Impact of EU pharmaceutical reform on market incentives for new antibiotics
Response of the German Network Against Antimicrobial Resistance (DNAMR) to the European Union's pharmaceutical reform.
The Council of the European Union and the European Parliament have reached a political agreement on the comprehensive reform of EU pharmaceutical legislation. The legislative package reforms a legal framework that is more than 20 years old and includes important measures to combat antimicrobial resistance (AMR). The provisional agreement must now be formally approved by both the Council and the European Parliament before it enters into force after publication in the Official Journal of the EU.
DNAMR welcomes agreement and introduction of TEV
The German Network Against Antimicrobial Resistance (DNAMR) is a voluntary association of organizations, institutions, companies, and natural and legal persons that are committed to the development of new, resistance-breaking antibiotics. Members of the DNAMR include the German Center for Infection Research (DZIF) and the German Association of Research-Based Pharmaceutical Companies (vfa). The network welcomes the conclusion of the negotiations:
Timo Jäger, spokesperson for the DNAMR and managing director of the DZIF, says: "We welcome the decision. Particularly noteworthy is the introduction of market incentives for new antibiotics in the form of transferable exclusivity vouchers (TEV). The TEV is an instrument designed to make the development of urgently needed new antibiotics more financially attractive. It enables companies to extend the exclusive market rights of a new antibiotic for a limited period of time and even transfer them to another drug. This allows companies to expect predictable sales during the exclusivity period. These revenues create the basis for investment in the research and development of new antibiotics. At the same time, research institutions such as the DZIF also benefit, as more reliable market conditions increase the chances of our R&D projects finding industrial development partners."
Harald Zimmer, spokesperson for DNAMR and Senior Manager International Affairs at the German Association of Research-Based Pharmaceutical Companies (vfa), says: "In principle, research-based pharmaceutical companies welcome the introduction of TEV. However, the legislation proposed by the Commission has been watered down in order to reach a consensus with Parliament and the Council. Due to the currently very limited scope of TEV, additional, complementary incentives are necessary to effectively promote the development of new antibiotics. The additional framework for complementary funding that has been agreed upon is therefore to be welcomed. Against the backdrop of the active location policy of the US, the EU and the German government should keep an eye on the dynamically changing environment when implementing the decisions that have now been made in order to ensure their effectiveness."
The DNAMR appeals to those responsible: now that the EU trilogue process has been completed and national implementation is underway, a transparent consultation process with stakeholders—in particular research institutions and research-based pharmaceutical companies—should be sought. We need a steady supply of new antibiotics, and the EU's contribution to this is crucial. The implementation measures to be taken should be coordinated with corresponding activities in other regions, such as the United Kingdom.
Source: Press release from the German Network Against Antimicrobial Resistance (DNAMR) (in German)
