Belgian politicians raise concerns on pharma regulatory data protection change

In its last stretch, the Belgian Presidency of the Council of the EU is discussing regulatory data protection (RDP) for medicinal products. The goal is to balance pharmaceutical innovation with timely patient access across the EU.

With EU elections just around the corner, Belgian politicians have shared with Euractiv their perspectives on this complex issue.

Petra De Sutter of the Groen party (Greens) highlights proposed changes to regulatory data protection (RDP). The European Parliament aims for a 7.5-year standard RDP period, with possible extensions based on specific conditions.

“In total, the data protection period can amount to a maximum of 8.5 years. This is six months longer than the current period, so the competitive position would not necessarily worsen.” De Sutter flags that additionally, there will be a market protection period of at least two years, and there is an exception for orphan drugs.

Groen supports linking the duration of data protection to patient-centric conditions. “Comparative clinical trials remain the gold standard, contributing to the quality of drug evaluation. Governments now have few resources to direct drug development towards societal needs; this would give them an additional tool.”

Industry interests and competitiveness

Jo Brouns of CD&V (EPP) emphasises to Euractiv that RDP is crucial for pharmaceutical companies’ business models and investment in new medicines.

“Restricting the standard RDP period and tying conditions to its extension should not necessarily be understood as a “reduction of incentives for research, development, and production of new medicines.”  Instead, he asserts, it focuses on Europe’s specific needs, such as unmet needs and antimicrobial products.

According to Brouns, the proposed EU pharmaceutical legislation also aims for a significantly faster “market authorisation” procedure. This streamlined process could stimulate research and development, leading to quicker access to new medicines. “Notably, Flanders invests nearly 3.7% of its GDP in research and development, ranking second globally after Korea. The ambition is to maintain or strengthen this level of investment.”

Brouns underscored the importance of offering incentives for industry investment in Europe, saying “These incentives should not be market-distorting and are best provided at the European level to avoid harmful intra-European competition.”

Balancing RDP

Kathleen Van Brempt, representing the Vooruit party (S&D), stresses the importance of conditionality in RDP. She clarifies, “The European Parliament does not advocate for a standard six-month reduction of the RDP but makes it conditional on certain requirements.”

Van Brempt highlights the critical need for RDP to align with the simultaneous launch of medicines across the entire European market. This ensures equitable access for every European patient. She highlighted the case of baby Pia, where medicine was available in Germany but not in Belgium – a situation she said must be avoided.

“The intention behind these proposed changes is not to reduce incentives for research, development, and production of medicines. Instead, they aim to better align with existing healthcare needs,” Van Brempt clarifies.

She advocates for a special European agency for health research and development, coordinating joint investments in medicines, vaccines, and treatments while facilitating production scalability during emergencies.

Relaxation of conditions in the latest proposal

President of Open VLD (Renew), Tom Ongena, raises a critical concern about the impact of legislative changes on innovation and patient welfare. He emphasises that “Today’s innovative medicines are the critical medicines of the future. If Europe, through its policies, kills innovation with its legislation, then patients will be the ones who suffer most.”

The recent RDP proposal eases conditions, requiring companies to file – not necessarily achieve – pricing/reimbursement applications in all EU countries within 12 months.

Ongena notes this increases the administrative load, particularly for small biopharmaceutical firms. Despite an EU-level HTA, individual assessments by countries remain.

“This aims to provide EU citizens with innovative medicines access; however, it may be counterproductive.”

In Belgium, only half of authorised innovative medicines get reimbursed; and a quarter did not even request reimbursement because companies assess the probability of reimbursement as too low or non-existent.

This forced application process could seem like administrative harassment when considering separate country submissions. Ongena also cautioned that sanctions could reduce innovation protection levels adding that recognising that many headquarters are overseas is vital.

Deep concerns by N-VA

While acknowledging positive aspects of EU pharmaceutical legislation, N-VA (ECR) expresses deep concerns about reducing regulatory data protection.

“We call for the protection of current intellectual property rights and stress that ecological criteria for market authorisation must be better balanced against medical necessity. Moreover, the new orphan drug legislation threatens us with a €45 billion investment, which will reduce access to innovative therapies in Europe,” Kathleen Depoorter told Euractiv.

N-VA asserts that European regulation should prioritise R&D, intellectual property protection, and patient-centric innovation.

“Without adjustments, especially concerning orphan drugs, the industry risks missing out on the biotech revolution, impacting both industrial strength and patients.”

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

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