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'European FDA' one step closer

Published on 06/11/03 at 02:08pm

Europe looks set to emulate US medicines regulator the FDA by transferring responsibility from national agencies to a single centralised authority.

The London-based EMEA was established in 1995 to provide regulatory approval for medicines across the European Union, but this centralised procedure is not currently mandatory (except for biotech products), with the parallel 'mutual recognition' system also available to pharma companies.

But concerns over the inefficiency and lack of transparency in the dual system, and the implications of next year's EU expansion means the many groups involved in making Europe's laws are finally nearing agreement on the issue after two and half years discussion.

The European Commission drafted its plans for a complete transfer of power from national regulatory agencies such as the UK MHRA to the EMEA in July 2001, but has been held up ever since by opposition from MEPs, and the pharmaceutical industry.

In 2001, Brian Ager, director-general of the EU industry body EFPIA said the industry opposed the move, claiming the European system was "fundamentally based on the various national expertises, and we believe it is essential to keep [these] up to date."

In the intervening period, EFPIA and the industry has had a change of heart, influenced by strong signs that Europe pharma sector is falling behind the US, and that a stronger EMEA can improve competitiveness and address public health needs.

Mr Ager told a press conference this week: "Anything we can do in Europe to make the market authorisation faster and more efficient will help very much in giving the EU a world class regulatory system and nurturing an innovative pharmaceutical sector."

'Rapporteurs' from the European Parliament health committee have now produced a final draft of the reforms they want to see in the pharma sector, including a compromise proposal for the EMEA, bringing new impetus to plans for new laws by summer 2004.

If the proposals become law, any new active substances to treat AIDS, cancer, neurodegenerative disorders or diabetes would have to be submitted through the centralised procedure. Then after four years, the Commission could propose to widen the remit to all products with the approval of member states.

This phased change to a completely centralised procedure has won the backing of the EFPIA, although Mr Ager expressed doubts that the agency could cope with an overnight switch and a sudden increase in its workload, particularly in the context of ten new EU members from April next year.

Despite a broad consensus that the status quo is not acceptable, Mr Ager predicted that the fine detail may have to be thrashed out in conciliation talks between health ministers from the member states and the Commission, a process reserved for major changes to EU law.

"It might need conciliation  - it a very fundamental issue. It's all about the communication between the member states and the Commission," he said.

All sides accept that the EMEA must change to reflect its greater responsibility, and the EU Parliament committee wants to see a number of new measures introduced to make the agency more transparent and accountable, while the most preferable composition of its management board remains highly contentious.

The European Parliament health committee will vote on the proposals at the end of November, with a vote by all MEPs on whether to accept following in December.



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