TIME TO ACT: THE VITAL STEPS CMOS
SHOULD BE TAKING
The European Stakeholder Model (ESM) suggests that four to
five years is a realistic timeframe to establish and implement a robust solution. So, with just over a year until the new enforcement
date in the U.S. and then the EU deadline shortly afterwards, a
lot of pharmaceutical companies are now looking for alternative
ways to meet serialization requirements.
Outsourcing serialization to a third-party provider is becoming increasingly popular. Selecting a contract manufacturing
organization (CMO) that is well-prepared for serialization and
potentially already delivering these to services to some territories will no doubt speed up the time it takes to ensure a suitable
solution is in place, as well as mitigate the need for substantial
upfront investment and extensive staff training.
Cost is still a huge concern for a lot of industry players, particularly small and mid-sized pharmaceutical companies. The initial upfront investment required to equip packaging lines and develop an end-to-end solution is substantial and as a result many
have found outsourcing to partners who can build the cost into
new or existing supply agreements a more viable option.
The delay to the enforcement deadline should not be a reason to become complacent about the matter at hand. For those
CMOs who are just starting out on their serialization journey,
the time to act is now. Serialization presents a huge opportunity
for contract partners and those who can offer a tried and tested
solution combined with a comprehensive knowledge of market
requirements will find themselves at the forefront of the industry.
A UNIQUE OPPORTUNITY
While the majority of CMOs are still in the early stages of developing and implementing serialization,1 those who have adopted a proactive approach are now in the ideal position to offer
pharmaceutical companies an alternative to investing in internal
resource to meet serialization requirements.
For those who were ready for the serialization deadlines, this
delay may seem unfair. While the disruption to their deployment
and delivery plan will be minimal, the extra time will mean a de-
lay in receiving payment fees from customers to cover the costs
of equipping its lines and implementing a wider solution. Nev-
ertheless, these delays should be a positive thing as those who
have spent considerable time developing a solution now have the
luxury of being able to further test their lines to minimize the risk
of any mistakes once serialization becomes compulsory.
In addition, CMOs who are already on track to meet the dead-
lines can add further value to their offering by exploring the wider
business benefits that can be achieved because of these new sys-
tems and processes, such as improved operational efficiencies.
While patient safety must be the focus of track and trace solutions, there is also a whole host of other opportunities that can be
gained by introducing serialization. For example, implementing a
solution that requires such a high level of data management and
exchange capability could help to improve data transfer in other
areas of the business.
End-to-end supply chain visibility could also offer a host of
benefits beyond eradicating counterfeit medicines from the market. Greater visibility will help to improve order management and
in turn reduce the amount of medicines being wasted, as well as
allowing companies to spot any potential supply shortages before
they happen. It can also make the logistics surrounding product
recalls simpler. For example, if a certain batch has been exposed
to the wrong conditions, a supplier can easily identify exactly
which products need to be recalled, even after they have reached
the market, and ensure all the effected drugs are accounted for.
Serialization has been gravely underestimated by a lot of pharmaceutical companies and CMOs meaning many simply aren’t in a
position to implement a suitable solution in time for the deadlines.
As a result, well-prepared CMOs are now ideally placed to offer
an outsourced serialization solution. The delays to the DSCSA enforcement should be taken as a valuable lesson by the industry. It’s
now imperative that all members of the supply chain act now to
help ensure full compliance and avoid any future delays. CP
1. NEXUS 17 polls, TraceLink, Barcelona, June 2017
ERIK HAEFFLER is the Vice President of Manufacturing Services and the
Head of CSR at Recipharm. He is responsible for the group’s sustainability
work, as well as its focus on operational and commercial excellence. As part
of his role, Erik is continuously developing a model for working with multi-site
projects and is accountable for operations development across the company,
including elements such as project management resources, corporate IS and
project/product sourcing decisions.
“While patient safety must be the focus of track and trace solutions,
there is also a host of other opportunities that can be gained by introducing
serialization. For example, implementing a solution that requires such a high
level of data management and exchange capability could help to improve data
transfer in other areas of the business.”