Are you worried about the effect that the EU Falsified Medicines Directive and other regulations might have on your business? Do you know that you need to implement a securer supply chain, but just don’t know where to start? Read on for tips and advice from Ian Haynes at 3C Integrity Consulting, speaker at the FlyPharma Conference 2015.
Why is it so difficult to keep the pharma supply chain secure?
Keeping the pharma supply chain secure is a particular challenge because the rewards of illegal trade far outstrip those of other areas of criminal endeavour. Currently the detection of counterfeit products is difficult and, as the penalties are often small, counterfeiters do not fear prosecution.
What’s the most commonly held assumption about serialisation?
Whether it is the most commonly held assumption or not is difficult to say, but it is clear that many companies assume that serialisation is just about printing and reading codes, and that there is plenty of time to implement their serialisation programmes before major deadlines like the EU Falsified Medicines Directive (FMD) come around.
Do you see some companies struggling to implement anti-counterfeiting regulations? Why do you think this is?
Many companies are struggling with their implementations, and while there are many reasons for this, probably the most significant reason is a failure to identify the full scale and scope of their serialisation programmes in the early phases. This means that these projects are often developed with a narrow scope, designed with unrealistic expectations of the size of the undertaking, and thus – ultimately – set up for failure.
The early adopters have had the time to discover the full implications of serialisation, running their programmes in phases over multi-year implementations. Late entrants must identify the full scope from the start, and simultaneously deliver all aspects right first time in order to meet current and emerging requirements.
What is the best part of your job?
Having been involved in the protection of pharmaceutical products for almost a decade, it is very rewarding to see the FMD legislation emerge, as well as the work of European stakeholders leading to the European Medicines Verification System and finding recognition and official support. At the end of the day though, it is working to protect patients that gives me the most satisfaction.
Is there anything you find yourself repeating over and over to clients?
Certainly in the case of small and medium-sized pharma manufacturers, both brand owners and contract packers, the message we repeat over and over is that they should get started on their serialisation implementation programme before time runs out, and that they need to engage with their senior stakeholders and get buy-in from them (as well as sign-off of a realistic budget).
Are we likely to see a global serialisation programme in the near future?
As more and more markets are added to the list demanding serialisation – GS1 publish an excellent slide that graphically illustrates the mass of current and anticipated requirements – you could argue that we are already seeing a global programme roll out.
For many pharma companies, commentators have widely predicted that 80% of their products will be subject to serialisation requirements by 2018.
While requirements vary by market in approach, scope and timing, there is increasing alignment on key features: 2D data matrix codes as data carriers; coding based on the global GS1 standard; and data sharing with health authorities or along the supply chain. It is therefore possible to define a common sub-set of requirements and, consequently, the key elements of a company response that – when put in place – will allow compliance with all currently known and announced serialisation requirements.
Ian Haynes will be presenting his session Security Alert at FlyPharma this September, discussing the growing security challenges facing the supply chain and the regulations that you need to be aware of. Join us and register your seat at the conference now!
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