The political agreement reached on the revision of the EU pharmaceutical legislation garnered much attention in December 2025 (see our briefing – EU Pharma Package: Agreement reached). The protracted interinstitutional negotiations reached an outcome which it was expected would lead to formal adoption during the course of 2026. No text was published when the agreement was announced. By way of reminder, the existing legislation is to be replaced with both a new Directive and new Regulation, generally referred to as the Pharma Package (the “Pharma Package”)
At the end of last week, COREPOR (Permanent Representative Committee of the Council of the European Union) included the Pharma Package on its provisional agenda and the so-called “compromise texts” were then published on the relevant Council page, signalling that the Pharma Package had passed another hurdle on the way to formal adoption.
We know that SANT, which is the relevant Committee within the European Parliament, also needs to formally adopt the texts. This could happen as early as next week.
This is the first time we have seen the language inserted during the final negotiations. The texts are extensive and whilst the final binding texts will be those appearing in the Official Journal, we can see the shape of the finished product at this stage. The legislation will be in force 20 days after publication in the Official Journal and, for the Directive, the transposition clock will then start.
Some key points to note, in terms of the language inserted in the published compromise texts, are set out below.
Transposition, Definitions and Scope
- The Directive has a transposition date of 24 months (Article 219 of compromise text) – full applicability looks to be during 2028;
- The criteria for establishing an “unmet medical need” have been tightened and competency for same rests with the European Medicines Agency (Recital 50 of compromise text);
- Scope – it is expressly stated that the Directive shall not apply to substances of human origin, unless they fall within the definition of an advanced therapy medicinal product or a certain specific category of medicinal product (Article 5 of compromise text);
- Biosimilars are expressly defined (Article 4(14)(a) compromise text) as is the term “platform technology” (Article 4 (30) (a));
Member State Requests for Supply
- Article 56 (a) of the compromise texts contains some important wording dealing with the situation when a Member State requests a marketing authorisation holder to supply to it, so as to meet the needs of patients in that Member State, with ramifications for market protection within that Member State if the medicinal product has not been made available withing 3 years of the request.
Regulatory Data & Market Protection
- All eyes will be on Articles 80 and 81 of the compromise texts which set out the detail of the agreement on regulatory data and market protection. There is an eight year regulatory protection period, with a flat one year extension. Article 81 goes on to extend this for a further year under one of four distinct options.There is also the possibility of a once-off additional extension of a year if, during the first regulatory protection period, an authorisation is obtained for one or more new therapeutic indications, subject to certain conditions. The cumulative duration of that extension is capped at two years. Overall this brings a combined ceiling of 11 years of potential regulatory data protection and market exclusivity, for standard medicinal products.
- The above should be read in tandem with Article 41 of the compromise text of the Regulation, which provides for transferable exclusivity vouchers for development of priority antimicrobials, to be used with either the antimicrobial or another medicinal product. The voucher may be used only once, for a centrally authorised product and in the fifth or sixth year of regulatory data protection. The product must not have annual gross sales in excess of 490 million euros during any of the first four years (to be verified by an independent external auditor).
- Article 85 of the compromise text of the Directive sets out and expands the Bolar exemption.
Next Steps
Following the meeting of the SANT Committee, the texts will need to be formally adopted by both the European Parliament and Council, translated into all of the official Union languages and published in the Official Journal. This could potentially happen before the summer, as an indicative date of 15 June 2026 has been listed for the necessary plenary in the European Parliament.
For more information, please contact our Life Sciences Group.