24 Amendments of Peter LIESE related to 2008/0142(COD)
Amendment 60 #
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 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, the fundamental ethical choices of Member States 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 65 #
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
(5a) This Directive respects and does not prejudice the freedom of each Member State to decide what type of healthcare it considers appropriate. No provision of this Directive should be interpreted in such a way as to undermine the fundamental ethical choices of Member States, in particular as regards the protection of the right to life of every human being.
Amendment 87 #
Proposal for a directive
Recital 11
Recital 11
(11) As recognised by the Member States in the Council Conclusions on Common values and principles in European Union Health Systems there is a set of operating principles that are shared by health systems throughout the Community. These operating principles include quality, safety, care that is based on evidence and ethics, patient involvement, redress, the fundamental right to privacy with respect to the processing of personal data, and confidentiality. Patients, professionals and authorities responsible for health systems must be able to rely on these shared principles being respected and structures provided for their implementation throughout the Community. It is therefore appropriate to require that it is the authorities of the Member State on whose territory the healthcare is provided, who are responsible for ensuring compliance with those operating principles. This is necessary to ensure the confidence of patients in cross-border healthcare, which is itself necessary for achieving patients' mobility and free movement of provision of healthcare in the internal market as well as a high level of health protection. In view of these common values it is nevertheless accepted that Member States take different decisions on ethical grounds as regards the availability of certain treatments and the concrete access conditions. This Directive is without prejudice to ethical diversity. It does not impose on Member States to make treatments and services accessible their territory or to reimburse costs for those treatments (received in another Member State) which are not allowed under national laws, regulations and codes of conduct of the medical professions.
Amendment 107 #
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 135 #
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 in that Member State, even if the medicinal product is not authorised for marketing in the Member State of affiliation, insofar as it is an indispensable part of obtaining effective treatment in another Member State.
Amendment 169 #
Proposal for a directive
Recital 39
Recital 39
(39) Where medicinal products are authorised within the patient's Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and have been prescribed in another Member State for an individual named patient, it should be in principle possible for such prescriptions to be medically recognised in pharmacies and used in the patient's own Member State. The removal of regulatory and administrative barriers to such recognition is without prejudice to the need for appropriate agreement of the patients' treating physician or pharmacist in every individual case, if this is warranted by protection of human health and is necessary and proportionate to that objective. Such medical recognition should also be without prejudice to the decision of the Member State of affiliation regarding the inclusion of such medicinal products within the benefits covered by the social security system of affiliation and without prejudice to the validity of national pricing and payment rules. The implementation of the principle of recognition will be facilitated by the adoption of measures necessary for safeguarding the safety of a patient, and avoiding the misuse or confusion of medicinal products.
Amendment 176 #
Proposal for a directive
Recital 41 a (new)
Recital 41 a (new)
(41a) The interoperability of e-health solutions should be achieved whilst respecting national regulations on the provisions of health services adopted in order to protect the patient, including legislation on internet pharmacies, in particular national bans on mail order of prescription-only medicinal products in accordance with the case-law of the European Court of Justice and Directive 97/7/EC on the protection of consumers in respect of distance contracts.
Amendment 214 #
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 private. This Directive shall not apply to services whose main focus is in the field of long-term care, especially including those services provided over an extended period of time whose purpose is to support people in need of assistance in carrying out routine, everyday tasks.
Amendment 251 #
Proposal for a directive
Article 4 - point (a)
Article 4 - point (a)
(a) "healthcare" means a health service provids or products, in particular medical or pharmaceutical services and medicinal products or medical devices, provided by, prescribed by or under the supervision of a health professional in the exercise of his profession, and regardless of the ways in which it isthey are organised, delivered and financed at national level or whether it isthey are public or private;
Amendment 298 #
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 and which can only be related to the obligation of effort of the health professional.
Amendment 305 #
Proposal for a directive
Article 5
Article 5
Amendment 385 #
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, including administrative regulations, guidelines and codes of conduct of the medical professions, 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. Healthcare can only be considered as being similar if it does not contravene the laws, regulations and codes of conduct of the medical professions of the Member State of affiliation. 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 413 #
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 including codes of conduct of the medical professions 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 neitherot discriminatory nor an obstacle to freedom of movement of persons.
Amendment 571 #
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 guarantee applicable national standards 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;
Amendment 579 #
Proposal for a directive
Article 12 – paragraph 2 – point b - d
Article 12 – paragraph 2 – point b - d
Amendment 614 #
Proposal for a directive
Article 14
Article 14
Amendment 615 #
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. If a medicinal product is authorised to be marketed on theirits territory in accordance with Article 6(1) of Directive 2001/83/EC, a Member States shall ensure that prescriptions for this medicinal product issued by an authorised person in another Member State for a named patient can after recognition by a doctor be used in theirits 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 about the authority of the prescriber. Costs will be reimbursed according to the conditions applying in the Member State of affiliation.
Amendment 620 #
Proposal for a directive
Article 14 – paragraph 1 – subparagraph 1 a (new)
Article 14 – paragraph 1 – subparagraph 1 a (new)
The recognition of such a prescription shall not affect the application of the following national regulations: (i) rules governing the dispensing of medicinal products, including generic substitution, (ii) rules relating to pricing and reimbursement, (iii) professional or ethical rules which would require the pharmacist to refuse to dispense had the prescription been issued in his own Member State.
Amendment 633 #
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 in accordance with this EU template shall be written in International Nonproprietary Names (INN).
Amendment 635 #
Proposal for a directive
Article 14 – paragraph 2 – point ba (new)
Article 14 – paragraph 2 – point ba (new)
(ba) measures to facilitate the establishment of contacts between the prescriber and the dispenser, so as to clarify any doubts concerning the prescription.
Amendment 639 #
Proposal for a directive
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c
Amendment 649 #
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, in particular in the area of 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 693 #
Proposal for a directive
Article 17 – paragraph 2 – point b
Article 17 – paragraph 2 – point b
(b) to support provision of objective, reliable, timely, transparent and transferable information on the short- and long-term effectiveness of health technologies, and on possible side-effects and effects on society, and enable an effective exchange of this information between national authorities or bodies.
Amendment 694 #
Proposal for a directive
Article 17 – paragraph 4
Article 17 – paragraph 4