After establishing its first track-and-trace program in Turkey in 2010, Sanofi already is seeing some benefits.
“Roughly 30 percent of the drug supply in developing countries is counterfeit, and Sanofi took a number of steps to protect its global supply chain as its track-and-trace program evolved,” Jeffrey Beck, Sanofi’s head of global quality supply chain North America, said.
First, Sanofi started using tamper-evident seals and packaging so that patients can determine if their prescriptions had been opened. In addition, Sanofi now employs product authentication using overt and covert security features, as well as serialization programs to increase the level of security.
Although companies currently only are required to track products at the lot level, serialization — the assignment and application of a unique, verifiable product identifier to an individual pack — will be required by 2017 in the U.S. Aggregation — tracking the individual pack within the larger pack — will be a requirement by 2023.
Sanofi has added an additional security measure with the placement of GPS devices on its high-risk and high-value cargo and truck shipments, from which the company receives intelligence on when to make shipments to certain areas. For example, weekends can be risky, Beck said. “You never want a shipment sitting around, because cargo at rest is cargo at risk. We have also found a gray market of reimported products in some regions, and just by tracking those serial numbers, we know who the guilty parties are behind those product diversions.”
Sanofi is meeting the track-and-trace requirements in other countries as they pop up. Turkey was the first country to require serialization in 2010. Beck said the company (then Genzyme) learned a lot from that first experience and pointed to four lessons learned:
- Resources (both internal and external vendors and consultants) were one of the biggest challenges. “Once the project was under way, we underestimated how much assistance we would need from the IT department to build the infrastructure of a serialization program, as well as to validate the database.”
- Employee turnover. “The project is not a six-month project but rather years in the making, so every time an employee left there was significant lost time retraining another person.”
- Down time on manufacturing lines. “At Genzyme, we were in the midst of a drug shortage, and having access to the manufacturing lines and line availability was not always easy to secure. We had to stop production, we had to install equipment, and then we had to validate and qualify that equipment.”
- Budget. “We had to request additional funds for the project.”
When asked about costs, Beck explained that factors vary from company to company and country to country, including the number of manufacturing sites and the number of distribution centers. The biggest expense was the IT infrastructure and database, as well as all the manpower hours involved.
From an overall project management standpoint, the company conducts weekly status updates and monthly steering committee meetings to maintain project deadlines that can be challenging with so many departments involved, Beck said.
“From our team alone, we had purchasing, IT, security, supply chain, distribution, finance, packaging — and those were only colleagues at the corporate level. The complexity increases when we include departments at the regional or country level where requirements are coming up, as well as the management of our external consultants.”
Turkey, China, Argentina, India, South Korea, Brazil, Saudi Arabia, Jordan, the U.S. and Europe all have serialization deadlines. Italy and France already require serialization stickers on packaging, and most have staggered implementation dates.
Some markets — such as Turkey, Argentina and China — have well-defined database structures with strong governance processes, while other markets — such as the U.S. and EU — require stakeholders to develop the database.
The EU initiated legislation in 2006 under which each country operates its own repository for holding serialization data for all products in the supply chain. There is a central European hub, which is funded by manufacturers and provides interconnection between the different national systems.
But the U.S. has not yet developed a central database or decided how the data will be managed, Beck said, noting that the FDA has conducted numerous town hall meetings with industry to determine the best way forward.
“From the beginning of the regulation, the FDA has truly partnered with us to listen to our challenges and recommendations,” he said. Intellectual property, data security, funding and bandwidth have all been concerns for industry.
“In an ideal world, we would have a globally harmonized standard, not individual government solutions.”
Beck said that given the deadlines for staggered timelines for implementation, it should give companies enough time to digest the law and develop a game plan if they haven’t started getting ready to implement a track-and-trace program.
His advice to those companies just getting started: “Don’t wait any longer, and keep your finger on the pulse. If you want to continue doing business in these countries, you have to implement these programs.”
More than 150 countries worldwide will require pharma track and trace regulations over the next 10 years. Order out webinar Preparing for Global Track & Trace Regulations and hear from track and trace expert Bill Fletcher of Pharma Logic Solutions tackle the numerous issues and misconceptions surrounding new track and trace requirements.