The EU pharma package: what we know and what to expect

After years in the making, the much-awaited political agreement reached by the EU institutions on the so-called “EU pharma package” will transform the EU’s pharmaceutical legislative framework. The agreement, reached on 11 December 2025, has wide-ranging implications for innovation, access to medicines, and the competitiveness of the pharmaceutical and biotech sectors in Europe.

The package is formed by a new directive and a new regulation, each of them replacing Directive 2001/83/EC on medicines and Regulation (EC) No 726/2004 on the centralised procedure and functioning of the EMA.

Even if the final text is yet to come, these are the main points agreed as we know them.

Regulatory data protection and market exclusivity periods

The EU institutions have decided that the formula “8+1(+1)(+1)” will substitute the familiar “8+2(+1)” regulatory data protection period.

It has been agreed that, in line with the current regime, innovative medicinal products will benefit from a baseline of eight years of regulatory data protection, meaning that applicants of generic and biosimilar marketing authorisations cannot rely on the pre-clinical and clinical data contained in the dossier of the reference product for the purpose of obtaining their approvals.

Going forward, however, the two-year period of market exclusivity that automatically follows the period of regulatory data protection, during which generics cannot be commercialised, will be reduced to one year. Importantly, this period can be extended from one to up to three years if certain conditions are met. In particular, innovators will be able to benefit from up to two additional one-year periods of market exclusivity if the following conditions are met:

• the medicine addresses an unmet medical need;
• the medicine contains a new active substance, fulfilling a combination of conditions on comparative clinical trials, clinical trials carried out in several EU member states, and the obligation to apply for market authorisation within 90 days after the submission of the application for the first marketing authorisation outside the EU; or
• an authorisation is obtained for one or more therapeutic indications that bring a significant clinical benefit over existing therapies.

The rationale behind this important change is that it is true innovation which addresses unmet medical needs that should be worthy of protection.

Orphan medicinal products

For rare diseases, the EU institutions have agreed that:

• “normal” orphan medicinal products will benefit from nine years of orphan market exclusivity; and
• “breakthrough” orphan medicinal products, which will have to show a significant clinical benefit for conditions without existing treatments, will benefit from eleven years of orphan market exclusivity.

We expect that the EU institutions will have agreed the introduction of the concept of “global orphan marketing authorisation”. This would mean that additional 9- or 11-year periods of orphan market exclusivity will no longer be available for a given product for new indications relating to different orphan designations. Instead, we expect a short extension of 12 months for a new indication relating to a different orphan designation (to be granted up to two times).

The expansion of the Bolar exemption

The agreement confirms an expanded Bolar exemption. For the duration of patent and SPC rights, amongst other things, generics and biosimilars will be able to obtain pricing and reimbursement approval. They will also be able to submit applications on procurement tenders, as long as their activities do not entail the sale, offering for sale, or marketing of the medicinal product during the protection period.

The scope of the Bolar exemption at EU level does not seem to have been extended to allow innovators to benefit from it. Indeed, according to the official public statements on the political agreement, the changes are meant to support earlier market entry of generic and biosimilar medicinal products.

As the Bolar exemption will continue to be part of a directive, EU member states will be able to further expand its scope when implementing the provision nationally. It is expected that EU member states that allow innovators to benefit from the Bolar exemption will continue to do so in the future.

Shortages and supply chain resilience

A key focus of the EU institutions is the need to strengthen the security of supply and tackle medicine shortages, which is an issue that has increasingly affected EU member states.

Under the deal, marketing authorisation holders will have to put in place and update shortage prevention plans for medicinal products subject to prescription and as identified by the Commission.

Importantly, EU member states will have the power to require companies to supply certain medicines benefiting from regulatory exclusivities in sufficient quantities to meet patient needs.

Incentives for priority antimicrobials

The transferrable exclusivity voucher for priority antimicrobials was something that generated a lot of excitement at the time of the Commission’s proposal, and rightly so. This incentive seems to have been watered down, but will hopefully still be enough for developers to invest in much-needed priority antimicrobials. In a nutshell, this voucher will give an additional year of regulatory data protection for the priority antimicrobial or for another centrally authorised medicinal product of the same or different marketing authorisation holder.

It is not clear how many of these vouchers will be available (hopefully between 10 and 15), and the agreement introduces some stricter requirements in relation to the use of antimicrobials.

Next steps and what it means for stakeholders in the industry

Once we have the final text of the directive and the regulation, they will have to be formally adopted by both the Council and the European Parliament and published in the Official Journal of the EU before they enter into force. It is expected that a 24-month transition period will apply in relation to both pieces of legislation (a good compromise between the 18-month period proposed by the Commission and the 36-month one proposed by the Council).

For everyone, the deal brings much needed clarity and predictability. However, the changes do not seem to be profound enough to yield substantive results on European competitiveness. Only time will tell if we have missed the opportunity that this reform presented to address the region’s standing compared to leading markets like the US and China.