Early Thursday, European Parliament and Council negotiators reached a provisional agreement on comprehensive reforms to the EU’s pharmaceutical legislation. The changes aim to improve competitiveness, encourage innovation, and strengthen the security of medicine supply across the Union.
The agreement sets an eight-year period of regulatory data protection for new medicines. During this time, other companies cannot access product data. Afterward, there will be one additional year during which generic or biosimilar versions cannot be sold. Additional market protection periods are available in certain cases: if a product addresses unmet medical needs; if it contains a new active substance meeting specific requirements regarding clinical trials and authorisation timing; or if new therapeutic indications with significant clinical benefits are authorised. However, total regulatory protection is capped at eleven years.
For orphan medicinal products that treat diseases with no current treatment options—termed “breakthrough orphan medicinal products”—up to eleven years of market exclusivity is possible.
The deal clarifies the so-called “Bolar” exemption, allowing manufacturers to carry out studies and activities necessary for marketing authorisations or health technology assessments during the original product’s market protection period without infringing patent rights.
To address antimicrobial resistance (AMR), negotiators introduced a transferable data exclusivity voucher for priority antimicrobials. This voucher provides an extra 12 months of data protection for one authorised product and can be used once either for that antimicrobial or another centrally authorised medicine from the same or a different holder. The agreement also includes stricter rules on antibiotic use: all antimicrobials must be prescribed by a doctor, specific information must accompany packaging, and an “awareness card” will be included in paper form if instructions are only available electronically. Companies seeking approval for antimicrobials must submit stewardship plans and assess risks related to antimicrobial resistance as part of environmental risk evaluations.
The revised rules streamline procedures within the European Medicines Agency (EMA) by simplifying its internal operations and making electronic submission standard for marketing applications. By default, marketing authorisations will have unlimited validity unless safety concerns arise. The Commission may also establish regulatory sandboxes under special conditions to test innovative therapies under supervision.
To prevent shortages of medicines, companies with marketing authorisations will need shortage prevention plans for prescription medicines and others identified by the Commission as requiring such measures. Shortages will be monitored at both national and EU levels; EMA will maintain an updated list of critical shortages across Europe.
Adam Jarubas (EPP, PL), chair of the Committee on Public Health; Tiemo Wölken (S&D, DE), rapporteur for regulation; and Dolors Montserrat (EPP, ES), rapporteur for directive provided statements regarding the agreement: “Statements from Adam Jarubas (EPP, PL), chair of the Committee on Public Health, Tiemo Wölken (S&D, DE), rapporteur (for the regulation) and Dolors Montserrat (EPP, ES), rapporteur (for the directive) are available here.”
A press conference is scheduled with Jarubas, Wölken, and Montserrat at 9:30 CET on Thursday 11 December in Brussels’ Anna Politkovskaya press room. Accredited journalists can attend in person or participate remotely via Interactio; proceedings will also stream live through Parliament’s Multimedia Centre.
This agreement follows negotiations after Parliament’s first reading was adopted in plenary as part of an early second reading process. Next steps include formal adoption by Council before endorsement by Parliament in second reading.
The legislative reform stems from a package proposed by the Commission on 26 April 2023 aimed at improving medicine availability while supporting industry competitiveness and raising environmental standards within EU pharmaceutical law.
