Value Beyond Compliance – The DSCSA as an Opportunity for Businesses

As from November, prescription medicines destined for the American market will have to be serialized, meaning pharmaceutical companies and CMOs alike will have to have an operational serialization solution in place before the end of the year. But requirements of the Drug Supply Chain Security Act (DSCSA) don’t stop there. Full implementation will be reached in 2023 when full unit level traceability with data exchange will be mandatory.

A compliance program of this scale creates substantial implementation challenges as well as disruptions across organizations and the pharmaceutical supply chain. DSCSA compliance will also require significant investment on hardware and software level together with the development of new processes to ensure correct serialization, aggregation, reporting and so forth.

While the challenges and business risks linked to serialization mandates and DSCSA compliance are undeniable, the right serialization and traceability solution can offer a multitude of benefits. According to a recent KPMG report*, more and more organizations are aware that “serialization-enabled processes and transactional data can lead to companies deriving value from their investments, increasing productivity, and enhancing brand and revenue protection”. A scalable Cloud solution with integrated business intelligence applications and more can help businesses manage, enrich, analyze and enhance the immense amount of data generated through serialization and track&trace processes. Indeed, more than of 70% of the KPMG survey respondents “have or plan to use serialization data to enhance business processes” and only 29% “of participants have no future plans to use serialization data with existing business practices”.

Tracking where your products are going and (or not) arriving is an effective means to protect your brand from gray markets. Other industries have been using track&trace to fight counterfeits and product diversion in the supply chain for a while now. In light of upcoming serialization and traceability requirements in the United States, 52% of respondents from the pharmaceutical industry taking part in the KPMG survey consider diversion monitoring as an important feature when putting in place a serialization solution to comply with the Drug Supply Chain Security Act.

* The 2017 Serialization & Traceability Trends by KPMG Healthcare & Life Sciences Institute “explores the industry’s current state of readiness to meet the 2017 DSCSA requirements and intentions to leverage associated value-added opportunities.”