Parallel imports and the role of pharmacies still unresolved in pharma package negotiations [Advocacy Lab Content]

The ongoing pharma package negotiations were marked by Belgium’s focus on combating medicine shortages and shaping the incentives system for new medicines development. Key issues remain in play for Hungary, including parallel imports.

During its EU Council presidency, Belgium zeroed in on the pressing issue of medicine shortages. Belgium’s Deputy Prime Minister Frank Vandenbroucke and his team, including advisor Gloria Ghéquière, 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.

Compromises and challenges

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,” Murray told Euractiv.

Pharma.be, representing the innovative pharmaceutical industry in Belgium, told Euractiv that shortage prevention plans should be limited to products with high impact on patients and not extended to all medicines due to the administrative burden.

It also emphasises that double reporting must be avoided by favouring links between the various EU and national databases.

Navigating incentives in pharma revision

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, a number of EU member states stated their red lines during a political debate. Some made it clear that they cannot accept a six-year RDP baseline,” said Murray.

This has led to a political impasse, with countries including Germany, Denmark, France, Greece, Italy, and Sweden advocating for an eight-year RDP, while Spain and Portugal favour seven years, and others such as Austria and the Baltic states supporting 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.

“Belgium should, as one of the countries with a major biopharmaceutical industry footprint, and in line with other large footprint countries like Germany, France, Italy, Denmark, Sweden, and Ireland, support an unconditional RDP of 8 years, plus two years of market exclusivity,” said Pharma.be.

Modulation debate

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.

Supply in the European market

The proposed directive addresses whether companies should be incentivised 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 favours a more flexible approach, decoupling market supply obligations from incentives.

Pharma.be calls for a broader multistakeholder discussion, emphasising that access issues have multifactorial causes and require several different solutions.

Hungary’s proposal

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.

As Murray stated, “Basically, de-linking RDP and access.” 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,” concluded Murray.

[By Nicole Verbeeck, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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