[Blog] The covid vaccine and its distribution through the supply chain – a “flexibility test” for the anti-counterfeiting model in Europe and EU FMD compliance
Several crucial challenges for the EU FMD regarding the COVID-19 vaccine distribution in Europe
Almost 10 months ago, the EU announced its COVID-19 vaccine strategy. The strategy is a call-to-action for ensuring the quality, safety, and efficacy of vaccines and securing easy access to vaccines.
Just a couple of days ago, INTERPOL recently alerted about the emerging threats of counterfeit COVID-19 vaccines, masks, and other medical devices.
The fast-paced distribution which has one main goal – to bring the vaccine to patients as quickly as possible – must not be at the price of exposing the security of the pharmaceutical supply chain.
Of course, the facts hold that possible problems are negligible in European Union due to the secured and highly regulated medicines distribution thanks to the European Medicines Verification System (EMVS) that has been established to carry out the requirements of the European Falsified Medicines (EU FMD) directive.
The EU model’s system provides a high level of protection against counterfeiting but only if the medicines and medical products are produced and supplied in compliance with the established process by the EU FMD compliance.
All prescription medicines (Rx products), including COVID vaccines, must be serialized and have a valid tamper-evident sticker. The system requires all product and batch information i.e. unique identifiers (UIs) to be sent/uploaded to the European Hub through a secured connection when the batch is ready for release, and again at the point of dispense when every packaging level is scanned and checked by the appropriate National Medicines Verification System.
It is possible for an exemption from some of the required actions to be skipped due to the rush of vaccine distribution, and it is likely that temporary exemptions may be granted for the first batches of vaccines. However, extending such discharges out of the initial batches would pose a negative effect on the full protection that the EU FMD offers.
Since the supply chain offers a high percentage of protection for patients’ safety, these exemptions can be the most sensitive part of the pharma supply chain, and the European population would be preyed upon by counterfeiters. Therefore, serialization must be a key weapon in brand protection and become integrated as a key element in the commercialization of sensitive products.
This key argument has been laying in SoftGroup company philosophy: counterfeiting is not a strategy. As a Trusted Gateway Provider, ensuring secured serialization data transfer to the EMVO, the company recognizes the solid protection of EMVS, but there is no denying that the EU FMD obligations will bring unexpected challenges for COVID vaccinations across Europe.
COVID vaccines will be dispensed during a COVID-19 vaccine strategy published on June 17, 2020, for mass vaccination. This means large numbers of products will be dispensed in a very short time, often in different locations, by different supply chain actors, using different protocols to medicines. This scenario has been foreseen in the Delegated Regulation (Article 23) giving member states the scope to allow for medicines to be dispensed outside hospitals or pharmacies in non-routine supply scenarios.
A new wave of EU FMD alerts can possibly hit the EMVS due to the combination of newcomers, the non-standard scenario, the vaccine distribution specifics at many locations, and different scanning technologies. It is considered by the SoftGroup experts as a real concern since many manufacturers are not well-prepared to manage the EU Alerts nowadays in a timely manner and they can be swamped by a flood of new alerts.