The EU Pharmaceutical Package: Reshaping Regulatory Strategy and Exclusivity Planning

As the EU pharmaceutical landscape undergoes its most significant regulatory overhaul in decades, understanding the practical implications for originator companies has become increasingly urgent. Central to this transformation is the European Commission’s effort to reshape the framework governing Loss of Exclusivity (LoE) — a pivotal factor in life cycle planning and competitive positioning for pharmaceutical manufacturers, through the legislative proposal introduced on April 26, 2023, under the “EU Pharmaceutical Package.” This proposal aimed at revising the Regulatory Data Protection (RDP) framework, which determines the limited period that protects innovative drugs from generic and biosimilar competition. The regulatory protection framework consists of two main phases: first, a period of data exclusivity, during which the marketing authorisation holder has exclusive rights to the use of preclinical and clinical trial data; and second, a market protection period, during which competitors, including approved generics, are prohibited from entering the market.

This new regulation includes a range of incentives aimed at benefiting pharmaceutical manufacturers, patients and EU member states:

·       Promoting Innovation and Competitiveness

·       Improving Access to Antibiotics and Orphan Medicines

·       Ensuring Supply Security

·       Enhancing Environmental Sustainability

 While the motivations behind the proposal are well-intentioned, the key questions remain: What are the actual changes compared to the current legislation? And what will be the practical impact on pharmaceutical manufacturers?

These questions are central to understanding how originators will need to adapt their regulatory strategies, particularly in terms of securing exclusivity and managing the life cycle of their products from launch to patent expiration.

What is the pharmaceutical package?

Under the current legislation (2001/83/EC), the RDP timeline includes eight years of data protection, an additional one year extension for a new therapeutic indication, and two years of market exclusivity. The commission‘s proposition sought to revise the structure significantly. It proposed a six-year period of data protection, with additional extensions of six months for unmet medical need (UMN), six months for new active substances, and 2 years if the product is launched and suplied in all 27 EU member states (cumulated maximum of 3 years), followed by two years of market exclusivity.

The European parliament introduced a counter-proposal in April 2024. This revised version presented a less drastic alternative to the original plan. It increased the base period of data protection from six to seven and a half years, with an additional extensions of 1 year for unmet medical needs, six months for products containing new active substances, six months for product developed through EU-based research collaborations, and an additional one year transferable voucher for medicines targeting antimicrobial resistance. This data exclusivity period would be followed by two years of market exclusivity and one year extension for new therapeutics indications.

On June 4th, 2025, the European council, comprised of all 27 member states under the Polish EU presidency, provided their recommendation of the legislation. This new version proposes 8 years of data protection followed by 1 year of market protection, and 1 year extension for an unmet medical need, or new active substance where the clinical trials followed EMA scientifc advice, Efficacy trials were lead in more than one member state, MA application was first submitted in the EU or within 90 days of the first submission outside of the EU. A third year extension could be granted if during the RDP the product gains approval for new indications with significant clinical benefit. However, the Council may revoke market protection if a manufacturer fails to meet specific access and supply obligations. These obligations include submitting pricing and reimbursement applications, fulfilling defined rollout and access requirements, and ensuring that the product is available and continuously supplied during the first four years following marketing authorization. If market protection is lost, generic and biosimilar applications may be assessed as early as year 6 of the Regulatory Data Protection (RDP) period. However, final approval and commercialization would still be aligned with the end of the full data exclusivity term.

The European council proposed to increase the current RDP of 9 years of the orphan medicines by 1 year if the medicine in question addresses a high unmet medical need or is launched in all member states. This change would bring the total protected period for orphan drugs to 12 years with the additional 2 year of Market protection.

The European Commission, the Parliament, and the Council must now reach a compromise on the final text of the legislation—many aspects of which, particularly those related to access and incentives, remain sensitive and potentially contentious.

What will be the impact on pharmaceutical manufacturers?

 Pharmaceutical manufacturers have been closely monitoring the proposed revision of the EU pharmaceutical package legislation, and its potential implications. While the current draft is significantly less radical than earlier versions and remained aligned with the existing framework, it still introduces meaningful changes that could alter how manufacturers operate. It’s important to note that this impact assessment is preliminary, as the legislation has not yet been finalized or adopted.

 Positive Impacts

·       More extensions opportunities:  The proposal introduces additional opportunities for market protection extensions, including for new indications, unmet medical needs, new active substances, and the use of transferable market exclusivity vouchers for priority antimicrobials. However, these vouchers are expected to be extremely rare, with only five to be granted.

·       Overall protection period remains comparable: If all conditions are met, the total period of protection could still amount to 11 years (8 years of data exclusivity + 3 years of possible extensions), versus the current framework (previously 8+2+1 years).

·       Support for Repurposed Medicinal products: Repurposed medicines may be eligible for 4 years data protection, if they demonstrate significant clinical benefit and meet criteria such as no prior data protection or 25 years since initial Marketing authorization.

 Negative Impacts

·       Reduced De facto Protection: Although there are more extension options, the base exclusivity period effectively becomes 8+1 years, potentially reducing market protection by one year compared to the current standard (8+2 years), thus losing an invaluable 1 year of market protection.

·       Increased procedural burden: While beneficial, the extensions come with strict conditions. Manufacturers must apply for pricing and reimbursement in all EU member states, and the marketing authorization (MA) must be first submitted in the EU—or within 90 days of the first submission outside the EU. This creates a significant barrier for manufacturers who might have deprioritized EU applications later in their launch timelines. It will also impact prices in other markets through International Reference Pricing (IRP). With a smaller protection period, some manufacturers might reconsider their EU launch and delay an additional 2-3 years to match US timelines.

·       Stricter Penalties and compliance requirements: mechanism to revoke market protection if the manufacturer fails to meet the access and supply obligations, generic/biosimilar companies can apply for MA earlier than from the year 6 of RDP, but approval will wait until full Data excluisivity, but no Market protection

·       Reduce predictability and visibility: Member States will have the discretion to request that Marketing Authorization Holders (MAHs) place products on the market or ensure national supply. This adds uncertainty, as the criteria and enforcement may vary significantly between countries.

·       Limited flexibility for extension applications: Although the Council’s position is less rigid than earlier proposals from the European Commission and Parliament, it still imposes a strict deadline—extensions must be applied for within four years of the initial MA in the relevant Member States.

Will this Impact how Loss of Exclusivity is managed?

 Well, it’s complicated! The extent of the impact depends on the outcome of the negotiations between the European Commission, Parliament, and Council. Under the current proposal, ensuring broad and timely product availability across all Member States becomes essential to prevent the early entry of generics or biosimilars. This may significantly affect strategies for managing LOE.

Manufacturers delaying launch in the EU are particularly at risk. To benefit from data protection extensions, manufacturers would need to submit an EU MA application within 90 days of their first global submission—a requirement that may necessitate an additional sense of urgency to obtain extensions. IRP could also become an important factor, impacting prices in country where the product would still be protected.

Conclusion

Looking ahead, the path to implementation remains long and complex. While the European Commission provided an updated proposal, negotiations will start in mid-June 2025 with the three parties (council, commission and parliament) with a conscensus expected by 2026. Once adopted, a 36-month transition period will follow to allow various stakeholders – regulators, manufacturers, and healthcare providers alike – to prepare for operational changes, to transpose the regulation into local legislations. The full implementation of the EU pharmaceutical package is expected at the earliest by 2028 or 2029.     

Let’s discuss – which components above or additional areas are you and your teams closely tracking with respect to Regulatory Data Protection?   Feel free to reach out to anyone on the Marbls team or themarblsteam@marblsgroup.com for further insights and discussion on the EU pharma package or any other recent regulatory activity!