1. 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
I URL:

2. 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 “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector”

3. 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

4. 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

5. 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:

6. 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

7. 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

8. 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

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

10. 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

11. 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

12. 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

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

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

15. 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