Market access for patent-free drugs is generally free in Germany. However, there are restrictions with regard to reimbursement which have to be observed in the case of generic or similar drugs:
- Fixed amounts according to § 35 SGB V determine a maximum reimbursement amount;
- Individual discount agreements with health insurance funds in accordance with § 130a (8) SGB V can represent a barrier to market access;
- The price moratorium has applied since 2010 and may represent an upper price limit for new packaging;
- The manufacturer discount for drugs with the same active ingredient is covered by specific rules.
We support you in your market access strategy for off-patent drugs. If you have any questions about fixed prices or discount agreements, we will be pleased to provide you with our expertise and support you individually and efficiently.