2 Amendments of Louis GRECH related to 2012/0035(COD)
Amendment 28 #
Proposal for a directive
Recital 6
Recital 6
(6) In order to reduce the effects of the disparities on the internal market, national measures should comply with minimum procedural requirements enabling the parties concerned to verify that those measures do not constitute quantitative restrictions on imports or exports or measures having equivalent effect thereto. Those requirements are also intended to ensure more predictability, transparency, fairness and legal certainty to producers of pharmaceutical products, to contribute to encouraging research and development and the placing on the market of innovative medicinal products to the benefit of patients and to increase patient accessibility to medicinal products across the board in general. However, those requirements should not affect the policies of those Member States which rely primarily upon free competition to determine the price of medicinal products. They also should not affect national policies on price setting and on the determination of social security schemes, except as far as it is necessary to attain transparency within the meaning of this Directive and to ensure the functioning of the internal market.
Amendment 48 #
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall ensure that a reasoned and objectively justified decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation. However, with respect to medicinal products for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 15 days, provided that the price of the reference medicinal product has been approved by the competent authorities. That decision should be made available to the public in a clear and transparent manner within a reasonable time following adoption.