Data exclusivity for Rx-to-OTC switches in Europe

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Prescription-free medicinal products are crucial for individuals dealing with self-diagnosable and self-treatable conditions, offering safe and effective treatment options. The transition of medicinal products from prescription to non-prescription status (Rx-to-OTC switch) is essential for enhancing self-medication. This process aims to introduce new and improved self-treatment options while ensuring safety and effectiveness for diseases that may not yet be recognized as suitable for self-treatment. Although the development of new medicinal substances follows standardized protocols, the transition to non-prescription status lacks clear guidelines, complicating decision-making with various confounding factors. This thesis explores the legal framework for changing the classification of prescription products in Europe and the regulatory pathways necessary for a successful Rx-to-OTC switch. It emphasizes data exclusivity as a strategy to influence patient behavior and improve treatment outcomes. The analysis includes post-hoc evaluations of actual cases to identify options for obtaining data exclusivity and proposes methods to generate data that better reflect patients' needs and understanding of self-medication, thereby introducing new categories of relevant data for consideration.