Innovating Self-medication European Rx to OTC to OTC Switch Strategies

James Dudley’s ‘Innovating Self-medication European Rx to OTC Switch Strategies’ presentation is the essence of twenty years of developing strategic frameworks for launching new consumer healthcare brands successfully. It is based on James Dudley’s tested approach and important case studies of successful switch strategies from companies leading the field.

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The difference between success and failure in switching a prescription only medicine to create or renew a consumer brand has been a subject of study and exploration at the heart of James Dudley’s professional reputation. Successful Rx to OTC switching is about getting the balance right between using switchable entities to create or renew brands to fulfill consumer needs and expectations better, managing the regulatory pathway strategically to achieve consumer led positioning and designing the brand offer in terms of product presentation, brand name, message, channel and price.

James W Dudley is a well respected strategy consultant, speaker, facilitator and writer in the European Healthcare sector. He has been involved in Rx to OTC switching for over twenty years. He has been the lead strategy consultant supporting teams that have been responsible for launching ground breaking new healthcare brands and for setting the frameworks for developing strategies for Rx to OTC switches.

James Dudley has written several leading studies based on empirical analysis and observational research to define factors that contribute to successful Rx to OTC switches in Europe.

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Since 1994 the European Union has seen a gradual harmonising of regulations covering the reclassification of medicines. With a more codified regulatory framework switching prescription only medicines to OTC self-medication in Europe has become a fairly straight forward set of processes. It allows marketing companies to adopt Europe wide brand positioning for innovative self-medication. This has resulted in the release of a large number of active entities into the consumer domain.

What is Rx to OTC Switching about? - Switching medicines from prescription only to over the counter (OTC) self-medication, describes the legal process of reclassification of medicines. Yet it is providing a brand of choice through meeting consumer needs and stretching expectations that is at the root of success.

Successful Rx to OTC Switches have been shown to have a number of common success factors which together act in a synergistic manner. Comparative analysis of successful new brand entities against failed Rx to OTC switches shows repeatedly that in all cases at least some of these success factors were missing in the planning for the brand commercialization strategy.

• Non-prescription medicines (abbreviated non-Rx) describes the legal status of registered medicines not requiring a doctor’s prescription even though some such pharmaceutical entities are both prescribed and reimbursed in some European States
• OTC (medicines) is an abbreviation of Over The Counter – usually meaning available for self-medication although not necessarily self-selection in many European pharmacies
• Rx to OTC means prescription only to over the counter availability
• POM to P means prescription only medicine to pharmacy only over the counter availability
• SPC means Summary of Product Characteristics and is the legal basis for marketing approval, prescription or non-prescription status and documentation to support advertizing claims. It is essential to get this right in Rx to OTC switch planning