BRUSSELS, Belgium ¿ The European Commission¿s planned report on how to improve the European Union system for authorizing new medicines ¿ due at the start of 2001 ¿ is still not ready. The latest projection is that it will be submitted to the European Commission for adoption on July 18, but this may slip again, as consultations continue.
Meanwhile, the new grouping of European biopharmaceutical companies, EBE (Emerging Biopharmaceutical Enterprises), has been refining its own position on what it wants to see out of the upcoming review.
EBE recommended priority be given to access to continuous high-quality scientific advice when applications for new medicines are being assessed in the European Medicines Evaluation Agency in London. This could be achieved, it said, through the establishment of new specialized working groups focusing on therapeutic areas or specific scientific disciplines.
Fast-track options for innovative drugs should also be introduced to address unmet medical needs in serious and life-threatening diseases, it said. This should include the option for an early conditional approval and wider access to faster processing of applications. But there is no urgent need to change the EU¿s ¿compassionate use¿ systems, under which unauthorized products can be given special permission for use in desperate cases, EBE said.
In addition, EBE said the EU should act to cut significantly the time that elapses between a scientific opinion in favor of authorizing a new medicine, and the actual delivery of the authorization through the EU¿s formal decision procedures.
The review is, said EBE, an opportunity to improve the procedures ¿so that they deliver faster access to innovative medicines for all EU patients.¿ It is important that the EU regulatory environment encourages the establishment and growth of small and medium-sized research-based enterprises.