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The Impulse of the Legal Framework
The Impulse of the Legal Framework
I joined the pharma industry in 2012, when the earthquake of the Falsified Medicines Directive from 2011 had set as its objective the implementation of the European Medicine Verification System (EMVS) by 2019 and boosted the “Good Distribution Practice for Human Use” guideline awaited by the European pharma industry with anxiety.
Was the European pharma distribution market devastated by the GDP tsunami? Not really… Despite being set back decades in terms of transport performance and technological development, most stakeholders seemed prepared, or at least on the right path to meet the new requirements. Wholesale distributors and other logistics services providers were already actively working on the re-thinking of their quality systems and recovering the technological delay.
I highlight below some key developments I observed in the European pharmaceutical distribution market such as the “Quality Management Systems” implemented at distributor and transporter levels, the impact of the technological standardization of trucks, synergies between new container technologies and transport services and finally some new challenges like IoT which should rally the stakeholders of the pharmaceutical distribution market.
Wholesale Distributors Quality Management
The EUGDP guideline was designed for the wholesale distributors and other entities performing similar activities. It acted as a breath of fresh air and propagated a drastic improvement of the control of transport operations through the implementation of quality management systems. These systems, in the majority IT-based, are a prerequisite for obtaining the GDP licenses. They allow managing the procedures, trainings, third parties, complaints and deviations in a controlled environment.
Truck Transport Hegemony
Road freight shipments dominate by far the market of pharmaceuticals transport in terms of volume. It has reached a high level of standardization in terms of fleets, following the United Nations Agreement on Transport of Perishables (ATP). Although this standard wasn’t globally implemented, it is well applied in Europe. High temperature control reliability has become a reality using a family of trucking assets certified under ATP / FRC (usual level required for cold chain) requirements. Security is guaranteed by real time geo-fencing (following TAPA rules) and the labelled temperature conditions of the products are monitored thanks to real time temperature data availability on cloud platforms.
This standardization and the emergence of the aforementioned industry leaders also contributed toward the growth of less than truck load (LTL) services dedicated to pharmaceuticals, allowing rationalization of the transport and major cost reductions.
Shipping Containers and Services
In the jungle of new temperature-controlled passive packaging containers ranging from small parcels to full pallet shippers, alliances have been established between express forwarders and manufacturers. This new trend enables the use of re-usable containers mainly utilizing phase change material (PCM)-based cooling elements. PCM is more robust in comparison to simple water-based solutions and contributes towards making the pharma transport more ecological.
Pallet shippers and aircraft pallet size (ULD) semi-active or active containers are also increasingly connected and combined with services. Manufacturers are now opening electronic platforms where temperature data and other transport information are captured and accessible to customers.
IoT in Pharma Distribution: The Future?
I hear many service providers claiming they provide “IoT” solutions for temperature-controlled transports. This seductive marketing speech is often far-fetched from reality… Most temperature monitoring systems are simple, stand-alone solutions. This means an additional layer of monitoring instead of leveraging the available data through connectivity.
In many distribution flows, temperature monitoring is built into the transport asset (container, truck, etc…) and might be shared between the temperature management platforms. The remaining challenge is to establish the required interconnections and to solve the compatibility issues.
The current focus of the monitoring device manufacturers is on developing IoT-capable devices. These should be used to monitor the uncontrolled steps of the transport when packaging solutions are not equipped with built-in temperature monitoring devices.
The real-time availability of geographical data comprises a regulatory and security challenge in transport due to IATA and road security regulations. Real-time geo-fencing indeed presents a major susceptibility to misuse, fraud and other cyber-criminal activity. Most IoT-like features in the monitoring devices must be strictly controlled or restricted making their certification difficult. Therefore, the current priority is the just-in-time availability of the data upon shipment delivery and reduction of the administrative workload thanks to data transfer using wireless communication protocols such as GPRS, BLE (Bluetooth Low Energy), and NFC technologies.
New technologies and services contribute to lighten the dark zones of the transport. The IATA Pharma CEIV certification of the airport operators contributes in generalizing the GDP requirements in the air freight and dedicated pharma services are becoming common in the European road transport. The next challenges are gaining visibility and control in sea freight and standardizing the level of service linked to small parcels distribution to hospitals and pharmacies.
The European pharmaceutical distribution is now closer to cutting edge technologies; not only owing to the increasingly competitive environment but especially due to a pretty uncompromising legislator imposing sharp deadlines. We can expect the continuous incremental tightening of the regulatory requirements in the coming months and years for the benefit of the product quality and finally, the patient.