6 Amendments of Anja WEISGERBER related to 2012/0035(COD)
Amendment 52 #
Proposal for a directive
Recital 8
Recital 8
(8) Due to diversity of national measures managing the consumption of medicines, regulating their prices or establishing the conditions of their public funding it is necessary to clarify Directive 89/105/EEC. In particular this Directive should cover all types of measures devised by Member States and susceptible to impact the internal market. Since the adoption of Directive 89/105/EEC, the pricing and reimbursement procedures have evolved and have become more complex. While some Member States have interpreted the scope of Directive 89/105/EEC restrictively, the Court of Justice ruled that those pricing and reimbursement procedures fall within the scope of Directive 89/105/EEC given the objectives of that Directive and the need to ensure its effectiveness. Therefore, this Directive should reflect the developments in national pricing and reimbursement policies. Given thatDespite the existence of specific rules and procedures exist in the area of public procurement and voluntary contractual agreements, national measures involving public procurement and voluntary contractual agreements should only be excluded from the scope of this Directive to the extent that the voluntary agreements also allow transparency about the drug sales price which is of primary concern to the insured person. It must be clear to doctors and pharmacists as distribution points for drugs which costs are incurred by the patient and the health care systems for a medicine in order to be able to choose the most economically rational drug regardless of the type of agreement.
Amendment 65 #
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2 a (new)
Article 5 – paragraph 3 – subparagraph 2 a (new)
Member States shall ensure that dispensaries possess information about the actual price of the medicinal product in order to prevent possible distorting effects caused by a lack of transparency in prices displayed on the market.
Amendment 83 #
Proposal for a directive
Article 1 – paragraph 2 – subparagraph 1 – point a
Article 1 – paragraph 2 – subparagraph 1 – point a
(a) voluntary contractual agreements concluded between public authorities and the holder of a marketing authorisation for a medicinal product that have as their object to enable the effective provision of this medicine to patients under specific conditions, provided that such arrangements also meet the transparency requirements of Article 5, paragraph 3 a (new);
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 172 #
Proposal for a directive
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3a. Member States shall ensure that dispensaries possess information about the sale price of the medicinal product applicable to the insured person in order to prevent possible distorting effects caused by a lack of transparency in prices displayed on the market.
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.