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New legislative proposals in Germany to encourage the use of biosimilars

Author
Zhuleku Eda
Eda Zhuleku

Counsel

Munich

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26 November 2018

The German Federal Ministry of Health recently released draft legislation on the safety of medicinal products – “Gesetz für mehr Sicherheit in der Arzneimittelversorgung” – GSAV

In the wake of several recent safety issues, for example,  the release of contaminated pharmaceuticals with potentially carcinogenic substances in 2018, the government aims to improve the safety of medicines by stricter controls and extending the powers of authorities. Additional monitoring and  recall powers are intended for the higher federal authorities. In case of a recall or other defects regarding medicinal health insurance funds will have a compensation claim against pharmaceutical companies.

The bill also addresses the supply of biosimilars. Against the background of the variability of biologicals caused by the manufacturing process, the substitution of biosimilar  medicinal products is assessed differently from the substitution of small molecule generic medicinal products. According to current law, the pharmacist is only entitled and obliged to substitute the biological if the biological is obtained in a manufacturing process identical to that of the reference pharmaceutical (so-called: bioidentical). As the government wants to encourage the use of biosimilars, the Federal Joint Committee (Gemeinsamer Bundesausschuss – GBA) would, under the proposals, be  entitled to specify which biosimilars are to be substituted. There are also measures on a regional level to influence the prescription behaviour.

The bill also proposes the introduction of compulsory registries for orphan medicinal products (OMPs) and marketing authorisations (MA) under conditional approval or exceptional circumstances.

 

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