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Magda Chlebus
European Federation of Pharmaceutical Industries and Associations (EFPIA)
@EFPIA
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.
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
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
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
Benefits of Multistakeholder Perspectives
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.