European Federation of Pharmaceutical Industries and Associations

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Summary of the initiative

Name of Private Regulator:

Website(s) :

http://www.efpia.eu/

Objective(s):

It was felt important to clearly set out ethical standards to be met by all members of EFPIA and of its specialised groups EBE and EVM and to ensure that relationships between the pharmaceutical industry and patient organisations take place in an ethical and transparent manner.

Description of the Initiative

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Sector

Commission DG:

Health and Food Safety DG: SANTE

Contact Point - Commission:

SANTE D5 and D6

Self/Co-Regulation Basic Act

Private Act

Year:

2007

Title of Act:

EFPIA, Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations

Geographical Coverage

Global coverage:

More than EU

Participating Countries:

Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey

Description

Problems that lead to the introduction of Self/Co-Regulation and the adoption of the Founding Act:

Target Group(s):

Pharmaceutical companies.

Type of Instrument(s):

Unilateral code of conduct, effective from 1 July 2008.

Type of Monitoring:

	Conduct regular visits and spot checks	Initiate complaints procedures	Maintain database of those bounded by the norms	Produce regular reports	Receive complaints and verify if norms were breached or not
European Commission
National public authority
International public authority
Private regulator (code owner)			yes	yes
Private independent party with a mandate (e.g. auditors)
Self-appointed private parties (e.g. NGOs)
EFPIA member associations	yes	yes		yes	yes

Succinct description of the type of Monitoring:

The EFPIA Code Committee monitors the implementation of the code at national level through its members associations and prepares an annual report, based on the national reports, which is submitted to the Board.

Type of Enforcement:

	Faming, shaming and blaming	Membership suspension/exclusion	Private fines
Private Regulator	yes
Private independent party with a mandate (e.g. auditors)
Court system
Alternative dispute resolution (ADR) / Online dispute resolution (ODR)
EFPIA member associations	yes	yes	yes
In France: CEMIP, in Germany: FSA	yes	yes	yes

Succinct description of the type of Enforcement:

CONTRASTE ALTO

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European Federation of Pharmaceutical Industries and Associations

Summary of the initiative

Description of the Initiative

Horizontal tabs

Sector

Self/Co-Regulation Basic Act

Geographical Coverage

Description

Downloads

EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations