On 11 December 2025, the Council and the European Parliament reached agreement on the revision of the EU general pharmaceutical legislation, also known as the "EU Pharma Law Package." The new legislation is a full recast of the European pharmaceutical legislation, also amending regulatory data protection for innovator medicinal products and orphan market exclusivity for orphan medicinal products for rare diseases, which were among the most debated topics since the publication of the first proposal of the Pharma Law Package in 2023.

Regulatory data protection

Regulatory data protection will consist of 8 years of data exclusivity and one additional year of market exclusivity, so a total of 8+1 years of protection, compared to 8+2 years under the current system. There will be a possibility to obtain one additional year of exclusivity (8+1+1) under certain circumstances and another year (8+1+1 or 8+1+1+1) for a new indication of significant clinical benefit, with a capped overall regulatory protection of 11 years. The (prolongation of) market protection can however be cut off if the marketing authorization holder does not comply with a request from a Member State to market the product there within 4 years after grant of the marketing authorization. Whereas the 8-year baseline duration of the regulatory data protection remains the same, the standard overall protection period is shortened by one year and there is a new risk of potential reduction of incentives for innovation.

Orphan market exclusivity

Orphan market exclusivity will be reduced from the current 10 years to 9 years. Extension by another 2 years will be possible for "breakthrough orphan medicinal products." Although the final text has not yet been published, previous drafts also included the concept of "Global Orphan Marketing Authorization," which would no longer grant additional separate orphan market exclusivity for second or further orphan therapeutic indications. Also, previous drafts allowed generics, biosimilars, or other second applicants to apply for marketing authorization two years before expiry of orphan market exclusivity, thus effectively reducing the innovator's market exclusivity compared to the current legal framework. The current two-year pediatric extension of orphan market exclusivity would no longer be available, according to earlier published drafts.

Therefore, although at first glance the reduction of regulatory data protection and orphan market exclusivity are not as drastic as some had proposed or expected previously, significant changes and reductions in overall regulatory incentives for innovative medicinal products are due in the EU.

Entry into force of the new legislation is expected in 2026, upon publication of the final text in the EU's Official Journal, following formal adoption. The new legislation is expected to apply after a transition period from mid-2028, but it potentially already affects pipeline products. Therefore, when developing and investing in novel products, medicinal product sponsors should consider the potential modification in EU regulatory exclusivity rights.