Health Council rejects proposal to lift advertising ban for medicines 

• the Council decided to require the centralised marketing authorisation of new medicines aimed at treating AIDS, cancer and neurodegenerative disorders. There will be a possibility to extend the list of diseases four years after the entry into force of the regulation.
  
  
• The other key decision taken by the Council concerns the regulatory data protection period, during which innovative pharmaceutical companies can keep their generic counterparts out of access from clinical data required to manufacture a given medical product. Based on the decision, clinical data is protected from generic manufacturers for at least a period of 10 years in the case of biotech products or those that require marketing authorisation under the centralised procedure. For other products, applications from generic drug makers are accepted after eight years but their marketing cannot take place for an additional two years.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) took the Council's political agreement as a "mixed signal" on innovation and research. EFPIA welcomed the agreement on full 10 years of data protection in mandatory centralised procedure but would have preferred an agreement to provide 10 years of regulatory data protection for all new products. EFPIA expressed concern over the tight timetable for the completion of the legislative package and warned the Council needs to reach a common position in October 2003 if the proposals are to be passed prior to the next EU enlargement.