Blockchain has the potential to reinforce a broad range of pharmaceutical and healthcare industry functions, both within and outside of the drug supply chain. Its ability to create a decentralised and distributed database is ideally suited to these sectors, which have been under a global spotlight recently.

Blockchain enables the sharing of information on a secure, tamper-proof and indelible database. In a utopian blockchain environment, a blockchain database could facilitate the sharing of information between pharmaceutical and healthcare institutions, such as the Malta Medicines Authority (the “MMA”), as well as manufacturers and distributors. Blockchain could also be a useful facilitator for electronic health records that are shareable between different health organisations but with improved data security.

Management of Pharmaceutical Supply Chains

Today, different players within the pharmaceutical industry use various processes and software to manage supplies. In fact, supply chain costs are one of the largest expenses incurred. Blockchain provides an opportunity for industry players to stream-line these costs. For example, the efficiency of the supply chain could be facilitated by tagging pharmaceuticals with a unique barcode, which is then scanned and entered onto the decentralised database. Whenever these products are transferred from one organisation to another, the product is re-scanned, creating a new block which is then added onto the existing chain. This technology allows organisations to track the movement of pharmaceutical supplies and any movement recorded onto the ledger is updated in real-time, creating a realistic picture of the true whereabouts of the product.

Improved Interoperability

Better data sharing practices both between healthcare providers and between pharmaceutical companies on a European and/or global scale, would result in a higher probability of accurate diagnoses, more effective treatments and the overall increased ability of the healthcare sector to deliver cost-effective healthcare. These results arise because data inputted and stored on a Blockchain database is stored in a decentralised manner. This means that healthcare providers and pharmaceutical companies are able to access the database at any point in time, without needing to outsource their storage of data to multiple third parties. The information stored on the distributed database is updated in real-time and time stamped, allowing a doctor, for example, to retrieve accurate information on a patient as soon as it is needed. Moreover, the implementation of a national, private Blockchain, whereby each participant within the network has authorised permission to view the ledger, could facilitate in the creation of unified patient identifiers. This would hopefully result in the creation of a longitudinal type of health record which a patient or healthcare provider could access no matter in what hospital, pharmacy or clinic he or she walks into.

Clinical Trials

Clinical trials are experiments or observations performed during clinical research. A clinical trial begins with researching a large pool of various drugs in order to establish which of those drugs demonstrates the most promising results. Once that is established, the drug (or drugs) moves into the next stage where it is administered to various groups of patients in order to determine its efficacy and efficiency. The underlying architecture of Blockchain, with its tamper-proof method of function, could prove to be an ideal type of database that pharmaceutical companies could utilise to collect data at any point during a clinical trial, but particularly during phase IV. This phase is also known as the post-market surveillance phase and requires that the drug be monitored after it has been given permission to be placed onto the market. Creating a Blockchain ledger which permits patients or their healthcare service providers to upload the patient’s progress after starting the course of the drug would drastically facilitate this phase of the clinical trial.

Medical Records

In Malta, certain electronic records, like x-ray and blood results for example, already exist within the healthcare system. These records are held in a centralised manner and each record has a unique identifier. Using a Blockchain-based database, medical records would be operated on a decentralised network. This could result in a decreased risk of unauthorised access if the Blockchain developed included protocols that would govern when and how medical records could be accessed. If this type of network were ever to be implemented, regulators would need to determine whether the medical records inputted into a Blockchain are legally considered to be conclusive evidence of the records’ validity and existence; or whether those Blockchain-based records are merely indicative of the existence of such records as a matter of fact, especially in cases of medical negligence and insurance claims.

Counterfeit Products

Applying Blockchain technology to management and distribution of pharmaceutical products would permit the products to be indelibly inserted on the Blockchain. In this way, a patient or healthcare provider would be capable of tracing the product back to its origin, and thereby be able to distinguish between counterfeit products in market circulation. A patient or healthcare provider would also be able to ascertain that a particular product has been produced in the country or by the manufacturer indicated on its label, for example.

The ability to add unalterable blocks of data to a Blockchain database would be of particular relevance to many sectors where territorial management of rights is crucial, such as the manufacturing and distribution of pharmaceutical products. A Blockchain database could reveal the location and distribution of pharmaceutical products at all times, tracing them from manufacture, delivery and finally to the patient. Traceability on the Blockchain database could enable manufacturers to monitor and control leaks from their distribution networks. Products could be embedded with unalterable tags and the absence of such tag would easily get caught out in checks. Undoubtedly, these characteristics would be most useful for the products’ right-holders’ in order to control grey markets, where illegal parallel importation of products may tarnish the right-holders’ profits and goodwill.

What about Data Protection?

Whenever the storage or transfer of medical or health data is discussed, alarm bells surrounding data protection begin to ring. At first glance, the features which make up Blockchain technology may be difficult to reconcile with certain data protection aspects and, in particular, with the framework established under the forthcoming General Data Protection Regulation (“GDPR”). However, these data protection barriers are more evident in regard to public Blockchains, rather than private ones. In a private Blockchain, an administrator may be employed which might provide the solution to most Blockchain data protection related difficulties.

It is important for companies to note the principle of data protection by design and by default, which implies that companies developing Blockchain technologies must develop such technologies in a way that are embedded with data protection compliance.