Europe is often not planned too early. It is planned too late.

European market access preparation should begin while clinical and commercial assumptions can still be changed. Waiting until the evidence package is complete can leave a launch team with questions that a reimbursement dossier alone cannot resolve.

For life sciences companies developing a new medicine, postponing European planning is understandable. Teams want clearer clinical results, greater regulatory confidence and a more predictable investment case. Yet decisions about comparators, endpoints and patient subgroups may already be taking shape. Those decisions can influence the questions that European clinicians and assessment bodies will later ask.

Start before important choices become difficult to change

There is no single development phase that is right for every product. The useful moment is before pivotal study design and other consequential evidence choices are locked. A focused feasibility review at that point can identify which assumptions need testing and which decisions can still be influenced.

This does not require committing to a full affiliate or a complete launch organisation. It means giving European access requirements a place in development discussions early enough to matter.

What should an early feasibility review test?

• Clinical relevance: do the proposed comparator, endpoints and patient population reflect the treatment decisions in the intended markets?
• Evidence gaps: which uncertainties could matter to assessment bodies, clinicians or local budget holders?
• Economic assumptions: does the value story consider the relevant care pathway, resource use and budget impact?
• Country sequencing: is the proposed first market supported by access readiness, or mainly by an attractive market-size estimate?
• Adoption: who influences treatment decisions, and what practical barriers could remain after reimbursement?

Combine formal requirements with local experience

Published guidance is essential, but it does not answer every operational question. Senior local input can help a team understand how clinical practice, hospital decisions, pharmacy processes and funding arrangements interact. In the Benelux, that work needs to distinguish the Netherlands, Belgium and Luxembourg rather than treating them as interchangeable.

Formal scientific advice can also support evidence planning. EMA and the European HTA Coordination Group offer parallel joint scientific consultations for eligible developments, addressing regulatory and HTA evidence questions through their respective processes. Such advice complements local feasibility work; a consultant’s assessment does not replace it or guarantee an outcome.

Make the output useful for decisions

A practical review should leave the team with a prioritised assumption register: what is known, what remains uncertain, how each uncertainty could affect the launch, and who will investigate it. Each finding should connect to a decision, an owner and a development milestone.

The aim is to identify avoidable problems while options remain open. No review can promise access or eliminate delay. It can help management make a more informed decision about evidence generation, country sequencing and the next investment.

Discuss your European launch assumptions

At Health Devotion, we combine senior life sciences experience with local stakeholder understanding to challenge market-entry assumptions. Explore our Market Exploration & Validation services or contact us to discuss your development and launch questions.

About the author: Ivo Vink, Health Devotion.

Source: EMA: collaboration with health technology assessment bodies.