EU Reaches Pharma Package Deal: Key Changes at a Glance
On 11 December 2025, following overnight negotiations, the Council and the European Parliament announced a political agreement on the long-awaited Pharma Package (see here). The reform seeks to update the EU’s pharmaceutical rulebook to facilitate access to safe and affordable treatments and bolster the life sciences sector’s competitiveness. While more detailed information is still trickling out, including the official text of the provisional agreement, we summarise below the main axes of the package available at this time.
What the reform is trying to achieve
The package – consisting of a new directive and regulation – is designed to make the EU a more attractive environment for developing and supplying medicines. It introduces new incentives for innovation, particularly for priority antibiotics, while also tightening rules to ensure that essential medicines remain available across member states. At the same time, it seeks to streamline regulatory processes to reduce delays and costs for companies. For example, EMA authorisation timelines will be shortened to 180 days (down from 210 days) without a clock stop, and the subsequent Commission decision should not exceed 46 days (instead of 67), which will streamline the overall authorisation process.
A new structure for regulatory exclusivity
The agreement abandons the long-standing “8+2+1” regulatory exclusivity formula. Under the new system, regulatory data and market protection will follow an “8+1+1+1” model, still capped at a maximum of 11 years. Companies placing a new medicine on the market will receive:
- eight years of data protection; and
- one year of market protection; plus
- up to two additional one-year extensions.
One of these extensions is reserved for innovative medicines, for example those addressing an unmet medical need, supporting clinical research, or filed in a timely manner in the EU. This contrasts with the Commission’s original proposal, which suggested a more reduced and heavily modulated “6+2+1” framework.
For orphan medicines, the agreement provides nine years of market exclusivity, with an additional two years available for products that address a high unmet medical need.
Ensuring continuous availability of key medicines
The co-legislators have retained Article 56a of the proposed directive, allowing member states to require companies to supply medicines benefiting from regulatory data protection in sufficient quantities to meet patient needs. Following further negotiations, the provision now includes safeguards clarifying responsibilities for both companies and member states, and preventing the mechanism from being used to facilitate parallel trade.
Clarification of the Bolar exemption
The package confirms and broadens the so-called Bolar exemption, allowing manufacturers of generics and biosimilars to conduct the necessary studies and submissions so that competing products can enter the market immediately after expiry of any relevant intellectual property rights. The scope expressly expands to also include submissions for all marketing authorisations, health technology assessment (HTA), pricing & reimbursement, and procurement tenders.
Incentives to tackle antimicrobial resistance
To support the development of priority antibiotics and tackle antimicrobial resistance, the package introduces a transferable exclusivity voucher. This voucher grants one additional year of market protection for any chosen product and can be transferred between companies.
To address concerns about budgetary impact, the final text maintains the ‘blockbuster clause’, preventing the voucher from being applied to products with average annual gross sales exceeding €490 million over the past four years.
What happens next?
While the agreement is a major step in concluding the Pharma Package, it remains provisional and must still be formally endorsed and adopted by both institutions. Following publication in the EU’s Official Journal, the member states will need to transpose the new directive into national law, while the rules of the new regulation will only start applying after a transitional period.
We are available to address any questions you might have and can provide you with further information about this legal development.
ALTIUS’s Life Sciences team closely monitors regulatory developments in the pharma sector. For more information on this topic, please feel free to contact us.
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