Last week, the Pharmaceutical Distribution Security Alliance (PDSA) published two papers aimed at kickstarting the creation of a new non-profit organization that would accept the responsibility for setting up and executing governance over Drug Supply Chain Security Act (DSCSA) phase II interoperability (see “A Serious DSCSA Governance Organizational Proposal Emerges From PDSA”). PDSA defines “DSCSA phase II” to be the same as what the DSCSA text calls the “Enhanced Drug Distribution Security” (EDDS) phase (see “EDDS: The New Data Exchange Requirements”). The EDDS phase (err, Phase II of the DSCSA) starts on November 27, 2023. In most informal conversations this phase is usually just referred to as “2023”.
One of the two papers is an overview of PDSA’s “vision” of DSCSA phase II interoperability and governance, and the other is “white paper #1” of three they expect to publish over the next few months. White paper #1 is an actual detailed proposal for the structure and initial bylaws for such an organization. PDSA is clear—they do not want to be that organization. They believe it should be a new organization specifically designed to be “independent, balanced and sector-neutral”. It’s not easy to create an organization whose membership would be composed of people from different sectors and yet define it so the resulting whole is independent, balanced and sector-neutral. If the target organization fails to live up to “independent, balanced and sector-neutral”, odds are the whole thing will fail. PDSA is clearly aware of that because those goals are made evident throughout the proposal. Almost every clause of the proposal is carefully defined in a way to ensure those foundational principles prevail.
You can register to download both papers free here.
I strongly recommend that you read all of both of these initial papers, but if you don’t have time, make sure you read at least the first two pages of the Overview paper and at least through “C. Purpose and Functions” of White Paper 1. That will give you a solid understanding of where PDSA is going with this effort. Here are just a few key extracts taken from both papers.
“It is important to note that we use the term ‘vision’ broadly to mean an overarching approach to interoperability. In that way, PDSA recognizes such overarching approach may encompass multiple methods of compliance (i.e., multiple models, systems, solutions, technologies, architectures, etc.) that emerge and may compete with each other. PDSA believes that it should be the role of a governance body to establish and support the implementation of one vision for interoperability and connectivity among those multiple methods of compliance. The PDSA vision articulated in these white papers is simply one vision we suggest be considered by a governance body (once formed).”
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“We believe the vision for Phase II described in this series of white papers is a significant step forward on the path to implementation and will advance the collective dialogue regarding Phase II. The proposed vision in this series of white papers does not represent an absolute commitment by PDSA members to implement Phase II in the manner set out; rather, the vision in this series of white papers reflects PDSA’s best current thinking and is intended to stimulate conversation among all stakeholders, including FDA.”
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“PDSA recognizes that it is unlikely every trading partner will adopt and implement systems and processes that are based on the same vision for Phase II. In fact, the DSCSA bars FDA from requiring ‘the adoption of specific business systems’ and requires that FDA ‘provide for alternative methods of compliance’ with the Phase II requirements. As a result, it is recognized that multiple approaches to Phase II may be adopted. It is, however, also recognized that broadly divergent approaches to Phase II will present challenges to statutorily required interoperability. Therefore, alignment of a critical mass of industry (along with regulatory engagement) to a shared vision for Phase II, which as noted above may include multiple competing models, is critical to implementation of the statutory requirements for interoperability. Early and robust industry and regulator dialogue—hopefully building upon the vision outlined in this series of white papers—will support broad stakeholder alignment and interoperability.”
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“This paper sets forth a proposal for one possible structure for the establishment of an independent, balanced, sector-neutral governance body and the functions it would be anticipated to perform in executing the vision set out in this White Paper. PDSA is publishing this white paper as a well-thought-out starting point for consideration by stakeholders broadly, with the hope that a diverse set of stakeholders will form a governance body. It is recognized that revisions to the structure may be needed in order to develop the breadth of stakeholder support needed to ultimately establish the governance body. Although PDSA hopes this proposal will stimulate action toward establishment of a governance body, PDSA does not intend to act as the governance body. As noted, independence will be a critical attribute of successful governance, and to that end, we believe it is important that the governance body be established—by both PDSA members and non-members alike—as a new, independent legal entity.”
There is so much more in the papers. Make sure you read them.
Clearly, PDSA is in the camp that believes there is no way anyone—at least not them—can corral all members of the supply chain and get them to use a single technical approach to meeting the EDDS requirements. I’ve never been in that camp (see “DSCSA: Interoperable Data Exchange In 2023”), but I acknowledge that the vast majority of people with authority today are in that camp, so I’ve accepted it as reality (see “DSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific Technology”). Maybe if we had been able to start this process back in early 2014 we would have been able to establish a single approach that was acceptable to almost everyone. But now that’s water under the bridge. Since then, too many solution providers have leaped out in front of the industry with investments in technology that favors them. They’ve been corralling customers into their respective camps for several years now, thus forcing a level of complexity in future EDDS interoperability that will likely be more costly to everyone. It’s hard to blame them for filling a vacuum. That’s the way Capitalism works. And I’ll admit that blockchain—for one technology—probably would not have been selected back then, and it just might be a much better approach than those that would have been selected (see “Could Blockchain Technology Be Used For DSCSA Compliance?”, “Blockchain Will Not Be Used For DSCSA Data Exchange” and “An Open Letter To Blockchain Vendors: Please Pay More Attention”). So here we are. Time to pick up and move forward.
PDSA’s recent leap to the forefront of DSCSA governance thought-leadership is exactly what needed to happen (see “A US Medicines Verification Organization (USMVO)?”) and their “independent, balanced and sector-neutral” approach is the right way to do it. The one thing PDSA left out of these two papers is what needs to happen next to get this new organization off the paper and on the ground so it can start moving the ball forward. Hopefully that’s the purpose of the webinar tomorrow, April 2, 2019 at 1pm EDT (register for the webinar here) and the meeting in Washington DC on May 1st, 2019 (register for the meeting here). PDSA has done an admirable job kicking things off, and they still have two more papers to publish. Let’s get it on. Watch for more.
Dirk.
