Publication date: November 12, 2026
After three years of negotiations, the reform of EU pharmaceutical legislation is one step away from completion. A new regulation and a new directive will replace the current Community code and the EMA Regulation, reshaping data and market protection periods, the rules for orphan medicines, the Bolar exemption and supply obligations. Originator and generic companies alike will need to revisit their strategies, and Poland faces a thorough overhaul of its Pharmaceutical Law.
The EU Pharma Package is the broadest revision of EU pharmaceutical legislation since 2004. It aims to boost innovation and competitiveness, secure the supply of medicines and prevent shortages. The European Commission tabled its proposal in April 2023, the European Parliament adopted its position in April 2024 and the Council of the European Union adopted its mandate on 4 June 2025, under the Polish Presidency, which had made the package one of its priorities. The Council and the Parliament reached a political agreement on 11 December 2025, and on 28 September 2026 the Council formally adopted its first-reading position. To complete the procedure, the Parliament must still approve that position at second reading (a plenary vote has been signalled for autumn 2026), after which the acts will be published in the Official Journal of the EU.
The package consists of two acts:
Companies placing a new medicine on the market will keep an eight-year period of regulatory data protection. During this period, other applicants may not rely on the pre-clinical and clinical data submitted for the original marketing authorisation. It is followed by a period of market protection, during which generics and biosimilars may be authorised but not yet placed on the market. Baseline market protection is cut from two years to one.
The lost year can be regained. An additional year of market protection is available where the medicine addresses an unmet medical need, or where it contains a new active substance and one of the following scenarios applies:
A further year of market protection may be granted (once) for a new therapeutic indication bringing a significant clinical benefit. The overall protection period is, as a rule, capped at 11 years; the only exception is the use of the exclusivity voucher described below, which can take it to 12 years.
Orphan medicines treat rare diseases, and developing them is often not commercially viable. The standard period of orphan market exclusivity is reduced from 10 to 9 years, but breakthrough orphan medicinal products will benefit from 11 years. A product qualifies as breakthrough where it targets a condition for which no treatment is authorised in the EU and delivers a clinically relevant reduction in morbidity or mortality. Exclusivity will be tied to the product rather than to individual indications; a further 12 months may be obtained for a new indication in a different orphan condition approved at least two years before exclusivity expires. Applications for similar products may be filed during the last two years of exclusivity, so that they can enter the market as soon as it ends.
The EMA assessment will be shortened from 210 to 180 days, and the Commission decision should follow within 46 days instead of 67. The EMA structure will be streamlined from five scientific committees to two, the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), with broader representation of patients and healthcare professionals. Marketing authorisations will by default be valid for an unlimited period, reducing the burden of renewals.
The Bolar exemption allows generic and biosimilar manufacturers to carry out preparatory steps while the reference product is still protected by patents and regulatory exclusivities, without infringing those rights. The package extends it beyond studies, clinical trials and marketing authorisation applications to pricing and reimbursement procedures and participation in tenders. The aim is to allow equivalent products to launch on day one after intellectual property rights expire.
To tackle antimicrobial resistance, the package introduces a transferable exclusivity voucher for companies that develop a priority antimicrobial targeting multidrug-resistant organisms. The voucher grants an additional 12 months of regulatory data protection either to that antimicrobial or to another centrally authorised product, including one held by a different company. It is subject to limits:
Applicants for antimicrobials will also have to submit an antimicrobial stewardship plan.
A key aim of the reform is better monitoring and prevention of shortages. Marketing authorisation holders will have to report shortage risks earlier, maintain shortage prevention plans and respond to critical shortages. A Union list of critical medicines will be established and their availability closely monitored. Member States will also be able to require a holder to place a medicine on their market and supply it in quantities sufficient to meet patient needs, subject to exceptions for circumstances outside the holder’s control.
The requirements for the environmental risk assessment (ERA) submitted with a marketing authorisation application, and for the related risk mitigation measures, are strengthened. A specific methodology is foreseen to assess the risk that the manufacture of antimicrobials selects for resistance in the environment.
Both acts will enter into force on the twentieth day after their publication in the Official Journal of the EU. The regulation will generally apply 24 months after entry into force (with exceptions for certain provisions), and Member States will have 24 months to transpose the directive. Under the transitional provisions, reference products for which a marketing authorisation application is filed before that date will keep the current protection periods (8+2+1).
Under Article 288 TFEU, a regulation is binding in its entirety and directly applicable in all Member States. It needs no transposition, but national law must still be adapted, including by repealing conflicting or duplicating provisions, designating competent authorities and laying down penalties. A directive, by contrast, is binding as to the result to be achieved, leaves the choice of form and methods to the Member States, and must be transposed into national law.
The Polish Pharmaceutical Law Act of 6 September 2001 largely implements Directive 2001/83/EC and refers directly to its definitions, requirements and procedures, as well as to the regulations being repealed. Their repeal will require a thorough amendment of the Act, or a new statute, within two years of the package entering into force. As a significant producer of generic medicines, Poland stands to benefit from the broader Bolar exemption, including the ability to take part in tenders, file applications and conduct studies before protection expires. The shorter EMA procedure should speed up access to innovative therapies, and the new supply obligations should strengthen the security of medicine supply. Both originator and generic companies should already be reviewing their product portfolios and protection strategies against the new rules.