EU Pharma Package Sets Nine Years’ Default Protection and Rewards Comparative Trials With a Tenth
- The Council of the EU adopted the pharma package, a regulation and a directive overhauling EU pharmaceutical law, on 28 September 2026. The European Parliament must now adopt it, after which it enters into force on publication in the Official Journal.
- New medicines get 8 years of data protection plus 1 year of market protection, against 8 plus 2 under current law. An extra year is available for innovative medicines meeting two conditions, pairing comparative trials with early EU application or with trials in more than one member state, and another for unmet medical need, up to a cap of 11 years, or 12 with an antibiotic voucher.
- Orphan medicines get 9 years of market exclusivity, down from 10, with 2 more for breakthrough orphans: the first product authorised in the EU for the condition that also clinically reduces morbidity or mortality.
- Member states can require companies to supply protected medicines in sufficient quantity, with safeguards against parallel trade. The Bolar exemption now covers tender applications, so generics can launch on day one. A transferable voucher adds a year of protection for developing priority antibiotics, barred for products with gross sales above €490m a year.
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The default gets shorter, and the route back to the maximum runs through comparative trials and filing early in Europe.
- Comparative evidence is now worth a year. EU law will pay for head-to-head trials in the same week IQWiG argued joint assessments should push companies toward comparative data, and Germany’s health ministry proposed accepting best available evidence under AMNOG 2.0. Brussels and Berlin are sending different signals about evidence.
- Early EU filing is the counterweight to US most-favoured-nation pricing. MFN deals such as Lilly’s reference prices in France, Germany, Italy and Denmark, giving companies a reason to delay European launches. The package now prices that choice: file early in the EU, or give up a year of protection.
- Second orphans lose a year. Only the first authorised product for a condition, with a clinically relevant effect, can reach 11 years. Nezglyal, approved last week as the first drug treatment for cALD in the EU, meets the first of those two tests; later entrants in the same condition would not.