53 Amendments of Linda McAVAN related to 2008/0142(COD)
Amendment 70 #
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 and 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 the organisation and delivery of healthcare and medical care and social security benefits in particular for sickness.
Amendment 100 #
Proposal for a directive
Recital 15
Recital 15
(15) Research suggests that harm arises from healthcare in around 10% of cases. Ensuring clear common obligationsthat Member States of treatment have systems in place (including provision of aftercare) to deal with circumstances of responding to harm arising from healthcare as defined by the Member State of treatment is therefore essential to avoid lack of confidence in those mechanisms acting as an obstacle to taking up cross- border healthcare. Coverage for harm and compensation by the systems of the country of treatment should be without prejudice to the possibility for Member States to extend the coverage of their domestic systems to patients from their country seeking healthcare abroad, where this is more appropriate to the patient, in particular in the case of patients for whom use of healthcare in another Member State is necessary.
Amendment 113 #
Proposal for a directive
Recital 21
Recital 21
(21) It is appropriate to require that also patients who go for healthcare to another Member State in other circumstances than those envisaged for coordination of social security schemes established by the Regulation (EC) No. 1408/71 should be able to benefit from the principles of free movement of services in accordance with the Treaty and the provisions of this Directive. Patients should be guaranteed assumption of the costs of that healthcare at least at the level provided for the same or similarat healthcare had they been provided in the Member State of affiliation. This fully respects responsibility of the Member States to determine the extent of the sickness cover available to their citizens and prevents any significant effect on the financing of the national healthcare systems. Member States may nevertheless provide in their national legislation for reimbursement of the costs of the treatment at the tariffs in force in the Member State of treatment if this is more beneficial for the patient. This may be the case in particular for any treatment provided through European reference networks as mentioned in Article 15 of this Directive.
Amendment 125 #
Proposal for a directive
Recital 25
Recital 25
(25) This Directive does not aim either to crerecognises thate entitlement for reimbursement of treatment in another Member State, if such a treatment is not among the benefits provided for by the legislation of the patient's Member State of affiliation. Equally this Directive does not prevent the Member States from extending theito treatment is not always determined nationally by Member States and that Member States may organise their own healthcare and social security systems to provide for benefits in kind schtitlement to healthcare provided in another Member Sttreatment to be determined ate according to its provisions regional or local level.
Amendment 130 #
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 also 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 136 #
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 142 #
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 150 #
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 services. 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. The Member State of affiliation shall specify in advance and in a transparent way the criteria for refusal of the prior authorisation related to the overriding reasons of general interest.
Amendment 158 #
Proposal for a directive
Recital 32
Recital 32
(32) In any event, if a Member State decided to establish a system of prior authorisation for assumption of costs of hospital or specialised care provided in another Member States in accordance with the provision of this Directive, the costs of such care provided in another Member State should also be reimbursed by the Member State of affiliation up to the level of costs that would have been assumed had the same or similarat healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received. However, when the conditions set out in Article 22(2) of Regulation (EC) No 1408/71 are fulfilled the authorisation should be granted and the benefits provided in accordance with that Regulation. This applies in particular in instances where the authorisation is granted after an administrative or judicial review of the request and that the person concerned has received the treatment in another Member State. In that case Articles 6, 7, 8 and 9 of this Directive shall not apply. This is in line with the case law of the Court of Justice which has specified that patients who received a refusal of authorisation subsequently held to be unfounded, are entitled to have the cost of the treatment obtained in another Member State reimbursed in full according to the provisions of the legislation in the Member State of treatment.
Amendment 182 #
Proposal for a directive
Recital 45
Recital 45
Amendment 190 #
Proposal for a directive
Article 1
Article 1
This Directive establishes a general framework for the provision of safe, high quality and efficient cross-border healthcareprovides rules for access to safe and high-quality healthcare in another Member State and establishes cooperation mechanisms for healthcare between Member States, in full respect of national competencies in organising and delivering healthcare. In the application of this Directive, Member States shall take into account principles of universality, access to good quality care, equity and solidarity.
Amendment 212 #
Proposal for a directive
Article 2
Article 2
This Directive shall apply to provision of cross-border healthcare regardless of how it is organised, delivered and financed or whether it is public or private.
Amendment 221 #
Proposal for a directive
Article 3 - paragraph 1 - points (- a a) and (- a b) (new)
Article 3 - paragraph 1 - points (- a a) and (- a b) (new)
(-aa) Directive 2005/36/EC on the recognition of professional qualifications; (-ab)Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market;
Amendment 236 #
Proposal for a directive
Article 3 - paragraph 2 a (new)
Article 3 - 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 248 #
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, ands and goods provided or prescribed by health professionals to patients to assess, maintain or restore their state of health, regardless of the ways in which it is organised, delivered and financed at national level or whether it is public or private;
Amendment 274 #
Proposal for a directive
Article 4 - point (f)
Article 4 - point (f)
(f) "patient" means any natural person who receives or wisheseeks to receive healthcare in a Member State;
Amendment 288 #
Proposal for a directive
Article 4 - point (j a) (new)
Article 4 - point (j a) (new)
(ja) "medical device" means a medical device as defined by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices or by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices or by Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices;
Amendment 290 #
Proposal for a directive
Article 4 - point (k a) (new)
Article 4 - point (k a) (new)
(ka) "health technology" means a medicinal product or a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare.
Amendment 293 #
Proposal for a directive
Article 4 - point (l)
Article 4 - point (l)
(l) "harm" means adverse outcomes or injuries stemming from the provision of healthcareis defined in cross-border healthcare through reference to the existing legal framework of each Member State of treatment.
Amendment 301 #
Proposal for a directive
Chapter II – title
Chapter II – title
Amendment 309 #
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 When healthcare is provided in another Member State than the Member State of affiliation of the patient, or in a Member State other thand the delivery of healthcare. In such a context and takingat where the healthcare provider is established, such healthcare is provided according to the legislation of the Member State of treatment into account principles of universality, access to good quality care, equity and solidarity, they shall rdance with paragraph 2 of this Article. Healthcare shall be provided in accordance with standards and guidefline clears on quality and safety standards for healthcare provideddefined by the Member State of treatment. The Member State onf their territory, andreatment shall ensure that:
Amendment 321 #
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 336 #
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, prices and outcomes of the healthcare provided and details of theirpatients with information on availability, prices and outcomes of the healthcare provided including 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 347 #
Proposal for a directive
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) patients have a means of making complaints and are guarantthere are mechanisms in place to seedk remedies and compensation when they suffer harm arising from the healthcare they receive;
Amendment 350 #
Proposal for a directive
Article 5 – paragraph 1 – point e
Article 5 – paragraph 1 – point e
(e) systems of professional liability insurance or a guarantee or similar arrangementsystems where employers must comply with vicarious liability, which are equivalent or essentially comparable as regards their purpose and which are appropriate to the nature and the extent of the risk are in place for treatment provided on their territory;
Amendment 366 #
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 368 #
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 377 #
Proposal for a directive
Chapter III – title
Chapter III – title
Amendment 379 #
Proposal for a directive
Article 6 – title
Article 6 – title
Amendment 382 #
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 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 amin another Member State. It is for the Member State of affiliationg 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 foro determine the healthcare for which the insured person is entitled to receive the reimbursement, the level of reimbursement and the level of co- payment for which the person is liable, regardless of where it is provided.
Amendment 400 #
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 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 410 #
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, 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 418 #
Proposal for a directive
Article 6 – paragraph 3 a (new)
Article 6 – paragraph 3 a (new)
3a. This Directive does not oblige healthcare providers in a Member State either to provide healthcare to an insured person from another Member State or to prioritise the provision of healthcare to an insured person from another Member State to the detriment of a patient who has similar clinical needs and who is an insured person of the Member State of treatment.
Amendment 450 #
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 care shall mean: (a) healthcare which requires overnight accommodation of the patient in question for at las defined in a list by the Member State of affiliation, limited to the areast one night.f: (ba) healthcare, included in a specific list, that does not which requires overnight accommodation of the patient in question for at least one night. This list shall be limited to: - healthcare that requires use of; or (b) healthcare which is highly specialised and/or requires use of cost-intensive medical infrastructure or medical equipment; or -(ba) healthcare involving treatments presenting a particular risk for the patient or the population.
Amendment 459 #
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 476 #
Proposal for a directive
Article 8 – paragraph 3 and 3 a (new)
Article 8 – paragraph 3 and 3 a (new)
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 sociaof 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 implementatiify in advance and in a transparent way, the criteria for refusal of the prior authorisation related to the overriding reasons 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 secgeneral interest. Prior authorisation may be refused for reasons including the following: (i) The insurer or commissioner has no evidence that there is a clinical need for the treatment; (ii) The insurer or commissioner has determined that the patient is not entitled to the treatment in question; (iii) The insurer or commissioner judges that there is a clinical risk tor to avoid hospital overcapacity, imbalancehe 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 State. y travel abroad, or that there are inadequate aftercare or follow-up arrangements in place for the treatment in question; (iv) Where the insurer or commissioner has evidence to show that the provider the patient wishes to travel to in order to receive treatment is negligent or fraudulent. 3a. Member States may also turn down requests where patients can get treatment without undue delay in the Member State of affiliation and where there is evidence of patient mobility damaging, or being likely to damage, the provision of certain treatments at either the national or local level.
Amendment 483 #
Proposal for a directive
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The 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 546 #
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The Member States of affiliation shall ensure that there are mechanisms in place to provide patients on request with information on receiving healthcare in another Member State, including information on how patients' entitlements are determined, on procedures for accessing those entitlements and on systems of appeal and redress if the patient is deprived of such entitlements, and the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received in another Member State. Member States should consult stakeholders to ensure information is clear and accessible.
Amendment 552 #
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
Amendment 554 #
Proposal for a directive
Article 10 – paragraph 3
Article 10 – paragraph 3
Amendment 580 #
Proposal for a directive
Article 12 – paragraph 2 – point b
Article 12 – paragraph 2 – point b
Amendment 587 #
Proposal for a directive
Article 12 – paragraph 2 – point c
Article 12 – paragraph 2 – point c
Amendment 589 #
Proposal for a directive
Article 12 – paragraph 2 – point d
Article 12 – paragraph 2 – point d
Amendment 594 #
Proposal for a directive
Article 12 – paragraph 3 – introductory paragraph
Article 12 – paragraph 3 – introductory paragraph
3. The Commission shall, in accordance with the procedure referred to in Article 19(2), adoptand Member States shall work together to determine:
Amendment 627 #
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 629 #
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 644 #
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
Amendment 645 #
Proposal for a directive
Article 14 – paragraph 4 a (new)
Article 14 – paragraph 4 a (new)
4a. 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 660 #
Article 15 - paragraph 3 - introductory part
3. The Commission shall adwork with the European reference networks to developt:
Amendment 673 #
Article 15 - paragraph 4
Amendment 676 #
Proposal for a directive
Article 16
Article 16
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 687 #
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.
Amendment 695 #
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.