Organised by the FIP SIG on Analytical Sciences and Pharmaceutical Quality in collaboration with FIP’s Community Pharmacy Section & SIG on Regulatory Sciences & FIPEd & IPSF & YPG
ChairsMiranda Sertić, University of Zagreb, Croatia and Filipa Ferreira, Hovione FarmaCiencia, Portugal
The term fake or ‘counterfeit’ has been widely used to describe falsified, unlicensed, falsely packaged, stolen and substandard medical products. Counterfeit medicines is an ever-growing threat to global health. Although the highest prevalence of counterfeit medicines is in Asia and Africa, counterfeit medicines are found in nearly every country of the world, and in all therapeutic areas. According to industry estimates, counterfeit pharmaceuticals trade is worth 150-200 billion euros annually and rising. One of the biggest challenges in fighting this public health threat is that many people are not aware of how to identify counterfeit medicines and the risks that they pose.
Many efforts are being put into the fighting the counterfeits. General education and knowledge of the dangers are essential to addressing counterfeit medicines. All stakeholders across the supply chain should receive sufficient education on what they can do if they suspect a medicine to be counterfeit. Also, technology is enabling us to ensure quality medicines and their distribution to the right patient at the right time.
Tremendous efforts have been made globally in the use of robotics, artificial intelligence, blockchain and serialization to reduce the number of falsified medicines. On another note, although pharmaceutical globalization has not been followed by worldwide strengthening and harmonization of regulatory systems, significant legislative efforts have been made in some regions to curb the menace of counterfeit medicines.
The scourge of medication counterfeiting is global in reach and effect. The increase in the falsification of extremely expensive biotechnologically produced APIs, lifestyle medication, traditional herbal medicines and dietary supplements in industrialized parts of the globe indicates that this is no longer a problem exclusively limited to low- and middle-income countries.
This session aims to reflect on global effort to build a consensus on the different terminologies and definitions of such pharmaceutical products, its global distribution and consequences to the patient’s health, identifying the modern technological weapons and existing regulation that we have to fight them.
- Overview of the problem: Worldwide distribution, impact on public health and factors facilitating counterfeiting
Pernette Bourdillon Esteve, World Health Organization, Switzerland
- ”Track and trace” legislation – Introducing serialization to combat illegal drugs in the pharmaceutical supply chain
Stefan Artlich, Bayer, Germany
- A case study in the fight against counterfeit medicines: An example from Kenya
Mercy Maina, Moi University/AMPATH, Kenya
- Novel digital technology enablers to counter the counterfeit medicines
Renato Cataldo, American Pharmacists Association, USA
- Q&A and audience interaction
At the end of this session, participants will be able to:
1. Define the terminology around counterfeit medicine and why it poses a threat to for personal and public health
2. Describe different legal and regulatory aspects of counterfeit medicines
3. List advanced technologies available to combat the global counterfeit medicines
4. Specify actions that are being done by global organizations to combat falsified medicines
Type of session: Knowledge-based