Over the past few years, the European Union has been actively working to overhaul its pharmaceutical legislative framework to better address unmet medical needs, such as those relating to rare diseases, as well as to improve Europe’s competitiveness in the pharmaceutical market and to support innovation. In fact, in April 2023, the European Commission (the “Commission”) had published a new so-called ‘pharma package’ which included proposals for a new regulation and a directive aimed precisely at tackling such issues. Such proposals now have to be negotiated with the European Parliament for a final version of these new rules to be agreed upon.
To read the rest of the article, please visit this link.
