The European Federation of Pharmaceutical Industries and Associations (EFPIA) published a study on 21 April 2026 revealing that patient-centred research practices are applied inconsistently across EU member states, with significant variation in patient engagement in clinical trial design, regulatory processes, and health technology assessment. The study calls for harmonised standards to ensure patients are systematically involved throughout the medicine development lifecycle.
The report comes amid broader EU efforts to strengthen clinical research competitiveness. On 18 April 2026, the European Medicines Agency (EMA), the European Commission, and Heads of Medicines Agencies set a target to raise EU clinical trials by 11.1%, aiming to add 500 multinational trials over five years. A Frontier Economics study, published via EFPIA, estimated this could create 35,000 additional trial places and deliver €4 billion in economic impact. However, Europe still lags behind the US and China in attracting trial activity.
EFPIA's findings also align with concerns raised by national stakeholders. On 19 April 2026, Belgium's clinical research sector warned that competitiveness is strained by slow patient access to new therapies, with MSD Belgium's managing director calling for regulation and reimbursement pathways to evolve with scientific progress. Similarly, on 18 April 2026, the Czech health ministry warned EU colleagues that Extended Producer Responsibility rules under the Urban Waste Water Treatment Directive could raise drug costs and threaten supply, particularly for generics.
The study builds on the European Commission's broader health agenda. On 16 December 2025, the Commission proposed a Biotech Act to boost health biotechnology and manufacturing, aiming to simplify regulatory processes and facilitate access to finance. Commissioner Olivér Várhelyi, at the Euronews Health Summit 2026 on 17 March 2026, framed these reforms as essential to protect Europe's universal healthcare model from demographic and chronic disease pressures.
EFPIA's study highlights a cleavage between patient-centred ideals and practical implementation, with uneven application across member states risking disparities in access to innovative treatments. Positive impacts include potential for more relevant clinical outcomes and faster patient access if harmonised standards are adopted. Negative impacts include additional administrative burden for sponsors and regulators, and potential delays if new requirements are not carefully phased in. Key stakeholders affected include EU regulatory bodies (EMA, national agencies), pharmaceutical companies (especially SMEs), patient organisations, and national health technology assessment bodies.
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