BioWorld International Correspondent
BRUSSELS, Belgium - The European pharmaceutical industry is building up pressure for the European Union regulatory system to be made more friendly to innovative products, principally biotechnology products. It has published new calls for changes that would speed the authorization of new medicines.
The European Federation of Pharmaceutical Industries and Associations Industry presented its proposals in Brussels. To ease its anxieties that some members of key European regulatory bodies are ill-equipped to assess new medicines derived from a rapidly evolving science and technology, the industry wants to see greater professionalism introduced into the European Medicines Evaluation Agency, the principal European body responsible for drug registration.
At issue is the impartiality of the EU system. If every one of the 15 EU member states has equal rights to nominate its own nationals to the key groups that assess new medicines, irrespective of the fitness of those nominees, then the industry's evolution remains vulnerable, the industry said. So EFPIA's new position insists on the need for "coordination of appointments to key committees to ensure that the best medical and scientific expertise is represented," for "adequate mechanisms to ensure consistency across products and continuity," and for "appropriately qualified staff at the EMEA to provide scientific support."
EFPIA is calling for "a process whereby member states nominate potential representatives based on their scientific expertise and regulatory experience," followed by a pan-European body determining the final membership. Similarly, EFPIA is calling for the creation of new therapeutic working groups of recognized European experts to be set up within the EMEA, as another part of the industry attempt to inject new skills and objectivity into the assessment process for new medicines.
EFPIA noted that all member states need not be represented on all these new working groups. "The general principle is to ensure that the team is composed of the best European expertise irrespective of nationality," it said. The result should be faster and offer "higher quality reviews."
Similarly, the industry is calling for an independent appeal procedure. EFPIA said it is "unfair for the appeal to be heard by the same people who reached the initial opinion, as they are unlikely to change their view unless there is significant new data."
But when the responsible European Commission official, Philippe Brunet, sketched out his thinking on the modifications the commission is planning to propose later this year, they differed widely on appeals, and in terms of nuance on other issues. He said it would risk incoherence if there were more than one body ruling on EU medicines authorization decisions, so there should be no new appeal body.
He did accept the need to "design a new set of criteria or new procedures" for new products, and particularly biotechnology and high-technology products, and he does envisage new possibilities for scientific advice, particularly on biotechnology-derived products, with permanent specialist groups set up within the EMEA. But between now and mid-summer, when the commission is due to finalize its proposals, the research-based European pharmaceutical industry will be pushing for a revolutionary rather than an evolutionary approach to bringing impartiality into medicines evaluation, say industry insiders.