Reduction of EU regulatory data protection

In the European Union, innovators currently enjoy 8 years of regulatory data protection ("RDP"), during which other companies cannot access product data. After this period, generic or biosimilar manufacturers can file a marketing authorization application ("MAA"), followed by 2, and possibly 3 years of marketing protection before they can launch their products.

This is known as the "8+2+1" regime.

The European Commission has recently proposed changes to the regulatory data protection period, suggesting a reduction from the current standard of 8 years to 6 years, providing a "6+2" year regime. However, innovators could potentially extend this period up to 10 years of RDP through various incentives:

• An additional 12 months for approval of significant new indications.
• An additional 6 months if the product addresses an unmet medical need ("UMN").
• An additional 6 months for conducting comparative clinical trials.
• An additional 2 years if the product is launched in all Member States.

These extensions were cumulative with no cap, but there were challenges and uncertainties associated with achieving them.

The European Parliament has strengthened the RDP compared to the Commission's proposal, adopting a baseline RDP of 7.5 years, in addition to 2 years of market protection (during which generic, hybrid or biosimilar products cannot be sold), following a market authorization. This aligns with the European Parliament’s Committee on Environment, Public Health, and Food Safety (ENVI) report adopted on 19 March 2024. The intention behind this proposal is to foster a balance between encouraging innovation and ensuring competitive markets, while also improving access to medicinal products. However, Parliament has maintained the Commission's RDP modulation system with some amendments where pharmaceutical companies would be eligible for additional periods of data protection:

• An additional 12 months can be granted, which is no longer compared to the 6 months extension proposed by the European Commission if the particular product addresses UMN.
• A new incentive of 6 months if the innovator conducts comparative clinical trials (the same as under the Europeans Commission proposal).
• An additional 6 months can be granted for significant R&D conducted in cooperation with an EU research entity. This is a new incentive introduced by the European Parliament.

A one-time extension —an addition of 12 months— of the 2 year market protection period could be granted if the company obtains marketing authorisation for an additional therapeutic indication which provides significant clinical benefits in comparison with existing therapies.

The European Parliament has proposed capping the overall RDP at 8.5 years. While the European Parliament's amendments offer some improvements over the Commission's proposal, concerns among innovators remain about the overall reduction in RDP.