Saving Lives one Serial Number at a Time
The journey of SAP Information Collaboration Hub for Life Sciences
Counterfeit designer bags, watches or sneakers cause economic damage on impacted companies whose products are copied, but they do no real harm to consumers. That is very different when it comes to counterfeit medication.
Using counterfeit medication causes health risks, or even worse, death. This warning is included in a study recently published by the Organization for Economic Co-operation and Development (OECD) and the European Union Intellectual Property Office (EUIPO).
The 2020 report shows the extent and scope of problems caused by counterfeit medicine. Every year, according to the authors, up to 169,000 children die from pneumonia and over 100,000 people die from malaria because they are treated with counterfeit medicines. All kinds of medicine can be counterfeited: expensive lifestyle or anti-cancer medicine, antibiotics, medication for hypertension, cholesterol lowering drugs, hormones, steroids, antihistamines, and inexpensive generic versions of basic pain killers.
As a response, governments world-wide have enacted directives that require members of the pharmaceutical supply chain to uniquely identify their products on the smallest sellable unit level to enable identification of counterfeit products through track and trace or verification. This is known as serialization.
More and more countries and regions are enacting legislation to cover serialization. However, rules, message content, message orchestration and derived processes can vary considerably.
Companies often struggle with the variety of national regulations, the overall complexity of the topic, the large volumes of data, and the different requirements to establish connection to national reporting systems.
SAP Information Collaboration Hub for Life Sciences facilitates collaboration along the pharmaceutical supply chain. This is a productive business network for the pharmaceutical industry that facilitates messaging of traceability and serialization data across the supply chain, enabling each customer to connect once and only once to share data with all partners and regulatory bodies.
In 2015, SAP launched SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP). This was developed in co-innovation with nine of the top 20 pharma companies and a major U.S. wholesaler. ATTP OnPremise software enables pharma manufacturers to generate serial numbers and transmit them to packaging lines where they are printed on packing.
After the introduction of ATTP, customers and SAP discussed the idea of a Pharma Network. This Network, using public cloud infrastructure, aimed to enable organizations to exchange serialized data between stakeholders. Based on the idea, in 2016 SAP delivered the first customer specific Pharma Network solution. Several customers implemented this solution which covered the overall process and customer specific requirements.
During 2017, SAP chose to productize this solution by building the SAP Information Collaboration Hub for Life Sciences as a standard offering to the Pharma Industry.
With SAP Information Collaboration Hub for Life Sciences, SAP expands the serialization functionality of SAP ATTP beyond the walls of the OnPremise solution. This standard cloud service is built on the SAP Business Technology Platform and is offered as Software as a Service through subscription.
Addressing the EU Falsified Medicine Directive (FMS), to help Manufacturers report data about their products to a central hub run by the European Medicines Verification Organization (EMVO), in 2018 SAP delivered the option for regulatory reporting for the European Union as a first additional offering of the SAP Information Collaboration Hub for Life Sciences.
SAP enlarged the offering by addressing additional regulatory reporting scenarios. Today, besides reporting to the European Union regulatory body, the service covers regulatory reporting for Russia (OMS & MDLP), Saudi Arabia, Indonesia, Bahrain, and Brazil reporting to ANVISA. New capabilities are planned using a new generic reporting interface between OnPremise and SAP Information Collaboration Hub for Life Sciences to be faster and more agile in addressing future regulatory needs.
To help customers comply with the U.S. Drug Supply Chain Security Act (DSCSA), which protects consumers from fake, contaminated or stolen medication, and requires wholesalers to verify prescription drugs that are returned and intended for resale, SAP added a blockchain based verification repository, to authenticate pharmaceutical items returned from hospitals and pharmacies to wholesalers before the products are resold.
This blockchain allows wholesalers to verify the product code, lot, expiration date and a unique serial number embedded in the barcode against manufacturer data stored in the blockchain.
The most recent addition to SAP Information Collaboration Hub for Life Sciences covers regulatory collaboration between participants of the supply chain of prescription medicine.
The option for regulatory collaboration provides onboarding, integration, and messaging capabilities to support various legislations, including the need to onboard a high number of business partners to exchange fully standardized messages in a regulatory context. The service provides:
- Invitation Management from customers to business partners
- Self-onboarding of invited business partners
- Transmission of standardized notifications in legislation-specific formats using the generic reporting framework between SAP Information Collaboration Hub for Life Sciences and SAP Advanced Track and Trace for Pharmaceuticals
- Receiving standardized regulatory notifications from Business Partners
The first use case for this option for regulatory collaboration is the Brazilian market. This is planned as a basis for the U.S. market to support the requirements of the DSCSA 2023.
Today the seven largest pharmaceutical companies globally, 13 out of the top 20 pharmaceutical companies, and two of the three largest U.S. pharmaceutical wholesalers are using SAP Information Collaboration Hub for Life Sciences to connect to their ecosystem to verify saleable returns.
In 2019, SAP Information Collaboration Hub for Life Sciences, together with SAP Advanced Track and Trace for Pharmaceutical won the Frost & Sullivan “Visionary Innovation Leadership Award”.
“SAP has truly set the standard for how intelligent technology can be an invaluable tool in combatting drug counterfeits and promoting compliance with global serialization regulations,” said Frost & Sullivan Industry Analyst Kamaljit Behera. “We applaud the innovation SAP’s pharmaceutical supply chain solutions bring to the industry.”
The International Business Awards are the world’s premier business awards program. All individuals and organizations worldwide – public and private, for-profit and non-profit, large and small – are eligible to submit nominations. The 2021 IBAs received entries from organizations in 63 nations and territories.
“This is what can be thoroughly called innovation. When it comes to drugs, high control is needed to stop drug counterfeiting. There should be an innovation like this to prevent fake medicines from being sold. There is nothing more to say about this idea.”
The most recent release of SAP Information Collaboration Hub for Life Sciences is release 2108 released on August 21st, 2021.