Governments and Regulating Bodies

Governments and Regulating Bodies

National Governments and the various Regulating Bodies and Pharmaceutical Associations have the important and increasingly difficult job of securing the drug supply chain. It is their responsibility to create and enforce regulations that promote quality, safety, and public health.

Current Problems

One of the main responsibilities of these entities is to promote international cooperation in securing the global drug supply chain. The Medicines and Healthcare products Regulatory Agency in the UK lists as one their core responsibilities: “Promoting international standardisation and harmonisation to assure the effectiveness and safety of biological medicines.” This is also a major challenge, as the increasingly global nature of the pharmaceutical industry is also what makes ensuring quality and enforcing regulations so seriously difficult. As it stands, the huge volume as well as the lack of interoperability between enterprise management systems and product level track and trace requirements in many countries makes end-to-end visibility either impossible or hugely costly. To address these problems, the United States and the EU have put forth new regulations, the Drug Supply Chain Security Act (DSCSA) and the Falsified Medicines Directive (FMD), which will go into effect next year and require significant time and money of Pharmaceuticals and Logistics Providers in order to comply.

FarmaTrust Solution

Using FarmaTrust’s Zoi Platform, Regulators, and Governments will be able to vastly improve accountability, compliance, and visibility throughout the supply chain. Using the Regulator Report on Zoi Dashboard, regulators will have a full picture of the drug supply chain, which will allow for more thorough enforcement as well as comprehensive analysis for taking preemptive measures against potential issues that would be difficult or even impossible to see without excellent visibility. Additionally, with the impending regulations in the US and EU in mind, where most of the world’s largest pharmaceuticals are headquartered, the FarmaTrust platform offers a ready-made solution for track-and-trace at the product level, as required by the DSCSA and FMD. Lastly, on the company side, the Zoi Platform will have built-in functions for creating Regulatory Compliance Reports, which will streamline the process and bake the immutability of blockchain into the compliance reporting process. For a specific example of how FarmaTrust would aid regulatory bodies in securing and improving the drug supply chain, see the Case Study below.

Case Study: Regulators persona

Persona: Jennifer

Introduction

Jennifer is the Director of Inspection, Enforcement, and Standards the national regulating body for medicine, medical devices, and blood components in her country. One of her main responsibilities is to oversee inspections and compliance reporting for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). GMP are the minimum requirements medicines manufacturers and must meet in their production processes. GDP requires that medicines are obtained from the licensed supply chain and are consistently stored, transported, and handled under suitable conditions.

Problem Definition

Over the past 20 years, accountability and the tracking of counterfeits within pharmaceutical supply chains has become increasingly difficult due to a lack of interoperability in tracking systems as well as inadequate visibility and communication between pharma partners and regulatory bodies. During the past year, Jennifer has had to schedule an increasing number of surprise inspections as more and more problems arise in companies’ Manufacturing and Distribution operations due to increased complexity. What’s worse, there is evidence that companies are neglecting to disclose known issues in their compliance reports, and instead opt to roll the dice and deal with an inspection if and when it comes. This is not only unethical, but dangerous.
Jennifer has been asked by her leadership to develop a system to 1) improve reporting accuracy and accountability and 2) better anticipate when and where problems will arise.

Solution Overview

To address these problems, Jennifer has enlisted FarmaTrust’s Zoi Platform. Using the features outlined below, she will be able to dramatically improve accountability, thanks to the unprecedented visibility and immutability afforded by the FarmaTrust solution.

Track-and-Trace

1

The Tracking Map provides an intuitive and real-time full-picture of the drug supply chain with immutable and auditable track-and-trace data for every individual drug packet
There are also filter options to view the Map by product type, geographical region, company, company type, etc.

2

The Chronological View allows regulators to view the Transaction History of each and every packet, including dates, times, product specs, and very importantly, the name and function of current and previous custodians

Reporting / Analysis

1

Transaction Data, including Transaction Information, Statements, and History will be created contemporaneously as transactions occur, leaving no room for manipulation and an easy-to-audit trail

2

Companies will be able to generate compliance reports directly from the Zoi Platform, and regulating bodies can quickly but thoroughly conduct external audits, confident that the data is complete and accurate