Cooperation for Better Regulation AFAMELA & WSMI Conference Cooperation for Better Regulation Examples of best regulatory practices around the world Mexico City | 5 October 2015 Dr Hubertus Cranz, Director General Association of the European Self-Medication Industry 7 Avenue de Tervuren, B-1040 Brussels, Belgium E-mail: info@aesgp.eu I URL: www.aesgp.eu

European Commission “Non-prescription medicines play an important role since they offer economic as well as social benefits. Self-medication empowers patients to treat or prevent short term or chronic illnesses which they consider not requiring the consultation of a physician, or which may be treated by the people after an initial medical diagnosis. Consequently, access and availability of these medicinal products require particular attention.” Source: Communication from the European Commission of 10 December 2008 “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector”

Major political initiative 2010-2013 Bringing all relevant stakeholders together to define future policy on access to medicines in Europe 5 priority areas: Orphan medicines Managed market entries Biosimilars Shortages in small markets and Non-prescription medicines

Promoting good governance for non-prescription medicines (1) Evidence based work Economic and Legal Framework study Reports on: Market (sales and available ingredients) Reclassification impact Stakeholder views Distribution conditions Pricing & Reimbursement conditions Complementary reports + AESGP OTC database

Promoting good governance for non-prescription medicines (2) Report endorsed in 2013 by: 27 EU Member States European organisations/associations representing: . Consumers Patients . Health professionals . Payers Providers Industry Report is available at: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/otc_report_en.pdf

Promoting good governance for non-prescription medicines (3) Recommendations Self-care oriented training for health professionals, meaningful continuing education Supporting citizens’ self-care knowledge and skills Ensuring availability of reliable information for patients Setting up multistakeholder platforms in EU Member States

Follow up: United Kingdom National stakeholder platform on reclassification of non-prescription medicines established Revision of the UK reclassification guideline Specific reference to model developed with support of WSMI for the benefit-risk-evaluation of non-prescription medicines

Improving the benefit-risk (B/R) assessment process for non-prescription medicines Eric Brass UCLA, USA Ragnar Lofstedt Kings College, UK Ortwin Renn University of Stuttgart, Germany Supported by WSMI

A systematic and repetitive approach allows adjustments of regulatory decisions Governance institution Source: Brass et al.

Product-Specific Characteristics Common Domains for Non-prescription medicines Product-Specific Characteristics Value tree framework for non prescription drugs XXXXXXX Improved access XXXXXXXX Improved clinical outcomes XXXXXXXX Improved public health Benefit Considerations XXXXXXXXX Enhanced consumer involvement Economic benefits XXXXXXXXX Benefit-Risk Considerations YYYYYY Unintended misuse YYYYYY Intentional misuse with therapeutic intent Risk Considerations Accidental ingestion YYYYYY Intentional overdose YYYYYY Worsened outcome due to self-management YYYYYY Brass et al Clin Pharmacol Ther 90:791, 2011

Impact More structured and rational decisions related to change of classification status Ways of collaboration between regulators and industry defined  Positive impact on public health

National switch United Kingdom Azithromycin 500mg (Clamelle®) Treatment of infection with Chlamydia trachomatis Population: ≥16 years, positive test, without symptoms (+ partner) Pharmacist: checks test results, protocol to be followed

National switches Germany Naratriptan & Almotriptan Treatment of migraines with or without aura in adults (18-65 years) Condition: previous diagnosis by a doctor

EMA/ AESGP 9th Annual Meeting 14 January 2015 - Update on Switching in the Centralised Procedure- Zaide Frias

with the EU Heads of Medicines Agencies (HMA) 7th AESGP Conference with the EU Heads of Medicines Agencies (HMA) Amsterdam, The Netherlands 15-16 February 2016