Today SAP announced a partnership with Chronicled, the company behind the MediLedger pharmaceutical blockchain. Chronicled’s MediLedger has been integrated into the SAP Information Collaboration Hub for Life Sciences.
In the U.S., the Drug Supply Chain Security Act (DSCSA), which requires interoperability between organizations, is being phased in over several years. The ultimate deadline is 2023, but in November this year, there’s a deadline to verify that drugs returned from pharmacies and hospitals to wholesalers are not fakes. Most returned medications are re-sold so the new verification process will help to eliminate pharmacies inadvertently selling counterfeit drugs.
While the SAP Information Collaboration Hub for Life Sciences helps in the verification process, there’s a need to interoperate across the industry, including with organizations that don’t use the SAP platform. That’s where the MediLedger solution comes in by providing a distributed network that also integrates with other pharma technology solutions.
“At AmerisourceBergen Corporation, we’re working extensively to assure compliance in accordance with the DSCSA,” said Jeffery Denton, AmerisourceBergen senior director, Global Secure Supply Chain. “By partnering with SAP, which now includes Chronicled’s MediLedger solution, we are providing the best possible solution for our business by utilizing the unique benefits of both solutions to ensure our customers are receiving only authentic prescriptions medicines.”
SAP says the combined solution is already being used by nine out of the top 20 pharmaceutical companies, and two out of three of the big U.S. drug wholesalers. AmerisourceBergen and McKesson are publicly listed as MediLedger members. Together with number three wholesaler Cardinal Health, these three firms account for 94% of the U.S. pharma trade.
“This partnership across stakeholders in the distribution chain is the first step toward DSCSA interoperability,” said Pablo Medina, Genentech associate director, Contract and Channel Management. “This will support the continuous access to safe medicines for our patients, while meeting the DSCSA returned product verification requirements our trading partners must comply with. Blockchain technology can be a good fit for purpose for this use case. We look forward to continuing working toward an interoperable system that will further safeguard the supply chain.”
The FDA recently launched a pilot program where several blockchain solutions are being tested. In addition to MediLedger, they include TraceLink and IBM. However, the focus of the tests is on the 2023 interoperability deadline. The November 2019 target has people concerned.
MediLedger launched its solution two months ago. We’ve heard from industry sources that while the technology is available for the November DSCSA requirement, many participants in the supply chain are not ready. There’s a hope that either the deadline will be extended or the FDA will tread lightly on compliance for a short while.