An Overview of Russia’s Looming Drug Serialization Law
By Marc Blekkink, Managing Partner, Movilitas.Cloud
Pharmaceutical companies selling into Russia are facing a looming deadline. As of January 1, 2020, any new medication released after this date must comply with Russia’s Federal Law No. 425-FZ. It dictates the requirements of drug serialization that manufacturers must meet. The goal of this regulation, as with others put forth in the EU and Asia, is to reduce the occurrence of counterfeit medications that could affect patient safety. The pharmaceutical industry has found this regulation difficult to meet based on complex requirements, manual processes and the fact that some details have yet to be finalized. Meeting the challenge requires a different approach to the technology solutions that stakeholders implemented for EU and other countries’ regulations. Stakeholders must gather more key data and communicate with two different Russian systems.
First, let’s provide some background on why the regulations started (or were strengthened). Due to demand or the desire to gain a larger profit, there are falsified, substandard, unlicensed and unregistered medicines on the market. The World Health Organization notes “No countries remain untouched by this issue — from North America and Europe through to sub-Saharan Africa, South East Asia, and Latin America. What was once considered a problem limited to developing and low-income countries has now become an issue for all.” In addition, the International Federation of Pharmaceutical Manufacturers & Associations shared that the Pharmaceutical Security Institute (PSI) documented a 34% increase in “counterfeit incidents” between 2014 and 2015. Fake life sciences isn’t only about the bottom line but patient safety as well. Ineffective treatments can have harmful, and even deadly, consequences.
As a result, stakeholders in the pharmaceutical supply chain must comply with various regulatory systems throughout the world that intend to stem the flow of counterfeit medication. The EU’s Falsified Medicines Directive (EU FMD) took effect in February 2019. It mandates that specified prescription and free sold medicines sold in the EU have tamper-evident features and a unique 2D barcode identifier that is scanned at various stops in the supply chain. Other countries are in the process of implementing similar regulations such as Malaysia and Indonesia working to establish centralized full drug traceability systems after 2020.
Russia, however, is taking a stricter approach to track and trace by requiring a cryptographic key. This step encrypts the original serial numbers generated by the manufacturer. Therefore, technology used in compliance solutions must be able to handle the longer codes from data exchange to aggregation. The law also specifies 50+ transactions must be monitored and reported on from manufacturing to dispensary.
The cryptographic key is requested from the Russian OMS for each order which may contain multiple products. The drug expiration period is currently in discussion and revolves around (de)commissioned product serial numbers that expire after 180 days and then must be destroyed. However, no official decision has been made at the publication of this blog. In addition, the reports, which must be encrypted and signed, are uploaded to the MDLP. If you are not using SAP ICH, this process is manual. However, a supplementary solution can enable communication between SAP ATTP and the Russian MDLP system for message processing and retention.
While the pharmaceutical industry and other stakeholders are pushing for an extension to the current deadline (which was already moved from 2019), they continue to move forward with starting their pilot tests in the fall of 2019. Already some issues have popped up such as how to manage the 180-day expiration of medications to procuring signed reports to aggregating the data. Therefore, the Russian drug serialization regulation can be seen complex to solve. In the end, however, these rules do work as was recently seen in the EU when a “falsified batch of Roche’s cancer drug Avastin has been discovered by a wholesaler in the Netherlands…[it] came to light when a wholesaler scanned a box in the context of the new system of safety features.”
If you are using SAP ATTP or plan to use SAP ATTP and want to get more information on how Movilitas can help you comply with the Russian law, download our Movilitas.Cloud Russian MDLP solution brief here and learn what benefits it offers for Russian compliance.