Belgium’s tenure at the helm of the EU Council has seen a concentrated effort to tackle the pressing issue of medicine shortages and overhaul the pharmaceutical incentives system. Spearheaded by Deputy Prime Minister Frank Vandenbroucke and advisor Gloria Ghéquière, the initiative seeks to enforce early notification obligations and establish a Shortage Prevention Plan (SPP). However, challenges such as parallel imports and administrative burdens on pharmacies persist, necessitating further intervention.
One of the focal points during Belgium’s presidency has been the contentious negotiations surrounding regulatory data protection (RDP). The “8+2+1” RDP model, which provides eight years of data protection followed by two years of market exclusivity and one year of additional exclusivity for new therapeutic indications, has sparked debate. Various EU member states have divergent views, with some advocating for the full eight-year RDP period, while others push for shorter durations. Despite remaining neutral, Belgium faces pressure from Pharma.be to endorse the comprehensive eight-year RDP model with added market exclusivity.
As Belgium’s presidency transitions to Hungary, a new proposal emerges, suggesting an eight-year RDP with modulation based on specific conditions. This approach aligns with the European Parliament’s perspective and introduces new criteria to incentivize research and development. Hungary’s proposal aims to balance regulatory data protection with market access obligations, hoping to refine the pharmaceutical landscape further.
Belgium’s Efforts to Address Medicine Shortages Highlight EU Regulatory Challenges
Belgium’s focused efforts to address medicine shortages and refine pharmaceutical incentives underscore the complexity of balancing regulatory and market needs within the EU. During its EU Council presidency, Belgium zeroed in on the pressing issue of medicine shortages. Deputy Prime Minister Frank Vandenbroucke and his team garnered widespread support among member states for their efforts. “It was one with the most support from member states since shortages increased 20-fold in Europe,” Ghéquière said during a recent webinar.
Belgium’s groundwork is expected to guide Council negotiations until 2026, with implementation projected for 2028. Katja Murray, Senior Director at FTI Consulting, noted that Belgium almost concluded negotiations on the shortages cluster, aiming for an intermediate compromise to set the direction for the Hungarian presidency, with a few outstanding issues that require resolution in subsequent negotiations.
Belgium’s presidency managed to strike significant compromises on various measures to mitigate shortages, such as an early notification obligation for the pharmaceutical industry and the introduction of a Shortage Prevention Plan (SPP). However, unresolved issues remain on parallel imports and the role of pharmacies, and the pharmaceutical industry has raised concerns over the administrative burden of compliance. Pharma.be, representing the innovative pharmaceutical industry in Belgium, emphasized that shortage prevention plans should be limited to products with a high impact on patients and not extended to all medicines due to the administrative burden. It also stressed that double reporting must be avoided by favoring links between the various EU and national databases.
Belgian Presidency Navigates Complex Incentives in EU Pharmaceutical Legislation
The Belgian presidency also tried to tackle the complex terrain of incentives within the EU pharmaceutical legislation, promoting a framework that values transparency and predictability. The “8+2+1” model of regulatory data protection (RDP) is under review, with the European Commission’s proposal to reduce the RDP period facing resistance.
During June’s EPSCO meeting, several EU member states stated their red lines during a political debate. Some made it clear that they cannot accept a six-year RDP baseline, leading to a political impasse. Countries including Germany, Denmark, France, Greece, Italy, and Sweden advocate for an eight-year RDP, while Spain and Portugal favor seven years, and others such as Austria and the Baltic states support six years. Belgium, along with Bulgaria, Cyprus, Croatia, Finland, Hungary, Ireland, Luxembourg, Malta, the Netherlands, Romania, and Slovakia, has maintained a neutral position in this debate. However, Pharma.be has expressed a clear preference for maintaining the status quo of an eight-year RDP followed by two years of market exclusivity.
The EU is considering a modulated incentive system for pharmaceuticals, with most member states, including Belgium, Bulgaria, and others, supporting the idea. The Belgian Presidency proposed an eleven-year cap on modulation, focusing on market exclusivity adjustments. However, some countries, including Austria, prefer a definite cap on modulation, while others suggest modulating market exclusivity. A minority, including Denmark and Sweden, resist modulation, fearing it may deter investment in new medicines. Pharma.be suggests that extending regulatory data protection (RDP) to encourage research and development is viable if it builds upon the eight-year baseline RDP, with additional incentives for addressing Unmet Medical Needs.
Hungary’s EU Council Presidency Proposes Conditional Eight-Year RDP to Enhance Market Access and Innovation
The proposed directive addresses whether companies should be incentivized or obligated to ensure better market access in Europe. The European Commission combines both approaches, offering extended RDP if companies meet specific supply timelines. Conversely, the European Parliament favors a more flexible approach, decoupling market supply obligations from incentives. Pharma.be calls for a broader multistakeholder discussion, emphasizing that access issues have multifactorial causes and require several different solutions.
The Hungarian Presidency, which took over from Belgium on 1 July 2024, has proposed an eight-year RDP period, decoupling it from the launch of new treatments in the EU. “De-linking RDP and access,” stated Katja Murray. The proposal includes a modulation approach where a full eight-year RDP is granted if the treatment meets certain conditions, such as addressing unmet medical needs or significant EU-based R&D. Otherwise, the RDP will be seven years. “This introduces a new criterion aligned with the European Parliament’s views on R&D investment.”
For some EU Member States, this will be seen as a fresh start on incentives following the Belgium EU Presidency. However, on the access provisions, the Hungarian EU Presidency has proposed an approach with an obligation to file for pricing and reimbursement (P&R) and a high economic fine in case a company will not file for P&R despite a request by a Member State.
As Hungary takes over the EU Council presidency, its proposal for a conditional eight-year RDP could offer a nuanced approach to incentivizing research and development while ensuring market access. Stakeholders must stay informed and engaged as these discussions evolve, recognizing that the outcomes will significantly impact the pharmaceutical landscape and healthcare delivery in Europe.
Resource: Euractiv, July 16, 2024
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