The root causes of unavailability and delay to innovative medicines
EFPIA has investigated the root cause of unavailability and found there are 10 interrelated factors that explain unavailability and delays. These are rooted in the medicines access systems and processes in the EU member states and the corresponding impact on commercial decision-making. They range from a slow regulatory process to late initiation of market access assessment, to duplicative evidence requirements, to reimbursement delays, and local formulary decisions. As the root causes are multifactorial, they can only be solved by different stakeholders working together.