Dr Sanjit Singh Lamba, Managing Director, Eisai Pharmaceuticals
Falsified and counterfeit medicines make up around one per cent of the volume of the global market, according to the EU, and up to 60 per cent in West Africa, putting already vulnerable populations of patients at risk. The WHO believes that falsified medicines could be the reason behind around 100,000 deaths per year in Africa.
Pharmaceutical manufacturers must act now to avoid production scheduling clashes as well as technical and cost challenges ahead of next year’s Falsified Medicines Directive (FMD) deadlines. The trade in falsified medicines — medicines that look real but really aren’t what they seem — is a huge and growing one, and it is putting patients’ health and even their lives at risk. Along with regulatory authorities around the world, the European Union is putting directives into place that could begin to slow this deadly trade.
The approaches include track-and-trace and mass serialisation, which use unique codes tied to central databases and allow genuine packs of drugs to be traced back to the license holders, manufacturers, and distributors. The addition of tamper-proof technologies on the packs confirms that the product hasn’t been repackaged or tampered with in any other way. In combination, these make sure that users (doctors, pharmacists, and patients) can verify the packs are authentic and contain the correct drug at the correct dose. The implementation of this directive is expected to increase the cost of goods for drug manufacturers and lower short-term productivity as the companies face additional tech support, labour, and increased returns. A recent survey by Medicines for Europe found that the most compliant pharma companies were still only 55 per cent prepared for the FMD, while others are 30 per cent prepared or less, leaving a massive wave of work to be completed in 2018.
In just terms of Information Technology (IT), the implementation of the FMD is a huge undertaking that will see the systems of more than 28 EU countries connected to an EU hub, the European Medicines Verification System (EMVS). While this will allow end-to-end tracking of products, only pharma companies can enter serial numbers into the system. This makes the process especially complex when CMOs are involved, as Drechsle explained that third-party suppliers will not be allowed to connect to the EU hub.
To comply with the directive, companies need to put a number of processes and protocols in place. They need to buy and install hardware and software that can generate and print unique barcodes or 2D codes. Then they need to be able to scan the codes and store and track the data. And all of this hardware and software will need to integrate with any existing enterprise resource planning (ERP) software.
Packaging designs may need to be rethought because they will have to include space for the barcodes. Furthermore, those barcodes need to be clear enough and contrast well enough against the background for easy scanning. That means companies will need to have quality control in place, and they will need to ensure the codes remain stable and legible in storage throughout the product’s lifetime. This is the biggest change in the pharma industry in the last 40 years, and any system is only ever going to be as good as its worst part. Overall, the FMD covers three regulatory areas: serialisation, compliance reporting and verification. The directive requires companies to place ‘safety features’ on the packaging of certain medicinal products for the purposes of identification and authentication.
Specifically, according to the directive, safety features include anti-tamper devices and unique identifiers. An anti-tamper device is very simply described as a device that allows the verification of whether the packaging of a medicinal product has been tampered with. The unique identifier is more complex and must be composed of a product code, serial number, national reimbursement number (where required), batch number, and expiration date. It must be carried within a 2D Data Matrix barcode, and in human readable text on the package.
In short, the next few months are crucial for companies looking to outsource serialisation. Selecting appropriate partners to ensure compliance is important but companies should also look beyond the February 2019 deadline to see how these partners can help optimise their supply chain management given this new data requirements.
More problematic is the timeframe for selecting, delivering and validating line systems. Some vendors are currently proposing timescales of over 12 months to deliver line systems which will now take implementation beyond the EU deadline.
Serialisation is not a task that can be completed overnight and the repercussions of missing the deadline will have a significant detrimental impact on the success and longevity of a business. Companies that fail to comply with the regulations risk everything from production downtime to the loss of business to more prepared companies in key markets.More proactive businesses should begin reviewing processes and exploring the opportunities to improve productivity and, in some instances, achieve a competitive advantage as part of their serialisation programme.