A year following the European Health Technology Assessment (EUHTA) regulation coming into force, German pharmaceutical associations, the Federal Association of the Pharmaceutical Industry (BPI) and the Association of Research-Based Pharmaceutical Companies (vfa), released a joint statement claiming that the implementation of the regulation is now in a deadlock.
The BPI chairman feels that better involvement from all stakeholders is required including from the pharmaceutical industry to amend the direction of the implementation, thus releasing it from its deadlock. Both associations complain that there are too few opportunities for companies to participate in the joint process and so meaningful interactions with assessors are prevented.
The vfa president claims that currently the joint assessment has raised the fragmentation of different European countries to a European wide level rather than harmonising the processes into one convincing European method. Therefore, the president is concerned that this will not reduce the administrative burden of companies and HTA authorities.
The vfa president also urges that more information is specifically needed on the assessments of ATMPs and orphan drugs as they will be among the first to start being assessed by this procedure in 2025 and 2028 respectively. And are additionally concerned that the current process does not comply with the requirements of the EUHTA regulation that specify that adapted methods should be in place for rare diseases.
Sources:
- Gemeinsame Pressemitteilung: Europäische Nutzenbewertung in der Sackgasse. BPI. https://www.bpi.de/de/nachrichten/detail/gemeinsame-pressemitteilung-europaeische-nutzenbewertung-in-der-sackgasse. Accessed 12th January 2023.
- EU-Nutzenbewertung: Pharmaverbände sehen Beratungen in „Sackgasse“. ArzteZeitung. https://www.aerztezeitung.de/Politik/EU-Nutzenbewertung-Pharmaverbaende-sehen-Beratungen-in-Sackgasse-435706.html. Accessed 12th January 2023.
- Umsetzung der EU-HTA-Verordnung benötigt Richtungskorrektur. Vfa . https://www.vfa.de/de/wirtschaft-politik/euro-hta/positionspapier-eu-hta-vfa-bpi. Accessed 12th January 2023.