A trust-based system

Cross-industry collaboration

Electronic leaflet

Digitized future

Science

Unblocking healthcare impasses

Kick-started by a small Novartis team in 2017, the cross-industry association PharmaLedger aims to leverage blockchain technology to make healthcare safer and more efficient. The ambitious collaboration aims at nothing less than transforming the sector and solving some age-old problems with the use of smart tools.

Text by Jovana Rakovic and Goran Mijuk, photos by Laurids Jensen

A step-by-step experience of the PharmaLedger app. This could soon be the reality for millions of patients around the world.

Table of contents

A trust-based system

Cross-industry collaboration

Electronic leaflet

Digitized future

Published on 19/12/2022

Global healthcare made major strides in the past few years from developing breakthrough gene therapies that have the potential to cure diseases to the ubiquitous use of big data technologies to speed up drug research. But many elements along the complex road from bench to bedside still need fixing.

Just think of the following cases: A thousand miles from home, a tourist struggles to translate the instructions on the patient leaflet as his migraine gets worse; elsewhere, a batch of pills is recalled due to contamination, but not everyone who bought a package can be alerted; meanwhile, a patient is filling her shopping basket at an online pharmacy, unaware that the medicines are fake.

Such challenges have been burdening the industry for many years. While solutions for some of them have been developed in regional, often affluent pockets of the world, an elegant and cost-efficient panacea that could solve them globally – and especially support developing countries – is still lacking, at least until recently.

The seed to overcome many of these challenges was planted in 2017 by Dan Fritz and Marco Cuomo from Novartis, who dreamed up a plan that would leverage blockchain technology – a distributed database and software method that holds the promise to secure the entire value chain of the healthcare industry from distribution to drug delivery.

A trust-based system

Blockchain technology has been around for more than a decade – currently it is mostly associated with cryptocurrencies. Unlike classic database systems, which structure data into tables such as the popular Excel files, blockchain orders data into smaller groups called blocks – hence the name.

These data blocks, also often described as ledgers, are then strung together to form a chain. And this is the trick: The blocks, which can be shared by their creators, cannot be changed by anyone else, which protects them – at least theoretically – from manipulation. This technical ability, Cuomo and Fritz were convinced, would make blockchain an ideal vessel to move information safely and securely across the complex healthcare value chain and thus increase trust.

“Blockchain is a new way of thinking about digital technology within the healthcare system – our goal is to make information decentralized, without a single authority in charge,” Cuomo explained the underlying strength of the system. “By using a blockchain network we can create a system where every participant is equally in control and responsible for the information they share.”

After conceptualizing their idea, Cuomo and Fritz soon realized that if they wanted to succeed, it would not be enough to simply kick-start a venture within Novartis: They would need a much larger, industry-wide group of experts to lift their plan off the ground. “To make such a thing work, you need to pool resources and risk,” Fritz explained. Luckily enough, their call met with enthusiasm when they approached Gwenaelle Nicolas, who works as a liaison between Novartis and the Innovative Medicines Initiative. The IMI, and its successor program Innovative Health Initiative, is a European research venture that connects public and private partners to conduct cutting-edge research.

For Nicolas, the project was spot on to leverage IMI’s industry-shaping potential, as well as leveraging the possibility to collaborate with companies from other sectors outside the pharmaceutical industry.

Cross-industry collaboration

After pitching their idea to the IMI, Cuomo and Fritz, who originally called their project “Blockchain Enabled Healthcare,” received funding and were able to convince around a dozen other industry partners to join. “Blockchain was the buzzword at the time,” says Cuomo, “so everyone wanted to jump in.”

The team was joined by an applicant consortium of 17 public partners including universities, hospitals, patient organizations and technology providers to create the “PharmaLedger” consortium and project. As the project gained steam, some 200 people were involved in the venture at peak times, giving the team the strength to make rapid headway.

“Three elements are required to make blockchain succeed: mastering the technology, understanding the business aspect, and a strong grasp of legal and governance,” Fritz said, detailing the three pillars on which he based the project. “With respect to the legal and governance aspect, the collaboration within the framework of IMI was crucial for such a pioneering effort.”

Besides external partners jumping on the bandwagon, collaboration with Novartis Operations, which includes the company’s manufacturing division, was also vital for Cuomo and Fritz to make palpable progress. “As we wanted to achieve some tangible results within the three-year timeframe, which was planned as part of the IMI project, we found a strong partner in Novartis Operations,” Fritz said. “They took the lead in developing an electronic product information solution, which was one of the ideas we wanted to turn around first.”

Electronic leaflet

Creating electronic patient leaflets sounds like low-hanging fruit in a world that is getting increasingly digitized and in which millions of people only read books and news online. But to turn the idea into reality took quite a while given the regulatory and legal aspects surrounding such a move.

Nevertheless, the technical set-up for the first pilot was relatively straightforward. PharmaLedger engineered an app which can read the existing barcode on medicine packs and provide patients with access to vital product information in digital form, also known as an eLeaflet.

Compared to the classic patient leaflet, PharmaLedger’s app has the advantage that the latest approved version of the product information can be provided to patients. Furthermore, patients who also partnered with PharmaLedger and provided their input could switch between different languages and navigate quickly to the section they wanted to read.

“Patient advocates shared their insights about what they wanted to see in the app,” said Hirkirit Virdee, a clinical expert, who is also part of the team. “The inclusion of a search function, for example, was a direct consequence of our discussions with patients.”

Currently, pilot projects are underway in two countries, and the first electronic product leaflets are expected to go online next year. During the initial testing phase, patients will receive both the eLeaflet as well as the classic paper leaflets.

Digitized future

While PharmaLedger’s run as part of IMI is set to close by the end of 2022, the team’s work will continue. They have already set up a nonprofit, Switzerland-based association, which will oversee post-project governance and operations in future.

“Things in the pharma industry don’t move that quickly, and you need perseverance and discipline,” says Fritz, who left Novartis to continue work for the PharmaLedger Association. “But you also need passion. Our teams are not here just for their careers, they truly believe in what they can bring to the healthcare ecosystem,” Fritz adds, underlining his motivation to continue on the current path.

PharmaLedger’s team is aware that blockchain is not a silver bullet that will fix all of the industry’s challenges. But the technology can prove useful to tackle some age-old problems. All in all, the team still aims for a revolution, also because the nature of the internet is changing. "We are approaching the era of a decentralized World Wide Web,” Virdee said, referring to a trend that suggests the internet might in future not be dominated by a few large players, but rather by a multitude of service providers. “Blockchain technology will make it possible for patients to control their own data.”

As part of this process, the team plans to add more services to its roster of digital solutions, which are aimed at securing the supply chain, strengthen existing anti-counterfeit measures and enhance clinical trial recruitment.

If PharmaLedger can live up to its own expectation, the pharma sector and especially patients are set to benefit. Situations like the one described at the beginning of the article would be a thing of the past. Anyone who buys and scans a package of pills could in future receive an instant alert as to whether the drugs are fake or original. Product recalls could be sent to all patients who bought a specific product, without needing to resort to mass media. Likewise, patient leaflets could be read in any language, irrespective of where patients have bought their medicines.

This future might still be far off. But the first step has been taken and PharmaLedger is marching on, sticking to the team’s motto: “If you want to go fast, go alone. If you want to go far, go together.”

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