Counterfeit and substandard medicines are a global problem. In 2017, the WHO analyzed 100 surveys on medicine quality from more than 88 nations and found that in countries with low and middle incomes, one in 10 medical products is fake.
The WHO also found that the proportion of falsified products could be up to three times greater in some areas of Southeast Asia, South America, and Africa.
Examples of drug counterfeiting abound. During a supply bottleneck that occurred in the fight against a meningitis epidemic, pharmacies in Niger unknowingly bought expired vaccines that had been relabeled and redistributed in bulk. In the U.S., when a health insurance company stopped paying for a cancer drug, a counterfeit version of that very drug suddenly became available for purchase on a Canadian website. The world’s most counterfeited medicine product is Viagra, primarily because many customers buy it online.
Overall, 41 percent of counterfeit or substandard products reports come from Africa, 21 percent from Europe, and 21 percent from North, Central, and South America. While these products are big business, they pose a genuine and serious risk. Public health experts from the WHO estimate that they are responsible for 72,000 pneumonia deaths and 69,000 malaria deaths every year. Additionally, ineffective or substandard treatments make strains of bacteria even more resistant to drugs.
Serialization: SAP Cloud Platform Links Supply Chain Members
One important way of reducing counterfeiting is to ensure that medicine packs carry unique identifiers. The EU’s Falsified Medicines Directive defines the information that a data matrix printed on a medicine pack must contain, and how that data must be made available in digital form. In Europe, the data matrix typically includes a unique product code, a batch or lot number, and an expiration date. That information is stored in a dataset in a process known as “serialization.” Since February, any medical product that does not carry a serial number is prohibited from entering the market. By scanning a pack code, pharmacists can quickly and easily check whether the product inside was supplied by a listed pharmaceuticals manufacturer.
Apart from the equipment that pharmaceuticals manufacturers must buy to be able to label packaging and pallets, digitized product information must be accessible right along the supply chain – in pharmaceuticals factories, at logistics service providers, wholesalers, hospitals, pharmacies, and government authorities. One solution for meeting this requirement is SAP Information Collaboration Hub for Life Sciences. The hub links all stages in a medical product’s journey – from factory to patient.
Supply Chain Transparency with SAP Information Collaboration Hub for Life Sciences
Novartis was the first pharmaceuticals company to use the solution. It took the Swiss corporation about 18 months to prepare for go-live, which went ahead of schedule in February 2019. The main challenge was orchestrating all the IT systems deployed in the company’s serialization and product tracking system landscape. This landscape contains the equipment for printing data matrix codes on millions of medicine packs annually, solutions for transmitting digital information to SAP systems, ERP for integrating processes, and the SAP Advanced Track and Trace for Pharmaceuticals application.
Ross Doherty, team manager from SAP Innovative Business Solutions, sees the SAP Information Collaboration Hub for Life Sciences as a complement to SAP Advanced Track and Trace for Pharmaceuticals. According to him, one advantage of the information hub is that it is agnostic, so it can also be linked to non-SAP serialization systems. But the technical solution itself is not the biggest challenge for the companies that have already opted for SAP Information Collaboration Hub for Life Sciences.
“The portal is quick to build and the serial numbers are easy to obtain,” explained Doherty. “After that, it’s all about winning your business partners over to the solution” – or “onboarding,” as it is also known. So far, Doherty estimates that somewhere between 800 and 900 members of the supply chain are using the hub, including factories, logistics services providers, pharmacies, and physicians who require drug product information.
The more partners that participate, the more attractive the cloud platform becomes for other pharmaceuticals companies. Even a small or midsize pharmaceuticals company will sell over a million medicine packs every year – all of which must have the correct data matrix printed on them. Requests for serial numbers and status reports alone mean that the platform must handle several hundreds of thousands of information items every day.
Smooth Transitions to Blockchain Solutions
Just as with serialization, the U.S. market is again pioneering innovative technology to implement the next stage in the 2019 Drug Supply Chain Security Act: verification. Blockchain serves to secure transactions between independent parties and make them digitally traceable. When the act’s next milestone, all drug products returned to wholesalers in the U.S. must be verifiable.
As chief product owner for SAP for Life Sciences, Oliver Nürnberg has already pursued a blockchain-based approach that has been integrated into the SAP Information Collaboration Hub after two successful proofs of concept.
Currently, blockchain verification is limited to returned products. But the foundation has been established for creating mobile apps that use blockchain technology to make it even easier to check the authenticity of medications.