23 May 2019 - Deborah Wilkes
Germany's procedure for switching medicines from prescription to non-prescription status is "outdated and should be modernised", according to the German Medicines Manufacturers' Association, the BAH.
The BAH is calling for switch applications to be processed in a similar way to marketing authorisation applications.
Under the current procedure, switch applications are evaluated at two meetings each year by the Expert Committee for Prescription within Germany's Federal Institute for Drugs and Medical Devices (BfArM). Recommendations have to be approved by the Federal Ministry of Health as well as the upper house of parliament, the Bundesrat.
The BAH maintains the current procedure is "complicated, non-transparent and unpredictable".
Elmar Kroth, the BAH's managing director for scientific affairs, maintains that too many players are involved in the procedure, and the time taken to process switch applications has increased "significantly" in recent years. Kroth also points out that companies are not involved in the decision-making process once an application has been submitted.
Working with law firm Sträter Rechtsanwälte, the BAH has devised a "simplified, transparent and predictable" switch procedure. BfArM would sit at the heart of the procedure, and the Federal Ministry of Health and Bundesrat would no longer be involved.
The BAH addresses the lack of incentives for pharmaceutical companies to apply for a switch. The proposed procedure would, for example, be product based.
The lack of market exclusivity for switch innovators is an obstacle for many switches, as competitors can enter the market under the same conditions. The BAH is keen to see three years of market exclusivity for medicines switched from prescription to non-prescription status (click here to read the News story).
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