Pricing of generics in Germany: Are there any rules?

The process of determining the reimbursed price of a product with a new chemical entity is clearly defined and follows specific steps. But what about generic drugs, i.e. those that have the same active ingredient as another product?

First of all, the G-BA does not conduct early benefit assessments of generic products. Therefore, there are no subsequent price negotiations. Instead, manufacturers are completely free to set the price of their generic drugs, based on the competitive market.

However, the reimbursed price of a generic is set by reference prices. The reference price dictates the maximum price that SHI funds will pay for the generic. Thus, if the manufacturer priced their generic drug higher than the reference price, there are two options:

  • either the patients will have to cover the price difference,
  • or the pharmacies will switch to a different product that is therapeutically equivalent, but does not require a payment by the patient.

SHI funds then use tenders for contracts with the manufacturers. Therefore, it is in the interest of the manufacturers to not price their generic product higher than the reference price.

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