Transcript Self-regulation of Medicines Advertising

Self-regulation of Medicines Advertising
Peter Bogaert
Covington & Burling
[email protected]
Overview
 Pharmaceutical regulation
 UK
 The Netherlands
 Spain
 Italy
 Germany
-2-
Pharmaceutical Regulation
Pharmaceutical industry is highly regulated
–
–
–
–
marketing authorisation
GMP, GCP, GDP, …
restrictions on suppliers
testing on importation
-3-
Strict advertising rules (Directive 2001/83)
– no advertising of unapproved medicines
– comply with “SmPC” (prescribing
information)
– no advertising to public of prescription
products
– no reference to TB, cancer, diabetes and other
metabolic illnesses, … to public
-4-
– no sampling to public
– adequate training for sales representatives
– no gifts (unless inexpensive and for
professional use)
– hospitality ancillary to scientific conferences
– limited sampling
-5-
Enforcement (art. 97 of Dir. 2001/83)
–
–
–
–
courts or administrative authorities
allow for injunction
accelerated procedure (interim or final)
does not exclude extra voluntary control by
self-regulatory bodies
-6-
United Kingdom
OTC Products
– PAGB Code of Marketing Practice
– more self-regulation following end of Retail
Price Maintenance
– Royal Pharmaceutical Society of Great Britain
new Code of Ethics
-7-
Prescription products
– ABPI Code of Practice for the Pharmaceutical
Industry 2001 (2003 update)
– section 20.2 on medicines information
available to the public (factual and balanced)
– section 21 on internet
– Prescription Medicines Code of Practice
Authority
-8-
Other self-regulatory systems
– ASA
– BAC
–…
Link with legal rules and procedures
-9-
The Netherlands
OTC Products
– Keuringsraad Openlijke Aanprijzing
Geneesmiddelen (KOAG) - Code voor de
Publieksreclame voor Geneesmiddelen (CPG)
– self-regulation by “branche” since 1926
– pre-vetting of advertisement to the public
- 10 -
Prescription products
–
–
–
–
–
Stichting Geneesmiddelenreclame (CGR)
Code Geneesmiddelenreclame
close cooperation with authorities
complaint procedures widely used
e.g. two-study requirement for comparative
claims
- 11 -
Other self-regulatory systems
– Stichting Reclame Code - Nederlandse Reclame Code
Link with legal rules and procedures
– KOAG: “compliance with the Code implies in
principle compliance with the law”
– official endorsement of codes
e.g. Feb. 2003 policy rules on benefits to health professionals
– court case law
- 12 -
Spain
Farmindustria Code
– conciliation attempt before Ethics Commission
 if no agreement referred to AUTOCONTROL
– increased use
- 13 -
Italy
Farmindustria Code
IAP
Autorita Garante della Concorrenza e del
Mercato
- 14 -
Germany
VFA and BPI Codes
• No adjudication mechanism
Integritas
UWG litigation
• §1 Contra bonos mores
• Ex parte injunction
- 15 -