4 Amendments of Peter LIESE related to 2012/0035(COD)
Amendment 90 #
Proposal for a directive
Article 2 – point 5 a (new)
Article 2 – point 5 a (new)
(5a) "voluntary contractual agreement" as referred to in Article 1(2), point (a) means an agreement concluded between public authorities and the marketing authorisation holder for a medicinal product which is neither mandatory or required by law nor is the agreement the only alternative to be included in the national pricing and reimbursement scheme.
Amendment 155 #
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. In the event of a price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a Member State, that Member State shall publish a statement of reasons for its decision based on objective and verifiable criteria, including, if applicable, a justification of the categories of products subject to the price freeze or price reduction. Member States shall carry out an annual review.
Amendment 173 #
Proposal for a directive
Article 5 a (new)
Article 5 a (new)
Article 5a Member States shall ensure that the patient or the insured person also genuinely has the benefit of the agreed reimbursement prices. Any possible lack of transparency at dispensaries which results in distortion because of failure to present prices transparently shall be avoided.
Amendment 278 #
Proposal for a directive
Article 19 a (new)
Article 19 a (new)
Article 19a Monitoring and Reporting 1. Three years after entry into force of this Directive the Commission shall submit a report to the European Parliament and to the Council assessing the enforcement of this Directive. 2. The Commission shall be equipped with sufficient resources to monitor the enforcement of the Directive.