The pharma package: new EU rules on medicines

What is the pharma package?

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

Illustration of medication packaging, including a bottle with a yellow cross, pill blister packs, and an opened box.

In April 2023, the European Commission published its pharma package and on 4 June 2025 the Council agreed its negotiating position (mandate).

On 11 December 2025 the Council and the Parliament reached an agreement on the final shape of the new rules.

The package includes a recommendation, adopted by the Council in June 2023, on stepping up the fight against antimicrobial resistance (AMR), i.e. micro-organisms’ ability to survive despite being exposed to medicines designed to kill them.

What changes under the pharma package?

The package sets out reforms to encourage innovation, improve patient access to treatments, prevent shortages and reduce environmental impact, while keeping the EU pharma industry competitive.

Incentives to encourage innovation

Companies placing a new medicine on the market will benefit from eight years of ‘data protection’ – the time during which they have exclusive rights to data from pre-clinical tests and clinical trials. After this period, other companies can use the data to make generics.

Companies will also get one year of market protection, giving them the exclusive right to sell a product without competition from generic medicines or biosimilars.

This period can be extended by one more year for innovative medicines that address unmet medical needs or meet certain conditions, such as comparative clinical trials. A final year can also be added for medicines that have an “additional indication” (i.e. they can be used to treat conditions other than those for which they were originally developed). The total maximum combined protection period is 11 years.

Boost to antibiotics and orphan medicines

Drug makers developing new antibiotics may receive a voucher granting them an extra year of market protection for any of their pharmaceutical products. They can also sell this voucher to other drug companies.

Companies investing in rare disease medicines (‘orphan medicines’) may also benefit from generous periods of data and market protection, up to a maximum of 11 years for ‘breakthrough’ medicines addressing an unmet medical need. These incentives aim to encourage companies to invest in orphan medicines and help them recover their research and development costs.

Additionally, companies creating promising orphan medicines may receive early regulatory guidance, even years before they apply for marketing authorisation, to help new therapies reach patients as quickly as possible.

More efficient approval processes for medicines

The European Medicines Agency (EMA) oversees the approval of medicines in the EU. Once a medicine is authorised by the EMA, it can be sold in all member states.

The reform aims to make the EMA more efficient, reduce the regulatory burden and speed up approval times. It will also give patients a stronger voice by including patient representatives in the main scientific committee.

European medicines agency (EMA)

Better response to shortages

Medicine shortages have been a serious issue in the EU for years. The COVID-19 pandemic highlighted our dependency on non-EU countries for key medicines and ingredients, as well as weaknesses in the current rules.

The reform aims to improve how shortages are tracked and handled. Drug manufacturers will be required to notify shortages quicker, develop prevention plans and take measures to address critical shortages. In addition, the EU will establish a list of critical medicines and monitor their availability.

The new rules will also enable EU countries to require companies to supply certain medicines that are protected by regulatory measures, such as data or market exclusivity, in sufficient quantities to meet patient needs.

More sustainable pharma products

Pharmaceutical residues from production, use and improper disposal pollute water and soil, posing a risk to the environment and public health. Studies have found antimicrobials in the environment, for example in water sources, which can contribute to antimicrobial resistance.

The proposed new rules could require companies wanting to place medicines on the market to conduct environmental risk assessments and take risk mitigation measures.

New rules for critical medicines in the EU

Why new rules are needed

The last major revision of EU pharmaceutical legislation took place more than 20 years ago.

Since then, the medicines industry has become more global, but access to medicines still varies across the EU - with some treatments unaffordable or unavailable in certain countries - and many medical needs remain unmet.

There is also greater awareness today of the environmental impact of medicines.