Europe to reform medicines

A major extension of the powers of the European Medicines Evaluation Agency (EMEA) has been proposed by the European Commission as part of a sweeping reform of EU pharmaceutical legislation. At present the EMEA authorises only the use of high profile medicines derived from biotechnology, such as those used for cancer, AIDS, multiple sclerosis and Alzheimers disease among others.

Under the suggested new regime the EMEA would take over the evaluation of all new drugs, ending the right of pharmaceutical manufacturers to gain approvals and market new drugs in selected national markets. Companies at present can choose the latter for commercial reasons 'but they will no longer have this option for new medicines', said Martin Harvey of the London-based EMEA.

Other changes include the introduction of 'fast track' and 'compassionate use' procedures for new drugs on the lines of the policies of the Food and Drug Administration in the US.

'This is not an entirely new concept because we do it informally now but it is to be given a formal basis so that the EMEA has a clear role through a compassionate use protocol at EU level before the drug is authorised,' Mr Harvey told Manufacturing Chemist.

Finally, the package proposes a harmonisation to 10 years of the current national administrative protection periods for the approval of new medicines. Brussels said this would allow the innovative pharmaceutical industry more time to recoup investment before authorisation of a generic product. For the generic sector, the proposals will allow for authorisation tests to be performed in Europe in advance of the expiry of intellectual property provisions.

Besides helping guarantee EU-wide access to new drugs and completing the internal market for pharmaceutical products, the reforms (which also include speeded up approval procedures) will boost the competitiveness of the European pharmaceutical industry, helping it meet the challenges of enlargement and globalisation, the Commission said.