Substandard and falsified medicines have become a global pandemic, impacting the safety of patients around the world. It is estimated that on average 10% of the world’s medicines are counterfeit, with peaks of up to 70% in developing countries. For anti-malaria and anti-tuberculosis drugs alone, counterfeiting is estimated to cause 700,000 deaths each year. In addition to patients, pharma companies are also impacted, suffering damage brand image, IP losses and unfair competition. For governments, fake medicines compromise national health care policies, impacting life expectancy and public confidence in the health care system. Fakes also fuel the parallel economy and may be exploited by organised crime.
For many years brand owners have addressed these challenges by employing a mix of overt, covert, and forensic security features to protect the product packaging. A variety of authentication technologies including labels, seals, and direct marking are deployed. In addition to these brand-protection measures, government authorities are increasingly introducing regulations for the circulation of medicines. These regulations typically require the use of anti-tamper devices (e.g. seals) and of serialization & traceability technology:
- Each drug must be marked with a unique 2D barcode including various data fields, such as a product code, the batch ID, the expiry date, and a serial number. This data must be electronically reported and stored in a national repository.
- In some cases, the movement of drugs in the distribution chain must be captured and reported in the repository by supply chain actors such as distributors, wholesalers, points of dispense. This may require “aggregation” i.e. the ability to link individual traded items to their logistic packages, such as cases and pallets.
- In many cases, each drug must be verified at the point of dispense by checking that the packaging has not been tampered with and that the 2D barcode is valid.
Compliance with these regulations is becoming mandatory in more and more markets, including the European Union, the USA, China, Brazil and Russia.
SICPA has developed a comprehensive set of brand protection and pharma serialization solutions that address all the regulatory requirements applicable to marketing authorisation holders, contract manufacturing / packaging organizations (CMOs / CPOs), importers and supply chain operators. Thanks to its modular and flexible approach, the solution addresses the different needs of small, medium and large producers in the most cost-effective way.