2017: Preparing for the Falsified Medicines Directive
Johannes Schoen, Supply Network Quality Management Anti-Counterfeitng, Boehringer Ingelheim speaks to Pharma IQ, following facilitating the "Anti-Counterfeiting: Falsified Medicines Directive and beyond" roundtable. Schoen discusses the outcomes of the roundtable and shares best practices for preparing for the Falsified Medicines Directive
We know the Falsified Medicines Directive (FMD) was released last year and we have been expecting the delegated acts for some time but where are we regarding the implementation of the directive at present?
J Schoen: One problem with the delegated act list, was that there were a lot of comments around it, but none of the delegated acts are final issues, so we are still waiting, like, for the GDPs, we are still waiting for the real final versions, and the Falsified Medicine Directive will become effective 2017, and there is a lot of work to do up to then, and so we are waiting for also the further implementing act to come, and one key thing is that all call for comments are taken really serious in responding to the authorities that they will have a sound industry opinion for really manageable regulations to come up.
What do you believe will be the outcome of the Falsified Medicines Directive, and what do you think are realistic timelines?
J Schoen: Hopefully a very safe distribution of pharmaceuticals to the patient, not only in 2017, but also before, and that the system is really reliable. I hope that the system will serve an example for other regions in the world; that other countries are really joining or copying the system, because I think it's really, really powerful, and will guarantee that through serialisation and use of end of points, this will really guarantee that only original material will be delivered to the patient.
What are your recommendations for those still preparing for the Falsified Medicines Directive?
J Schoen: Ask your peers, join conferences, talk to other pharmacos. Talk to vendors for equipment, for services. The better we are liaising the better it is, and we have some pilots ongoing at the moment, one in Germany, for instance. Get information from the people involved there, and there are some other alliances, like the Alliance for Safe Online Pharmacy in Europe, and everybody can inform himself there on the websites, or even have a part, have stake in that, and this would be my recommendation. Be active, be proactive in that, and not wait until the final thing is on the table.
At Cool Chain Logistics Europe, you facilitated the Anti-counterfeiting Falsified Medicines Directive and Beyond roundtable, how did this go?
J Schoen: This was a brilliant discussion, very lively, but it also showed that the knowledge of the people is quite limited now, and we still have to do a lot educating industry, but also, it seems to me, educating other stakeholders, like pharmacists, like patients, like patients’ organisations, would be also key.
What was the hottest topic that came up in the discussion?
J Schoen: The hottest topic, which came up yesterday, it was about the serialisation, and how can it be safe, and how can it be implemented, and whether the data is not too huge, but this is only due to lack of knowledge, because the system is well, or the proposal is well designed, and we hope that the European Commission will also follow the FPR proposal in this way.
What are your predictions for the next 5 years regarding the Falsified Medicines Directive and serialisation?
J Schoen: Yes, serialisation will come, in Europe, and I'm pretty sure that once it is proven that it is effective in Europe, other countries will take up very, very quickly in the surroundings of Europe, so it will grow. Hopefully, also, there will be a certain alignment between the US and the EU that the US will also take up some bits and pieces, and that we will have a common global system. This will be more a wish than really a prediction.
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Interview conducted by Andrea Charles.
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