EU has centralized drug regulatory approvals with the EMA, they don’t do a country by country approval. The EMA doesn’t consider cost effectiveness for regulatory approval. But you’re right that it could affect availability since it plays a role in pricing negotiations at the country level
To what extent do cost effectiveness considerations play a role in country discrepancies in approvals and price negotiations?
EU has centralized drug regulatory approvals with the EMA, they don’t do a country by country approval. The EMA doesn’t consider cost effectiveness for regulatory approval. But you’re right that it could affect availability since it plays a role in pricing negotiations at the country level
This is very well written. Great job
As my regulatory icon, I welcome your insights!