Strengthening Pharmaceutical Supply Chain Security: Robust Supplier Approvals to Prevent Falsified Medicines

Pharmaceutical supply chain security is only as strong as its weakest supplier. Robust due diligence for supplier and customer qualification processes are essential – not just for compliance, but to safeguard business and patients from the growing threat of falsified medicines.

In the UK, the Human Medicines Regulations 2012 (and equivalent EU directives) require that wholesale licence holders obtain medicinal products only from authorised suppliers and supply only to authorised customers. Failure to establish an effective system can expose businesses to significant risks:

• Introduction of falsified or substandard medicines into the legitimate supply chain
• Patient safety incidents, product recalls, or reputational damage
• Regulatory non-compliance, leading to MHRA findings, licence suspension, or enforcement action
• Civil or criminal liability where negligence is proven

Despite regulatory controls, global reports indicate a rise in incidents involving falsified medicines.

Recent Examples

2023: Falsified Ozempic in the UK

The MHRA confirmed falsified Ozempic (semaglutide 1 mg) pens at two UK wholesalers, traced back to legitimate suppliers in Austria and Germany. No patients were harmed, but the case highlighted weaknesses even in regulated markets. Read more.

2024: Illegal Medicine Seizures in Ireland

The HPRA in Ireland seized over one million units of illegal medicines, with a spike in weight-loss drugs, underlining growing misuse and online trafficking. Read more.

2024: AI-Powered Enforcement on eBay

eBay, in partnership with the MHRA, blocked nearly two million illegal medicine listings using AI algorithms. This success story underscores the potential of collaboration and technology to strengthen supply chain security. Read more.

How Falsified Medicines Enter the Legal Supply Chain

A 2021 Council of Europe survey exposed serious gaps in tracking stolen, lost, or diverted medicines across member states. Many authorities lacked mandatory reporting systems or access to blacklists, and reporting was inconsistent. As a result, falsified or mishandled products could re-enter the legal supply chain undetected. Source: European Directorate for the Quality of Medicines & HealthCare.

Following the survey, the Council of Europe issued Recommendation CM/Rec (2024)3 in 2024, urging member states to make reporting thefts and losses mandatory, create centralised data-sharing systems, and improve cooperation across the supply chain. Source: EDQM.

The UK has required prompt investigation and reporting of missing stock since 2007 under the MHRA Green Guide, which mandates that all UK licence holders must promptly investigate any loss, theft, or unexplained disappearance of medicinal products. Where diversion or falsification is suspected, the incident must be reported to the MHRA via formal channels such as the Inspectorate mailbox or the Yellow Card Scheme. Reporting isn't optional – delayed or incomplete responses can lead to regulatory action or licence suspension.

Assuming everything is fine just because a supplier is licensed or has worked with you before, rather than continually verifying and monitoring, invites the risk of falsified medicines entering the legal supply chain. Common gaps include:

• Inadequate supplier qualification
• Lack of or incomplete due diligence checks
• Gaps in initial supplier and customer qualification
• Passive outsourced oversight
• Neglected requalification
• Not reporting suspected falsified medicines
• Not tracking, investigating, and reporting stock discrepancies
• Gaps in returns processes

Falsified Medicines Prevention: Essential Controls for Supply Chain Security

The following controls are essential to prevent falsified medicines from entering the legal supply chain:

• Robust supplier due diligence and ongoing bona fide checks
• Diligent oversight of outsourced activities
• Active monitoring for unusual transactions
• Systematic stock monitoring and trend analysis
• Vigilance in identifying unusual sales patterns
• Prompt investigation and reporting of missing stock
• Immediate reporting of suspected falsified medicines
• Ongoing monitoring of MHRA alerts and communications

Conclusion

Pharmaceutical supply chain security relies on established supplier and customer approval processes. However, relying solely on initial approvals is not enough. Criminals are becoming more sophisticated in their methods of introducing falsified medicines, making thorough initial due diligence and regular bona fide checks essential. Maintaining ongoing oversight, monitoring, and reporting is paramount for effective falsified medicines prevention.

Staying vigilant and continually strengthening processes – ensuring that every step from approval to regular review and prompt reporting – keeps the supply chain secure and protects patient safety.