Change #7 of 10: BD / RA / Commercial

EU regulatory data and market protection: the new 8+1 framework

The 8+2 years you modelled for? That's not the default anymore.

Articles 83 and 84 of the agreed directive text keep eight years of regulatory data protection but cut baseline market protection from two years to one. One extra year is available for addressing an unmet medical need or for a qualifying new active substance, and one more for a significant new indication, up to 11 years in total. Every pipeline NPV model needs revisiting.

Book an exclusivity walkthrough See how Regunaut helps

Art. 83–84: Regulatory protection

One guaranteed year less. The rest is conditional.

8+2 → 8+1

036912 years

Current: 8 + 2, plus 1 for a new indication

Data · 8y

Market · 2y

Agreed text: 8 + 1, then up to 2 conditional years

Data · 8y

Mkt · 1y

+1 +1

Extra market protection+ years

Unmet medical need, or a new active substance meeting comparator, EU filing or multi-country trial criteria+1

New indication with significant clinical benefit, during data protection+1

Maximum total protection, before any antimicrobial voucher11

The guaranteed baseline falls from 10 to 9 years. Reaching the 11-year maximum now depends on meeting conditions. Products whose MA application is filed before the directive applies keep the current periods.

The commercial impact

One fewer guaranteed year, unless you earn it back

The guaranteed baseline drops from 10 years to 9. The 11-year maximum stays, but only for products that meet the conditions.

8+1

Baseline protection: 8 years regulatory data protection plus 1 year market protection, down from 8+2

SourceArt. 83, agreed directive text

+2 max

Conditional market protection: one year for unmet need or a qualifying new active substance, one more for a significant new indication

SourceArt. 84, agreed directive text

11yr

Maximum total protection, the same ceiling as today, now reached only by meeting conditions (a transferable antimicrobial voucher can add 12 months of data protection on top)

SourceArt. 84(3), agreed directive text

What's actually changing

From guaranteed protection to earned protection

The old framework gave a fixed 10 years. The new one rewards unmet need, comparative evidence, EU-first filing and supply to Member States that ask for it.

Change areaCurrent EU rulesAgreed text

Baseline protection

Current EU rules

8 years data protection + 2 years market protection = 10 years, granted automatically.

Agreed text

8 years data protection + 1 year market protection = 9 years baseline (Art. 83).

Extra market protection

Current EU rules

+1 year for a new indication with significant clinical benefit authorised within the first 8 years.

Agreed text

+1 year for unmet medical need, or for a new active substance with a relevant comparator plus EU-first filing (within 90 days) or multi-Member State trials. +1 more for a significant new indication. Market protection capped at 3 years (Art. 84).

Supply to Member States

Current EU rules

No link between launch or supply and protection.

Agreed text

A Member State may ask the MAH, within a year of grant, to supply its market. If the product isn't made available within three years of the request, market protection doesn't apply there (Art. 59).

Orphan medicine exclusivity

Current EU rules

10 years orphan market exclusivity, extendable to 12 for paediatric investigation plan compliance.

Agreed text

9 years standard, 11 for breakthrough orphan medicines, 4 for orphans authorised on bibliographic data (Regulation Art. 73).

The agreed text is not yet published in the Official Journal. Application dates will be fixed by the published act.

How Regunaut helps

See the protection range for each asset

Workbench answers protection questions against the agreed text, asset by asset. Atlas keeps the authorisations and Member State supply requests the answer depends on, and Alerts catches new guidance as it is published.

Workbench+ New Chat

Quick Tasks

What's up next?

Fee CalculatorEstimate regulatory submission fees

→

Print ProofreaderCompare artwork against approved text

→

What regulatory task can I help you with today?

SubmissionsCMCQuality & GMPDrug safetyLabellingIntelligenceLifecycle

Plan an EU generic submission→

Map the pathway, dossier requirements, and key dependencies.

○ No documents needed

Prepare for an EU renewal→

Build a checklist of documents, submission timing, and next steps.

○ No documents needed

Review dossier readiness→

Find missing evidence and prioritise gaps before submission.

♧ Attach supporting documents

Draft an authority response→

Turn each question into a response outline with evidence gaps.

♧ Attach supporting documents

☷ Quick Tasks / Protection range for an in-licensed asset Sources

You09:14 AM

Our BD team valued an in-licensing deal on 8+2 years of protection. Under the agreed text, what can this asset actually expect, and what would it take to reach 11 years?

Regunaut09:14 AM

understanding your question…
Data exclusivity · current rules against the agreed text

Warning details⌄

Based on the agreed text, which is not yet in the Official Journal. Dates count from entry into force.

1. Short answer

The baseline drops to 8 years of data protection plus 1 of market protection. One extra year comes from unmet need or a qualifying new active substance, one more from a significant new indication, up to 11 years.

2. What changes

AreaTodayAgreed text

Baseline protection8+2 years, granted automatically8+1 years: 9 years baseline [Art. 83]

Extra years+1 year for a new indication+1 unmet need or new active substance; +1 new indication [Art. 84]

Member State supplyNo link to protectionUnmet supply request ends market protection there [Art. 59]

3. What to do now

Replace the single 10-year assumption with a 9, 10 and 11-year range.
Check the comparator and EU-first filing plan against the Art. 84(1) conditions.
Agree who carries supply obligations if a Member State makes an Art. 59 request.

Citations (5)⌄

Example response · Condensed for this product demonstration

Ask a follow-up question...↑

1 / 447

Council of the
European UnionBrussels, 28 September 2026
(OR. en)

Interinstitutional File:
2023/0132(COD)7106/2/26 REV 2

LEGISLATIVE ACTS AND OTHER INSTRUMENTS

Subject:

Position of the Council at first reading with a view to the adoption of a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directives 2001/83/EC and 2009/35/EC
Adopted by the Council on 28 September 2026

Article 83

Regulatory data protection and regulatory market protection

[Art. 83]1. Where a marketing authorisation has been granted for a medicinal product in accordance with Article 7(2) of this Directive, the data referred to in Annex I that were submitted with a view to obtaining that marketing authorisation shall not be referred to by another marketing authorisation applicant for a subsequent marketing authorisation for a period of eight years from the date when the marketing authorisation for that medicinal product was granted, or nine years from that date in cases where one additional year of data protection is granted in accordance with Article 41(1) of Regulation (EU) 2026/…+ (‘regulatory data protection period’). For marketing authorisations that belong to the same global marketing authorisation in accordance with Article 6(2) of this Directive, the regulatory data protection period shall start from the date when the initial marketing authorisation was granted in the Union.

2. A medicinal product covered by a subsequent marketing authorisation referred to in paragraph 1 shall not be placed on the market for a period of one year after the expiry of regulatory data protection period (‘regulatory market protection period’). The regulatory market protection period may be extended in accordance with Article 84.

3. By way of derogation from paragraph 1, the marketing authorisation holder concerned may grant the marketing authorisation applicant for another marketing authorisation access to its data submitted in accordance with Annex I by means of a letter of access in accordance with Article 15.

4. By way of derogation from paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union pursuant to Regulation (EU) 2025/2645 or to national compulsory licensing frameworks, the regulatory data protection and regulatory market protection with regard to that licensee shall be suspended to the extent required by the compulsory licence and for the duration and territory of the Member States for which the compulsory licence has been granted.

5. The regulatory data protection period shall also apply in Member States where the medicinal product is not authorised or is no longer authorised.

6. The competent authorities of the Member States shall make available on their website the list of medicinal products for which they have granted a national marketing authorisation and that are protected by regulatory data protection and regulatory market protection, indicating the applicable extension in accordance with Article 84. The Agency shall compile and publish a list of hyperlinks to the websites referred to in this paragraph.

Workbench

Answers protection questions against Articles 83 to 86 and reads your development plan to say which Art. 84 conditions an asset can still meet, with every point cited.

See Workbench

Atlas

Keeps each product's authorisations and dates by market, and puts Art. 59 supply requests on the timeline with an owner and status, so the three-year window per Member State stays in view.

See Atlas

Alerts

Watches EMA and national authorities for new guidance and notices on protection and supply, and matches each one to the products it affects, with the notice cited.

See Alerts

A 30-minute live walkthrough of Atlas, Alerts and Workbench, on your own products and markets

Book a demo Try for free

Other levers in the agreed text

The protection change reshapes pipeline valuations

Companies that quantify their new protection position and plan to earn every extra year will have an advantage in pipeline value and deal negotiations.

4 years

Data protection for a repurposed medicine: a new indication not previously authorised for the substance, with significant clinical benefit

Art. 86, agreed directive text

12mo

Extra data protection a transferable voucher adds to one product, earned by developing a priority antimicrobial

Regulation Art. 41, agreed text

Art. 221(5)

Reference products whose MA application is filed before the new rules apply keep today's protection periods

Agreed directive text

Common questions

What teams are asking about the new protection framework

Does the new framework apply to products already authorised?

No. Reference products whose MA application is submitted before the new rules apply keep the periods in Directive 2001/83/EC (Art. 221(5)). The impact falls on pipeline and in-licensing targets filed after that date, which the published act will fix.

What does it take to earn the extra year for a new active substance?

Clinical trials with a relevant, evidence-based comparator in line with EMA scientific advice, plus either an EU application filed first or within 90 days of the first non-EU filing, or efficacy trials in more than one Member State. Where a comparator trial isn't possible, multi-Member State trials and EU-first filing together can qualify (Art. 84(1)).

Can a product earn all the extra years at once?

Up to a point. The unmet need and new active substance routes each give the same single extra year, and market protection is capped at two years after data protection ends, plus one year for a significant new indication. The maximum is 8 + 1 + 1 + 1 = 11 years (Art. 84(3)), plus 12 months of data protection where a transferable antimicrobial voucher is used on the product.

We're mid-negotiation on a licensing deal. How should we adjust the term sheet?

Replace a single 10-year assumption with a range: base 9 years, expected 10 where a condition is likely met, upside 11 with a qualifying new indication. Reflect it in milestones and royalty terms, and agree who carries supply obligations if a Member State makes an Art. 59 request.

How does this affect biosimilar development timelines?

A shorter baseline helps biosimilar and generic developers, but the originator may earn extra years. Where a Member State has published a failure to supply under Art. 59, generic and biosimilar applications can be validated six years into data protection (Art. 59(7)). Model scenarios with ranges rather than single-point estimates.

Turning protection end dates into launch and defence plans is the job of loss-of-exclusivity and market entry planning.
The eight-year period itself is explained in the glossary entry on data exclusivity.
The period that drops from two years to one is market protection.
Orphan medicines authorised on bibliographic data, through well-established use, get four years of orphan exclusivity rather than nine.
The voucher and orphan rules sit in the companion EU pharmaceutical Regulation.
Protection periods are one of ten changes covered in our guide to the new EU pharmaceutical directive.
Dates that depend on publication are tracked on the EU pharma package legislative timeline.

Sources

Article numbers refer to the Council's position at first reading of 28 September 2026 (ST 7106/2/26 REV 2 for the directive, ST 7105/2/26 REV 2 for the regulation), which reflects the political agreement of December 2025. Numbering may change in the act published in the Official Journal.

Rebuild your protection assumptions before the next board review

A fixed 10 years is now a range of 9 to 11. Start with the assets still in development and the deals still under negotiation.

Book an exclusivity walkthrough

30 minutes on your own portfolio: which assets can earn the extra years, and how Workbench, Atlas and Alerts keep track of them.

Book a demo

Ask Workbench yourself

Put your data and market protection questions to Workbench and get answers that cite the agreed text and guidance.

Try for free

Portfolio impact monitoring

Obligation-to-action

ePI & labelling

Regulatory lifecycle planning

Pharma competitive intelligence

Where to expand next

Loss-of-exclusivity planning

EU regulatory data and market protection: the new 8+1 framework

One guaranteed year less. The rest is conditional.

One fewer guaranteed year, unless you earn it back

From guaranteed protection to earned protection

Baseline protection

Extra market protection

Supply to Member States

Orphan medicine exclusivity

See the protection range for each asset

1. Short answer

2. What changes

3. What to do now

Workbench

Atlas

Alerts

The protection change reshapes pipeline valuations

What teams are asking about the new protection framework

Related reading

Sources

Rebuild your protection assumptions before the next board review

Book an exclusivity walkthrough

Ask Workbench yourself