The European Union Council of Ministers has agreed on a 'Common Position' aimed at improving the regulatory framework for human medicines in Europe, sparking the start of a second reading of the EU Pharmaceutical Review in the European Parliament.
Industry groups on the whole responded positively to the document, but had some reservations, relating mainly to the thorny issue of data protection and arriving at appropriate definitions for generics and biologicals.
Data protection refers to the intellectual property on the clinical and preclinical data aimed at proving that a new compound is safe and effective. Earlier this year, the European Commission's Council on Employment, Social Policy, and on Health and Consumer Affairs agreed that this form of intellectual property for drugs approved under the centralised process should last for 10 years. There is the possibility to extend this by one year if the producer can demonstrate that the medicine is an innovative new treatment.
However, the Council of Ministers did not fully endorse the Commission's proposals for 10 years of regulatory data protection for all new products, across the board. It agreed that 10 years data protection would apply for products submitted through the mandatory Centralised Procedure, but said that a weaker level of protection should apply for products registered through the Decentralised Procedure, i.e. via the mutual recognition route.
"This misses the opportunity to boost the innovative capacity of the pharmaceutical industry to deliver the new medicines that all patients need and expect," according to Brian Ager, director-general of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
He said the group "generally supports the agreement to build the Centralised Procedure operated by the European Agency for the Evaluation of Medicinal Products (EMEA) into a truly world class regulatory system for the registration of all new products in Europe."
EFPIA said that the agreement on one additional year of data protection for significant new indications for mandatory disease areas (AIDS, cancer, neurodegenerative diseases and diabetes) in the Centralised Procedure is welcomed. "However, the Council's decision not to provide similar data protection in other disease areas is illogical and clearly detrimental to the interests of these patients," it said.
In the interest of public health and in particular assuring patients' safety, further attention must also be given to the definition of generics and biological medicines, said EFPIA, noting that the latter are becoming increasingly important to provide new breakthroughs in medical research.
It is also important to complete this key legislation prior to the enlargement of the Union in May and European elections in June 2004, said Mr Ager.