BETA

34 Amendments of Francisca PLEGUEZUELOS AGUILAR related to 2008/0142(COD)

Amendment 15 #
Proposal for a directive
Title of the Commission proposal
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
2008/12/16
Committee: ITRE
Amendment 19 #
Proposal for a directive
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).
2008/12/16
Committee: ITRE
Amendment 21 #
Proposal for a directive
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.
2008/12/16
Committee: ITRE
Amendment 22 #
Proposal for a directive
Recital 17 a (new)
(17a) In view of the opinion of the European Data Protection Supervisor on this Directive, the Commission should define the concept of an ‘acceptable security level’ for healthcare within the EU, which might be applied in the case of cross-border health services in relation to the possible implications as regards the processing of personal data. Likewise, it is appropriate to reiterate the importance of the shared responsibility of Member States where data is communicated electronically.
2008/12/16
Committee: ITRE
Amendment 23 #
Proposal for a directive
Recital 23
(23) The patient may choose which mechanism they prefer, but in any case, where the application of Regulation 1408/71 is more beneficial for the patient, the patient should not be deprived of the rights guaranteed by that Regulation.deleted
2008/12/16
Committee: ITRE
Amendment 24 #
Proposal for a directive
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.
2008/12/16
Committee: ITRE
Amendment 28 #
Proposal for a directive
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 cannot 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 8.deleted
2008/12/16
Committee: ITRE
Amendment 31 #
Proposal for a directive
Recital 31 a (new)
(31a) In 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 another 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.
2008/12/16
Committee: ITRE
Amendment 37 #
Proposal for a directive
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.
2008/12/16
Committee: ITRE
Amendment 38 #
Proposal for a directive
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.
2008/12/16
Committee: ITRE
Amendment 40 #
Proposal for a directive
Article 3 – paragraph 2
2. 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.deleted
2008/12/16
Committee: ITRE
Amendment 42 #
Proposal for a directive
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;
2008/12/16
Committee: ITRE
Amendment 43 #
Proposal for a directive
Article 4 – point c
(c) ‘use of healthcare in another Member State’ means healthcare provided in the Member State other than that where the patient is an insured person;deleted
2008/12/16
Committee: ITRE
Amendment 44 #
Proposal for a directive
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;
2008/12/16
Committee: ITRE
Amendment 46 #
Proposal for a directive
Article 4 – point f
(f) ‘patient’ means any natural person who receives or wishes to receive healthcare in a Member State;
2008/12/16
Committee: ITRE
Amendment 47 #
Proposal for a directive
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;
2008/12/16
Committee: ITRE
Amendment 48 #
Proposal for a directive
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;
2008/12/16
Committee: ITRE
Amendment 49 #
Proposal for a directive
Chapter II – title (before Article 5)
MEMBER STATE AUTHORITIES RESPONSIBLE FOR COMPLIANCE WITH COMMON PRINCIPLES FOR HEALTHCARE
2008/12/16
Committee: ITRE
Amendment 50 #
Proposal for a directive
Article 5 – title
Responsibilities of authorities of the Member State of treatment
2008/12/16
Committee: ITRE
Amendment 54 #
Proposal for a directive
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.
2008/12/16
Committee: ITRE
Amendment 61 #
Proposal for a directive
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.
2008/12/16
Committee: ITRE
Amendment 63 #
Proposal for a directive
Article 7
The Member State of affiliation shall not make the reimbursement of the costs of non-hospital 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.deleted
2008/12/16
Committee: ITRE
Amendment 66 #
Proposal for a directive
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.
2008/12/16
Committee: ITRE
Amendment 70 #
Proposal for a directive
Article 8 – paragraph 2
2. This list shall be set up and may be regularly updated by the Commission. Those measures, designed to amend non- essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).deleted
2008/12/16
Committee: ITRE
Amendment 73 #
Proposal for a directive
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 assume the cost of hospital care and specialised care (as defined in the legislation of the Member State of affiliation), pursuant to 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, provided prior authorisation has been obtained.
2008/12/16
Committee: ITRE
Amendment 79 #
Proposal for a directive
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.
2008/12/16
Committee: ITRE
Amendment 80 #
Proposal for a directive
Article 8 – paragraph 5
5. The Member State of affiliation shall make publicly available the list of hospitals and specialised healthcare services and all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 32.
2008/12/16
Committee: ITRE
Amendment 82 #
Proposal for a directive
Article 8 – paragraph 5 a (new)
5a. In the case of any requests for authorisation by an insured person to receive healthcare in another Member State, the Member State of affiliation shall ascertain whether the conditions laid down by Regulation(EC) No 883/2004 have been met and, if so, shall grant the prior authorisation in accordance with that Regulation.
2008/12/16
Committee: ITRE
Amendment 83 #
Proposal for a directive
Article 8 – paragraph 5 b (new)
5b. The Member State of affiliation shall specify in advance and in a transparent way the criteria for refusal of prior authorisation, based on essential general interest considerations.
2008/12/16
Committee: ITRE
Amendment 84 #
Proposal for a directive
Article 8 – paragraph 5 c (new)
5c. In any event, the Member State may refuse to grant prior authorisation if the same treatment can be provided within its territory within a medically justifiable timeframe, taking into account the current state of health of the patient in question and the probable development of his or her illness.
2008/12/16
Committee: ITRE
Amendment 86 #
Proposal for a directive
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), reimbursement, 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.
2008/12/16
Committee: ITRE
Amendment 87 #
Proposal for a directive
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 dealing with such requests, account should be taken of the urgency of the case and of individual circumstances.
2008/12/16
Committee: ITRE
Amendment 88 #
Proposal for a directive
Article 9 – paragraph 3
3. Member States shall specify in advance and in a transparent way the criteria for refusal of the prior authorisation referred to in Article 8(3).Deleted
2008/12/16
Committee: ITRE
Amendment 89 #
Proposal for a directive
Article 9 – paragraph 4
4. Member States shall, when setting out the time limits within which requests for the use of healthcare in another Member State must be dealt with, take into account: (a) the specific medical condition, (b) the patient’s degree of pain, (c) the nature of the patient’s disability, and (d) the patient’s ability to carry out a professional activity.Deleted
2008/12/16
Committee: ITRE