EU Pharmaceutical Package: what the Council’s revised texts mean for companies

The Council has adopted its position on the EU Pharmaceutical Package at first reading, and the legally and linguistically revised texts are now available. The main elements of the political compromise remain intact, but several clarifications warrant attention. Companies can use the texts to refine their implementation plans, while recognising that the legislative process is not yet complete.

This update identifies the most relevant changes in the Council’s revised texts, assesses their practical significance and outlines the next steps in the legislative process. It refers to the proposed regulation as the new Regulation and the proposed directive as the new Directive.

The Council texts are available, but the package is not yet law

The co-legislators reached a provisional agreement on 11 December 2025. The compromise was endorsed by the Committee of Permanent Representatives on 6 March 2026 and approved by the European Parliament’s SANT Committee on 18 March 2026. Following legal-linguistic revision, the Council formally adopted its position at first reading on 28 September 2026.

The proposed rules should not yet be treated as law as the European Parliament must still consider the Council’s position. A plenary vote in autumn 2026, with November as an indicative date, has been signalled. 

The main protection and incentive rules remain intact

Articles 83 and 84 of the new Directive retain the package’s central protection framework: eight years of regulatory data protection, followed by one year of regulatory market protection, with conditional extensions and an overall cap of 11 years, or 12 years where a transferable data exclusivity voucher is used. Data protection restricts a subsequent applicant’s reliance on data submitted for an earlier marketing authorisation; market protection restricts when a subsequently authorised product may be placed on the market.

The voucher scheme in Articles 41 to 44 of the new Regulation also retains its principal limits. A voucher extends the regulatory data protection period by 12 months for one authorised medicinal product. It may be transferred once, cannot be used for a product exceeding the specified EUR 490 million annual Union gross-sales threshold, and forms part of a scheme limited to five vouchers or 15 years, whichever comes first.

Article 41(3) sets out when an antimicrobial may qualify for a transferable data exclusivity voucher, which can extend regulatory data protection by 12 months. The product must address a multidrug-resistant organism, demonstrate a significant clinical benefit in tackling antimicrobial resistance and meet further criteria concerning its mechanism of action or active substance. In the scientific assessment of those criteria, the EMA must take into account the “WHO bacterial priority pathogens list”, or an equivalent Union list. In the February texts, this assessment reference was expressly limited to antibiotics; the September revision removes that limitation. The change concerns the scope of the EMA’s assessment methodology rather than the substantive eligibility criteria themselves: the WHO list now serves as a reference point for the assessment of antimicrobials generally, not only antibiotics. What practical effect this has on non-antibiotic antimicrobials remains to be seen, since inclusion of a pathogen on the list informs the EMA’s assessment but does not, by itself, establish that a product meets the eligibility requirements.

Orphan exclusivity and the hospital exemption are clearer

Article 73(1) of the new Regulation expressly covers both “centralised or national marketing authorisation[s]” when restricting authorisations for similar medicinal products for the same therapeutic indication during orphan market exclusivity. This express clarification of national procedures does not fundamentally change the framework of the February texts. The principal exclusivity periods remain nine years, or 11 years for breakthrough orphan medicinal products, under Article 73(2).

The new Directive also expressly includes the EMA in the advisory arrangements for advanced therapy medicinal products prepared under the hospital exemption. Under Article 3(4), national competent authorities or the Agency provide scientific and regulatory advice on request to the specified developers and approval holders. This may assist developers considering further development or a Union marketing authorisation. It does not replace the national hospital-exemption approval required by Article 3.

Supply and advertising wording calls for targeted review

For centrally authorised medicinal products benefiting from regulatory protection, Article 6 of the new Regulation allows a Member State to require the marketing authorisation holder to place the product on its market and supply it to meet patients’ needs. The February compromise already provided for exceptions where compliance was prevented by exceptional and unforeseeable circumstances, including supply disruptions, or by “duly justified circumstances” fully outside the holder’s control whose consequences could not have been avoided despite all reasonable measures. The September text replaces “duly justified circumstances” in that second, catch-all category with “other circumstances”. Because the provision still refers to exceptional and unforeseeable circumstances, and the catch-all remains subject to the requirements of lack of control and unavoidable consequences, the change is likely to have limited effect, although it may matter in individual cases. More broadly, questions remain about what may prevent a product from being marketed in a Member State and what efforts a holder must make, including the extent to which it must meet requirements set by the relevant authorities as a condition for reimbursement, such as pricing requirements.

Transitional rules preserve the previous protection periods for pending applications

The February compromise already provided for a transitional period, and the September texts retain this approach. The previous regulatory protection periods can still apply to a reference medicinal product if its marketing authorisation application is submitted before the date falling 24 months after the new Directive enters into force. Under Article 221(5), the protection periods in Article 10 of Directive 2001/83/EC then apply, even if the marketing authorisation is granted after that cut-off. Companies approaching the transition date should carefully assess whether they can submit their marketing authorisation application before the cut-off and thereby remain eligible for the previous regulatory protection periods.

The EMA’s role is clarified across the Directive

The revised Directive expressly names the EMA alongside national competent authorities in a number of provisions that previously referred only to the competent authority. This includes the requirements for medicinal products manufactured outside the Union under Article 9, environmental risk assessment submissions under Article 23, and requests for samples and sales data under Article 58. For centrally authorised medicinal products, the wording makes clearer which authority may receive information or perform the relevant task. It does not, by itself, establish that these functions have newly transferred from national authorities to the EMA or that marketing authorisation holders face additional substantive obligations. Its practical effect is likely to lie chiefly in reducing uncertainty about the appropriate authority in individual procedures.

What happens next?

The European Parliament must still consider the Council’s first-reading position. A plenary vote in autumn 2026, with November as an indicative date, had been signalled, but no date was confirmed in the available legislative timetable. Once the legislative process is completed, both instruments will enter into force on the twentieth day following publication in the Official Journal of the European Union.

The new Regulation will generally apply 24 months after entry into force, subject to the exceptions in Article 187. Member States must generally transpose and apply the new Directive after 24 months under Article 222. 

Key takeaways

The core compromise remains intact. The principal protection periods, voucher limits and orphan exclusivity periods are unchanged in the revised Council texts.

Targeted wording changes warrant review. The texts expressly address national authorisations under orphan exclusivity and EMA advice under the hospital exemption. Changes concerning voucher assessment and exceptions to supply obligations may matter in individual cases.

Submission timing may determine the applicable protection regime. Reference medicinal products whose marketing authorisation applications are submitted before the 24-month cut-off can remain subject to the previous regulatory protection periods. Companies with applications approaching that date should assess their filing timetable carefully.

The package is not yet law. Parliament’s consideration remains outstanding, and companies should keep their preparations under review as the legislative process and implementing measures progress.