We all should ask ourselves why it has been so hard to reach an agreement between EU member states for drafting a common framework to tackling counterfeit medicines in the EU. In case you have not noticed, we finally reach the draft version after years of working on it to put forward this piece of legislation.
Still, we have now 3 more years ahead to finally take effect. In EU we have a common currency (or fixed rate currency linked to Euro), I can travel between 28 different countries without boundaries, I can even receive instructions from EU Commission regarding on how my country allocates its annual budgets. Still, I have not been able to timely find a way to put efforts into fighting the occurrence of counterfeit medicines or medical devices.
So what is the challenge?
Is the problem due to the lack of political commitment or strategic vision? Is the pharmaceutical lobby delaying this process? It is the inability to set a common language or perhaps because each country want to have their own system and end up to be an isolated island?
Well, I believe that a bit of all above have put us in this current anxious situation. And what is interesting to see is that for most of these challenges there are already successful and feasible answers.
But before we approach the traceability issue (yes, let’s be honest, when we talk about the counterfeit we all think in traceability) we should focus first on the quality of the master data of medical items (and how much it costs to stakeholders to obtain it).
Why should a stakeholder be concerned about where a certain item came from if it does not know effectively what it is? The equation should be this:
Counterfeit Mitigation = quality master data + traceability data
And that would have a huge impact in the supply chain especially at a B2B level. So two measures should be followed:
1. Adopt a common language that allows the exchange of information between all key supply chain players;
2. Choose proven technologies to support the exchange of this information at both local and global level.
If we look at the role that GS1 healthcare standards have now in the supply chain we immediately realize that the required common language is indeed GS1 standards. We might argue that in EU we also have CEN working in standards and harmonization, but looking to what GS1 is doing – and I apologize for the cliché – we wonder why the need of “reinventing the wheel”.
Regarding technology and especially with globalization we cannot only think at EU level. So, once again GS1 provide us the Global Digital Synchronization Network (GDSN) which, by the way it has been recognized by USFDA, as a reliable source to feed USFDA database (at least medical devices for now). I trust this is a clear evidence that a feasible and sustainable option is there readily available to be adopted.
Having sorted out the challenge of quality master data, traceability issue comes along. And once again it requires:
1. Common language – how should traceability information be communicated between all actors within supply chain until it reaches the end-user (in this case, the patient)?
2. And again, technology to be chosen….
In theory only good news should come up. GS1 standards have the ability to support it. So far countries such as Turkey and Saudi Arabia decided to make it mandatory (yes…mandatory). Plus, technology is already there ready to be used. Of course it needs to be clear to all stakeholders who is going to have access to the traceability data and to be accountable for it. Also, as long as traceability matters, the above equation (‘Counterfeit Mitigation’) should not be forgotten that integration between master data and traceability systems is critical to create the necessary synergies.
But if in theory these are good news, pragmatically in EU zone they are not. What is need is that each EU regulatory agency start to share a common and strategic vision about it and change the culture of “what I am doing is better than the others”.
Bottom line, should we be happy that EU draft framework is out there to be finalized and being looking forward for 2018? My opinion is: always celebrate achievements. Just make sure you celebrate the right ones, since in the meantime the truth is that the guarantee of patient safety is in fact still postponed for 2018. Perhaps if we listen to GS1 the future could be near.
Original article published on LinkedIn on 13th october 2015.