Dr. Marco Stief
Partner
Maiwald GmbH
Munich, Germany
Konstantinos Tsakiliotis
Associate
Penforce Law
Munich, GermanyEuropean pharmaceutical law is currently undergoing its most ambitious reform in more than two decades. Through the so-called EU pharmaceutical package - centered on a recast directive and a new regulation - the Union has spent the last several years redesigning core rules on authorization, regulatory protection, access, shortages, unmet medical need, and antimicrobial stewardship. After extensive drafting, negotiation, and political compromise among the Commission, Parliament, and Council, the reform now stands close to implementation.
One of the most novel and controversial elements of that package is the attempt to address antimicrobial resistance (“AMR”) through a new protection mechanism that EU law has not previously known: the transferable data exclusivity voucher. U.S. readers may be familiar with exclusivity vouchers as they have been proposed in a similar form by the U.S. Congress in the “Re-Valuing Antimicrobial Products Act” of 2018.¹ The instrument is intended to create an additional incentive for antibiotic R&D by generating a new form of tradable regulatory exclusivity. In that sense, it is not merely another adjustment of existing data- or market-protection rules, but the creation of a genuinely new regulatory asset designed to stimulate antimicrobial innovation and, in policy terms, to strengthen pharmaceutical R&D in Europe.
AMR is frequently described as a “silent pandemic,” and for good reason. According to the European Centre for Disease Prevention and Control (“ECDC”), more than 35,000 people die each year in the EU/ EEA as a direct consequence of infections caused by a ntimicrobial-resistant bacteria.² At the same time, the development pipeline for novel antimicrobials remains inadequate when measured against the public health need.³
The structural reason is well known. Antibiotics are medically valuable precisely because they should be used prudently. Unlike therapies for chronic conditions, they are usually taken for a limited period only. Their commercial potential is therefore constrained from the outset, and stewardship policies further restrict use in order to preserve efficacy. The result is a classic market-failure scenario: the social value of innovation is high, but the expected private return is often too low to justify the underlying R&D risk.⁴
Under the revised EU pharmaceutical package, a transferable data exclusivity voucher (“TDEV”) is intended to reward the development of a “priority antimicrobial” with an additional 12 months of regulatory data protection.⁵ The crucial point, and in practice the far more important one, is that the voucher may be used not only for the priority antimicrobial itself, but for another centrally authorized medicinal product of the same or a different marketing-authorization holder.⁶ In economic terms, the mechanism is therefore designed less as a reward tied to commercialization of the antibiotic itself than as a tradable instrument whose principal value will normally lie in extending exclusivity for another product. As a practical matter, one may expect that the voucher will often not be used for the antibiotic that generated it but will instead be transferred and monetized in order to prolong the regulatory protection period of a different medicinal product. The mechanism is designed to “delink” the reward for antimicrobial innovation from the sales volume of the antibiotic itself.
That basic architecture remains consistent with the earlier Commission proposal. However, the legislative text has evolved materially during the negotiations. The co-legislators reached a provisional political agreement in December 2025, and the Council’s 2026 compromise text now reflects a significantly more constrained and more sophisticated voucher model than the one originally proposed in 2023.⁷
The voucher is reserved for human medicines that qualify as “priority antimicrobials.” Substantively, the antimicrobial must represent a genuine advance against AMR. The relevant legislative text requires non-clinical and clinical data demonstrating a significant clinical benefit with respect to antimicrobial resistance and, in addition, at least one of the following characteristics: it must represent a new antimicrobial class, or have a mechanism of action distinctly different from any authorized antimicrobial in the Union, or contain an active substance not previously authorized in the Union that addresses a multidrug-resistant organism or a serious or life threatening infection.⁸
For antibiotics, the assessment is tied to pathogen prioritization systems. The legislative text still refers to the WHO priority pathogens list or an equivalent Union list.⁹ In that respect, the surrounding scientific context has also moved on since the earlier draft. WHO updated its bacterial priority pathogens list in 2024; the revised list covers 24 pathogens across 15 families and continues to emphasize multidrug resistant Gram-negative bacteria, while also updating the categorization of several other high-burden resistant pathogens.¹⁰ That update reinforces the basic point already made in the earlier version of this article: the voucher is not meant for ordinary follow-on products, but for genuinely high-priority antibacterial innovation.
The formal conditions for obtaining the voucher are also strict. The applicant must demonstrate the capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market. It must also disclose all direct financial support received for research related to the development of the product. In addition, the more recent legislative text now requires the applicant to show that the EU marketing-authorization application was submitted first to the European Medicines Agency, or at least no later than 180 days after the first filing outside the European Union.¹¹ This is a significant addition. It reflects the broader logic of the pharmaceutical reform package, which seeks not only to reward innovation, but also to anchor innovation in the Union and to encourage timely EU filing.
Once the marketing authorization is granted, the marketing authorization holder must publish the information on direct funding on a dedicated webpage and provide the corresponding link to the Agency.¹² The transparency rationale is explicit: the institutions want a clearer basis for assessing whether the voucher risks overcompensating the developer when public funding has already materially de-risked the underlying R&D effort.¹³
The dogmatically and economically most striking feature of the voucher remains its one-time transferability. Its practical importance lies above all in the fact that the voucher can be deployed for another medicinal product, and that this will likely be the commercially decisive use case in many situations. The voucher may be transferred once to another marketing-authorization holder, but it may not be transferred further. This creates a tradable exclusivity asset that is detached from the medicinal product whose development is being incentivized. It is precisely this detachment - and the possibility of extending protection for a different product with materially greater market value - that gives the instrument its commercial appeal, but it is also the source of its controversy.
In the original proposal, the voucher could be used for a centrally authorized medicinal product if that product was still within its first four years of regulatory data protection.¹⁴ That version was criticized because it potentially allowed the extension of protection for very high-revenue products and created substantial uncertainty for generic and biosimilar entry planning.
The current compromise text now substantially narrows that risk. If the voucher is used for a medicinal product other than the priority antimicrobial itself, the use must occur only in the fifth or sixth year of the regulatory data protection period, and only if the annual gross sales of that product in the Union did not exceed €490 million in any of the first four years following the grant of the marketing authorization.¹⁵ Moreover, the holder must demonstrate that the sales information is accurate and complete and has been audited by an independent external auditor.¹⁶ This is, in substance, the “blockbuster clause” that had already begun to appear in the later drafts and political discussion, but it is now much more concretely formulated.
According to a study by Charles River Associates published in 2025, only 21 medicines would, in theory, be eligible to buy and use a TEV. The main reason the pool of potential candidates becomes so small is the rule that a TEV can be used only for products still protected by regulatory data protection as a last line of IP protection, which removes 67% of otherwise possible candidates. A further 23% of the remaining products are excluded by the rule limiting use to the fifth year of data protection, and another 9% are excluded by the sales cap, which bars products that exceeded €490 million in annual sales in any of their first four years on the EU market. Accordingly, there are no blockbuster products that would be able to use a TEV, even in the absence of a revenue cap, since the average forecasted revenue of the 21 eligible products in their final year before loss of RDP is estimated at €257m.
However, these changes significantly reduce the distant theoretical prospect that the voucher will be used to prolong the monopoly of a mega blockbuster in a manner grossly disproportionate to the antimicrobial innovation being rewarded – also in the future. In addition, the voucher may be used only if the marketing authorization for the priority antimicrobial has not been withdrawn.¹⁷ This further ties the continuing value of the voucher to the continuing regulatory life of the antimicrobial product that originally earned it.
Transparency has also been strengthened. When a voucher is transferred, the receiving marketing authorization holder must notify the Agency within 30 days and state the value of the transaction; the Agency is then to make that information public.¹⁸ From a policy perspective, that disclosure requirement is sensible. If the voucher is justified as a targeted pull incentive, legislators and the public need visibility into how much economic value is in fact being generated and captured.
The core advantage of the voucher model remains the same as in the original draft: it seeks to decouple return on investment from antimicrobial sales. That is its principal conceptual strength. For SMEs and other developers that do not themselves possess a lucrative late-stage commercial portfolio, the transferability feature may be particularly important, because it permits monetization through sale to a larger company with a suitable target product.¹⁹ In that sense, the instrument may support precisely the type of collaboration structure that often characterizes antimicrobial R&D: smaller innovation-focused firms on one side, larger commercialization-capable firms on the other.
At the same time, the classic objections have not disappeared. Even in its narrowed form, the voucher works by delaying follow-on competition for another medicinal product. The cost of that delay is not borne by the innovator alone, but by health systems and, ultimately, by payers and patients. Critics have therefore argued that transferable exclusivity vouchers are a poor and potentially regressive method of financing antimicrobial innovation because they externalize the reward onto unrelated product markets and healthcare budgets.²⁰
That criticism is serious and cannot simply be dismissed. Earlier economic analyses in the United States likewise warned that voucher-type systems may generate extreme and volatile social costs unless their value is capped or otherwise tightly constrained.²¹ The recent EU compromise text is best understood as a direct response to precisely that concern. The €490 million cap, the fifth- or sixth year use restriction, the one-time transfer rule, the publication of transaction value, the disclosure of public funding, and the limited overall application period all serve the same objective: reducing the risk of overcompensation.²²
Whether those safeguards are sufficient is another matter. The answer is not obvious. Much will depend on how many vouchers are eventually granted, which products become realistic targets, and whether the narrowed design still provides enough expected value to change investment behavior in antimicrobial R&D. If the economic value is cut back too far, the instrument may cease to function as an effective pull incentive. If the value remains too high, the cost objection returns. The TDEV therefore remains a calibration problem.
There is also a broader policy question whether exclusivity-based rewards are the best available instrument at all. The revised pharmaceutical package itself expressly recognizes subscription models as another response to antimicrobial market failure.²³ The United Kingdom has already moved from pilot experimentation to a broader antimicrobial subscription model under which companies are paid a fixed annual fee linked to the value of the product to the health system rather than to sales volume.²⁴ From a conceptual standpoint, that model addresses the “delinkage” problem more directly than a transferable exclusivity voucher. It avoids extending monopoly protection on an unrelated product. Whether it is politically and fiscally scalable across the EU is a different question, but as a matter of design, it remains an important comparator.
The earlier draft correctly identified the data exclusivity voucher as a potentially important new protection instrument in European pharmaceutical law. That remains true. But the legal and political context has changed. What began as a comparatively open-ended Commission proposal has evolved into a much more conditioned mechanism. The current text reflects an attempt to preserve the basic delinkage logic of the voucher while constraining its fiscal and competitive side effects through tighter eligibility, use restrictions, transparency obligations, and anti windfall safeguards.²⁵
Whether the instrument will ultimately prove effective depends on two unresolved issues. First, it must still create enough expected value to influence real-world R&D decisions in the antimicrobial field. Second, that value must not be generated at a cost to health systems that is out of proportion to the benefit achieved. The TDEV is therefore neither an obviously flawed measure nor an obviously successful one. It is a carefully hedged experiment in regulatory incentive design.
For that reason alone, it deserves close attention from pharmaceutical companies, generic and biosimilar manufacturers, payers, and legal practitioners. If adopted in its present form, the voucher will not merely add another exclusivity rule to the European pharmaceutical acquis. It will create a new type of tradable regulatory asset at the intersection of pharmaceutical law, innovation policy, market access, and competition. That is why the instrument is likely to become a significant focus of pharmaceutical strategy and legal analysis in the coming years.
However, in its current form, it remains to be seen whether the incentive is sufficiently attractive to induce pharmaceutical companies to shift investment in antimicrobial R&D away from less risky and more profitable fields, or to attract additional talent to this area. Rather, it appears more likely to function as a strong pull incentive for undertakings already engaged in antimicrobial research.
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