Drugs firms demand action to speed up approvals procedure

Date: 12/10/00

By Peter Chapman

EU PHARMACEUTICALS firms are calling on Enterprise Commissioner Erkki Liikanen to streamline the current drug approval process, claiming it is preventing vital medicines from reaching the market quickly.

The demand comes as the European Commission prepares to unveil plans later this year to overhaul the rules governing the system. These will include proposals to restructure the London-based European Medical Evaluation Agency (EMEA), the clearing house for determining whether drugs should be allowed onto EU markets.

Brian Ager, secretary-general of European drugs lobby group EFPIA, says EMEA's performance since it was set up has been excellent, with the organisation living up to its promise to report on new applications within 210 days.

But under the current system, the agency must submit its recommendation on each application to the Commission, which then consults with every member state before deciding whether to approve a product. Ager says unnecessary delays in this part of the process add an average of 90 days to getting a medicine authorised.

One solution suggested by EFPIA would be to strip the Commission of the right to approve new drugs altogether and allow EMEA to oversee the entire process. "It is the bureaucracy that is the problem. Do you need that amount of time - and is there some other way it can be done faster? These are genuine questions to pose," said Ager. "But I think we are more interested in the objective - that is to cut down the time frame - rather than the means for achieving it."

He added that there were also problems with going down the only other route which firms can take to get their products authorised in more than one member state.

EU countries are supposed to grant drug approvals made by other member states under 'mutual recognition' rules. But bureaucratic red tape can clog up this system, especially when national bodies reject the assessments made by authorities in the country which first approved a product. "This system does not function. There is more duplication and repetition of work," said Ager.

EFPIA's demands are in line with the interim findings of consultants hired by the Commission to study the situation. Law firm Cameron McKenna and Andersen Consulting said respondents to their survey had "almost universally" expressed a need for "significant changes" in approval procedures.

The report added that some national authorities were concerned that they might not be able to handle the increase in new cases expected when the EU expands. It also found that industry was strongly opposed to the growing tendency of national regulators to examine the cost effectiveness of drugs as well as their clinical performance.

EU pharmaceuticals firms are calling on Enterprise Commissioner Erkki Liikanen to streamline the current drug approval process, claiming it is preventing vital medicines from reaching the market quickly.