Last March, the European Parliament's SANT Committee approved both the directive and the regulation of the pharmaceutical legislative package, agreed on December 11 in the meetings between the European Commission, the Council, and the European Parliament, the well-known trilogues.
The result of the vote was 29 votes in favor, three against, and six abstentions for the regulation, while the directive received 30 votes in favor, two against, and six abstentions.
This set of measures drives a far-reaching reform of EU pharmaceutical legislation, aimed at ensuring the availability of safe, effective, and accessible medicines throughout its territory. The new regulation also aims to maintain an attractive environment for innovation, although linking regulatory incentives more closely to the therapeutic value of medicines and to effective patient access.
At the same time, it reinforces the security of supply and the capacity of the authorities to prevent and manage shortage situations.
During the session held last March, Adam Jarubas, chairman of the SANT Committee, announced that the final vote on the text could be held, at the latest, on October 2, 2026.
Regulatory incentives change
One of the most novel aspects is the profound revision of the regulatory incentives system, with eight years of data protection, with exclusive rights over preclinical data and trial data. In addition, one year of market protection is established, which implies the exclusive right to sell a product without immediate competition from generic or biosimilar drugs.
On the other hand, market protection will be extended for one additional year if the product addresses an unmet medical need or is a medicine containing a new active substance. Furthermore, it must be demonstrated that comparative clinical studies have been carried out in more than one Member State or that an application has been submitted in the EU or within a period not exceeding 90 days from the first application outside the EU.
Market protection may be extended for another additional year if, during the first eight years of data protection, the holder obtains authorization for one or more new therapeutic indications, which during the scientific evaluation prior to their authorization have demonstrated to provide a significant clinical benefit with respect to existing therapies.
Market protection may not exceed 3 years in any case and consequently the drug protection period will be a maximum of 11 years.
New orphan drug regime
Another important novelty is the comprehensive reform of the regulation of orphan medicinal products, which replaces the separate scheme that, until now, rested on Regulation (EC) No. 141/2000.
The objective is to unify, in the same instrument, the rules of designation, authorization, and incentives applicable to this type of medicine. Thus, orphan designation becomes the responsibility of the European Medicines Agency and its validity is generally set at seven years, with the possibility of extension if convincing and promising study evidence regarding future applications is provided.
The new framework maintains as central elements of this regime the rarity of the disease, the non-existence of an authorized satisfactory method or, where applicable, the need to prove a significant benefit compared to existing alternatives.
In terms of incentives, the reform establishes market exclusivity with three categories. In the first, nine years are established for orphan drugs as a general rule. In the second, it is extended to eleven years for those orphan drugs considered breakthrough. That is, those that are the first to be authorized by the EU to treat certain diseases and those that clinically relevantly reduce the mortality of a certain disease. Finally, those orphan drugs that were authorized under art. 13 of Directive 2001/83/EC will have four years of exclusivity.
Likewise, specific twelve-month extensions are added for those authorized who demonstrate the possibility of launching new medicines for orphan indications in the European Union, with a maximum of two extensions for this concept. It should be noted that this extension only applies to orphan medicines in general and those considered breakthrough.
Differentiated treatment for antimicrobials
The reform expressly recognizes antimicrobial resistance as a structural threat to public health. For this reason, specific measures are incorporated aimed at both fostering the development of new antimicrobials and ensuring their prudent and sustainable use.
On the other hand, the pharmaceutical package expressly reinforces the obligation that medicines benefiting from regulatory protection be effectively available to Member States, linking regulatory protection and incentives to real patient access and supply continuity to a greater extent.
Also, the so-called Bolar exemption is expressly extended, with the aim of facilitating the effective entry of generic, biosimilar, hybrid, and bio-hybrid medicines from the very moment the patent expires. Or, where applicable, the supplementary protection certificate of the reference medicinal product.
One Health Approach
Finally, the One Health approach is incorporated into the regulatory framework for medicines, placing environmental protection as one of the material axes of the new pharmaceutical package. Thus, it is admitted that the impact derived from the manufacture, use, and disposal of medicines can generate risks for ecosystems. And, in certain cases, also for public health, especially in relation to antimicrobial resistance.
For these reasons, it will be required that marketing authorization applications be accompanied by an environmental risk assessment and, where appropriate, by adequate mitigation measures. If such an assessment is incomplete or not sufficiently substantiated, authorization may be denied.
The reform also provides for the imposition of post-authorization studies of an environmental nature and additional mitigation measures, conditioning marketing authorization on environmental risks being adequately assessed and managed.