{"entity":{"id":"eu-data-exclusivity","kind":"term","name":"EU data and market protection (8+2+1)","aka":["8+2+1","regulatory data protection","EU data exclusivity","EU market protection","eight years data exclusivity","Directive 2001/83/EC","Article 10 Directive 2001/83","global marketing authorisation"],"tldr":"In the EU a new medicine's trial data cannot be relied on by a generic or biosimilar for eight years, the copy cannot be sold for ten, and an eleventh year is added for a valuable new indication; it is the target of the 2023 reform.","summary":"European Union, directive and regulation. The harmonised '8+2+1' rule was introduced by the 2004 review of pharmaceutical legislation (Directive 2004/27/EC amending Article 10 of Directive 2001/83/EC, and Article 14(11) of Regulation (EC) No 726/2004) and applies to medicines authorised from November 2005. Primary text: EUR-Lex.\n\nHow it works: for eight years from the first authorisation in the Union, a generic or biosimilar applicant may not refer to the originator's preclinical and clinical data; for a further two years the copy may be authorised but not placed on the market; and the market protection is extended by one year if, during the first eight, the originator obtains a new therapeutic indication with significant clinical benefit. Protection attaches to the 'global marketing authorisation', so new strengths, forms and indications of the same active substance do not restart the clock. Orphan market exclusivity (ten years) runs in parallel and the supplementary protection certificate protects the patent side.\n\nThe arguments: at eleven years maximum, Europe's combined term is the longest in the world for small molecules, and the Commission's 2023 pharmaceutical package proposed cutting the baseline to six years with conditional extensions; the European Parliament settled on seven and a half years and the Council kept eight, leaving the question to trilogue. Industry argues that data protection is the only certain protection for biologics and for medicines with weak patents; payers argue that the length delays biosimilars for cancer medicines by years compared with the United States' effective dates.","asOf":"2026-09-17","wikipedia":"https://en.wikipedia.org/wiki/Test_data_exclusivity","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Test_data_exclusivity"},{"label":"EUR-Lex: Directive 2001/83/EC (Article 10)","url":"https://eur-lex.europa.eu/eli/dir/2001/83/oj"}],"tags":["law","eu"],"related":["us-regulatory-exclusivity","spc","eu-pharma-package","eu-orphan-regulation","biosimilar","hatch-waxman","bpcia","eu-regulation-726-2004"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-drug-pricing"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Regulation & policy"},"route":"/terms/eu-data-exclusivity/","neighbours":{"term":[{"id":"bpcia","kind":"term","name":"Biologics Price Competition and Innovation Act 2010","route":"/terms/bpcia/"},{"id":"biosimilar","kind":"term","name":"Biosimilar","route":"/terms/biosimilar/"},{"id":"eu-pharma-package","kind":"term","name":"EU pharmaceutical package reform (2023 proposal)","route":"/terms/eu-pharma-package/"},{"id":"hatch-waxman","kind":"term","name":"Hatch-Waxman Act 1984","route":"/terms/hatch-waxman/"},{"id":"eu-orphan-regulation","kind":"term","name":"Regulation (EC) No 141/2000: EU orphan medicines","route":"/terms/eu-orphan-regulation/"},{"id":"eu-regulation-726-2004","kind":"term","name":"Regulation (EC) No 726/2004: the EU centralised procedure","route":"/terms/eu-regulation-726-2004/"},{"id":"spc","kind":"term","name":"Supplementary protection certificate (EU)","route":"/terms/spc/"},{"id":"trips-doha","kind":"term","name":"TRIPS Agreement and the Doha Declaration","route":"/terms/trips-doha/"},{"id":"us-regulatory-exclusivity","kind":"term","name":"US regulatory exclusivity periods","route":"/terms/us-regulatory-exclusivity/"}],"bottleneck":[{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"}]}}