OUR PURPOSE PIONEERING SCIENCE 130 SASB CONTENT INDEX BIOGEN 2021 YEAR IN REVIEW PATIENTS OUR PEOPLE ENVIRONMENT COMMUNITY REPORTING Code Accounting Metric Biogen 2021 Response Counterfeit Drugs HC-BP-260a.1. Description of methods and technologies used to maintain traceability of products throughout the supply chain and prevent counterfeiting Counterfeiting is now the largest criminal enterprise in the world, accounting for more than 3% of global trade. Not one industry is exempt from this growing threat. Patient safety is our number one priority, and we take the issue of counterfeit, falsified drugs very seriously. The main goal of our Product Security function is to implement a holistic strategy in order to proactively identify, mitigate and manage illicit trade risks that could be impacting reputation and trust, and most importantly jeopardizing the health and safety of patients who take our drugs. We aim to disrupt diversion, counterfeiting, theft and other nefarious activities through the following five pillars: • Threat Assessments: Identify, assist and mitigate risks and vulnerabilities across the supply chain. • Auditing: Audit supply chain partners to ensure industry best practice requirements are met regarding product security. • Monitoring: Monitor markets, channels, supply chain, customer complaints and other network elements to detect illicit trade signals and potential threats to supply chain resiliency and robustness. • Investigations: Respond to incidents with robust investigation and enforcement capability, including legal actions to stop and deter illicit trade. • Product Security: Ensure we have the appropriate level of security measures for products and supply chain nodes in order to minimize the threat of counterfeits, diversions and thefts for the purpose of ensuring patient safety. In addition to the above, a majority of our global production is serialized, meeting all global compliance requirements on serialization including requirements in the U.S. and the EU. Whenever we serialize, we also aggregate the serialization information to enable Track&Trace. We have implemented Track&Trace capabilities at our main distribution sites, beyond compliance requirements, to provide additional elements of traceability. For example, in the EU each medication is verified against the list of serial numbers in circulation prior to dispensing. If a medicine’s serial number cannot be verified, a notification, called an alert, is electronically generated by the relevant National Medicines Verification Organization (NMVO) and shared with TraceLink, Biogen’s Serialization System. Biogen reviews these alerts and resolves them in correspondence with the relevant NMVO. Serialization alerts that indicate suspect or illegitimate product will trigger the internal process described above. HC-BP-260a.2. Discussion of process for alerting customers and business partners of potential or known risks associated with counterfeit products Biogen employs quality governed processes to manage the handling of suspect or illegitimate medicinal products: Upon detecting a potential or known product security risk, the event is captured as a complaint in the TrackWise system for formal tracking. Furthermore, there are requirements on segregation of product and the investigation process. Once the product is physically acquired, the technical product complaints group performs an investigation to verify if the product is genuine or falsified. If determined that the suspected product is falsified, potentially falsified or high risk of being falsified, a DMRB (global distributed material review board) must be completed, defining further specific market actions and communications. As necessary, all impacted competent authorities and impacted distribution partners are then notified. Once a case is closed, Biogen notifies the applicable authorities and impacted trading partners. In addition to the above internal processes, Biogen also participates in industry-wide systems and processes utilizing serialization data. For example, in the EU, each medication is verified against the list of serial numbers in circulation, prior to dispensing. Medicines shall not be dispensed if the number cannot be verified. If a medicine’s serial number cannot be verified, a notification, called an alert, is electronically generated by the relevant National Medicines Verification Organization (NMVO) and shared with TraceLink, Biogen’s Serialization System. Biogen reviews these alerts and resolves them in correspondence with the relevant NMVO. Serialization alerts that indicate suspect or illegitimate product will trigger the internal process described above. HC-BP-260a.3. Number of actions that led to raids, seizure, arrests, and/or filing of criminal charges related to counterfeit products Biogen did not take any actions in 2021 that led to raids, seizure, arrests and/or filing of criminal charges related to counterfeit products. Ethical Marketing HC-BP-270a.1. Total amount of monetary losses as a result of legal proceedings associated with false marketing claims Biogen did not sustain any monetary losses in 2021 as a result of legal proceedings associated with false marketing claims. Biogen discloses all material legal and regulatory proceedings in our Annual Report and Quarterly Reports on Form 10-Q . HC-BP-270a.2. Description of code of ethics governing promotion of off-label use of products Please visit our Early Access page for a description of Biogen’s approach to off-label use.
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