Adapting To Change: Examining The Implications Of New EU Regulations On Commercialization From The Perspectives Of Patients, Providers, And Pharma Companies

By Mike Ryan, Executive Vice President, Europe, EVERSANA

The average rate of availability for pharmaceuticals in Europe is 45%, down 2% on the previous year, according to the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) 2022 Patient W.A.I.T Indicator. The root cause of delay in availability can be attributed to many things, but it is primarily caused by variance in assessment for pricing and reimbursement by national Health Technology Assessment (HTA) bodies and in some cases, an inability of national healthcare systems to accommodate or afford new therapies.

Compared to the U.S., which has historically offered advantageous regulatory timelines and launch prices, Europe’s fragmentation and challenging infrastructure is more difficult to navigate and ultimately less lucrative for manufacturers. However, recent policy changes in Europe hold promise to enable expanded patient access and accelerate approval for novel therapeutics.

Learn how the EU joint health technology assessment regulation (HTAR) and the finalization of the pharma legislation review can help to use resources more efficiently and reduce the time span of assessments and review why pharma companies must still take precautionary steps beginning at the pre-clinical stage, all the way through to market access.