After more than two years of intense legislative debate, the EU institutions reached an agreement on the EU Pharma Package – the most far-reaching reform of European pharmaceutical legislation since 2001. In early March 2026, the European Council published the near-final text of the new pharmaceutical Directive and Regulation (accessible here and here "Compromise Text"). Formal adoption is pending but substantive changes are not expected. Companies should thus now begin assessing what the new framework means in practice for their pipeline and portfolio strategies.

Of all the contested elements of the EU Pharma Package, none was more hotly debated than the reform of regulatory data and marketing protection ("RDP") – the regime that determines how long originator companies enjoy a competitive shield before generic and biosimilar competitors can enter the market. This article unpacks what has changed, what has survived intact, and what this implies for market participants. 

The Current Framework in Brief – the 8+2(+1) Model

The existing system operates as follows:

• 8 years of data exclusivity during which generic and biosimilar applicants cannot rely on the pre-clinical and clinical data of the reference medicinal product to support an abbreviated marketing authorisation ("MA") application.
• 2 years of market protection, a further two years during which abbreviated MA applications may be filed and processed, but the generic or biosimilar product cannot be placed on the market.
• 1 additional year of market protection which is available where the MA holder obtains, during the data exclusivity period, a MA for one or more new therapeutic indications demonstrating significant clinical benefit over existing therapies.

The combined maximum under the current system is therefore eleven years. 

The 8+2(+1) model has attracted persistent criticism. Innovator companies have long argued that it fails to reward differentiated investment: whether a product breaks genuinely new therapeutic ground or represents an incremental advance, it receives the same fixed protection. On the other hand, the generics and biosimilars industry has contended that the combination of RDP with patent and supplementary protection certificate ("SPC") coverage creates exclusivity periods far exceeding the nominal framework. The Pharma Package reform attempts to address both sets of concerns – at least in theory.

The New Structure – the 8+1(+1)(+1) Model

Data Exclusivity: No Changes after all

The most politically debated question throughout the legislative process was whether to reduce the eight-year data exclusivity baseline. 

The Commission had proposed a reduction to six years, arguing that a shorter baseline would accelerate generic market entry and reduce healthcare system expenditure. The European Parliament's position landed at seven and a half years. Neither position survived trilogue.

The Compromise Text follows the Council's approach: the eight-year data exclusivity baseline is maintained in full under Art. 80(1) of the new Directive. An extension of this data exclusivity period is generally not intended. The sole exception is a one-year extension through the Transferable Exclusivity Voucher ("TEV") for antimicrobials.

Marketing Protection: Shorter Baseline, With Conditions for Extension

Under Art. 80(2) of the new Directive, the baseline market protection period is reduced from two years to one year. 

Art. 81 of the new Directive sets out several possible twelve-month extensions to the market protection period. However, they cannot be arbitrarily combined with the maximum being capped at eleven years (Art. 81 (2b) of the new Directive). A pharmaceutical company aiming to achieve the maximum duration will need to obtain an new therapeutic indication extension (Module 1 below) in combination with an extension for either meeting unmet medical needs (Module 2a below) or for fulfilling certain development and launch related requirements (Module 2b below). Notably, the extensions in Modules 2a and 2b are alternative and not cumulative – even if a pharmaceutical company would qualify for more than one extension from Modules 2a and 2b, they can only achieve one.

None of these extensions are automatic - they each require meeting substantive criteria which are outlined in more detail in the following:

• Module 1: New Therapeutic Indication with Significant Clinical Benefit (Art. 81(2a) new Directive)

Identically to the existing +1 extension, this module grants an additional year of market protection where a new therapeutic indication offering significant clinical benefit over existing therapies is authorised during the data exclusivity period.

• Module 2a: Unmet Medical Need (Art. 81(2)(a) new Directive)

A twelve-months extension is available where the medicinal product meets an "unmet medical need", as defined in Art. 83 of the new Directive, broadly understood to cover conditions for which no satisfactory authorised therapy exists, or where the product represents a substantial therapeutic advancement. The unmet medical need concept has been a consistent feature of EU pharmaceutical policy discourse, but its codification as a formal RDP incentive trigger is new.

The precise scope of an "unmet medical need" as defined in Art. 83 will be critical. Ambiguity in the definition could either undermine the incentive (by making qualification uncertain) or lead to over-broad application. Stakeholders should thus closely monitor EMA guidance elaborating on the Art. 83 criteria.

• Module 2b: New Active Substance & Fulfilment of Development and Launch Related Requirements (Art. 81(2)(b)-(d) new Directive)

This is the most technically complex module, and the one that underwent the most significant modification between the Council's June 2025 position and the final Compromise Text. For products containing a new active substance (NAS), a twelve-month extension is available if any one of the following three sets of conditions is satisfied:

• The clinical trials use a relevant and evidence-based comparator in line with EMA scientific advice, and the MA application was filed first in the EU (or within 90 days of the first non-EU filing);
• The clinical trials use a relevant and evidence-based comparator in line with EMA scientific advice, and efficacy clinical trials Used to support the MA were conducted in more than one Member State; or
• Efficacy clinical trials used to support the MA were conducted in more than one Member State, and the MA application was filed first in the EU (or within 90 days of the first non-EU filing) – available only where the applicant can justify that a comparator trial is not feasible.

The Council's June 2025 draft had treated the comparator, multi-Member State, and EU-first filing requirements as cumulative. The Compromise Text converts them into alternatives, which substantially lowers the qualification threshold. 

That said, companies developing NAS products will need to plan for these conditions from the earliest stages of clinical development. The EU-first (or near-first) filing obligation, in particular, intersects with global regulatory strategy – and companies accustomed to seeking FDA approval before EMA authorisation will need to reconsider their sequencing approach if they wish to access this module.

Repurposed Medicines – A New Standalone Incentive

Further, Art. 84 of the new Directive introduces a standalone four-year data exclusivity period for repurposed or "value-added" medicines. Two eligibility conditions apply alternatively: (i) either no data exclusivity period previously existed for the product, or (ii) the original authorisation was granted at least 25 years ago. 

This is designed to create a meaningful incentive for investment in what is sometimes called "drug repurposing", i.e., the identification of new therapeutic applications for active substances already well-characterised in terms of safety profile. It may also accelerate the availability of new indications that would otherwise be commercially unattractive without protection.

RDP Suspension Under Compulsory Licensing

One further implementation should be noted: Where a Member State grants a compulsory licence under the new Regulation (EU) 2025/2645, the RDP applicable to the relevant product is suspended – but only with respect to that licensee, only within that Member State's territory, and only for the licence’s duration. Critically, the suspended period is not added back when the licence expires; the original RDP end date is not extended.

This provision sits at the intersection of pharmaceutical law, IP law, and public health policy. Whilst compulsory licensing in EU Member States remains relatively rare, the provision signals the legislature's intent to ensure that RDP does not operate as an absolute barrier to access in crisis or public health emergency situations.

Transparency – Publication of Applicable Protection Periods

A rather practical but important addition in the Compromise Text is a transparency obligation concerning the duration of applicable RDP periods. Under Art. 80(5a) of the new Directive, national competent authorities must publish an overview of applicable RDP periods (including extensions) for nationally authorised products. The EMA will maintain a list of links to the relevant national pages.

Enhanced transparency around RDP durations is of genuine practical value for generic and biosimilar companies planning market entry, for healthcare procurement authorities, and for litigation purposes. The current landscape – in which the applicable RDP for any given product can be difficult to ascertain with precision – has been a source of commercial and legal uncertainty that this provision begins, at least, to address.

Open Items - No Clarification on the Global Marketing Authorisation Concept

The concept of a Global Marketing Authorisation ("GMA") – which determines what products and indications are treated as part of a single authorisation for RDP purposes and thus critically determines a product's RDP start date – is carried forward from Art. 6 of Directive 2001/83/EC into Art. 5 of the new Directive. However, the Compromise Text neither defines it, nor does it codify the conditions for determining what belongs within the same GMA. These questions remain governed only by non-binding Commission guidance and the evolving case law of the Court of Justice of the EU (see for example the longstanding DMF litigation). The Pharma Package represented an opportunity to resolve these uncertainties through primary legislation – that opportunity has been passed over.

Equally unresolved is the question of the legal nature of RDP rights themselves – specifically, whether they are private rights that can be directly enforced by MA holders before national courts and regulatory authorities, or whether they are exclusively public law obligations enforceable only by competent authorities. The EU Pharma Package leaves the point unresolved.

Timeline

The new RDP rules will apply only prospectively. For existing marketing authorisations and for MA applications submitted before the date of application of the new Directive and Regulation (that is, within 24 months of their entry into force), the RDP rules under the current regime will continue to apply. Depending on the timeline for formal adoption and publication, the new regime is broadly expected to apply sometime from approximately Q4 2028. For further details we refer to our article "EU Pharma Package: transitional provisions" (accessible here). 

Companies with products currently under development that are likely to receive their MA within the transitional window will therefore need to assess whether they fall within the new or old framework.

Conclusion

The RDP reforms in the EU Pharma Package achieve a compromise that, in structural terms, is closer to the current framework than either the Commission or the Parliament originally proposed – but one that is meaningfully more conditional and complex than the status quo. Originators retain the eight-year data exclusivity they fought to preserve but lose one year of automatic market protection. Generics and biosimilar companies gain a shorter marketing protection baseline but face a more complex landscape in which protection periods are harder to predict in advance.

What is certain is that the new framework demands earlier and more integrated planning across regulatory, clinical, and commercial strategy functions. The extension modules are not retroactively accessible: they should be built into development programmes from the outset. Companies that engage with the new architecture proactively will be better positioned to access the full protection period that the law makes available.

Regarding the exclusivities applicable to orphan medicinal products, watch out for our upcoming article on how the framework applicable to orphans will change under the Pharma Package.