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PharmaLedger Association — Who We Are

Building a Digital Trust Ecosystem
for Healthcare

PharmaLedger Association is a Swiss nonprofit founded in 2022. We connect pharmaceutical manufacturers, technology organisations, and patient associations on shared, open-source infrastructure — so the industry can solve pre-competitive problems together instead of building the same foundations separately.

Swiss nonprofit · Est. 2022Open-source platformIHI founding project46 countries · 29 languagesGS1 Digital Link · EPCIS 2.0 · HL7 FHIR

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MEMBER ORGANISATIONS INCLUDE
GSKMSDTakedaModernaElanco+ technology partners & patient associations

Our mission

The pharmaceutical industry builds a lot of the same infrastructure twice. We exist to stop that.

Every major pharmaceutical manufacturer is solving the same problems independently: how to distribute structured product information globally, how to get real-time visibility into a fragmented supply chain, how to connect patients with trustworthy medicine data at the point of use. The technology is not proprietary. The governance is.

PharmaLedger Association provides the pre-competitive layer: open-source platform infrastructure, a neutral nonprofit governance model, and the committee structure that lets competitors collaborate on shared foundations while competing on everything above them.

The result is the Product Trust Platform (PTP) — operational today across AstraLabel (electronic product information) and AstraTrace (supply chain traceability), with AstraEngage (patient intelligence) on the roadmap.

Connect

We connect MAHs, technology organisations, health authorities, and patient associations on shared infrastructure. One connection to the PTP network provides visibility and collaboration with all participants simultaneously.

Protect

We maintain the governance frameworks, compliance oversight, and data sovereignty model that make it safe for regulated pharmaceutical organisations to share data on shared infrastructure. Swiss law. No data monetisation. Audited financials.

Build

We develop and maintain open-source platform infrastructure — the Product Trust Platform — that member organisations use, contribute to, and govern together. No single member owns it. Every member benefits from it.

How PLA works

Pre-competitive collaboration — what it means in practice.

PLA operates a pre-competitive umbrella model. Members compete in the market on products, brands, and commercial relationships. They collaborate within PLA on the infrastructure layer that none of them has an interest in owning exclusively: open standards, shared platform architecture, regulatory compliance frameworks, and industry best practice.

What members compete onWhat members collaborate on at PLA
Commercial relationships with customers and partnersOpen-source platform infrastructure and technical standards
Product portfolio, brand, and market strategyRegulatory compliance frameworks and health authority relationships
Internal operational efficiency above the platform layerIndustry best practice — shared through Committees
Speed of adoption and internal change managementGlobal ePI and supply chain standard-setting

The Product Trust Platform

Three products. One governed infrastructure. One network.

The PTP is the operational expression of PLA's mission — open-source infrastructure, live in production today, connecting manufacturers, health authorities, and patients on the same governed data layer.

AstraLabel™ — Electronic Product Information

GxP-validated ePI distribution. Upload once — structured product information distributed to 46+ national health authority repositories in 29 languages. GS1 Digital Link QR codes. Live in Spain for veterinary medicines. EU transition ready for human health.

Learn more about AstraLabel →

AstraTrace™ — Supply Chain Traceability

Continuously updated supply chain observability above your existing serialisation stack. EPCIS 2.0 native. Hyperledger Fabric blockchain audit trail. Connected to Alberta Health Services. Network-level shortage intelligence for manufacturers and health authorities.

Learn more about AstraTrace →

AstraEngage™ — Patient Intelligence

Patient engagement and medicine adherence intelligence. Connecting patients with trustworthy, accessible medicine information at the point of use. Roadmap for H2 2026 and beyond — closing the loop between manufacturer, health authority, and patient.

Coming H2 2026

The PTP is built on open standards throughout: GS1 Digital Link · EPCIS 2.0 · HL7 FHIR · Hyperledger Fabric. No proprietary lock-in. No single vendor controls the infrastructure. The open-source codebase is governed by PLA and accessible to all members.

Who we work with

Three stakeholder groups. One ecosystem.

PLA's network spans the full pharmaceutical value chain — from manufacturers and technology providers to patient associations and health authorities. Each group brings something the others cannot: scale, technical capability, regulatory authority, and patient voice.

Marketing Authorisation Holders

Pharmaceutical and animal health MAHs use AstraLabel and AstraTrace as commercial platform services. They also shape the platform roadmap through Committees and, at Patron level, through Board representation.

Current MAH members: GSK · MSD · Takeda · Moderna · Elanco

Technology Organisations

Technology members contribute to the open-source PTP codebase, integrate with the platform via API, and participate in technical standards-setting. PLA's technology committee sets the architecture direction for the platform's evolution.

Standards: GS1 · HL7 FHIR · Hyperledger · EPCIS 2.0

Patient Associations

Patient associations ensure that platform development remains patient-centric — not just technically compliant. Their participation in PLA governance anchors the mission in the outcomes that matter: patients receiving trustworthy, accessible medicine information.

Focus: accessibility · adherence · patient safety

How best practice is shared

Committees — where industry standards are shaped, not just discussed.

PLA's Committee structure is the operational mechanism for pre-competitive collaboration. Committees are not advisory bodies — they have real governance scope: they review the platform roadmap, propose standard evolutions, and produce outputs that member organisations use in their own regulatory and operational programmes.

AstraLabel Committee — Quarterly · Open to all members

Reviews the AstraLabel platform roadmap. Members propose new country integrations, regulatory format updates, and ePI standard evolutions. The Committee's outputs directly inform the PLA development roadmap — features requested here get built.

Current focus: EU ePI transition timelines · national repository format compliance · QR code accessibility standards

AstraTrace Committee — Quarterly · Open to all members

Supply chain intelligence roadmap. Reviews EPCIS standard evolution, cold chain pilot programmes, and network expansion priorities — which new health authorities, distributors, and markets to onboard next. The Alberta Health pilot was incubated in this Committee.

Current focus: Alberta Health pilot · EPCIS 2.0 adoption · Point of Dispense API · Cold Chain PoC

Technical Committee — Quarterly · Open to all members

Open-source platform architecture and API standards. Sets the technical direction for PTP development: Hyperledger Fabric governance, FHIR implementation guides, interoperability frameworks, and the roadmap for platform capabilities beyond 2026 — clinical data, eConsent, patient matching.

Current focus: SaaS Control Plane · Hybrid Deploy model · Point of Dispense API · ESPR / EU DPP readiness

"The Committee structure is what makes PLA different from a vendor relationship. Members don't just use the platform — they govern it. Features that matter to the industry get prioritised because the industry sits in the room where the roadmap is set."
— Stefan Schwarzfischer, Executive Director, PharmaLedger Association

Setting the standards of the future

PLA does not follow standards. It helps write them.

The Product Trust Platform is built on the open standards that regulators and health authorities are converging toward: GS1 Digital Link for product identification, EPCIS 2.0 for supply chain event data, HL7 FHIR for structured health content, and Hyperledger Fabric for governed distributed ledger infrastructure.

PLA's Committee outputs — implementation guides, best practice frameworks, interoperability specifications — are contributed back to the relevant standards bodies. Members who participate in PLA Committees shape not just the platform, but the industry direction that every organisation in the sector will eventually need to follow.

GS1Digital Link · product identification · QR code standard
EPCIS 2.0Supply chain event data · traceability · GS1 standard
HL7 FHIRStructured ePI · health content · EMA direction
HyperledgerFabric permissioned blockchain · audit trail · governance

Become part of the ecosystem

Four ways to engage with PharmaLedger Association.

Use the platform commercially

AstraLabel and AstraTrace are available under standard commercial subscription contracts — independently of membership. No membership required to use the platform. Start with the product that addresses your most immediate need.

AstraLabel →
AstraTrace →

Join as a Standard Member

Access all three Committees. Input into the platform roadmap at the Committee level. 10% discount on AstraLabel pricing. Standard membership is the entry point for organisations that want governance participation alongside their commercial relationship.

Membership details →

Join as a Patron Member

Board seat. Direct influence on PLA's strategic direction, budget, and platform roadmap. 20% discount on AstraLabel. For organisations for whom shaping the direction of pharmaceutical digital infrastructure is a strategic priority, not just a compliance exercise.

Patron membership →

Partner with us

Technology organisations, patient associations, health authorities, and standards bodies participate in PLA through partnership arrangements tailored to their role in the ecosystem. If your organisation's work intersects with pharmaceutical digital infrastructure, there is a participation path for you.

Contact us →

Governance & transparency

A nonprofit you can audit.

PharmaLedger Association is a Swiss nonprofit association (Verein) registered under Swiss law in Zürich (CHE-178.875.143 MWST). Governance is designed for the pharmaceutical industry's expectations — not a startup's. Independent annual audit by Copartner Revision AG. Board representation from member organisations. Published bylaws and governance framework.

Published governance

PLA bylaws, governance framework, and committee terms of reference are publicly available. No hidden decision-making. No private ownership structure.

PLA Bylaws →

Independent audit

Annual financial statements audited by Copartner Revision AG. Governance documentation and audited financials available to member organisations and qualified prospects conducting vendor due diligence.

Open-source platform

The Product Trust Platform codebase is open-source. No black-box infrastructure. Members and technology partners can inspect, contribute to, and build on the platform.

pharmaledger.org →

Healthcare infrastructure should not be owned by one company.

PharmaLedger Association exists to make that possible. Whether you are an MAH evaluating AstraLabel or AstraTrace, a technology organisation looking to integrate, or a health authority exploring the Regulator Portal — there is a place for you in the ecosystem.

Explore Membership