In 2020, the New York Times published a story about a scandal involving AstraZeneca, a multinational pharmaceutical and biotechnology company, and one of China’s biggest vaccine makers, Shenzhen Kangtai Biological Products. The British-Swedish drugmaker partnered with the Chinese company to become the exclusive manufacturer of their coronavirus vaccine.
However, Shenzhen Kangtai has a long history of infamies, including legal battles, bribes for drug approvals and infant death reports. While the partnership plays a vital role in distribution, AstraZeneca’s relationship with Kangtai can hurt the reputation of the pharmaceutical company and its vaccines.
Numerous scandals like these exist in the pharmaceutical industry in which data is often fabricated to pass a crucial approval process. It’s not surprising that public trust in the pharmaceutical industry is dwindling.
In a Bitcoin Association panel discussion on Better Health Care with Blockchain: Patient Records & Clinical Research, Phillip Runyan emphasises the significance of trust in the pharmaceutical industry: ‘Trust is paramount, and there’s a lot of times it’s extended without asking for much in return.’
The healthcare industry should make moves to rebuild people’s declining trust. One way to do that is to incorporate blockchain into their systems. Runyan adds, ‘Blockchain technology can help create more trust in the drugs that are released in a proven marketplace to help curb instances of fabrication and fraud.’
In the infographic and article below, we’ll explore how pharmaceutical blockchain can serve as a solution to several industry challenges.
The pharmaceutical model is built on a house of cards
According to the Food and Drug Administration (FDA) ‘s Generic Drugs Director, ‘The approval system requires the ethical behaviour of the applicant. Otherwise, the whole house of cards will fall down.’
In pharmaceutical scandals, data integrity is often at risk. Without it, the whole pharmaceutical model will crumble. Every aspect of the pharmaceutical model requires trust: Patients rely on the doctor to prescribe safe medicine. Doctors rely on the FDA to approve safe drugs. The FDA relies on pharmaceuticals to provide truthful and verifiable data.
Ranbaxy: the dirty drugs scandal
When one party isn’t truthful with its operations, the whole model collapses. Take the Ranbaxy scandal, for example. American investigative journalist and author Katherine Eban revealed in her book, Bottle of Lies: The Inside Story of the Generic Drug Boom how Ranbaxy committed fraud and potentially harmed patients on a global scale.
Ranked eighth in the Global Generic Drug Manufacturing, Ranbaxy operated in 49 countries with over 200 products. It was later discovered that they used falsified testing data and substituted lower purity ingredients. The large scale of the case put Ranbaxy under the media spotlight that prompted more investigations into similar cases.
During an investigation of 86 plants, 67 plants located in India and China were found to be actively engaging in fraud. This data is concerning, as 97% of all antibiotics in the U.S. are manufactured in China, making it more likely for you to encounter a fraudulent drug.
Counterfeit drug manufacture
Another challenge the pharmaceutical industry faces is counterfeit drugs. Dr Ruchi Dana, a medical doctor and a Stanford MBA, brings this issue to light during the Bitcoin Association panel discussion. She says, ‘Drug counterfeiting is a big industry, specifically with generic drugs, but even with branded drugs. In emerging countries, these counterfeit drugs are sold without things like an expiration date or the origin.’
In this regard, she highly thinks that the healthcare blockchain can help. She adds, ‘Blockchain is ideal for supply chain operations, which goes for drug supply chains, as well.’
The COVID vaccine bubble
Pharmaceutical data integrity isn’t only applicable to drugs but also vaccines. With vaccine rollouts, there is no space for wrong information. Small mistakes can lead to grave consequences; hence, the management system should properly plan, procure and prioritise the distributions relevant to this mass campaign.
In the Bitcoin Association panel discussion, Muhammad Salman Anjum, managing director of the Avantas Tech/Bin Zayed Group, warns, ‘Many companies are coming forward claiming to have invented a COVID vaccine. There’s plenty of money up for grabs, and a ton of fraudsters are paying attention.’
He adds, ‘Unless these mass campaigns are based on a trustworthy layer, like a blockchain that creates an immutable and transparent record of the entire chain of custody, there could be a disaster.’ He also says, ‘Vaccination management system on the blockchain is very heavily required. If we don’t do it right, we’ll have another 2020.’
In the next section, we’ll discuss the features of blockchain and how it’s a suitable solution to the challenges above.
A blockchain solution to building trust in the pharmaceutical model
As a public distributed ledger, blockchain can secure all the data logged into it, making all information accurate and transparent. The following are some ways blockchain can improve the pharmaceutical model and regain the public’s trust.
- Data integrity
Blockchain ensures data integrity as each bit of data acquired is stamped with time and origin. You can obtain data from different sources, share it with the ecosystem, and secure it. If needed, updating the data is possible, but the version history is never overwritten. Since everything is publicly recorded, the data can never be destroyed or tampered with, making blockchain ideal for healthcare and patient data.
- Prevent counterfeit manufacturers
With blockchain, you can authenticate manufacturers similar to the Know Your Customer or KYC process in which individuals and organisations can verify identities using a provider ID. Due to the secure tracking system of blockchain, you’ll be able to access the proof-of-origin of a product. This feature will allow legal enforcement agencies to spot the counterfeit nature of suspect products.
- Sharing of data with highly granular permissions
The nature of research data is sensitive. It entails not only corporate IP but also personal health data. Therefore, it requires a highly secure system. Blockchain can be that system as it allows data sharing with highly granular permissions. Access permission is distributed to data owners. If hackers want in, they will have to infiltrate each data owner’s security individually, making it highly unprofitable to hack.
Research integrity and data authenticity with a blockchain-based platform like Veridat
Veridat is an example of how blockchain works to protect healthcare data. It’s a SaaS platform provider that harnesses the power of the BSV enterprise blockchain to help improve data security and authenticity in the pharmaceutical industry.
The company’s flagship product, Bench, is a cloud-based service that effortlessly captures critical time-dependent information to the BSV blockchain to provide what they call ‘Trust as a Service.’ Veridat verifies the occurrences of events and data accuracy, from pre-clinical trials to production and distribution.
Runyan explains the process of Veridat that starts with “capturing the information as it occurs in real-time. Then, it hashes the information to the BSV blockchain. From there, that hash will then create a timestamp verifying that this event occurred on this day and at this time. Any data that is created from that again is hashed. We can verify these things against our own hash generators.”
All data files and iterations are stored and hashed in cloud service and blockchain for easy viewing and retrieval, never deleting or overwriting. By utilising BSV—the only global enterprise-ready blockchain—Veridat and its users can ensure security and immutability.
Always access accurate information
When data is on the blockchain, no one can make any changes under the radar as everything is recorded. Individuals and organisations will be able to access the information they’re looking for, like the product’s origin, and verify its legitimacy.
Runyan shared during the Bitcoin Association panel discussion that they are working together with the FDA in incorporating blockchain in their systems. “The FDA is not new to blockchain technology. They discovered that they could verify data during the manufacturing process or clinical trials and easily authenticate data by having one-click options to view on the chain.”
When more healthcare organisations implement blockchain, the people can get the transparency they need and deserve, increasing the trust with pharmaceuticals.
If you want to learn more about blockchain and how it can help different industries, visit BSV Blockchain.