Blockchain, the technology popularized by Bitcoin is now making waves in almost every industry. Finance, Automotive, Real Estate, Food, Jewellery, Logistics, and many others have implemented blockchain to streamline various business processes.
Many recent global incidents call for a more efficient and trustworthy management system in the Pharma industry. For instance, the COVID-19 vaccine project is shining a spotlight on ways to improve supply chains, to make them more efficient, safer, and trustworthy. The Drug Supply Chain Security Act (DSCSA) passed by the US congress requires pharma companies to serialize and track the drugs sold in the US. One technology that could provide added value to the monitoring and problem-reduction efforts of the drug supply chain is blockchain. Apart from this, there is a need for improved data security and privacy when it comes to pharmaceutical R&D, clinical trials, etc. Blockchain technology is best known for its security features, making it suitable for handling these sensitive data.
How blockchain technology could prove an asset to the pharmaceutical sector
Blockchain technology provides a unique combination of features that makes it suitable for a wide range of applications in various industries. Several pharma companies are exploring its usage as a more secure business solution, which could address major pain points of the traditional Pharma industry—including supply chain disruption, data discrepancy, stagnation, and low scientific productivity.
The major use cases of blockchain technology in the Pharma industry are
Supply Chain Tracking
Blockchain solves the supply chain problems the pharmaceutical industry is currently facing. The technology’s enhanced features provide the foundation for full traceability of medicines, from manufacturers to the end consumers, as well as being able to pinpoint where the supply chain for pharma breaks down in the event of a problem. If a drug supply chain is built on a blockchain and monitored, every time the drug is touched, from manufacturing, shipping, and registration to warehousing and sales, each transaction will be entered into the blockchain and tracked. If there were ever a problem in delivering drugs or medicines, the blockchain could enable the identification of the final stakeholders that a product passed through.
Cold Chain tracking could also benefit from blockchain since it allows manufacturers to track and verify the integrity of the pharmaceuticals’ temperature throughout the supply chain, based on the guidelines and regulations set forth by organizations such as the FDA and WHO. Blockchain technology can also potentially help in the prevention of diversion and counterfeiting, as medication products can be tracked from production until the moment of their arrival in patients’ hands.
Pharma companies must comply with multiple regulations set by governments and other regulatory bodies. Blockchain technology will play a pivotal role in the pharma industry’s ability to comply with the regulations. Regulations such as the Drug Supply Chain Security Act (DSCSA) by the US and EU Falsified Medicines Directive 2011/62/EU (FMD) are in place to ensure drug safety and require serialization of drugs at a unit level. In order to meet such regulations, blockchain is ideal since it is transparent and enables secure data transfer. Regulatory auditing will be easy on a blockchain network as the ledger is distributed and immutable.
Accelerating Drug Research and Development
Blockchain technology’s ability to transfer data securely within a wide network helps the Pharma industry to boost drug research and development. It helps drug researchers working from various locations to share data and collaborate easily for faster drug development. Blockchain facilitates faster and more secure data and tech transfer. Its security features ensure that the research and patient data is always protected and not tampered with. Smart contracts in blockchain can be used to establish and enforce IP protection without human involvement. Blockchain can be combined with technologies such as Machine Learning and Artificial Intelligence for faster data mining and analysis, accelerating the R&D process in pharma.
Protecting Clinical Trials
Transparency is a primary concern for patients participating in clinical trials. Pharma companies can utilize blockchain technology to bring trust and transparency to the clinical trial process. Since blockchain is a distributed ledger technology, it can be used to record trial information. This makes the clinical trial protocols more transparent. Patients can access the required information from the ledger at every stage of the clinical trial process and understand the developments taking place and the risks involved. Yet another important application of blockchain in clinical trials is managing patient consent. Consent issues such as unapproved forms, unsigned consent papers, missing protocols, not informing the patient about revised protocol, etc. are common in clinical trials. Blockchain technology solves this problem by time stamping consent forms and protocol updates, verifiable by the patients at any time. Since it is an immutable ledger, no one can tamper with the information.
Keeping the Investors Informed
The major challenge that pharmaceutical R&D is facing is information asymmetry. R&D is a complex process and there is a high level of difficulty for investors to derive information. The information asymmetry exists between the drug manufacturers and investors and the investors themselves. This creates uncertainty among the investors regarding their ROI and complicates the valuation. Meanwhile, drug manufacturers and researchers want to keep their information and processes protected at the early research stages. Blockchain technology could be a viable solution to this problem. Researchers and manufacturers can manage their research process using a blockchain network that increases information access to investors while keeping track of the ownership of proprietary information. Contracts relating to confidentiality can be automated using smart contracts, thereby reducing transaction time and cost. Blockchain technology can ensure effective collaboration between firms, researchers, and investors while maintaining a high level of trust and transparency.
Blockchain is the next big thing in tech. It’s been coming for a while and now it has arrived. The technology is still new, but more and more organizations are beginning to commit to pilot projects and research the benefits and challenges of setting up and managing blockchain nodes, as well as adopting new processes that utilize the technology. Blockchain has already started a momentum towards revolutionizing the pharma industry because of its uniqueness & zero chances of data tampering thanks to its blockchain databases. Perhaps, this is only the beginning of Blockchain in pharma industry and more and more use cases will be developed over time. Given the substantial amounts of money spent on drug companies for research, R&D, and manufacturing, blockchain is going to bag a huge number of opportunities and traction in this sector.