PDSA advocates a Governance Body and Interoperability Model for DSCSA 2023

On May 1^st, in a law office in downtown Washington D.C., the Pharmaceutical Distribution Security Alliance (PDSA) hosted a public DSCSA Workshop open to all pharmaceutical supply chain participants, solution providers and associations. The goal of the workshop was to discuss and gain consensus for an industry led governance body whose primary purpose would be developing an interoperability model for the 2023 DSCSA enhanced drug distribution security requirements (see PDSA information here).

Gaining consensus on any technology or business rules between trading partners is difficult. It took many years for Advanced Shipping Notice (ASN) to become “standard” in the pharma industry. More recently, the Verification Router Service (VRS) – aiming at ensuring the verification of saleable returns in the US – has been in development and implementation for almost two years. There are still questions being raised about how best to manage access to the VRS.

If we measure the amount of time dedicated to producing a workable solution across all industry participants for these relatively “easy” business scenarios, and apply that measurement to the far more complex interoperability challenge for 2023, there is little doubt the only way the industry will be ready by 2023 is through an industry recognized and focused governance body.

PDSA published two papers in April to established a concept and foundation for governance. The first paper provided an overview of PDSA’s vision on interoperability and governance for 2023, and the second paper is a whitepaper detailing the scope and makeup of an independent governance body.  PDSA recognized the need for a sector-neutral governance body to ensure industry-wide representation and acceptance.

At the public meeting on May 1st, the pharma industry sectors were all represented including manufacturers, wholesalers, dispensers, trade groups and solution providers. The PDSA proposed governance model has also caught the attention of the FDA: Dr. Ilisa Bernstein was in attendance to hear the discussions and comment when appropriate. There is not much explicit guidance the FDA can provide, but by attending and listening there is inherent interest of the concept of an industry-led governing entity.

Adents supports the governance model, and Julien Faury, VP Operations participated in opening panel discussions. There were 4 panel discussions throughout the day, and input was received from all market sectors. 

It is highly recommended that all industry trading partners participate in some way as the governance model is defined and begins to form. Participation is not mandatory, but the output from this governance body will most likely determine your business requirements in the next year or two.