Testing time for clinical trials, warns Busquin

Date: 25/07/02

By Peter Chapman

A HOTCH-POTCH of national rules for clinical trials is hampering EU efforts to lead the world in drug research, research chief Philippe Busquin has warned.

The Belgian commissioner told European Voice the EU must create a US-style level playing field otherwise American firms will forge ahead in the race to develop the next generation of pharmaceuticals.

'We must have the mentality in Europe to attract the best development,' said Busquin, who also pointed out that the EU's share of global research on drugs has dropped from 72 in the late 1990s to 59 today.

He said scientists in the US faced exactly the same clinical trial rules whether they are based in San Francisco or New York.

This made it easier and cheaper to conduct large-scale tests of advanced new treatments.

'In Europe we have different rules in UK, France, Germany and Belgium and its difficult to have a critical mass,' he added.

Under the EU's complex division of powers, member states have sole competence for setting health policy.

But Busquin said the EU must, nevertheless, agree to harmonise rules governing research for new drugs.

He said the Commission would press for the change in a follow-up to its action plan on biotechnology - set to be unveiled in the autumn.

The report will be the focus of a debate on biotechnology planned later this year by Denmark during its six-month presidency of the EU.

'Health is a national competence - that is normal for the organisation of hospitals and so on.

'But we can differentiate. To develop research you must have common rules.

'You can't develop a new drug if you must give too large a differentiation between member states in research,' he said.

Until the EU acts, Busquin warns that the consequences in the drugs sector it once dominated could be dire.

For example, the 'clear and simple' US regime means the country is already well-ahead in the fledgling genetic therapy field.

Busquin said the EU regime is also feeding a brain drain to the US as European firms up sticks and conduct research in America - typified by Swiss bio-tech giant Novartis' decision to develop a new R&D centre in the US.

A hotch-potch of national rules for clinical trials is hampering EU efforts to lead the world in drug research, Research Commissioner Philippe Busquin has warned. Article is part of a European Voice survey on pharmaceuticals.