The European Commission has just released a Staff Working Document (SWD) outlining its analysis in support of the Biotech Act I. The publication comes more than five months after the Commission presented its proposal in mid-December.
One of the more contentious proposals in the Act is the proposal to offer an additional one-year Supplementary Protection Certificate (SPC) extension for certain advanced therapies, on the condition that late-stage clinical trials are conducted in more than two EU member states and that at least part of the manufacturing process takes place within the EU.
While the Commission argues that the measure could strengthen Europe’s biotechnology ecosystem, critics warn that it could come at a high cost to public healthcare systems and delay patient access to cheaper biosimilar medicines.
As Europe tries to ensure the competitiveness of its biotech sector – one of few areas where Europe is still highly productive – SPCs may seem like an easy solution that does not require a direct demand on the EU’s cash-strapped national treasuries, however it’s a solution that does not come without costs….
