This month, the European Council adopted the regulation on the EU-wide assessment of health technologies (EU-HTA). At the same time, the first call for applications is now open for scientific advice within the framework of EUnetHTA.
In the open call of the EUnetHTA 21 JSC Secretariat, pharmaceutical companies can apply for parallel consultations with the EUnetHTA 21 and the European Medicines Agency (EMA). The aim of the consultations is to provide non-binding, scientific advice regarding the design of clinical trials to generate high-quality data for future benefit assessments. The EUnetHTA 21 Joint Consortium will be led by the National Health Care Institute of the Netherlands (ZIN). The Joint Federal Committee (G-BA) in Germany acts as the secretariat of the joint scientific consultations. Applications can be submitted to the G-BA email address EUnetHTA21-JSC@g-ba.de until December 7, 2021.
The price-volume regulation shall no longer be subject to arbitration. The default mechanism kicks in if no agreement between the pharmaceutical company and the statutory health insurances is reached and adjusts the reimbursement amount annually (starting in the third calendar year after launch) usi…
The current draft bill on statutory health insurance contribution rate stabilization (BStabG) sets out the health policy objective of tighter expenditure control — with direct implications for pricing, market access, and reimbursement in the German market. An overview of the key changes for innovati…
Pediatric drug shortages: has the situation really improved? In recent years, Germany has faced shortages of essential medicines for children, including antipyretics and antibiotics. To encourage manufacturers to increase production and supply, the GKV-SV (GKV-Spitzenverband, German SHI association)…
Since the beginning of 2025, member states of the European Economic Area (EEA) have been working together on joint clinical assessments (JCA) of new medicines. Recently, the first 9 JCAs were announced, assessing 2 ATMPs with Orphan drug status and 7 oncologics. Germany, France, and Ireland are curr…
