Europe is the second largest biopharmaceutical market in the world, with the 28 European Union (EU) countries accounting for $211 billion (18 per cent) of the total $1,133 billion market in 2018.
While countries such as the United States and Japan are essentially single markets, Europe provides a unique and distinct challenge for the pharma industry.
Within the EU, once the European Medicines Agency (EMA) has clinically approved a drug product, each manufacturer has to navigate a range of diverse European health care systems (largely split between Social Health Insurance and National Health Service frameworks); and local regulatory, market access and cost containment mechanisms before it can launch its products successfully across the continent.
These approaches to pricing and reimbursement vary country-by-country, and in some cases, even within countries.
A 2019 overview conducted by Deloitte Centre for Health Solutions provides a eight year (2012-2019) snap-shot on EU5 policy development aimed at influencing drug prices while maintaining a balance on patient-access.
The analysis identified a ratio of 2:1 in terms of unfavourable to favourable polices, as evidence requirements increase and the tolerance for imperfect and inconclusive clinical data decline.