Beyond the Data: Is Blockchain the Answer to Improving Global Health?

The pharma industry has long been riddled with data accuracy, privacy and transparency issues affecting clinical trials, supply chain and counterfeit drugs. The industry has been exploring technological solutions to address these issues. The COVID-19 pandemic has highlighted the urgency for adoption of digital platforms by both the healthcare and life sciences industries to overcome the challenges and address vulnerabilities. Patients have also demonstrated an increased inclination to adopt digital technology in order to achieve better treatment outcomes.

Including technology within each company’s DNA by using big data, AI, machine learning and other technologies available is the key to progress. In order to improve medical research and achieve patient-centricity, the industry needs to exploit emerging technologies. This will facilitate the creation of user and customer centric interfaces and data driven decisions for new ways of data collection and better outcomes. For example, the use of data and AI supports the identification and targeting of specific patients for drug discovery and development, important for personalized drug development and reducing timelines. The management of clinical trial data using computational drug design methods and AI is used for repurposing existing drugs, analysis of efficacy of combination of drugs and measurement of dosages.

As a result of this rapid changing environment, we must consider the best methods to manage this data and drive the change while maintaining the necessary privacy, compliances and data security. This raises an important question: “Is it time to reconsider other technologies such as blockchain as the technology to facilitate the change and improve global health?”

Blockchain

During the COVID-19 pandemic, digital adoption has increased and most probably will stay in some or in many of the three main areas shown in Figure 1 below, whether in R&D area, in manufacturing and distribution or in commercial. Consequently, there is a more prominent need of having a secure platform for the exchange of digital information across the different participants of drug discovery and healthcare network.

Figure 1. The drug value chain, from R&D to clinical trials to Supply Chain and commercialization. (click to enlarge)

There are five parameters to consider when selecting the most suitable technology to turn digital and blockchain does have its own uniqueness to achieving them:

1. Data provenance: It is important to establish data traceability i.e. where is the data coming from, who is sending it and who is supposed to receive it and data reproducibility. Depending on the purpose and the number of stakeholders involved, one technology will be more suitable than another. Blockchain is a good fit when there are a high number of participants (e.g. sponsor, investigators, patients/subjects, laboratories, health authorities, etc.) and multiple geographies involved, where data needs to be shared within a network of participants. This also provides for transparent and real time data visibility removing time delays common in clinical trials. Furthermore, blockchain inherently provides data quality and drives a new governance model that is compulsory to be followed by the participants.
2. Data integration and interoperability: Data needs to be securely exchanged between disparate systems e.g. EHR and EDC while maintaining the necessary security against unauthorized access or tampering with the data. Blockchain by design helps achieving this ask.
3. Data privacy: It is not only about who is sharing with whom and why but also the intended bodies should be able to see the data only for a specific purpose. As such, privacy and access controls are even more crucial in the highly restrictive clinical trial area. With blockchain, different privacy accesses are granted based on authorizations.
4. Data auditability: Maintaining an audit trial is a given task of any digital platform.The immutable time stamping of events/transactions and adopting a one-way hashing/encryption establishes data trust. Thus, reducing risk of fraud and carrying out cost effective improvements which may be difficult to achieve with existing technologies.
5. Collaboration and disintermediation: Blockchain platforms provide the opportunity to create a distributed ledger where data can be shared with all intended recipients in real time. For e.g. a patient can enter his health data and provide access to investigators, CROs, etc. as necessary with complete assurance of data control, maintenance of privacy and confidentiality.

Blockchain – Use cases

During (and post-) COVID-19, blockchain can be a game changer in the healthcare and pharmaceutical industry. This is achieved by adding value to the different stages of the drug discovery value chain and consequently, considerably reducing the timelines and cost for a drug / vaccine to go-to-market.

Moreover, the blockchain technology is also relevant in the supply chain from manufacturing to the distribution channels and commercialization (see Fig.1). Due to the growth of e-commerce and considering the current pandemic situation, there has been an increase of the purchases of medicines from unauthorized sources. The use of blockchain could help increase the access, quality and safety of the distribution of health products by bringing drug traceability during the entire shipping process. This would facilitate possible investigations for drug trafficking, ensuring patients that the medicines are not falsified and allowing a sturdier control on the prescribed medicines. The company MediLedger Network is currently developing a blockchain solution for a consortium of companies, including Gilead, Amgen, Genentech, AmerisourceBergen, and McKesson among other big retailers such as Walmart and transportation providers such as FedEx for drug authentication and traceability.¹

Currently, health data is collected and shared in silos. However, by looking at the different stakeholders involved in the healthcare sector (Fig.2), it is obvious that the exchange of data between them would add value to the whole in many aspects and more when facing a pandemic of these characteristics.

Figure 2. Blockchain in healthcare and life science ecosystem. (click to enlarge)

In an ideal scenario and with the use of the blockchain technology, an entire and unique healthcare and life science blockchain ecosystem could be created. It would allow the exchange of information at a global level and at the same time be able to compare data taking into consideration different constraints and specific parameters, for example populations. Having a global highly secured collaboration platform where all the stakeholders upload the information / data brings transparency, ensures the authenticity of the data and adds real value to improve global health. These factors will help manage this pandemic and any future global health challenges.

This way of sharing the data will avoid duplication of effort during medical research and help speed up the processes for drug discovery, clinical trials and repurposing of known drugs which will result on a significant reduction of cost for life science companies. With the use of an identity management process, different accesses to the data would be granted to the stakeholders depending on each users’ purposes and maintaining the necessary confidentiality in each of the health blocks. Figure 3 summarizes all the components of blockchain that create value.

Figure 3: Blockchain benefits. (click to enlarge)

By creating a new healthcare and life science ecosystem using digital health and blockchain, the healthcare sector will considerably reduce administrative cost. Pharmaceutical and life science companies will be able to target the identification of the right candidates for clinical trials more efficiently. Online targeted recruitment and remote monitoring of patients through digital tools will qualify clinical trials to take place in a more daily-life setting and in a safer way considering the COVID-19 situation. Hospitals could also benefit from the real time platform by creating individual digital patients' profiles, skipping tedious administrative processes which are now managed directly by them (e.g. doctor's appointment or prescriptions). This way, the healthcare sector will make sure to utilize the health experts in an efficient manner avoiding the unnecessary administrative burden.

Healthcare and life science companies could take this crisis as an opportunity to bring more awareness of the advantages of going digital and explain the benefits of having access to patients' data during and after COVID-19. A digital profile with real-time data interfacing with a blockchain platform can additionally change patients’ lives by providing the necessary medical information at any time in any place directly to patients. On the other hand, the real-world data shared by researchers and other stakeholders will support clinician’s evaluation and diagnosis, when needed.

Another good use case for blockchain is the traceability of COVID-19 patients. A good example is the joined efforts between Google and Apple to enable contact tracing for positive cases. This is also developed in collaboration with universities, public health authorities and NGO´s around the world.²

So, if blockchain is the solution to interconnect all the health efforts for our future, why is the global health blockchain not yet implemented?

There are certain important limitations with blockchain. One of the main obstacles to implement a global blockchain is to define who is the ultimate owner of the data and consequently grant the permissions to access it. The ownership will usually determine from where the investment is coming, if this is private or public funding which is also a big obstacle as the implementation of this technology requires high initial costs.

Another challenge to consider amongst blockchains is the standardization of the written data. Apart from there being many users within a blockchain, there are also several different blockchains which must consider an interoperability between their protocols.

It must also be necessary to agree on regulatory guidelines to manage the medical information as well as establishing the financial and ownership rules. In addition to the appropriate regulations, there are certain conflicts between the key principles of GDPR (in the EU) and the fundamental features of blockchain such as the deletion of data. This requires smart contracts to be deployed. As many stakeholders are constantly managing the data, there must be contracts that protect the use of the information.

So, coming back to the question as to whether blockchain technologies should be considered for the future, the right answer will depend on the challenge that we would like to solve. There is no doubt that blockchain as a collaboration platform will bring many benefits for global health and more under the current global health crisis but are we ready for it? Blockchain requires the different industry stakeholders to work together which can be a great challenge and even more considering that many of them may be competitors. Therefore, it requires a consortium thinking across the stakeholders (healthcare, regulators, pharmaceutical) with the patient's consensus as being the main factor to consider for this transition. For that, there must be better awareness in the market of how the collaboration of all the stakeholders will impact the future of the healthcare for good. Separately, the Gartner Hype Cycle shows the maturity and adoption cycle of technologies ³ which proves that people are likely to start experimenting on a topic that might be quiet for two years. It determines the correct time to exploit a technology. In this case where COVID-19 has triggered an increase in data usage, the cycle demonstrates that even though companies are focused on business continuity to survive the current crisis, data management is a challenge that must also be faced.

Nowadays, data means power. Clearly, the company and / or group of companies that can implement this new digital health ecosystem at a bigger scale will get a competitive advantage in the future.

The data race has started.

References

1. https://hbr.org/2020/05/why-big-pharma-is-betting-on-blockchain
2. https://www.apple.com/newsroom/2020/04/apple-and-google-partner-on-covid-19-contact-tracing-technology/
3. https://www.gartner.com/en/research/methodologies/gartner-hype-cycle

Marta Vila Ramos, VP Business Innovation and Strategy, Rajesh Jain, Principal Consultant, Clinical Services, Paola Del Valle, Manager, Corporate Development, Carolina Torio, Specialist, Corporate Development; all with PharmaLex