The EU pharmaceutical package: what the reform changes for exclusivity, and when

Where it stands

The Commission proposed a new Regulation and Directive in April 2023; Parliament adopted its position in April 2024; the Council agreed its position in June 2025; Parliament and the Council reached political agreement on 11 December 2025, and the compromise texts were published in March 2026. The Council adopted both instruments on 28 September 2026. Parliament’s plenary vote is expected this autumn, followed by publication in the Official Journal and entry into force twenty days later. Most provisions, including the exclusivity rules, apply 24 months after entry into force, which on the current timetable means late 2028. Some provisions start earlier (the antimicrobial voucher and the supply provisions at entry into force, shortage rules six months later, the member-state supply request a year later).

Regulatory data protection: from 8+2+1 to 8+1 (+1)(+1)

Today a new medicine gets eight years of data protection and two years of market protection, plus one more year for a significant new indication. The reform keeps the eight years of data protection but cuts the baseline market protection to one year, and then offers one-year extensions that must be earned: for addressing an unmet medical need, for comparative or multi-state trials with early EU filing, and for a new indication with significant clinical benefit, capped at two extra years in all. Extensions are conditioned on supply across the EU. The maximum regulatory protection therefore stays at eleven years for a product that earns everything, twelve with the antimicrobial voucher, but the typical product will have less than today’s ten. The detail, the conditions and the transitional rules are in the separate note on the new data and market exclusivity rules.

Commercial reading. The new periods apply only to products whose authorisation application is filed after the Directive applies, so the first generic entry date they move falls around 2038. The patent and SPC clocks are unchanged, so for most compounds they, not the regulatory clocks, will still bite last; the reform matters most for products with short or lost patent protection.

Bolar exemption widened

The existing Bolar exemption lets generics do the studies and trials needed for their authorisation while a patent or SPC is in force. The reform extends it expressly to health technology assessment, pricing and reimbursement procedures and tender submissions, provided no actual sale or offer for sale takes place during protection, and says that intellectual property rights may not be used to refuse or suspend decisions on those activities.

Commercial reading. This answers the problem the UPC’s nintedanib decision exposed: today, entering a pricing procedure before SPC expiry can be treated as imminent infringement. Once the new rules apply, the procedure can run during the protected period, which should bring generic launches closer to the expiry date itself. The agreed wording (“in particular”) leaves some room for national interpretation.

Orphan exclusivity

The flat ten-year orphan market exclusivity is replaced by a tiered system: a nine-year baseline, eleven years for “breakthrough” orphan products (a condition with no existing EU treatment and a clinically relevant reduction in morbidity or mortality), and shorter periods for products authorised on bibliographic data; further years for supply across the member states and for new orphan indications, capped; the six-year review of orphan status is abolished; and generic and biosimilar applications may be filed and assessed during the last two years of orphan exclusivity. The new orphan periods apply only to products whose application is filed after the Regulation applies.

Transferable exclusivity voucher

To reward new priority antimicrobials, the reform creates a voucher giving one extra year of data protection that can be used on the antimicrobial itself or transferred to another centrally authorised product, subject to timing limits and a sales cap (products with EU sales above EUR 490 million a year in the preceding four years are excluded). The voucher is valid for five years from grant and the scheme is time-limited. Expect vouchers to appear on the exclusivity position of a small number of large products in the 2030s.

What does not change

Patents, SPCs and the paediatric extension are untouched by this package; the separate unitary SPC proposal remains pending. Parallel import rules are not reset: the established case law on repackaging and exhaustion continues to apply. The UK is outside the reform and keeps 8+2+1.

What to do now

• For products authorised, or filed, before the new Directive applies, nothing changes; plan on 8+2+1.
• For products filed after application, model regulatory protection as 8+1 and treat each extension as uncertain until earned and published.
• Watch for Parliament’s vote and the Official Journal publication, which fix the exact application dates; they will be added here.