OUR PURPOSE PIONEERING SCIENCE 128 BIOGEN 2021 YEAR IN REVIEW PATIENTS OUR PEOPLE ENVIRONMENT COMMUNITY REPORTING Code Accounting Metric Biogen 2021 Response Safety of Clinical Trial Participants HC-BP-210a.1. Discussion, by world region, of management process for ensuring quality and patient safety during clinical trials Biogen has a Global Pharmacovigilance (PV) team comprised of medical and scientific professionals with extensive safety and/or clinical or healthcare experience who are trained in PV and worldwide health authority regulations relevant to medicinal product safety. Biogen’s safety signal management processes, combined with our robust safety governance framework, allow Biogen to determine if new safety information on our products (a ’signal’) poses a risk to patients and how best to manage, mitigate and communicate the risk. All safety and benefit/risk decisions for marketed and investigational products are made by the Safety Monitoring Committee (SMC). The Safety team collaborates with Regulatory Affairs to communicate product information in a timely, transparent and accurate manner to regulatory agencies across the globe. In addition to complying with our company’s global standards, the conduct of our clinical trials adheres to the International Council for Harmonization Good Clinical Practice (ICH GCP) standards and to the principles that have their origin in the Declaration of Helsinki. Each country has its own regulatory authority with its own regulations, or laws, for conducting a clinical trial. The regulatory authority reviews and approves the protocol and ensures that the clinical trial follows national regulations. An Institutional Review Board (IRB) or Ethics Committee (EC) is an independent committee that includes medical, scientific and non-scientific members, whose responsibility is to protect the rights, welfare, safety and well-being of clinical trial participants. Each clinical trial location is monitored by a specific IRB/EC. It is responsible for reviewing all clinical trials as well as conducting ongoing reviews of active clinical trials. Þ For more information, please visit our clinical trials webpage HC-BP-210a.2. Number of FDA-Sponsored inspections related to clinical trial management and pharmacovigilance that resulted in: (1) Voluntary Action Indicated (VAI) and (2) Official Action Indicated (OAI) Biogen is committed to collaborating with regulatory agencies on a wide range of issues, including clinical trial management and pharmacovigilance and taking any actions that are needed. Please see Biogen’s 2021 Annual Report for any relevant disclosures. HC-BP-210a.3. Total amount of monetary losses as a result of legal proceedings associated with clinical trials in developing countries Biogen did not sustain any monetary losses in 2021 as a result of legal proceedings associated with clinical trials in developing countries. Biogen discloses all material legal and regulatory proceedings in our Annual Report and Quarterly Reports on Form 10-Q . Access to Medicines HC-BP-240a.1. Description of actions and initiatives to promote access to healthcare products for priority diseases and in priority countries as defined by the Access to Medicine Index While not listed as a company in scope for the 2022 Access to Medicine Index (“Index”), Biogen is deeply committed to health access and equity across our business. We are expanding its portfolio and pipeline, which includes a focus on diseases and conditions prioritized by the Index, including Alzheimer’s disease, depression and stroke. Additionally, Biogen serves patients in a number of countries included in the Index, such as Brazil, China, India and Mexico, and we actively work with a variety of stakeholders to understand opportunities to meet patient needs. For example, in India, we advanced our SPINRAZA Individual Patient Humanitarian Aid Access Program (SIPHAP) to a total of 211 patients across 14 public hospitals in 2021. In India and in other markets we serve, we are continuing to explore opportunities and advance programs that promote health access. For additional detail on this and other programs designed to promote health access and equity, please see the Patients section of Biogen’s 2021 Year in Review and Biogen’s Early Access webpage . HC-BP-240a.2. List of products on the WHO List of Prequalified Medicinal Products as part of its Prequalification of Medicines Programme (PQP) Biogen has no products on the WHO List of Prequalified Medicinal Products . SASB Content Index