The European Union is facing perilous times as new challenges emerge every day at the international level. The pharmaceutical sector is deeply affected by this ongoing evolution; innovation and competitiveness are among the main keywords inspiring the work of the EU Commission, but results are often contradictory.
The trade deals closed with the US, for example, have already been challenged by the decision of the German government and Parliament to impose a fixed 15.5% rebate on the prices of patented, branded, innovative medicines to better sustain the domestic health insurance system. The decision was paralleled by a new Section 301 investigation launched by the US Trade Representative and aimed at determining “whether persistent underpayment for innovative pharmaceutical products by Germany is unreasonable or discriminatory and burdens or restricts U.S. commerce”.
Another worrying signal is contained in the latest report by the European Patent Office (EPO): in 2025, the number of applications received for pharmaceutical patents decreased by 6.3% compared to the previous year, placing the sector in eighth place in the ranking.
Furthermore, as the EU confirms its ambitious 2030 targets for clinical trials, the US has accelerated reforms to regulatory frameworks to support innovation. We examine where Europe stands, what remains to be fixed, and how the transatlantic — and increasingly trans-Pacific — race is evolving.
Innovation as an investment, not a cost
Every euro invested in innovative medicines generates, on average, €5.67 in socioeconomic benefit, according to a recent report drafted by the WifOR Institute for EFPIA.
Reduced mortality, avoided hospitalisations and higher labour productivity are the main expected drivers. Hospitalisation alone could yield savings of approximately 80 cents per euro invested, with returns highest for antineoplastic and immunomodulating agents (6.8-fold).
The report analyses 29 European countries over the period 2014–2022. Findings show that the pharmaceutical industry’s R&D-to-sales ratio in Europe (13.72% in 2021) is approximately 3.5 times the average across all industries, confirming its role as a core engine of innovation and competitiveness rather than a peripheral cost centre.
But the structural weakness relative to its competitors has also been confirmed: Europe’s share of global pharmaceutical R&D investment fell from 41% in 2001 to 31% by the mid-2020s, while the absolute R&D spending gap between the US and Europe widened from €2 billion to €25 billion over the same period. According to the EFPIA W.A.I.T. Indicator 2025 survey, the median time from market authorisation to medicine availability for patients in the EU reached 597 days, 19 days more than the previous year.
The EFPIA report also renews its requests to the EU institutions to strengthen the conditions for innovation, ensure timely and equitable access to new medicines, and preserve Europe’s competitiveness in the global life sciences sector. These objectives must be treated as interconnected priorities rather than separate agendas, the report suggests. The current geopolitical and policy environment risks undermining Europe’s attractiveness as a destination for life sciences investment, it also warns, and could result in delayed patient access with measurable economic consequences. Positioning Europe as a leading destination for clinical trials should not be a separate ambition but rather a precondition for achieving a return on investment.
Progress toward the 2030 targets for clinical trials
The Accelerating Clinical Trials in the EU (ACT EU) issued in 2025 by the EU Commission sets the goals to improve Europe’s attractiveness for conducting clinical trials to be achieved by 2030. The ACT EU is part of the wider effort to renew the legislation governing the pharmaceutical and life sciences sector, including the EU Biotech Act I on healthcare biotechnologies and the EU Biotech II on biomanufacturing.
The European Medicines Agency published its first quarterly monitoring report on progress towards the2030 clinical trials targets in May 2026, covering the period January-March 2026.
The EU’s attractiveness is measured by the number of multinational trial authorisations, with 19 newly authorised trials in the quarter, in addition to the historical average. The set goal is an additional 500 multinational clinical trials authorised over the 2026–2030 period (100 extra per year and 25 extra per quarter). In Q1 2026, a total of 2,830 trials were authorised (vs 2,836 planned), with monthly figures markedly rising from January (58) to March (110).
The time needed to recruit trial participants remains lower (40.5%) than the target for 2030 (66%). The report highlights an unresolved disparity in institutional and academic trial infrastructure, with non-commercial sponsors facing longer delays between application submission and the start of recruitment. On the other hand, trials conducted by commercial sponsors are closer to meeting the target.
According to the report, the median time from submission to decision for new initial clinical trial applications in Q1 is 118 days. In the quarter, more than 6,425 initial clinical trials were ongoing across the EU/EEA under the Clinical Trials Regulation. The pilot FAST-EU is also underway to assess the feasibility of shortening multinational evaluation timelines within the existing legal framework, under the coordination of the Heads of Medicines Agencies (HMAs).
In the US, Operation TrialBlazer and the reform of early-phase trials
On the other side of the Atlantic, the US government is putting competitiveness at the top of its political agenda. The US Department of Health and Human Services (HHS) announced on 22 June 2026 a coordinated, department-wide effort to strengthen theleadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world.
All the main US health agencies are participating in the initiative (including the FDA, NIH, ARPA-H, ONC and the HHS Office of Inspector General), which is named “Operation TrialBlazer”.
According to the initiative’s roadmap, the true threat is posed by China: the Asian giant already surpassed the US in 2024 in total registered clinical trials, with over 7,100 trials representing 39% of the global total. If current trends continue, drugs developed by Chinese biotech companies are projected to account for 35% of FDA approvals by 2040.
To contrast this trend, Operation TrialBlazer supports a proposed Expedited-IND Acceleration Pilot program aimed at shortening the time needed from drug identification to first-in-human Phase 1 clinical trials. According to the roadmap, the current time between a Pre-IND meeting request and IND submission is on average 380 days, with a range of almost 700 days; sponsors often must wait up to 60 days just to secure a pre-IND meeting with the FDA. The delays are often due to sponsors’ misunderstanding of upfront Chemistry, Manufacturing, and Controls (CMC) requirements and Pharmacology/Toxicology testing, leading to unnecessary data generation at a stage when there is still high uncertainty about a therapy’s effectiveness.
The new science-driven, risk-based FDA approach to nonclinical development aims at eliminating unnecessary animal toxicology studies, pointing to single-species testing or use of alternative methodologies in appropriate cases. As for CMC requirements, stability data will only be referred to the proposed duration of the Phase 1 study rather than a full long-term stability package, potentially saving sponsors up to 6 to 12 months of development time.
The FDA has also issued a draft guidance supporting single high-quality late-stage clinical trials with confirmatory evidence to provide substantial evidence of effectiveness for new drug approval.
The Expedited-IND Acceleration Pilot will also create a network of Qualified Research Institutions to partner with sponsors on IND development, while the FDA will review submissions on a rolling basis using a new real-time submission platform. Clarification of regulatory guidance on adaptive designs and simplification of the Institutional Review Board (IRB) approval and contract negotiation are other measures aimed at improving recruitment through the use of alternative trial designs.
Among other US institutions taking part in the Operation TrialBlazer, the National Institutes of Health (NIH) will provide support on the responsible use of artificial intelligence, human cell-based models, real-world data, and practical clinical trial tools, without compromising scientific rigour. The NIH’s National Center for Advancing Translational Sciences (NCATS) will use its knowledge on the development of fully personalised CRISPR-based gene-editing treatment to support the development of future therapies for patients with rare diseases. The NIH’s National Cancer Institute (NCI) will collaborate with cancer centres, researchers, and other stakeholders to streamline clinical trial activation and improve recruitment, while the Office of the National Coordinator for Health Information Technology (ONC) is exploring ways to better connect patients with clinical trials through electronic health records. The Advanced Research Projects Agency for Health (ARPA-H) launched several initiatives to modernise clinical research, including the Treating Hereditary Rare Diseases with In Vivo Precision Genetic Medicines (THRIVE) and Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) programs.
From innovation to implementation, the roadmap for Europe
The HLTH Europe 2026 conference, held in Amsterdam from 15–18 June, focused on supporting competitiveness and innovation amid evolving scenarios.
According to the conference report published by Pharmaceutical Technology, the many innovations produced in the pharmaceutical and medtech fields should be considered within the specific, fragmented context of European healthcare systems. Innovation does not translate into implementation; a gap remains that must be closed for healthcare systems to adopt innovative approaches. As an example, panellists noted that only 2–3% of eligible European patients are treated with GLP-1 receptor agonists for obesity, compared with roughly 10% in the United States.
The “consumerisation” of healthcare was another key theme discussed at the conference. It refers to patients increasingly seeking health information through unconventional sources, e.g. social media and large language models such as ChatGPT. As a result, many patients may make autonomous decisions and consider unregulated, unapproved treatments outside conventional pathways. Building trust in the pharmaceutical sector is thus a key priority, together with closer partnerships with payers, patient advocacy groups and healthcare systems.
The evolution of the European healthcare systems is increasingly supported by AI tools, including AI-enabled diagnostics, digital therapeutics, and next-generation biologics. According to the Pharmaceutical Technology article, integrated care systems should be the goal, combining medication with complementary care under unified coverage.
Read together, the resulting picture indicates that Europe is able to produce high-return innovation but is losing pace in R&D share and time-to-access, as competitors are moving faster on innovation in regulatory design. The EU’s 2030 clinical trial targets show early progress, while the US is aggressively re-engineering its own early-phase pathway specifically to tackle China’s advances. For Europe, as suggested by HLTH 2026, the decisive battleground may not be discovery, but implementation: regulatory ambition and capital availability should be turned into medicines that reach patients faster and evenly across all Member States.
