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Our Commitments

Biogen’s commitment to patient communities is in our DNA. We are in the business of helping people fight devastating diseases, which puts patients and patient communities at the center of everything we do. Our employees care deeply about what they are doing because they come to work every day knowing that hundreds of thousands of people worldwide depend on Biogen and our products to make a meaningful difference in their lives.

Our commitment to improving lives goes beyond scientific research and development. We prioritize engagement with patients and caregivers to understand their needs and identify how we can help them achieve better health outcomes.

To achieve this goal, Biogen is proactively engaged with a variety of stakeholders as we work to ensure broad access to our treatments through clinical trial programs and expanded access programs (EAPs). We recognize that prices for, and access to, treatments are chief concerns for patients, providers, payers and policy makers, and we work with all parties with the goal of ensuring that patients are not denied access to life-changing therapies. We also engage patient advocacy organizations and professional associations to solicit their input and insights and educate them on important topics related to our products and development pipeline.

  Our Commitments

Biogen’s commitment to patient communities is in our DNA. We are in the business of helping people fight devastating diseases, which puts patients and patient communities at the center of everything we do. Our employees care deeply about what they are doing because they come to work every day knowing that hundreds of thousands of people worldwide depend on Biogen and our products to make a meaningful difference in their lives.

Our commitment to improving lives goes beyond scientific research and development. We prioritize engagement with patients and caregivers to understand their needs and identify how we can help them achieve better health outcomes.

To achieve this goal, Biogen is proactively engaged with a variety of stakeholders as we work to ensure broad access to our treatments through clinical trial programs and expanded access programs (EAPs). We recognize that prices for, and access to, treatments are chief concerns for patients, providers, payers and policy makers, and we work with all parties with the goal of ensuring that patients are not denied access to life-changing therapies. We also engage patient advocacy organizations and professional associations to solicit their input and insights and educate them on important topics related to our products and development pipeline.

Our Focus

Access to Treatments

One of the more complex tasks that we navigate as a company, and as part of the broader biopharmaceutical industry, is helping to ensure that the people who need our therapies have access to them. We employ two complementary approaches to help accomplish this:

  • Investigational access: increasing participation in clinical trials and offering expanded access programs (EAPs) to patients who are unable to participate in clinical trials
  • Affordability access: adhering to a pricing philosophy that secures reimbursement in public and private health care programs and offers financial assistance to patients who are otherwise unable to access our medications

The complexity of the healthcare marketplace requires us to always be vigilant and committed to ensuring patients who need our therapies have access to them. In addition to our support of clinical trial and EAPs, Biogen routinely engages a variety of stakeholders (patients, healthcare providers and payers) when setting our market prices, balancing the competitive nature of our industry with the need to support further research and development that will create the therapies of the future. We also invest significant time and energy on interrelated issues around access, such as obtaining regulatory approvals in many countries around the world, educating physicians and demonstrating product efficacy and value.

Learn more about our access programs.

Expanded Access Programs (EAPs) and Single Patient Access

Our EAPs bridge an important availability gap for therapies that have not yet become commercially available, providing access to treatment for patients with unmet medical needs while the regulatory approval process and reimbursement negotiations take place. For example, our EAP for spinal muscular atrophy (SMA) offers early access for infantile and childhood SMA patients who would not otherwise be eligible for clinical trials. In addition to our EAP programs, in some situations Biogen may be able to provide access to investigational therapies through what is essentially emergency use, also known as single-patient access. Learn more about our Expanded Access Programs (EAPs). The complexity of the healthcare marketplace requires us to always be vigilant and committed to ensuring patients who need our therapies have access to them.

In addition to our support of clinical trial and EAPs, Biogen routinely engages a variety of stakeholders (patients, healthcare providers and payers) when setting our market prices, balancing the competitive nature of our industry with the need to support further research and development that will create the therapies of the future. We also invest significant time and energy on interrelated issues around access, such as obtaining regulatory approvals in many countries around the world, educating physicians and demonstrating product efficacy and value.

Learn more about our access programs.

Clinical Trials

Clinical trials are an essential part of the drug development process. They are designed to answer specific research questions related to the efficacy and safety of a potential therapy.

We are grateful to the patients, healthy volunteers, healthcare providers, hospitals and clinics that participate in testing our investigational therapies. Deciding to participate in a clinical trial requires careful consideration because in most cases, the therapies being investigated in clinical trials are not yet approved by regulatory agencies.

For some patients, participation in a clinical trial means access to a potentially life-improving medication when there may not be any other options. These experimental treatments are not available elsewhere and sometimes can be a last resort for patients who have tried many other therapies with limited or no success.

Historically, minorities have been underrepresented in clinical trials. Recognizing this reality, in recent years, we have focused on expanding the pool of participants in clinical trials to be more inclusive. This not only makes access more equitable, but also gives us a better understanding of how our therapies work in people of different genders, races and ethnicities.

Learn more about clinical trials.

Patient Health Outcomes

Through ongoing dialogue, dedicated research and interactions with advocacy groups, we support patients and address their key concerns – from the safety and availability of our therapies to the costs of treatment, the overall patient experience and long-term health outcomes. We help patients and their support networks navigate the emotional and logistical considerations that often accompany a chronic disease, and we provide important therapeutic information with the aim of enhancing their quality of life.

We believe it is ideal for patients to be backed by services that support them emotionally, financially and medically. By partnering with patient advocacy organizations, we are able to better understand the needs and challenges patients face as we work to improve access to treatments and services. These organizations provide a critically important voice, representing the interests of patients and families affected by diseases throughout the healthcare system.

Our programs are designed to help patients get started on and adhere to treatments. Our Above MS™ program, for example, offers tips, tools and inspiration for people living with multiple sclerosis (MS). In 2017 we launched MS PATHS, an innovative collaboration with ten leading MS centers that uses technology to capture real-time, standardized data to help us better understand MS. We also launched a new MS campaign, 1MSg™, in the United Kingdom to encourage people with MS to work with medical specialists to educate themselves about their condition and how to best manage their treatment.

We have been working closely with those affected by SMA to create a disease education program called Together in SMA™. The program provides information about SMA and its symptoms, insight into care options and perspectives on a range of topics – such as nutrition and adaptive equipment – from experienced caregivers and healthcare professionals.

Spotlight Stories

Advocating for Early Newborn Screening for SMA in the U.S.

Spinal muscular atrophy (SMA) is a neuromuscular disease that is a leading genetic cause of death for infants under two years old. SMA impacts approximately one out of every 10,000 babies born in the U.S. Due to its debilitating and often fatal nature, early detection of SMA in newborn babies is critically important. Early detection allows for earlier treatment, which can dramatically reduce the symptoms of the disease.

However, in the U.S., newborns are not typically screened for SMA. Newborn screening (NBS) is a public health program that aims to identify newborns who have certain serious and life-threatening genetic diseases that can be treated, and for which earlier treatment may contribute to better outcomes. Currently, newborn babies in the U.S. are screened for approximately 30 different disorders, with the exact number varying by state.

Recently, Biogen launched an initiative advocating for every baby born in the U.S. to be screened for SMA. This U.S. initiative also supports our global efforts to promote newborn screening for SMA in other parts of the world.

Recent studies suggest that SMA therapy is most effective when started in the first few months of life. Early treatment for the disease is now possible with the availability of SPINRAZA®, the first and only approved treatment for SMA.

Working collaboratively with colleagues from patient advocacy and government affairs, we adopted a multi-faceted approach to advocate at both the federal and state levels for universal SMA screening for newborns in the U.S. As the final decision on SMA screening implementation differs by state, we are taking a state-by-state approach to support adoption of screening recommendations. We are committed to engaging policymakers, patient communities, caregivers, regulators and payers to make a difference in how SMA is screened for and identified across the country.

We recognize that our work advocating for universal SMA newborn screening in the U.S. takes patience and persistence. Since launching our effort, four U.S. states have adopted SMA screening and several other states are in the process of doing so, which means more children getting the early diagnosis and treatment they desperately need. We will continue to do everything we can to improve quality of life for children and families affected by the disease – today and in the future.

MS PATHS: Harnessing Real-Time Patient Data to Reshape MS Care and Research

With the launch of our learning health system, MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions), we are helping to transform the future of MS care and research.

MS PATHS is a one-of-a-kind collaboration with ten leading MS centers in Europe and the United States that uses technology deployed in routine care to generate standardized, high-quality data from a diverse, real-world patient population. Using this data, we hope to gain powerful insights and a better understanding of how MS impacts patients – with the goal of enabling us to further improve their lives and their health outcomes.

The MS PATHS program collects clinical, MRI and biologic data from MS patients in real-time, at the point of care, to better understand the disease. At the heart of the program is the Multiple Sclerosis Performance Test (MSPT), a suite of iPad-based assessments taken by patients before routine office visits. The MSPT provides quantitative assessments of motor, visual and cognitive performance. Using our MSPT device, patient self-assessments are integrated into the clinic visit and doctors get a real-time view of the results without additional administrative hurdles.

Relevant patient data are then generated and collected in an efficient and standardized way and shared with researchers participating in MS PATHS while protecting the privacy of individual patients.

According to Alfred Sandrock, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Biogen, “By leveraging technology we are able to collect a robust set of real-world data that is unprecedented in scale and will contribute to a more precise approach to managing patients by supporting providers in real-time to meet the diverse needs of people living with MS.”

With more standardized data, researchers are able to meaningfully compare information from across the MS population, and to identify underlying trends. This provides both doctors and researchers with a more holistic view of the disease and how it affects patients’ lives. The program is a global effort with more than 12,000 patients participating in MS PATHS at our network of partner healthcare institutions.

2017 Goals & Performance

36%

of MS patients worldwide treated with Biogen products as of March 31, 2018¹

MS PATHS

launched MS PATHS, an innovative collaboration with ten leading MS centers, using technology with the aim of transforming the future of MS care and research

#1

ranked first on IDEA Pharma’s 2017 Pharmaceutical Innovation Index

Together in SMA™

created Together in SMA, a disease education program to provide information about SMA and its symptoms

1MSg™

launched 1MSg, a new MS-focused campaign, to encourage patients to work with their healthcare providers to become more informed

1st

and only approved treatment for spinal muscular atrophy (SMA)

Footnotes:

  1. Biogen data on file.

2017 Goals & Performance

36%

of MS patients worldwide treated with Biogen products as of March 31, 2018¹

MS PATHS

launched MS PATHS, an innovative collaboration with ten leading MS centers, using technology with the aim of transforming the future of MS care and research

#1

ranked first on IDEA Pharma’s 2017 Pharmaceutical Innovation Index

Together in SMA™

created Together in SMA, a disease education program to provide information about SMA and its symptoms

1MSg™

launched 1MSg, a new MS-focused campaign, to encourage patients to work with their healthcare providers to become more informed

1st

and only approved treatment for spinal muscular atrophy (SMA)

Footnotes:

  1. Biogen data on file.

2017 Goals & Performance

36%

of MS patients worldwide treated with Biogen products as of March 31, 2018¹

1st

and only approved treatment for SMA

MS PATHS

launched MS PATHS, an innovative collaboration with ten leading MS centers, using technology with the aim of transforming the future of MS care and research

#1

ranked first on IDEA Pharma’s 2017 Pharmaceutical Innovation Index

Together in SMA™

created Together in SMA, a disease education program to provide information about SMA and its symptoms

1MSg@™

launched 1MSg, a new MS-focused campaign, to encourage patients to work with their healthcare providers to become more informed

Footnotes:

  1. Biogen data on file.

Our Guiding Principles

Our commitment is grounded in our Values in Action – Code of Business Conduct, our Sustainability Policy and our other related policies and position statements. These principles and policies outline our focus on ethical business conduct, compliance, accountability and transparency and other topics, including:

Values in Action - Code of Business Conduct

Our Code of Business Conduct provides guidance on making ethical decisions while conducting business on behalf of Biogen. Our clinical research and other ethical standards for our employees and business partners are included in the Code.

Product Stewardship

We comply with applicable regulations and work to minimize adverse health, safety, environmental and social impacts of our products, and we do this while working to maximize their benefits and value through their full life cycle. One example of our efforts in this area is that we are investing in serialization technology to make our product more difficult to counterfeit, improving patient safety and health outcomes.

Patient Safety

Patient safety is our highest priority and we are committed to complete and timely evaluation of the benefits and risks of our therapies and to communicating this information to help patients and health care professionals make informed treatment decisions. We take seriously our ethical and regulatory responsibility to continually assess and communicate the benefits and risks of our products to patients, health care professionals and regulators.

Global Privacy Program

We respect the privacy and safeguard the security of the personal information we collect. Doing so is fundamental to our commitment to patients, health care professionals, business partners, employees and the communities we serve.

Pricing and Access Philosophy

We have the opportunity and responsibility to bring transformative treatments to patients. We recognize that prices for, and access to, treatments are chief concerns for patients, providers, payers and policy makers. We work collaboratively with all parties to help ensure that patients are not denied access to life-changing therapies.

Supply Chain Responsibility

Our Code of Business Conduct, Human Rights Position Statement and U.K. Modern Slavery Statement establish the principles and practices of ethical business, which we expect all of our suppliers, business partners and employees to follow. In addition, our commitment to inclusive sourcing and procurement practices is represented in our supplier diversity program.

Human Rights Position

Biogen respects fundamental human rights and believes that every individual deserves to be treated fairly and with dignity. Biogen is committed to supporting internationally recognized fundamental human rights activities and initiatives.

U.K. Modern Slavery Act

At Biogen, we are committed to upholding human rights and ensuring that modern slavery (in all its forms) is not tolerated within our global business or our supply chain.

Research Collaborations

We are committed to bringing novel therapies to market and focusing on hard-to-treat disease areas with significant unmet medical needs. As this challenge is often bigger than any individual company, we collaborate with partners in both the public and private sectors to harness the latest advances in science and technology.

Transparency Reporting

We believe transparency is an important part of our ongoing collaboration with the health care community, helping to build a community of trust and respect with healthcare professionals, patients, industry peers, shareholders and the public.

Clinical Trial Transparency and Data Sharing

We are committed to sharing information about our clinical research with patients and researchers to enhance public health.

Supplier Diversity - Working With Us

We believe that partnering with small and diverse suppliers supports economic growth, fosters innovation and enables us to achieve a competitive advantage globally. Our supplier diversity program ensures that small and diverse business enterprises have an equitable opportunity to compete for Biogen’s business. As such, supplier diversity is integrated into our procurement procedures. Our supplier diversity program includes businesses owned by minorities; women; veterans and service-disabled veterans; lesbian, gay, bisexual and transgender individuals and persons with disabilities.

Animal Welfare

At times, we are required by standards of scientific best practice, or by government agencies charged with the protection of public health, to conduct or sponsor research that uses animals. When we do so, we adhere to applicable national and international laws, policies and guidelines on the humane treatment of animals used in research. These include, but are not limited to, the Animal Welfare Act, the U.S. Public Health Service Policy, the National Institutes of Health and the Association for Assessment and Accreditation of Laboratory Animal Care.

Sustainability Policy

Sustainability at Biogen stems from our commitment to both innovation and ethical conduct. By continually expanding our approach to sustainability and encompassing economic, social and environmental factors, we believe we will build a stronger, more vital company capable of making new discoveries that could improve the lives of many more people in the future.

Climate Strategy

We carefully manage the way we use resources, striving to reduce, mitigate and, in the case of carbon emissions, neutralize our footprint wherever possible.

Climate Change Position

We believe that meeting the global challenge of climate change will require businesses to take actions that go beyond the regulatory requirements. We have committed to establishing a science-based greenhouse gas (GHG) reduction target to align with global efforts aimed at ensuring the earth’s average temperature does not rise more than 2 degrees Celsius.

Comprehensive Compliance Program

To conduct our business with the highest level of integrity, we have established and maintain a compliance program in accordance with the laws of our industry and the “Program Guidance for Pharmaceutical Manufacturers” published by the U.S. Department of Health and Human Services.

Corporate Governance Principles

The Company’s Certificate of Incorporation and Bylaws, together with our corporate governance principles, provide the framework for the corporate governance of Biogen.

Environmental Health and Safety Policy

Our Environmental, Health and Safety Policy Statement sets forth our commitment to provide and maintain a healthful and safe work environment and to minimize the impact of our business operations and products on the environment.

Political Contributions Policy

Our policy outlines Biogen’s participation in the political and legislative processes.