Balancing Risk, Cost, and Access: Early Access Programmes and Competing Policy Objectives in the EU

Early access is an exception to the general pharmaceutical marketing authorisation procedure that allows for market access in an early stage of development. The criteria for access revolve around the concept of ‘unmet medical need’, which indicates its exceptional character. Its key component is the multitude of actors and policy objectives, whose hierarchy is inverted in relation to the usual circumstances. In parallel, the distribution of competences between Member States and the Union are slightly shifted. This article explores, using early access as the golden middle example, whether the hierarchisation of policy objectives affects the distribution of competences between Member States and the Union, all of this while underlining the potential early access has in the new Pharma Package both independently and as a potential tool of the upcoming sandbox regulatory model.