from becoming ill, regardless of the ways in which it is organised, delivered and financed at national level or whether it is public or private;
Amendment 256 #
Proposal for a directive
Article 4 - point (b)
Article 4 - point (b)
(b) "cross-border healthcare" means healthcare provided in a Member State other than that where the patient is an insured person or healthcare provided in a Member State other than that where the healthcare provider resides, is registered or is established;
Amendment 267 #
Proposal for a directive
Article 4 - point (d)
Article 4 - point (d)
(d) "health professional" means a doctor of medicine or a nurse responsible for general care or a dental practitioner or a midwife or a pharmacist within the meaning of Directive 2005/36/EC or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC or a person legally exercising healthcare activities in the Member State of treatment;
Amendment 272 #
Proposal for a directive
Article 4 - point (f)
Article 4 - point (f)
(f) "patient" means any natural person who receives or wisheseeks to receive healthcare in a Member State;
Amendment 289 #
Proposal for a directive
Article 4 - point (k a) (new)
Article 4 - point (k a) (new)
(ka) "health technology" means a medicinal product or a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare.
Amendment 371 #
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
3. In so far as it is necessary to facilitate the provision of cross-border healthcare and taking as a basis a high level of protection of health, the Commission, in cooperationMember States shall develop guidelines in order to facilitate the implementation of paragraph 1 and inform the Commission about the content of the guidelines within theree months after the entry into force of the legislation. If Member States, shall fail to develop such guidelines in order to facilitate the implementation of paragraph 1, the Commission, in cooperation with the Member State, shall develop those guidelines. The Member States and the Commission shall make sure that those guidelines are easily accessible by healthcare providers and patients.
Amendment 384 #
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 Member State of treatment or the insured person, which would have been paid for by its statutory social security system had the same or similar healthcare been provided in its territory. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is providedf there are several methods available for treating a certain disease or injury, the patient shall have the right to reimbursement for all methods of treatment that are sufficiently tried and tested by international medical science, even if they are not available in the patient’s Member State of affiliation. If a Member State of affiliation rejects the reimbursement of such a treatment, the Member State has 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. The Member State of affiliation shall put in place appropriate and coherent mechanisms to pay healthcare providers directly for those costs.
Amendment 401 #
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The costs of healthcare provided in another Member State shall be reimbursed or paid 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 490 #
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, shall be based on fair, clear and transparent criteria and shall not constitute a means of arbitrary discrimination.
Amendment 551 #
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 result of healthcare received in another Member State. Patients' organisations may be involved in cooperating with competent national authorities in the process of providing and disseminating information to patients.
Amendment 563 #
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Member States shall designate national contact points for cross-border healthcare and communicate their names and contact details to the Commission. These national contact points should be established in an efficient and transparent way. Information about their existence shall be disseminated across Member States, so that patients have easy access to the information.
Amendment 567 #
Proposal for a directive
Article 12 – paragraph 2 – introductory paragraph
Article 12 – paragraph 2 – introductory paragraph
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, with patients' organisations and with the Commission:
Amendment 569 #
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, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and coutgoing patients on receiving healthcare in another Member State, and the terms and conditions which apply, in particular on their rights related to cross-border healthcare; national contact points shall also help outgoing patients to protect their rights and seek appropriate redress in the event of harm caused by the use of healthcare in another Member State; the national contact point shall in particular inform patients about the options available to settle any dispute, help to identify the appropriate out-of-court settlement scheme for the specific case and help patients to monditions applicableor their dispute where necessary;
Amendment 581 #
Proposal for a directive
Article 12 – paragraph 2 – point b
Article 12 – paragraph 2 – point b
(b) help patients to protect their rights and seek appropriate rprovide and disseminate information to incoming patients about the existing national standards on quality and safety, protection of personal data, proceduress in the event of harm caused by the use of healthcare in another for complaints and means of redress available for healthcare received in this Member State; t. The national contact point shall in particular inform patients, where necessary, about the options available to settle any dispute, and help to identify the appropriate out-of-court settlement scheme for the specific case and help patients to monitor their dispute where necessary;.
Amendment 586 #
Proposal for a directive
Article 12 – paragraph 2 – point c
Article 12 – paragraph 2 – point c
Amendment 588 #
Proposal for a directive
Article 12 – paragraph 2 – point d
Article 12 – paragraph 2 – point d
Amendment 604 #
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. The Commission shall encourage and support cooperation among Member States to share experiences and information (such as about best-practice, treatments available, clinical trials and results from research projects) and thus contribute to an improved quality and safety of healthcare throughout the EU.
Amendment 663 #
Article 15 - paragraph 3 - point a - introductory part
(a) a list of specific criteria and conditions that the European reference networks must fulfil, including also a list of rarer disease areas to be covered and the conditions and criteria required from healthcare providers wishing to join the European reference networks, in order to ensure, in particular, that the European reference networks: