From local to global: Exploring traceability solutions to bridge the EU(FMD)-DSCSA gap
A pharma supply chain is a global affair, especially in modern times. The raw materials can be processed and packaged in a different country, sent for manufacturing in a developed region and then sent back to developing countries like Africa for repackaging or distribution. Drugs change hands several times before it finally reaches the end user, which means it is also susceptible to the counterfeit drug market every time it does. DSCSA, world’s toughest regulatory body in the United States has come up with a solution to this. It is working in collaboration with the EU Falsified Medicines Directive (EU FMD) since 2019 to ensure that transaction between countries are cheat-proof and without any data leaks.
However, meeting the compliance requirements of both the governing bodies is complicating the way pharmaceutical companies, contract manufacturers or packaging companies are functioning in the United States, getting them more worried. This is because, any delay in the understanding and syncing their activities with the two most popular healthcare bodies would mean staying away from the mainstream drug distribution, which further translates into a loss of profits and business.
EU(FMD) versus DSCSA: Bridging the gap
It is important to understand the difference between them and the way they want to see the supply chain working. Owing to the difference in their milestones and the way they expect supply chains to meet with them might create a lot of confusion and chaos, which can add additional pressure to the operational standards of the participants in the drug supply chain management. However, this can be avoided if the right software is deployed, under the supervision of an expert who has experience dealing with both the types of standards.
Coming back to understanding the differences, this table by FarmaTrust serves the purpose very well:
The milestones of both the regulatory bodies are certainly different but not incommunicable. They just need the right pace that matches and fulfils the compliance requirements of both the regulatory bodies.
Having said that, it must also be remembered that DSCSA has more regulatory acts than that of the EU(FMD), which is clearly implied by the long timeline the former has. As against DSCSA’s multiple deadlines (in the years 2015, 2018, 2019, 2020, and 2023), FMD required only one deadline (in the year 2019) to make the European supply chain compliant. The case rests- the milestones of both the bodies are wide apart and require interventions at all levels of software design, engineering, infrastructure, and solution.
Thus, bringing us to our next section- exploring the milestones and bridging them with advanced technology.
Milestone difference 1: Data requirements
While both the government bodies require manufacturers and packagers to label each product with unique identifiers, both differ in the requirements that need to be printed. For DSCSA, the data required include the National Drug Code (NDC interchangeable with GTIN, FDA), the origin of the lot number, the expiry date and the serial number (non-randomized). The FMD, on the other hand, requires the product code (GTIN according to EFPIA, European Federation of Pharmaceutical Industries and Associations), the lot number, Serial number (randomization is required) and the expiry date.
Now, if the drug is for domestic use, the companies need to comply with only one of the set rules, if the product will be passed across boundaries, finding a way to bridge the two variances becomes very difficult.
Solution: Communication across an international supply chain merely becomes more complicated when it crosses borders because of the differences in supply chain management regulations. Traceability platforms or suit, which are being used by the majority of US supply chain stakeholders can be customized to store T3 information, crucial for both the regulatory bodies. For instance, the platform will have the ability to capture the NDC identifier and present it as a GTIN Supply Chain identifier for the European participants of the supply chain. It will also be able to handle the randomized and non-randomized serial numbers parallelly so that details can be store effectively in a centralized master data, with easy accessibility for stakeholders to take better and informed decisions at every stage of the supply chain. This way, the communication flow is bi-directional, not limiting but liberating the process of drug delivery.
Milestone Difference 2: Differences in recording business events
The GS1 standard of labelling is accepted across the world. This is because it has a defined set of business events that cover most of the processes a drug may experience in its lifecycle. However, since FMD/DR has included “commissioning” and “decommissioning” as a part of the business event set, all the products that are to be exported to EU from the US need to ensure that the commissioning event has been recorded properly.
Decommissioning of medicines happens only once and only when a particular medicine has been returned for verification. In other words, it is extremely crucial to know whether a medicine in the supply chain has been decommissioned because of suspected compromise or has it been commissioned back into the mainstream supply chain after verification. Similar to the DSCSA VRS process in the US supply chain, the information holds great value in the European supply chain management because it is the single point of drug verification just before the medicines are sent off to be delivered to the end users (unlike DSCSA pre-requisites requiring verification at every stage of drug production).
Solution: Capturing and recording commissioning events in an international supply chain is subject to errors if the human-labor is involved. It is, therefore, important to deploy multiscanners with API-first approach, which can interact with any portal without transgressing into the main framework. AR-enabled multiscanners can get real-time commissioning data that can then be stored in a centralized cloud-inventory, easily accessible to any of the stakeholders anytime. These master-data repositories are cheat-free and leak-proof making them the safest place to hold confidential data.
Milestone difference 3: Data storage and central repository
For manufacturers in the EU, data must be sent to the central repository through a central router called the EU Hub. Going further, this data is shared with relevant country-partners at a later stage or whenever they need the information about a product. Things, however, are more complicated in the US. Despite GS1’s Global Data Synchronization Network (GDSN) that is aimed at storing identifiers and attributes and other important track and trace regulatory information, there’s no clear idea as to how participants in the supply chain ought to function with it. This forces each of the partners to manage and maintain their own 3Ts information in localized repositories. So, when there’s an import or an export contract, information has to be passed on to either of the parties in a complicated manner. Bridging the two systems is important here because otherwise crucial information will be lost.
Solution: In the US many companies are deploying the solutions of third-party service providers or vendors who use advanced mobile-edge traceability platforms and central cloud repositories to ensure that data is captured and stored centrally. This central repository has the capacity to communicate with individual data ledgers maintained by individual stakeholders, thus making access to crucial information quick and seamless. So, be it an internal process or an export process, companies are ready with data pre-requisites before exporting or importing consignments.
Last word
It is evident that both the DSCSA and the EU (FMD) are independently working toward the same goal of making supply chain counterfeit-free. But when it comes to working together to fulfil a global mission, the connections are shorted. Bridging the gap between two uniquely functioning entities is a challenge that not all can supervise. It needs the expertise, experience and the technical craftsmanship of years. Software innovation is merely one side of the coin, but implementing them at the right place, in the right manner is the work of deep-insight and knowledge. The solutions provided above are not hypothetical but practical- something that is existing and implementable, tried and tested by many companies on the American soil. It is only a matter of time when the others realized the value these solutions add to profitability and business acumen and finally start implementing them from a global business standpoint.
