Drug firms’ alarm over costly delays

Date: 04/01/01

COSTLY red tape at the national level is hampering drugs companies hoping to get new products approved, a European Commission-funded study has warned.

Under Union rules, firms can seek authorisation for most medicines either by applying to the centralised European Medicine Evaluation Authority (EMEA) or to regulators in one 'reference' country - whose opinion is supposed to be recognised in other member states.

But the report cites complaints from firms over the way the EU-wide system has worked in practice, particularly the time it takes for the Union to formalise decisions taken by the London-based EMEA.

The study by UK law firm Cameron McKenna and management consultants Andersen Consulting found even more "deep-seated alarm" in the industry over the way many member states continue to ignore the alternative system, insisting that drugs accepted elsewhere still run the bureaucratic gauntlet of domestic authorisation procedures.

"The competent authorities do not seek to disguise the fact that there is unwillingness of member states to abide by the principle of mutual recognition," states the report.

The results of the study will be debated at an industry conference in Brussels later this month, and will form the basis of a Commission review of the EU drugs authorisation process due to be completed this year.

Costly red tape at the national level is hampering drugs companies hoping to get new products approved, a European Commission-funded study has warned.