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EFPIA Code of Practice Summary

Purpose & Principles

• Ethical Guidelines: Ensures ethical promotion of prescription-only medicines (POM) and interactions with healthcare professionals (HCPs), healthcare organisations (HCOs), and patient organisations (POs).
• Transparency: All communications must be truthful, balanced, and compliant with the highest ethical standards.

Scope & Applicability

• Applies to all EFPIA Member Companies and interactions within Europe.
• Covers promotion, marketing authorization, gifts, sponsorship, and disclosure of transfers of value (ToVs).

Key Structural Sections

1. Promotion of POM to HCPs

• Marketing authorization: No promotion until valid marketing authorization is granted.
• Balancing & substantiation: Information must be accurate, scientific, and substantiation provided upon request.

2. Interactions with HCPs, HCOs, and POs

• Restrictions on hospitality, gifts, and consultancy fees: Limited to "appropriate" levels.
• Engagement with Patient Organisations: Focuses on patient benefit, not Promotional activities.

3. Disclosure

• ToV Disclosure: Full transparency in transferring and documenting value to HCPs, HCOs.
• Format Requirements: Standardized disclosure templates and digital platforms for accessibility.

4. Procedural Requirements

• Enforcement: Through national and EFPIA mechanisms, ENFORCEMENT includes sanctions where necessary.
• Guidance: Code evolves with regular review and adaptation.

Notable Additions & Updates

• Adoption of digital ethics in communication.
• Enhanced transparency in promotion through aggregated data.
• Binding guidance for interactions with Patient Organisations.

Compliance Mandate

• Ethical & Legal Compliance: Alignment with national laws and other applicable codes.

Contact for Queries

• EFPIA Website: Provides full versions, national codes, and further guidance.