The European Commission released its pharma legislation proposal in 2023 to make access to medicines more secure and affordable, encourage innovation, and reduce the gaps.

One of the key changes it proposed was to shave two years off the amount of time new branded medicines have to themselves on the market before rivals launch, down from the current eight years to six.

The newly voted in the EP text bumps that up to seven and a half years of regulatory protection, with a cap of one extra year for those that qualify.

The Parliament’s directive proposal also includes new incentives not listed in the Commission’s original text: six more months of data protection for medicines in which “significant development, including clinical and preclinical” was carried out in the EU; or for where development was done in collaboration with university hospitals, centres of excellence, or bioclusters.