Crackdown on falsified medicines
Falsified medicines pose a threat to patient safety. A new system will prevent falsified medicines from reaching the distribution chain.
The falsified medicines business is worth billions globally. The illegal medicines business is rife on the grey market, but falsified medicines may also occasionally find their way into the legal distribution chain.
“In the legal distribution chain falsified medicines are usually detected at the wholesale stage or at healthcare units before the medicines have been distributed to patients. However, we do know of European cases where a falsified medicine has reached a patient via the legal distribution chain,” says Maija Gohlke-Kokkonen, Senior Advisor at Pharma Industry Finland.
The EU wants to prevent falsified medicines from entering legal distribution chains, which will improve patient safety. The Falsified Medicines Directive entered into force in 2011. A delegated Regulation complementing the Directive was published in February this year. The Regulation defines the medicines verification system that is required to be operational in February 2019.
“The purpose of the medicines verification system is to protect consumers from falsified medicines in the legal distribution chain in the European Union,” says Gohlke-Kokkonen.
The system is intended for prescription medicines for human use that are sold in the legal distribution chain. In practice this means medicines that are available from pharmacies, hospitals and other official sources.
The aim is to get the system up and running in the first half of 2019 in all EU countries.
“The system is made up of national databases and a comprehensive EU database,” says Marika Launonen, IM Director at Oriola.
At the pharmaceutical manufacturing plant each package is given a unique identifier, which is first entered in the EU database and then via this into the national databases. The medicines verification system also includes an anti-tampering device. In other words, the packages have tamper-evident stickers or foil seals that prove that the package has not been opened.
The packages will display a 2D barcode which, in terms of functions and appearance, is very similar to a QR code. The medicine package’s unique identifier will be displayed when this data matrix is scanned with a barcode reader. These arrangements will ensure that it is very difficult for pirate medicines to infiltrate the legal distribution chain.
New practices for everyone
On the EU level the system has already been set up and is being tested. Over the following three years, the plan is to get the national systems functioning.
“A national organisation will be needed to administer the system. Pharma Industry Finland was given the task of setting up the system, but other pharmaceutical industry operators are also actively involved,” says Gohlke-Kokkonen.
Hospitals, pharmacies and wholesale distributors, among others, are working with Pharma Industry Finland. To set up a national organisation, decision-making methods must be created and an IT supplier selected. The IT supplier will develop a technical solution for the falsified medicines system.
The system’s expenses derive from three sources. In addition to the administration and the IT solution, pharmaceutical companies will have to modify their distribution chains to conform with the new system. The system will also have an impact on the practices of pharmaceutical distributors and pharmacies. For example, pharmacies will have to update their own systems and scanning equipment in order to be able to read and verify the unique identifiers on the pharmaceutical packages. Pharmacies will also have to check to make sure that delivered packages have not been tampered with.
“Wholesale distributors will be responsible for carrying out risk-based verifications to ensure the authenticity of the products received from pharmaceutical companies. In some cases we will have to check every product. And in certain cases wholesale distributors will be responsible for deactivating and removing products from the system,” says Launonen.
Text: Mikko Huotari
Image: Jenna Syrenius