The CMO Serialization Threat

The serialization race has begun. Worldwide, countries are implementing rules for improving the security of medical supplies – and serialization has become the weapon of choice for fighting counterfeiters and fraudsters. Some countries are even going further by aggregating serialization with product traceability to control their medical supply chains. By 2020, we should expect approximately 90 percent of prescribed (Rx) medications worldwide to bear a serial number.

Serialization poses challenges to all stakeholders in the medicines supply chain, but I believe that there are some unique challenges for contract packers in particular. They will need to be equipped with adequate solutions to meet international requirements, but must also be flexible enough to meet all of the (very) different requirements of their customers.

Looking at the current situation in Europe and the US, with serialization deadlines fast approaching, I believe the majority of contract manufacturing organizations (CMOs) are not ready. When discussing the situation with CMOs, they often tell me that they have asked their customers for their serialization requirements, but are not getting sufficient feedback. Additionally, they think that modifications to their machines and infrastructure can be completed within just a few months!

Are CMOs using the lack of feedback and general ignorance from customers of what needs to be done as an excuse to not think too deeply on the issue or do they honestly believe that the challenge isn’t that great? A significant percentage of Rx medicine production is covered by CMOs. And the deadline for serialization is well known. CMOs – and their customers – need to prepare now.

If I sit and try to think like a CMO, I can see a few choices before me...

• Invite my customers to help plan a joint strategy, define budgets and set milestones.
• Invest in a track-and-trace system – and hope that I have made the right choice and that some of my customers will pay for it.
• Give up working in the pharma industry!

Serialization will add cost to the bottom line – a fact that must be accepted. Perhaps through optimizing the system, some of the costs will decrease later, but that is another subject for another day. If CMOs and their customers are caught between two stools over when they should make a move, they need to be aware that time is critical and they really need to get moving – or both will suffer the consequences of being late starters.

My appeal to CMOs is for them to ensure that they remain in the game as deadlines approach. They must get in touch with their customers and assess potential track-and-trace vendors. Make sure that you treat this as a priority and not just a sideline project; it requires a dedicated full-time team to run a serialization project and to exploit serialization as a competitive opportunity.

I also have an appeal for pharmaceutical companies: you must provide the necessary support early enough by ensuring that your CMO partners understand the needs of the legislation – and that you meet your own specific needs too. As the deadline approaches, it is likely that the CMO market will consolidate as unprepared CMOs end up pushed out of the market. And by then, it will be too late for pharma companies to register their products with another CMO. For that reason, it is in the core interest of the pharma industry to support their CMOs in defining the right strategy.

As the author Douglas Adams is reported to have said, “I love deadlines. I like the whooshing sound they make as they fly by”. Don’t let that whooshing sound be the last thing your company hears...