The EU's new data and market exclusivity rules: eight plus one, extensions to earn, and who they apply to

Where it stands

The rewrite of the EU’s medicines law has taken three and a half years to agree and is now one vote from the statute book.

• 26 April 2023: the Commission proposes a new Directive and Regulation, with data protection cut to six years.
• 10 April 2024: Parliament adopts its position (seven and a half years).
• 4 June 2025: the Council agrees its position (eight years plus one).
• 11 December 2025: political agreement between Parliament and the Council on the Council’s model.
• 6 March 2026: the compromise texts are published.
• 28 September 2026: the Council adopts the Regulation and the Directive.
• Next: Parliament’s plenary vote, expected this autumn; publication in the Official Journal; entry into force twenty days later; and, for most provisions including the exclusivity rules, application 24 months after entry into force, which on the current timetable means late 2028.

Nothing below is law until the Official Journal publishes it, but the texts are settled and are not expected to change.

The rules today

Since 2005 the EU has run an “8+2+1” system under Article 10 of Directive 2001/83. From the first authorisation of a new medicine anywhere in the EU, generic and biosimilar applicants cannot rely on the originator’s trial data for eight years (data protection, often called data exclusivity). They can file at year eight, but cannot be placed on the market until ten years have passed (market protection), or eleven if, during the first eight years, the originator obtained a new indication with significant clinical benefit. The periods are automatic: nothing has to be earned, and nothing has to be supplied.

The UK copied this system into the Human Medicines Regulations 2012 and is not part of the reform; its 8+2+1 stays as it is.

What was agreed

Data protection stays at eight years. The Commission’s six years and Parliament’s seven and a half did not survive. For most products the day a generic may file does not move.

Baseline market protection falls from two years to one. A product that earns nothing else opens to generic supply at year nine instead of year ten.

One-year extensions of market protection can be earned. As reported from the compromise texts, the grounds include:

• the product addresses an unmet medical need at the time of the initial application (orphan medicines qualify automatically; a conditional authorisation must be converted to a full one within four years);
• the pivotal trials used a relevant comparator under EMA scientific advice and the EU application was filed within 90 days of the first application outside the EU;
• the trials were run in more than one member state, with the same filing-timing condition where a comparative trial was not possible or appropriate;
• a new therapeutic indication with significant clinical benefit was authorised during the data-protection period (once only).

Some summaries also list smaller developers (SMEs, not-for-profit bodies and companies with no more than five centralised authorisations) as a ground; that wording should be checked against the adopted text.

The cap is eleven years. However many grounds a product meets, the market-protection extensions together cannot exceed two years beyond the end of data protection: eight plus one plus at most two. A product that earns everything therefore ends where today’s product with a new indication ends; a product that earns nothing ends a year earlier than today’s baseline.

A transferable voucher for priority antimicrobials adds one further year of data protection, which the holder may use on the antimicrobial itself or transfer to another centrally authorised product, within timing limits and with a sales cap (products with EU sales above EUR 490 million a year in the preceding four years are excluded). That is the only way to reach twelve years.

Two smaller changes in the same chapter: a known active substance authorised for a new indication can receive a new four-year data-protection period, once per product; and a compulsory licence suspends data and market protection for the licensee in the territory and for the term of the licence.

The strings attached

The extensions are not free. The texts make them conditional on the product being released and kept in supply, in sufficient quantities and presentations, in the member states where it is authorised. Separately, any member state may ask the holder of a protected medicine to supply its market; if the holder has not complied within three years of the request, the market protection stops applying in that state. Safeguards were reportedly added so that a supply request cannot be used simply to open a parallel-trade channel; how those work in practice will only be clear from the final text and from use.

For holders, that turns market protection from a right into a programme: launch sequencing across 27 markets will have exclusivity consequences, not only pricing ones.

Who it applies to, and when

This is the part most often missed. The new periods apply to reference products whose marketing authorisation application is submitted after the new Directive applies, that is from about late 2028. Everything authorised before then, and every application already filed by then, keeps today’s 8+2+1 for its whole life.

So the first product to carry the new periods will be authorised in 2029 or 2030 at the earliest, its data protection will run to 2037 or 2038, and the first generic entry date actually moved by this reform falls around 2038. Until then, every data-protection and market-protection date in use today is unchanged.

What it means

For generic and biosimilar planners. Nothing changes for any product currently on the market or in review. For products filed from late 2028, model regulatory protection as eight plus one and treat each extension as unearned until it is published; the Agency’s register will show the granted protection period. The widened Bolar exemption, which lets pricing, reimbursement and tender work proceed during protection, is in the same package and matters more, sooner.

For originators and licensors. Market protection beyond year nine has to be designed in: comparator trials, multi-state trials, early EU filing, supply across the Union, and a new indication inside the first eight years. Launch-sequencing decisions that delay small markets will have a price in exclusivity.

For parallel traders. The supply obligation and its safeguards are the clause to read when the text is final. A product kept out of a market by its holder will, in principle, be obtainable on request by that member state rather than through import; whether that narrows or widens the differential depends on the price at which it is then supplied.

For wholesalers and buyers. No effect on prices or availability before the 2030s. The near-term changes that bite are elsewhere in the package: shortage notification, supply obligations and the orphan rules.

What does not change

Patents, SPCs and the paediatric extension are untouched; for most compounds they, not the regulatory clocks, still set the date that matters. The UK keeps 8+2+1. Orphan market exclusivity is reformed separately within the same package (a nine-year baseline, eleven years for “breakthrough” orphan products, shorter periods for products authorised on bibliographic data, with capped extensions), and is covered in the package overview.

What to watch

1. Parliament’s plenary vote and the Official Journal publication date, which fixes entry into force and therefore the application date.
2. The final article numbering and wording of the extension grounds, especially the smaller-developer ground and the supply conditions.
3. Guidance from the Commission and the EMA on how “unmet medical need” and “significant clinical benefit” will be assessed, since those decide whether a product gets nine, ten or eleven years.

MPA Search records the first EU authorisation date for each product, from which both the current and the future regulatory periods are counted, alongside the patent and SPC position in each country.