4. PharmaLedger’s Anti-Counterfeiting Use Case

Anti-Counterfeiting Use Case | Watch PharmaLedger’s Use Case presentation and topic-specific Q&A – and join us in our Trust-Centric Healthcare Journey.

PharmaLedger hosted our first public Open Webinar “A Trust-Centric Healthcare Journey” at the end of 2020, which covered the challenges, solutions and added value of our four blockchain-enabled supply chain use cases. If you missed out, you can rewatch the full webinar as well as each individual use case presentation and topic-specific Q&A on our YouTube channel.

Anti-Counterfeiting Use Case

Following ePI – Electronic Product Information, the fourth use case introduced in this webinar was Anti-Counterfeiting. It was presented by the use case co-leads: Daniel Fritz (Novartis) and Dr. Alberto López (INCM). You can find this use case recording below, along with the topic-specific Q&A asked by the participants at the end of the video:

Here is a brief overview of the presentation, with minute markers to help you navigate the video recording.

Anti-Counterfeiting – The Problem (0:45)

Counterfeiting in healthcare is a pressing issue that poses a huge threat to public health and safety across the world. As you can see from the statistics above, the problem only continues to worsen. These pharmaceutical crimes impact our society in many ways:

  • Patient Safety: If a patient falls victim to a low quality, counterfeit medicine that doesn’t treat their medical needs, it could result in distrust in healthcare professionals. The worst case scenario is therapeutic failure, disease complications, or death. 
  • Public Health: Oftentimes, counterfeit drugs contain harmful ingredients, decreasing trust and declining efficiency of the healthcare system as a whole. 
  • Economic Impact: Counterfeiting could lead to higher healthcare costs; decreased income of pharmaceutical companies, which would impact industry innovation and jobs; a loss of tax income for National Revenue authorities; and waste of resources if governments are forced to develop and implement regulatory and enforcement measures. 

PharmaLedger’s Anti-Counterfeiting Use Case aims to build on existing regulatory requirements using blockchain technology to tackle this defenselessness. 

Our Proposition (3:30) 

Above, you can see our proposed Anti-Counterfeiting process flow. The foundation of this use case begins with ePI – Electronic Product Information, which enables anyone to access their product information (eLeaflet) by scanning a Datamatrix code on a product via the PharmaLedger app on their smartphone. Information embedded in the Datamatrix is stored and can be used to perform additional security checks known as Multi-Factor Product Authentication (MFPA) – a key component of this use case that permits patients to verify their product themselves by answering the following questions: 

  • How has this product been produced? Does it have an eLeaflet associated with it?
  • Does this product have a valid serial number?
  • What is the status of the product? Has it been released to the market? Reported stolen? Has it been recalled? Etc. 
  • Are there any embedded authentication features on the product packaging that can be checked (physically or via smartphone)?

Another key element of this use case is Anti-Counterfeiting Data Collaboration (ACDC). ACDC allows data taken from industry checks and transactions across all different medicines and locations to be consolidated on one shared source of truth.

Vision (6:44) 

Our overall vision for this use case is to create an interoperable and trust driven anti-counterfeiting solution by building on current legislation (Falsified Medicines Directive in the EU and Drug Supply Chain Security Act in the USA), empowering patients to be part of the solution, and leveraging big data to generate real-time insights. This solution aims at filling the current gaps of current processes as well as enhancing other functionalities to support different users. 

In the image above, you can see that all intended users of the proposed solution would have access to a shared interface that would be supported on two kinds of devices: (1) an app available on a smartphone for patients to view product information and perform authentication checks, and (2) a web app that would enable institutional users to better manage data that is  acquired throughout the process. As it stands now, data supported through this platform includes information from individual medicine boxes, though our long-term vision extends this functionality to batch verification. 

Scanning the 2D Datamatrix code through the PharmaLedger app enables the Multi-Factor Product Authentication (MFPA) functionality, which consists of 5 different types of product checks: 

  1. Product Status (as discussed in our Finished Goods Traceability presentation)
  2. ePI – Electronic Product Information
  3. Serial Number
  4. Anti-Counterfeit Data Collaboration (ACDC)
  5. Authentication Features

From this list of checks, we consider authentication features to be the core of MFPA, allowing the patient to answer the question, “is my product genuine, or false?”

 Authentication Features Example (9:35)

There are many different ways that products are protected. In fact, we all carry around items that contain security or authentication features on a daily basis, such as a banknote. Features can be both overt, which can be perceived by the human senses (holograms, textured surfaces, tamper-evident seals, etc.), and covert, which provide an extra layer of security, but require special devices in order to be validated (ultraviolet images, microtexts, etc.). 

Another example of an authentication feature is UniQode, which uses a combination of covert and overt features. This combination of physical and digital elements can be used to encode information and also as a means to validate additional features. This all allows the creation of a traceable unique identifier that’s adaptable to any product.   

We see a future where patients are empowered to easily use multiple means of authentication to verify their medicines. If a manufacturer includes an authentication feature on a product’s packaging, the PharmaLedger app would grant the patient power to check this in addition to other MFPA checks, regardless whether they are covert or overt features. By making these different means of verification easily accessible to the patient, we aim to create a greater sense of trust in the product and its quality, as well as a higher degree of confidence in product authenticity

We’re looking at this solution from a feature-agnostic perspective, meaning our vision doesn’t suggest disrupting any currently used authentication features. It would instead provide a solution that would be able to support a variety of authentication features currently embedded in product information packets, while also allowing other features to be seamlessly introduced. This allows the industry to keep their current processes without having to change them, and empowers patients to be part of the solution. 

Anti-Counterfeiting Data Collaboration (13:08)

A key element of this use case is the ability to take all of the data acquired through the different functions of the PharmaLedger app and turn it into an industry-wide shared source of truth using a data collaboration tool known as Anti-Counterfeit Data Collaboration (ACDC).

The image above highlights the added value of this blockchain-enabled feature that comes in its ability to consolidate additional data collected from manufacturers, legal and regulatory authorities, and MFPA checks on different medicines across multiple locations, all on the PharmaLedger platform. This shared source of truth would allow the supply chain actors to have a better insight of the data generated while enabling real time reporting and alerts. It could even allow law enforcement to locate where counterfeit problems are occurring and better determine how to combat them. 

Value Proposition (15:28)

PharmaLedger’s Anti-Counterfeiting Use Case aims to leverage blockchain technology as a means to combat this issue on a global scale. This includes giving patients and supply chain actors a powerful tool for multi-factor product authentication and increasing supply chain security. Consolidating this data on one collaborative shared source of truth would also provide greater insight into the macro trends of pharmaceutical crimes. 

Q&A (16:23)

  • What’s the status of this project? When do they go-live, and is this only for the EU market or global? (16:28)
  • What is the greatest benefit of blockchain to a regulatory agency? (19:07)
  • Can a counterfeiter also counterfeit the 3D matrix code? Which would negate the effectiveness of using a mobile app (20:08)
  • What are the coming milestones to achieve this distributed ledger? each pharma company has first to implement blockchain use cases before, it will take time. (22:10)
  • What if a patient does not have a mobile/smartphone or can no use one? (25:12)
  • Aren’t wholesalers and pharmacy associations missing in the consortium? They probably have a different view on the benefits of PharmaLedger as you presented (26:55)
  • Regarding anti-counterfeiting use case: have you planned integration with EU HUB and/or other (out of EU markets) national databases? (29:05)
  • Who is the ‘owner’ of the blockchain? (30:18)

You can watch the full “A Trust-Centric Healthcare Journey” webinar recording below, which includes the other three supply chain use cases.

Unanswered Questions

As promised, we made sure to find out the answers to any unanswered questions asked during the webinar. You can read the answers provided by PharmaLedger’s Industry Lead Daniel Fritz (Novartis) below.

Question: What do you perceive as most difficult in the implementation of the technology?

Answer: Implementation of technology is one thing- adoption is another.  As far as implementation goes, the biggest challenge we have run into has been integration into our backend legacy systems.  These systems are the “systems of record” that need to be integrated to a blockchain solution and in many cases, they are fragmented solutions where one interface won’t suffice.  But the bigger issue is adoption, which requires a common decision among a critical mass of ecosystem players to actually use the solution. This is no easy step as it requires common data and process standards, agreed consensus mechanisms, an effective governance setup, and much more. The success of value-adding blockchain solutions will depend more on the people and process parts of the picture than the technology one.

Question: Is there work going on a use case for an eHR (electronic Health Record)?

Answer: Not within PharmaLedger.  That said, we are innovating in areas like identity and off-chain storage, which are fundamental to any eHR solution.  We are exploring the concepts of self-sovereign identity and self-sovereign data, where the user is in control, versus someone else.  Some of our use cases could also potentially contribute to an eHR in the future, like ePI (electronic Product Information) which could be linked to a doctor’s prescription and then automatically entered into a patient’s eHR when scanned. Shouldn’t we know exactly what batch of medicine was dispensed and used to treat a sickness or disease?   When and if we prove the value of a self-sovereign approach, this could certainly influence the development of eHR solutions in the future… or maybe lead to another Innovative Medicines Initiative project!

Question: Who is funding all these projects/use cases? And who is having the lead?

Answer: PharmaLedger is a project under the Innovative Medicines Initiative, a joint undertaking between the EU and EFPIA (European Federation of Pharmaceutical Industries and Associations).  The funding approach is normally 50/50 from the industry, usually in the form of in-kind resources (people’s time).  The EU matches the industry contribution with cash to fund the public partners.  The project itself, and each work package is co-led by an industry representative and a public representative.  With 29 partners in the consortium, this is a challenge to ensure everyone has the same information and alignment.  But as they say, if you want to go fast, go alone.  If you want to go far, go together!

PharmaLedger has eight use cases in total covering supply chains, clinical trials and health data. PharmaLedger is a three-year project sponsored by the Innovative Medicines Initiative (IMI) and European Federation of Pharmaceutical Industries and Associations (efpia) that brings together a consortium made up of 29 partners who are working together to build a trusted platform using blockchain technology and in addition create many healthcare applications. 

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