Access to New Medicines in Europe || Why It’s Becoming Harder-part2

      In the longer term, the trends are profoundly concerning. The pharmaceutical industry is not merely delaying launches; it is systematically shifting research, manufacturing, and commercial focus away from Europe. Novartis and Sanofi have openly criticised EU policy as unattractive, citing regulatory uncertainty and price controls, and have announced investments of over USD 165 billion in the United States. Europe’s share of global pharmaceutical manufacturing has been in steady decline for decades, with many laboratories relocating production to China and India, and the continent’s traditional strength in innovative high‑complexity medicines is now being aggressively targeted by US expansion. 

Access to New Medicines in Europe || Why It’s Becoming Harder

     The implications for European health sovereignty are clear. If the continent cannot attract the launch of new medicines, cannot conduct a proportionate share of global clinical trials, and cannot sustain its pharmaceutical manufacturing base, then European patients will inevitably receive new treatments significantly later if at all. Already, between 2018 and 2023, new medicines reached the UK an average of fifteen months after global launch, compared to just four months in the US, twelve months in Germany, and seventeen months in France. The US leads in access, while the UK has experienced a year‑over‑year decline in launches.

     The European Union’s response to this crisis has been fragmented and slow. A much‑anticipated Critical Medicines Act, published by the European Commission in November 2025, aims to tackle shortages by addressing supply chain vulnerabilities and promoting diversification and international partnerships. However, the act stops short of mandating price transparency or creating a truly unified procurement system that could offer drugmakers the scale and predictability they need. 

      Meanwhile, the European Parliament has been debating proposals for a European price list based on US prices, the elimination of member‑state spending caps, and a continent‑wide target for innovative medicine uptake. But these discussions remain preliminary, and member states have been loath to cede control over pharmaceutical budgets each country’s health spending is a fiercely protected aspect of national sovereignty. Until that changes, the fragmentation that currently plagues European drug access with some countries approving a medicine within months while others take years will persist. The inevitable consequence is that pharmaceutical companies will prioritise the largest, wealthiest, fastest‑to‑reimburse markets, and smaller or slower‑moving nations will be left further behind.

     Given the current trajectory, what can European patients and policymakers expect for the remainder of this decade? The most likely scenario is a continued divergence in access between the continent’s wealthier western nations and its eastern and southern members. Germany, which currently provides access to 90% of approved innovative drugs, will continue to be a priority launch market. France and Italy will remain significant, albeit with longer delays. However, smaller markets particularly the Baltic states, the Balkan members, and Malta will see filing rates remain in single digits, with average wait times exceeding 550 days. Meanwhile, the US will cement its position as the primary launch market for almost all innovative medicines, with European launches serving as secondary follow‑ons, often delayed by a year or more. 

    The MFN policy will continue to depress European launches, and the Pharma Package, while a welcome first step, will take at least two years to transition into full implementation. During that transition period, many of the old rules will persist, and the new incentives for innovation may not be sufficient to reverse the flow of investment toward the US and China. The European Commission’s own plans for joint procurement of the newest medicines are being viewed with deep suspicion by pharmaceutical companies, which fear that pooled EU purchasing will further depress prices and reduce the incentive to launch.