Counterfeit Medicines

The development, manufacture and controlled distribution of high quality products is only valuable and efficacious to our patients if they actually have genuine therapies available to them via a reliable and secure supply chain.

CSL has developed and implemented a supply chain security management system that combines product and security requirements, together with loss prevention practices and anti-counterfeiting measures which establish protections throughout its supply chain. Any CSL or business partner facility engaged in the collection, manufacture, storage, handling or shipment of raw or ancillary materials, products or product data, and assets must develop and implement a risk-based, comprehensive and documented supply chain security management system.

CSL previously implemented global processes to quickly respond to reports of counterfeit product and assist local law enforcement and health authorities in the investigation of counterfeit reports. These reports are managed with the highest urgency with oversight and direction provided by global policies, procedures and reporting systems that assure the right representatives from all relevant functions around the world are made aware of the situation and resources are allocated to support confirmation of product distribution channels, batch validity and product analytical testing, as requested by authorities. In 2015/16, CSL received and investigated 11 counterfeit product reports in four countries. Of these investigations, only one report was found to be counterfeit product.

While it is virtually impossible to prevent attempts to counterfeit products, CSL has undertaken significant investment to allow for product serialisation in multiple countries. Serialisation involves the use of unique identifiers on product vials and cartons that allow for rapid verification of whether product is genuine. Where serialisation regulations and systems have been approved for implementation of serialised packaging, CSL is in full compliance with these systems.

To further protect patients, CSL has begun to package product with tamper-evident measurements, which provide visual evidence that the product has been opened, providing a high level of confidence to patients and healthcare providers that the therapies that we administer are genuine.

To assure that products are transferred through approved, legitimate supply chain routes, CSL is prohibited from conducting business with any individual, group or organisation that has been designated on any sanction or blacklist.

In addition, Trusted Trader partnerships, whereby importers and exporters are qualified by a regulatory agency, enhance CSL’s reputation with authorities and reduce our risk profile as CSL goods move across borders. The internal control and security infrastructure in place to support these partnerships reduce CSL’s risk and exposure to both internal and external supply chain interruptions, and reduce the likelihood of a loss event where CSL assets could be used in the counterfeit market.