Industry and legislators create incentives for the development of new antibiotics

the privileged position of reserve antibiotics when entering the German market

Wed, 2020 / 08 / 05
Under the "Fairer-Kassenwettbewerb"-Act, reserve antibiotics are now given a privileged position when entering the German market: The additional benefit is considered proven, the extent and therapeutic significance are not subject to any assessment by the Federal Joint Committee. The legislator hopes that this will provide an incentive for the pharmaceutical industry to develop new effective antibiotics. The pharmaceutical sector has recently established an action fund against antimicrobial resistances, which is also supposed to ensure the development of novel antibiotics. Here, funding is often a critical aspect since development is risky and not very profitable.

On the 27th of July, the European Commission granted approval for lefamulin, as expected following the already positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the EMA. Lemafulin belongs to the new class of pleuromutilin antibiotics derived from fungi and is indicated "for treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed". Such reports of newly approved (reserve) antibiotics have unfortunately become increasingly rare over the last few years.

Although the focus in infectiology is currently on viruses such as SARS-CoV-2, the threat of antimicrobial resistance is growing. In order to ensure the further development of new effective antibiotics, more than 20 large pharmaceutical companies have joined forces in an initiative against antimicrobial resistance (AMR) and founded a comprehensive action fund. Financing is often a critical aspect since development is risky and not very profitable.

The legislator has now also created new incentives within the framework of the "Fairer-Kassenwettbewerb"-Act to make the development of reserve antibiotics more attractive for the industry. The details of the structure will be regulated by the Federal Joint Committee (G-BA) in its Rules of Procedure (VerfO) until 31st of December 2020:
  • The Robert Koch Institute (RKI) together with the Federal Institute for Drugs and Medical Devices (BfArM) will define a public list of criteria for classification as "reserve antibiotic" by 31.12.
  • If the pharmaceutical manufacturer's application for exemption as a reserve antibiotic is granted, the additional benefit is considered proven - the extent and therapeutic significance are not subject to any assessment by the G-BA.
  •  Involving the RKI and the BfArM, the G-BA specifies requirements for quality-assured use, taking into account the effect on the resistance situation.

We at SKC welcome the planned amendment of the G-BA VerfO and look forward to its practical implementation and uptake. We analyze any changes of the legislator and anticipate the resulting individual best possible strategy for our clients. Extensive monitoring on all channels is absolutely necessary in order to assess possible risks due to any future planned adjustments of legal requirements at an early stage, and to develop individual solutions.

Sources in German:

About the author

Ihr Ansprechpartner Dr. rer. nat. Ingo Hantke
Dr. rer. nat. Ingo Hantke
M. Sc. Life Science
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
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