10 Amendments of Sirpa PIETIKÄINEN related to 2012/0035(COD)
Amendment 33 #
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products an the similarity of biosimilar medicines with the reference product, are ascertained in the framework of marketing authorisation procedures. In the framework of pricing and reimbursement procedures, Member States should therefore not re- assess the elements on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product.
Amendment 36 #
Proposal for a directive
Recital 15
Recital 15
(15) In accordance with Directive 2001/83/EC, intellectual property rights do not provide a valid ground to refuse, suspend or revoke a marketing authorisation. By the same token, applications, decision-making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which, as such, are independent from the enforcement of intellectual property rights. The national authorities in charge of those procedures, when examining an application with respect to a generic or biosimilar medicinal product, should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic or biosimilar medicinal product be manufactured or placed on the market subsequently to their decision. Consequently, intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the Member States.
Amendment 46 #
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 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 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities.
Amendment 60 #
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. In the event of a temporary 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.
Amendment 67 #
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 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 1530 days, provided that the reference medicinal product has already been included in the public health insurance system.
Amendment 70 #
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 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 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 guidelines.
Amendment 72 #
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 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 92 #
Proposal for a directive
Article 13 – title
Article 13 – title
Additional proof of quality, safety, efficacy or, bioequivalence or biosimilarity
Amendment 101 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
In the framework of pricing and reimbursement decisions, Member States shall not re-assess the elementscriteria on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product.
Amendment 103 #
Proposal for a directive
Article 16
Article 16