BRUSSELS, Belgium - The European Federation of Pharmaceutical Industries and Associations formally launched its group of Emerging Biopharmaceutical Enterprises, with its constituent meeting in Brussels last Friday.
More than 20 biopharmaceutical companies indicated a firm interest in joining the new grouping - including Serono, Baxter, British Biotech, American Home Products, Biogen, Centocor, Genzyme, Schering AG and Schering-Plough, Anne Papin, manager of the project, told BioWorld International.
The aim is to present a common front at European level in discussions of regulation affecting the development of medicines derived from biotechnology. The group intends to offer joint services, particularly to smaller biotechnology firms with limited resources in regulatory and political affairs.
Hurdles to product launch in the biopharmaceutical sector fall disproportionately on start-ups and smaller companies, the new grouping said. EBE will seek maximum use of fast-track registration facilities in the EU for its members' products, and is likely to call for new opportunities - such as early and limited "conditional marketing" for life-saving products - to be built into the review of the entire European Union drug registration system due to take place in 2001.
The group also will review the operation of the EU's new orphan drug regulation, to see how closely it meets biopharmaceutical companies' needs, and will seek simpler clinical trials authorization procedures. The current proposal for new EU rules on clinical trials discriminate against biotechnology products, according to the group. This can slow down new drug development in the sector, and perpetuates misunderstandings about biotechnology and its safety by comparison to conventional pharmaceutical technology, it said.
The outline EBE work program also assesses incentives to innovation (including price liberalization and intellectual property questions), and looks at how to help boost public acceptance of biotechnology products.