Activities of Alda SOUSA related to 2012/0035(COD)
Plenary speeches (2)
Transparency of measures regulating the prices of medicinal products for human use (A7-0015/2013 - Antonyia Parvanova) (vote)
Transparency of measures regulating the prices of medicinal products for human use (debate)
Shadow reports (1)
REPORT on the proposal for a directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems PDF (517 KB) DOC (660 KB)
Amendments (11)
Amendment 45 #
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 168(7) and 114 thereof,
Amendment 46 #
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 medicineal products, 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 replaced.
Amendment 49 #
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 medicineal products 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 medicineal products, to regulate their prices or to establish the conditions of their public funding. Such measures mainly aim at promoting public health for all citizens by ensuring the availability of adequate supplies of effective medicinal products at reasonable costs, while ensuring the financial stability of public health insurance systemsan equal access to high quality healthcare for all.
Amendment 60 #
Proposal for a directive
Recital 12
Recital 12
(12) In its Communication ‘Executive Summary of the Pharmaceutical Sector Inquiry Report’ the Commission demonstrated that pricing and reimbursement procedures often unnecessarily delay the launch of generic medicineor biosimilar medicinal products in Union markets. Approving the price of generic or biosimilar medicinal products and their coverage by the health insurance system should not require any new or detailed assessment when the reference product has already been priced and included in the health insurance system. It is therefore appropriate to lay down shorter time limits for generic or biosimilar medicinal products in those cases.
Amendment 65 #
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including orphan medicinal products and the bioequivalence of generic or biosimilar 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.
Amendment 74 #
Proposal for a directive
Recital 15 a (new)
Recital 15 a (new)
(15a) ) Member States should ensure the public availability of documents and information in an appropriate publication, in accordance with national practice, which should include electronic and online formats.
Amendment 76 #
Proposal for a directive
Recital 15 b (new)
Recital 15 b (new)
(15b) The principles of transparency, integrity and independence of the decision-making processes should be carried out by national competent public authorities, who are responsible for pricing and reimbursement decisions.
Amendment 78 #
Proposal for a directive
Recital 16
Recital 16
(16) Member States have frequently amended their health insurance schemes or adopted new measures falling within the scope of Directive 89/105/EEC. It is therefore necessary to establish information mechanisms intended, on the one hand, to ensure the consultation of interested stakeholders including patient and consumer organisations and, on the other hand, to facilitate preventive dialogue with the Commission as regards the application of this Directive.
Amendment 239 #
Proposal for a directive
Article 13
Article 13
Amendment 257 #
Proposal for a directive
Article 15
Article 15
Where a Member State intends to adopt or amend any measure falling within the scope of this Directive, it shall give interested parties, including patient and consumer organisations, the opportunity to comment on the draft measure within a reasonable period. The competent authorities shall publish the rules applicable to consultations. The results of consultations shall be made publicly available, with the exception of confidential information in accordance with Union and national legislation regarding business confidentiality.
Amendment 262 #
Proposal for a directive
Article 16
Article 16