Project Team:  Marco Carvalho,  Baiju Jacob, Ben Taylor, John Hopkins, Kent G Lau, @Richard Duncan

THIS SUB-GROUP HAS BEEN RETIRED. PLEASE USE THE MAIN GROUP INSTEAD.


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Pharma & DSCSA sub-SIG

Meeting Invitehttps://lists.hyperledger.org/g/supply-chain-sig/message/57
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Description:

  • Using Blockchain for Drug Supply Chain Security Act (DSCSA)


Purpose/Benefit:

  • How Blockchain can be used to address the FDA's DSCSA regulatory requirements


Scope:

  • What is the DSCSA?

DSCSA stands for Drug Supply Chain Security Act. It is a regulation passed by FDA aimed at eliminating counterfeit drugs from entering the supply chain and enable real-time tracking, tracing and verification of drugs. The regulation is being rolled out in phases with complete rollout scheduled to happen in 2023.

  • Why is the DSCSA important?

The DSCSA is important as it aims to eliminate counterfeit drugs from entering the supply chain.

  • What is the impact of the DSCSA?

DSCSA compliance is mandatory for any company that is part of pharma supply chain in US

  • What are the various options to address the DSCSA?

There are many ways to address DSCSA and it is not necessary to use a blockchain. A blockchain based solution is appealing however as it enables creation of a central repository without the control being in hands of any single company. 

  • How can Blockchain be used to address DSCSA regulation?

As a drug moves in the supply chain, its transfer from one company to another will be recorded onto the blockchain. This will enable tracking and tracing of a drug as well as verification of its legal owner and complete provenance.

  • How can Blockchain be used beyond the DSCSA requirements?
  • and more..


Meeting times

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15 Comments

  1. Marco Carvalho

    Email addresses (comma separated):

    • Marco.Carvalho@rsmus.com

    Description:

    • Using Blockchain for Drug Supply Chain Security Act (DSCSA)

    Purpose/Benefit:

    • How Blockchain can be used to address the FDA's DSCSA regulatory requirements

    Scope:

    • What is the DSCSA?
    • Why is the DSCSA important?
    • What is the impact of the DSCSA?
    • What are the various options to address the DSCSA?
    • How can Blockchain be used to address DSCSA regulation?
    • How can Blockchain be used beyond the DSCSA requirements?
    • and more..

  2. Ben Taylor

    Above is a table from the FDA DSCSA pilots press release (https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/dscsa-pilot-project-program).  Our partnership with UCLA will run on LedgerDomain's DocuSeal Framework on HYPERLEDGER FABRIC.  Hyperledger Fabric will presumably also power IBM's entry (https://www.in-pharmatechnologist.com/Article/2019/06/18/Big-names-in-pharma-and-food-team-up-for-FDA-s-blockchain-pilot-program).  FDA will be summarizing all this work in a consolidated write-up next year.

    Happy to chat with anyone offline as well, ben.taylor@ledgerdomain.com

    FOLLOWUP... good call today (20Jun19)... further to your points on GS1 & FDA, here are the relevant FDA documents... you'll note that blockchain is NOT actually specified, but the majority of the FDA pilots incorporate some form of distributed timestamped ledger...

    https://www.fda.gov/media/106198/download

    https://www.fda.gov/media/78317/download

    https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/fda-issues-draft-guidance-product-identifier-requirements-under-drug-supply-chain-security-act

    Further to the US regulatory calendar

    GS1 is doing a great job of working with individual countries extend and embrace as DSCSA is US only...

    https://www.gs1.org/industries/healthcare/standards

    https://www.gs1.org/industries/healthcare/regulations-pharmaceuticals

    https://www.gs1us.org/DesktopModules/Bring2mind/DMX/Download.aspx?command=core_download&entryid=614&language=en-US&PortalId=0&TabId=134

    https://www.gs1us.org/industries/healthcare/standards-in-use/pharmaceutical

    https://www.gs1.org/sites/default/files/docs/healthcare/broch_a4_epcis_0.pdf

  3. Marco Carvalho

    Ben Taylor Thanks for the post. I'll reach out for more details.

  4. Marco Carvalho

    Added a poll for times to meet next week here, https://wiki.hyperledger.org/polls/viewpoll.action?guid=abf1f18741184cb68b25db7254f32832. Please vote for which time is most suitable for you.

  5. Jay Chugh

    Meeting notes from 6/20 discussion: 

    Using Blockchain for Drug Supply Chain Security Act 

    • Action: Put a link to the actual DSCSA regulation document
    • Government wants to more granuarly track drugs in supply chain
    • Ben shared a link to the FDA page that outlines things like MediLedger - their specs for smart contracts are on Github
    • Legislation is being transformed into specs through 2023 - i.e. Unique identifier for all drugs at a salable unit level that carries though from manufacturer, to wholesaler, to pharmacy - several FDA pilots are underway
    • One use case for MediLedger is to verify returned drugs 
    • Baiju, Marco, Ben and others will jump on a call next week - others please add your name to wiki if you want to be included in that call.
    • FDA already has a “guidance document” - Ben to provide link on wiki page - that’s already established data models, schemas, etc.
    • Also, GS1 has a spec for healthcare and pharmaceutical already - that talks about DSCSA - to frame up data models and schemas - https://www.gs1us.org/industries/healthcare/standards-in-use/pharmaceutical. For this use case, defining a schema (data model) and smart contracts to handle the type of transactions that need to be processed by a distributed solution would be a great exercise for this use case.  ("Definition of Done" could be completing those deliverables.)
    • Marta to make introductions to GS1 team, and invite them to the next call

  6. John Hopkins

    This seems like a really ideal use case to apply Overlay Data Capture Architecture, and since Paul Knowles, who is leading that project, is already working with some pharmaceutical companies on a different application there could be some synergy possible. 

    1. Ben Taylor

      Is "Overlay" an alternative to Hyperledger Fabric Private Collections or an add-on?  We have gotten good results from Private Collections [or whatever its name is today (wink)] . We generally try to leverage as much of vanilla Fabric as possible and once we do everything in GOlang and smooth things out, it runs well.  

  7. John Hopkins

    I think they would compliment one another.  Overlays are designed to enable the automation of enforcement of privacy rules, so GS1, for instance, could define a standard set of schemas for the pharma industry, and then publish them as a set of overlays. Then if a schema had sensitive fields they should be marked as PII (personally identifiable information) in the overlay, and therefore go into a private collection instead of being stored in the channel's public state. 

    1. Marco Carvalho

      I still have yet to read and digest the RFC myself to understand it overlays better in order to put in layman's terms. Based on our discussion, it seems overlays could be applicable for scenarios where bank information, social security numbers, etc. are captured and stored in the blockchain? For example, on a schema, you could flag a field that is sensitive so that it is automatically encrypted or only shared between certain types of participants who have authority? Or am I missing the point? 

      1. John Hopkins

        Yeah, I think that's the most accessible use case, and indeed the purpose for which overlays were created - blinding sensitive information and automatically enforcing privacy. But I'm also interested in exploring other uses such as how they could be used to improve audit capabilities, or enable automatic transfers across the boundary of two unassociated blockchains. Since the Overlay is essentially a schema with a Decentralized ID it has the potential to impart meaning in multiple contexts. I think of them as a solution for the question of interoperability between blockchains: how do you ensure that no meaning is lost in the translation from one context to the other?

        1. Ben Taylor

          I would NOT dispute any of the foregoing, but DSCSA regulations are not typically perceived as extending all the way to the patient, so many DSCSA implementations would not be conceived as having significant PII/PHI.  That doesn't suggest that certain communities don't value enhanced privacy, but it might be a leap to say our DSCSA project requires enhanced privacy compared to other use cases.

        2. jeff stollman

          Ben is correct!  DSCSA explicitly avoids going down to the patient level in order to avoid having to capture personal health records.  It tracks products only from Manufacturer through Dispenser (hospitals, pharmacies, etc.).

          1. John Hopkins

            Yeah, I think the tough part here is that privacy is the purpose that ODCA was created for - and I personally think there is always a case to be made for enhanced privacy, even if we're talking about at the entity level instead of the individual - but actually I'm not advocating for applying Overlays for that purpose.  The use case I'm really interested in is for track and trace.  Specifically, I think that ODCA in combination a PeerDID scheme has the potential to provide for "portable context" which would enable interoperability between blockchains.

  8. Marco Carvalho

    Just a friendly reminder, tomorrow we’ll have a guest speaker, Bob Celeste, from the Center for Supply Chain studies. Bob will be covering the following topics:

    • Drug Supply Chain Security Act
    • The Challenge
    • The Center’s work in blockchain
    • Current emphasis
      • Decentralized Identity
      • Verifiable Credentials
    • Q&A / Open discussion

  9. Tomomi Yamano

    Marco Carvalho

    People, I am interested in this agenda and see now this sub-group has been already retired. 

    Any discussions plus projects are still going on with respect to this group?  PM  Tomomi Yamano