Falsified medicines impacts : A direct threat to Public Health and Economy
Counterfeit medicinal products are widely spread around the world, affecting developing countries as well as the developed ones. Counterfeit rate may vary from 1% in certain developed regions and may reach 50% in some States.
Counterfeit medicines may affect both the legal (e.g. authorized pharmacies and wholesalers) and the illegal (e.g. supplies from/to unauthorized internet sites) supply chain. Moreover, as per the E.U Directive, the most targeted medicines by fraudsters are medicinal products against sexual dysfunction, heartburn and cancer.
As per a study conducted by the “Pharmaceutical Security Institute” about counterfeit medicines in legitimate supply chain, falsified medicines would cost annually around $75 billion to pharmaceutical industry. This amount remains relative as this report only highlighted falsified/counterfeited medicines within the legitimate supply chain.
Besides a deep economical impact, counterfeit medicines have worrying consequences on public Health such as: treatment fails, toxicity, and may facilitate spread of epidemics. As for example, a severe incident occurred in 2008, including a falsified blood thinner, that one caused dozens of deaths around the world even in the US and in the European Union.
In order to fight against falsified medicines, the European Council adopted in 2011 the following Directive 2011/62/UE called « Falsified Medicines ».
Counterfeit Medicines : Definitions according to the EU
As per the European Union definition, falsified medicines are medicinal products with false identity (e.g. name, composition), false history (e.g. batch number), the ones passed off as genuine, or products containing active ingredients with wrong dosage or low quality.
Thanks to the Directive 2011/62/UE called « falsified medicines » the European Union will have several harmonized tools to control and secure the medicines supply chain. This directive aims to guarantee a high security level within the UE States member.
Directive Prerequisites : Tamper Evidence and Unique Identifier
The supply chain of medicines is quite complex and might offer opportunities to fraudsters and traffickers to penetrate the legal medicines supply chain. Indeed, there wasn’t any mandatory technological solution to combat illicit medicines: Injection of false medicines in the supply chain or authentic medicines box recovering in order to repackage them with counterfeit medicinal products.
The European Directive “Falsified medicines” aims to combat counterfeit medicinal product by developing 5 major axes:
- Define “falsified medicines” accurately.
- Affix 2 safety features: a unique identifier (traceability and serialization) and an anti tampering device (Tamper evidence).
- Enhance the control of distribution channel
- Issue new requirements about excipients and raw material
- Monitor and to harmonize sales of medicinal products online
Bringing identification and anti-tampering solutions does not only aim to check both authenticity and identification of individual medicines boxes but also to verify whether the packaging has been violated. These safety features will have to be affixed to all medicines sold on prescription within the EU; nevertheless non prescription medicinal products will be exempted for the time being.
What solutions to fight against falsified medicines ?
Building on our deep rooted-experience in pharmaceutical products protection, Arjo Solutions offers authentication and tamper evident solutions responding to the EU directive prerequisites for pharmaceutical products. However, both anti tampering and unique identifiers might be considered as the first step to combat counterfeit medicines but they might not be seen as sufficient.
Thus, Arjo Solutions went further than the directive needs by implementing anti-counterfeiting technologies and anti tampering devices in order to offer a fully secured and a customizable solution for pharmaceutical market players.
Secure serialization thanks to security inks
The unitary identification of each medicine (called serialization) allows ensuring traceability and monitoring on the medicines supply chain. However, as this unique identifier is visible, counterfeiters have the opportunity to copy them limitless.
To palliate this weakness, Arjo Solutions proposes security inks enabling the authentication of printing codes by implementing a proprietary chemical marker within the ink used to print the unique identifier, Arjo Solutions enables the Pharmaceutical laboratories to authenticate their products via a simple tool giving a clear response “YES/NO” in less than one second.
A Tamper Evidence device allowing authentication of medicines
The European Directive imposes the implementation of a tamper evidence system on the medicines packaging. This device may take the form of either a directly integrated system into the packaging design or a label based solution affixed during the manufacturing process. This one, constituted of powerful adhesive or/and a fragile layer material, allows to quickly underline any attempt to the integrity of the medicinal product.
Arjo solutions offers tamper evidence labels for pharmaceutical industry that may also integrate authentication functions with several security levels, depending on the public targeted (patients, internal controllers, customs, laboratories, etc.). Built on a STES™ base, the label will contain authentication features directly integrated on the substrate-mass, while at the same time a tamper evidence function thanks to its laminated layer.
Fight against parallel trades thanks to the packaging material fingerprint
The second scourge affecting Pharmaceutical industry is the parallel market. Authenticated medicines are diverted from the legal distribution channel in order to be sold within regions where pharmaceutical labs haven’t delivered any authorization yet or within areas whose price policies are different. This trade agreement between unscrupulous wholesalers is a common practice and may open the way to many frauds such as counterfeit medicines or re-packaged ones.
In order to combat this issue, Arjo Solutions proposes the Signoptic™ technology displayed on many markets affected by parallel markets. This digital solution (invisible, without any packaging modification), is based on the material singularity of each packaging in order to generate a unique identifier, a unique signature for each product. Paired with serialization from the production, the signature allows a unitary authentication of each product and instantaneous frauds detection.
Educate the patient to medicine verification using its Smartphone.
Serialization, via a unitary printing datamatrix code (2D code) on each medicine is an outstanding communication vector to the patient. This one enables, via a smartphone application, to check the authenticity of a product, to have an access to traceability information, to have information about dosage…
Arjo solutions offers X’track, a modular and complete solution to implement serialization, track and trace system and interaction between laboratories and patients. This solution, responding to the European Directive imposing the implementation of unique identifier, proposes to pharmaceutical laboratories, a complementary approach up to the patient, offering both the verification of the product authenticity and the collection of data market.