Next step to revise pharmaceutical legislation made by EU parliament

European Parliament adopted a comprehensive pharmaceutical reform package to address drug pricing, accessibility, and safety concerns across the EU.
Reform measures include enhancing price transparency, strengthening pharmacovigilance efforts, and streamlining regulatory processes to ensure patient access to safe and affordable medications.
Parliament members hail the reform as a significant milestone in promoting a more competitive and patient-centered pharmaceutical sector, while challenges in implementation remain.

In a landmark decision, the European Parliament has adopted a comprehensive pharmaceutical reform package aimed at addressing critical issues within the industry. The move comes amidst growing concerns of EU citizens over drug pricing, accessibility, and safety standards. The reform is set to lead us into the new era of regulation and transparency within the pharmaceutical sector, impacting millions of patients and other stakeholders. It is the first legislative overhaul of such big caliber since 2004. It comes one year after the publication of draft proposal by the European Commission.

The reform package seeks to revise various aspects of the pharmaceutical system. Key provisions include measures to enhance drug affordability, streamline regulatory processes, and improve pharmacovigilance efforts. One of the central objectives of the reform is to tackle the issue of surging drug prices, which have been a persistent challenge for both patients and healthcare systems. Also, by implementing regulations to promote price transparency and competition, policymakers aim to ensure that essential medicines remain accessible to all EU citizens without compromising on quality or safety standards. For several years now the healthcare system has been plagued by severe drug shortages. While the shortages emerged long before 2020, the COVID-19 pandemic and military conflict in Ukraine have further destabilized the global supply chains, exacerbating the already dire situation. Among the key solutions in the adopted package are the creation of the EU list of critical medicines and establishment of European Solidarity Mechanism that ensures their availability across all member states. The new regulations will also foster the access of EU patients to innovative drugs by lowering the duration of regulatory data protection from 8 to 7.5 years. This is much less than hoped by the public, especially since the pharmaceutical companies have multiple options to extend this period. The extension can be granted if the drug in question addresses unmet medical needs, is developed mostly in Europe or in collaboration with the EU institutions, or its manufacturer performs an additional comparative trial. The longer regulatory protection is intended to work as a powerful incentive for pharma companies to

develop the treatments for rare diseases, invest in local economy and finance the studies that shape medical practice. Despite the numerous available options, the industry remains critical of any proposals to shorten the duration of data or market exclusivity, while praising many other solutions offered by the reform.

The new legislation places a strong emphasis on strengthening pharmacovigilance mechanisms to monitor the safety and efficacy of pharmaceutical products. This includes enhancing post-market surveillance systems to promptly identify and address any adverse effects or safety concerns associated with medications. Furthermore, the reform also attempts to counteract the rising antimicrobial resistance (AMR) by offering market entry rewards and milestone payments for companies developing new antibiotics. Another incentive is the transferable data exclusivity voucher for priority antimicrobials, which provides additional 12 months of regulatory protection. These solutions were highly anticipated by medical profession – due to the AMR emergence, many big pharma companies abandoned this research area, turning their attention to cardiovascular diseases, diabetes, oncology and other more profitable indications.

Irrespective of the political affiliation, members of the European Parliament (MEPs) have hailed the adoption of the pharmaceutical reform package as a significant step towards ensuring the sustainability and resilience of Europe’s healthcare systems. By addressing longstanding challenges and modernizing regulatory frameworks, policymakers aim to foster a more competitive and patient-centered pharmaceutical sector. However, the adoption of the reform by EU parliament is only one step toward the full implementation of new policies, albeit a pivotal one. The MEPs will gather again to discuss the draft legislation after June 6-9 elections and the package must be approved by European Commission before final negotiations can take place. The process is expected to pose challenges, particularly in balancing the interests of various stakeholders, including pharmaceutical companies, healthcare providers, and patient advocacy groups. Nevertheless, proponents of the reform remain optimistic about its potential to deliver tangible benefits for patients while promoting innovation and affordability in the pharmaceutical market

Prepared by:

Adam Tuszyner

Sources and further reading

RAPS Regulatory Focus „European Parliament adopts pharmaceutical reform package” (April 11, 2024). Link: https://www.raps.org/news-and-articles/news-articles/2024/4/european-parliament-adopts-pharmaceutical-reform-p.
European Commission (EC). Reform of the EU pharmaceutical legislation. Link: https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en.