Activities of Iles BRAGHETTO related to 2008/0142(COD)
Plenary speeches (1)
Patients' rights in cross-border healthcare (debate)
Amendments (32)
Amendment 46 #
Proposal for a directive
Recital 24 a (new)
Recital 24 a (new)
(24a) This Directive recognises that entitlement to treatment is not always determined by Member States at national level and that not all Member States have a defined list of the services they do or do not provide. Member States must retain the right to organise their own healthcare and social security systems in such a way that availability of treatments and entitlement to them, can be determined at a regional or local level.
Amendment 57 #
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; the list of services which fall under the headings of telemedicine services, laboratory services and remote diagnosis and prescription; 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 82 #
Proposal for a directive
Article 4 – point l
Article 4 – point l
(l) "harm" means adverse outcomes or injuries stemming from“adverse event” means an unintended injury or complication, which would not ordinarily be an outcome of the condition treated or the provision of healthcare required.
Amendment 83 #
Proposal for a directive
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. The Member States of treatment shall be responsible for the organisation and the delivery of healthcare. In such a context and taking into account principles of universality, access to good quality care, equity and solidarity, they shall define clear quality and safety standards for healthcare provided on their territory, and ensuretake into account that:
Amendment 90 #
Proposal for a directive
Article 5 – paragraph 1 – point g
Article 5 – paragraph 1 – point g
(g) patients from other Member States shall enjoy equal treatment with the nationals of the Member State of treatment, including the protection against discrimination provided for according to Community law and national legislation in force in the Member State of treatment. 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.
Amendment 95 #
Proposal for a directive
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 that insured persons travelling to another Member State with the purpose of receiving healthcare (planned care) there or seeking to receive healthcare (planned care) 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 provided.
Amendment 105 #
Proposal for a directive
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 for receiving healthcare and reimbursement 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. This may include a requirement that the insured person be assessed for the purposes of applying those conditions, criteria or formalities, by a health professional providing services for the statutory social security system of the Member State of affiliation.
Amendment 115 #
Proposal for a directive
Article 7
Article 7
Amendment 118 #
Proposal for a directive
Article 8 – Title
Article 8 – Title
Hospital and specialised care Prior authorisation
Amendment 127 #
Proposal for a directive
Recital 25 a (new)
Recital 25 a (new)
(25a) This Directive recognises that entitlement to treatment is not always determined by Member States at national level and that not all Member States have a defined list of the services they do or do not provide. Member States must retain the right to organise their own healthcare and social security systems in such a way that availability of treatments, and entitlement to them, can be determined at a regional or local level.
Amendment 134 #
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 140 #
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 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 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 concernedand other specialised care as defined by each individual Member State.
Amendment 186 #
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; a list of the services covered by telemedicine and remote laboratory, diagnostic, and prescription services; 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 14 – paragraph 1 – point (a)
Article 14 – paragraph 1 – point (a)
(a) are not limited to what is necessary, andre not proportionate to safeguard human health and are non-discriminatory or
Amendment 194 #
Proposal for a directive
Article 14 – paragraph 1 – point (b) a (new)
Article 14 – paragraph 1 – point (b) a (new)
(ba) imply a modification to the right of Member States to determine the benefits which the States themselves decide to grant.
Amendment 200 #
Proposal for a directive
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c
(c) measures to exclude specific categories of medicinal products from the recognition of prescriptions provided for under this article where the conditions referred to in paragraph 1 above apply or where necessary in order to safeguard public health.
Amendment 202 #
Proposal for a directive
Article 1
Article 1
This Directive establishes a general framework for the provision of effective, safe, high quality and efficient cross-border healthcare.
Amendment 291 #
Proposal for a directive
Article 4 - point (l)
Article 4 - point (l)
(l) “harm” means adverse outcomes or injuries stemming fromadverse event” means an unintended injury or complication, which would not ordinarily be an outcome of the condition treated or the provision of healthcare required.
Amendment 318 #
Proposal for a directive
Article 5 – paragraph 1 – introduction
Article 5 – paragraph 1 – introduction
The Member States of treatment shall be responsible for the organisation and the delivery of healthcare. In such a context and taking into account principles of universality, access to good quality care, equity and solidarity, they shall define clear quality and safety standards for healthcare provided on their territory, and ensuretake into account that:
Amendment 335 #
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 in practice is regularly monitored and assessed and corrective action is taken when appropriate standards are not met, taking into account progress in medical science and health technology;
Amendment 358 #
Proposal for a directive
Article 5 – paragraph 1 – point g
Article 5 – paragraph 1 – point g
(g) patients from other Member States shall enjoy equal treatment with the nationals of the Member State of treatment, including the protection against discrimination provided for according to Community law and national legislation in force in the Member State of treatment. 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.
Amendment 391 #
Proposal for a directive
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 that insured persons travelling to another Member State with the purpose of receiving healthcare there (planned care) or seeking to receive healthcare (planned care) 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 provided.
Amendment 414 #
Proposal for a directive
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 for receiving healthcare and reimbursement 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. 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 providing services for the statutory social security system of the Member State of affiliation.
Amendment 435 #
Proposal for a directive
Article 7
Article 7
Amendment 441 #
Proposal for a directive
Article 8 – title
Article 8 – title
Amendment 472 #
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 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 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 concernedand other specialised care as defined by each individual Member State.
Amendment 536 #
Proposal for a directive
Article 9 – paragraph 4 – point (d a) (new)
Article 9 – paragraph 4 – point (d a) (new)
(da) the formal accreditation of the healthcare provider.
Amendment 577 #
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, protection of personal data, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and conditions applicable; provide and disseminate information about any centres of excellence or care facilities considered particularly effective in the treatment of given diseases;
Amendment 622 #
Proposal for a directive
Article 14 – paragraph 1 – point (a)
Article 14 – paragraph 1 – point (a)
If a medicinal product is authorised to be marketed on their territory in accordance with Article 6(1) of Directive 2001/83/EC, Member States shall ensure that prescriptions issued by an authorised person in another Member State for a named patient can be used in their territory and that any restrictions on recognition of individual prescriptions are prohibited unless they: (a) are limited to prescriptions in question: (a) go beyond what is necessary and proportionate to safeguard human health and are non-discriminatory or
Amendment 623 #
Proposal for a directive
Article 14 – paragraph 1 – point b a (new)
Article 14 – paragraph 1 – point b a (new)
(ba) anticipate a change in the right of Member States to decide which services to provide.
Amendment 641 #
Proposal for a directive
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c
(c) measures to exclude specific categories of medicinal products from the recognition of prescriptions provided for under this aArticle where the conditions set out in paragraph 1 apply or where such measures are necessary in order to safeguard public health.
Amendment 647 #
Proposal for a directive
Article 15 - paragraph 1
Article 15 - paragraph 1
1. Member States shall facilitate the development of the European reference networks of healthcare providers, which shall draw on the health cooperation experience acquired within the European groupings of territorial cooperation (EGTCs). Those networks shall at all times be open for new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria.