EU Biotech Act clause could cost health systems €70m per medicine, Commission warns

A clause in the European Commission's proposed Biotech Act could cost public health payers up to €70 million per medicine by delaying the entry of cheaper generic drugs onto the market, EurActiv reported.

The estimate comes from the Commission's own internal analysis and centres on a provision that would extend data protection periods for certain biotechnology products, pushing back the point at which generics can compete.

Health economists and patient groups have long warned that extended exclusivity periods drive up costs for national health systems already under fiscal pressure. The Commission figure — €70 million per medicine — gives concrete weight to those concerns and is likely to sharpen debate in the European Parliament as the Biotech Act moves through the legislative process.

No timeline for a parliamentary vote has been confirmed, according to EurActiv.