Not launching in Europe is not the solution. European access preparedness – growing opportunities and risk mitigation

Not launching in Europe is not the solution
European access preparedness – growing opportunities and risk mitigation

Taking a look at the new global access and pricing strategy context

In today’s turbulent geopolitical dynamics, there are many more moving parts when it comes to pricing, reimbursement and market access.

What are the key trends that come together, and what is the case for paying closer attention to European markets when there is considerable price & access pressure from the other side of the Atlantic? Here are my observations and recommendations from over 15 years in international Market Access & biotech investment due diligence:

Strategic access and price considerations are getting more complex and urgent. Fund raising, partnering and licensing deals are harder to come by, favouring the best prepared companies. While several US policies now aim to push a US-centric development and first-time launch, side-lining European and global markets and their potential revenues is not going to be a viable business model for many companies.

At the same time, European countries – including some of the largest markets such as France, Germany and the UK – are looking to increase their biotech attractiveness, creating incentives to attract clinical studies, strengthen local supply chains and to speed up innovation access for healthcare system efficiency. The role of the pharma sector in national economies is recognised, especial when solutions for the aging populations, rising healthcare costs and public health crises preparedness are required.

Whether or not you are planning to commercialise yourself across European markets, market and payer considerations are no longer a nice-to-have but a crucial element of your strategic clinical development.

Putting go-to-market preparedness for Europe on hold is not a solution, potentially distorting global strategies, creating delays and endangering overall product value.

What requires early attention? What has changed?

New US and European policies, their effects and related uncertainties

European Market Access procedures now start before marketing authorisation and launch; evidence and strategy preparations need to be developed earlier. The new EU Joint Clinical Assessment (JCA) requires companies to prepare for and submit a full dossier of access evidence at the same time as their EMA Marketing Authorisation Application.
Similarly, from 2026, the UK is opening an option for parallel regulatory and reimbursement approval through the “aligned pathway”. While the UK fast-track is entirely optional, faster access will require earlier HTA submissions and early engagement with the regulators and evaluators at least 3 years before UK MHRA marketing authorisation.
With US price pressure increasing (MFN, IRA), international pricing and launch strategy need additional attention. Putting go-to-market preparedness for Europe on hold is not a solution, potentially distorting global strategies, creating delays and endangering overall product value. Biotechs cannot afford to miss out on European revenue, nor to lose investor confidence through negative bias in revenue forecasts. Your access strategy and international vision need to be clear; your payer evidence needs to be impeccable for an optimal reimbursement negotiation base line.
Being able to choose the best option for European commercialisation in tight financial markets and a tough partnering environment, requires companies to present evidence packages that will either ease the launch burden for licensees or allow financing of “go-alone”-options. Not being able to find the right commercialisation partner is a risk that is becoming more tangible.

Indicators of lacking Market Access preparedness

With tight budgets, biotech companies tend to heavily focus on the scientific, clinical and regulatory aspects of drug development. But with new global policy environments, delaying commercial and market access considerations can become more costly later on.

In Europe, industry bodies and patient associations have long since highlighted that the misalignment on payer evidence requirements, value proposition and price are the key reasons for patient access delays and restrictions. *

Internationally, findings from industry surveys indicate that 75% of biotech first-time launches considered Market Access too late in development, with management noting a negative effect on launch performance and commercial KPIs. **

81% of pharma companies now initiate their market access planning earlier than five years ago, many already involved in market access research by phase 1.***

These survey findings are consistent with my experience in European market access. The most prevalent errors leading to delayed access or less than optimal reimbursement that I frequently observe include:

Mismatched clinical trial designs and payer requirements. Most commonly these are: Designing the Phase 3 trial only for FDA approval, neglecting specific comparators, patient reported outcomes (PROs), or subgroup analyses required by key European HTA bodies.
Neglecting local expertise: For example: Many US-based companies rely on global vendors lead by US teams to manage market access research but may not capture nuanced local requirements and situations in major European countries
And more recently: The “Price-First” Mentality: Focusing on the list price before having a robust, market-specific understanding of price (value) drivers and other access relevant and revenue driving factors and opportunities that specific country launches can bring to the development and commercialisation efforts.

Access excellence to de-risk reimbursement and revenue

Creating a valuable global asset today means staying on top of dynamic policy developments, to evaluate policy impact and incorporate new realities instead of standing still, immobilised by market uncertainty. Integrate this new understanding with clinical and regulatory efforts to mitigate access and commercial risks during development. Questions of strategic positioning, patient need, launch and pricing need to be aligned early with clinical and regulatory efforts to create opportunities in the tension between global and local.

Putting in place activities, teams and systems to proactively follow and evaluate policies and competitor efforts, to work with market scenarios and to understand opportunities more broadly than a list price will be the way forward as we are going through 2026. In this environment of uncertainty, coherent global Market Access Excellence is something that needs to be prominent and start early, so that conflicting international priorities can be navigated strategically.