2 Amendments of Karin KADENBACH related to 2012/0035(COD)
Amendment 54 #
Proposal for a directive
Recital 9
Recital 9
(9) Any measure to regulate, either directly or indirectly, the prices of medicinal products, as well as any measure, including recommendations that may be required, to determine their coverage by public health insurance systems should be based on objective and verifiable criteria that are independent from the origin of the product and should provide adequate legal remedies, including judicial remedies, to affected companies. These requirements should equally apply to national, regional or local measures to control or promote the prescription of specific medicinal products as such measures also determine their effective coverage by health insurance systems.
Amendment 57 #
Proposal for a directive
Recital 10
Recital 10
(10) Applications to approve the price of a medicinal product or to determine its coverage by the health insurance system should not delay the placing on the market of that product beyond what is necessary. It is therefore desirable that this Directive sets out mandatory time limits within which national decisions should be made. In order to be effective, the prescribed time periods should run from the receipt of an application until the entry into force of the corresponding decision. They should include all recommendations and expert evaluations, including health technology assessments where applicable, and all administrative steps required for the decision to be adopted and take legal effect.