16.12.2025
The Danish government has made a major effort and succeeded in securing a better agreement than the Commission’s original proposal.
The agreement has a broad scope, but the most important elements are:
Security of supply
With the agreement, the EU strengthens requirements for pharmaceutical companies to secure the supply of medicines to Europe. This will better meet patients’ needs and reduce the risk of supply shortages.
Regulatory protection period
One of the main points of contention in the revision of the EU pharmaceutical legislation has been the length of the data and market protection periods. The final agreement sets data protection at eight years and market protection at one year.
In addition, the agreement allows companies to extend regulatory protection further if they meet a number of specific requirements.
Bolar exemption
The new pharmaceutical package also includes changes to the so-called Bolar exemption, which concerns generic manufacturers’ access to the market.
The change ensures that generic medicines can enter the market the day after the protection period for the original medicine expires. This means that generic manufacturers may now carry out the necessary steps, such as conducting studies of the medicine, early enough to allow generics to be available on day one.
Antimicrobial resistance
At Pharmadanmark, we are particularly pleased with the part of the agreement that focuses on antimicrobial resistance and the need to create incentives that support the development of new antibiotics. More specifically, pharmaceutical companies can be offered a voucher for developing a new antibiotic. The voucher can be used to extend market protection for a medicine.
The voucher is transferable. This means that the extended data protection can be used for another medicine or sold to other companies. Offering companies a financial incentive in the form of one additional year of data protection, combined with the transferability of the voucher, makes it easier to attract risk capital.
As a co-founder of the AMR Alliance, which works to ensure a sustainable incentive structure for the development of new antimicrobial medicines, we welcome that the revision of the pharmaceutical package addresses this serious public health crisis. It is a step in the right direction, even though the work is not yet finished.
The final agreement on the pharmaceutical package must now be approved by the European Parliament and the Council of Ministers. We look forward to the expected approval in early 2026.