For decades, European patients have enjoyed the security of universal healthcare systems that provide access to a wide range of treatments. The European Medicines Agency has long been a cornerstone of global drug regulation, and the continent has played a central role in pharmaceutical development. However, a quiet but profound shift is now taking place – and it matters to every single patient, doctor, and taxpayer across the continent. Access to new medicines in Europe is becoming harder, more fragmented, and increasingly delayed. Between 2020 and 2023, a comprehensive review of 173 innovative medicines with central marketing authorisations revealed that European patients wait an average of 578 days nearly a year and a half before these treatments become available to them. This is not an issue confined to a few struggling economies; it affects the entire continent, from Germany to Greece.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) found that some patients wait seven times longer than others depending on which member state they live in, and that the majority of delays 69% occur not during the initial regulatory assessment but after companies have filed for pricing and reimbursement, waiting for decisions from individual member states. In other words, once a medicine has been proven safe and effective at the European level, it often disappears into a labyrinth of national pricing negotiations, health technology assessments, and budget constraints that can stretch on for years.
The situation has dramatically worsened in the past twelve months. Since May 2025, when the United States introduced a most‑favoured‑nation (MFN) pricing policy aimed at tying American drug prices to the lower levels paid in Europe and other wealthy countries, the number of new drug launches in the European market has fallen by around a third. A GlobalData analysis found that new drug launches in EU markets fell by some 35% in the ten months following the executive order, compared with the previous ten months.
This is not a theoretical statistic; it represents concrete decisions by pharmaceutical companies to pause or cancel the introduction of innovative therapies that could extend or improve the lives of Europeans. “We’re seeing first signs of delayed introductions into Europe,” Stefan Oelrich, president of the EFPIA trade body and a senior executive at Bayer, told Reuters, noting that it is “a consequence of uncertainty around what that ultimately does to U.S. pricing”. The mechanism is simple but devastating: for drugmakers, the United States represents the single most profitable pharmaceutical market in the world. If a low EU price drags down the price they can charge in the US because of the MFN policy, then launching in Europe suddenly becomes a commercial liability rather than an opportunity. Some companies are now reconsidering every single launch decision.
The human cost of this trend can be seen in real‑world examples. Frank Hennemann, a German patient suffering from the debilitating lung condition bronchiectasis, has been waiting for a new medicine that could dramatically alleviate his symptoms. The drug Brinsupri (brensocatib), developed by Insmed – won European approval in November 2025, but the company has openly stated it will delay launching in Europe and Japan until it has clarity on the US most‑favoured‑nation policy. The drug began selling immediately in the United States after receiving FDA approval in August. “This is a political issue,” Hennemann told Bloomberg, regretting that “decision‑makers count numbers, not emotions or patient stories”. His case is far from unique. More than 90% of drugs approved in 2025 first launched in the United States, with most still not available elsewhere.
Meanwhile, France’s HAS health authority saw its early‑access decisions fall to just ten in 2025, down from twenty‑five in 2024. Lionel Collet, head of HAS, told Reuters that “the arrival of Trump has altered companies’ strategy of how they put products on the market”.
Why should the average European citizen be concerned about this trend? The answer lies in the fundamental bargain that underpins every universal healthcare system on the continent. European nations have historically relied on a delicate balance: they negotiate relatively low drug prices with manufacturers in exchange for predictable, voluminous public‑sector purchasing. This has kept healthcare systems sustainable while still allowing patients to benefit from medical progress. However, that balance is now breaking. Drugmakers are publicly warning that Europe is no longer paying its “fair share” for pharmaceutical innovation.
AstraZeneca chief executive Pascal Soriot has warned that Germany risks missing out on new drugs if it presses ahead with plans to limit pharmaceutical spending, and that Europe could become a mere “sales office” for the industry rather than a true centre of research and launch. Roche’s chief executive Thomas Schinecker went further, telling a Reuters event in Barcelona in April 2026 that Europe risks falling further behind the United States and China because of “mind‑blowing” bureaucracy and government policies that threaten pharmaceutical jobs. “Europe is so far behind and in most industries, I’m sad to say, they’ve lost the race,” Schinecker said, adding that “illogical” regulation was holding back innovation.
The data supporting these warnings is stark. Europe’s share of global clinical trials has dropped precipitously since 2013, falling from roughly 18% to just 9% for all trials, and from 22% to 12% for commercial studies. In terms of pharmaceutical innovation, the US share has now risen to 55% of global research and development, while Europe’s has dropped to 26%. Meanwhile, China has emerged as a formidable competitor, with one third of all new medicines approved by the FDA in recent years originating from Chinese research, and the country now accounting for roughly 30% of global pharmaceutical innovation. Pascal Soriot, chief executive of AstraZeneca, warned that “Europe spends a substantially lower share of GDP on innovative medicines than the US and, as a result, is falling behind in attracting R&D and manufacturing investments, putting its ability to protect the health of its own people at risk”.
Even if a medicine is eventually launched in Europe, the delays are punishing. In Poland, patients wait an average of 823 days for access to newly‑approved medicines, while just across the border in Germany the average is only 127 days. Greece faces waiting times stretching to 654 days, and Ireland’s patients wait an average of 644 days nearly two years for the latest therapies. In smaller countries such as Estonia, Latvia and Lithuania, filing rates for new medicines are as low as 9%, and average wait times exceed 550 days.
The European Union is not standing still. After more than two decades without a major overhaul, the EU has finally agreed on the Pharma Package the most significant revision of pharmaceutical legislation since 2004. The package, which was formally published in March 2026 after trilogue negotiations concluded in December 2025, aims to improve patient access to medicines, strengthen incentives for innovation, address antimicrobial resistance, and modernise regulatory procedures. However, the final text represents a highly complex balancing act. The current “8+2+1” model of regulatory protection (eight years of data protection, two years of market protection, plus one additional year for new therapeutic indications) has been replaced with a baseline of eight years of data protection followed by just one year of market protection, with the possibility of two further one‑year extensions under specific conditions.
This is a significant concession to generic and biosimilar manufacturers, who will be able to enter the market slightly earlier than before. However, the European Commission’s initial proposal had actually aimed for a six‑year data protection period a move that would have dramatically reduced exclusivity in favour of affordability. According to the Commission’s own impact assessment, the decision to maintain an eight‑year baseline instead of reducing to six years will cost European health systems an estimated €1.13 billion each year in higher prices, delaying access to cheaper generic alternatives.
The Pharma Package also introduces a more nuanced system for orphan medicines drugs developed for rare diseases that affect fewer than five in 10,000 EU citizens. Breakthrough orphan products that address indications without any existing authorised treatment will now receive eleven years of market exclusivity, while other orphan products will receive nine years.
This represents an improvement over the current uniform ten‑year period for some products, but a reduction for others. Additionally, a new transferable exclusivity voucher has been created to stimulate the development of priority antimicrobials, addressing the growing threat of antibiotic resistance. On paper, the package appears to balance affordability and innovation fairly. However, the Association of European Cancer Leagues has warned that “while several measures in the Pharma Package improve patients’ access to medicines, the final agreement falls short of fully addressing the issue of affordability”. Specifically, the organisation notes that generics and biosimilars will not be able to enter the market earlier than is the case today, and the eight‑year data protection period delays price reductions that could make cancer medicines accessible to all.
Looking toward the immediate future, the outlook for 2026 and beyond remains deeply uncertain. The MFN pricing policy continues to cast a long shadow over every launch decision. In March 2026, the head of the European Medicines Agency, Emer Cooke, told the Reuters Pharma Europe 2026 event in Barcelona that Europe is at “a very critical point” for ensuring future access to new drugs, and pressed regional authorities to work together more closely to navigate the global pricing turmoil. “Everybody’s struggling with what the impacts of the U.S. policy on pricing will be,” Cooke said. “And that’s not just on pricing, it’s on where you do your clinical trials, where you market, where you launch”.
The EMA head noted that the Commission had recently met with senior industry leaders to discuss how the regulator could support innovation and speed medicines to market, and pointed to ongoing efforts such as joint procurement for the bloc to access newly approved drugs. However, others are less optimistic. Bill Coyle, global head of biopharma at consulting firm ZS, warned the same conference that “MFN is creating a huge hesitation to launch here in Europe if it exposes price in the U.S., which, of course, is the major driver of profit for the entire industry”.
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