46 Amendments of Martí GRAU i SEGÚ related to 2008/0142(COD)
Amendment 31 #
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, efficient healthcare under equitable conditions
Amendment 54 #
Proposal for a directive
Recital 10
Recital 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 59 #
Proposal for a directive
Recital 12 a (new)
Recital 12 a (new)
(12a) According to Court of Justice case law (C-496/01), if no harmonisation measures exist, Community law does not prevent any Member State from imposing its own level of public health coverage on healthcare providers established in another Member State, who wish to provide services to patients insured in the first Member State, provided that the legal obligations of the providers of healthcare services have been established. However, the conditions which need to be met in order to secure authorisation shall not duplicate equivalent legal conditions already satisfied in the Member State of establishment.
Amendment 70 #
Proposal for a directive
Recital 23
Recital 23
Amendment 75 #
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 modify the conditions of such reimbursement, if the former are set out 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 88 #
Proposal for a directive
Recital 31
Recital 31
Amendment 90 #
Proposal for a directive
Recital 31 a (new)
Recital 31 a (new)
Amendment 104 #
Proposal for a directive
Article 1
Article 1
This Directive establishes a general framework for the provision ofEU citizens' access to safe, high quality and efficient cross-borderhealthcare, under equitable conditions, and establishes cooperation mechanisms between Member States in the field of health, respecting national responsibility for organising and providing healthcare.
Amendment 116 #
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, as defined in Article 4, which is not guaranteed by Regulation (EC) No 883/2004 on coordinating social security systems.
Amendment 130 #
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 144 #
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 147 #
Proposal for a directive
Article 4 – point c
Article 4 – point c
Amendment 150 #
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 152 #
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 153 #
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 with 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 ofing to the definition in Article 1(c) of Regulation (EC) No 883/2004;
Amendment 155 #
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 161 #
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 162 #
Proposal for a directive
Chapter II – heading (before Article 5)
Chapter II – heading (before Article 5)
MEMBER STATE AUTHORITIES RESPONSIBLE FOR COMPLIANCE WITH COMMON PRINCIPLES FOR HEALTHCARE HEALTHCARE
Amendment 163 #
Proposal for a directive
Article 5 – heading
Article 5 – heading
Responsibilities of authorities of the Member State of treatment
Amendment 209 #
Proposal for a directive – amending act
Article 5 a (new)
Article 5 a (new)
Amendment 218 #
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 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 244 #
Proposal for a directive – amending act
Article 7
Article 7
Amendment 252 #
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 specialised care shall mean, as defined in the legislation of the Member State of affiliation, healthcare which is subject to planning, in that it entails overnight accommodation of the patient in question for at least one night. This list shall be limited to: - healthcare that or which requires use of highly specialised and cost- intensive medical infrastructure or medical equipment;, or - healthcare involving treatments presenting a particularspecific risk for the patient or the population.
Amendment 261 #
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 271 #
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 287 #
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 293 #
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 294 #
Proposal for a directive
Article 8 – paragraph 5 a – (new)
Article 8 – paragraph 5 a – (new)
5a. 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 297 #
Proposal for a directive
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (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 300 #
Proposal for a directive
Article 8 – paragraph 5 b (new)
Article 8 – paragraph 5 b (new)
5b. 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 304 #
Proposal for a directive – amending act
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 306 #
Proposal for a directive – amending act
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. When dealing with requests, account shall be taken of the degree of urgency and individual circumstances.
Amendment 307 #
Proposal for a directive – amending act
Article 9 – paragraph 3
Article 9 – paragraph 3
Amendment 313 #
Proposal for a directive – amending act
Article 9 – paragraph 4
Article 9 – paragraph 4
Amendment 316 #
Proposal for a directive – amending act
Article 9 – paragraph 5
Article 9 – paragraph 5
Amendment 321 #
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 326 #
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 336 #
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 wi provide patients who so request with contact details for the national contact points in other Member States, in particular in the Member State of treatment, and with the Commission:.
Amendment 341 #
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 342 #
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 344 #
Proposal for a directive
Article 12 – paragraph 2 – point d
Article 12 – paragraph 2 – point d
Amendment 347 #
Proposal for a directive
Article 12 – paragraph 3
Article 12 – paragraph 3
3. The Member States, with support from the Commission, shall, in accordance with the procedure referred to in Article 19(2), adopt:
Amendment 361 #
Proposal for a directive
Article 14 – paragraph 2
Article 14 – paragraph 2
2. For facilitating the implementation of paragraph 1, the Member States, with support from the Commission, shall adopt:
Amendment 364 #
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 requirements, and supporting interoperability of ePrescriptions and the confidentiality of the patient's data;
Amendment 367 #
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 371 #
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.