19 Amendments of Umberto GUIDONI related to 2008/0142(COD)
Amendment 89 #
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11a) All medical treatments, excluding the basic ones, require an increasingly complex organisation process. The quality of medical treatments depend on macro- elements such as the level of professional training of operators, technological and infrastructural requirements, organisation and available resources.
Amendment 90 #
Proposal for a directive
Recital 11 b (new)
Recital 11 b (new)
(11b)The information to which patients can have free access has to be accurate and transparent and has to show, in a way understandable even to a non- professional, the results of certifications received and recognised by every Member State, including any indication about any deficit in safety and quality of services supplied.
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 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 162 #
Proposal for a directive
Recital 36 a (new)
Recital 36 a (new)
(36a) Each Member State is responsible for identifying the national networks where patients from any Member State could have free access, with the assurance of a minimum level of quality and safety, requiring a mechanism of certification of treatment processes. The certification could take place through designated international institutes that will assess elements of quality and safety and criteria of sustainability of the public and private health systems. A European board made by representatives of Member States and the most relevant alliances of patients' associations, in charge of supervising and monitoring the implementation ensured by Member States, could be put in place.
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 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 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 330 #
Proposal for a directive
Article 5 – paragraph 1 – point a a (new)
Article 5 – paragraph 1 – point a a (new)
(aa) the certification and the accreditation of treatment processes take into account elements of both quality and security and criteria of sustainability for public and private medical systems. A cost increase that cannot be estimated nor justified by a real increase in people's health could determine the collapse of public medical systems and progressive discrimination, by insurance systems, against patients affected by pathologies requiring more expensive treatments;
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 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 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 650 #
Article 15 - paragraph 1 a (new)
1a. Member States shall identify mechanisms of certification and accreditation of the national reference networks in order to guarantee treatment processes compliant with quality and safety standards. These certification mechanisms shall be provided through designated international institutes and an European board which consists of representatives of Member States and of the most relevant patients' associations. They shall be in charge of supervising and monitoring their actual implementation.
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.