EU Reaches Landmark Agreement on Pharmaceutical Legislation Revision

After a long night of negotiations, EU co-legislators have reached a long-awaited political agreement on the revision of the Union’s pharmaceutical legislation. The breakthrough came in the early hours of the morning, marking the conclusion of nearly three years of intensive debate and technical discussions.

Since the publication of the EU Pharmaceutical Strategy, antimicrobial resistance (AMR) has steadily risen to the forefront of political priorities. Today’s agreement confirms that AMR is now recognized at the highest levels of policymaking as a critical public health challenge requiring dedicated, forward-looking solutions.

Under the newly agreed text, legislators have endorsed the introduction of an AMR incentive voucher, granting 12 months of additional regulatory exclusivity. Notably, the voucher will be transferable to another product, provided that product has not exceeded €490 million in annual sales over the previous four years. This clause, along with others, limits the attractiveness of the scheme, and consequently its intrinsic value.

In addition to the voucher, the agreement establishes the framework for a voluntary subscription mechanism for Member States. While operational details remain to be defined, the mechanism is intended to support sustainable market conditions for innovative antimicrobials and ensure their availability to those countries that would like to have access to them.

“On paper, these measures reflect exactly the type of dual-incentive system—voucher plus subscription—that we have been advocating since January 2022. Their inclusion represents an important step toward rebuilding the antimicrobial pipeline and addressing the growing threat of AMR for the benefit of patients”, says Marc Gitzinger, President of BEAM Alliance.

However, much will depend on implementation. Several constraints remain, including the strict limitation on the number of vouchers, as well as uncertainties surrounding the practical deployment of the subscription model. The true impact of the reform will therefore hinge on how these provisions are operationalized in the months and years ahead.

We remain committed to supporting policymakers and partners as the agreed measures move toward implementation. Ensuring that the final system delivers its intended impact for patients, public health, and innovation will continue to be our priority.