The EC is yet to provide an updated timeline for the proposal’s release, but a spokesperson said that the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”

Approximately a year ago the EC released a ‘road map’ which outlined the issues it plans to address, such as unmet medical needs, market failures, antimicrobial resistance, drug shortages, and competition and unnecessary regulatory burdens, along with various other topics.

This roadmap states: ‘The EU pharmaceuticals system needs to remain attractive in a competitive global environment, which demands regulatory attractiveness and agility while upholding the fundamental principles of safety, efficacy, quality and making sure that innovation reaches those who need it.’ It was also noted in the roadmap that the Commission was considering ‘a tailored system ofincentivesthatlinksrewards with possible obligations,’ for example launching products in all or most EU member states and increasing transparency around research and development funds.

Catherine Drew, a partner with the London-based law firm Pinsent Masons, who specialises in life sciences regulation, commented on the delay: “It’s such an important project, and the suggestion of overhauling the entirety of the pharmaceutical regulatory regime, industry wants it to be right.”