2022.03.30
Blockchain in Pharma
While blockchain is popularly associated with cryptocurrencies, like bitcoin and ethereum,
companies can band together and use it as a highly secure solution allowing different entities to
communicate without revealing confidential information.
Blockchain, or Distributed Ledger Technology (DLT), is a method of building a decentralized network
where transparency, trust, immutability and privacy can be ensured with remaining control over
data.
DLT is more or less a decentralized network managed database. All data (full content) is stored in
every computer of the network, which can be public, private or a mixture of both of it (hybrid). This
model of data distribution is the first feature and benefit besides the very important factor of
security.
All information is stored using advanced encryption. So called Hash Functions make each block a
unique signature based on its original content. A change in the content, even a single bit, would
result in a change of the unique signature, making the record invalid. This feature is what makes
data stored in a blockchain immutable.
To hack or tamper a Blockchain would require simultaneous hacking of multiple computers and/or
servers at the same time, which makes it highly unlikely and extremely costly.
Blockchain advantages are
- Decentralized data storage
- No central office (mediator / intermediary / middleman) necessary
- Not censorable
- No system owner/operator
- Transparancy / the database operation ledge is open to public viewing
- Consistent view of all data, "only one truth"
- End-to-end encryption between participants
- Traceability / where does information come from and where does it go.
- Automation / "smart contracts" reduce human interventions and reliance on third parties
- Immutability
- Indelibility
- Security / Very difficult to compromise/hack
Practical USE cases for Blockchain in Pharma Medicine
Blockchain tech was introduced over a decade ago, and now it is not only used for cryptocurrency platforms, but in the meantime, it has also evolved into something more significant with the powers to change the rules and introduce new ways for cooperation.Companies including the pharmaceutical industry seem to become more interested than ever in blockchain technology and slowly try to implement it as part of their daily course of business. It allows for the secure management of a shared ledger, where operations are verified and stored on a system without a central governing authority.
Solution can come in different flavours, ranging from public, open-source systems to private ones that require explicit permission to read or write.
Pharma is driven by digitalization
Like many other industries Pharma works with loads of data thus including research, testing, drug development but also the very big area of distribution. DLT solutions can help the industry overcome some of those challenges.How could Blockchain be used in the Pharma Industry?
General logistics and distribution of drugs thus enhancing the supply chain"End to End" medical supply chain management
Recent events have shown that managing and enhancing the supply chain is key for successful business and business continuity itself. DLT can be implemented to ensure faster and more secure global transactions. In an ideal world a full auditable trial of some medicine along its full supply chain can be created. A system like this would ensure that all of the involved parties would have full access to all data but not be able to tamper/manipulate it. In addition, proper inventory management helps to manage production and demand of specific drugs.
Medical records for physicians and their patient
Decentralized data storage- and management across all the different providers and participants like patients, physicians or even Insurance companies, from research to the application of some treatment can be facilitated. In case patients decide to "opt in" all of their information can be shared with the healthcare system based on a single identifier.
Managing credentials for vendors and/or physicians (via digital certificates)
Besides the protection of Intellectual property immutably stored "digital certificates" can reduce fraud and rise trust in all involved parties. Thus, including organizations, physicians and any other authorities depending on any type of certificates.
Managing and tracking Drug pricing
Blockchain can be a tool which helps you to cut cost. Eliminating 3rd parties involved in pricing is only one of many applications which can be directly implemented to cut down on cost. Claims management via DLT can help to ensure that only valid claims are paid.
Data from IoT/IIoT at a pharmaceutical manufacturing plant in combination with "Smart contracts" let you automatically adapt prices based on the efficiency of your current output.
Drug trial data (reporting)
A DLT platform for Drug-trials can ensure the all-trial protocols are implemented and followed. All involved parties can be sure that no data has been manipulated or like in a worst-case scenario "hacked". In addition to this organizations or involved persons will be unable to have "unsatisfying" trial data disappear.
The ongoing Covid Pandemic has shown that in case of emergency "Time to Market" has to be as short as possible. If the industry is able to limit necessary resources in such a process to the minimum by utilizing "Smart contracts" instead of dozens of law firms, advisors, banks and other 3rd parties, this could (have) save(d) a lot of time and money.
Rules, regulations and compliance issues are kicking in
Several governments have plans to implement and have already implemented audit trails and total traceability for drugs and medical equipment. At the beginning of 2019, the US Food and Drug Administration kicked of a POC for identifying solutions to meet the already ratified 2023 requirements of the Drug Supply Chain and Security Act (DSCSA). DSCSA passed US Congress and was created to improve traceability and the security of the pharmaceutical supply chain and therefore enhance patient safety.DSCSA requires that in 2023 a "system" must be in place that tracks any changes of ownership of prescription drugs as they move through the supply chain.
A sample EU initiative
The Pharmaledger project is a sponsored POC initiated by the EU & EFPIA including several Pharma companies like J&J, Bayer & PDM and others.The Pharmaledger EU initiative
Sponsored by the Innovative Medicines Initiative (IMI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) under the Horizon 2020 programme, PharmaLedger is a 36-month project that brings together 12 global pharmaceutical companies and 17 public and private entities; including technical, legal, regulatory, academia, research organizations and patient representative organizations.Their objectives are: The goal of the project is to provide a widely trusted platform that supports the design and adoption of blockchain-enabled healthcare solutions while accelerating delivery of innovation that benefits the entire ecosystem, from manufacturers to patients.
Find more information here: https://pharmaledger.eu