New Products’ Data Protection Shortened by 6 Months in Proposed EU Drug Legislation

The EU’s Environment, Public Health and Food Safety Committee (ENVI) has supported a legislative proposal that would grant up to 7.5 years of regulatory data privacy to pharmaceutical companies developing new drugs, effectively trimming six months of protection from the current eight years for some products.

The amendments passed by a large majority in a March 19 vote (67 to 6, with seven abstentions).

The proposed legislation would offer additional extensions of up to 12 months for products that fill unmet medical needs or are largely developed in the EU or with EU collaborators, according to a press statement. But it also includes a cap of 8.5 years on available data protection.

Read about the proposed legislation here.

To read the whole story, click here to subscribe.

Related Topics