The EU Pharma Package is the first complete overhaul of EU pharmaceutical rules in more than twenty years. In this blog we start to unpack what this will mean for our clients.

International competition for pharmaceutical investments has been increasing for decades. The European Union ("EU") has seen a progressive migration of pharmaceutical activities towards other parts of the world (e.g., Brazil, China and India). The pharmaceutical strategy for Europe and the Draghi report identified the (over-) complexity of the EU regulatory framework as one of the explanatory factors.

To address this issue, negotiations have been ongoing for more than two years on a complete overhaul of EU pharmaceutical regulations.

There have been extensive debates on key topics, such as the regulatory protection period for innovators, which has had a direct impact on the length of time for generic manufacturers to enter the market. Related technical topics have also come under scrutiny, such as the "Bolar exemption", which makes it possible for generic manufacturers to carry out certain activities during the patent protection period.

On 11 December 2025, following a third negotiation meeting, the key EU legislative bodies, the European Parliament and the Council of the European Union, announced that they have reached agreement.

Key takeaways

We will need to wait for publication of the final texts, but from what we know so far, the key changes include:

1. Significant changes in the period for which an originator product can enjoy regulatory protection before competition from generics, biosimilars or hybrid competitors

• This is a critical topic for pharmaceutical companies, considering research costs and the length of R&D cycles for medicinal products. Indirectly, it affects investor decisions.
• As part of negotiations on the package, the European Commission and the European Parliament considered significantly reducing exclusivity periods (e.g., 6 years of data protection baseline instead of 8) to increase competition and reduce prices.
• Currently, there is an "8+2+1" mechanism: 8 years of data protection followed by 2 years of market protection and (potentially) an extra 1 year of protection for new therapeutic indications (with specific rules for orphan and paediatric drugs).
• Under the new rules, "8+2+1" will become an "8+1+1+1" protection period for innovators: 8 years of data protection followed by 1-year increments of market protection, based on specific criteria.
• The goal is to incentivise (i) innovation answering to "unmet medical needs" and (ii) quick product launches.
• We will be watching with interest for how concepts will be interpreted during implementation. 

2. Incentives for the development of priority antimicrobials

• Pharmaceutical companies developing priority antimicrobials will be able to use a "voucher", which will give the right to 1 additional year of data protection for one authorized product.
• The voucher would be available not only for the antimicrobial itself, but also for any other centrally authorized product, though "blockbuster" medicinal products are excluded from the scope (gross annual sales above €490 million over the previous four years).

3. Measures to enable market access for generics immediately upon expiry of the intellectual property rights

• Until now, the "Bolar" exemption allowed generic manufacturers to conduct certain activities in advance of the expiry of the regulatory protection period without being in breach of patent rights.
• The scope of this exemption will be extended and expanded. Notably, generic manufacturers would now be allowed to participate in public procurement tenders before an originator's patent expires. They can also obtain pricing and reimbursement approvals in advance. 

4. Shorter authorisation procedures

• In particular, there will be a faster scientific assessment by the European Medicines Agency ("EMA") of 180 days compared to the current 210 days.

5. Rules against drug shortages:

• There will be a 6-month notification requirement for anticipated shortages of medicinal products by pharmaceutical companies.
• EU Member States will have the power to require companies to supply medicines benefiting from regulatory protection in sufficient quantities to meet patient needs.

6. Introduction of regulatory sandboxes

• This will open up opportunities to develop and test very innovative products in close connection with regulatory authorities.

Remaining steps

This political agreement now needs to be formally adopted. Once adopted and published, we expect that most of the new rules will enter into force within 24 months of their publication. Given the nature of R&D and manufacturing cycles, pharmaceutical companies only have a short window to make plans for adjusting to the changes.

Additional texts will be adopted to complete the Package, including the Critical Medicines Act and the Biotech Act. We expect additional incentives for localisation projects for the manufacture of essential medicinal products within the EU.

Why does it matter and how to prepare?

With the range of recent initiatives around fast-track clinical trials, incentives for critical medicines, and now the Pharma Package, the EU has made it clear that it wants the sector to thrive.

From a global perspective, many jurisdictions are heading in a similar direction to find ways to accelerate bringing medicines to market, and reduce the regulatory burden. The EU's new regime is not the most progressive when it comes to incentives and investment attractiveness. However, the EU is one of the world's largest markets, in terms of population and patients; manufacturers and R&D; as well as private capital investors.

Clients with global operations will be balancing the following challenges across competing regulatory regimes:

• Predictability vs. Modulation:
  The EU is introducing conditional extensions, which reduces predictability compared to U.S. fixed exclusivity periods.
• Launch Attractiveness:
  EU risks losing first-launch preference to the U.S. and China due to shorter exclusivity and complex obligations.
• Innovation Incentives:
  While EU reforms aim to balance affordability and innovation, other jurisdictions (U.S., Switzerland) offer faster approvals and clearer incentives for high-impact therapies.

Pharmaceutical companies will review their go-to-market strategy to make the most of the incentives on offer. The same is true for strategic investors and private equity firms, as the EU seeks to attract pharmaceutical investment.

Our Global Healthcare & Life Science team is uniquely positioned to support clients across the Globe at all stages of their product lifecycle: from molecule to market.