12 Amendments of Justas Vincas PALECKIS related to 2012/0035(COD)
Amendment 47 #
Proposal for a directive
Recital 2
Recital 2
(2) In order to take into account the evolution of the pharmaceutical market and of national policies to control public expenditure on medicines, substantive changes are necessary to all major provisions of Directive 89/105/EEC. Therefore, in the interest of clarity, Directive 89/105/EEC should be replacamended;.
Amendment 55 #
Proposal for a directive
Recital 9
Recital 9
(9) Any measure to regulate, either directly or indirectly, the prices of medicinal products, as well as any measure to determine their coverage by public health insurance systems should be based on objective and verifiable criteria that are independent from the origin of the product and should provide adequate legal remedies, including judicial remedies, to affected companies. These requirements should equally apply to national, regional or local measures to control or promote the prescription of specific medicinal products as such measures also determine their effective coverage by health insurance systems.
Amendment 64 #
Proposal for a directive
Recital 13
Recital 13
Amendment 107 #
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall ensure that a 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 1530 days, provided that the generic product is essentially similar to the reference medicinal product, according to Directive 2001/83/EC and that the price of the reference medicinal product has been approved by the competent authorities.
Amendment 120 #
Proposal for a directive
Article 3 – paragraph 5
Article 3 – paragraph 5
5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. However, with respect to medicines 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 in all events 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
Amendment 151 #
Proposal for a directive
Article 4 – paragraph 4 – subparagraph 2
Article 4 – paragraph 4 – subparagraph 2
The applicant shall furnish the competent authorities with adequate information, including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
Amendment 159 #
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons. These reasons must be drawn from a pre-defined list determined and published in an appropriate publication by the Member State. The application shall contain an adequate statement of reasons. Member States shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in time. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 192 #
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Member States shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system, submitted by the marketing authorisation holder in accordance with the requirements laid down in the Member State concerned, is adopted and communicated to the applicant within 60 days of its receipt. 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 1530 days, provided that the generic product is essentially similar to the reference medicinal product, according to Directive 2001/83/EC and that the reference medicinal product has already been included in the public health insurance system.
Amendment 202 #
Proposal for a directive
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. 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 1530 days, provided that the reference medicinal product has already been included in the public health insurance system. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelinesgeneric product is essentially similar to the reference medicinal product, according to Directive 2001/83/EC and that the reference medicinal product has already been included in the public health insurance system.
Amendment 211 #
Proposal for a directive
Article 7 – paragraph 6
Article 7 – paragraph 6
6. Irrespective of the organisation of their internal procedures, Member States shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this Article and the price approval procedure set out in Article 3 does not exceed 120 days. However, with respect to the medicinal products for which Member States use health technology assessment as part of their decision-making process, the time limit shall not exceed 180 days. With respect to generic medicinal products, that time limit shall not exceed 360 days, provided that the generic product is essentially similar to the reference medicinal product, according to Directive 2001/83/EC and that the reference medicinal product has already been included in the public health insurance system. Those time-limits may be extended in accordance with paragraph 5 of this Article or Article 3(5).
Amendment 220 #
Proposal for a directive
Article 8
Article 8
Amendment 259 #
Proposal for a directive
Article 15 a (new)
Article 15 a (new)
Article 15a Price transparency 1. At least once a year, the competent authorities shall publish in an appropriate publication and communicate to the Commission, a complete list of the medicinal products covered by their health insurance systems, the prices of which have been fixed during the relevant period, together with the prices which may be charged for such products. 2. The Commission and the Member States shall examine how to continue to co-operate on the functioning of the EURIPID price information database, which provides EU-wide added value in terms of price transparency.