EU pharma package – EU Council adopts new rules

The Council of the EU has adopted the ‘pharma package’, the most comprehensive reform of EU pharmaceutical legislation in over 20 years, aimed at boosting competition in the EU pharmaceutical sector and improving patient access to medicine.

The reforms seek to balance patient needs with creating a more competitive and innovation-friendly environment for pharmaceutical companies. The reforms, which will be the biggest revision to EU medicine regulation since 2004, are aimed at addressing various areas, including regulatory protection mechanisms for companies selling new medicines, specific incentives to combat antimicrobial resistance and to promote medicine supply and early availability of generics.

What is the ‘pharma package’?

The ‘pharma package’ comprises an EU regulation and EU directive and was first proposed by the European Commission in April 2023. Following agreement between the Council of the EU and the European Parliament at the end of last year, the Council of the EU adopted the reforms on 28 September 2026. The new framework will enter into force following adoption by the European Parliament and publication in the EU’s Official Journal.

Key areas addressed by the ‘pharma package’ are considered below:

New medicines – data protection and market protection measures

Incentives to encourage innovation are included, with various periods of protection available to companies placing new medicines on the market, including the following:

• data protection period: an eight-year data protection period will apply where a company places a new medicine on the market. This will ensure the company’s exclusive rights to data from pre-clinical tests and clinical trials during the protection period.
• market protection period: separately, exclusive rights to sell a new medicine without immediate competition from generic medicines / biosimilars will apply for one year. A further year of market protection can apply via either of the following routes:
  • innovative medicines that meet at least two criteria in one of the following way
    • comparative clinical trials were undertaken and early application in the EU;
    • comparative clinical trials were undertaken and clinical trials were undertaken in more than one member state; or
    • where comparative clinical trials are not possible, clinical trials in more than one member state were undertaken and early application in the EU.
  • unmet medical need – where a product will fulfil an unmet medical need.
• orphan medicinal products – specific provision is made for orphan medicines, which are products developed to treat rare conditions. Under the new regime:
  • such products will receive nine years of market exclusivity, increasing to eleven years where the orphan medicine is ‘breakthrough’. An orphan medicine will be considered ‘breakthrough’ if:
    • no medicinal product has yet been authorised in the EU to prevent, diagnose or treat the relevant orphan condition; and
    • the medicine leads to a clinically relevant reduction in sickness or mortality rates resulting from that condition;
  • orphan medicinal products authorised under a ‘well-established-use pathway’ will receive four years of market exclusivity.

Addressing antimicrobial resistance – data protection incentives

To incentivise pharmaceutical companies to help address antimicrobial resistance, provision is made for a new transferable data exclusivity voucher to reward development of priority antimicrobials. As noted above, this voucher will grant companies one additional year of data protection and can be applied to a pharmaceutical product of their choice within certain prescribed parameters.

Safeguards are included to limit the potential impact of the use of such vouchers in the form of a ‘blockbuster clause’, which provides that the voucher cannot be used for products with annual gross sales in the EU of more than €490 million in the preceding four years.

Availability of key medicines

Where medicines benefit from market protection, EU countries may require pharmaceutical companies to supply sufficient quantities to meet patient needs. Safeguards are included to ensure these measures address patient needs in the relevant member state, rather than facilitating parallel trade to other member states.

Extension of Bolar exemption

The pharma package includes an intellectual property exemption that will facilitate the availability of generic versions of a medicine immediately after the expiry of relevant intellectual property rights. This will be achieved by making provision for manufacturers to take necessary steps to develop generic versions, including access to studies or trials, before such rights expire.

Provision is also made for the submission of procurement tender applications without infringing patent or supplementary protection certificate rights as long as there is no actual sale or marketing of the relevant medicine during any protection period.

Faster EMA assessments

The standard EMA scientific assessment timeline will be reduced from 210 to 180 days from receipt of a valid application, with a 150-day timeline available under the accelerated assessment pathway.

What needs to happen before the ‘pharma package’ is in force?

The regulation and directive that make up the pharma package now need to be adopted by the European Parliament. The draft directive includes a deadline of two years following the entry into force date for member states to transpose the directive into national law, save for certain provisions subject to different timing.

We will continue to monitor the progress of the new rules. If you would like to discuss any of the matters addressed above, please contact Disputes and Investigations partner Charleen O’Keeffe, Emma Doherty, Rebecca Ryan, Kate Mckenna or your usual Matheson contact.