AseBio welcomes the European institutions’ decision to move forward with the EU pharmaceutical legislative package

On 11 December, the European Parliament, the Council and the European Commission announced that an agreement had been reached at trilogue stage on the reform of the European Union’s (EU) pharmaceutical legislation. The agreement must now be formally endorsed separately by each institution.

The new framework aims to improve equitable access for patients to safe, effective and affordable medicines across all Member States, while also introducing significant changes to regulatory protection periods, incentives for innovation and supply obligations. This agreement, which must be formally approved by the European Parliament and the Council before the European Commission can translate it into binding legislation, has direct implications for key issues affecting the biotechnology and pharmaceutical industries.

This agreement allows progress towards the objectives of the regulatory package: ensuring fair, safe, effective and affordable access to medicines, and strengthening industrial competitiveness, which are the core pillars of all the measures set out in the original text presented by the Commission.

Strengthened regulatory protection

The proposal maintains a framework for the protection of preclinical test data and clinical trial data that is very similar to the previous one for companies bringing new medicines to market, for a period of eight years. This protection may be extended annually up to a maximum of eleven years under very specific conditions (mainly for orphan medicines), such as:

Addressing an unmet medical need

Innovation in the active substance with particular comparative interest in clinical trials conducted across different Member States, requiring an application for marketing authorisation within a maximum period of 90 days.

A company obtaining one or more therapeutic indications with clinical benefits significantly superior to existing options.

If two of the three conditions above are met, companies may also benefit from an additional year of market protection, i.e. the right to market their product without competition from generic or biosimilar medicines.

Although these periods have not been reduced, as initially envisaged in the original proposal, the text does include certain cases in which data protection would not apply. We believe that longer periods of protection would generate stronger incentives to retain R&D investment in Europe.

As regards generic and biosimilar medicines, the extension of the so-called “Bolar exemption” clause is intended to facilitate earlier market entry by allowing manufacturers to conduct clinical trials or studies while patent protection is still in force, so that alternative versions can be made available as soon as possible, thereby ensuring supply.

Accelerating market access

The regulation is expected to have a significant impact on the internal functioning of the European Medicines Agency (EMA) and its drug approval procedures, enabling marketing authorisation applications for new medicines in the EU to be assessed within shorter timeframes. As a general rule, authorisations are expected to be granted for an unlimited period, while allowing the EMA to restrict this duration for safety reasons.

In cases of particular public interest, the EMA will also be empowered to establish regulatory sandboxes and foster the development of new therapies with high potential to address unmet medical needs.

Similarly, companies holding valid marketing authorisations will be required to establish and regularly update shortage prevention plans for prescription-only medicines, as well as for those designated by the Commission.

With this agreement between the Parliament and the Council, the European institutions are signalling their commitment to reducing administrative barriers in order to promote competition within the European pharmaceutical ecosystem. Shorter timelines for granting marketing authorisations and increased investment are proposals that AseBio has consistently put forward to the Commission throughout all public consultation phases of the regulatory initiatives in force since 2024.

Combating antimicrobial resistance

The package includes attractive incentives for companies that contribute to tackling antimicrobial resistance through research into priority antibiotics.

These companies will be offered a transferable data exclusivity voucher granting an additional year of market protection for any of their products.

Measures promoting the responsible use of antimicrobials are also included, such as making a medical prescription mandatory for their use. Companies will be required to provide accurate usage information through a paper information card if the medicine leaflet is available only in electronic format.

Finally, as part of marketing authorisation applications, companies will need to demonstrate that they have corporate plans in place for the responsible management of antimicrobials, including an environmental risk assessment. We support efforts to promote research against multidrug-resistant bacteria and recognise the role of the new EU pharmaceutical legislative package in acknowledging the need for public education on the responsible use of antimicrobials.

AseBio welcomes the European institutions’ decision to accelerate this high-impact legislation for the European biotechnology and pharmaceutical ecosystem, with trilogues having concluded at first reading. Given that this legislation has not been updated for over two decades, we encourage the Commission to adopt a more ambitious approach in the final text, as many industries are convinced that the resulting legal framework will lay the foundations for the much-needed competitiveness in R&D compared to markets where Europe is currently lagging behind, such as the United States and China.