Activities of Kurt LECHNER related to 2008/0142(COD)
Legal basis opinions (0)
Amendments (8)
Amendment 80 #
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, as it is an indispensable part of obtaining this specific effective treatment for the patient in another Member State.
Amendment 98 #
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 medically or 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 141 #
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 355 #
Proposal for a directive
Article 14 – paragraph 1 – introductory part
Article 14 – paragraph 1 – introductory part
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 for that medicinal product by an authorised person in another Member State for a named patient can be used in their territory and that any restrictions on recognition of individual prescriptions are prohibited unless they:
Amendment 358 #
Proposal for a directive
Article 14 – paragraph 1 – point b
Article 14 – paragraph 1 – point b
(b) are based on legitimate and justified doubts about the authenticity or content of an individual prescription or about the prescribing party's right to issue the prescription.
Amendment 360 #
Proposal for a directive
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1a. The recognition of such a prescription shall not affect the application of: (i) national rules on the dispensing of medicinal products, including generic substitution, (ii) national rules on pricing and reimbursement, (iii) national professional rules under which a pharmacist would be entitled to refuse to dispense if the prescription had been issued in his own Member State.
Amendment 368 #
Proposal for a directive
Article 14 – paragraph 2 – point b a (new)
Article 14 – paragraph 2 – point b a (new)
ba) measures to facilitate contact between the prescribing party and the dispensing party with a view to resolving uncertainties about prescription;
Amendment 370 #
Proposal for a directive
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c