Drug firms call for fast-track trials system

Date: 29/01/1998

By Peter Chapman

EU DRUGS companies are calling on MEPs to support moves to cut the red tape involved in winning approval for running clinical trials on patients in hospitals and universities.

They claim that the current system slows down the launch of potentially life-saving new products on to the market.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) says it wants the European Parliament to support the introduction of a fast-track 'notification' system, allowing trials of new drugs to get under way as soon they have been approved by member states' leading ethical committees.

Under the scheme, companies would notify governments of their intention to launch a trial after winning the approval of the ethical committee, which decides whether tests are in line with moral and legal requirements.

Once the authorities had acknowledged receipt of this notification, the trial could go ahead.

The EFPIA's Stefan Callewaert said he was optimistic that MEPs were beginning to understand the drugs industry's concerns, and claimed a key report on clinical testing drawn up for the Parliament's environment committee by Italian independent member Amedeo Amadeo would now support the industry's demand for less red tape.

The report follows the launch last September by the European Commission of a draft directive on clinical testing which was criticised by the industry for leaving too much scope for member states to keep old bureaucratic systems in place.

Currently, EU drugs companies face an uneven patchwork of rules and regulations when they apply for clinical trials approval.

"The UK system is quite quick. You can start your trial after four to five weeks. But in some countries like Italy, it is a disaster. You send in your submission and then wait for months," claimed Callewaert.

He said the Commission's original proposals were meant to harmonise member states' approval procedures more closely. They called on governments to ensure that just one national ethics committee had the final say on approvals, with one local 'site' committee - often based in the hospital where trials would take place - also being allowed to give its view.

The EFPIA fears the proposals now being scrutinised by MEPs would still leave too many differences in place. "The directive is so open that any country is able to arrange its own system. No one thinks the directive will help to resolve the situation. On the contrary, it could add to the bureaucracy," said Callewaert.

The federation complains that the directive does not set a time-limit for 'national' and 'site' ethical committees to give their approval.

It argues that decisions should be made in 30 days if national committees alone are asked for their opinion, or 45 days if a site committee gets involved in the process.

The new fast-track approach which MEPs look set to approve would be good news for industry and patients alike, as products would make their way on to the market more quickly, claims Callewaert.

"Amadeo's report will mainly focus on how to improve and speed up the process for the start of clinical trials. In this respect, he is very much in favour of a system that is as unbureaucratic as possible. He favours the notification system and he wants this to be uniformly applied," he added.

A uniform system would cut down the time it takes for drugs to be tested at the same time in more than one member state.

If things go well, MEPs could vote on proposed amendments to the directive at the May plenary session of Parliament.

But EU governments have yet to agree between themselves on the proposed reform and there are fears that many may be keen to hang on to their old approval processes.

"Some member states will have difficulties in leaving their formal authorisation systems.

The southern EU states are more in favour of authorisation procedures while in general the northern states tend to prefer something more informal," explained Callewaert.