National Verification Systems: NMVO’s share what they’ve learned so far with FMD
We hear insights from Slovenia, Switzerland and Norway about the compliance learning curve post serialization
European Union’s Falsified Medicines Directive (EU FMD) has been enacted since February and all of Europe’s pharma supply chain members must comply with its mandates.
Under EU FMD, Marketing Authorisation Holders (MAHs) upload master data and serialisation data for their medicines to the EU Hub; the Hub then routes this information to one or more National Medicines Verification Systems (NMVS) where the product pack is to be sold. National Systems, run by a National Medicines Verification Organization (NMVO) in each EU country, provide the platform and the means for wholesalers, hospitals, and pharmacies to verify the authenticity of physical products against this data.
Three months in and EU’s NMVOs are busy fulfilling their functional role in compliance and working to put into practice the law’s intended drug supply chain security outcomes. Here, we share the insights of Mitja Pirman of Slovenia, Nicolas Florin of Switzerland, and Kai Mjaanes from Norway, about their particular NMVOs and the compliance learning curve so far. The panelists are slated to share their experiences in the afternoon breakout session “National Perspectives: What We’ve Learned from EU FMD” at FutureLink Barcelona, June 12.
The FutureLink panelists represent the diversity of Europe’s National Systems operatives and their comments and insights shed light on the similarities as well as the differences in their operations, as well as lessons learned post-FMD.
EMVO, NMVO, FMD: Untangling the alphabet
EMVO technology suppliers were thoroughly assessed to deliver the serialized data exchange, interoperability and drug supply chain security FMD is seeking to achieve. Known as the blueprint model, EMVO selected two primary software providers, SolidSoft and Arvato, for NMVOs to build their national systems; all countries have opted to use a blueprint provider since the recommendation.
Since the law’s start date, the general consensus of the panelists is that there is still plenty of work to be done and that for the most part, the whole European Medicines Verification System (EMVS) is now experiencing a period of stabilization. Nevertheless, the group agrees that there are still “many things to figure out,” as well as the need to work closely together to realize the industry’s and regulator’s vision of technically competent compliance.
Be on alert for falsified alerts
Feedback from the initial months of compliance is pointing to issues related to the quality of data entered into the systems and its effects. In the list of “growing pains,” handling falsified alerts tops the list and users say they did not anticipate they would have to deal with so many so soon. Fortunately, it is being recognized that a large portion of these false alerts are due to data entry problems rather than malfeasance and actual falsified data.
Kai Mjaanes, NOMVEC AS
Norway’s NMVO, NOMVEC, adopted Arvato’s blueprint system. And although NOMVEC’s Kai Mjaanes was not assigned to his post at the time the platform was specified, he notes that, “at the time there were three potential system suppliers courting the NMVOs. Arvato had been co-operating with the German NMVO for some time, and that experience was a contributing factor in the decision-making process. Ultimately, Norway was one of the first NMVOs to choose Arvato as the system provider.”
“In Norway,” explains Mjaanes, “we have all 941 pharmacies connected to the system, including about 11 wholesalers out of almost 200 now registered.” Mjaanes says most of the remaining ones do not handle prescription human drugs, so NOMVEC is not expecting many more to connect to Norway’s national system.
Hospitals expected to connect this summer
What about Norway’s hospitals? “These institutions,” says Mjaanes, “are working on implementing their systems and are expected to connect in June.” Mjaanes explains that NOMVEC is working closely with all end-users, the industry and the National Competent Authorities (NCA), noting “This has been a priority, and because we have worked together we have been able to solve connecting problems very efficiently.”
All pharmacies are connected through the same system, concludes Mjaanes, “so on the positive side we can work effectively to connect pharmacies. But on the flip side, any problems with the pharmacy system affects all pharmacy end-users.”
Mitja Pirman, Slovenia
Like NOMVEC, Slovenia’s NMVO administrators were looking to its neighbours for advice and implementation guidance. Unlike Norway, Slovenia chose to implement the SolidSoft platform to assimilate best practices and flatten the learning curve.
“Slovenia is one of the 12 countries that cooperates with SolidSoft,” says Mitja Pirman, a top director for his country’s NMVO, “and uses this provider for its National Medicines Verification System (NMVS).” In order to speed up progress in the development phase, Pirman explains the countries organized a joint task force to foster closer cooperation and share the workload, knowledge, ideas, resources “and even the strategic aspects of our relationship with the blueprint supplier and other stakeholders.”
With such collaboration the whole process was made better says Pirman: “We significantly increased speed and quality of the deliverables.” However, Pirman notes that after the first three months of the operational phase, “there are still many open issues in the overall performance of the EMVS and end-user systems,” but, he notes positively, “stakeholders are working hard on solving those issues and stabilizing the system.”
According to Pirman, the coalition represents approximately 18,000 end users obliged to connect to national system and perform medicines verification in the 12 countries using the SolidSoft (SSR) blueprint system for compliance and interoperability.
“Slovenia, as one of the smaller markets,” notes Pirman, “has 340 pharmacies, 20 wholesalers and 30 hospitals and medical centres connected to the blueprint system.” There are, he explains, over 200 MAHs uploading data to the system. Implementation has not gone without challenges, says Pirman. “IT software providers of end-user information systems faced their biggest challenge; properly integrating their solutions within the blueprint system.”
Besides issues developing appropriate robust GS1 barcode parsers and application program interfaces (APIs) says Pirman, problems did arise implementing the hardware. More specifically, explains Pirman, “integrators were having trouble accurately setting up the many different 2D barcode scanners that are specifiable and in use at dispensing locations.”
Nicolas Florin, Switzerland
“Because of its sovereignty,” Switzerland’s Nicolas Florin explains, “EU FMD does not apply at all to Switzerland.” Nevertheless, Switzerland is playing ball with EU regulation. According to Florin, his country has ratified the Medicrime Convention and has prepared its own law accordingly.
The law, explains Florin, takes on most of the principles of the EU FMD, “except the fact that applying the safety features is voluntary for the industry and decommissioning is voluntary for end users.” Currently, says Florin, Swiss authorities are working on an ordinance that will go through a period of public consultation seeking commentary from the country’s primary stakeholders. “Stakeholders, in particular the industry,” Florin notes, “are in favour of a mandatory application of the law.” Law and ordinance are likely to become effective sometime in 2020.
Currently, says Florin, 81 pharmaceutical companies participate on a voluntary basis with Switzerland’s NMVO based in Liechtenstein (LiMVO). Florin says these companies represent about 74 million of the 100 million packs the system might encounter.
Switzerland joins the EMVO party
Although prior to the law’s enactment there was some speculation the Swiss might not join the party, Liechtenstein, as an EEA country, joined EMVO last February, via LiMVO. Florin explains that the NMVO for Switzerland and Liechtenstein is attached to the EU-Hub and running productively since then.
One of the more interesting aspects of Switzerland’s journey to EU FMD collaboration is that users have been applying to use the system even though they’re not legally bound to do so at this time.
“Beside the arguments on improving patient safety,” notes Florin, “we put a lot of emphasis on the fact that products are now marked with the data matrix code, a data carrier that contains much more than just simple product code.” Florin points out that the automated extraction of the expiry date and lot number have the potential to dramatically improve the value chain, from manufacturing to patient adherence. “There are positive impacts possible at all levels of the supply chain for partners,” Florin declares.
“So far, only the consumer packaged goods (CPG) industry has executed on a worldwide standard to identify over 95% of the products in the market (GS1 GTIN and EAN-13 1D-barcode),” explains Florin. “The healthcare industry is about to do better, as medicines and medical devices are going to apply not only the GS1 GTIN, but also the expiry and lot number in a 2D GS1 data matrix. This opens a new perspective to all the partners in the supply chain.”
National Blueprints and FMD: The means to more positive and business-friendly ends
As the EU FMD continues to bring new security to the pharma supply chain in Europe, the learning curve should taper off. Practical implementation continues and the supply chain’s response is evolving. Future opportunities resulting from serialized data will continue to be realized by the industry in the form of enhanced business value.