Author: Malcolm Boyd, Senior Consultant, Policy & Public Affairs

At the World EPA Congress 2026 in Amsterdam, I had the pleasure of moderating a fireside discussion on one of the most pressing questions facing the pharmaceutical and biotech sectors today: how policy and pricing shifts across the EU, UK and globally are reshaping market access. 

Over the past two years, the environment for pricing, reimbursement and access has become markedly more complex. Governments are seeking greater control over healthcare spending, industrial policy is becoming more closely linked to health policy, and global pricing dynamics are increasingly interconnected. Measures such as Most-Favoured-Nation (MFN) pricing proposals, the US Inflation Reduction Act, the EU Biotech Act, EU HTA implementation, and reforms to the UK VPAG and NICE framework all point to a system in flux. 

At the same time, these changes are taking place against a backdrop of rising expectations for innovation, increasing pressure on public finances, and a growing recognition that life sciences are a strategic sector. 

To explore these issues, I was joined by an excellent panel bringing perspectives from policy, HTA and industry: 

• Vlad Olteanu, Healthcare Public Affairs Director, EuropaBio 

• Meindert Boysen, HTA Expert and former Chair of HTAi Global Policy Forum and NICE Executive Team Member 

• Andrew Olaye, General Manager UK & Ireland & Head of Partner Markets EMEA, Orchard Therapeutics 

 The discussion highlighted both the risks and the opportunities emerging from the current wave of policy change across the EU and UK and reinforced that success in market access will increasingly depend on how well companies adapt to uncertainty, generate evidence earlier, and align with evolving payer expectations. 

A shifting global policy environment 

One of the clearest themes from the discussion was that policy change is not happening in isolation. Instead, we are seeing simultaneous reforms across multiple regions, each influencing the others. 

Vlad Olteanu noted that, from a global perspective, the pace of change in recent months has been striking. While Europe is often perceived as a highly regulated environment, he suggested that the current moment reflects something deeper than incremental regulatory reform. 

According to Vlad, there is a fundamental shift in how governments view biotech and pharmaceuticals, with the sector increasingly treated as a strategic technology alongside artificial intelligence, semiconductors and energy security. 

This shift is visible in initiatives such as the EU Biotech Act, growing discussions around strategic autonomy, and increased political focus on supply chains, manufacturing capacity and innovation competitiveness. 

However, this new attention brings both opportunity and risk. On one hand, recognising biotech as a strategic sector could lead to stronger support for innovation, faster pathways and more coordinated policy. On the other, it also increases the likelihood of political intervention in pricing, reimbursement and market access decisions. 

Vlad emphasised that companies should avoid reacting too quickly to individual policy announcements. Policy has moved very fast in recent months, but it will continue to change. Companies should not rush decisions based on short-term signals, they need to take a longer-term view. 

This point resonated strongly throughout the discussion. In a world where pricing rules, thresholds and international reference baskets can change quickly, strategic patience and flexibility are becoming as important as speed. 

Europe: more coordination, but also more complexity 

The European environment is becoming more integrated, but not necessarily simpler. 

The implementation of the EU HTA Regulation, combined with ongoing national pricing reforms, is creating a system where companies must navigate both centralised evidence requirements and local reimbursement constraints. 

This could improve consistency in clinical assessment, but it does not remove the reality that pricing and access decisions remain national — and increasingly political. 

Several panellists noted that European governments are under strong fiscal pressure, which is leading to greater scrutiny of value, tighter budget controls, and more willingness to intervene in pricing policy. 

At the same time, industrial policy considerations are becoming more visible. Governments want to attract investment, support domestic manufacturing, and ensure access to innovation — but they also want to control spending. 

This tension is likely to remain a defining feature of the European market access landscape for the foreseeable future. 

The UK: thresholds, evidence and the politics of pricing 

Turning to the UK, Meindert Boysen offered a perspective shaped by his experience at NICE and in global HTA policy. 

Recent changes to NICE thresholds and wider discussions around the UK pricing framework have generated significant debate within the industry. However, Meindert suggested that the practical impact of some of these changes may be more limited than initially assumed. 

In his view, threshold adjustments alone are unlikely to transform decision-making. 

“It’s not so much about the threshold, it’s about the evidence we provide.” 

He emphasised that uncertainty remains one of the biggest challenges in HTA submissions, and that the ability to manage uncertainty, through better data, clearer value narratives, and appropriate use of managed access mechanisms, will continue to be critical. 

Rather than focusing solely on the headline threshold number, companies should focus on: 

• the quality of the clinical evidence, 

• the relevance of comparators, 

• the robustness of economic modelling, 

• and the credibility of assumptions around long-term benefit. 

Meindert also highlighted a more structural shift in the UK system: the increasing role of government in determining pricing parameters. 

The fact that the Secretary of State can influence the threshold was described as a notable change in the balance between technical assessment and political decision-making. 

This reflects a broader trend where policy, pricing and power are becoming more closely linked, with industrial strategy, NHS affordability and access decisions increasingly considered together. 

For companies, this means that market access is no longer purely a technical HTA exercise — it is also a policy and political one. 

SMEs, capital risk and the challenge of predictability 

Andrew Olaye brought the perspective of smaller and mid-sized biotech companies, where the consequences of policy uncertainty can be particularly acute. Large pharmaceutical companies often have diversified portfolios and global revenue streams that allow them to absorb delays or pricing changes. For SMEs, however, a single reimbursement decision can determine the future of the company. 

Andrew noted that the current environment creates a difficult balance. On the one hand, stronger political involvement in life sciences could signal a growth agenda and a desire to support innovation. On the other, the same political involvement can increase unpredictability. 

For smaller companies, predictability is essential not only for planning launches, but also for attracting investment. 

 “We need predictability. We need to know that the rules won’t change halfway.” 

He also pointed to the potential impact of MFN-type policies and international reference pricing dynamics, which can disproportionately affect companies with small portfolios or highly specialised products. 

If pricing decisions in one market influence others, companies may delay launches, change sequencing strategies, or reconsider where to invest. This has implications not only for industry, but also for patients, because uncertainty can slow access to innovation. 

The discussion highlighted that policy stability is itself a form of access policy. 

MFN, global pricing and the growing interdependence of markets 

One of the recurring themes across the discussion was the increasing interconnection between markets. Policies such as MFN proposals, international reference pricing, and US price negotiation mechanisms mean that decisions in one country can influence pricing in many others. 

This creates a more complex strategic environment for companies, who must consider: 

• launch sequencing, 

• reference baskets, 

• confidential discounts, 

• and long-term global pricing implications. 

While these dynamics are not new, they are becoming more visible and more politically sensitive. Governments are aware that high prices in one market can affect affordability elsewhere, and are increasingly willing to act. 

At the same time, industry faces the challenge of maintaining incentives for innovation while operating in a system where price controls are tightening. 

This tension between affordability and innovation was a consistent theme throughout the discussion. 

Evidence generation is becoming the central battleground

Across all regions, one message came through clearly: evidence generation is becoming more important, earlier in the development process. 

As HTA bodies and payers become more demanding, companies need to think about access long before submission. This includes: 

• designing trials that reflect real-world practice, 

• selecting appropriate comparators, 

• planning for long-term outcomes, 

• and considering how uncertainty will be managed.

The panel agreed that successful market access strategies increasingly require alignment between: 

• clinical development, 

• regulatory planning, 

• HTA strategy, 

• and policy engagement. 

In other words, access cannot be an afterthought. It must be built into development from the beginning. 

Uncertainty as the defining feature of the current era 

From my perspective, the discussion reinforced that we are entering a period where uncertainty is likely to be the defining feature of market access in the EU, UK and globally. 

Policy is changing faster than in previous decades, and the direction of travel is not always clear.  We are seeing: 

• stronger political involvement in pricing decisions, 

• greater focus on affordability, 

• increasing coordination across countries, 

• and growing use of policies that link markets together.  

For companies, this creates real challenges. MFN dynamics, reference pricing, and evolving HTA frameworks mean that decisions cannot be taken in isolation. Launch strategy, evidence generation, pricing and policy engagement are more interconnected than ever. At the same time, this period of change also brings opportunity. Greater coordination across Europe could improve consistency. Earlier dialogue with payers could reduce uncertainty.

New policy frameworks could support faster access for high-value innovation. But realising these opportunities will require adaptation. Companies will need to: 

• generate stronger evidence earlier, 

• engage with policy makers as well as payers, 

• plan globally rather than market-by-market, 

• and build flexibility into their access strategies.

Perhaps most importantly, the discussion highlighted that the question is no longer whether the environment is becoming more complex, it clearly is. The question is whether this complexity can ultimately lead to a system that delivers both sustainability for healthcare systems and faster access for patients. 

That will depend on how industry, HTA bodies and policy makers respond to the changes now underway. 

Acknowledgements 

A big thank you to our excellent panel — Meindert Boysen, Andrew Olaye and Vlad Olteanu — for a thoughtful and engaging discussion, and for bringing perspectives from HTA, industry and public affairs. 

Thank you as well to everyone who joined the session at the World EPA Congress 2026 in Amsterdam, and for the insightful questions from the audience. 

Conversations like these are essential as we collectively navigate the evolving policy landscape shaping patient access to innovation.