Activities of Roberto MUSACCHIO related to 2008/0142(COD)
Plenary speeches (1)
Patients' rights in cross-border healthcare (debate)
Amendments (32)
Amendment 52 #
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty establishing the European Community, and in particular Article 95 and 152 thereof,
Amendment 56 #
Proposal for a directive
Recital 2
Recital 2
Amendment 69 #
Proposal for a directive
Recital 8
Recital 8
(8) This directive aims to establish a general framework for provision of safe, high quality and efficient cross-border healthcare in the Community and to ensurein relation to patients mobility and freedom to provide healthcare ands well as a to a high level of protection of health, whilst fully respecting the responsibilities of the Member States for the definition of social security benefits related to health and for the organisation and delivery of healthcare and medical care ands well as of social security benefits in particular for sickness.
Amendment 79 #
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: - Uonly the use of healthcare abroad (i.e.: a patient moving of his/her own accord 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 92 #
Proposal for a directive
Recital 12
Recital 12
(12) Given that it is impossible to know in advance whether a given healthcare provider will supply healthcare to a patient coming from another Member State or a patient from their own Member State, it is necessary that the requirements to ensure that healthcare is provided according to common principles and clear quality and safety standards are applicable to all type of healthcare in order to ensure the freedom to provide and obtain cross border healthcare which is the aim of the directive. Member States' authorities have to respect the shared overarching values of universality, access to good quality care, equity and solidarity, which have been already widely recognised by the Community institutions and by all the Member States as constituting a set of values that are shared by health systems across Europe. Members States also have to ensure that these values are respected with regard to patients and citizens from other Member States, and that all patients are treated equitably on the basis of their healthcare need rather than their Member State of social security affiliation. In doing so, Member States must respect the principles of freedom of movement within the internal market, non- discrimination inter alia with regard to nationality (or in the case of legal persons, with regard to the Member State in which they are established), necessity and proportionality of any restrictions on free movement. However, nothing in this Directive requires healthcare providers to accept for planned treatment or to prioritise patients from other Member States to the detriment of other patients with similar health needs, such as through increasing waiting time for treatment. Nevertheless special provision should be made for victims of accidents and mass emergencies requiring emergency medical treatment.
Amendment 122 #
Proposal for a directive
Recital 24
Recital 24
(24) The patient should, in any event, not derive a financial advantage from the healthcare provided in another Member State and the assumption of costs should be therefore limited only to actual costs of healthcare received. Member States may decide to cover other related costs, such as travel and accommodation or therapeutic treatment provided that the total cost does not exceed the amount payable in the Member State of affiliation.
Amendment 132 #
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 143 #
Proposal for a directive
Recital 30
Recital 30
(30) There is no definition of what constitutes hospital care throughout the different health systems of the Community, and different interpretations could therefore constitute an obstacle to the freedom for patients to receive healthcare. In order to overcome that obstacle, it is necessary to provide a Community definition of hospital care. Hospital care generally means care requiring the overnight accommodation of the patient. However, it may be appropriate to submit to the same regime of hospital care also certain other kinds of healthcare, if that healthcare requires use of highly specialised and cost-intensive medical infrastructure or medical equipment (e.g. high-technology scanners used for diagnosis) or involving treatments presenting a particular risk for the patient or the population (e.g. treatment of serious infectious diseases). A regularly updated list of such treatments shall be specifically defined by the Commission through the comitology procedure.
Amendment 149 #
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 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 servicesof movement. 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.
Amendment 163 #
Proposal for a directive
Recital 37
Recital 37
(37) Realising the potential of the internal market for cross-border healthcareIt requires cooperation between providers, purchasers and regulators of different Member States at national, regional or local level in order to ensure safe, high quality and efficient care across borders. This is particularly the case for cooperation in border regions, where cross- border provision of services may be the mosthealthcare may be an efficient way of organising health servicescare for the local populations, but where achieving such cross-border provision on a sustained basis requires cooperation between the health systems of different Member States. Such cooperation may concern joint planning, mutual recognition or adaptation of procedures or standards, interoperability of respective national information and communication technology systems, practical mechanisms to ensure continuity of care or practical facilitating of cross-border provision of healthcare by health professionals on a temporary or occasional basis. Directive 2005/36/EC on the recognition of professional qualifications stipulates that free provision of services of a temporary or occasional nature, including services provided by health professionals, in another Member State should not, subject to specific provisions of Community law, be restricted for any reason relating to professional qualifications. This Directive should be without prejudice to those provisions of Directive 2005/36/EC.
Amendment 170 #
Proposal for a directive
Recital 39
Recital 39
(39) Where medicinal products are authorised within the patient's Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and have been prescribed in another Member State for an individual named patient, it should be in principle possible for such prescriptions to be medically recognised and used in the patient's own Member State. The removal of regulatory and administrative barriers to such recognition is without prejudice to the need for appropriate agreement of the patients' treating physician or pharmacist in every individual case, if this is warranted by protection of human health and is necessary and proportionate to that objective. Such medical recognition should also be without prejudice to the decision of the Member State of affiliation regarding the inclusion of such medicinal products within the benefits covered by the social security system of affiliation. The implementation of the principle of recognition will be facilitated by the adoption of measures necessary for safeguarding the safety of a patient, and avoiding the misuse or confusion of medicinal products. Where a prescription is issued in the Member State of treatment for drugs which are not normally available on prescription in the Member State of affiliation it should be for the latter to decide whether to authorise exceptionally or to provide an equivalent drug on the basis of scientific evidence.
Amendment 184 #
Proposal for a directive
Recital 45
Recital 45
(45) In particular, power should be conferred on the Commission to adopt the following measures: a list of treatments, other than those requiring overnight accommodation, to be subject to the same regime as hospital care;define for the purposes of this Directive the following measures: accompanying measures to exclude specific categories of medicinal products or substances from the recognition of prescriptions issued in another Member State provided for in this Directive; a list of specific criteria and conditions that European reference networks must fulfil; the procedure for establishing European reference networks. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, or to supplement this Directive by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Amendment 193 #
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 218 #
Proposal for a directive
Article 2 - subparagraph 1 a (new)
Article 2 - subparagraph 1 a (new)
In order to accomplish the missions of general interest entrusted to their healthcare systems Member States shall follow in the application of this Directive the principles of general interest; namely universality, accessibility to good quality care, equity, solidarity and affordability of health services. In order to guarantee a high level of public health as required by Article 152 of the Treaty Member States should give precedence to those principles in cases where they conflict with the provisions of this Directive.
Amendment 249 #
Proposal for a directive
Article 4 - point (a)
Article 4 - point (a)
(a) "healthcare" means a health service provided by or under the supervision of a health professional in exercise of his profession,to patients in order to assess, prevent, maintain or restore their state of health and regardless of the ways in which it is organised, delivered and financed at national level or whether it is public or private;
Amendment 258 #
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 283 #
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 or the Member State where the patient resides if this Member State is not the same as the former;
Amendment 314 #
Proposal for a directive
Article 5 – paragraph 1 – introduction
Article 5 – paragraph 1 – introduction
1. The Member States of treatment shall be responsible for the organisation and the delivery of healthcare. In such a context and taking into accounton the basis of principles of universality, access to good quality care, equity and solidarity and the public- service missions that derive from those principles, as conferred upon health service providers, they shall define clear quality and safety standards for healthcare provided on their territory, and ensure that:
Amendment 325 #
Proposal for a directive
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) mechanisms are in place for ensuring that healthcare providers and medical emergency services are able to meet such standards, taking into account international medical science and generally recognised good medical practices;
Amendment 329 #
Proposal for a directive
Article 5 – paragraph 1 – point a a (new)
Article 5 – paragraph 1 – point a a (new)
(aa) those quality and safety standards are made publicly available in a clear and accessible format for citizens;
Amendment 334 #
Proposal for a directive
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) the application of such standards by healthcare providers and medical emergency services in practice is regularly monitored and corrective action is taken when appropriate standards are not met, taking into account progress in medical science and health technology;
Amendment 340 #
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 particular on availability, quality, safety, prices and outcomes of the healthcare provided and details of their insurance cover or other means of personal or collective protection with regard to professional liability;
Amendment 346 #
Proposal for a directive
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) patients have athe means of making complaints and arethere are free of charge mechanisms in place to guaranteed remedies and compensation when they suffer harm or become aware of harm caused arising from the healthcare they receive;
Amendment 361 #
Proposal for a directive
Article 5 – paragraph 1 – point g a (new)
Article 5 – paragraph 1 – point g a (new)
(ga) systematic and continuous efforts are made to ensure that these standards are improved, in line with the European Council Conclusions on Common values and principles in European Union Health Systems and taking into account advances in international medical science and generally recognised good medical practices as well as taking into account new health technology;
Amendment 363 #
Proposal for a directive
Article 5 – paragraph 1 a (new)
Article 5 – paragraph 1 a (new)
1a. The public authorities in the Member State of treatment monitor regularly the accessibility, quality and financial state of their healthcare systems on the basis of the data collected under Article 18 of this Directive. They take timely measures to maintain the level of public health and the financial sustainability of the social security systems.
Amendment 364 #
Proposal for a directive
Article 5 – paragraph 1 b (new)
Article 5 – paragraph 1 b (new)
1b. Member States define clearly patients’ rights and people’s rights in relation to healthcare in accordance with the Charter of Fundamental Rights of the European Union.
Amendment 372 #
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
3. In so far as it is necessary to facilitate the provision of cross-border healthcare and cross-border emergency medical services and taking as a basis a high level of protection of health, the Commission, in cooperation with the Member States, shall develop guidelines to facilitate the implementation of paragraph 1.
Amendment 398 #
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 byor paid for by the social security system of 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. Member States may decide to cover other related costs, such as accommodation and travel costs.
Amendment 480 #
Proposal for a directive
Article 8 – paragraph 3 a (new)
Article 8 – paragraph 3 a (new)
3a. No provision of this Directive requires healthcare providers and/or healthcare systems to accept for planned treatment or to prioritise patients from other Member States to the detriment of other patients with similar health needs, such as through increasing waiting time for treatment.
Amendment 534 #
Proposal for a directive
Article 9 – paragraph 4 – point (a a) (new)
Article 9 – paragraph 4 – point (a a) (new)
(aa) the urgency of the treatment,
Amendment 558 #
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. When healthcare is provided in a Member State other than that where the patient is an insured person, or in a Member State other than that where the healthcare provider resides, is registered or established, such healthcare service is provided according to the legislation of the Member State of treatment in accordance with Art.5.
Amendment 688 #
Proposal for a directive
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Member States shall facilitate development and functioning of a network connecting the national authorities or bodies responsible for health technology assessment. Member States shall set up a system based on the principles of good governance including transparency, objectiveness, fair procedures, and full stakeholder participation of all relevant groups, including social partners, health professionals, patients, scientists and industry, for the operation of the network.