Activities of María SORNOSA MARTÍNEZ related to 2008/0142(COD)
Plenary speeches (1)
Patients' rights in cross-border healthcare (debate)
Amendments (47)
Amendment 45 #
Proposal for a directive
Title
Title
Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the application of patients’ rights in cross-border healthcareto access to safe, high- quality and effective healthcare, under equitable conditions
Amendment 47 #
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty establishing the European Community, and in particular Article 95152 thereof,
Amendment 82 #
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).
Amendment 97 #
Proposal for a directive
Recital 12 a (new)
Recital 12 a (new)
Amendment 117 #
Proposal for a directive
Recital 23
Recital 23
Amendment 124 #
Proposal for a directive
Recital 25
Recital 25
(25) This Directive does not aim either to create entitlement for reimbursement of treatment in another Member State, if such a treatment is not among the benefits provided for by the legislation of the patient’s Member State of affiliation, or to alter the conditions governing such entitlement, where these are laid down in the legislation of the Member State of affiliation. Equally this Directive does not prevent the Member States from extending their benefits in kind scheme to healthcare provided in another Member State according to its provisions.
Amendment 146 #
Proposal for a directive
Recital 31
Recital 31
Amendment 153 #
Proposal for a directive
Recital 31 a (new)
Recital 31 a (new)
(31a) In the light of the case law of the Court of Justice, Member States may impose a prior authorisation requirement where the national system is called upon to assume the costs of hospital care administered in another Member State. Such a requirement should be considered a reasonable as well as a necessary step. That being the case, the number of hospitals, their geographical spread, the way in which they are organised, and the facilities that they have, and even the nature of the medical services which they are able to offer, are all matters that should be possible to deal with by means of planning, couched in general terms in order to satisfy varied needs. Such planning should, firstly, be intended to ensure that the necessary access is provided at all times to a balanced range of efficacious hospital treatment in the Member State concerned. Secondly, it should help to satisfy the desire for rational use of resources, thus making for social efficiency in terms of financial, technical, and human resources.
Amendment 195 #
Proposal for a directive
Article 1
Article 1
This Directive establishes a general framework for the provision ofaccess by EU citizens to safe, high quality and efficient cross-borderhealthcare, under equitable conditions, and establishes mechanisms for cooperation among Member States in the field of health, respecting national competences as regards the organisation and provision of healthcare.
Amendment 207 #
Proposal for a directive
Article 2
Article 2
This Directive shall apply to provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or private, defined in Article 4, which is not guaranteed by Regulation (EC) No 883/2004 on the coordination of social security systems.
Amendment 230 #
Proposal for a directive
Article 3 - paragraph 2
Article 3 - paragraph 2
Amendment 257 #
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 262 #
Proposal for a directive
Article 4 - point (c)
Article 4 - point (c)
Amendment 264 #
Proposal for a directive
Article 4 - point (d)
Article 4 - point (d)
(d) "health professional" means a doctor of medicimedical practitioner 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;
Amendment 276 #
Proposal for a directive
Article 4 - point (f)
Article 4 - point (f)
(f) "patient" means any natural person who receives or wishes to receive healthcare in a Member State;
Amendment 278 #
Proposal for a directive
Article 4 - point (g)
Article 4 - point (g)
(g) "insured person" means: (i) until the date of application of Regulation (EC) No 883/2004: a person who is insured in accordance withunder the provisions of Articles 1, 2 and 4 of Regulation (EC) No 1408/71, (ii) as from the date of application of Regulation (EC) No 883/2004: a person who is an insured person within the meaning ofthe definition in Article 1(c) of Regulation (EC) No 883/2004;
Amendment 282 #
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 patient is legally resident in a Member State and not insured by any European social security scheme, but has a recognised entitlement to healthcare, the Member State of affiliation shall be the Member State of residence;
Amendment 300 #
Proposal for a directive
Article 4 - point (l a) (new)
Article 4 - point (l a) (new)
(la) "Patient's medical records" or "medical history" means all the documents containing data, assessments and information of any kind on a patient's situation and clinical development throughout the care process.
Amendment 302 #
Proposal for a directive
Chapter II – title
Chapter II – title
MEMBER STATE AUTHORITIES RESPONSIBLE FOR COMPLIANCE WITH COMMON PRINCIPLES FOR HEALTHCARE
Amendment 303 #
Proposal for a directive
Article 5 – title
Article 5 – title
Responsibilities of authorities of the Member State of treatment
Amendment 388 #
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 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 forin respect of which the insured person is entitled to assumption of the costs, as well as the level of reimbursement and co-payment to be met by that person, regardless of where it is provided.
Amendment 430 #
Proposal for a directive
Article 6 – paragraph 5 a (new)
Article 6 – paragraph 5 a (new)
5a. Subject to the provisions of Articles 8 and 9, the Member State of affiliation shall not make the reimbursement of the costs of healthcare provided in another Member State subject to prior authorisation.
Amendment 434 #
Proposal for a directive
Article 7
Article 7
Amendment 448 #
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the purposes of reimbursement of the costs 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 requireand specialist assistance shall mean, in accordance with the definition of the legislation of the Member State of affiliation, healthcare requiring planning, in that it necessitates overnight accommodation of the patient in question for at least one night. This list shall be limited to: - healthcare that requires, or calls for the use of highly specialised and cost- intensive medical infrastructure or medical equipment;, or - healthcare involvinges treatments presenting a particularspecific risk for the patient or the population.
Amendment 460 #
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 473 #
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
3. The Member State of affiliation may provide for a system of prior authorisation 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 rationameet the cost of hospital care and specialist assistance (subject to the definition prevailing in the Member State of affilisation 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 Sta) under paragraph 1 provided in another Member State, if prior authorisation has been granted.
Amendment 485 #
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.
Amendment 495 #
Proposal for a directive
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Member State of affiliation shall make publicly available the list of hospitals and specialist care services, as well as all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 3.
Amendment 499 #
Proposal for a directive
Article 8 – paragraph 5a (new)
Article 8 – paragraph 5a (new)
5a. With regard to any request for authorisation made by an insured person with a view to receiving healthcare in another Member State, the Member State of affiliation shall ascertain whether the conditions laid down in Regulation (EC) No 883/2004 have been met, and, if so, shall grant prior authorisation pursuant to that Regulation.
Amendment 500 #
Proposal for a directive
Article 8 – paragraph 5b (new)
Article 8 – paragraph 5b (new)
5b. Member States shall specify in advance and in a transparent way the criteria for refusal of the prior authorisation in the context of overriding considerations of general interest.
Amendment 501 #
Proposal for a directive
Article 8 – paragraph 5 c (new)
Article 8 – paragraph 5 c (new)
5c. In whatever circumstances, the Member State may refuse to grant prior authorisation if the same treatment can be provided within its own territory within a medically justified time-frame and taking account of the existing state of health of the person concerned and the probable development of that person's illness.
Amendment 511 #
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The Member State of affiliation shall ensure that administrative procedures regarding the use of healthcare in another Member State related to any prior authorisation referred to in Article 8(3), reimbursement2) and the meeting of costs of healthcare incurred in another Member State and other conditions and formalities referred to in Article 6(3), are based on objective, non-discriminatory criteria which are published in advance, and which are necessary and proportionate to the objective to be achieved. In any event, an insured person shall always be granted the authorisation pursuant to Regulations on coordination of social security referred to in Art. 3.1 f) whenever the conditions of Art.22.1 c) and Art. 22.2 of Regulation 1408/71 are met.
Amendment 516 #
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Any such procedural systems shall be easily accessible and capable of ensuring that requests are dealt with objectively and impartially within time limitthresholds set out and made public in advance by the Member States. Requests shall take account of degree of urgency and individual circumstances.
Amendment 519 #
Proposal for a directive
Article 9 – paragraph 3
Article 9 – paragraph 3
Amendment 529 #
Proposal for a directive
Article 9 – paragraph 4
Article 9 – paragraph 4
Amendment 542 #
Proposal for a directive
Article 9 – paragraph 5
Article 9 – paragraph 5
5. Member States shall ensure that any administrative decisions regarding the use of healthcare in another Member State are subject to administrative review and also capable of being challenged in judicial proceedings, which include provision for interim measures. They shall facilitate the development of an international out-of- court settlement scheme for disputes arising from cross-border healthcare.
Amendment 548 #
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 anthe provision of healthcare to nationals of other Member States, and the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received in anotherone's own Member State.
Amendment 555 #
Proposal for a directive
Article 10 – paragraph 3
Article 10 – paragraph 3
3. The Member States, with the assistance of the Commission, may, in accordance with the procedure referred to in Article 19(2), develop a standard Community format for the prior information referred to in paragraph 1.
Amendment 566 #
Proposal for a directive
Article 12 – paragraph 2 a (new)
Article 12 – paragraph 2 a (new)
2a. The national contact point in the Member State of affiliation shall provide patients who so request with contact details for the national contact points in other Member States.
Amendment 573 #
Proposal for a directive
Article 12 – paragraph 2 – point a
Article 12 – paragraph 2 – point a
(a) provide and disseminate information to patients who are nationals of other Member States, at their request, 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 anotherthat Member State, and on the terms and conditions applicable;
Amendment 583 #
Proposal for a directive
Article 12 – paragraph 2 – point b
Article 12 – paragraph 2 – point b
(b) help patients who are nationals of other Member States, at their request, to protect their rights and seek appropriate redress in the event of harm caused by the use of healthcare in anotherthat Member State; the national contact point shall in particular inform patients who are nationals of other Member States, at their request, 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;
Amendment 590 #
Proposal for a directive
Article 12 – paragraph 2 – point d
Article 12 – paragraph 2 – point d
Amendment 595 #
Proposal for a directive
Article 12 – paragraph 3 – introductory paragraph
Article 12 – paragraph 3 – introductory paragraph
3. The Member States, with support from the Commission, shall, in accordance with the procedure referred to in Article 19(2), adopt:
Amendment 625 #
Proposal for a directive
Article 14 – paragraph 2 – introduction
Article 14 – paragraph 2 – introduction
2. For facilitating the implementation of paragraph 1, the Member States, with support from the Commission, shall adopt:
Amendment 628 #
Proposal for a directive
Article 14 – paragraph 2 – point a
Article 14 – paragraph 2 – point a
(a) measures enabling a pharmacist or other health professional to verify the authenticity of the prescription and whether the prescription was issued in another Member State by an authorised person through developing a Community prescription template, establishing the data necessary for its validity and the language requirement, and supporting interoperability of ePrescriptions and the confidentiality of the patient's data;
Amendment 632 #
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; where the name of the medicinal product prescribed is an invented name or a trade mark, the international non-proprietary name (INN) shall also be shown;
Amendment 642 #
Proposal for a directive
Article 14 – paragraph 2 – point c a (new)
Article 14 – paragraph 2 – point c a (new)
(ca) measures to establish cases where medicines may be substituted, for example supply problems and emergencies.