The European Union (EU) has long been recognized as a global leader in pharmaceutical legislation. In light of evolving healthcare needs, patient care, and technological advancements, the EU amended 2 of their legislative frameworks on April 10th, 2024, named Directive on medicinal products for human use and the Regulation on authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency.
The amendments in the legislations aim to address challenges like supply chain disruptions, environment risk assessment, and sustainability while ensuring patient access to essential medicines and encouraging pharmaceutical innovation. The proposed revisions and amendments aim to ensure timely, equitable access to safe, effective, and affordable medicines for all EU patients, enhance supply security, promote innovation in the pharmaceutical sector, and promote environmental sustainability, while also harmonizing the internal market for medicinal product supervision and control across Member States.
What are the Key Changes in the New EU Pharma Law?
1. Reduction in regulatory data protection (RDP)
– Baseline reduction: The baseline period for regulatory data protection (RDP) has been reduced from 8 to 7.5 years. These changes aim to balance the need for innovation incentives to increase access to generics and biosimilars.
– Cap on RDP: The total RDP is capped at 8.5 years, which includes potential extension based on specific criteria, such as addressing unmet medical needs or conducting comparative clinical trials.
– Incentives for unmet medical needs: additional RDP can be granted:
• 12 months for products addressing critical unmet medical needs.
• 9 months for those addressing high unmet needs
• 6 months for medium unmet needs
2. Transferable exclusivity vouchers (TEVs)for Antimicrobials
The regulation proposed TEVs to incentivize the development of new priority antimicrobials. TEVs provide an additional year of regulatory data protection to developers of priority antimicrobials. TEVs provide added regulatory data protection (RDP) of 12, 9, or 6 months for developing ‘critical’, ‘high’, or ‘medium’ priority antimicrobials, respectively.
The issuance of TEVs is capped at a maximum of 10 vouchers over 15 years, ensuring that only the most critical products receive this benefit while maintaining access to treatments.
3. Orphan drug market exclusivity (OME)
The current orphan market exclusivity for medicinal products is 10 years, with a revised period of 11 years for products addressing high unmet medical needs.
Other changes that companies must take into consideration:
Pharmaceutical companies in the EU are required to prevent drug shortages and maintain a stable supply chain for essential medicines. Marketing authorization holders (MAHs) must provide explanations for supply disruptions and notify regulatory agencies at least six months in advance. Additionally, all pharmaceutical companies introducing medicinal products to the EU market must submit Environmental Risk Assessments (ERAs) to agencies to limit potential adverse impacts on public health and the environment.
How is the New EU Pharma Law Influencing the Global Pharma Market?
Increased Competition: The reforms are likely to make the EU market more competitive, encouraging pharmaceutical companies worldwide to adapt their strategies accordingly. Pharmaceutical companies may prioritize launching products in the EU first due to the streamlined processes and potential financial incentives, thereby influencing global launch strategies.
Challenges for Small and Medium Enterprises (SMEs): SMEs might face difficulties adapting to the new regulations due to their limited resources compared to larger firms. The modulation of incentives based on market launch across all EU member states could disproportionately affect these smaller entities, potentially stifling innovation if they cannot compete effectively within this new framework.
Impact on Global Health Initiatives: By addressing issues like antimicrobial resistance and ensuring equitable access to medicines, the new laws could enhance global health outcomes. This focus aligns with international health initiatives aimed at improving access to essential medicines worldwide, potentially fostering collaborations between European firms and global health organizations.
Global supply chain: The updated shortage notification obligations and reporting requirements aim to better manage and mitigate the impact of the global supply chain. The increasing roles of national competent authorities in providing up-to-date information and ensuring communication with healthcare professionals, patients, and the EMA will further strengthen the system’s resilience against shortages.
Conclusion
The newly enacted EU pharmaceutical laws are not merely a set of new rules, it is a call to action for the entire pharma industry. By understanding and anticipating the implications of these changes, stakeholders can better prepare for a future where innovative therapies are accessible, safe, and effective. The new regulation will help tackle the drug shortage and increase access to medicine for patients.
As companies adapt to these reforms, they will play a vital role in shaping the future of healthcare, ensuring that innovation continues to thrive while the diverse needs of patients around the world. The success of these reforms will ultimately depend on collaboration among industry stakeholders, regulatory authorities, and healthcare providers as they work together to achieve shared goals of improved health outcomes and sustainable practices.
In addition to providing regulatory and pharmacovigilance services for global customers, DDReg Pharma offers specialized clinical regulatory services to assist with Clinical Trial Applications in Europe. For further information, connect with our experts. Read more about EU regulations from the experts here: Accelerating Clinical Trials in the European Union