Rx to OTC switch remains a proven opportunity to expand access and drive long-term growth, but the context around it is changing. While core requirements around safety, efficacy and self-care remain unchanged, increasing pressure on healthcare systems is accelerating the need for switch as a practical solution to expand access and relieve primary care.

At the same time, success now depends on more than the molecule. Regulators are increasingly focused on whether consumers can select and use products safely in real-world settings—making behaviour, access models and targeted real-world evidence critical to achieving switch approval.

Key discussions you won’t want to miss:

• Why Rx to OTC switch is re emerging as a healthcare priority
  driven by system pressure, workforce shortages and the need to expand self-care access
• What has changed in the switch environment—and what hasn’t
  core safety and efficacy requirements remain, but the context and expectations have evolved
• Why Europe is harmonised in regulation but fragmented in access
  with national differences in pharmacy roles, access models and routes to market
• How real-world evidence supports regulatory confidence in switch
  demonstrating correct self-selection, product use and safety in real-life settings
• What regulators need to see for switch to work in practice
  from symptom recognition and self-selection through to adherence and safe use at scale
• Why switch decisions go beyond the molecule itself
  with regulators assessing behaviour, access design and system-level impact alongside science