In the past decade, Europe has seen a number of major pan-European cases where medicines have disappeared from the legal supply chain, and then been manipulated or tampered with before being reintroduced into it. This clearly presents a risk for public health.
Follow-up enquiries and discussions on a European level in the wake of these cases identified several gaps of concern. In particular, thefts are rarely reported to the health regulatory authorities in charge of the medicines supply chain and responsible for their safety and quality: theft being a criminal matter, if reported at all, these cases would be notified to the law-enforcement authorities, and sometimes only to the regional law-enforcement offices. Other weaknesses within the regulatory framework were also identified and it has become clear that these serious issues were not isolated events.
However, as data collection is not centralised and reporting is fragmented, the scale of the problem is still widely underestimated. The situation is compounded by a lack of awareness and co-operation between relevant stakeholders that reduces or prevents effective multi-agency responses, rendering preventive action impossible.
The Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED) has drafted a recommendation that aims to address these issues. The recommendation calls for member states to create and deploy suitable frameworks and systems for reporting, information sharing and data collection, preferably under the guidance of the national competent authority for medicines. The recommendation further emphasises the need for co-operation: addressing and preventing disappearances of medicines cannot be successful if not addressed in co-operation with law-enforcement authorities and other stakeholders.
Recommendation CM/Rec(2024)3 of the Committee of Ministers to member States on reporting of disappearances of medicinal products for human and veterinary use from the legal supply chain was adopted by the Council of Europe Committee of Ministers on 10 April 2024.