加强欧盟一般药品立法中新型抗菌药物的激励措施

Strengthening incentives for novelantimicrobials in the EU General September 2025 Background Giventhegrowingthreatof antimicrobial resistance (AMR)andthebrokenantimicrobialpipeline1,Europeurgently needsto introducepredictableand meaningfully sized pull incentivestostimulatetheresearchanddevelopment(R&D)of novel antimicrobials. Recognising this, theEuropean Commissionput forwardpull incentive provisions in its 2023 proposal for a Pharmaceutical Regulation. Chapter III introduced Beyond the potential TEV, the EU has nocentralised pull incentivefor antimicrobials.Existing initiativesare limited in scope and, at best, might improve uptake of existing antimicrobialsbut do notprovidethe predictable, long-term rewards required to bringnovelantimicrobials to market.For example, the2025 EU4Healthprogramme allocates negligible amounts to AMR incentives3 and while nationalreimbursementschemesexist in a handful of Member States,theseare either too small in budget,toolimited in duration to provide a credible basis for sustained investment inR&D, or do not address keyissues impacting the broken antimicrobial market.In addition,several of these schemes are not delinked Other regions have demonstratedhow a meaningful pull incentive can be introduced.For example, theUK’s subscription modelestablishes contracts of up to£23.7 million per year per antimicrobial, awardedfor an initial term of 3 years and extendable up to a maximum of16 years or until market exclusivity ends.5Themaximum value of a single contract is around £379 million. The scheme is designed as a long-term,predictablereward, spreading costs over time.By contrast,throughtheEuropean Commission’s proposal,a single TEVwouldprovidea reward funded through the sale of a voucher offeringone-yearof additionalexclusivity. The Commission’simpact assessment estimates a single TEV could cost EU healthcare systems The EU has theopportunity to build on these experiencesand show leadership in the fight against AMR.WhiletheTEVproposed by the European Commissionwould still fall short of the scale of incentives subscription model),strengthened appropriately, the TEV could become Europe’s first dedicated pullincentive and send a clear signal of political commitment to antimicrobial innovation.EFPIA's positionis that theTEV should be strengthened, ratherthan diluted further.In parallel,complementary Several provisions currently under discussion risk renderingTEVineffective in practice. These include: •Eligibility criteriarestricted to narrowly defined public health value (Commission proposal,tightened further by Council).•Amandatory application of the TEV in the 5th year of the buyer product'sregulatory dataprotection(Commission proposal, amended by Council).•Arevenue cap of €490 million in annual saleson the buyer product (Council proposal). The rationale behindsome ofthese restrictions is to contain potential costs for Member State healthcaresystems.Researchshows that undera hypotheticalframeworkincludingthe 5th year RDP restriction andthe €490 million sales cap,the estimated cost of a TEV would fall to around €162 million, approximately45% lower than the Commission’s original estimate of €294 million.7This is problematic, as theCommission’s proposal was already insufficient to deliver Europe’s fair share8of global antimicrobialincentives, and further reductions undermine the TEV’s effectiveness as a meaningful pull mechanism.It is also important tonotethat the cost to healthcare systems is not equivalent to the benefit receivedby theantimicrobial’sdeveloper. The “cost” reflects one additional year of branded sales before genericentry, while the developer’s actual reward is determined through competitive bidding.For the These provisionscompound other Chapter III conditionalities on access, supply, transparency and globalaccess planningthat, while well-intentioned, risk becoming impractical ifnot adapted to the realities of Furthermore,thebroaderPharmaceutical Legislationalready contains general provisions on access andsupply that apply to all products, and these obligationswouldcome on top of thecurrent Chapter IIIrequirements.It also remains unclear how the Critical Medicines Act would interact with this The question is whether co-legislators intend to design an instrument that can genuinely work, or one soconstrained by cost-containment logic that it becomes unfit for purpose. The following recommendations EFPIANeo BuildingRue Montoyer 511000 BruxellesBelgiumTel.: +32 (0)2 626 25 55www.efpia.euinfo@efpia.eu