European Parliament Adopts Its Position on EU Pharmaceutical Reform

The Commission presented the package on 26 April 2023 as the largest reform of EU pharmaceutical legislation in over 20 years, with a new directive and a new regulation to replace the existing rules, including those on medicines for children and for rare diseases. Its proposal set a minimum regulatory protection period of eight years, which could be extended in specified cases.

What MEPs want on protection periods

According to the Parliament's press release, MEPs propose a baseline of 7.5 years of regulatory data protection, during which competitors cannot access a product's data, plus two years of market protection after authorisation, during which generic, hybrid or biosimilar versions cannot be sold. Additional data protection would be available for addressing an unmet medical need (up to 12 months), for conducting comparative clinical trials (6 months) and for carrying out a significant share of research and development in the EU, at least partly with EU research partners (6 months). The total period of data protection would be capped at 8.5 years.

A one-off 12-month extension of market protection would be possible where a new indication offers significant clinical benefit over existing therapies. Orphan medicines addressing a high unmet medical need could receive up to 11 years of market exclusivity.

Antimicrobials and shortages

To encourage development of priority antimicrobials, MEPs back a transferable data exclusivity voucher giving up to 12 additional months of data protection. The voucher could be transferred only once and could not be used for a product that already benefits from the maximum protection period. The reform also aims to improve security of supply and address medicine shortages.

What happens next

The vote fixes Parliament's first-reading position before the June 2024 European elections. The file will be taken forward by the new Parliament, and the final shape of the EU pharmaceutical reform will depend on negotiations with the Council once it has agreed its own position. Originator and generic manufacturers will be watching how the protection periods change in those talks.

Sources

• European Parliament: Parliament adopts its position on EU pharmaceutical reform
• European Commission: Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines