31 Amendments of Evelyne GEBHARDT related to 2008/0142(COD)
Amendment 35 #
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty establishing the European Community, and in particular Articles 95 and 152 thereof,
Amendment 37 #
Proposal for a directive
Recital 1
Recital 1
(1) According to Article 152(1) of the Treaty, a high level of human health protection must be ensured in the definition and implementation of all Community policies and activities. This implies that high level of human health protection has to be ensured also when the Community legislature acts under other Treaty provisionFurthermore, Article 95(3) of the Treaty explicitly requires that, in achieving the approximation of the provisions laid down by law, regulation or administrative action in the Member States, a high level of protection of human health should be guaranteed taking account in particular of any new development based on scientific facts.
Amendment 40 #
Proposal for a directive
Recital 2
Recital 2
(2) Given that the conditions for recourse to Article 95 of the Treaty as a legal basis are fulfilled, the Community legislature shall rely on this legal basis even when public health protection is a decisive factor in the choices made; in this respect Article 95(3) of the Treaty explicitly requires that, in achieving harmonisation, a high level of protection of human health should be guaranteed taking account in particular of any new development based on scientific facHealthcare is one of the most fundamental services of general interest. It must meet the demands of universality and the highest requirements as regards safety and quality for patients.
Amendment 52 #
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 57 #
Proposal for a directive
Recital 11
Recital 11
(11) As recognised by the Member States in the Council Conclusions on Common values and principles in European Union Health Systems there is a set of operating principles that are shared by health systems throughout the Community. These operating principles include quality, safety, care that is based on evidence and ethics, patient involvement, redress, the fundamental right to privacy with respect to the processing of personal data, and confidentiality. Patients, professionals and authorities responsible for health systems must be able to rely on these shared principles being respected and structures provided for their implementation throughout the Community. It is therefore appropriate to require that it is the authorities of the Member State on whose territory the healthcare is provided, who are responsible for ensuring compliance with those operating principles. This is necessary to ensure the confidence of patients in cross-border healthcare, which is itself necessary for achieving patients' mobility and free movement of provision of healthcare in the internal market as well as a high level of health protection.
Amendment 62 #
Proposal for a directive
Recital 14
Recital 14
Amendment 63 #
Proposal for a directive
Recital 18
Recital 18
(18) The right to reimbursement of the costs of healthcare provided in another Member State from the statutory social security scheme of patients as insured persons was recognised by the Court of Justice in several judgements. The Court of Justice has held that the Treaty provisions on the freedom to provide services includes the freedom for the recipients of healthcare, including persons in need of medical treatment, to go to another Member Sate in order to receive it there. The same applies to recipients of healthcare seeking to receive healthcare provided in another Member State through other means, for example through e-health services. Whilst Community law does not detract from the power of the Member States to organise their healthcare and social security systems, Member States must when exercising that power comply with Community law, in particular with the Treaty provisions on the freedom to provide services. Those provisions prohibit the Member States from introducing or maintaining unjustified restrictions on the exercise of that freedom in the healthcare sector.
Amendment 71 #
Proposal for a directive
Recital 23 a (new)
Recital 23 a (new)
(23a) The facilitation of cross-border patient mobility achieved through this Directive does not on any account absolve the Member States from their obligation to provide their population with adequate healthcare at a high level of quality and capacity in their own country and thereby to ensure local care in the language of the population.
Amendment 77 #
Proposal for a directive
Recital 26
Recital 26
(26) This Directive does not provide either for transfer of social security entitlements between Member States or other coordination of social security schemes. The sole objective of the provisions regarding prior authorisation and reimbursement of healthcare provided in another Member State is to enable freedom to provide healthcare for both patients and healthcare providers and to remove unjustified obstacles to that fundamental freedom within the patient's Member State of affiliation. Consequently the Directive fully respects the differences of national health-care systems and the Member States' responsibilities for organisation and delivery of health services and medical care.
Amendment 79 #
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 in the Member State of treatment, even if the medicinal product is not authorised for marketing in the Member State of affiliation, as it is an indispensable part of obtaining this specific effective treatment for the patient in another Member State.
Amendment 93 #
Proposal for a directive
Recital 33
Recital 33
(33) Procedures regarding cross-border healthcare established by the Member States should give patients guarantees of objectivity, non-discrimination and transparency, in such a way as to ensure that decisions by national authorities are made in a timely manner and with due care and regard for both those overall principles and the individual circumstances of each case. This applies also to the actual reimbursement of costs of healthcare incurred in another Member State after the patient's return. It is appropriate that patients should normally have a decision regarding the cross-border healthcare within fifteen calendar days. However, that period should be shorter where warranted by the urgency of the treatment in question. In any event, recognition procedures and rules on the provision of services as provided for by Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications should not be affected by these general rules.
Amendment 94 #
Proposal for a directive
Recital 35
Recital 35
(35) When healthcare is received by a patient in a Member state, which is not the country where he is insured, it is essential for the patient to know in advance which rules shall be applicable. An equivalent level of clarity is needed in case where healthcare providers temporarily move to another Member State to provide their medical services there or when healthcare is provided cross-border. In those cases, the rules applicable to healthcare are those provided by the legislation of the Member State of treatment in accordance with the general principles set out in Art.5, given that in accordance with Art. 152(5) of the Treaty the organisation and delivery of health services and medical care is of responsibility of Member States. This will help the patient in making an informed choice, and will avoid misapprehension and misunderstanding. It will also establish a high level of trust between the patient and the healthcare provider
Amendment 132 #
Proposal for a directive
Article 3
Article 3
1.This Directive shall apply without prejudice to: (a) Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data and Directive 2002/58/EC concerning the processing of personal data and the protection of privacy in the electronic communications sector; (b) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and Directive 2001/83/EC on the Community code relating to medicinal products for human use; (c) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (d) Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services; (e) Directive 2000/43/EC of the Council of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin; (f) Regulations on coordination of social security schemes, in particular Article 22 of Regulation (EC) No 1408/71 of the Council of 14 June 1971 on the application of social security schemes to employed persons and their families moving within the Community and Council Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems; (g) Regulation (EC) 1082/2006 of 5 July 2006 on a European Grouping of territorial cooperation (EGTC); 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(h) Directive 2005/36/EC on the recognition of professional qualifications; (i) Directive 2000/31/EC of the European Parliament 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. 3. If the provisions of this Directive conflict with a provision of another Community act governing specific aspects of healthcare, the provision of the other Community act shall prevail and shall apply to those specific situations concerned. These include: (a) Directive 2005/36/EC on the recognition of professional qualificationse Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market; (bj) Directive 2000/311/83/EC of the European Parliament and of the Council of 8 June6 November 20001 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Marketthe Community code relating to medicinal products for human use.
Amendment 138 #
Proposal for a directive
Article 3 – paragraph 4
Article 3 – paragraph 4
Amendment 145 #
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 providreceived by a patient who resides, is registered or is established in a Member State other than that where the healthcare is provider resides, is registered or is established;
Amendment 204 #
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 231 #
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The costs of healthcare provided in another Member State shall be reimbursed or paid 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 had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received.
Amendment 238 #
Proposal for a directive
Article 6 – paragraph 3 a (new)
Article 6 – paragraph 3 a (new)
3a. The Member State of treatment may adopt rules that would make it possible to refuse patients access to benefits if the treatment options are exhausted. These rules shall be based on objective criteria.
Amendment 246 #
Proposal for a directive
Article 7
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 and the system of mutual support is not jeopardised.
Amendment 250 #
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, hospital and specialised 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 no, as defined in the legislation of the Member State of affiliation, which shall be subject to planning if it requires overnight accommodation of the patient in question for at least one night. This list shall be limited to: - healthcare that or requires the use of highly specialised and cost-intensive medical infrastructure or medical equipment; or - healthcare involvinges treatments presenting a particular risk for the patient or the population.
Amendment 259 #
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 270 #
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
3. The Member State of affiliation may provide for a system ofshall submit for prior authorisation fthe payment or 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 of the cost of hospital or specialised care provided in another 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 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, as defined by the Member State of affiliation in accordance with paragraph 1.
Amendment 284 #
Proposal for a directive
Article 8 – paragraph 4
Article 8 – paragraph 4
4. TheRefusal of 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 291 #
Proposal for a directive
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Member State shall make publicly available all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 3. On each application by an insured person for authorisation of treatment in another Member State, the Member State of affiliation shall consider whether the conditions for the application of Regulation (EEC) No 1408/71 or Regulation (EC) No 883/2004 are met, and, where this is the case, shall issue the authorisation in accordance with those regulations.
Amendment 323 #
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 patientspatients are provided on request with information on receiving healthcare in anothertheir own Member State, and the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received in another Member State of treatment.
Amendment 327 #
Proposal for a directive
Article 10 – paragraph 3
Article 10 – paragraph 3
Amendment 335 #
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 Commissaffiliation:
Amendment 349 #
Proposal for a directive
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Member States shall facilitate cooperation in cross-border healthcare provision at regional and local level as well as through information and communication technologies, cross-border healthcare provided on a temporary or ad hoc basis and other forms of cross-border cooperation.
Amendment 372 #
Proposal for a directive
Article 14 – paragraph 2 a (new)
Article 14 – paragraph 2 a (new)
2a. Where a prescription is issued in the Member State of treatment for a medicinal product which is not authorised in the Member State of affiliation, the Member State of affiliation shall not be required to provide that medicinal product.
Amendment 374 #
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The measures referred to in points (a) and (b) of paragraph 2 shall be adopted in accordance with the regulatory procedure referred to in Article 19(2). The measures referred to in point (c) of paragraph 2, 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).
Amendment 383 #
Proposal for a directive
Article 16
Article 16
The Commission shall, in accordance with the procedure referred to in Article 19(23), 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 them. 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.