Revue Prescrire, article en une, Medicines in Europe: Appeal to EU Ministers March 2003 (9)

Medicines in Europe:
Appeal to EU Ministers: don't forget the fundamentals!

The working party preparing the decisive meeting of the Council of Ministers on 2-3 June 2003 is meeting regularly and productively, but several key matters concerning public health have not yet been taken into account.

More information

Areas in which the draft Regulation remains to be improved, as of 4 February 2003
• Click here

Medicines in Europe: campaigning goes on!
• Click here

Duration of data protection: precisely worded texts to limit abuses

The current version of the draft Regulation vaguely refers to a ten-year data protection for new drugs authorised through the centralised procedure (article 13-8). It does not state the type of data or the type of protection concerned.

Given the controversy over the relevant articles of the draft Directive, and attempts by some drug companies to artificially prolong the various protections (through pseudo-innovation in pharmaceutical formulation, serial applications for new therapeutic indications, applications for more or less useful paediatric indications, complementary indications in orphan diseases, creation of a vague notion of "biosimilarity", etc.) a far more explicit text is required.

The Medicines in Europe Forum requests that the paragraphs relating to data protection in the Regulation and Directive be examined simultaneously, so that the relevant texts are consistent and take into account the viewpoints of all those concerned.




	[Retour haut de page]