Blockchain is a buzzword and this new technology is maturing day by day. It is amply clear from banking to supply chain; it is ready for disruption. Blockchain technology can revolutionise various fields particularly in the healthcare sector to bring the change and lead a digital transformation, from medical records to pharmaceutical supply chains to smart contracts for payment distribution, there are plenty of opportunities to leverage this technology. Blockchain technology can change the healthcare in three ways: –
- Health Records – Electronic Medical Records (EMRs) are the backbone of every modern healthcare system. But as the medical record grows longer and becomes more complex with each visit to the doctor, it is not always easy for healthcare providers to obtain them. Companies like Patientory, Medibloc or Medical chain aim to solve this problem with a goal to give patients the authority over their entire medical history and provide a one stop access for patients and physicians as well. Blockchain would not only simplify and make access more efficient, but inherently bring data security to this field as well.
- Supply chains – The pharmaceutical industry has one of the highest standards for product safety, security and stability vulnerable to disruption. For example: supply chain management with the help of blockchain technology can be monitored securely and transparently, reducing time delay and human error. It can also be used to monitor costs, labour and even waste emissions at every point in the supply chain. It can also be used to verify the authenticity of products by tracking them from their origin source, combating the counterfeit drug market that costs 200 billion dollars in losses to the market annually. Companies like Chronicled, Block pharma and Modem are already working towards more efficient Blockchain logic solutions.
- Genomic Market – Companies like Encrypgen and Nebular Genomics are building Blockchain platforms to enable people to share genomic data safely and securely in a new emerging market. They claim that in future, opportunities around personal genome sequencing will create a data market with billions of dollars and will be the best technology to solve data security issues and to ensure that data gets from the source to its end-user without any middlemen.
Underlying Problems in Pharma Industry
As per WHO reports,
- One in ten products circulating in low and middle-income countries are either substandard or falsified and in western markets about 1% of all drugs in circulation are believed to be fake.
- The global market for fake drugs is blooming, counterfeit pharmaceuticals are a lucrative sector with roughly 200 billion euros in circulation.
- The rising complexity of supply chains in a globalized world as well as the growing number of online pharmacies leveraging the anonymity advantage of the internet surely contribute to these developments
- Developing new medications that can treat (or prevent) the incurable illnesses of today – The most visible obstacle remains the greatest one. There are some new treatments for already incurable diseases that Big Pharma has to come up with. Alzheimer’s Disease and multiple cancers continue to be among the list of people that need to make real progress.
- Customer standards are constantly increasing – The market climate is only becoming tougher and more ruthless. Payers of healthcare continue to impose further rate controls on the providers. Around the same time, they are actively scrutinizing the dollar value provided by individual drugs to their members even more closely than ever before. They expect better medications and therapies that deliver higher benefits at more cost-effective rates than the existing ones. In order to reinforce all arguments made about the supremacy of one medication versus rivals in the region, they often insist on seeing evidence for real world clinical outcomes.
- Issues of management culture slow much needed changes – Another ingrained aspect, which is difficult to reform in a rush, is management culture. The prevailing management culture, industry-wide strategies, and mental models on which the sector has become dependent are more or less identical to what it has always relied upon. Despite this fact that newer methods of doing business today and for tomorrow have disrupted them. Through the design of their pharmaceutical website, pharma seo, and the development of integrated content experiences, management would need to concentrate on developing better digital experiences for their consumers.
Therefore, it is a top concern for the pharma industry and health regulators to fight the shady world of the largest fraud market.
How can the problem be solved?
Several countries have been working on a medicine tracking system for years, but tracing and authenticating drugs moving through the distribution network requires an appropriate electronic system. Until now, serial numbers and barcodes or radio frequency identification are the basic steps to verify drugs with the pose-pedigrees being another tracking option. However, these supply chain solutions are not interoperable and won’t have a significant impact on preventing counterfeits and in the end protecting patients.
Blockchain Technology can be used to track all transactions of an asset in a distributed ledger of cryptographically secured time -stamped records, thus enabling the digital transfer of values -directly and without middlemen. Blockchain is a decentralized and transparent system that does not need trusted third parties such as banks but establishes trust via secure and traceable transactions with an immutable IT infrastructure. Also, everybody can participate in a peer-to-peer network ecosystem making faster and cost -saving dealings possible.
In order to address the counterfeit drug problem caused by insecure supply chains, blockchain could work as a drug supply platform with manufacturers as well as end customers for it’s unique ability to track pharmaceutical products throughout the whole supply chain by ensuring drug identification, tracing and verification, thereby benefits such as trust and transparency can be achieved. E.g. – Cryptotec ensures the authenticity of drugs from production house to delivery of the pharmaceutical product, thus preventing introduction of counterfeit products into the market.
“The pharmaceutical industry has one of the highest standards for product safety, security and stability vulnerable to disruption.”
Pharmaceutical Supply Chain
The capacity to create an auditable trail and establish drug provenance throughout the entire supply chain is one of the greatest advantages of blockchain technology. A survey conducted by the Pistoia Alliance revealed that nearly 70% of pharmaceutical and life science leaders believe that blockchain will have the greatest impact in this area. Both manufacturers and their customers would be able to independently verify the quality and point of origin of drugs quickly and securely with a decentralized blockchain solution.
For members of the pharmaceutical supply chain, transparency and security are two other key benefits of blockchain technology. All stakeholders involved in the supply chain must be able to share and update information while also ensuring that the information is timely and accurate. The entire supply chain can be managed with blockchain technology with one piece of software shared between authorized stakeholders. In addition to drug manufacturers and their suppliers, the data can be accessed by payers, suppliers, pharmacies, and patients to see when it is updated in near real-time.
“Blockchain Technology can be used to track all transactions of an asset in a distributed ledger of cryptographically secured time -stamped records, thus enabling the digital transfer of values -directly and without middlemen.”
Blockchain and Serialization
Blockchain technology will play a key role in the willingness of the industry to comply with various regulations on serialization around the world, including the U.S. 2013 Protection Act of the Drug Supply Chain (DSCSA) and EU Falsified Medicines Directive 2011/62/EU (FMD). Serialization includes the specific identification, at the level of individual units as well as in aggregated packaging units, of and drug product. It is important to exchange information on the product, its development (location, date, batch number, etc.), the logistics path, etc., with all supply chain partners involved in the distribution of the medication to the patient.
The aim is to make it possible to track goods back to their point of origin across the supply chain. Blockchain technology’s transparency and protection are ideally suited to allowing serialization, not just because it allows data exchange, but also because the records are unchangeable, which makes regulatory auditing simpler.
“In a doctor’s office or hospital, it can also allow 3D printing of personalized drugs.13 One such drug has already been approved by the FDA: Spritam®, as approved in 2015, for the treatment of epilepsy.”
Impacts of Manufacturing
The development of next-generation, individualized treatments may also be enabled by blockchain technology. The logistics involved in the development of autologous cell therapies are highly complex and require a chain of identification assurance. The sample taken from a patient must be returned to that patient until transformed into cell therapy. Blockchain technology can help the manufacture of this type of customized product.
In a doctor’s office or hospital, it can also allow 3D printing of personalized drugs.13 One such drug has already been approved by the FDA: Spritam®, as approved in 2015, for the treatment of epilepsy. Better structures are required for handling manufacturing and patient data to make this approach to drug manufacturing more practical. For the determination of the optimal dose and formulation for a given patient, AI and ML could be used to analyze this safe data and input it into a 3D printer for the development of a customized drug.
“The technology is an excellent match for monitoring the work carried out in a network that is decentralized and convoluted.”
IP and Tech Transfer
This issue could be resolved by blockchain-based platforms to manage early-stage technology details. The technology is an excellent match for monitoring the work carried out in a network that is decentralized and convoluted. Investors will use the platform to identify the owners of a given technology and create permanent records of any deals they execute. Smart contracts allowed by blockchain technology, once the underlying binding contract has been coded, allow the execution of a contract without human intervention.
These smart contracts will allow pharmaceutical companies, for the protection of intellectual property, to develop and enforce IP agreements, such as license agreements, and even to make payments in real time in response to the recording of milestone achievements. Blockchain security and accountability could also provide a digital way of protecting documentation of the roots of innovation and ensuring the safety of trade secrets, such as the specifics of the development process.
Blockchain and partnerships with payers
Through monitoring forms, negotiating discounts and rebates, and processing and billing prescription drug claims, usually through electronic channels, pharmacy benefit managers (PBMs) act as intermediaries between pharmacies, drug suppliers and payers. A much more effective and transparent solution could be provided by Blockchain technology that could minimize duplication, alleviate price variations and provide a better customer experience. Blockchain technology and intelligent contracts, for example, could accelerate the process of insurance authorization on the front end and pace claims processed on the back end.
One of the key limiting factors for the introduction of blockchain technology in the pharmaceutical industry and other industries is the construction of the infrastructure to enable data exchange and transaction monitoring through the pharmaceutical production supply chain and the broader healthcare system.
The development of applications that can exploit blockchain technology is the priority of all major application software companies and many new start-ups. Acceptance of data exchange must be realized in addition to the implementation of these physical networks, which will involve cooperation and demonstration of the protection and privacy features of blockchain solutions.
- Novartis is using blockchain technology and the IoT to identify counterfeit medicines and track temperature with real-time visibility for all participants in the supply chain.
- Merck recently garnered a blockchain patent on its own covering technology for preventing counterfeit drugs by increasing supply chain security.
- In a combined effort, Pfizer, Amgen and Sanofi are investigating the use of blockchain technology to safely store patient health data to speed clinical trials and lower drug development costs.
- Blockchain startup Exochain offers a way to securely store and manage clinical trial patient data that also allows patients to control how researchers may interact with their medical data.
- Boehringer Ingelheim (Canada) has partnered with IBM to test the ability of the latter’s blockchain platform to “improve trust, transparency, patient safety and patient empowerment in clinical trials” by improving the management of clinical trial processes and records.
- Recently, IBM announced that it is working with KPMG, Merck and Walmart to develop a pharmaceutical blockchain platform that can track drugs as they move through the global supply chain.
- MediLedger, which has over 20 members, including Pfizer, Amgen and Gilead. The goal is to leverage blockchain’s capabilities to create an interoperable system in which multiple parties, including manufacturers, wholesale distributors, hospitals and pharmacies can register, verify and transfer pharmaceutical products with absolute trust in their authenticity and provenance.
- With blockchain technology, the entire supply chain can be managed with one piece of software that is shared among authorized stakeholders.
The benefits of incorporating blockchain technologies to enhance the protection of the supply chain, promote clinical trials, and improve patient data management effectiveness are obvious. Of course, some degree of danger comes with the introduction of every new technology. While blockchain technology is attractive because it guarantees confidentiality, it is not possible to completely remove or ignore the risk of data breaches or system failures. Scalability is also a concern which has yet to be tackled.
“Composed by: Kritika Arora, Col Niteesh Kumar, Sneha Khurana are curious about emerging health innovations and want to use their expertise to help India’s healthcare sector develop while also gaining new experiences.”
“Dr Reshu Mathur and Dr Priyanka Gupta intend to use their medical backgrounds to help streamline the health-care system.”