Data exclusivity for Rx-to-OTC switches in Europe

Prescription-free medicinal products play an important role when it comes to providing people suffering from self-diagnosable and self-treatable diseases with safe and effective treatment options. The change of classification of medicinal products for human use from prescription to non- prescription status (commonly called Rx-to-OTC switch) is the key procedure when it comes to innovating and improving self-medication. The purpose thereof is to provide new and perhaps better options for self-medication, but granting effectiveness as well as safety in the treatment of diseases partly not yet established as a self-treatment option. While the development of new substances to be used as medicinal products is well standardized, the change to non-prescription status is much less defined, making decisions about how to proceed a process with several confounding factors. This thesis discusses the legal background for a change of class of prescription products in Europe and regulatory pathways to be considered when aiming for a successful Rx-to-OTC switch. Focus is laid on data exclusivity as a means to control and improve patient behavior and thus treatment outcome. Options for obtaining data exclusivity are analyzed via post-hoc analysis of some actual cases and proposals are set up how to generate data which reflect patients' needs and knowledge for self-medication more than data derived from prescription use, thus adding new categories of data to be acknowledged as necessary, relevant and new.