Activities of Manuel MEDINA ORTEGA related to 2008/0142(COD)
Legal basis opinions (0)
Amendments (46)
Amendment 15 #
Proposal for a directive
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The Committee on Legal Affairs calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to propose rejection of the Commission proposal.
Amendment 16 #
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 17 #
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 18 #
Proposal for a directive
Recital 12 a (new)
Recital 12 a (new)
(12a) In the light of the case-law of the Court of Justice of the European Communities (C-496/01), in the absence of harmonisation measures, Community law does not preclude a Member State from imposing, in the context of an authorisation scheme, its level of public health protection on healthcare providers established in another Member State which wish to offer services to patients insured in the first Member State. However, the conditions to be satisfied in order to obtain such authorisation may not duplicate the equivalent statutory conditions which have already been satisfied in the Member State of establishment.
Amendment 19 #
Proposal for a directive
Recital 23
Recital 23
Amendment 20 #
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 for that entitlement, if they are included 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 21 #
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 cIn the light of the case-law of the Court of Justice, the Member States may provide that the assumption by the national system of the costs for hospital care provided in annot 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 8her Member State is subject to prior authorisation. This requirement is considered to be a measure that is both necessary and reasonable. Thus 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, generally designed to meet various needs. On the one hand, such planning is geared to ensuring sufficient and permanent access to a balanced range of high-quality hospital treatment in the State concerned. On the other hand, it helps to meet the desire for rational use of resources by permitting the social efficiency of financial, technical and human resources.
Amendment 22 #
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 23 #
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) 883/2004 on the coordination of social security systems.
Amendment 24 #
Proposal for a directive
Article 3 – second paragraph
Article 3 – second paragraph
Amendment 25 #
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 26 #
Proposal for a directive
Article 4 – point c
Article 4 – point c
Amendment 27 #
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 28 #
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 29 #
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 30 #
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 31 #
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 32 #
Proposal for a directive
Chapter – title
Chapter – title
MEMBER STATE AUTHORITIES RESPONSIBLE FOR COMPLIANCE WITH COMMON PRINCIPLES FOR HEALTHCARE
Amendment 33 #
Proposal for a directive
Article 5 – title
Article 5 – title
Responsibilities of authorities of the Member State of treatment
Amendment 34 #
Proposal for a directive
Article 6
Article 6
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 35 #
Proposal for a directive
Article 6 a (new)
Article 6 a (new)
Article 6a Healthcare provided in another Member State 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 36 #
Proposal for a directive
Article 7
Article 7
Amendment 37 #
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 38 #
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 39 #
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 assume the cost of hospital care and specialised care (as defined by the Member State of affiliation) within the terms set out in paragraph 1 provided in another 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 concerned Member State, where prior authorisation has been obtained.
Amendment 40 #
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 41 #
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 specialised care services, as well as all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 32.
Amendment 42 #
Proposal for a directive
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5a. For all requests for authorisation made by an insured person to receive health care in another Member State, the Member State of affiliation shall check for compliance with the conditions set out in Regulation (EC) No 883/2004, and, should they be met, shall grant prior authorisation in line with that Regulation.
Amendment 43 #
Proposal for a directive
Article 8 – paragraph 5 b (new)
Article 8 – paragraph 5 b (new)
5b. The Member State of affiliation shall specify, in advance and in transparent fashion, the criteria applied in cases of refusal of prior authorisation, in relation to primary considerations of general interest.
Amendment 44 #
Proposal for a directive
Article 8 – paragraph 5 c (new)
Article 8 – paragraph 5 c (new)
5c. At all events, the Member State may refuse prior authorisation where the same treatment can be provided on its territory within a medically justifiable time-limit and taking account of the present state of health of the person concerned and the probable evolution of that person's illness.
Amendment 45 #
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 assumption 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 46 #
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 maximum time limits set out and made public in advance by the Member States. In the processing of such requests, account shall be taken of urgency and individual circumstances.
Amendment 47 #
Proposal for a directive
Article 9 – paragraph 3
Article 9 – paragraph 3
Amendment 48 #
Proposal for a directive
Article 9 – paragraph 4
Article 9 – paragraph 4
Amendment 49 #
Proposal for a directive
Article 9 – paragraph 5
Article 9 – paragraph 5
Amendment 50 #
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 51 #
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 52 #
Proposal for a directive
Article 12 – paragraph 2 – letter a
Article 12 – paragraph 2 – letter a
(a) provide and disseminate information to patientson request to patients who are nationals of other Member States, 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 anotherone's own Member State, and on the terms and conditions applicable;
Amendment 53 #
Proposal for a directive
Article 12 – paragraph 2 – letter b
Article 12 – paragraph 2 – letter b
(b) help patientsprovide help on request to patients who are nationals of other Member States seeking to protect their rights and seekobtain appropriate redress in the event of harm caused by the use of healthcare in anothertheir own Member State; the national contact point shall in particular, on request, inform patients who are nationals of other Member States 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 54 #
Proposal for a directive
Article 12 – paragraph 2 – letter d
Article 12 – paragraph 2 – letter d
Amendment 55 #
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, to patients so requesting, contact data for national contact points in other Member States.
Amendment 56 #
Proposal for a directive
Article 12 – paragraph 3
Article 12 – paragraph 3
3. The Member States, with the assistance of the Commission, shall, in accordance with the procedure referred to in Article 19(2),: (a) adopt: (a) measures necessary for the management of the network of national contact points provided for in this Article; (b) determine the nature and type of data to be collected and exchanged within the network; (c) adopt guidelines on information to patients provided for in paragraph 2(a) of this Article.
Amendment 57 #
Proposal for a directive
Article 14 – paragraph 2 – introductory part
Article 14 – paragraph 2 – introductory part
2. For facilitating the implementation of paragraph 1, the Member States, with the assistance of the Commission, shall adopt:
Amendment 58 #
Proposal for a directive
Article 14 – paragraph 2 – letter a
Article 14 – paragraph 2 – letter 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, and supporting interoperability of ePrescriptionsdetermining the data needed for its validity and the language requirements, supporting interoperability of ePrescriptions and ensuring the confidentiality of patient data;
Amendment 59 #
Proposal for a directive
Article 14 – paragraph 2 – letter b
Article 14 – paragraph 2 – letter 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 designation of the medicinal product prescribed consists of a made-up name or a brand name, the international common denomination (ICD) shall also be supplied.
Amendment 60 #
Proposal for a directive
Article 14 – paragraph 2 – letter ca (new)
Article 14 – paragraph 2 – letter ca (new)