Today, the pharma industry is using a central database based on the Electronic Data Interchange (EDI) standard. The EDI features point-to-point connections between product maker and supplier. This process is expensive and makes a bigger scale operation between the two entities very difficult. This process also suffers the threat of diversions, counterfeiting and a trust gap between isolated systems. A Blockchain network that allows the sharing of information in real-time with participants is a solution to fixing supply chain vulnerabilities, increase compliance in the Pharma supply chain and better the transparency and traceability of Clinical Trials.
One of the biggest benefits of blockchain technology is the ability to create an auditable trail and establish drug provenance across the entire supply chain. With a distributed ledger, both the manufacturers and their clients would be able to independently verify the quality and point of origin of drugs quickly and securely because drug products can be tracked from the time they are produced until the time they reach patients. Any attempts to change records will be visible to all parties immediately.
Blockchain technology will play a pivotal role in the industry’s ability to comply with various serialization regulations. Serialization involves the unique identification of every drug product at the level of individual units, as well as in aggregated packaging units. Information on the product, its manufacture (location, date, batch number, etc.), logistics route, and so on, must be shared with all supply chain partners involved in the delivery of the drug to the patient. The intent is to make it possible to trace products back through the supply chain to their point of origin.
The transparency along with the security offered by blockchain technology is perfectly suited for serialization, not only because it enables data sharing, but also because the records are unchangeable, which facilitates regulatory auditing.
Environmental conditions within the supply chain have a direct impact on the quality and efficacy of the drug. For example, temperature-sensitive products like vaccines need to be properly monitored throughout the supply chain.
In recent times, drugs are checked in the supply chain by using IoT devices. Humidity, temperature, and any other environmental factor is checked and noted using these smart technologies.
However, since each participant of the supply chain i.e. the manufacturer, the logistics company, the stores and the pharmacies etc, maintain their separate ledger, a problem within any particular segment of the supply chain is difficult to track.
Blockchain technology provides the pharmaceutical supply chain a better way to add compliance and governance within the supply chain.
Patients and physicians have had growing concerns due to the current standards for Clinical Trial funding and management. Blockchain with its decentralized, immutable ledger and a mechanism to ensure transparency provides a solution. Clinical trial data can be stored in a secure, unfalsifiable and publicly verifiable manner on the blockchain. This prevents tampering with clinical trial results, thus improving the reliability of the clinical trial data. Blockchain technology can also be used to directly increase the quantity and quality of patients recruited for clinical trials in several ways.
Using blockchain individual patients can store and control access to their medical data, and make it visible to trial recruiters, who could then reach out to the patients if their data qualify for the clinical trial. The decentralized nature of blockchain gives to the patients, control over their data, and consent and its revocation.