Market access is becoming a determinant of development success. Across the industry, access outcomes are increasingly being defined years before launch – shaping which development pathways remain viable at all. Evidence strategy, comparator selection, pricing architecture, and launch sequencing are no longer downstream considerations – they are becoming critical determinants of whether assets can achieve timely, sustainable access.
This is not being driven by a single reform, but by a convergence of system pressures that reduce the room for late correction. Joint Clinical Assessment (JCA) is raising the bar for European clinical credibility; renewed momentum behind US Most Favoured Nation (MFN)‑style pricing is increasing cross‑market linkage; and broader geopolitical uncertainty is reshaping global launch and pricing logic. What once could be managed country‑by‑country is now interconnected, less predictable, and far less forgiving of late correction. In practice, these forces are shifting access from an execution function to a development‑level feasibility constraint.
These themes were echoed in market discussions at EPA 2026, but the shift is broader – and already reshaping how organisations need to make decisions.
Challenge 1: Bringing Products to Market in an Era of Earlier Scrutiny
Where access risk is created faster than organisations are structured to govern it
Many organisational structures are not designed to support the extent to which access considerations now need to inform development. Decisions taken upstream – particularly around PICO, comparator choice, endpoints, and patient relevance – now materially influence whether assets can achieve viable access later in the lifecycle. What were once treated as clinical or technical design choices increasingly carry irreversible access consequences. This is no longer a marginal consideration, but a defining driver of development risk.
For many organisations, the challenge is not a lack of awareness, but a mismatch between when access risk is created and where access is formally empowered. Key development decisions are still frequently made outside formal access governance, even though their impact on reimbursement feasibility is now well understood. This leaves access teams in a largely reactive position, tasked with managing consequences rather than shaping choices.
As scrutiny continues to move earlier, reliance on late‑stage fixes – such as additional analyses, post‑hoc justification, or local adaptations – has become a weaker and more uncertain strategy. The system now offers less flexibility to compensate for early misalignment once development pathways are set. Access risk, therefore, needs to be actively managed at the point where clinical, commercial, and development trade‑offs are still open – a stage at which access has not historically been embedded as a decision‑making authority.
The implication is clear: market access is no longer simply an execution function focused on navigating reimbursement processes at launch. It is increasingly a determinant of whether development decisions translate into reimbursed, timely patient access at all. Until governance structures evolve accordingly, many organisations will remain exposed to avoidable late‑stage risk.
Challenge 2: JCA and the Push Toward Earlier Intervention
How declining tolerance for uncertainty shifts access risk into development
JCA is increasingly viewed not as a theoretical reform, but as a practical re‑allocation of accountability for access outcomes into development. Rather than concentrating risk at post‑authorisation assessment, JCA places greater weight on the coherence, relevance, and credibility of the evidence package at the point of first evaluation. As a result, regulatory approval alone is no longer sufficient to establish European clinical credibility, particularly where relative effectiveness or evidence consistency is questioned.
What fundamentally changes under JCA is not the structure of assessment itself, but the system’s tolerance for uncertainty at launch. Evidence packages that rely heavily on indirect comparisons, surrogate endpoints, or heterogeneous data now face earlier and more standardised scrutiny, with fewer opportunities for local reinterpretation or downstream mitigation. Ambiguity that might previously have been absorbed or managed at a national level is increasingly surfaced upfront and applied consistently across markets.
In this context, early anticipation of likely comparators, target populations, and outcomes becomes critical – not as a parallel HTA exercise, but as a direct input into development design. Increasingly, concerns raised during HTA reflect design choices made much earlier in development, rather than execution failures at launch. JCA brings these issues forward, tightens the assessment window, and applies a shared clinical lens that materially limits the scope for later correction.
The practical effect is that access risk now emerges by design rather than by exception. JCA surfaces weaknesses earlier, constrains remedial action options once programmes are underway, and increases the cost of misalignment once development pathways are fixed. In a system with lower tolerance for uncertainty, early access input becomes essential to preserving feasibility and protecting development value.
Challenge 3: MFN, Geopolitics, and the End of Local Pricing Logic
How global price linkage turns pricing feasibility into a development constraint
If JCA is reshaping expectations for evidence, MFN‑style pricing policies are reshaping the global environment in which access decisions are made. Across the industry, US MFN initiatives are increasing cross‑market price linkage, with both list and net prices more likely to travel across borders. This raises the risk that pricing decisions made in one market can have direct, immediate consequences elsewhere, increasing spillover risk for European countries that rely on differential pricing to support access.
This marks a fundamental shift: pricing is no longer a local optimisation exercise, but a portfolio‑level strategic variable. For many organisations, this creates a strategic constraint that cannot be reversed once early pricing and launch decisions are made. Early launch, pricing, and contracting decisions increasingly determine the feasible access envelope across markets and indications, limiting flexibility later in the lifecycle and requiring global coordination much earlier.
Critically, MFN introduces structural uncertainty that is difficult to model or mitigate after key launch and pricing decisions are set. The eventual global impact hinges on unresolved questions: whether MFN references list or net prices, how visible and shareable net prices become in practice, and how manufacturers respond through launch sequencing, contracting approaches, or selective market participation. What was once a late‑stage pricing challenge is now a development‑level risk management issue, influencing not only price levels but also where and when products can credibly be launched.
Layered onto this are broader geopolitical dynamics, including shifts in US trade and industrial policy and the growing role of China in biopharma innovation and supply chains. Together, these forces place access strategy within a multilevel policy environment in which pricing and reimbursement decisions can no longer be treated in isolation. Pricing feasibility, access, and development strategy are becoming tightly interdependent – a shift echoed across industry discussions, including at EPA 2026.
Why These Trends Make “Access by Design” More Urgent Than Ever
Taken together, these dynamics point to a clear conclusion: the traditional model of market access involvement is no longer sufficient. As access risk moves upstream under JCA, MFN, and growing geopolitical interdependence, organisations can no longer rely on downstream mitigation to protect development value.
In this context, an Access by Design approach becomes essential. As access risk moves upstream under JCA, MFN, and growing geopolitical interdependence, organisations can no longer rely on downstream mitigation to protect development value. Articulated at EPA 2026 in Stephen Hall’s keynote, Access by Design: Embedding Access into Core Development Decisions, the concept resonated not because it proposed a new framework, but because it addresses a structural challenge many organisations are now encountering: the need to embed access as a formal part of early development governance rather than a downstream corrective function. In practice, this means moving access from a predominantly advisory role to one with defined decision‑making authority at key inflexion points – such as comparator selection, evidence strategy, and launch planning – before decisions are locked.
Crucially, Access by Design reframed the challenge as a governance issue rather than a cultural one. Without clear decision rights, early resource allocation, and shared ownership of evidence and pricing strategy, organisations remain exposed to avoidable late‑stage adjustments, heightened uncertainty, and delayed or constrained patient access. The implication is clear: the system has changed, and governance around access must evolve with it.
What this means in practice
These shifts are widely understood conceptually — but less consistently operationalised in practice.
Embedding access upstream typically requires a shift in how development, evidence, and portfolio decisions are made and governed. In practice, this includes:
- Earlier access input into PICO, comparator, and endpoint trade‑offs, before development programmes and major investments are locked in
- Portfolio prioritisation and launch sequencing decisions assessed through an access feasibility lens, particularly where MFN‑driven spillover risk limits downstream flexibility
- Evidence strategies designed to support go/no‑go, sequencing, and value trade‑offs, not solely downstream HTA submission readiness
- Clear governance and decision rights for access at key development milestones, so risks are identified and managed while choices are still reversible
This is where targeted upstream access strategy support can materially reduce risk – by intervening before constraints are set, aligning evidence and pricing decisions early, and protecting development value in an environment that offers far less tolerance for late correction.
Three Key Takeaways
- Access risk is now created upstream, but organisational governance has not kept pace.
Development decisions with irreversible access consequences are increasingly being made early, while access remains positioned too late and too informally in decision‑making. Until access has defined authority at key development milestones, organisations remain exposed to avoidable risk that cannot be corrected downstream.
- JCA materially reduces the system’s tolerance for uncertainty at launch
By applying earlier, more standardised scrutiny through a shared clinical lens, JCA shifts access risk into development-by-design. Evidence gaps increasingly reflect early design choices rather than launch‑stage execution failures, leaving far less scope for mitigation once programmes are underway.
- MFN and geopolitics transform pricing feasibility into a development‑stage constraint
Global price linkage and policy spillovers mean pricing is no longer a local optimisation problem. Early pricing, launch sequencing, and contracting decisions now define what access is feasible across markets, reinforcing the need for coordinated, upfront access and pricing strategy.
Closing Thought
The question is no longer whether early access involvement is desirable, but whether organisations can afford not to redesign decision-making. In a world shaped by JCA, MFN, and geopolitical spillovers, development success is increasingly determined long before launch decisions are made. Access‑by‑Design is no longer aspirational – it is a practical necessity to protect development value, preserve strategic optionality, and enable sustainable patient access in an environment that is far less forgiving of late correction.
By Emma Robson, Valid Insight