By logging, at source, a unique identifier (e.g. QR code, serial number etc.) associated with pharmaceutical packaging into a decentralised [blockchain] database, it is possible to authenticate the origin of pharmaceuticals from manufacture to end-user without any risk of cyber-attacks.
GENUTEX does this by transforming each UI into a virtual identity which is logged into our proprietary Vaultex hybrid-blockchain platform. The core of Vaultex is a private, permission-based, templated and cryptographically secure blockchain ecosystem limited to pharmaceutical manufacturers and their suppliers. Vaultex creates an unalterable record of each pharmaceutical product at each stage of its life-cycle using cryptography, meaning the records are tamper-proof through time.
Access and control of Vaultex data is bound by legal and operating agreements (i.e. smart contracts"). Pharmaceuticals can easily be authenticated and tracked using our Vaultex supply-chain app which will provide permissioned access to our private blockchain database. End-user patients will also be able to easily authenticate pharmaceuticals via a separate Vaultex app which can access the public portion of our blockchain as they remain anonymous.
Using a hybrid-blockchain (i.e. public and private) in this way ensures that ledger entries can never be hacked or changed in any way. The Vaultex™ platform provides an immutable chain of origin, ownership and authenticity of every pharmaceutical entered into the system. In the event a UI is copied, the user will be alerted when scanned as no two entries in the database can be the same.
By working with manufacturers and UI partners around the world, we intend to offer the pharmaceutical industry an unambiguous [free-to-use] solution to pharmaceutical fraud that empowers the consumer with the knowledge that the pharmaceuticals they have purchased are genuine.
Vaultex represents the first integrated patient-driven pharmaceutical authentication tool that is both blockchain secured and free-to-use for patients. By removing all barriers to entry, we aim to greatly mitigate the infiltration of anti-counterfeit medicines from all supply-chains and, in particular, from digital distribution via the internet (i.e. e-pharmacies).
Key attributes of GENUTEX’s hybrid-blockchain solution are:
a. Our proprietary Vaultex platform is a private, permission-based, templated and cryptographically secure blockchain ecosystem limited to pharmaceutical manufacturers and their supply-chain. End-user patients will access Vaultex via non-permissioned public access. Hybrid refers to public/private access portals.
b. Open-source decentralised database software designed to automate real-world transactions in a legally enforceable virtual-environment;
c. Certificate Authorities (i.e. “Smart contracts”) are used as the basis for trust on our private blockchain and therefore computational-based ledger encryption. This allows user identities to be anonymised (encrypted and protected by Intel SGX);
d. Nodes are arranged in an authenticated peer to peer network allowing direct communication with one another (i.e. no “gossip” protocol is used hence speeding up the process of entry);
e. Data is shared on a need-to-know basis on our private blockchain. Nodes provide the dependency-graph of any ledger entry being sent to another node on demand (i.e. there is no global broadcast of all transactions);
f. Nodes are backed by a relational database and data placed in the ledger can be queried using SQL;
g. Anonymous end-user patient access will be allowed via the public portion of our blockchain;
h. GENUTEX follows a general philosophy of reusing existing proven software systems and infrastructure where possible.
Answer: GENUTEX's solution facilitates pharmaceutical compliance in relation to their legal regulatory requirements associated with Track and Trace including DSCSA (USA) and FMD (EU). Our system can be configured to meet any national regulation.
Answer: Vaultex™ is UI neutral. We can work with any third party sensors or standard 2D/3D dot matrix labels or RFID labels, and can convert any of these UI's into a virtual UI in the Vaultex™ blockchain database depending on the clients requirements.
Answer: The Vaultex™ technology has been designed to work globally, both in the developed and developing world. We intend using traditional cellular technology in the developing markets to facilitate the global coverage of Vaultex™. GENUTEX will subsidise our efforts to mitigate pharmaceutical fraud in the developing world from our work in the developed world were possible.
Answer: GENUTEX has developed the first free-to-use pharmaceutical anti-counterfeit and tracking technology. The anonymous end-user data we collect as part of the authentication process is analysed using proprietary non-linear statistics to establish the existence of any relationships between biosociometric data and the pharmaceutical being scanned. In the true sense of AI analysis, we convert the data into an image and use image analysis techniques to evaluate the non-linear data. The data is then offered to the pharmaceuticals companies for medical research and marketing purposes.
Answer: Yes, the food industry is a tougher prospect however there are some very good bio-marking companies out there (Flurotech in Canada for example) which could be used as a UI for expensive food types. In fact, we intend exploring this in the wine sector next where counterfeits are rife (and expensive). Converting the bio-marker UI will, unfortunately, require specialist equipment. We also intend utilising the Vaultex™ technology in the luxury goods market, currency, and electronics market etc.
Answer: In the pharma industry, if one purchases a packet of tablets that, when scanned, signals a duplicate and possible counterfeit product, there is of course no way of knowing whether it is the original or one of any number of copies. That is, until the blisters (which in most countries already have a separate mark) are checked. If the marks on the blisters are linked [in Vaultex™] to the QR code on the box, we know the contents are authentic. In the case of a bottle, there would be a second mark on the inside of the cap. The Vaultex™ alert would be sent to the manufacturer who would then alert law enforcement agencies (i.e. they would know exactly where in the supply chain the counterfeits penetrated and could plug the hole). Regulators would also be informed so that alerts could be put out to all distributors etc.
Answer: We decided to tackle to the pharmaceutical market first because our technology will help save lives. Also, focusing on the e-pharmacy market where there is 50-60% counterfeits seemed like an easy target that no one has attempted to tackle.
Answer: No it is not as there is no company that offers a free-to-use totally secure anti counterfeit system to mitigate pharmaceutical fraud.
Answer: In my previous role as CIO at a private equity firm, we only intended investing in blockchain-based start-ups so I became quite interested (and knowledgeable) about its commercial potential outside of virtual currencies (particularly in fintech applications although this is a very crowded space). Whilst many of the international pharmaceutical regulators have established similar anti-counterfeiting initiatives, their databases of virtual UI’s can easily be hacked and the criminal gangs that control the counterfeiting market are easily capable of doing this. It is the weakest point of their systems and the most vulnerable to attack.
Answer: The blockchain we use we call a hybrid. “Hybrid” refers to the fact that we are not using a traditional blockchain solution which uses a single notary to guarantee ledger entries. Instead, we use multiple notaries that provide their guarantees using a variety of different algorithms (i.e. no consensus algorithm required to confirm transactions in a block of the chain which means “miners” are no longer required). This dispenses with the traditional proof-of-work concept which means there is no longer any need to quantise the timeline of transactions into blocks because the parties asserting the transaction correctness of the ordering are known ahead of time hence regular virtual-signatures are sufficient. “Hybrid” therefore refers to blockchain security without the need for supercomputer algorithm-based encryption of each block.