EFPIA - European Federation of Pharmaceutical Industries Associations

Summary of the initiative

Name
EFPIA - European Federation of Pharmaceutical Industries Associations
Objective(s)
Providing accurate, fair and objective information about medicinal products so that rational decisions can be made as to their use; Raising industry standards; Improving sector's image; Increasing clients' trust in the quality of the products/services; Meeting legislative requirements. The EFPIA Code of Practice for the promotion of medicines covers any activity undertaken, organised or sponsored by a pharmaceutical company, or with its authority, which promotes the prescription, supply, sale, administration or consumption of its medicinal product(s).

Description of the Initiative

    Sector

    Sector

    Contact Point - Commission
    SANCO C.8.

    Self/Co-Regulation Basic Act

    PRIVATE ACT
    Year
    2004
    Title of Act
    Code of Practice on the Promotion of Medicines

    Geographical Coverage

    Global coverage
    Participating Countries
    Austria

    Description

    Problems that lead to the introduction of Self/Co-Regulation and the adoption of the Founding Act
    Risk of deceptive practices and potential conflicts of interest with healthcare professionals when promoting medicinal products towards healthcare professionals.
    Target Group(s)
    Pharmaceutical companies
    Type of Instrument(s)
    Unilateral code of conduct
    Type of Financing
    -
    Type of Monitoring
    Conduct an initial survey of compliance capacity of future regulateesConduct regular visits and spot checksInitiate complaints proceduresMaintain database of those bounded by the normsProduce regular reportsReceive complaints and verify if norms were breached or notReflexive dialogue with the - stakeholdersOther
    European Commission
    National public authority
    International public authority
    Private regulator (code owner)yes
    Private independent party with a mandate (e.g. auditors)yesyesyes
    Self-appointed private parties (e.g. NGOs)
    Succinct description of the type of Monitoring
    The EFPIA Code Committee monitors the implementation of the Code at national level through its member associations and prepares an annual report, based on the national reports, which is submitted to the Board.
    Type of Enforcement
    Faming, shaming and blamingJudicial sanctionsMembership suspension/exclusionPrivate finesOther
    Private Regulatoryes
    Private independent party with a mandate (e.g. auditors)
    Court system
    Alternative dispute resolution (ADR) / Online dispute resolution (ODR)
    Succinct description of the type of Enforcement
    -

    Results of Commission Monitoring

    Link / Reference of Evaluation
    -

    Downloads

    SMO self- and co-regulation database - private code 24