GC Blockchain Codefest

Global Drug Supply Chain

• Organization: Regulatory Operations and Regions Branch, Health Canada
• Submission Team: Technology and Business Innovation
• Contact: Martin Bernard, Peter Yoon

Abstract

The Technology and Business Innovation (TBI) Division within the Regulatory Operations and Regions Branch is seeking partners to explore and experiment with new digital infrastructure enabled by Blockchain to create an open environment of transaction based data within the global drug supply chain.

The Business

Health Canada plays a dual role of protecting Canadians and facilitating the supply of products vital to the health and well-being of Canadians. The Department regulates and provides oversight for thousands of products including pharmaceuticals, biologics (blood, cells, tissues, organs) and radiopharmaceuticals, natural health products, medical devices, consumer products, controlled substances, tobacco, cannabis, and pesticides. Health Canada conducts regulatory activities to ensure compliance with regulations and provides expertise to external partners such as law enforcement agencies and health authorities in support of compliance and enforcement and harm reduction activities. The Regulatory Operations and Regions Branch (RORB) leads compliance and enforcement and complementary scientific programs to inform and protect Canadians from health risks associated with products, substances, and their environment. TBI is responsible for supporting compliance and enforcement programs with technology-based business solutions.

Emerging Trends

New and emerging global trends require RORB to evolve to keep pace with national and international innovation. Trends that may provide experimental opportunities involve product lifecycle expansion and globalization, new emerging regulatory frameworks, rapid pace of scientific, technical and commercial innovation, maintaining harmonization with other regulators. The following two key areas present potentially significant opportunities to RORB:

• Scientific, Technical and Commercial Innovation: the arrival of new products (e.g., electronic cigarettes, new legal and illegal drugs, medical devices created with 3D printers) and non-traditional means of accessing these products (e.g., selling and advertising through the internet).
• Global Economy: the emergence of new products or [global] business practices outside of the current regulatory frameworks.

Experimentation Opportunity: Opening the Global Supply Chain

We are considering blockchain technology to enable the supply of large volumes of transactional and non-transactional data generated concurrently with underlying commercial processes/events for a “live stream” of occurrence data to support regulatory activities. This access to data would improve transparency (by default) within a permissionless blockchain creating improved abilities to provide oversight throughout the global supply chain. The goal is to remove passive methods with complicated processes of collecting compliance data from industry, and instead rely on active processing of data through automation and public ledgers.