Enterprise Healthcare Blockchain Consortia: PharmaLedger's Governance First Approach

Over the last six months we’ve written a series of posts analyzing the trend of enterprise blockchain consortia in healthcare. In these posts we have attempted to describe the companies leading the use of this innovative technology, the new business models enabled by the technology, the design patterns and use cases, and the technical protocols chosen to solve shared problems.

Table 1: Enterprise Healthcare Consortia, Hashed Health Feb 2020

In January 2020, a new consortium of pharma companies was added to our list. PharmaLedger is the second on our list to be convened by the Innovative Medicines Initiative (IMI), a public-private partnership funded by EU taxpayers and pharma companies. PharmaLedger consists of a who’s who of companies in the life sciences space including Novartis, Pfizer, UCB, Bayer, Janssen, Novo Nordisk, BI, Roche, GSK, AstraZeneca, Abbvie and Bambino Gesu Hospital. In total, 29 public and private entities will support the design and adoption of new blockchain-enabled healthcare solutions in the life sciences space. This could be the largest and most broad consortium effort to date.

Aside from the size and brand recognition of its members, the PharmaLedger network is notable because of its governance-first, use-case later approach. Instead of convening a network focused on a specific use case such as drug discovery, track & trace, or practitioner identity, this network is focusing on convening a network first, before enabling its members to bring their ideas forward for evaluation and prioritization. PharmaLedger’s areas of focus are clinical trials, supply chain, and data sharing.

Only one other network on our list, the Health Utility Network (HUN), has taken a similar governance-focused approach. The HUN, a consortium mainly comprised of large US health insurance companies, is working on a variety of member-driven use cases. The HUN has chosen a version of Hyperledger Fabric as its protocol.

PharmaLedger takes a more flexible stance when it comes to protocols, choosing to remain open to various technical models that fit each use case. According to Novartis’ Supply Chain Architect and PharmaLedger Industry Project Lead, Daniel Fritz, this protocol-agnostic approach provides maximum flexibility, viability, and stability from a governance perspective.

To decide on use cases, the network plans to use an evaluation approach that contemplates patient need, value, technical complexity, blockchain fit, stakeholder fit, governance complexity, and network roadmap. The network shares an underpinning contract that defines different levels of governance driven according to an existing IMI approach.

The “Governance First” and “Use Case First” models both have their pros and cons. The year 2020 will be the Year of Governance where we navigate the traps of each of these models.

Image 1: Consortia Approaches in Healthcare: Governance First vs Use Case First

- What protocol(s)?
No protocols as of yet. The initial focus is use case evaluation and prioritization. We will select the protocols after the use cases are selected.

- Does your choice of technical model vary by use case / design pattern?
Yes, most likely. We can imagine a number of different distributed ledger technologies, even that they are upgraded or replaced over time, but the overall framework should enable this kind of flexibility and remain sustainable from a governance perspective.

- Your chosen use cases seem to include supply chain, health data sharing, and clinical trials.
That is correct.

- How does the group decide?
For the use cases, there is an evaluation approach that is looking at patient need, value, technical complexity, if blockchain is the right technology, roadmap fit, stakeholder complexity, etc. The use cases are processed into a short list and then defined in more detail before being prioritized for realization sometime mid-year. In terms of the actual formal decision, there is a consortium agreement (underpinning contract) that defines governance at different levels. This is a standard approach used for all the IMI projects so we are able to benefit from this existing governance approach.

- Are you primarily focused on a single design pattern (data sync? data markets? business process automation?)
Design patterns will t will depend on the selected use cases, and the framework should be able to scale to include additional patterns.

- What is the first use case we will see and when?
This, of course, depends on the technical/organizational complexity, but the project is committed to an agile approach. We are also hoping to leverage the work already done in the industry in order to accelerate delivery. The complexity involved in such process changes is humongous…and we will have to manage that.

- Does this initiative have any relationship to the MELLODDY project?
We have been in contact with MELLODDY and Trials@home and will continue to align with them. We will engage with other IMI projects such as MyHealthMyData, and Harmony.

- Is this just in the EU or does it extend to the US?
It is EU but all industry participants are global players, and the supply chains for one are global in nature, so ideally the solutions could scale to other geographies.

- Will those of us in the United States be able to learn more at the HIMSS Conference Blockchain Symposium in Orlando in March?
We just kicked off in January and our first big focus now is the DIA Europe 2020 conference in Brussels later in March. This seems to be a good opportunity to spread the word among regulators. We are looking forward to participating at HIMSS next year – this is all part of our communication and dissemination plan.