EU Pharma Package: Regulatory Data Protection Compromise Proposal

Background

In our second alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission (Commission), the European Parliament (Parliament), and the Council of the European Union (Council) on one of the most debated and anxiously anticipated topics, the regulatory data protection (RDP). While all EU institutions proposed a modulation system, they differed significantly in terms of the baseline period and the structure of the possible extensions.

The current “8+2(+1)” regime grants originators the following:

• Eight years of data exclusivity, during which the data submitted in support of a marketing authorisation (MA) may not be relied upon by generic or biosimilar companies in their own applications.
• Two years of market protection, during which generic or biosimilar companies may use the data for their own MA but may not yet place their products on the market. This market protection may be extended by one additional year in the event of a new therapeutic indication offering significant clinical benefits for the originator product.

Analysis

1. The Regime Change: From 8 + 2 (+1) to 8 + 1(+1)(+1)

1.1 Data Exclusivity: Eight Years Maintained

The eight-year data exclusivity baseline period is ultimately maintained in Article 80(1) of the Proposed Directive. The compromise text follows the Council's proposal, rejecting both the Commission’s proposal to reduce the baseline to six years and the Parliament’s proposal of seven and a half years.

The only extension possible for the data exclusivity part of RDP is the transferable exclusivity voucher (TEV) — see the third alert in this series and our upcoming alert on the compromise position for more details on the TEV mechanism.

1.2 Market Protection: Reduced to One Year, With Modulations

As regards market protection, the compromise text again largely follows the Council’s proposal of a 1(+1)(+1) structure. The market protection baseline period is reduced from two years to one year in Article 80(2) of the proposed Directive.

Different extension modulations were proposed by the EU institutions, but ultimately, only the following three have been maintained in Article 81 of the proposed Directive:

• A one-year extension for a new therapeutic indication which can be granted only once (similar to the current regime).

This can be accumulated with either of the following:

• A 12-month extension if the medicine meets an unmet medical need (as defined in Article 83 of the proposed Directive^[1]).
• A 12-month extension for medicinal products containing a new active substance if any of the following apply:
  • The clinical trials use an evidence-based comparator in line with the European Medicine Agency’s (EMA) scientific advice and the MA application was first filed in the EU (or within 90 days of the first non-EU filing).
  • The clinical trials use an evidence-based comparator in line with EMA’s scientific advice and efficacy clinical trials were conducted in more than one Member State.
  • Efficacy clinical trials were conducted in more than one Member State and the MA application was first filed in the EU (or within 90 days of the first non-EU filing) — only possible where the MA applicant can justify that a comparator trial (i.e., scenario (a) or (b)) is not feasible.

This compromise position slightly softens the Council’s original proposal for this extension where (i) conducting comparative clinical trials and (ii) in multiple Member States and (iii) the EU MA filing were all considered cumulative conditions instead of alternative ones.

Overall, the total potential protection period under the compromise text would remain 11 years, as is the case now (or exceptionally, 12 years in case of the TEV) — which is the longest in the world.

2. Repurposed Medicines

All three EU institutions supported a standalone four-year data exclusivity period for “repurposed” or “value-added” medicinal products in case of a new therapeutic indication not previously authorised in the Union for the active substance(s) concerned.

This new incentive and the conditions to obtain it have been carried over into the compromise text.

3. Missed Opportunities: Global Marketing Authorisation and Enforcement of RDP

The concept of Global Marketing Authorisation (GMA) as detailed currently in Article 6 of Directive 2001/83/EC, and its repercussions on RDP, is maintained in Article 5 of the proposed Directive. However, the compromise text does not define GMA, nor does it codify the conditions for belonging to the same GMA — which are only discussed in non-binding Commission guidance and case law from the Court of Justice of the EU (CJEU).

This is a missed opportunity, especially considering the ongoing debate before the CJEU regarding the concept of GMA and the interplay with RDP and New Active Substance status (NAS), i.e., in the longstanding DMF litigation.

In addition, we previously flagged the absence of clarity concerning the private/public nature and enforcement of RDP rights, noting that the Pharma Package did not provide specific provisions on this point. It is equally regrettable that this has not been dealt with in the compromise text.

4. Suspension in Case of Compulsory Licenses

A suspension of RDP is introduced where a compulsory license is granted in a Member State in accordance with the new Regulation (EU) 2025/2645 on compulsory licensing. In such case, the relevant RDP is suspended only with respect to that licensee and for the duration and territory for which the compulsory license was granted. When the compulsory license expires, the RDP revives but is not recouped — meaning that the suspension does not result in an equal extension of the original duration.

Compared to the original Commission proposal, the compromise text clarifies that the RDP suspension is limited to the Member State territory where the compulsory license was granted. This in combination with the fact that the period of suspension is not recouped, means that in case of a centralised MA, there is no splintering of the RDP duration across the EU.

5. Transparency

The Council’s proposal that the national competent authorities publish on their website an overview of the applicable RDP periods (including extensions) for the medicinal products for which they have granted a national MA has been included in the compromise text (Article 80(5a) of the proposed Directive). The EMA shall compile and publish a list of hyperlinks to the relevant websites.

In addition, Recital 31(a) of the proposed Regulation states that the Union Register of medicinal products (for centrally authorised products) shall contain “pertinent information on the medicinal product in question, including the active substance, and any post-authorisation requirements as well as applicable prolongations to regulatory protection periods.” However, this does not appear to be mentioned in the actual provisions of the proposed Regulation.

Conclusion

The key policy shift regarding RDP is that, under the current regime, originators automatically received two years of market protection, whereas under the compromise text they only automatically receive one year with certain modulations. The idea of the modulation system is based on the premise that not all originator medicines “deserve” the same protection. It is intended to incentivize originator companies to satisfy certain conditions, and it rewards those who “go the extra mile”. The maximum of 11 years is preserved, but it is now more conditional rather than automatic. The EC will evaluate the revised RDP framework and present a report to the Parliament and the Council 10 years after the date of application of the new rules.

Note that for existing MAs and for MA applications submitted before the date of application of the proposed Directive and Regulation (i.e., 24 months after their entry into force), the RDP rules under the current regime will continue to apply.