When someone buys a pharmaceutical product, they get more than just a set quantity of a physical substance. They are also buying lots of important information about how to administer and how not to administer it, as well as assurances of the authenticity of both the substance and that information. Without these, medicines would be dangerous and inappropriate for laypersons to administer. Traditionally, these closely related information and authenticity functions have been delivered by informational inserts and by sophisticated packaging processes, such as seals and stamps.
Digitizing these two functions is Spherity’s vision for how the pharmaceutical sector could benefit from our electronic product information solution, or “ePI” for short. A simple and powerful mobile app could scan the unique QR code on any medicine product’s packaging and uses it to unlock a personalized and intuitive interface. That interface allows the consumer to get precise, trustworthy information about that specific bottle or box of medication. While the new capabilities this opens up are exciting, it is also important to underscore that this digital solution competes favorably with today’s paper solutions on both efficacy and efficiency.
With our work on ePI we are not only offering a building block to make the medical handling process compliant with the US American DSCSA law, but we are also contributing to the recently published “Key principles for the use of electronic product information for EU medicines” filed by the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) of EU Member States and the European Commission (EC).
From Leaflets to eLeaflets, Powerful Digital Twins at Batch Level
Today’s outsized paper inserts are inefficient in at least three ways that can readily be improved upon.
- For users,
they are inconvenient and hard to use, particularly if printed in many languages and folded many times to fit into a small package.
- For manufacturers,
they add much cost and complexity to manufacturing and regulatory approval, introducing many opportunities for human error, recalls, and other problems.
- For the environment,
it is vastly and avoidably inefficient to use that much paper, ink and energy for a supplement that gets so little use on average.
There are pharmaceutical companies that have to print so many leaflets each year, that they could use them to completely cover the land mass of Liechtenstein (a small country in Europe).
Today’s packaging technology similarly does a great deal to make both counterfeited drugs and drugs that have been tampered with detectable, at least to the trained eye. This is only one of many mechanisms used to keep the estimated $30 billion worth of annual counterfeit drug commerce happening primarily outside of the United States and Europe. But some observers warn these mechanisms are no longer enough to keep large-scale forgery out of the developed world’s pharmaceutical markets. Allowing an independent, last-mile authenticity check as a failsafe would both reassure the end-consumer and make counterfeiting prohibitively expensive.
Electronic product information can fulfil both of these functions for a unit price comparable to the paper inserts they replace. The key is replacing a passive paper insert with an interactive mobile app, and a passive tracking identifier with a feature-rich “digital twin” full of cryptographically self-verifying information. This twin travels alongside a specific product or batch as it winds through the supply chain and distribution network. This multi-dimensional data model allows tiered access to many kinds of information, and separate methods for verifying the authenticity of each. Digitizing this information and putting it in a “digital twin” gives all parties more options, especially the end-consumer.
Just as important as the informational content delivered is the highly customizable and interactive channel used to deliver it. This robust mechanism connects the consumer to a user-friendly knowledge base, with images, videos, and other interactive content. Our solution allows manufacturers to deliver each customer a personalized mobile app offering targeted recommendations and automatically checking for interactions with other medicines. The customer could keep track of exactly when and how she uses the product, which can be a powerful tool for maximizing efficacy and ongoing refinement of emerging medications and treatments. This kind of accurate, zero-party data about real-world usage could be a powerful tool for clinical trials, identifying usability issues, and building meaningful relationships between customers and brands.
This last feature might be the most powerful of all: apps like these could also serve as a privacy-preserving, secure communication mechanism between the patient and the many parties involved in that patients’ care, not just the manufacturers of the drug. One of these parties is the trusted brand itself, which is particularly valuable and technically difficult given the degree of consumer privacy that needs to be preserved in the case of medications. Such secure channels are particularly useful when, in the rare case that there is something suspicious about the patient’s product, an end-consumer has reason to manually check the product’s authenticity. With a robust “digital twin,” end-consumers can not only check the authenticity, but report any problems directly and anonymously to the manufacturer.
The Business Case for Electronic Product Information
We have been highlighting how the information delivered to each customer can be more trustworthy, more tailored, and more effective. But the delivery of this information is also more efficient, in the sense that information can be precisely fine-tuned at a granular scale and customized geographically or seasonally for each product, at a remarkably low cost. The differential cost of binding additional information to each product once a digital twin is already in place essentially falls to zero, which could facilitate richer traceability and environmental data, for example.
Furthermore, this kind of granular control over product information can have knock-on effects for all kinds of business processes, from manufacturing to sales, and from marketing to quality assurance. Erroneous or outdated information can be updated or appended without recalls; paper leaflets might be phased out altogether in some cases; more agile or spontaneous processes can be adopted throughout pharmaceutical supply chains and distribution channels. Whether new or old, all business processes can be audited more precisely and verifiably by introducing fine-grained, product-scale accuracy to all the underlying data from which business intelligence and internal metrics are derived.
While better auditing is obviously quite valuable to a pharmaceutical manufacturer or a global brand overseeing these complex supply chains, the privacy of the end-consumer which digital-twin technology preserves also unlocks real value for the sector. We could say that electronic product information is about nourishing deeper trust between the consumer and the product, and everyone in between as well. It is hard to put a price tag on trust or on the benefits that accrue to brand loyalty and brand identity when the end-consumer feels their privacy has been respected and feels empowered by a last-mile/last-chance authenticity check or any number of other value-add services
Under the hood: Retrofitting the Data Matrix of Today
Prescription medicines already have product identifiers (technically referred as “GTINs”) about specific lots and expiration dates encoded into large, unique, seemingly random numbers called sGTINs, or “serialized” GTINs. These are assigned by trusted service providers and registered at the time of manufacture, before being printed on each individual package in the form of 2D Matrix codes. In other articles, we’ve explained how “transparent” serial numbers can leak data dangerously; here, the “opacity” (in layman’s terms, the unpredictability and meaninglessness) of these identifiers is a crucial security feature. Otherwise, bad actors could imitate or falsify these identifiers, thus allowing false products or duplicate serial numbers to bypass inspection and enter the market. At some points of inspection, including to verify the authenticity of saleable returns, the data matrix code is scanned and parsed by the same set of trusted service providers to confirm when, where, and by whom a given product was manufactured.
This system is powerful for allowing a limited number of inspectors and service providers to track products by these opaque and passive identifiers in one or more centralized lookup tables. There are, however, essentially two levels of access to the information that goes into a unique product identifier: full access via centralized database, and no access. Giving a third level of access to end-consumers, or for that matter to any other parties, requires a more complex identifier scheme. Deterministically binding each of these passive identifiers to a decentralized identifier (DID) allows such additional capabilities, without affecting the underlying identifier system.
Each product’s unique DID is as opaque as the sGTIN from which it is derived, except it is anchored in an immutable ledger and brings additional capabilities into play, superpowers even. The first of is a general-purpose cryptographic signing capability, which can be used to place a unique seal of authenticity on every transaction or resource attached to it at a later point in time. Anyone querying these identifiers can verify these “signatures” and in turn query the other signing identities. This additional superpower (we could call it recursive-discovery auditing) strengthens all the authenticity and security checks, which map securely to the processes and privacy solutions of today’s intermediaries or industry-wide consortia. This identity-secured, automatic signing of all recorded events generates a verbose and tamperproof audit trail that is equally useful in case of internal audits, saleable return queries, or other external processes.