Activities of John BOWIS related to 2008/0142(COD)
Reports (1)
REPORT Report on the proposal for a directive of the European Parliament and of the Council on the application of patients' rights in cross-border healthcare PDF (1 MB) DOC (2 MB)
Amendments (34)
Amendment 95 #
Proposal for a directive
Recital 12
Recital 12
Given that it is impossible to know in advance whether a given healthcare provider will supply healthcare to a patient coming from another Member State or a patient from their own Member State, it is necessary that the requirements to ensure that healthcare is provided according to common principles and clear quality and safety standards are applicable to all type of healthcare in order to ensure the freedom to provide and obtain cross border healthcare which is the aim of the directive. Member States' authorities have to respect the shared overarching values of universality, access to good quality care, equity and solidarity, which have been already widely recognised by the Community institutions and by all the Member States as constituting a set of values that are shared by health systems across Europe. Members States also have to ensure that these values are respected with regard to patients and citizens from other Member States, and that all patients are treated equitably on the basis of their healthcare need rather than their Member State of social security affiliation. In doing so, Member States must respect the principles of freedom of movement within the internal market, non-discrimination inter alia with regard to nationality (or in the case of legal persons, with regard to the Member State in which they are established), necessity and proportionality of any restrictions on free movement. However, nothing in this Directive requires healthcare providers to accept for planned treatment or to prioritise patients from other Member States to the detriment of other patients with similar health needs, such as through increasing waiting time for treatment. In order to enable patients to make an informed choice when they seek to receive healthcare in another Member State, Member States shall ensure that patients receive on request the relevant information on health and quality standards enforced in the Member State of treatment as well as on the characteristics of healthcare provided by a specific healthcare provider. Such information shall also be made available in formats accessible to persons with disabilities.
Amendment 105 #
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 126 #
Proposal for a directive
Recital 25
Recital 25
(25) This Directive does not aim either to create 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 their benefits in kind scheme to healthcare provided in another Member State according to its provisions. This Directive recognises that entitlement to 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 entitlement to treatment to be determined at a regional or local level.
Amendment 156 #
Proposal for a directive
Recital 32
Recital 32
(32) The Member States should decide on the form of those national contact points as well as the number of them. The national contact points may be also incorporated in or build on activities of existing information centres provided that it is clearly indicated that they are also national contact points for cross-border healthcare. The national contact points should have appropriate facilities to provide information on the main aspects of cross- border healthcare and to provide practical assistance to patients if needed. The Commission should work together with the Member States in order to facilitate cooperation regarding national contact points for cross-border healthcare, including making relevant information available at Community level, such as through the European Health PortalMember States should ensure the participation of bodies representing health professionals in these activities. The existence of national contact points should not preclude Member States from establishing other linked contact points at regional or local level, reflecting the specific organisation of their healthcare system. The national contact points should be able to provide patients with relevant information on cross-border healthcare and to assist them. This does not include legal advice.
Amendment 188 #
Proposal for a directive
Recital 46 a (new)
Recital 46 a (new)
(46a) The Member State of affiliation and the Member State of treatment should by prior bilateral cooperation and in consultation with the patient ensure that appropriate aftercare and support is made available in either Member State following the authorised medical treatment and that clear information is available to patients about aftercare options and costs. To do this, Member States should adopt measures to ensure that: (a) the necessary medical and social care data is transferred with due regard to patient confidentiality; (b) medical and social care professionals in both countries are able to consult each other to ensure the highest quality treatment and aftercare (including social support) for the patient.
Amendment 192 #
Proposal for a directive
Article 1
Article 1
This Directive establishes a general framework for the provision of safe, high quality and efficient cross-borderprovides rules for access to safe and high-quality healthcare in another Member State and establishes cooperation mechanisms on healthcare between Member States, in full respect of national competencies in organising and delivering healthcare.
Amendment 220 #
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 225 #
Proposal for a directive
Article 3 - paragraph 1 - point (g a) (new)
Article 3 - paragraph 1 - point (g a) (new)
(ga) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC;
Amendment 226 #
Proposal for a directive
Article 3 - paragraph 1 - point (g b) (new)
Article 3 - paragraph 1 - point (g b) (new)
(gb) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells;
Amendment 227 #
Proposal for a directive
Article 3 - paragraph 1 - point (g c) (new)
Article 3 - paragraph 1 - point (g c) (new)
(gc) Directive 92/49/EEC on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance, as regards the implementing powers conferred on the Commission;
Amendment 238 #
Proposal for a directive
Article 3 - paragraph 3
Article 3 - paragraph 3
Amendment 246 #
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 or prevent them from becoming ill, regardless of the ways in which it is organised, delivered and financed at national level or whether it is public or private;
Amendment 250 #
Proposal for a directive
Article 4 - point (a)
Article 4 - point (a)
(a) "healthcare" means a health service provids or goods, including pharmaceuticals and medical devices provided or prescribed by or under the supervision of a health professional in exercise of his profession, and regardless of the ways in which itcare is organised, delivered and financed at national level or whether it is public or private;
Amendment 255 #
Proposal for a directive
Article 4 - point (b)
Article 4 - point (b)
(b) "cross-border healthcare" means healthcare provided in a Member State other than that where the patient is an insured person or healthcare provided in a Member State other than that where the healthcare provider resides, is registered or is established;
Amendment 261 #
Proposal for a directive
Article 4 - point (c)
Article 4 - point (c)
Amendment 266 #
Proposal for a directive
Article 4 - point (d)
Article 4 - point (d)
(d) "health professional" means a doctor of medicine or a nurse responsible for general care or a dental practitioner or a midwife or a pharmacist within the meaning of Directive 2005/36/EC or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC; or a person legally exercising healthcare activities in the Member State of treatment;
Amendment 271 #
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 287 #
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 292 #
Proposal for a directive
Article 4 - point (l)
Article 4 - point (l)
(l) "harm" means adverse outcomes or injuries stemming from the provision of healthcaris defined in cross-border healthcare through reference to the existing legal framework of the Member State of treatment and understanding of what constitutes harm may vary from Member State to Member State.
Amendment 357 #
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, 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 person who has similar health needs and is an insured person of the Member State of treatment.
Amendment 411 #
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 or goods. This may include a requirement that the insured person is assessed for the purpose of referral to a healthcare provider in other Member States.
Amendment 419 #
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
4. For the purposes of the provisions of this paragraph, Member States shall have a mechanism for calculation of costs that are to be reimbursed to the inassurmed 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.
Amendment 492 #
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 or an obstacle to freedom of movement of persons. Subject to the referrals procedures in the Member State of affiliation, patients affected by rare diseases should have the right to choose where to access healthcare without prior authorisation.
Amendment 515 #
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Any such procedural systems shall be easily accessible and capable of ensuring that requests are dealt with objectively and impartially within reasonable time limits set out and made public in advance by the Member States. Urgency and individual circumstances shall be taken into account when dealing with such requests.
Amendment 523 #
Proposal for a directive
Article 9 – paragraph 3 a (new)
Article 9 – paragraph 3 a (new)
3a. Member States may offer patients a voluntary system of prior notification whereby, in return for such notification, the patient shall receive a voucher indicating the maximum reimbursable cost. This voucher can then be taken to the hospital of treatment and reimbursement would then be made direct from the Member State of affiliation.
Amendment 527 #
Proposal for a directive
Article 9 – paragraph 4
Article 9 – paragraph 4
Amendment 610 #
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. Member States may exchange information about ethical and criminal procedures against healthcare providers.
Amendment 616 #
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. 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 in respect of that medicine can be used in their territory and that any restrictions on recognition of individual prescriptions are prohibited unless they: (a) are limited to what is necessary and proportionate to safeguard human health and are non-discriminatory or (b) are based on legitimate and justified doubts about the authenticity or content of an individual prescription, or the status of the prescriber.
Amendment 618 #
Proposal for a directive
Article 14 – paragraph 1 – subparagraph 1 a (new)
Article 14 – paragraph 1 – subparagraph 1 a (new)
The recognition of such prescription shall not affect: (i) national rules governing dispensing, including generic substitution; (ii) national rules governing the reimbursement of European prescriptions; (iii) any professional or ethical duty that would require the pharmacist to refuse to dispense had the prescription been issued in the Member State of treatment.
Amendment 634 #
Proposal for a directive
Article 14 – paragraph 2 – point b a (new)
Article 14 – paragraph 2 – point b a (new)
(ba) measures to ensure, if needed, contact between the prescribing party and the dispensing party in order to ensure complete understanding of the treatment;
Amendment 637 #
Proposal for a directive
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c
Amendment 659 #
Article 15 - paragraph 3 - introductory part
3. THaving consulted key stakeholders, the Commission shall adopt:
Amendment 682 #
Proposal for a directive
Article 16 – paragraph 1 a (new)
Article 16 – paragraph 1 a (new)
Member States shall ensure that the use of e-Health and other telemedicine services adhere to the same quality and safety standards as those in use for non- electronic healthcare provision.
Amendment 686 #
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. It shall set up an operation based on the principles of good governance including transparency, objectiveness, fairness of procedures, and full stakeholder participation of all relevant groups including health professionals, patients, scientists and industry, except in cases where national law precludes the participation of one or more of these stakeholders.