The European Commission published today its draft proposal for revised EU pharmaceutical legislation. In its press release the EC states this to be the largest reform in over 20 years. The proposal consists of a draft Regulation and a draft Directive.
According to the Commission’s press release, the proposal will make medicines more available, accessible and affordable, as well as support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry, while promoting higher environmental standards.
However, one of the more contentious aspect of the proposed legislation are amendments to regulatory exclusivities with a change of the current regime of the minimum standard 8+2 years of exclusivities (eight years data exclusivity plus two years marketing exclusivity) to 6+2 years, with further time of exclusivity being available subject to certain conditions.
A further analysis of the draft proposal will follow in due course.