1. Improving the agenda for Advertising and Switching for Nonprescription products Advancing Self-Care and Responsible Self-Medication for a Healthier Future 5 – 6 October 2015, Mexico City Dr. Gerald Dziekan, Director General World Self-Medication Industry (WSMI)

2. Evolving landscape for self-care Daily choices Self- managed ailments Minor ailments Chronic conditions Acute conditions Major trauma Medical Care Lifestyle Compulsory psychiatric Care Collaborative CareSelf Care Limited engagement in healthcare Passive recipient of care Limited in influencing own health Engages in improvement of own health Proactive participation Able to influence own health Classic medical care system Empowered and health-literate people- driven self-care system Demand for involvement Patients / consumer organizations Internet (NetDoctor, social media etc.) mHealth Health literacy Patient empowerment

3. 10 minor ailment responsible for over 75% of consultations Burden on HC systems & potential for cost savings > 16 billion Euro annual savings by shifting 5% of care to self-medication (EU, 2004) AESGP, Economic and public health value, 2004

4. Value of access to OTC +80% +50% OTC medicines provide symptomatic relief for an estimated 60 million US citizens who would otherwise not seek treatment Booz & Co study, 2012 Nicotine Replacement Therapy (NRT) up 150% in 1 st year after RX to OTC switch Appr. 114,000 to 300,000 new ex-smokers annually Appr. 2 billion USD annual societal benefit from NRT switch Shiffman (1997, 2000), Keeler (2002)

5. New paradigm People driven self-care is the foundation of health care Economic studies demonstrating huge cost savings to the HC system … but … in evaluating the regulation on advertising and switching, economic and public health benefits are not (always) taken into account Need for an appropriate regulation based on proportionality Secondary / tertiary Care Primary Care Self-Care Hospital costs Professiona l / medical costs Self–care costs

6. Improving the benefit-risk (B/R) assessment process for non-prescription medicines Brass et al Clin Pharmacol Ther 90(6):791, 2011 Brass et al J Clin Pharmacol 53(5):475, 2013 Benefit-Risk Considerations Benefit Considerations Risk Considerations Improved clinical outcomes Improved public health Enhanced consumer involvement Economic benefits Improved access Unintended misuse Intentional misuse with therapeutic intent Accidental ingestion Intentional overdose Worsened outcome due to self-management Decision analysis tool Value tree Common Domains for Nonprescription Drugs Referenced in national guidelines (e.g. UK, Canada, New Zealand)

7. Improving the benefit-risk (B/R) assessment process for non-prescription medicines Integrating value tree to decision making framework More structural dialogue and collaboration between regulators and the industry Emphasizing transparency, communication and rational evidence- based decision making Adapted from International Risk Governance Council (IRGC) Framework: maximize communication and transparency

8. Thank you