EU hangs back from mandatory EMEA filings

At a 2 June meeting, the European Union's Employment, Social Policy, Health and Consumer Affairs Council reached an agreement on the proposals by the European Commission to modernise the current pharmaceutical legislation in Europe. Crucially, the Member States did not press ahead with proposals to implement a mandatory centralised marketing authorisation scheme for all medicines, to the relief of the pharma industry.

They agreed that centralised applications should cover medicines for the treatment of cancer, AIDS, neurodegenerative diseases and diabetes, concluding that industry should have the choice between filing with the European Medicines Evaluation Agency and a de-centralised procedure based on mutual recognition of national approvals for medicines for other types of diseases.

Erkki Liikanen, European commissioner for Enterprise, said: "The reinforcement of the centralised procedure will help speed up the marketing authorisations in Europe. This will mean faster access to market for the pharmaceutical industry and quicker access to newer and better medicines for patients for these types of illnesses. This is a genuine win-win situation.​"

Another sensitive issue discussed at the meeting was that of a so-called data protection scheme, referring to the protection of the clinical and preclinical data aimed at proving that a new compound is safe and effective. This form of intellectual property for drugs approved under the centralised process should last for 10 years, the Council agreed, with the possibility to extend this by one year if the producer can demonstrate that the medicine can be used for a new treatment.

For medicines authorised under the de-centralised procedure or optional centralised procedure, the period would also be 10 years, with the possibility that generic medicine manufacturers could file for approval two years before the expiry of this period. Liikanen said this agreement represented a good balance between keeping the necessary incentives for innovation in Europe while ensuring better access for Europe's patients to generic drugs.

"With today's agreement, we have taken an important step towards ensuring that Europe gets a more robust, modern, effective and competitive regulatory framework for pharmaceuticals. Despite the fact that the Member States on some issues did not follow our proposal, this is a well balanced compromise​," concluded Liikanen.

Industry's response was less positive, with the European Federation of Pharmaceutical Industries and Associations describing the outcome of the meeting as a "mixed signal​." EFPIA said it welcomed the data protection proposals but disagreed with the Council's decision to grant weaker protection to products filed via the de-centralised and optional centralised routes.

In addition, EFPIA said: "The agreement on one additional year of data protection for significant new indications for mandatory products in the Centralised Procedure is welcomed. However, the Council's decision not to provide similar data protection for significant new indications in other disease areas is illogical, provides no support for research and innovation and is ultimately detrimental to the interests of patients with these diseases.​"

The industry group also said that the lack of agreement on some other aspects of the proposed legislation, for example concerning veterinary medicines, has made it fearful that the programme will not be implemented prior to EU enlargement in 2004.