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A Viable European Union Medicines Regulatory System Must be a Cornerstone for Innovation in Europe
Mark Mayer
Eli Lilly
Nick Sykes
Julie O’Brien

Sini Eskola
Magda Chlebus

European Federation of Pharmaceutical Industries and Associations (EFPIA)
Chloé Garay
Eli Lilly, on secondment to EFPIA

he European Union (EU) regulatory system has been a model of collaboration and innovation over many decades. In the current environment of rapidly advancing science, growing demands on data science expertise, and geopolitical changes, insufficient resources limit the EU regulatory system’s global competitiveness. This hinders the expertise-based decision making necessary to deliver new medicines for EU patients as effectively and efficiently as possible.

For example, data from 2021 demonstrates that it took 428 days to approve a new active substance in the EU, compared to 245 days in the USA, 301 in Canada and in Japan, and 350 in Australia. Since 2020, even as the numbers of requests to receive scientific advice have increased, the research-based pharmaceutical industry represented by EFPIA has reportedly experienced delays of between one and two months for scientific advice, impacting the ability to rapidly move forward development plans in the EU.

During DIA Europe 2022, it was repeatedly voiced that “the system suffers from resource issues at EU member state agencies that mean the European Medicines Agency’s human drugs committee, the CHMP, cannot do its job properly, according to CHMP chair Harald Enzmann” (Schofield, “Top EU Regulator Attacks Complexity & Duplication In European System”; Pink Sheet, 14 April 2022).

The pharmaceutical strategy, including a potential revision of the general pharmaceutical legislation (Dir 83/2001 and Reg 726/2004) and EMA Fees Regulation (Reg 297/95) as well as the next EU financing cycle (multiannual financial framework), offers a possibility to address resourcing and expertise issues. These can be opportunities to ensure that the EU has a regulatory system fit to embrace future innovation in a timely and efficient manner for the benefit of public health and one that continues to act as a center of excellence for regulatory sciences. This article outlines how.

The Resource Challenge

Making medicines and vaccines available to European patients in an effective and efficient manner is a shared interest of all stakeholders. The EU regulatory system has recently become far more encumbered than at the time of its inception. This is due to increasing complexity of innovative medicines and vaccines; the consequent need for specialized expertise for their review; capacity and budget constraints across the system; and, most recently, additional pressure on regulators from the COVID-19 pandemic.

To guarantee the future success of the EU regulatory network at this juncture, the research-based pharmaceutical industry considers it essential to strengthen it with the necessary resources, talent, and expertise.

Adequate Funding of EMA and NCAs for a Viable EU Regulatory System

EFPIA recognizes the significant resourcing challenges faced today by the EU regulatory network and considers it essential that the European Medicines Agency (EMA) and National Competent Authorities (NCAs) have the necessary resources and infrastructure to deliver their public health mission.

Given its essential role in public health, public funding should contribute a significant portion to achieving a well-resourced, robust EU regulatory system that will also cover many activities and infrastructure investments that do not generate fees. Without correcting the resourcing problems for both EMA and NCAs, the EU regulatory system’s viability to support the delivery of innovative medicines and to implement its future-proofing agenda (EMA’s Regulatory Science Strategy to 2025) may be compromised.

In the EU, the EMA collects fees from applicants and distributes a proportion to the NCAs to remunerate them for the work they undertake for the EMA. The agency also receives a small proportion of its overall budget through a contribution from the EU. Any revision of the current fee system should consider and be consistent with the fundamental principles of transparency, fairness, proportionality, sustainability, simplicity, and flexibility. It should be supported by a stakeholder dialogue on potential new funding models to advance the regulatory science areas of PRIME, iterative R&D dialogue, and dynamic regulatory assessment. Implementation of these types of proposals would have a near-term positive impact on capability and capacity advances.

In addition, to support changes to the fee system, EFPIA supports the introduction of a proportionate annual maintenance fee that includes all Type IA/IB variations, together with additional changes to the rest of the fee structure, to remove a number of anomalies that have developed over time. The implementation of such models should also be gauged by ongoing measures of their impact.

The impending review of the EU pharmaceutical legislation is a once-in-a-generation opportunity to update the EU regulatory system and to add legislative language in support of sufficient resources to ensure the longer-term sustainability and success of the EU regulatory system.

Root Causes of Resourcing Challenges: Budget versus Capabilities and Capacity Constraints

EFPIA supports changes to the EU regulatory system’s resourcing model that will improve capacity stability and enable capability enrichment. These current challenges do not simply rest on budgetary constraints but also stem from issues with regulator recruitment and limited opportunities in Europe to obtain regulatory science training, evolving expertise needs, and retention of regulators. Expanding the network’s regulatory science expertise, offering cutting-edge scientific training and educational opportunities, and setting priorities for capability growth will help address availability of the necessary expertise at the levels required. These investments would make the EU regulatory system fit for purpose today and prepared to support medicines innovation of the future.

Benefits of Multistakeholder Perspectives

Given the complexity of challenges facing the EU regulatory system, a holistic approach and collaboration with all stakeholders having a viable and vibrant EU regulatory system at heart will be essential to finding sustainable solutions.

This type of dialogue would bring a broad spectrum of views—for example, from regulators, patient advocacy groups, academia, researchers, healthcare professionals, and industry associations—into this discussion.

The EU regulatory system’s resourcing challenges will persist unless tangible solutions are introduced and multiple stakeholders are engaged over the much longer term. All stakeholders in the regulatory ecosystem should try to find a way to make this happen.