The European Parliament and Council reach provisional agreement on the EU “pharma package”

The pharma package is a reform of EU pharmaceutical legislation designed to modernise regulatory frameworks, incentivise innovation, and strengthen access to medicines across Europe.

Core reforms to exclusivity periods

The provisional agreement retains the current 8‑year regulatory data protection period. However, the current 2-year market exclusivity period has been reduced to 1 year.

Companies can obtain an additional period of market exclusivity if their product meets specific criteria:

(i)

     (a) The product addresses an unmet medical need (1 year); or

     (b) The product contains a new active substance that has undergone comparative clinical trials, potentially in several member states, and the market authorisation application has been submitted within 90 days after the submission of the application for the first marketing authorisation outside the EU (1 year); and/or

(ii) The marketing authorisation holder obtains authorisation for at least one additional indication which provides a significant clinical benefit compared to existing treatments for the new indication (1 year).

The agreement proposes a cap of 11 years of combined regulatory protection for eligible medicines. This refines the previous 8+2+1 model into anew 8+1(+1 +1) structure.

Orphan drug exclusivity

Standard orphan products will benefit from a baseline period of 9 years of orphan market exclusivity, reduced from 10-years under the current regime.

A new “breakthrough orphan” category for drugs treating conditions with no current treatment and demonstrable benefit can receive up to 11 years of orphan market exclusivity.

Well-established use products will be awarded 4 years of orphan market exclusivity.

Antimicrobial voucher

The deal introduces a transferable exclusivity voucher for priority antimicrobials offering one extra year of regulatory data protection. However, this may only be applied to products with sales under €490 million in the preceding 4 years.

Expanded Bolar exemption

The Bolar exemption has been expanded to allow generic manufacturers to not only conduct necessary studies, trials and other activities for the purposes of obtaining marketing authorisations, but now to also allow them to obtain pricing and reimbursement approvals and to submit procurement tender applications.

This provision is to help ensure that generic versions of a medicine can be available on day one after the intellectual property rights have expired.

Enhancing access and competition

Member states may now require pharma companies to guarantee sufficient supply of protected medicines to meet patient demand. Safeguards are included to avoid misuse via parallel trading.

Next steps

The agreed texts have not yet been published and so the full details of the agreement are not yet known. However, negotiations will continue in the form of trilogues among Parliament, Council, and Commission. Once formally adopted, an implementation timeline of around 24 months is likely to apply, along with a transition period. The agreed length of this transition period has not yet been announced.