Around the world, an estimated 1 million deaths are attributed to substandard and counterfeit drugs. The World Custom Organization’s Anti-Counterfeiting and Piracy Coordinator Christophe Zimmerman has claimed in the past that, “We have more fakes than real drugs in the market.” Inflexible, legacy systems and fragmented technical solutions have stymied improvement to the pharmaceutical supply chain. With new US and European legislation expected to come into effect by early 2019 aiming to increase accountability, a new approach, ideally one connecting all stakeholders, will be required.
Stepping into this opportunity is FarmaTrust, an interoperable, secure, blockchain-based global tracking system for the pharmaceutical industry. FarmaTrust’s capabilities include:
- Regulatory Compliance and Track-and-Trace tools to ensure compliance and allow monitoring for accountability
- Supply Chain Visibility features to share a verifiable picture of the full supply chain
- Consumer Confidence app to allow authentication of each packet of drugs by end consumers
FarmaTrust completed an ICO earlier this year issuing FarmaTrust Compliance Tracking Tokens which assign digital IDs to each packet of drugs. To learn more about FarmaTrust, Medgadget heard from CEO Raja Sharif.
Michael Batista, Medgadget: Thank you for taking the time tell us about FarmaTrust. To begin, help us understand current challenges in the drug industry pertaining to substandard and counterfeit drugs. More specifically, how do fake or counterfeit drugs enter the supply chain to begin with?
Raja Sharif: According to the WHO, the counterfeit drugs industry is worth approximately $200B per year and kills around 1M people globally. The European Association for Access to Safe Medicines estimates that 60% of drugs bought online are fake or substandard. I find that this article does a good job characterizing the global problem.
Medgadget: Why is it so difficult to track drugs through the supply chain and keep stakeholders in the supply chain accountable?
Sharif: The global pharmaceutical supply chain, like other complex supply chains, has many different companies involved, large and small. Each have their own processes, and use their own IT infrastructure differing hardware and software, so integration is an issue. Privacy and confidentiality of commercial data also makes it difficult to share data amongst the supply chain participants. All these factors lead to gaps in information or doubts around data integrity which makes it easier to insert fake drugs along the supply chain.
Medgadget: I understand that upcoming legislation will begin to drive change in the industry. Can you tell us more about this legislation, what it aims to change, and if you believe it has the potential to make a meaningful impact?
Sharif: In the US, changes to the DSCSA (Drug Supply Chain Security Act), and in Europe, the FMD (Falsified Medicines Directive), create new regulations that will allow pharmaceutical companies to track individual packets of drugs. Each pharmaceutical packet should be uniquely labelled with tamper-proof packaging. This will make it extremely difficult for non-registered drugs to penetrate the supply chain and therefore more difficult for fakes to reach consumers.
Medgadget: Let’s switch gears to FarmaTrust. What is FarmaTrust doing to make an impact in the drug supply chain?
Sharif: FarmaTrust brings all the participants together. We track a packet of medicine from the point of production to the point of consumption. We can tell you where the packet was, who had it, when they had it, and how long they had it. We get this information through data from scanners or ERM (enterprise resource management) systems used by most modern supply chain processes and put it on our system at each data point. In countries that do not have tech infrastructure, they use it mobile phone Apps. This gives us access to large amounts of data, which we can then use for the benefit of our customers, including pharmaceutical companies, governments, regulators, NGO’s and law enforcement.
Medgadget: FarmaTrust’s Zoi Platform is built on blockchain. Why use blockchain for these use cases? Can you share a little more about which blockchain FarmaTrust is using?
Sharif: Blockchain ensures that data is immutable and incorruptible. Blockchain gives the assurance of data integrity and transparency. This then allows us to make sure our customers have better data which allows them to make better, faster decisions to have a competitive edge while ensuring consumer safety
FarmaTrust maintains a blockchain neutral strategy as we believe it is still a nascent technology much like search engines in the late 1990s. With that mindset, we want to be cautious and see which blockchain platform rises to the top. Currently we mainly use Ethereum but have also worked with Qurom, Cardano, Microsoft Coco and Tomochain.
Medgadget: Who are the stakeholders that will engage with FarmaTrust’s technology? Who is FarmaTrust working with today?
Sharif: Pharmaceutical companies, distributors, wholesalers and third-party logistics companies would all engage with FarmaTrust, particularly from a regulatory perspective in order to provide data. Our services are provided to governments for transparency, budget, and planning purposes, regulators for regulatory and compliance needs, and NGOs for tracking, and law enforcement like Interpol for detection of counterfeits.
An example of an existing client is SystechOne, a global leader in supply chain safety. SystechOne has 700 clients, 1700 production lines, and work with 19 of the top 20 pharmaceutical companies worldwide. They began selling our service this month. Others announced partners include Peterson Projects and Solutions and the Mongolian government.
Medgadget: How do these different types of organizations interact with FarmaTrust?
Sharif: FarmaTrust collects data as products move through the supply chain. This data is presented in different data dashboards, depending on the information requirements of our particular customers.
For instance, government agencies will want to know which drugs they have in their territory, what drugs went to waste or worse, were lost through corruption, what budgets they should plan for, and which companies have complied with their regulatory requirements. NGOs will want to make sure they know how much supply they have, what additional supply is required, if their drugs are getting to the people and places they are needed, and where drugs have going missing. Pharmaceutical companies want to comply with their regulatory reporting requirements, streamline their return process, and prevent return fraud. The also want to prevent wasted drugs through expiry dates and re-route drugs to where they are needed most. Pharmaceutical companies can data mine and get insights that they otherwise don’t have through our global solution. Law enforcement will want to know how many fake medicines were detected, where and by whom, and which particular brands are being targeted.
Medgadget: How will FarmaTrust’s platform change the state of the art today?
Sharif: Our base service allows regulatory compliance, however, we believe that we will fundamentally disrupt the healthcare and pharmaceutical sector because of the following reasons:
- FarmaTrust works both in the emerging markets (i.e. Mongolia and Thailand) as well as the developed world.
- FarmaTrust automates certain processes such as payments, regulatory compliance, audits, and notifications.
- FarmaTrust is sensor neutral, we do not impose a proprietary sensor.
- FarmaTrust is hardware and software neutral, we can work with existing legacy systems.
- FarmaTrust provides different data dashboards and views for different clients
- Over time, FarmaTrust will use data to provide predictive service such as identifying which medicines to produce, how much to produce, when to produce, and where to send new volume. The goal is to reduce overcapacity which estimated to be at 50% today.
- Today, FarmaTrust is a fully functioning system and are at installation stage rather than concept or theory.
- Finally, FarmaTrust works across healthcare verticals including cell and gene therapy as well as clinical trials.