Understanding the ABPI Code of Practice

The Association of the British Pharmaceutical Industry (ABPI) Code of Practice forms the foundation of self-regulation within the UK pharmaceutical industry. It provides comprehensive guidance on promoting prescription medicines and on interactions with healthcare professionals, patients, and the public.

Administered independently by the Prescription Medicines Code of Practice Authority (PMCPA), the ABPI Code sets standards that often go beyond statutory regulation. It is regularly updated to reflect evolving industry practices, patient needs, and ethical expectations.

Core principles of the ABPI Code include:

• Transparency: Full disclosure of sponsorships, collaborations, and financial relationships
• Accuracy and balance: Information must be clear, fair, evidence-based, and not misleading
• Patient welfare: Activities must prioritize patient safety and the appropriate use of medicines
• Ethical standards: Professional independence must be respected in interactions with healthcare professionals
• Certification: Promotional materials must be reviewed and certified by a registered medical practitioner or pharmacist before use

Compliance with the ABPI Code is not just about avoiding penalties; it is key to building public trust, maintaining ethical standards, and ensuring sustainable business operations.

Implementing a promotional material review system: Requirements and best practices

Developing a strong promotional material review (PMR) system is essential for meeting the requirements of the ABPI Code. A good PMR system ensures that all promotional activities are thoroughly vetted before release.

Key requirements of an ABPI-compliant PMR system

• Formal certification process: All promotional materials must be certified by a UK-registered medical practitioner or pharmacist
• Secondary review (examination): A second qualified individual must also examine the materials
• Comprehensive documentation: Complete records must be kept, including drafts, final versions, certifications, supporting references, and usage dates
• Review of all promotional formats: Print, digital, and presentation materials must be reviewed
• Pre-approval of materials: Certification must be obtained before materials are used publicly
• Alignment with SmPC: Claims must be consistent with the approved product information

• Centralized workflow: Use a unified platform for a consistent review process
• Clear role definitions: Assign responsibilities across authors, reviewers, certifiers, and approvers
• Training and education: Provide regular training for all involved staff
• Template use: Develop standard templates for compliance and consistency
• Reference management: Implement a strong system for verifying scientific references
• Version control: Ensure robust version control for drafts
• Audit trails: Maintain a record of all review and approval actions
• Proactive monitoring: Periodically audit materials in circulation
• Digital adaptation: Include email, websites, webinars, and social media in the review process
• Rapid updates: Create processes for withdrawing or updating materials promptly

✔ Certification and approval

• Material reviewed and certified by a registered medical practitioner or pharmacist
• Secondary review by a suitably qualified individual completed
• Final material version approved before first use

✔ Documentation and record keeping

• Certification documentation filed and stored
• Copy of the final approved material archived
• Supporting references documented and accessible
• Date of first use and withdrawal recorded

✔ Content accuracy and consistency

• Claims supported by up-to-date scientific evidence
• Content consistent with the approved SmPC
• Balanced presentation of benefits and risks maintained
• Comparisons with other products factual, fair, and substantiated

✔ Patient-centric and ethical communication

• Patient safety information clearly presented
• No misleading content by omission, exaggeration, or distortion
• Promotional intent clearly indicated
• No direct-to-consumer promotion of prescription-only medicines

✔ Digital and social media compliance

• Digital content reviewed and certified before publication
• Monitoring systems for user-generated content in place
• Clear separation between professional and public-facing content maintained

✔ Training and oversight

• Regular training provided to reviewers and certifiers
• Internal SOPs for promotional review updated regularly
• Periodic audits of promotional materials conducted
• Lessons from complaints or breaches incorporated into training programs