Medicinal products for human use: Community code

2001/0253(COD)
The European Parliament adopted, by 504 to 30 with 16 abstentions, the report by Mrs Françoise GROSSETETE (EPP-ED, F) which aims to update an EU code relating to pharmaceutical products, together with a number of amendments. The Parliament voted for a ban on direct advertising such products, thus rejecting the Commission's proposal for a pilot project to allow information to be provided on new drugs to treat diseases such as AIDS, asthma and diabetes. With regard to patent protection, MEPs voted for a period of 10 years, which could be extended to 11 in certain circumstances, with protection for the results of clinical tests during this period. MEPs take the view that this is a sufficient time period to guarantee the viability of new products before allowing generics on the market. Parliament proposes that Member States shall take all appropriate measures to ensure that the procedure for granting an authorisation to place a medicinal product on the market is completed within 150 days of a valid application, including 80 days for scientific data analysis and preparation of the report by the rapporteur. Parliament also wants to see the new rules applying to candidate countries. �