BRUSSELS, Belgium - According to a senior spokesperson for the European pharmaceutical industry, changes are needed to the European Union's procedures for marketing biotechnology and high-technology medicines.
Sue Barrowcliffe, of British Biotech plc, said it is important to ensure that high-quality scientific opinions with a European, rather than a national focus, are delivered when marketing authorization applications are assessed by the European Medicines Evaluation Agency.
The system should allow more efficient use of review time, and should rapidly generate a European view on an application, rather than an uncoordinated range of national views. This, she said, would help counter the current predominance of the U.S. FDA in high-technology drug development. Smaller firms that now have a tendency to rely on readily available advice from the FDA might be induced to operate increasingly in the European Union, and the EU itself would gain in influence on international development programs, she predicted.
Overall, what she recommended is a more coherent European approach with a greater degree of continuity during the successive stages from early scientific advice on product development through to authorization. The procedures should provide for more dialogue between regulators and industry from an early stage.
"Submission of the marketing authorization application is too late to start the discussion," she told a joint meeting of the European pharmaceutical industry and the EMEA staff in London last week. Scientific and medical experts also should be involved throughout, she said.
She outlined proposals worked out within the European Federation of Pharmaceutical Industries and Associations for the creation of therapeutic working groups, alongside the EMEA's chief scientific body, the Committee for Proprietary Medicinal Products. These groups would be new CPMP subcommittees, with a secretariat supplied by the European agency, a multidisciplinary membership including relevant national experts, able to provide scientific advice to industry during drug development, scientific review of applications, and preparation of regulatory guidelines with a European rather than a national focus. The concept already operates satisfactorily on quality issues in the EMEA's current biotech working party, Barrowcliffe said. "This is a permanent group that has worked together over time and has consequently built up trust."
Establishing new therapeutic working groups to review quality, safety and efficacy in this focused fashion might cost more, but it would make for better quality preparation of decisions, and allow the CPMP to concentrate on the critical licensing issues, industry officials said. At present, according to Barrowcliffe, the CPMP's workload is excessive, and it cannot debate scientific issues satisfactorily in its monthly meetings. The situation must evolve toward a more efficient and Europe-oriented system, she said. "It is important that a European position is reached. We cannot rely only on nationally driven assessments."