53 Amendments of Anne FERREIRA related to 2008/0142(COD)
Amendment 50 #
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty establishing the European Community, and in particular Articles 95, 137 and 152 thereof,
Amendment 53 #
Proposal for a directive
Recital 1 a (new)
Recital 1 a (new)
(1a) whereas citizens’ entitlements to social security derive from their status as workers, in accordance with Article 137, in particular paragraphs 1, 2 and 4 thereof, and the Commission has a duty to guarantee the Member States’ responsibility with regard to health,
Amendment 58 #
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 facts.
Amendment 59 #
Proposal for a directive
Recital 3
Recital 3
(3) This Directive respects the fundamental rights and observes the general principles of law as recognised in particular by the Charter of Fundamental Rights of the European Union. The right of access to healthcare and the right to benefit from medical treatment under conditions established by national law and practices are recognised by Article 34(1) and (2) and Article 35 of the Charter of Fundamental Rights of the European Union. Specifically, this Directive has to be implemented and applied with due respect for the rights to private and family life, protection of personal data, equality before the law and the principle of non- discrimination and the right to an effective remedy and to a fair trial, in accordance with the general principles of law, as enshrined in Articles 7, 8, 20, 21, 47 of the Charter.
Amendment 61 #
Proposal for a directive
Recital 4
Recital 4
(4) Health and health systems in the Member States are a matter of general interest. The health systems of the CommunityMember States are a central component of Europe’s high levels of social protection, and contribute to social cohesion and social justice as well as to sustainable development. They are alsoAlthough their specific nature should be noted, at the same time they are part of the wider framework of services of general interest.
Amendment 72 #
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 ensurepermit patients’ mobility under certain conditions 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. (The third modificationalready uses the terms in the FTrench original does not apply to the English version whichaty.)
Amendment 75 #
Proposal for a directive
Recital 9
Recital 9
(9) This Directive on the application of patients’ rights in cross-border healthcare applies to all types of healthcare. As confirmed by the Court of Justice, neither their special nature nor the way in which they are organised or financed removes them from the ambit of the fundamental principle of freedom of movementindividual patients who decide to seek treatment in a Member State other than the Member State of affiliation; it may therefore apply to all types of healthcare. As regards long-term care, the Directive does not apply to assistance and support for families or individuals who are, over an extended period of time, in a particular state of need. It does not apply, for example, to residential homes or housing, or assistance provided to elderly people or children by social workers or volunteer carers or professionals other than health professionals.
Amendment 108 #
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 119 #
Proposal for a directive
Recital 23
Recital 23
(23) The patient may choose which mechanism they prefer, but iIn any case, where the application of Regulation 1408/71 is more beneficial for the patient, the patient should not be deprived of the rights guaranteed by that Regulation.
Amendment 138 #
Proposal for a directive
Recital 29
Recital 29
(29) Any healthcare which is not regarded as hospital care according to the provisions of this Directive and the law of the Member State of affiliation should be considered as non-hospital care. In the light of the case- law of the Court of Justice on the free movement of services, it is appropriate not to set a requirement of prior authorisation for reimbursement by the statutory social security system of a Member State of affiliation for non- hospital care provided in another Member State. In so far as the reimbursement of such care remains within the limits of the cover guaranteed by the sickness insurance scheme of the Member State of affiliation, the absence of a prior authorisation requirement will not undermine the financial equilibrium of social security systemsHowever, the provision of non- hospital care in another Member State requires the patient to notify the social security administration of the Member State of affiliation about it, this notification being accompanied by a statement that the patient has received all the necessary information before his departure to the other Member State where the care is to be provided. This stipulation does not call into question the principle of automatic authorisation in the case of non-hospital care.
Amendment 140 #
Proposal for a directive
Recital 30
Recital 30
(30) There is no general 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 Communitygeneral definitions of hospital care and specialised care. Hospital care generally means care requiring the overnight accommodation of the patient. However, it may beis also 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 procedurEach Member State of affiliation should draw up a list of such treatments which will be paid for by its social security system. This list must be published and should not constitute a disproportionate obstacle.
Amendment 151 #
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 therefore provide for a system of prior authorisation for assumption of costs for hospital and specialised 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 159 #
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, the period being reduced where the state of health of the patient and the urgency of the treatment so warrant. 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 164 #
Proposal for a directive
Recital 37
Recital 37
(37) Realising the potential of the internal market for cross-border healthcare requires cooperationCooperation is required 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 most efficient way of organising health services 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 167 #
Proposal for a directive
Recital 37 a (new)
Recital 37 a (new)
(37a) Directive 2005/36/EC 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 the provisions of Directive 2005/36/EC. However, Directive 2005/36/EC takes account only very imperfectly of the specific details of health care qualifications, to the detriment of patients' safety. Appropriate procedures for the recognition of qualifications should therefore be established either as part of the revision of Directive 2005/36/EC or in a specific legislative instrument.
Amendment 178 #
Proposal for a directive
Recital 41 a (new)
Recital 41 a (new)
(41a) The interoperability of on-line health solutions should be achieved in compliance with national rules on health services adopted to protect patients, including legislation on Internet pharmacies.
Amendment 185 #
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; 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 197 #
Proposal for a directive
Article 1
Article 1
Amendment 209 #
Proposal for a directive
Article 2
Article 2
This Directive shall apply to provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or privatcross-border healthcare and to individual patients who independently choose to seek healthcare abroad. This Directive shall not serve to encourage the provision of cross-border healthcare or the referral of patients by the social security scheme of a Member State to the healthcare system of another Member State in order to receive treatment there.
Amendment 223 #
Proposal for a directive
Article 3 - paragraph 1 - point (f)
Article 3 - paragraph 1 - point (f)
(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 and their implementing regulations;
Amendment 224 #
Proposal for a directive
Article 3 - paragraph 1 - points (g a) and (g b) (new)
Article 3 - paragraph 1 - points (g a) and (g b) (new)
(ga) Directive 2005/36/EC on the recognition of professional qualifications; (gb) 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 229 #
Proposal for a directive
Article 3 - paragraph 2
Article 3 - paragraph 2
Amendment 239 #
Proposal for a directive
Article 3 - paragraph 3
Article 3 - paragraph 3
Amendment 242 #
Proposal for a directive
Article 3 - paragraph 4
Article 3 - paragraph 4
Amendment 244 #
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, and regardless of the ways in which it is organised, delivered and financed at national level or whether it is publics and products provided or prescribed by a health professional to patients with a view to assessing, maintaining or restoring their state of health or preventing the appearance orf privateathologies;
Amendment 275 #
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 296 #
Proposal for a directive
Article 4 - point (l)
Article 4 - point (l)
(l) ‘harm’ means adverse health outcomes or injuries stemming from the provision of healthcare where these outcomes or injuries can be linked only to the best- endeavours obligation which requires health professionals to do everything in their power to restore a patient’s state of health.
Amendment 312 #
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 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 ensure that: [Translator’s note: The first change in French, not shown here, introduces the term used in the EC Treaty. The English already uses the term used in the Treaty (Article 152(5).]in accordance with principles of general interest, universality, access to effective, uninterrupted, good quality care close to home and at a reasonable cost, equity and solidarity, they shall define clear quality and safety standards for healthcare provided on their territory, and ensure that:
Amendment 328 #
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 are able to meet such standards, taking into account international medical science and generally recognised good medical practices, and that they are properly met;
Amendment 337 #
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 their contract status, availability, prices and outcomes of the healthcare providedreimbursement levels and procedures, quality indices and details of their insurance cover or other means of personal or collective protection with regard to professional liability;
Amendment 353 #
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 arrangement, 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 and that health professionals inform the competent authorities that they have taken out such insurance;
Amendment 392 #
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 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 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 402 #
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 had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received.
Amendment 412 #
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Member State of affiliation mayshall 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 similar healthcare was provided in its territory, in so far as they are neither discriminatory nor an obstacle to freedom of movement of persons.
Amendment 423 #
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
4. Member States shall have a mechanism for calculation of costs that are to be reimbursed to the insured person by the statutory social security system for healthcare provided in another Member State. This mechanism shall be based on objective, non-discriminatory criteria known in advance and the costs reimbursed according to this mechanism shall be not less than what would have been assumed had the same or similar healthcare been provided in the territory of the Member State of affiliation, in accordance with the provisions contained in paragraph 2.
Amendment 426 #
Proposal for a directive
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Patients travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State shall be guaranteed, by the Member State of affiliation, access to their medical records, in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC.
Amendment 437 #
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. . Any patients who receive non-hospital care in another Member State shall notify this care to the social security scheme of their Member State of affiliation before they leave to receive the care They shall also declare that they have received information concerning the care, in accordance with Article 10 of this Directive. If such a declaration is not sent with the notification of non-hospital care in another Member State, the social security scheme of the Member State of affiliation shall ascertain from the patients that they have taken steps prior to their departure to receive all the necessary information relating to this non-hospital care in another Member State.
Amendment 443 #
Proposal for a directive
Article 8
Article 8
1. For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, hospital care 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 noas 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 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. 23. This list shall be set up and may be regularly updated by the Commission. Those measures, 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).3. 3. The Member State of affiliation may provide for a system ofe Member State of affiliation shall submit for prior authorisation fthe payment or reimbursement by its social security system of the cost of hospital or specialised 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 seriousl, as defined by the Member State of affiliation in accordance with Paragraph 1. 4. The refusal of prior authorisation shall be limited to what is necessary uandermine: (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. 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 proportionate and shall not constitute a means of arbitrary discrimination. 4a. The authorisation required under Paragraph 1 may be refused if it is established that a move may compromise the patient's state of health or the provision of medical treatment. 5. The Member State shall make publicly available all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 3.
Amendment 508 #
Proposal for a directive
Article 9
Article 9
1. The Member State of affiliation shall ensure that administrative procedures regarding the use of healthcare in another Member State related to any prior authorisation referred to in Article 8(32), reimbursement of costs of healthcare incurred in another Member State and other conditions and formalities referred to in Article 6(3), are based on objective, non- discriminatory criteria which are published in advance, and which are necessary and proportionate to the objective to be achieved. In any event, an insured person shall always be granted the authorisation pursuant to Regulations on coordination of social security referred to in Art. 3.1 f) whenever the conditions of Art.22.1 c) and Art. 22.2 of Regulation 1408/71 are met. 2. Any such procedural systems shall be easily accessible and capable of ensuring that requests are dealt with objectively and impartially within time limits set out and made public in advance by the Member States. 3. Member States shall specify in advance and in a transparent way the criteria for refusal of the prior authorisation referred to in Article 8(32). 4. Member States shall, when setting out the time limits within which requests for the use of healthcare in another Member State must be dealt with, and when considering these requests, take into account: (a) the specific medical condition, (b) the patient's degree of pain, (c) the nature of the patient's disability, and (d) the patient's ability to carry out a professional activity. 5. Member States shall ensure that any administrative or medical decisions regarding the use of healthcare in another Member State are subject to administrative review, possibly on the basis of a medical opinion, and also capable of being challenged in judicial proceedings, which include provision for interim measures.
Amendment 545 #
Proposal for a directive
Article 10
Article 10
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, and the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received. In particular, the information shall contain: • a list of the healthcare covered by the health system of the Member State of affiliation and the rates of reimbursement or coverage; • the quality and safety standards applicable in another Member State. 2. The information referred to in paragraph 1 shall be made easily accessible, including by electronic means, and shall include information on of treatment; • the availability, prices, quality certifications and risks inherent in the healthcare provided, and details of the insurance cover or other means of personal or collective protection with regard to professional liability of the healthcare providers in the Member State of treatment; • a list of the healthcare providers recognised by the competent authorities of the Member State of treatment; • patients' entitlements, on procedures for accessing those entitlements and on systems of appeal and redress if the patient is deprived of such entitlementsredress if patients are deprived of such entitlements; • the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received in another Member State. The Member States shall ensure that this information complies with public health considerations, and is impartial, comparative, unbiased and complete. 2. The information referred to in paragraph 1 shall be made easily accessible, including by electronic means, and shall be gathered in accordance with the cooperation mechanism described at Article 13. 3. The Commission may, in accordance with the procedure referred to in Article 19(2), develop a standard Community format for the prior information referred to in paragraph 1.
Amendment 562 #
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Member States shall designate nationWithout prejudice to the particular organisation of their healthcare systems, Member States shall designate existing structures such as central contact points for cross-border healthcare and communicate their names and contact details to the Commission.
Amendment 611 #
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. Member States shall exchange information on disciplinary and criminal law proceedings taken on their territory against health professionals.
Amendment 612 #
Proposal for a directive
Article 13 – paragraph 2 b (new)
Article 13 – paragraph 2 b (new)
2b. Member States shall guarantee that Member States' registers of health professionals can be consulted by the counterpart competent authorities in other Member States.
Amendment 613 #
Proposal for a directive
Article 13 – paragraph 2 c (new)
Article 13 – paragraph 2 c (new)
2c. Member States shall inform the Commission of the failure by a Member State to fulfil its obligations to provide mutual cooperation and assistance. If necessary, the Commission shall take the appropriate action under Article 226 of the Treaty. The Commission shall keep Member States regularly informed about the application of provisions relating to the duty of cooperation.
Amendment 621 #
Proposal for a directive
Article 14 – paragraph 1 – subparagraph 1 a (new)
Article 14 – paragraph 1 – subparagraph 1 a (new)
These prescriptions shall be recognised without prejudice to: a) national provisions concerning the form of the medicinal product dispensed, including provisions concerning the substitution of generics; (b) national provisions concerning the reimbursement of European prescriptions; (c) all professional or moral obligations that allow the pharmacist to refuse to dispense the medicinal product that is the subject of the prescription issued in the Member State of treatment.
Amendment 631 #
Proposal for a directive
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) measures 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; prescriptions issued using this Community form must be formulated in accordance with the international non-proprietary name (INN) system;
Amendment 640 #
Proposal for a directive
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c
Amendment 648 #
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 provider services and healthcare providers for rare diseases. 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.
Amendment 653 #
Proposal for a directive
Article 15 - paragraph 2 - point c
Article 15 - paragraph 2 - point c
(c) to maximise cost-effective use of resources by concentrating them where medically appropriate;
Amendment 679 #
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 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; - the rules on access to the medical file and, more specifically, the rules on obtaining the explicit consent of the patient for access to his medical file.
Amendment 700 #
Proposal for a directive
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The Commission shall be assisted by a Committee, consisting of representatives of the Member States and chaired by the Commission representativea representative of the Member States. The Committee shall consult stakeholders, such as the representatives of payer organisations, including health mutuals, patients and health professionals (including hospitals), as it deems necessary or if one of the stakeholders so requests.
Amendment 703 #
Proposal for a directive
Article 20 – paragraph 1
Article 20 – paragraph 1
The Commission shall within fivthree years after the date referred to in Article 22(1) draw up a report on the operation of this Directive and submit it to the European Parliament and to the Council, and thereafter at least every five years. That report shall pay particular attention to the effects of the application of this Directive on access to healthcare and health services from a financial and geographical viewpoint, and on the mobility of patients and of all the actors in the Member States’ health systems. It shall involve all stakeholders and all actors, infrastructures and health systems in the Member States, including hospitals and payer organisations. If necessary, the Commission shall enclose proposals for legal amendments with the report.
Amendment 706 #
Proposal for a directive
Article 22 – paragraph 1
Article 22 – paragraph 1
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by … [onthree years after its entry into force].