To date, each of the 27 EU markets required its own national dossier submission for drug pricing & reimbursement – sometimes multiple dossiers and supporting economic models. Most innovator biotech and pharma companies, with multiple launched products, have standardised processes for country-level submission strategy, dossier compilation and governance approval.

Adding in a new, mandatory dossier, which addresses the clinical value component at the EU-wide level, is a significant change to such standard business practice.

If your Company is a clinical stage biotech launching its first product with a European staff in single figures, this pan-European process is almost a gift from the gods – but you will still likely need a capable value & access partner, routinely operating at the European level, to develop a truly European (rather than single country) submission strategy and ensure the ultimate dossier aligns.

If your Company is a more established biotech, with >1 product on the market and a few in the pipeline, staffed by country clusters like DACH, BeNeLux and the Nordics, a pan-European process is perhaps readily manageable with a team of a dozen or so across key internal stakeholder groups – but still likely needs to appoint a value & access expert team to align across the clusters and, again, develop a truly European submission strategy and dossier.

If your Company is a major global biopharma with 20+ European GMs used to decision-making power, each of whom has Medical, Marketing and Market Access staff involved, the complexity multiplies. This huge community then also needs to co-ordinate with HQ equivalents, all within the mere 2-month window from CHMP Opinion to “exhaustive” dossier submission that has been set by the regulation. Here, the business process re-design and governance adjustments needed to deliver on time but maintain strategic and operational alignment across countries requires not just expert value & access co-ordination but also effective management consultancy from advisors who also understand the content.