Pharma serialization snapshot: Russia

As the pilot phase for Russia’s medicines traceability system draws to a close, we take a fresh look at the requirements and progress towards a proposed 100 per cent implementation date of January 1, 2019. (Now January 1, 2020 - see here)

About the market: Russia is in the midst of an economic recovery after a recession in 2015-2016 that has returned the market to its former position as a key growth opportunity for the pharma industry, with pharmaceutical sales expected to swell from an estimated $21bn this year to $28.5bn in 2021, according to BMI Research data. There are some causes for reservation for overseas producers however, including a drive to stimulate domestic production that is leading to increased state control in the pharma market and – in at least one case – a monopoly position for Russian firms. For example, state-owned drugmaker Natsimbio was awarded a monopoly on supplying drugs to the country’s prison service earlier this year. The government aims to increase the market share of domestic producers from 27 per cent to 50 per cent by 2020, according to GlobalData.

Medicine traceability model: Russia’s labelling system for medicinal products is intended to tackle a number of supply chain issues, including not only the protection of consumers from substandard, falsified drugs but also providing data that can be used to avoid inefficiency in healthcare and provide cost-savings, monitoring the use and cost of medicines and the management of medicinal product supplies.  The system involves applying unique serialized identification codes to drug products, and capturing and reporting to a central repository key events associated with those products as they move through the supply chain.

A pilot programme was proposed last October and signed into law at the end of January, and is due to come to a close on December 31. To date 37 pharma manufacturers, eight distributors and more than 300 pharmacies and hospitals have joined in the pilot (a list is available here), which is testing data exchange processes for 50 drugs as they pass through the supply chain, according to a recent status update from Deloitte and Movilitas. The key requirements are serialization (via a 2D data matrix code on secondary packaging) and aggregation of medicines (choice of three 2D code types) on shipping units such as boxes and pallets for drugs produced in Russia and abroad, and reporting on each stage of medicines circulation from manufacturer to the sale to pharmacy/hospital or disposal.

Commenting on the proposals, Iiro Jantunen of Servicepoint Oy told SecuringIndustry.com that an obvious difference of the Russian pharmaceutical track and trace plan to the EU system is the high level what they are trying to achieve. “In Russia, track and trace is not only about following the serial numbers through the logistics chain but for visibility on use, storage levels, bottlenecks, pricing and age of products that the government officials are going to get. The full track and trace requires aggregation, and the aggregation data should be sent to the government data repository, the FGIS-MDLP,” he tells us.

Smaller manufacturers have been taken into account, he notes, as in addition to the semi-automatic data upload system, there is a web interface available, which should be sufficient for small-scale producers. “This is again a difference to the European system, as the federal system provides a supposedly cheap alternative to the small producers,” says Jantunen, although he notes the investment in systems to assign and print serial numbers – as well as adding tamper-evidence (if the product requires one) - is of course still left to the manufacturer.

Future developments: The proposed mandatory compliance date for 100 per cent of medicines distributed within Russia is in just over a year – January 1, 2019 according to amendments to the legislation approved by the Russian parliament in November and due for a second reading this month – although there are already discussions about a possible extension to the deadline driven by smaller drugmakers. There have also been proposals for a phased implementation which would see the deadline for some medicine categories – for example high-cost drugs for haemophilia and multiple sclerosis – brought forward.