Self-regulation of Medicines Advertising

Peter Bogaert

Covington & Burling

pbogaert@cov.com

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Overview

Pharmaceutical regulation

UK

The Netherlands

Spain

Italy

Germany

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Pharmaceutical Regulation

Pharmaceutical industry is highly regulated

– marketing authorisation– GMP, GCP, GDP, …– restrictions on suppliers– testing on importation

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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

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– no sampling to public– adequate training for sales representatives– no gifts (unless inexpensive and for

professional use)– hospitality ancillary to scientific conferences– limited sampling

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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

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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

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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

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Other self-regulatory systems

– ASA– BAC– …

Link with legal rules and procedures

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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

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Prescription products

– Stichting Geneesmiddelenreclame (CGR)– Code Geneesmiddelenreclame– close cooperation with authorities– complaint procedures widely used– e.g. two-study requirement for comparative

claims

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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 codese.g. Feb. 2003 policy rules on benefits to health professionals

– court case law

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Spain

Farmindustria Code

– conciliation attempt before Ethics Commission if no agreement referred to AUTOCONTROL

– increased use

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Italy

Farmindustria Code

IAP

Autorita Garante della Concorrenza e del

Mercato

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Germany

VFA and BPI Codes• No adjudication mechanism

Integritas

UWG litigation• §1 Contra bonos mores

• Ex parte injunction