Activities of Françoise GROSSETÊTE related to 2012/0035(COD)
Plenary speeches (1)
Transparency of measures regulating the prices of medicinal products for human use (debate)
Amendments (8)
Amendment 50 #
Proposal for a directive
Recital 4
Recital 4
(4) Member States have been confronted to a steady rise in pharmaceutical expenditure over the last decades, leading to the adoption of increasingly innovative and complex policies to manage the consumption of medicines in the framework of their public health insurance systems. In particular, Member States’ authorities have implemented a broad range of measures to control the prescription of medicines, to regulate their prices or to establish the conditions of their public funding. Such measures mainly aim at promoting public health by ensuring the availability of adequate supplies of medicinal products at reasonable costs, while ensuring the financial stability of public health insurance systems. These measures should also aim to promote research and development of new medicinal products and to recognise medical innovation.
Amendment 70 #
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products 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. Similarly, in the case of orphan drugs, Member states shall not re-assess the criteria of the orphan designation.
Amendment 71 #
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 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 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 procedurprocedures for reimbursement of generic medicines in the Member States.
Amendment 80 #
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
1. Member States shall ensure that any national, regional or local measure, whether laid down by law, regulation or administrative action, to control the prices of medicinal products for human use or to determine the range of medicinal products covered by public health insurance systems, including the extent and conditions of their coverage, complies with the requirements of this Directive. Member States shall ensure that these measures are not duplicated at regional or local level in their respective states.
Amendment 85 #
Proposal for a directive
Article 1 – paragraph 3 a (new)
Article 1 – paragraph 3 a (new)
3a. This Directive may not call into question granted as per the procedure referred to in Article 6 of Directive 2001/83/EC.
Amendment 93 #
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in time or by the applicant once the Committee for Medicinal Products for Human Use (set up by Regulation (EC) No 726/2004) or a competent national authority has delivered a favourable opinion. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 176 #
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States shall ensure that an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time or by the applicant once the Committee for Medicinal Products for Human Use (set up by Regulation (EC) No 726/2004) or a competent national authority has delivered a favourable opinion. If the public health insurance system comprises several schemes or categories of coverage, the marketing authorisation holder or the applicant shall be entitled to apply for the inclusion of its product in the scheme or category of its choice. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 245 #
Proposal for a directive
Article 13
Article 13
In the framework of pricing and reimbursement decisions, Member States shall not re-assess the elements on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product or the criteria for orphan designation.