30 Amendments of Arlene McCARTHY related to 2008/0142(COD)
Amendment 81 #
Proposal for a directive
Recital 27
Recital 27
(27) This Directive provides also for the right for a patient to receive any medicinal product authorised for marketing in the Member State where healthcare is provided, even if the medicinal product is not authorised for marketing in the Member State of affiliation, as it is an indispensable part of obtaining effective treatment in another Member State. This is without prejudice to the ability of Member States to organise their own healthcare and social security systems and to the applicable rules in the Member State of affiliation regarding the reimbursement of medicinal products.
Amendment 110 #
Proposal for a directive
Article 1
Article 1
This Directive establishes a general framework for the provision of safe, high quality and efficient cross-borderprovides rules for the access to safe and high-quality healthcare in another Member State and establishes cooperation mechanisms on healthcare between Member States, in full respect of national competencies in organising and delivering healthcare.
Amendment 164 #
Proposal for a directive
Article 5 – paragraph -1 a (new)
Article 5 – paragraph -1 a (new)
-1a. When healthcare is provided in another Member State than the Member State of affiliation of the patient, or in a Member State other than that where the healthcare provider is established, such healthcare is provided according to the legislation of the Member State of treatment in accordance of paragraph 2 of this article.
Amendment 167 #
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The Member States of treatment shall be responsible for the organisation and the delivery of healthcare. In such a context and takHealthcare shall be provided according into account principles of universality, access to good quality care, equity and solidarity, they shall define clear quality and safety standards for healthcare providedstandards and guidelines on quality and safety defined by the Member State of treatment. The Member States onf their territory, andreatment shall ensure that:
Amendment 173 #
Proposal for a directive
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) mechanismpatients are in place for ensuring that healthcare providers are able to meet such standards, taking into account international medical science and generally recognised good medical practicesceive upon request information on such standards and guidelines, including provisions on supervision and assessment;
Amendment 179 #
Proposal for a directive
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 182 #
Proposal for a directive
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) healthcare providers provide all relevant information to enable patients to make an informed choice, in particularpatients with information on availability, prices and outcomes of the healthcare provided and details of theirincluding in terms of quality, as well as details of the healthcare provider’s registration status, insurance cover or other means of personal or collective protection with regard to professional liability;
Amendment 185 #
Proposal for a directive
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) patients, health providers and the public have a means of making complaints and are guaranteediven recourse to appropriate remedies and compensation when they suffer harm arising from the healthcare they receivor become aware of harm caused arising from cross-border healthcare;
Amendment 202 #
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 219 #
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 thate reimbursement of costs incurred by an 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 for regardless of where it is providedif the health care in question is among the benefits to which the insured person is entitled in the Member State of affiliation.
Amendment 227 #
Proposal for a directive – amending act
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The costs of healthcare provided in another Member State shall be reimbursed 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 hadby the same or similar healthcare been provided in the Member State of affiliationMember State of affiliation had this healthcare been provided in its territory, without exceeding the actual costs of healthcare received.
Amendment 235 #
Proposal for a directive – amending act
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Member State of affiliation may impose on a patient seeking healthcare provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities, whether set at a local, national or regional level, for receiving healthcare and reimbursementassumption of healthcare costs as it would impose if the same or similaris healthcare was provided in its territory, in so far as they are neither discriminatory nor an obstacle to freedom of movement of persons. , services and goods. This may include a requirement that the insured person is assessed for the purposes of applying those conditions, criteria or formalities, by a health professional or healthcare administrators providing services for the statutory social security system of the Member State of affiliation, where such an assessment would also be required for accessing services in the Member State of affiliation.
Amendment 263 #
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
2. This list shall be set upEach Member State shall establish 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) such a list applicable to patients affiliated in that Member State.
Amendment 272 #
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 anomake the reimbursement of the cost of hospital care and specialised care as defined by ther 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 sociof affiliation in accordance with paragraph 1 provided in another Member State subject to prior authorisation. The Member State of affiliation shall specurity system; and (b) the purpose of the system is to address the consequent outflow of patients due to the implementify in advance and in a transparent way, the criteria for refusal of the prior authorisation related to the overriding considerations of the present Article and to prevent it from seriously undermining, or being likely to seriously undermgeneral interest. Prior authorisation may be refused for reasons including the followineg: (i) tThe financial balance of the Member State's social security system; and/orpatient does not meet the criteria provided for in Article 6 (3); (ii) tThe planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalanceinsurer or commissioner judges that there is a clinical risk to the patient or to wider public health inf 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 Statey travel abroad, or that there are inadequate aftercare or follow-up arrangements in place for the treatment in question; (iii) Where the insurer or commissioner has evidence to show that the provider the patient wishes to travel to is negligent or fraudulent.
Amendment 279 #
Proposal for a directive
Article 8 – paragraph 3 a – (new)
Article 8 – paragraph 3 a – (new)
3a. A Member State may also refuse requests for prior authorisation where the patient can receive the treatment they are entitled in accordance with Article 6 (3) without undue delay in the Member State of affiliation and where there is evidence that the outflow of patients is damaging, or is likely to damage, the provision of certain treatments at either the national or local level.
Amendment 320 #
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The Member States of affiliationtreatment shall ensure that there are mechanisms in place to provide patients on request with informationmake information publicly available on receiving healthcare in anotherthat Member State, and on the terms and conditions that would apply, inter alia, wheneverregistered health professionals and providers in that Member State. The Member states of treatment shall also make available information on the quality and safety standards that apply, the regulatory system in place, and the process for making complaints where harm is caused as a result of healthcare received in anotherthat Member State.
Amendment 325 #
Proposal for a directive
Article 10 – paragraph 3
Article 10 – paragraph 3
Amendment 334 #
Proposal for a directive
Article 12 – paragraph 2
Article 12 – paragraph 2
2. The national contact point in the Member State of affiliationtreatment 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, and with the Commission:
Amendment 338 #
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 standards, protection of personal data, procedures for complaints and, the means by which professionals and providers are regulated and the means by which regulatory action can be taken, the means of redress available for healthcare provided in anotherthat Member State, and on the terms and conditions applicable;
Amendment 346 #
Proposal for a directive
Article 12 – paragraph 3
Article 12 – paragraph 3
Amendment 350 #
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. Member States shall immediately and proactively inform each other about health providers or health professionals when regulatory action is taken against their registration or their right to provide services.
Amendment 363 #
Proposal for a directive
Article 14 – paragraph 2 – point (a)
Article 14 – paragraph 2 – point (a)
(a) measurnon-binding guidelines 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 ePrescriptions;
Amendment 366 #
Proposal for a directive
Article 14 – paragraph 2 – point (b)
Article 14 – paragraph 2 – point (b)
(b) measurnon-binding guidelines 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;
Amendment 373 #
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
Amendment 375 #
Proposal for a directive
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
3a. Nothing in paragraph 1 of this Article obliges a Member State of affiliation to reimburse an insured person for a medicinal product prescribed in the Member State of treatment which is not among the benefits provided to that insured person by the Member State of affiliation.
Amendment 378 #
Proposal for a directive
Article 15 – paragraph 3
Article 15 – paragraph 3
3. The Commission shall adwork with the European reference networks to developt:
Amendment 381 #
Proposal for a directive
Article 15 – paragraph 4
Article 15 – paragraph 4
Amendment 382 #
Proposal for a directive
Article 16 – paragraph 1 (new)
Article 16 – paragraph 1 (new)
1. The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt specific measures necessary for achieving the interoperability of information and communication technology systems in the healthcare field, applicable whenever Member States decide to introduce themworking with Member States, develop measures to facilitate interoperability of information and communication technology insofar as is necessary to ensure patient safety in the field of cross-border healthcare. Those measures shall reflect developments in health technologies and medical science and respect the fundamental right to the protection of personal data in accordance with the applicable law. They shall specify in particular the necessary standards and terminologies for inter-operability of relevant information and communication technology systems to ensure safe, high- quality and efficient provision of cross- border health services.
Amendment 385 #
Proposal for a directive
Article 16 – paragraph 1 a (new)
Article 16 – paragraph 1 a (new)
1a. Those contracting e-health services from providers and professionals in other Member States shall ensure they are appropriately regulated and qualified and that they have demonstrated, via the relevant competent authority, that they are fit to practise and to provide e-health services.
Amendment 394 #
Proposal for a directive
Article 17 – paragraph 4
Article 17 – paragraph 4
4. The Commission shall, in accordance with the procedure referred to in Article 19(2), ad work with Member States to developt the necessary measures for the establishment and the management of this network and specifying the nature and type of the information to be exchanged.