4 Amendments of Elisabetta GARDINI related to 2012/0035(COD)
Amendment 248 #
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Applications, dDecision-making procedures and decisions to regulate the prices of medicinal products in accordance with Article 3 or towhich determine their inclusion within the scope of public health insurance systems in accordance with Articles 7 and 9 shall be considered by Member States as administrative procedures which, as such, are independent from the enforcement of intellectual property rights.
Amendment 250 #
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Paragraphs 1 and 2 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property. With a view to ensuring that the provisions of this article are properly applied, those provisions shall not prevent applications submitted to the competent authorities or decisions by competent authorities regarding the setting of the price of a given product or the inclusion of that product in public health insurance systems from being considered objective and reasonable factors that may be taken into account by the competent judicial authorities when determining whether an intellectual property right is being or will be infringed.
Amendment 253 #
Proposal for a directive
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
3a. Paragraphs 1 and 2 may be waived in Member States in which the issue of a marketing authorisation or a reimbursement authorisation for a generic product results in a change in the price of and/or reimbursement terms for the relevant reference product.
Amendment 255 #
Proposal for a directive
Article 14 – paragraph 3 b (new)
Article 14 – paragraph 3 b (new)
3b. Member States may adopt specific measures and legal procedures to protect intellectual property rights in cases where the issue of a marketing authorisation or a reimbursement authorisation for a generic product results in a change in the price of and/or reimbursement terms for the relevant reference product.