Quality & use of medicines
Anti-falsification activities
Falsified medical products (medicines and medical devices) represent a serious threat to public health. The EDQM’s anti-falsification activities aim to foster international dialogue and co-operation, encourage expertise and information sharing, and develop tools, frameworks and strategies for risk prevention and harm mitigation. They are conducted mainly through the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH), its subordinate Committee of Experts on Minimising the Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED), and the OMCL Falsified Medicines Working Group. The EDQM also provides support to the Council of Europe MEDICRIME Convention and its Committee of the Parties.
Work programme
One of the highlights of the CD-P-PH/CMED’s work programme was a workshop for GMP/GDP/Pharmacy inspectors in June 2023 at the EDQM with participants from Austria, Germany and Switzerland. This was the 6th workshop of its kind, the previous five having taken place before the COVID pandemic. The goal was to raise awareness of signals which might indicate cases of falsification, in an interactive and hands-on way through real case scenarios.
Good progress was made throughout 2023 on the drafting of a guidance document on definitions related to the fight against falsified medicines.
The committee also worked on medical devices. A survey was conducted in 2022 and 2023 regarding different aspects of falsified medical devices and related fraudulent behaviour. The key outcomes were published in a visual report available on the EDQM web site (Work programme CD-P-PH/CMED).
Borderline products (i.e. cases in which it is not clear from the outset whether a given product is a medicine or another health product) represent a specific challenge. The Network on Borderline Products supported work on issues touching on the enforcement or supervision of legislation for borderline products. Several cases were discussed by the network and presented to the CD-P-PH, which is responsible for the network. A plenary meeting was organised in co-operation with Swissmedic in the spring of 2023 and an online meeting in November made it possible to elaborate the terms of reference for 2024-2025.
Communication with partners and stakeholders
Throughout 2023, representatives of the EDQM took part in the meetings of the EU Heads of Medicines Agencies’ Working Group of Enforcement Officers (HMA-WGEO) to strengthen co-operation.
The EDQM attended the plenary meetings of the MEDICRIME CoP and actively worked with its secretariat on aligning activities and in other fields where the CD-P-PH/CMED had projects underway.
An online meeting with stakeholders active in the field of falsified medical products and pharmaceutical care was organised jointly with the Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (CD-P-PH/PC).
Publications, databases and website
The EDQM’s Know-X database stores comprehensive information on individual cases of falsified medical products. The database enables health and law-enforcement authorities across Europe to share information and to act more rapidly in cases of suspect medical products (for instance via its “Rapid Alert” function that allows users to alert others to new cases in real time). The CD-P-PH/CMED and the OMCL Falsified Medicines Working Group work together to maintain the database and continue to work on improvements. They also co-operate on promoting the database and offer training to users.
More information is available on the EDQM web site (Anti-falsification activities).
