LSE Health launches Pharmaceutical Policy Lab to address global drug policy challenges
New international research collaboration tackles pressing questions around medicine innovation, access, and affordability.
LSE Health has launched the Pharmaceutical Policy Lab, an international research collaboration dedicated to evaluating, informing, and shaping pharmaceutical policies worldwide. The launch event, held on 10 December, brought together 300 attendees in-person and online to explore how different health systems are navigating the complex tensions between pharmaceutical innovation, evidence generation, and equitable access.
"Our mission is to maximise the benefits and minimise the harms of medicines for patients, health systems, and societies," explained Dr Huseyin Naci, Associate Professor of Health Policy at LSE Health and the Lab's director. "The questions that matter in this field cannot be answered from a single perspective or within one disciplinary focus."
Dr Naci's vision for the Lab emerged from recognising the urgent need for independent, rigorous evidence on pharmaceutical policy. In a recent interview, he described how pharmaceuticals are central to modern healthcare - widely used, often highly effective, and among the most expensive interventions - yet critical questions remain about whether approval, pricing, and reimbursement decisions truly deliver value for patients and health systems.
The Lab represents a truly international effort, bringing together experts from across Europe, North America, and beyond. Collaborators include Dr Anita Wagner (Harvard Medical School), Dr Steven Woloshin (Dartmouth School of Medicine), Dr James Lomas and Dr Beth Woods (University of York), Dr Courtney Davis (King's College London), Dr Christine Leopold (University of Utrecht), and Dr Maximilian Salcher-Konrad (National Public Health Institute, Vienna).
When innovation moves faster than evidence
The launch event featured presentations from leading experts examining pharmaceutical policy challenges in the US and Europe, with the central question: what happens when innovation moves faster than evidence?
Dr Foluso Agboola, Senior Vice President of Research at the Institute for Clinical and Economic Review (ICER), provided a stark assessment of the US landscape. She revealed that approximately 70% of drugs assessed by ICER between 2022 and 2024 were priced above what their clinical benefits would justify based on ICER's Health Benefit Price Benchmark. The consequences extend beyond costs—excess spending from these pricing decisions is estimated to result in 97,000-115,000 people losing insurance coverage in a single year as premiums rise.
"We must be guides on a journey, not combatants seeking to win," Dr Agboola reflected, describing the challenges of conducting rigorous health technology assessment without statutory authority while US pharmaceutical policy shifts constantly: from the Inflation Reduction Act to tariff deals to evolving FDA approval standards.
A particularly pressing concern highlighted in her presentation was the widening gap between evidence needed and evidence available. Data from 2022-2024 showed that between 61% and 70% of FDA drug approvals were based on a single pivotal trial, making it increasingly difficult to distinguish substantial therapeutic advances from marginal improvements.
Europe's coordination challenge
Dr Beate Wieseler, Head of the Department of Drug Assessment at the German Institute for Quality and Efficiency in Health Care (IQWiG), outlined Europe's response through the new EU Health Technology Assessment Regulation. Since January 2025, the system has begun conducting Joint Clinical Assessments (JCAs) for oncology drugs and advanced therapy medicinal products, aiming to avoid duplication of work and provide all member states with high-quality HTA reports in a timely manner.
However, Dr Wieseler was candid about the limitations. While Joint Clinical Assessments can help by providing shared evaluations of relative effectiveness and safety, they won't solve all access disparities across Europe. Variation in access stems from different reimbursement systems, budget constraints, and local priorities: factors that remain under national control.
Both speakers identified a shared challenge: drugs are increasingly approved on less evidence while the questions health systems need answered grow more complex. This creates uncertainty for decision-makers trying to balance rapid access to potentially beneficial treatments with responsible stewardship of limited healthcare resources.
Professor Emily Jackson from LSE Law School facilitated a rich discussion following the presentations, exploring the legal, ethical, and practical dimensions of pharmaceutical policy reform.
Looking ahead
The Pharmaceutical Policy Lab's research spans every stage of pharmaceutical development and use, from early evidence generation through to post-market surveillance and real-world effectiveness. Beyond producing rigorous research, the Lab aims to actively engage with patients, prescribers, regulators, payers, and industry to ensure its work addresses real-world challenges.
"In the short term, we will continue producing rigorous research that evaluates, informs, and shapes pharmaceutical policies," said Dr Naci. "In the longer term, we aim to train the next generation of interdisciplinary pharmaceutical policy scholars. Ultimately, our success will be measured by tangible improvements in how medicines are developed, evaluated, and used."
The Lab represents a critical addition to the global pharmaceutical policy landscape at a time when health systems worldwide are grappling with how to reward genuine innovation while ensuring medicines remain accessible and affordable for the patients who need them.
For more information about the Pharmaceutical Policy Lab and its research, visit: https://www.lse.ac.uk/lse-health/research/ppl
Watch back the launch event on YouTube.