Faster Availability of Innovative Drugs via Better Cooperation with Licensing Authorities Working Group on Regulatory Affairs and Health Policies

Many years still pass until innovative drugs can be made available to patients, even after they have already proved their positive risk-benefit relationship in clinical tests. BIO Deutschland supports the reduction of this timeframe by the promotion of national competence in the development and evaluation of innovative drugs and technologies. This involves the companies affiliated in the association (developmental competence), on the one hand, and the licensing authorities (evaluation competence) on the other. The association’s interlocutors are primarily the German authorities (for example, the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute), followed by the European institutions (such as the EU Commission and the EMEA). The establishment of a dialogue on mutual benefits at an early stage is of vital importance. The early involvement of the licensing authorities in new therapeutic approaches and innovative technologies should sustainably support the already apparent transformation of these authorities into modern, effective and internationally competitive institutes. Likewise, the early recognition of scientific and regulatory standards makes it possible for companies to develop drugs rapidly and cost-effectively; after this process, companies are faced with high-cost licensing applications.

Among the factors that are decisive for the success of these aims, the most important are as follows:

• Intensive cooperation on mutual benefits between the association’s member companies and the authorities.
• Facilitation of clinical research, for example by the abolition of barriers specific to Germany.
• Cost relief in authorisation applications (clinical testing, drug licensing).
• Avoiding new, additional barriers before the launch of drugs on the market.

Measures for the achievement of the above-mentioned success factors for the creation of an infrastructure that would be exemplary in Europe are suggested in the position paper.