Sponsored: Transatlantic Alignment

Happy Martin Luther King day!  Today we have a special guest blog essay by Mark Davison of Blue Sphere Health in the U.K..   Mark is the author of the book, “Pharmaceutical Anti-Counterfeiting”, published by Wiley in 2011. – Dirk.

BPH.logo-lrg2Pharmaceutical traceability (in its various nuances of serialization, aggregation, track and trace, epedigree etc) has been proposed, debated, boosted and resisted for a very long time. The labyrinthine twists and turns have been examined in near real time on RxTrace and I won’t revisit them here. However, the passing of the Drug Quality and Security Act (DQSA) late last year opens a new chapter.  It means greater transatlantic clarity of future compliance requirements and (whether intentional or not) it also brings near synchrony of some key deadlines.


The initial serialisation compliance deadline of the DQSA, occurring four years after enactment, means that by late 2017 manufacturers must have pack coding and associated data management nailed down as routine processes.  This is likely to fall within weeks of the deadline imposed by the European Union’s Falsified Medicines Directive (FMD).  The situation in the EU is not quite as clear cut since some of the technical details of the FMD have still to be released in the form of a Delegated Act.

The Delegated Act is a supplement to the FMD which amongst other things will lay out the required data carrier specification for traceability. This is almost certain to be based on the GS1 numbering system and datamatrix format already in use by many manufacturers. The Delegated Act is expected to be published towards the end of this year. According to the FMD, manufacturers will then have three years to comply which brings us again to the fourth quarter of 2017.


By 4Q17 more than 800 million people in the EU and USA will be reliant on pharma’s ability to make and distribute accurately coded medicines. That’s without considering existing or pending traceability requirements in China, Brazil and elsewhere. Now is the time to put plans into action. Those who cheered when the California deadline of January 2015 was superseded by the DQSA timeline shouldn’t delay getting back to work. Your plans for finishing everything this year were probably unrealistic anyway. Now you have a chance to do it right within an achievable but shorter-than-you-think timeline.


As well as detailing the coding requirements for the EU, the Delegated Act will shed light on some other critical stuff mandated by the FMD such as tamper-evidence. Secure closure and unique coding of unit-of-sale packs are the twin pillars of the EU strategy. The theory goes that if pack integrity is maintained and the sealed pack is opened only by the patient then fewer code checks are needed en route. In fact, the model proposed by a multi-stakeholder consortium including the industry body EFPIA would reduce mandatory code checkpoints to just two: once by the manufacturer when the code is applied and once by the dispensing pharmacist (sometimes referred to as Point-of-Dispense Authentication, or PoD). The public-sector eTACT model takes a broadly similar approach but with additional emphasis on patient verification and internet sales.

However, don’t assume that FMD compliance is only about serialisation. Depending on your current pack portfolio, the requirement for additional tamper-evidence (new equipment, pack redesigns, regulatory submissions, revalidations etc) may end up costing you at least as much time and money as serialisation. Running Europe as a 51st state within your DQSA project won’t cut it.


Those of a gloomy persuasion will see the requirement for serialisation in two major economic regions at the same time as a curse. At Bluesphere our glasses are half full, and we think there are major opportunities in the challenges ahead. Pack coding is an enabler of “mobile Pharma” and personalised medicine.  We are at the early stages of a multi-faceted revolution that will disrupt our industry, destroying old business models and creating new ones.  Those who embrace the opportunity will thrive. Data from projects in the developing world show that alphanumeric and/or scannable pack codes are an ideal interface between product (your drug) and service (your added value after the product is dispensed). Combining these two elements leads to improved health outcomes. Better health is a good thing for patients. In this age of value-based pricing, being able to prove your drug made a difference in the real world might also mean a noticeable improvement to your bottom line.


The 800 million people I mentioned above are served by hundreds of thousands of pharmacies. Since pharmacists are the key control point for drug traceability systems, the efficient integration of pharmacies into DQSA and FMD systems will be critical. There are several potential roadblocks. Pharmacy point-of-sale software is a highly fragmented market not easily conducive to rapid standardisation. Many stores use barcode scanners which are not compatible with datamatrix codes and will need to be replaced. Some rural pharmacies don’t have the reliable broadband internet connection needed for real-time authentication. Discussion on industry forums and at conferences tends to focus on manufacturers’ coding obligations or on how to design the big-ticket IT components like databases, routing systems etc. But we should not underestimate the complexity and sheer grunt work of getting tens of thousands of drugstores on board over a relatively short timespan.  I suspect that governments or manufacturers may have to support and underwrite the process. Vendors who can provide scalable, secure and low-cost solutions to these issues will find a ready market.

The ocean of serialisation is easier to navigate now than it was three months ago, but there are still whirlpools and headwinds to divert or delay the unwary. Stay tuned to www.RxTrace.com and www.bluespherehealth.com and we’ll try to keep you moving forward.


2 thoughts on “Sponsored: Transatlantic Alignment”

  1. I think that 2014 is a crucial year. As the EU develops the FMD Delegated Acts, and as the US FDA come to terms with the practical implications of DQSA (hopefully leveraging some of the excellent work done by the California Board of Pharmacy) there is real scope to align expectations and thereby allow manufacturers to come up with a single model that will meet both US and UE requirements (albeit with some market specific variation).

    As PIC/S members, and with increasing cooperation between the US FDA and EU agencies the potential for coordination is there to be ceased – let’s hope that our regulators are up to the challenge of securing the supply chain at reasonable cost.

    Now if we could only get the Chinese SFDA on board…

    1. David,
      Well said. Regarding the China SFDA, I think as long as China remains a closed society we are not likely to see any real alignment with the rest of the world. China has made a few concessions to an open society over the last few decades, but here is one explanation for why they have struck their own path when it comes to pharma serialization. I am told by people who visit China that RxTrace.com is blocked by the government. That seems odd, but I’m sure it is just one of millions that are blocked in bulk. Intentionally blocking the free exchange of ideas will not lead to standardization…or modernization.


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