News
Four years of securing Europe from falsified medicines – How is it going in the Nordic region?
Kai Mjaanes, General manager of Nomvec in Norway, says that the Nordic countries cooperates well on the verification system.
– In Finland and Norway, we have the same system supplier, so among the Nordic countries we have the most meetings together with Finland. But we also have meetings together with the other countries in the Nordics. The pharmaceutical companies have products that are sold in several countries in the Nordics, and the pharmaceutical companies in the various countries cooperate, so it is natural that we talk together, says Mjaanes.
The system operates in 29 countries with 150 thousand users connected in Europe.
– The system is starting to become stable, and we now see that the number of false deviations is stabilizing at an acceptable level. Eventually we will see what role the verification system will play in a more digitized Europe. Perhaps it can be a building block for more functions, perhaps other needs will be solved by other systems and the verification system will have a more limited function, says Mjaanes.
Maija Gohlke, General Manager of the Finnish Medicines Verification Organisation (FiMVO), says that the cooperation between the various parties works well.
– All the major supply chain stakeholders are represented in FiMVO, either on the Board or in working groups. The cooperation is smooth, the Board works towards consensus. Our strategy focuses on system stability, preventing falsifications and building operational excellence.
– We’ve worked hard with supply chain IT providers and End Users to reduce the alert rate, and this has been successful. We’re well below the critical level with 0,02 percent for some time already. We have also made sure we have the right tools to provide great service to pharma companies and End Users, says Gohlke.
– What do you think will be the challenges for the system and developing the system in the time ahead?
– Change management and providing a technically sound system is one thing. We need to make sure that the whole EMVS is developed in the same direction and that EMVO and NMVOs share a common vision. I’m sure there will be many discussions on what to do with the system and how to best utilise it – discussions around this topic will certainly cause a lot of debate. We should not become complacent but move towards being better all the time, says Gohlke.
The General manager of e-Verifikation in Sweden (e-vis), Kristina von Sydow, says that the stabilization period for the FMD system ended on November 1st 2020 in Sweden.
– The strategy of a soft launch in Sweden was to let MAHs sort out the many data issues causing alerts instead of exposing the pharmacies to all the technical alerts. The soft launch was therefore only for end users – MAHs needed to react on all alerts. Some of the alerts categories were never in the soft launch and needed investigation from start – for example alerts due to inactive packs, says von Sydow.
As challenges ahead, she mentions the new Medical Device Directive, where medical equipment must be marked with a 2D code, which can quickly cause confusion.
– The completion of the verification system with alert management system is a challenge, but in the long run the efforts of having an integrated way for communication on alert investigation will benefit all stakeholders involved. Another challenge that is the new Medical Device Directive that prescribes mark up of medical devices with a 2D-code. There will be many mix ups on what to scan or not to scan, for FMD purposes.
– The development of the system, both from technical side and functionality side, is a challenge because of the distributed stakeholder model, with one system in each country. But we are also starting to see progress and coordination thanks to the approach of having a common Change Control Board for the whole EMVS, says von Sydow.
Tina Hou Marer, Director of the Danish Medicinal Verification Organization (DMVO), believes it is important to take the further development and use of the system into consideration.
– I think it is very important to look ahead, not just for a year or two – but in the longer term. Our view must be more strategic, by means of how the system must evolve in the coming years to remain fully operational and in compliance with the legislation. We must ask ourselves, what will be beneficial for our stakeholders, what can be the steps forward and how can we best support and assist our stakeholders and their business needs. Therefore, we must continue working closely together with our NMVO colleagues and EMVO to ensure that we are all well prepared for the needs in the future, both in terms of security, technology, and business. The Nordic recommendations for recall and withdrawn is an example of excellent collaboration, which contributes to a well-functioning EMVS. I believe that it is initiatives of this kind that we need going forward, and I would like to see a lot more of that in the future, says Hou Marer.
For Hou Marer it is important to maintain a good balance between the interests of all stakeholders, so that no one is favored and the NMVOs remain objective and constitute good sparring partners for all stakeholders.
– The most challenging part will most likely be to ensure a balance between the interests of all our stakeholders as some interests are conflicting, and our role is to remain neutral and find solutions which works for everyone, says Hou Marer.
Hjörleifur Thorarinsson, CEO of the Iceland Medicines Verification Organization (ICEMVO), talks about NMVS-Alerts as the notification management system, and what experiences they have so far made in Iceland.
– Harmonization with other verification system with regards to double decommissioning permissions and the necessary end-user training is also key. In 2023 ICEMVO plans to connect our alert management system to the new EMVO Alert Management System to further facilitate investigation of alerts in Iceland and across the whole EMVS. In Iceland, the information available in the 2D barcode is used by pharmacists to verify that correct medicine is being dispensed to patients. Additional benefits of the structure and network that has been established with EMVS will for sure be evident in the time ahead, says Thorarinsson.