Deliver package leaflets digitally and always up to date
Sector: Secondary sector · Industry: Pharmaceutical industry · Organisation: PharmaLedger Association · Maturity level: Pilot
The European PharmaLedger consortium, with 29 partners across ten EU member states, built a cross-manufacturer blockchain platform for electronic product information. Scanning the code on a medicine pack returns the currently valid version of the leaflet, which the manufacturer can update in real time. Participating pharmaceutical companies include AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, GSK, Janssen, Merck KGaA, Novartis, Novo Nordisk, Pfizer, Roche and UCB.
Documentation status
- Project status: Superseded (as of 31 December 2022) — The 36-month research project ended in December 2022; since then, the work has been continued by the non-profit PharmaLedger Association with around 32 members.
- Evidence: Evidence medium
- Editorial review: pending
Description
The European PharmaLedger consortium has developed a cross-manufacturer blockchain platform through which electronic product information for medicines is provided. Printed package leaflets only reach newly produced packages when updated, so outdated information remains in circulation for years. Via the shared platform, scanning the package code delivers the currently valid version, regardless of which manufacturer provided it.
PharmaLedger ran from January 2020 to December 2022 as a 36-month project of the Innovative Medicines Initiative within Horizon 2020, bringing together 29 partners from ten EU member states. Twelve global pharmaceutical companies participated, including AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, GSK, Janssen, Merck KGaA, Novartis, Novo Nordisk, Pfizer, Roche, and UCB, complemented by 17 partners from academia, technology, and patient representation. The most developed use case is the electronic product information: the manufacturer stores the package leaflet referenced to the packaging, and anyone scanning the code with a smartphone immediately receives the currently valid version. Because the platform is operated cross-manufacturer, the information is not tied to a single company’s website, increasing its credibility with patients and pharmacies. Beyond ePI, further use cases on supply chain integrity, clinical trials, and health data were addressed. After the project ended, participants transferred the work into a non-profit, member-based association with around 32 members, so the platform did not end with the funding period.
Perspectives
B2B — organisations perspective
For pharmaceutical companies, PharmaLedger demonstrates how information obligations can be decoupled from print logistics and how multiple competitors can use the same infrastructure. Companies in other regulated industries with mandatory product information, such as medical devices or chemicals, can adopt the consortium model and transfer it into a sponsoring association.
B2C — consumers perspective
Patients receive the currently valid version of the product information when scanning the packaging, even if the packaging has been in circulation for some time. The digital presentation also allows better readability and selection of the appropriate language.
Employees perspective
In Regulatory Affairs and pharmacovigilance, work is shifting from managing print cycles to maintaining digital information inventories that take immediate effect. Pharmacists receive a manufacturer-independent source of information but must understand how to assess its validity.
Benefits
General
- Updated product information also reaches packages already delivered.
- The information is cross-manufacturer and therefore not tied to a single company’s website.
- Twelve global pharmaceutical companies and 17 other partners collaborated in a consortium.
- The work was transferred into a permanent sponsoring association after the project ended.
B2B — organisations
- Decoupling information obligations from print logistics.
- A shared infrastructure that multiple competitors can use simultaneously.
B2C — consumers
- Always the valid version of the package leaflet when scanning the packaging.
- Better readability and selection of the appropriate language.
Employees
- Digital information maintenance instead of managing long print cycles.
- A manufacturer-independent source of information for the pharmacy.
Challenges
General
- Regulatory recognition of electronic product information alongside or instead of the paper leaflet is not conclusively settled everywhere.
- The benefit only arises when a relevant portion of manufacturers participate.
- Patients without smartphones must not be excluded from access to information.
B2B — organisations
- Competing manufacturers must agree on common governance and data standards.
Employees
- Regulatory Affairs must establish processes for immediately effective updates.
Technology foundation
PharmaLedger is a consortially operated blockchain platform where manufacturers store electronic product information referenced to the respective package. A shared register is necessary here because patients and pharmacies should trust the information even if it does not come from the individual manufacturer’s website, and because several competing companies use the same infrastructure.
Implementation examples
Electronic product information in the PharmaLedger consortium
Printed package leaflets only reach newly produced packages when updated; outdated information remains in circulation for years, and there is no manufacturer-independent way to verify a package as genuine and current.
The PharmaLedger consortium of 29 partners developed a cross-manufacturer platform where electronic product information referenced to the medicinal package is stored. Scanning the package code provides the currently valid version.
The project ran from January 2020 to December 2022 as a 36-month project of the Innovative Medicines Initiative within Horizon 2020 with partners from ten EU member states. Twelve global pharmaceutical companies participated, including Novartis, Pfizer, Bayer, AstraZeneca and Janssen, complemented by 17 partners from science, technology and patient representation. After the project ended, the participants transferred the work into a non-profit, member-based association with around 32 members, which continues to develop the use cases in working groups.
Outdated product information on already delivered goods, lack of manufacturer-independent verification, and coordination of competing pharmaceutical companies on a common infrastructure.
Tags
Pharmacovigilance, Electronic package leaflet, Pharma consortium, EU research, Product information