Translation of "Conférence nationale sur l'assurance-médicaments " (French → English) :

You sponsored the national home care, pharmacare, and information technology conferences.

The new law places new tasks on both the EMA (European Medicines Agency) and the National Competent Authorities (NCA) - the national medicines regulators - in each Member State.

national measures intended to determine the prices or the coverage of medicinal products by public health insurance systems which are subject to national or Union legislation on public procurement, in particular Council Directive 89/665/EEC , Council Directive 92/13/EEC and Directive 2004/18/EC of the European Parliament and of the Council .

(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 transparent, objective and verifiable criteria that are independent from the origin of the product and should provide adequate legal remedies, including judicial remedies , in accordance with national procedures , to affected companies.

8. Calls for information campaigns to enhance consumers' awareness about products and practices that are harmful during pregnancy, in particular smoking, including second hand smoke, and use of alcohol, but also other consumer goods, such as medicinal products or chemicals, that pose health risks when taken or used during pregnancy; calls on the Commission to encourage manufacturers clearly to state on the packaging of such products that such a risk exists, in order to ensure that pregnant women are properly informed; calls on the European institutions – particularly the European Medicines Agency –, ...[+++]national institutions and consumer organisations to approach the pharmaceutical industry and its representative bodies with a view to ensuring that due account is taken of consumer diversity, with specific reference to gender-based differences, in the preparation of pharmaceutical products old and new;

On the main issues being debated at this first reading I feel that: 1- without this meaning the total elimination of the decentralised procedure (national with mutual recognition), I believe it is crucial, where the marketing authorisation is concerned, to demonstrate increasing commitment to the centralised procedure (via the European Agency for the Evaluation of Medicinal Products), in particular when it comes to new active substances, in the aim of achieving more rapid access for sufferers to new medicines and in the aim of ensuring that small and medium-sized enterprises are not penalised; 2- authorisation must be granted for the ma ...[+++]rketing of generic products whose reference medicine has been authorised for more than eight years in a Member State or in the Community (and not ten years, as the Commission proposes); 3- with regard to information, the Commission proposal is ambiguous, whereas it is crucial to ensure the ban on direct advertising.