First two medicinal products to undergo EU joint clinical assessments announced
On 16 April 2025, the European Commission (EC) published a press release announcing the launch of and details regarding the…
All articles by Brendan Melck
Brendan Melck
-
-
All change in Germany – confidential pricing in, IRP out
On 1 January 2025, important legal amendments relating to drug pricing in Germany that were included in the Medical Research…
-
Germany’s Ministry of Health refutes accusations of worsening market conditions
Germany’s Federal Ministry of Health has published its evaluation report on the impact of the GKV Financial Stabilization Act on…
-
The large amendment to Poland’s Reimbursement Act—disappointing, but not disastrous
The large amendment to Poland’s Reimbursement Act (Duża Nowelizacja Ustawy Refundacyjnej, DNUR) finally came into legal force on November 1,…
-
The Unitary Patent and the Unified Patent Court: possible opening in second half of 2022 will mean a complex European patent patchwork
A unified system of European patents has been a goal of those working towards European integration since before the establishment…
-
Will IRP upend Czech orphan drug reforms?
On 14 September, the Czech Chamber of Deputies gave its final approval to the amendment of the Public Health Insurance…
-
Germany’s ESG Law: A case study for new pharma pricing model
Pharmaceutical pricing is increasingly becoming a broader topic in the global push towards sustainability and environmental, social, and government (ESG)…
-
Polish pharma associations unite in appeal for greater access to biologics
Poland's pricing and reimbursement system has always had a reputation for restrictiveness when it comes to originator therapies, with its…
-
Germany’s fixed pricing for medicines faces European reckoning
Fixed prices for prescription medicines are an important part of the framework of pharmaceutical pricing and reimbursement regulation in Germany.…
-
New payment-by-results and payback regulations for Bulgaria
Earlier this year, important amendments to of Ordinance 10 (on the terms and procedure for the payment of medicinal products)…