Revision of the Medication Law: Hearing at the German Federal Ministry of Health

BIO Deutschland demands greater inclusion of the interests of innovative small and medium-sized biotechnology enterprises in the revision of the Medication Law. In a statement issued for the hearing of associations at the German Federal Ministry of Health, the biotech industry association made it clear that the motivation for investments in medical advances and the planning security necessary for the safeguarding of companies must be guaranteed for researching companies that develop new agents and treatments for patients.

Peter Heinrich, Chairman of the Board of BIO Deutschland, commented, "Some of the planned amendments, particularly those concerning treatment with unauthorised drugs in extreme cases, must be regarded critically." He added that short-term and disadvantageous amendments to operating conditions would more often and more rapidly lead to the risk of mainly small and medium-sized medication manufacturers and therapy providers facing bankruptcy than would be good for Germany as a business location. In his concluding remarks, Peter Heinrich stressed, "Small and medium-sized biotechnology companies in particular are not only an important element in the value-added chain in medicine but are also a source of new business models, products and processes. Above all, they make an above-average contribution to the creation of jobs and the increase of expenditure on research and development."

Michael Pehl, Chairman of BIO Deutschland’s Working Group on Health Policy, welcomed the use of current European regulations by the German Federal Ministry of Health in the adaptation of the Medication Law. However, he was also very disappointed that the opportunity to tackle urgently needed improvements in the conditions for clinical studies had been missed.

Commenting on the same topic, Markus Hofbauer, Chairman of BIO Deutschland’s Working Group on Regulatory Affairs, said, "To a certain extent, the procedure for the authorisation of clinical studies in Germany is unnecessarily complicated and time-consuming. By making some amendments to the existing regulations, the bureaucratic process could be significantly simplified without putting control over the studies or the safety of patients at risk. At the same time, the procedure could be aligned with European standards, thus significantly improving the competitiveness of Germany as a location for clinical studies."

The draft law will now be amended and passed in this legislative period. The Working Group on Health Policy will meet in Martinsried near Munich on 16 February to discuss details that may be of relevance to the parliamentary debate.