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: [email protected] 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
Complementary reports
+ AESGP OTC database
Reports on:
- Market (sales and available ingredients)
- Reclassification impact
- Stakeholder views
- Distribution conditions
- Pricing & Reimbursement conditions
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
Report is available at:
http://ec.europa.eu/enterprise/sectors/healthcar
e/files/docs/otc_report_en.pdf
 Industry
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 nonprescription 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.
Common Domains for
Non-prescription medicines
Value tree framework
for non prescription
drugs
Improved access
Product-Specific Characteristics
XXXXXXX
XXXXXXXX
Improved clinical outcomes
XXXXXXXX
Improved public health
Benefit
Considerations
XXXXXXXXX
Enhanced consumer involvement
Economic benefits
Benefit-Risk
Considerations
Unintended misuse
Intentional misuse with
therapeutic intent
Risk
Considerations
YYYYYY
YYYYYY
Accidental ingestion
YYYYYY
Intentional overdose
Brass et al Clin Pharmacol
Ther 90:791, 2011
XXXXXXXXX
Worsened outcome due
to self-management
YYYYYY
YYYYYY
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
7th AESGP Conference
with the EU Heads of Medicines Agencies (HMA)
Amsterdam, The Netherlands
15-16 February 2016