Germany Agrees on New Pharmaceutical Bill

On 30 January, the German government has agreed on a draft Act for more safety in the supply of pharmaceuticals (“GSAV”). Although the wording of the original bill has been amended since it was released by the Ministry of Health last year, it still contains provisions that would have a significant impact on, inter alia, OMPs, ATMPs, and biologics in general if it enters into force unchanged. The bill will now be introduced to both chambers of the German parliament. It is expected that the new law will enter into force in July this year. The most important aspects of the legislative proposal are:

OMPs

• In order to assess whether or not the 50 million threshold has been reached, the manufacturer must, upon request of the Federal Joint Committee (G-BA, which defines guidelines for health care services that are eligible for reimbursement), also communicate the sales of the drug in the hospital sector.
• As far as conditional marketing authorisations and authorisations granted under exceptional circumstances are concerned, the G-BA can request the collection of additional data through post-marketing studies, in particular by means of registries.

ATMPs

The bill also obliges the G-BA to lay down requirements in its guidelines to ensure the quality of the use of ATMPs. In particular, the G-BA may set minimum requirements concerning the qualification of the involved healthcare professionals, structural standards (e.g. regarding diagnosis, manufacturing, transport etc.) and further measures to ensure the quality of the treatment (e.g. the healthcare professionals’ obligation to participate in registries).

Consequently, ATMPs may only be used by those healthcare professionals and designated centres who meet these minimum requirements.

Biosimilars

The bill also aims to increase the uptake of biosimilars through various measures:

• As far as the substitution of a reference medicine by a biosimilar at pharmacy level is concerned, such substitution is permissible only after the G-BA has issued guidelines on the interchangeability of the product(s) in question. In addition, the bill provides that such substitution only takes place after a lead time of three years (i.e. according to the current planning as of mid-2022). During this three-year period, the switch from the original product to a biosimilar shall only be made by the physician under consideration of the above mentioned guidelines. However, the law also requires the G-BA to immediately initiate the work on the guidelines on the interchangeability.
• In addition, the bill stipulates that targets concerning the uptake of biosimilars have to be defined at regional level.