Europe entered 2025 with an urgent focus on ‘competitiveness’ after a series of reports – written by respected political operators like Mario Draghi – positioned the European Union’s economic weakness as an existential threat. A section of the report dedicated to pharma cited the EU’s weakening market share in biologics and ATMPs and faltering trial activity. The Commission responded swiftly, promising a Biotech Act and Life Science Strategy. In the UK, we’ve seen a broadly similar desire to talk up the economic value of health innovation from the Labour government.
The idea that Europe’s medicines regulators should become like the US’s Food and Drug Administration (FDA) is part of this push on innovation. Yet this year has also seen new industry complaints against changes at the FDA. To disabuse European policymakers that these complaints and European intentions would be enough to change the balance between the US and Europe, industry chief executives used a media blitz in April to point out the continent’s pricing regime and cost-containment measures were the real problem.
Complicating the picture further, President Trump revived his ‘Most Favored Nation’ (MFN) pricing policy, aiming to lower US prescription list drug prices by aligning them to other developed nations. How it will work and whether it will be legally enforceable is still unclear. Finally, for the first time, we now expect branded medicines going from the EU to the US to be covered by tariffs.
So where does this leave those looking to bring healthcare innovation to market in Europe?
Implications for Europe
The regulatory message is simple: Europe wants to make clinical trials and launches easier. Even prior to 2025, the political appetite to streamline EU regulations and strengthen engagement with the healthcare industry was strong – now, that’s mixed with a desire to take advantage of disruption and uncertainty in the US. Expect more regulatory sandboxes, clinical trials streamlining and a push for regulatory-industry engagement. If the EMA can deliver faster decisions, then this might have implications for launch sequencing.
There’s more ambiguity and complexity around pricing and reimbursement changes. Industry leaders point to three barriers: how HTA bodies assess value, how rebate schemes operate and how long exclusivity lasts. Reforming these will almost certainly require greater health spending, a tough sell, even if it attracts investment long term.
Oncology is the test case for whether EU HTAs can be more aligned in how they assess the clinical impact of treatments. The French Prime Minister has asked officials to examine how pricing frameworks could be altered to attract investment – not just defend healthcare budgets – while the UK is reviewing its own rebate scheme and seems open to raising NICE’s cost effectiveness thresholds. Meanwhile, the EU’s general pharmaceutical legislation – currently being negotiated – might reduce exclusivity for companies that delay EMA filings or skip EU trials. The debates about them will continue to be shaped by actions in the US and exactly how these processes end will have implications for launch strategies.
What does this mean for industry
Determining what this all means is a real challenge. Companies should focus on resilient strategies founded upon long-term trends not just noise in the moment. Instead, that noise should be used to predict potential risks and opportunities to plan a nimble response.
For example, one long-term trend is that France seems to be following Germany as a more supportive market for rare disease treatments – this could feasibly dovetail with regulatory innovation from the EMA to make Europe a valuable ‘hedge’ for US biotechs worried about relying fully on the FDA. Another long-term trend, higher oncology medicines spending in Eastern Europe, suggests broad-based launch strategies across the continent could become appealing.
This is no time for a static playbook, but making decisions at pace – based on poor quality and rapidly changing information – is difficult. Decisions and programmes can, to a certain extent, be de-risked with an understanding of the long-term trends and data.
New opportunities are opening up as policymakers push through their competitiveness agenda and shape the priorities of other stakeholders, from HCPs to payers. In this febrile situation, early, on-the-ground engagement can enable the early identification of trends, an ability to shape the market and crucially, give individual companies a competitive advantage.
Finally, in an environment filled with talk of competitiveness, investment and tariffs there is a risk that the needs of patients, and the implications for them, become unclear. Platforms that can articulate how these patient, economic, political and regulatory issues link together are desperately needed – this is ‘white space’ companies could help fill.
Noah Froud is Associate Director, PR & External Affairs at Syneos Health Communications