Drugs approval process gets speed treatment

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Date accessed: 9 October 2001

Drugs approval process gets speed treatment

ERICA KLARREICH

[LONDON] The European Union (EU) is mulling over changes that could halve the average time taken to approve new drug treatments.

A proposal adopted by the European Commission (EC) on 18 July would, its supporters say, cut the average licensing time for new active substances from 18 months to about 9 months. "We want to increase the availability of new and innovative medicines on the European market," says Erkki Liikanen, the EC commissioner for enterprise.

The plan will now go to the Council of Ministers, which represents the 15 members of the EU, and to the European Parliament. Both can suggest amendments. Before it can be implemented, the plan must be approved by the council and the parliament — a process that may take several years and modify the proposals significantly.

EC officials say the new plan would make the drug approvals process in Europe faster than that in the United States — although Liikanen denies that the EC is in a race with the US Food and Drug Administration (FDA) to speed up approval. "We just want to guarantee that European patients and industry have the same opportunities as anywhere else," he says.

The plan would shorten deadlines for various parts of the approval process, introducing a 'fast track' for especially promising medicines. To streamline the process, the London-based European Agency for the Evaluation of Medicinal Products would be given much broader responsibilities. At present, drug companies can choose to go through this agency to obtain EU-wide approval for drugs containing new active substances. However, most medicines are still licensed by individual member states.

In the United States, a recent acceleration of the FDA's approval processes has been criticized by consumer groups. And some health experts warn that speeding up the European procedure may endanger patients. "Probably what will happen is that the amount of data that regulators check independently will be reduced to make deadlines," says John Abraham, director of the Centre for Research in Health and Medicine at the University of Sussex.

A faster approval process will require the commission to spend more on licensing, draining resources from other public-health needs, says Joe Collier, a health-policy specialist at St George's Hospital Medical School in London. "The commercial arm of the European Commission has driven these changes, not the public-health arm," he says.

But Liikanen says the changes would not compromise drug safety. "The cuts will be on the bureaucratic side, not the scientific side," he says.

The pharmaceutical industry gave the plan a cautious endorsement. "Broadly speaking, we welcome efforts to approve drugs more quickly," says Richard Ley, a spokesman for the Association of the British Pharmaceutical Industry.

The commission thinks that the slow pace of approvals in Europe has driven away pharmaceutical research in recent years. Europe's share of the global pharmaceutical market has dwindled from 32% to 22% in the past decade, whereas the US share has grown from 31% to 43%, according to the European Federation of Pharmaceutical Industries and Associations. But some observers say that price controls in Europe — and their absence in the United States — has provided most of the impetus for the change.

Nature © Macmillan Publishers Ltd 2001 Registered No. 785998 England.

Category: 38. Medical and Pharmaceutical Innovation and Policy