2025年SPC框架的重新制定和统一SPC：欧盟有效SPC的原则

Principles for an Effective SPC in the EU Author:EFPIADate:15/09/2025Version:FINAL Progress on the SPC Legislation The ongoing reform of theSupplementaryProtectionCertificate (SPC) framework—includingboth the recast of national SPC grant procedures as well as the creation of a Unitary SPC (uSPC)—provides Europe with an opportunity to increase its competitiveness and attractiveness to As the primary organisation representing the research-based pharmaceutical industry inEurope, the European Federation of Pharmaceutical Industries and Associations (EFPIA) haslong advocated for the introduction of a unitary Supplementary Protection Certificate (uSPC)for medicines. Its introduction would fill a criticalgapin fully realizing the benefits of the EFPIA is, however, concerned about thelegal and practicalchallenges facing advancement ofthe SPC package.Thus far, progress on the file toward a viable, effective solution has beenlimited.At a time when competitiveness and regulatory simplification are strategic priorities,we strongly encourage the European Commission and Member States to advance discussionsand explore all viable institutional options that could best achieve these key policyobjectives. EFPIA members stand ready to contribute to this process and are hopeful that progresscan bemade balancing speed with the quality and effectiveness of the SPC framework, supporting the Principles for an Effective and Competitive SPCFramework While the ultimate arrangement ofinstitutionalcompetence and responsibility could takemultiple forms, EFPIA strongly believes that a well-functioning SPCframeworkshould be built (1)A single, centralized examining body (CEB) with the necessary technical expertise toensure EU-wide harmonisation in procedures and outcomes.This body should oversee Ideally, a CEB would primarily operate as a virtual office, gatheringexperienced examiners fromrelevant national patent offices(NPO) currently engaged in substantively examining SPCapplications.As such, the specific institution in which the CEB administration and examination (2)A unified, competent, and efficient forum for handling invalidity requests and appealsagainst refusalsfor uSPCs.`For consistency, this forum should be the Unitary Patent Court(UPC)—with the ability to refer cases to the Court of Justice of the European Union (CJEU) whennecessary.This would ensure that legal questions would be handled by a forum with therequisite expertise, a sufficient scope of review, andadequatetimelines for specializedintellectual property matters such as SPCs. At the same time, this would also avoid legal (3)Efficient, timely, and uniform proceedings for both unitary and national SPCs,ensuringpredictability and reducing administrative complexity.In this vein, EFPIA specifically believesthat a pre-grant opposition procedure is unnecessary, as it would add undue complexity andweaken the system without addressing any identified substantive need.It is critical to bear inmind that, currently, less than 1% of granted SPCs ever face a revocation action; this number (4)To maximize harmonization, coherence, and legal certainty, the uSPC system and thenational procedure (SPC recast) legislative proposals should advance together as much aspossible, as an overall consideration.If, for example, a viable uSPC proposal is tabled thatincorporates the above key principles, it could later be expanded to national SPC applications In summary, in line with European strategic priorities of competitiveness and regulatorysimplification, it is imperative to establish a well-functioning SPC framework that is effectiveand efficient. This framework must ensure that the critical uSPC system aligns with the existingUnitary Patent regime.EFPIA advocates for the finalisation of these regulations so that