eu

The EU rule, in force since January 2022, under which a cancer trial is submitted once through a single portal for all the countries it will run in, with results made public, replacing a 2001 directive that made every country's approval separate.

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.

From January 2025 every new cancer medicine in the EU gets one shared assessment of how well it works compared with existing treatments, done jointly by member states, so that each country's payer no longer repeats the clinical review, though each still decides on price.

The biggest rewrite of EU medicines law in twenty years, proposed in 2023: shorter default protection from generic competition with extensions for launching everywhere in the EU and for meeting unmet needs, faster assessments, and tighter orphan and paediatric rules, argued over by Parliament and Council since.

A 2025 EU regulation that gives patients electronic access to their health records across the Union and creates national bodies that can grant researchers, regulators and companies permission to use anonymised or pseudonymised health data, phased in over the rest of the decade.

The EU's 2016 data law, applied since May 2018, that treats health and genetic data as a special category needing a specific legal basis, gives people rights over their records, and shapes how cancer registries, biobanks and trials share data, including across borders.

The EU's 2000 answer to the US Orphan Drug Act: ten years during which no similar medicine may be authorised for the same rare disease, plus fee reductions and scientific advice, for conditions affecting no more than 5 in 10,000 people.

Since 2007 every new medicine in the EU must come with an agreed plan for studying it in children, or a waiver, and completing the plan earns six extra months of patent protection; a loophole let adult-cancer drugs skip children, which is now being closed.

The 2004 EU regulation under which every new cancer medicine is assessed once by the European Medicines Agency and authorised for all member states by the European Commission, and which also carries the rules for conditional authorisation and compassionate use.

The EU's version of patent term restoration: up to five extra years of protection for a medicine to make up for the years spent in trials and review, so that a cancer drug gets about fifteen years of protected sales after approval, plus six months for paediatric studies.