What are ‘falsified medicines’?
Falsified medicines are medicines that pass themselves off as real, authorised medicines. The term ‘falsified’ refers to all forms of falsification, while the term ‘counterfeit’ specifically refers to an infringement of intellectual property rights. Falsified medicines may contain ingredients, including active ingredients, which are of poor quality or in the wrong dose – either too high or too low. As they have not been properly evaluated to check their quality, safety and efficacy, as required by strict EU authorisation procedures, they could be detrimental to the health of patients who take them. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year.
There have been reports of fake medicines coming through legitimate supply channels in other countries including in Estonia, and so the risk cannot be ignored.
How does the Falsified Medicines Directive tackle this threat?
The EU passed legislation in 2011 – known as the Falsified Medicines Directive (Directive 2011/62/EU) – to prevent falsified medicines infiltrating the legal supply chain and ultimately from reaching European patients.
Measures to tackle the threat include
- A requirements for medicine packs to carry special safety features in the form of an anti-tampering device (e.g. foil seal, breakable cap) and a barcode containing ‘unique identifiers’ (including a serial number) to enable the authenticity of the pack to be checked prior to dispensing.
- A common, EU-wide logo to identify legal online medicines suppliers, making it easier to distinguish them from illegal operators.
High-level Project plan
Falsified Medicines Directive (FMD) must be fully applyed on 9th of February 2019.
The implementation of Estonian Medicines Verification System is currently ongoing. The Estonian System will be ready by the end of the second quarter of 2018, after which the connection will be made with the EU Hub (planned in the middle of July).
All Estonian system end-users (pharmacies, hospitals, wholesalers) information systems should be ready to connect to the Estonian Medicines Verification System in the end of June 2018, to be able to perform the necessary testing. The pilot for the Estonian system is planned in August-September and representatives of all stakeholder groups are expected to take part of the pilot.
REKS will start signing the contracts with end-users in the end of the second quarter of 2018. Signing contracts with the Market Authorisation Holders is planned at the same time.
For all of the piloting pharmacies and wholesalers, there are planned trainings in the beginning of summer, just before the pilot. A summary meeting is planned for the end-users in October to provide information on the pilot results and the following timeplan of the system implementation.
All end-user systems must be connected with the Estonian Medicines Verification System by the mid-October to ensure the full operation on 9th of February 2019.
Market Authorisation Holders
Marketing authorisation holders (MAHs) who market in-scope products in Ireland must ensure that all packs released for the Irish market from 9th February 2019 carry safety features (unique identifiers and anti-tamper devices). In practice, many companies will start updating their packaging and releasing serialised packs to the market well ahead of that date.
Find more detailed information here about the activities of MAHs needed for implementing the system.
Pharmacies & hospital pharmacies
Pharmacies and other locations in the health services (including hospitals) that supply medicines to the public will have to verify the authenticity of medicines and ‘decommission’ them from the Estonian MVO repository before they the medicines are supplied to patients.
Estonian MVO will have an onboarding process for pharmacies and other locations that connect to the Estonian MVO repository but they will not be required to pay any fees to Estonian MVO.
Pharmaceutical wholesales will be required to verify medicines that pass through their warehouses in specific circumstances as set out in the Delegated Regulation. They may also have to decommission medicines supplied to certain customers such as dispensing doctors, nursing homes and prisons. Wholesalers in Estonia will have to adapt their software systems to create a connection to the Estonian MVO repository.
Estonian MVO will have an onboarding process for wholesalers that connect to the Estonian MVO repository but they will not be required to pay any fees to Estonian MVO.
Find more detailed information here about the activities of wholesalers needed for implementing the system.
IT Software providers
Pharmacies, hospitals and wholesalers must create an electronic connection to the Estonian MVO repository and may do this using existing dispensing and stock management software systems. Estonian MVO will work directly with the providers of these systems (and internal software developers in wholesalers and the hospitals if required) to provide them with the software development kit (SDK) and support they need to create an interface between their system and the Estonian MVO repository. Estonian MVO will not any charges any fees for this.
Medicines Verification System
In order to counter the threat of falsified medicines entering the legal supply chain, the European Parliament and Council have released a Directive on Falsified Medicines (2011/62/EU) (amending Directive 2001/83/EC). It aims at improving patient safety by mandating the Marketing Authorisation Holders and manufacturers to put a system in place that is preventing falsified medicines from entering the legal supply chain. This system, the European Medicines Verification System (EMVS), should guarantee Medicines authenticity by an end-to-end verification.
The manufacturers are required to apply two safety measures on the outer packaging: an anti-tampering device and a Data matrix code which incorporates a unique identifier (UI) for each sale package.
At the point of dispense the medicine will be scanned, checked and verified for authenticity against a national (or supranational) repository. If the UI on the pack matches the information in the repository, the pack is decommissioned and supplied to the patient. Otherwise, if there is a warning related to this pack, then the system will highlight this as an exceptional event and the package will not be supplied to the patient. An investigation needs to determine whether the pack has been falsified or not.
The EMVS is composed of a central HUB and the different National Verification Systems (NMVS).
Typically, the Market Authorisation Holders and the Parallel Distributors are connected to the Hub for uploading the product information and the Unique Identifiers. These stakeholders are also responsible for adapting their production line to the new requirements and finance the set up and management of the EMVS, ie the Hub and the National systems.
The end-users, such as the wholesalers for risk-based verification, and the pharmacies, in retail and hospital, for patient delivery verification are connected to the NMVS. These stakeholders are responsible for adapting their system and finance the required connection.