In brief
- The EU Council and the European Parliament have reached a provisional agreement on the EU 'pharma package', a new set of rules aimed at increasing patients' access to medicine and making the EU's pharmaceutical sector fairer and more competitive.
- Far-reaching changes will be made to the regulatory framework governing regulatory exclusivities, which will need to be taken into consideration when developing life cycle management and protection strategies.
- The political agreement is now subject to formal approval by the European Parliament and the Council.
In April 2023, the European Commission initiated a number of legislative proposals focusing on modernisation of the EU pharmaceutical regulatory framework, known as the 'pharma package'. The reform was initiated to ensure fair access to safe, effective and affordable medicines across the EU, whilst supporting the competitiveness and attractiveness of the EU pharma industry. On 11 December 2025, following over two years of negotiations, a provisional agreement was reached between the Council and Parliament. The provisional agreement is now subject to formal approval by the European Parliament and the Council before being formally adopted and entering into force upon publication in the EU's Official Journal.
The new legislative framework, once approved, will have far-reaching implications for the pharma and life sciences industry in Europe. In particular, the reform will bring about shortened authorisation procedures, a more adaptive regulatory framework, EU-level coordination, faster assessments, and greater use of digital solutions.
Key changes to regulatory exclusivities
Reformed data and market protection - under the text agreed by the co-legislators, companies placing a new medicine on the market will benefit from eight years of data protection (i.e. generic competitors will not be able to rely during that period on the data in the originator's dossier for their generic marketing authorisation application), followed by one year of market exclusivity (i.e. the exclusive right to sell the product on the market, blocking generic entry). An extension of an additional year may be granted if two out of three conditions are satisfied (e.g. addressing unmet medical need or adding new indications with significant benefit over existing therapies). A cap of 11 years for the combined regulatory protection period will be applied (including for orphan medicines with additional changes introduced to modify the regulatory framework for orphan medicinal products).
Expanded Bolar exemption - the Bolar exemption, which allows generic manufacturers to conduct certain activities during the market protection period of the original product, has created a degree of uncertainty due to variations in its implementation and interpretation by national legislation and judicial decisions. In particular, the question of whether a specific activity fell within the scope of the exemption was not always easy to confirm.
The co-legislators have clarified the wording of the exemption, expanding it from its current form (exempting clinical trials and preparation of regulatory submissions) to include price and reimbursement procedures, and specifically to include tender submissions. This will enable generic manufacturers to prepare for day one launch once the relevant intellectual property rights have expired.
Incentivising antimicrobial resistance development – to address increasing antimicrobial resistance (AMR) and incentivise the development of novel effective antimicrobials, the pharma package rewards companies that successfully develop novel antimicrobials, with a new transferrable exclusivity voucher that will grant one additional year of data protection for a pharmaceutical product of their choice. This will be in addition to the "blockbuster clause" which stipulates that this voucher cannot be used on products with annual gross sales of more than EUR 490 million in the preceding four years.
Impact on the industry
Pharmaceutical companies should now be assessing how to integrate the new rules on regulatory exclusivities (including new concepts such as the exclusivity voucher) into their life cycle management, market access and protection strategies. In general, the package of measures provides welcome news to the generic and biosimilar industries: the expansion of the Bolar exemption together with the already implemented supplementary protection certificate (SPC) manufacturing waiver enables day one launch preparation. For originators, meanwhile, the ability to obtain an injunction based on regulatory activities is reduced, together with enhanced competition due to generics' ability to participate in tenders.