What is the pharma package?

The pharma package updates the current rules on medicines to better meet patient needs and support competition and innovation

The pharma package is the first major revision of EU pharmaceutical laws since 2004. Its aim is to better meet patient needs by:

• boosting innovation and competitiveness through incentives for new antimicrobials, rare disease medicines and treatments for children
• addressing security of supply and shortages to ensure the timely availability of safe and affordable medicines across the EU.

On 11 December 2025, the Council and the European Parliament reached a provisional agreement on the EU's pharma package, delivering the most far-reaching reform of EU pharmaceutical legislation in over 20 years.

What changes under the pharma package?

Key elements include:

• Eight years of data protection and one year of market protection for new medicines, with a one-year extension possible for innovative products.
• Measures to ensure the availability of essential medicines , allowing Member States to require sufficient supply where regulatory protection applies.
• A strengthened «Bolar exemption» enabling generic and biosimilar medicines to enter the market immediately after patent expiry.
• A new transferable exclusivity voucher to incentivise the development of priority antibiotics, with safeguards to limit impacts on national healthcare budgets.

Next steps

The agreement now awaits formal approval by the Council and the European Parliament before entering into force upon publication in the Official Journal of the EU.