The current Covid-19 crisis has exposed many vulnerabilities of the global healthcare system. Including a major problem, that our EU-funded project PharmaLedger is trying to address, that of counterfeit drugs. This is a scourge that not only affects the manufacturers, but to an extended degree, it affects the end users – who may be patients, family members, healthcare workers, and the population in general.
Last year we’ve already seen examples of counterfeit Covid-19 tests, or counterfeit and sub quality personal protective equipment. In 2021 there are going to be millions if not billions of doses of vaccines in distribution around the world and it’s going to be a great challenge and subsequent opportunity for these counterfeiters to take advantage of those strong volumes and the strong desire of the population to get vaccinated.
This is only more visible now due to the global healthcare crisis we are going through. But the problem goes even deeper than that.
Drug counterfeiting: a global scale problem
Illicit trading of counterfeit products is a global problem. Globalization has opened up new opportunities for criminal networks that expand the scope of illicit trade in counterfeit goods. In 2016, international trade in counterfeit pharmaceuticals has reached over 4 billion dollars. While this poses a threat to public safety, it also encourages criminals and organized crime because it’s such a lucrative business.
Counterfeit medicines affect society in many ways. Patients who fall victims to low quality counterfeit products that don’t address their medical needs may end-up losing their confidence in health practitioners and health systems, or even losing their lives.
Since bad quality counterfeit medicines are not properly inspected, they may contain dangerous ingredients so they pose a threat to public health.
If we look at the economic impact, counterfeit medicines may also result in higher healthcare costs, as patients may require additional treatment for the potential adverse effects. Governments may be forced to dedicate resources to develop regulatory and enforcement measures against these kind of crimes.
Criminals have also found a way to benefit from increasing trends in e-commerce, and the purchase of pharmaceutical products on-line. World Health Organization has estimated that half of the medicines purchased online from illegal sites are, in fact, counterfeits.
It’s highly unlikely that the majority of consumers are able to detect counterfeit products on their own.
Taking all this into account, one of the areas of interest of the PharmaLedger initiative is to propose new ways to address and reduce counterfeiting in the medical field.
This use case intends to build on existent regulatory requirements and the use of blockchain to tackle this defenselessness. Read on to see what we are proposing.
Why put it on blockchain?
The anti-counterfeit use case is built on top of the electronic product information use case (a.k.a. ePI or eLeaflet).
As stated before, by building a blockchain based system we are in fact securing this layer of trust that stakeholders throughout the industry can use and moreover, they can plug into with their own applications and use cases.
Here are some key benefits that justify the use of blockchain technologies for the anti-counterfeiting use case:
- Trusted source of truth: there’s no need for a third party authority to validate the data records, the transactions and the execution of smart contracts on the PharmaLedger platform. The system is programmed to be a source of trust
- Privacy and security: Decentralized identities (DIDs) guarantee anonymity in read-only public access scenario
- Interoperability: The same solution can be adopted by all manufacturers and markets without lock-in proprietary solutions
- Scalability to additional use cases: The anti-counterfeiting use case is built on the ePI and is linked to other use cases such as digital recall alerts or real-time reporting of secondary effects.
How it works?
This information flow or process flow illustrates what we’re trying to implement. There are two key aspects to pay attention to:
- the user empowerment aspect when patients and other types of users have access to this powerful tool right on their smart phone
- the data consolidation aspect that offers the industry and law enforcement authorities unprecedented insights to fight counterfeit issues on a global scale.
In the first column we have all the different intended users of the solution starting from the medicine users, hospitals and healthcare practitioners, pharmaceutical dispensaries, distributers, law enforcement and manufacturers. The solution aims at filling the gaps of current processes, as well as contributing further, enhancing functionalities to support the different users.
The use case will be developed to be supported on two different type of devices.
- A mobile application that will have the ability not only to display the product information but also to allow the user to perform the authentication of different pieces of information.
- A web app that will be used by institutional users to better manage the data that is fed in the process.
Regarding data input, in the first phase, information coming from individual medicine boxes will be supported. But we intend to extend those functionalities to batch verifications, which may be of help to hospitals and medical distributers.
By scanning the 2d data matrix code, checks will be performed as displayed in the multifactor product authentication column. Two of those checks come from two other use cases – Product Status and ePI (eLleaflet). The additional checks are the serial number check, the anti-counterfeiting data collaboration (ACDC) check and an authentication feature.
With regard to this last check, it is planned for the app to support a variety of authentication features, always under the premise that they can be collected by the user by using the mobile phone’s camera or the sensors.
The last two columns refer to the ACDC. A data collaboration tool that will allow regulatory authorities, the industry and law enforcement to have a deep insight about the user generated data. The ACDC module uses a consolidation of big data approach.
The data is collected from all the industry checks and all the transactions across different medicines and geographies, and is used to get bigger insights and enable real time reporting and alerts to see where the counterfeit problems are and how they could be combated in a more effective manner.
What does authentication mean?
For PharmaLedger to address drug counterfeiting, it will first need to tap into an authentication system. By authentication we mean the answer to this simple question: “is this product genuine or is it false?”
If you look at a 20 EUR banknote, you can see that it is embedded with a variety of security features that prevent counterfeiting. All these features are considered hovered features and they can be perceived by the human senses.
There are other kind of features known as covered that provide an additional layer of security to items on products. But those typically require special devices to be validated.
The approach to authentication in PharmaLedger
In PharmaLedger we’re planning to be able to identify and validate a variety of authentication features that are currently embedded in different medicine packages, as well as allow others to be seamlessly introduced. This would be one part, the multi-factor product authentication.
In this way, we hope to be able to give patients the ability to validate authentication features on medicine packages, with just a few taps on their smartphones.
We’re looking at this from a feature agnostic perspective. We understand that there are a lot of different ways to protect products in the market and we’re not saying manufacturers have to use one or the other feature. The use of a common app to check the features using a different back-end system will enable the industry to keep their current processes (i.e. packaging procedures).
The other part of it is the anti-counterfeit data collaboration (ACDC).
This involves predominantly the institutional users and it basically means that manufacturers are feeding the system with information. This information is then processed and consolidated in order to give valuable insights back to the manufacturers but also offer the needed support for law enforcement agencies, empowering them to take action.
Ultimately, the PharmaLedger approach is to become the common approach in the industry and create value for anybody using the common approach. And the upside is that there’s no end to additional use cases that can be built on top of it.
Conclusions and a key question
Here’s a round check of the key value propositions of the anti-counterfeit use case in PharmaLedger:
- Leverage blockchain emerging technologies to give the patients a powerful tool (patient empowerment) and basically consolidating the data to get some insights to fight counterfeit issues on a global scale.
- Reduce patient safety risks
- Guarantee privacy of patient data
- Collaborate to collect and analyze related data to gain insight on macro trends of pharmaceutical criminal activities
- Strengthen supply chain security with a single source of truth architecture that is interoperable across the industry and accessible with a common application
Before we part ways for now, here’s a quick question: If you could verify a product or authenticate it by using your smartphone, even if you were based in a high income country without a huge counterfeiting issue, would you use this application to check the medicine’s authenticity? Let us know in the comments section.