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Health Council rejects proposal to lift advertising ban for medicines

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Published 04 June 2003 - Updated 04 August 2006
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pharmaceuticals review
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On 2 June, the Health Council reached political agreement on two legislative proposals in the "pharma review package". Two Member States, Belgium and the Netherlands, immediately expressed their intention to vote against the upcoming common position. A number of accession candidates also expressed reservations.

Agreement was reached particularly on two main issues, notably:
  • 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.

 

Positions: 
The European Consumers' Organisation (BEUC) welcomed the Council's decision to reject the Commission's proposal lifting the ban on advertising prescription medicines directly to consumers, which would have enabled Member States to authorise under certain conditions the provision of information on AIDS, asthma and diabetes drugs directly to patients.

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.

 

Next steps: 
The Council is to come to a political agreement on the third pillar of the pharma review package concerning veterinary medicinal products at a later stage. The three common positions will then be forwarded simultaneously to the European Parliament for a second reading.

 

Background: 
The Council has reached political agreement on two legislative proposals in the so-called "pharma review package": concerning a proposal for a regulation on the authorisation and supervision of medicinal products, as well as a proposal for a directive on the Community code for medicinal products for human use. This new legislative package juggles to provide incentive for the pharmaceutical industry to innovate and to preserve at the same time the right of patients to access cheaper products.

 

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