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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:
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.