Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Prescription Status and Its Implications for Pharmaceutical Companies ***

Stefan Brunkhorst (Abschlußjahr: 2017)

Summary
Language: English
The prescription status is a powerful tool to restrict patients’ access to pharmaceutical products dependent on the products’ safety profile, abuse and misuse potential as well as sufficient marketing experience. It differentiates between prescription drugs and non-prescription drugs; any pharmaceutical product is assigned upon registration to one of the sub-categories of free sale drugs or pharmacy-only drugs for non-prescription, as well as common, special and restricted prescription drugs.
However, the status does not only affect patients but also has a sizable effect on pharmaceutical companies. Legal implications set the boundaries for advertisement, distribution channels and customer target groups as well as pricing and drug reimbursement by the public healthcare system. But eventually the most important question for pharmaceutical companies is to what extent the prescription status impacts turnover, unit sales and market share.
This thesis provides an overview on the legal background of the prescription status in the EU and compares the respective implementation into German and British law. Options to influence the legal status by choosing the optimal registration strategy or initiating a switch are discussed. Real-life case studies illustrate each topic, underlining the practical relevance of the problem and providing examples on how existing regulations were applied and made use of. In the end, recommendations for pharmaceutical companies are derived from the insights and strategies analyzed before, taking into account how to adapt pricing and customer target groups in relation to the prescription status and ultimately maximizing profit for a pharmaceutical product.
Pages: 73
Annex pages: 3