Activities of Andrés PERELLÓ RODRÍGUEZ related to 2012/0035(COD)
Plenary speeches (1)
Transparency of measures regulating the prices of medicinal products for human use (debate)
Amendments (6)
Amendment 56 #
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9a) The criteria underlying any decision directly or indirectly regulating the prices of medicinal products, as well as any measure determining the extent to which they shall be covered by public health insurance systems should include the assessment of unmet medical needs, clinical and social benefits and innovation, as laid down in the European Economic and Social committee opinion 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, of 12 June 20121. Such criteria should also include protection for the most vulnerable groups of the population. _____________ 1 OJ C 299, 4.10.2012 p. 83
Amendment 91 #
Proposal for a directive
Article 2 – point 5 a (new)
Article 2 – point 5 a (new)
(5a) ‘Vulnerable groups’: those sections of the population most sensitive to measures determining the extent to which medicinal products are covered by public health insurance systems, such as children, pensioners, the unemployed, those reliant on orphan drugs, the chronically ill, etc.
Amendment 215 #
Proposal for a directive
Article 7 – paragraph 7 – subparagraph 2 a (new)
Article 7 – paragraph 7 – subparagraph 2 a (new)
The criteria governing the decisions referred to in the previous paragraph shall include assessments of unmet medical needs and of the clinical benefits, the social benefits, innovation and protection of the most vulnerable groups in the population.
Amendment 217 #
Proposal for a directive
Article 7 – paragraph 8
Article 7 – paragraph 8
8. Member States shall publish in an appropriate publication and communicate to the Commission the criteria which the competent authorities must take into account when deciding whether or not to include medicinal products within the scope of the public health insurance system.These criteria shall include assessments of unmet medical needs and of the clinical benefits, the social benefits, innovation and the protection of the most vulnerable groups of the population.
Amendment 226 #
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Any decision to exclude a medicinal product from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the product concerned, shall contain a statement of reasons based on objective and verifiable criteria. Such decisions shall include assessments of unmet medical needs, the clinical impact and social costs, the protection of the most vulnerable groups of the population and any evaluation, expert opinion or recommendation on which they are based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 228 #
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Any decision to exclude a category of medicinal products from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the category concerned, shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication. These criteria shall include assessments of unmet medical needs, the clinical impact and social costs and the protection of the most vulnerable groups of the population