EU data and market protection (8+2+1)

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.

How 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.

The 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.