Mark Hammond, Commercial Director, Aesica
A: With serialization legislation already enforced in markets such as Brazil and China, and set to be fully enforced in the EU by February 2019, we’ve seen a very varied state of preparedness for serialization across the CMO sector.
The ability to support drug companies to meet this complex regulatory packaging challenge appears to depend on the size of the CMO, the customers it serves and regions that those customers supply.
Serialization is complex and, with different country legislations having different requirements, serialization systems need to be configurable to be able to deliver what the customer needs. CMOs are at the service of the pharmaceutical customer, who determines the scope of support they wish the CMO to take on, whether it’s external reporting requirements, artwork services or managing the whole process.
At Aesica, we have fully implemented a comprehensive serialization solution across all our packaging sites and are continuing to invest to ensure that our systems have the flexibility to support the various needs of our customers.
Ultimately, it will be down to the specific business strategy of both drug companies and CMOs as to how they decide to meet the regulatory
serialization demands. However, flexibility and a close relationship
will underpin success.
Natalie Landrito, Marketing Director, STEQ America
A: STEQ America works with companies across all these sectors in addressing this from a general perspective — it’s a serious problem. You can have counterfeiters in other industries and theft in various areas of a product supply chain, but in the pharmaceutical industry, you’re ultimately risking the health and lives of patients.
It’s essential to keep up with serialization because it’s only going to continue to grow and become even more elaborate and precise (replicating products and labels), as there’s a huge incentive for counterfeiters to duplicate original products for high margin profits. Currently the black market for counterfeited drugs amounts to over $75 billion annually. Not only do falsely labeled medicines with incorrect or poor-quality ingredients have a direct impact on reputable pharmaceutical companies, but even worse, they impact people’s lives and health. Furthermore, there is the added complication that it’s almost impossible to trace whether a patient’s adverse side effect came from an approved drug on the market or one from illegitimate business.
More work needs to be done by pharmaceutical companies to prepare for the imminent change of legislation by national and international regulatory bodies. There needs to be a collective and uniform approach by everyone — scientists, manufacturers and packaging companies — in order to establish systems that comply with the upcoming regulations.
Chris Howell, Senior Director, Global Engineering and Technology, Patheon
A: Patheon is a global contract drug development and manufacturing
organization. As such, we work with a wide variety of brand-owner organizations from large pharma through small virtual companies. The state of brand-owner engagement and awareness varies across this range. On one end, some
large companies have developed detailed specifications for their serialization
CMOs and are driving engagement. On the other end, smaller virtual companies are seeking support to achieve basic understanding.
As for contract organizations, Patheon feels it is well positioned to meet client needs for the various regulatory markets. At some sites, we’re already serializing for early-market needs such as China and South Korea. There are certainly other CMOs who are also well prepared, but the general perception is that many CMOs are just beginning to engage in planning and execution. There appears to be some market concern that a number of CMOs will not be ready.