Creating Better Health for a Better World

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Our Vision for Social Responsibility

Global social responsibility is intrinsically woven within Mylan’s commitment to achieve our mission and deliver better health for a better world. It is what drives our enduring passion to improve access and serve unmet needs across all geographies, while respecting the environment and positively impacting our stakeholders.

Mylan at a Glance*

Building on Our Heritage

Our mission of access informs everything we do, and we understand the important role we play in giving everyone the opportunity to live the healthiest life possible.

our heritage
Frequently Asked Questions
  • How is Mylan Providing Access to High Quality Medicine in Low- and Lower-Middle-Income Countries?

    Everyone deserves the opportunity to live a healthy life. All too often, however, circumstances largely beyond an individual’s control, such as geography, ethnicity, economic status and gender affect the ability to achieve positive health outcomes. Throughout our history, Mylan’s foundation and core business model have been focused on providing access to medicine.

    According to the U.N., non-communicable diseases (NCDs) are the leading cause of death and disability globally.1 Populations in low- and middle-income countries face added difficulty as access to preventive care, healthcare providers, diagnostic equipment and medicine is often limited or non-existent.

    Our medicine reaches patients in more than 165 countries and territories, including 90% of low- and lower-middle income countries. It is capable of addressing 9 of the top 10 causes of death globally and almost 80% of the top causes of death across low- and lower-middle income countries. Mylan is among the leaders in products listed on the WHO list of prequalified products, with 68.2 Prequalification allows for U.N. procurement and accelerated registration processes in low- and middle-income countries.

    Mylan is also currently the largest supplier by volume of anti-retrovirals to low- and middle-income countries3 with costs significantly lower than those charged by brand companies.4

    In 2018,

    • ~40% of the nearly 22m HIV+ patients and ~60% of the world’s HIV+ children on treatment depended on one of our products; and
    • Mylan provided hepatitis B and C treatments for more than 350,000 patients in low- and middle-income countries and supported free hepatitis screenings in countries such as Egypt and India

    We are partnering with Otsuka Pharmaceuticals to treat tuberculosis, especially multi-drug resistant TB (MDR-TB) and have a license from Otsuka to prioritize access to Deltyba® in India. Further, we have agreed to extend commercial rights and registration responsibilities to many other high MDR-TB burden countries. India is considered by the World Health Organization (WHO) as among the highest-burden countries for multi-drug resistant tuberculosis (MDR-TB) and TB/HIV co-infection, with more than 150,000 estimated new cases of MDR-TB/rifampicin-resistant TB in 2015 alone.5

    For more information, please visit Serving Patients

    1https://news.un.org/en/story/2011/04/373282-non-communicable-diseases-leading-cause-deaths-worldwide-says-un-report 2https://extranet.who.int/prequal/content/prequalified-lists/medicines, as of 2.1.19 3https://clintonhealthaccess.org/content/uploads/2016/10/CHAI-ARV-Market-Report-2016-.pdf 4https://msfaccess.org/sites/default/files/HIV_Brief_SpotlightOnAccessGaps_ENG_2017.pdf 5World Health Organization. Global tuberculosis report 2016. WHO/HTM/TB/2016.13.

  • How is Mylan Ensuring Quality and Product Safety?

    Quality

    We know that what we do directly impacts the health and well-being of patients. As a result, protecting patients and consumer health by ensuring the quality and safety of our products is at the heart of how we operate. From product development to making or sourcing raw materials to producing finished dosage forms, every step of our development, manufacturing and monitoring processes is grounded in this commitment. Mylan has companywide product quality and safety standards, and applicable processes and management systems to ensure quality and manage risk.

    Quality begins at product development. We employ a team of highly-trained scientists and technical professionals with extensive experience in the pharmaceutical industry to develop each formulation and identify the specific processes and technologies used to manufacture our products. We monitor the performance of our products after approval and identify and implement any changes necessary to ensure quality. Significant changes also are subject to review by regulatory agencies. All applications are also subject to a robust regulatory review before a product can be brought to market.

    When it comes to manufacturing, we are committed to maintaining high standards at all our facilities and ensure regular, comprehensive oversight of our entire production network. In addition to Good Manufacturing Practices (GMP), we apply all other applicable quality guidelines and practices, including, for example: Eudralex, Falsified Medicines Directive, ICH Quality Guidelines, WHO GMP, Food and Drug Administration Safety and Innovation Act (FDASIA) and the EU Excipient Risk Assessment for ascertaining GMP for excipients of medicinal products for human use. We use a Regulatory Intelligence and Knowledge Management Dissemination Program to inform, evaluate and implement regulatory updates, industry trends and internal knowledge.

    Working with Health Authorities

    We constantly review our products, processes and facilities throughout our network and work closely with external health authorities to ensure transparency with emerging information, including shortages, adverse event reporting of other manufacturers’ products, development of new scientific and testing criteria and evolving regulatory and manufacturing expectations everywhere we operate. We continuously learn from these interactions as scientific, technology and regulatory expectations continue to evolve.

    Additionally, we have a global operations training program, promote regular self-inspection of our sites and conduct annual audits. Our Quality Council Program drives appropriate quality management action by tracking quality issues; analyzing metrics to identify trends, issues and risks; examining key performance indicators; and providing clear and accurate data analysis. In 2018, we expanded our self-inspection auditor certification program across all our operations to further strengthen site self-regulation.

    Externally, we apply an audit schedule based on business prioritization, cyclical audit requirements of facilities, key launches and historical regulatory inspection performance.

    Product Safety

    Global Product Safety and Risk Management (PSRM) is responsible for oversight of pharmacovigilance activities and is committed to patient safety. In line with applicable global legislation, Mylan has robust pharmacovigilance programs, including monitoring adverse events arising from the use of authorized medicinal products. These programs promote the safe and effective use of medicine by providing timely information about the safety of products to patients, healthcare professionals and the public. Our PSRM department also is responsible for conducting internal and external audits along with ensuring that the personal health information of those participating in our clinical trials is carefully safeguarded. It is subject to external audits and inspections from health authorities and ensures that practices evolve and adapt to the changing regulatory landscape.

    Another key component of our product safety effort is our global policy on product safety. It uses a global pharmacovigilance system to continuously monitor the safety profile of Mylan products and detect any changes to their benefit: risk profile. The system is supported by a comprehensive, multi-disciplined organizational structure, using safety experts who are medical and scientific professionals with extensive safety and/or clinical or healthcare experience. These individuals are trained in drug safety, pharmacovigilance and worldwide health authority regulations relevant to drug safety. Suspected adverse reactions are collected and carefully evaluated to ensure they are legible, accurate, consistent, verifiable and as complete as possible for their clinical assessment; they are reported in a timely manner within the legal reporting time frame.

    For more information, please visit Serving Patients

  • How Does Mylan Enforce Compliance of its Code of Business Conduct and Ethics?

    At Mylan, we:

    • Operate a global structure of Compliance Officers and liaisons providing compliance advice, customized training, investigations and governance across all regions and countries where we do business;
    • Maintain due diligence procedures including ethical business practice risk and sanction list reviews for intermediaries and consultants, and an enhanced risk-based process for completing advanced due diligence for channel partners and suppliers;
    • Have a Compliance Review Committee that meets quarterly for senior officers of the company, as do regional and local compliance and product committees;
    • Utilize technology and automated tools to monitor and report on compliance matters; and
    • Conduct timely investigations of any potential compliance violation that is raised through any means of reporting. Company investigations follow standard procedures to ensure that all reviews are performed properly and fairly, and that the Company identifies all actions necessary.
  • How is Mylan Helping to Address the Opioid Epidemic?

    Over the course of Mylan’s history, we have worked to help address some of the world’s most pressing public health problems. The ongoing opioid crisis is no exception. Mylan fully recognizes the scope of this issue and is committed to doing our part to help in the fight against opioid addiction, abuse and misuse.

    Regarding Mylan’s presence in the U.S. opioid market, the company has a limited role. We supply approximately 1.1% of opioid-containing drug products sold, according to 2017 IMS data. Mylan’s opioid portfolio consists of generic products and one branded product that is not part of the national discussion on opioids because it is an intravenous anesthesia medicine administered only by healthcare professionals in a surgery-center setting for which patients do not receive prescriptions. Mylan is not promoting or marketing any of its opioid products.

    However, given our leadership position within the generic pharmaceutical industry in particular and our extensive scientific capabilities, we are committed to finding ways to be a part of the long-term solution to this challenge. In 2014, Mylan launched a generic, injectable, single-vial version of Naloxone, a product that is indicated for the complete or partial reversal of opioid depression induced by some natural and synthetic opioids, as well as for diagnosis of suspected or known acute opioid over-dosage. In the summer of 2016, Mylan launched a multiple-vial version of its generic Naloxone injectable, thereby increasing supply for customers, physicians and other providers seeking additional inventory of this important therapy. Mylan’s injectable Naloxone products are primarily used by hospitals. Today, Mylan’s Naloxone presentations are the lowest price options in the overall Naloxone market, which includes auto-injectors and prefilled syringes. Mylan stands ready to continue to provide reliable supply and access to this important product, including through a commitment to develop an auto-injector drug-device combination for Naloxone.

    In April 2018, the company announced plans to leverage its world-class scientific platform to develop a novel delivery for Meloxicam, a non-opioid pain medication, and we remain committed to bringing this product to market. Promoting the development of non-opioid pain treatments is one of the many areas the FDA is focused on as part of its efforts to address this growing public health problem.

    Mylan’s portfolio includes the fentanyl transdermal system, which is a generic version of Johnson & Johnson’s branded fentanyl patch product, Duragesic™. Mylan’s fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. Mylan’s generic patches utilize a matrix technology in which the fentanyl is incorporated into the adhesive layer of the patch. Accordingly, Mylan’s patches have no drug reservoir containing fentanyl gel. Mylan’s matrix patches are among the products containing the least amount of fentanyl needed to deliver the labeled dose. At the time of its approval, Mylan’s matrix technology design represented an important innovation for the product.

    Mylan recognizes that fentanyl is a big part of the national opioid crisis. Importantly, however, lawful fentanyl products such as Mylan’s fentanyl transdermal system have been broadly acknowledged by federal authorities as not being responsible for the current fentanyl crisis. In its 2017 National Drug Threat Assessment Summary, the U.S. Drug Enforcement Administration concluded that “illicitly-produced fentanyl is responsible for the current fentanyl epidemic.” Mylan further recognizes that there has been focus on payments made by drug manufacturers to third-party advocacy groups and professional societies. Former Senator McCaskill issued a report on February 15, 2018 on this topic that positively differentiated Mylan, finding that the company is “[a]t the other end of the spectrum” from the other companies whose payments were examined because Mylan made only de minimis payments, and to only one of the 14 third parties cited in the report. Moreover, Mylan continues to cooperate with separately disclosed government inquiries that it has received.

    Mylan is also fighting the opioid epidemic by taking seriously the need to safeguard against diversion and abuse of opioids. We have internal practices designed to detect suspicious orders and prevent the sale of opioid-containing products where there may be a risk of diversion.

    We remain dedicated to working with key stakeholders across the spectrum of opioid-related issues to continue to identify avenues to help bring an end to this public health challenge.

    We remain dedicated to working with key stakeholders across the spectrum of opioid-related issues to continue to identify avenues to help bring an end to this public health challenge.

    Read the Mylan Report on U.S. Opioid Crisis

  • What is Mylan’s Pricing Model?

    Given our long history of providing high quality, low cost generic pharmaceuticals, we are uniquely situated to work with customers, payors, non-governmental organizations (NGOs) and other partners to find solutions and meet the needs of the patients and families we serve. We also have a strong track record of developing new products, particularly complex and difficult-to-formulate medicines, and are committed to making safe, high-quality products accessible to patients across all income levels.

    With respect to Mylan’s generic portfolio, we offer hundreds of affordable products all at a fraction of the price of the equivalent brand name medicine. The prices of these drugs often decrease every year. As negotiations occur with our customers or as we participate in tender programs or public/private partnerships around the globe, we will continue to do so based on an assessment of supply, demand, patient need and the affordability of our product, especially as it relates to the equivalent brand name drug.

    As it pertains to our brand portfolio, Mylan is committed to pricing its products in a way that reflects their value to patients and providers. Mylan will endeavor to not raise the prices of our branded products more than once per year, however we will assess the prices of our products on a regular basis. Our aim is for any price increases to be reasonable in light of relevant factors, including current economic indicators and the state of the overall business marketplace.

    The socioeconomic conditions within each market that Mylan does business are inherently considered as part of our generic and brand pricing assessments, as is the importance of sustaining our ability to consistently provide patients in each market with the quality products needed. This is reflected in our ability to provide 59 billion doses of medicine in 2018 to more than 165 countries and territories around the world at an average price of 19 cents per dose.

  • What is Mylan Doing to Help Fight Antimicrobial Resistance?

    Antimicrobial resistance (AMR) is a major global public health problem negatively impacting the lives of hundreds of thousands each year. Low-income and middle-income countries are disproportionately burdened. Contributing factors include patients’ vulnerability to invasive bacterial illness, irrational use of antibiotics and poor laboratory support for clinical diagnosis resulting in overuse of antibiotics.

    Mitigating AMR requires a holistic approach and multi-stakeholder cooperation to address issues such as universal access to antimicrobials, appropriate use, surveillance, stewardship and responsible manufacturing. As a global healthcare company, we must consider the diverse needs and circumstances of patients and communities when supporting and developing measures to address AMR. Policy intended to protect patients in one region may create unintended disadvantages for patients in another. Mylan is a signatory to the Davos Declaration on combating AMR since 2016 and a board member of the AMR Industry Alliance. We support the AMR Industry Alliance Common Antibiotic Manufacturing Framework and are an active member of its manufacturing work group.

    In addition to the AMR Industry Alliance, we engage on AMR issues through our national and regional trade associations, NGO collaborations and the Eco-Pharmaco-Stewardship Inter- Association Initiative, a cross-industry collaboration on environmental issues. In India, we are also engaged with the Ministry of Environment, Forest and Climate Change (MOEF) and other agencies with regard to setting pollution standards for AMR.

    Mylan supports efforts to raise awareness around AMR in addition to encouraging the appropriate use of medicines including the rational use of antibiotics. Additional resources include:

    The AMR Industry Alliance is one of the largest private sector coalitions established to provide sustainable solutions to curb AMR. It has rallied more than 100 biotech, diagnostics, generics and research-based pharmaceutical companies and associations to join forces. The Alliance measures and drives the progress of the life-sciences industry to curb AMR in four areas: appropriate use; access; research and science; and the environment.


  • How is Mylan Promoting a Sustainable Supply Chain?

    Mylan relies on its suppliers to deliver high quality, affordable and accessible products to our customers and ultimately to patients. We expect our suppliers to act in accordance with applicable laws, regulations and Mylan’s Supplier Code of Conduct which provides guidance for doing business with Mylan.

    The Supplier Code is available on Mylan.com and is part of Mylan’s terms and conditions for purchase orders. All suppliers bidding for new business must accept Mylan’s terms and conditions.

    Mylan’s internal Council for Sustainable Sourcing oversees our practices and provides guidance on sustainable sourcing; sets annual goals and objectives; and develops, implements and monitors compliance with sustainable sourcing practices and metrics. We plan to build out competency in sustainable sourcing processes and procedures across the organization.

    Maintaining good relationships helps ensure a high quality and reliable supply. We have a Supplier Relationship Management program, focusing on preferred suppliers.

    Mylan’s Supplier Code of Conduct reflects our commitment to the U.N. Global Compact and applicable international conventions.

    It establishes expectations in areas such as the following: Freely Chosen Employment, Child Labor and Young Workers, Freedom of Association, Wages, Benefits and Working Hours, Anti-Corruption and Business Integrity, Fair Competition, Conflicts of Interest, Conflict Minerals, Environmental Authorizations, Business Continuity, Legal Requirements, Commitment and Accountability, and Compliance Assessments.

    The Code communicates our expectation that suppliers apply comparable standards throughout their supply chain.

    We have a robust due diligence process to better understand supplier capabilities and ensure their ability to comply with regulatory and compliance requirements. Mylan has a proactive risk mitigation program to protect the supply chain by strengthening supply agreements with current suppliers and qualifying alternate suppliers. We monitor performance through reporting, trend analysis and consistent business review meetings. Mylan has established escalation and cross-functional issue management processes. Sourcing teams routinely meet with suppliers to review the performance of supply and create action plans to address identified risks.

    We continually work to improve our operations and expect our business partners to promote similar principles throughout their supply chain.

    For additional supply chain information:

  • How Does Mylan Manage its Wastewater?

    Minimizing Pharmaceuticals in The Environment (Pie)

    As a pharmaceutical company and member of the global community, Mylan is committed to caring for the environment and promoting responsible manufacturing by taking steps to minimize the environmental impact of our operations and products, while also balancing our need to produce high quality, life-saving medication.

    The primary pathways for pharmaceuticals entering the environment from human use are by normal patient excretion and improper disposal of medicine by consumers1, in addition to the use of pharmaceuticals in agriculture. A significantly smaller contribution stems from emissions resulting from the pharmaceutical manufacturing process, which is attributed to less than 2% of the overall contribution2. While gaps remain in the scientific link between pharmaceuticals in the environment and human health risk, we recognize and understand the concerns raised by stakeholders and are committed to reducing pharmaceuticals discharged from our manufacturing operations.

    Mylan’s approach to addressing and minimizing the potential impact of Pharmaceuticals in the Environment (PiE) from our own manufacturing is based on a wide range of activities and governance:

    • Risk and impact evaluation
    • Risk reduction and control
    • Engagement and policy

    Responsible wastewater management

    Responsible wastewater management is an essential part of Mylan’s environmental stewardship, as well as the work to reduce pharmaceuticals from entering the environment in connection to our manufacturing.

    Wastewater from all of Mylan’s operations undergoes treatment prior to discharge to the environment, and in India, multiple sites apply a ZLD technology that eliminates discharge. Mylan maintains applicable permits and authorizations for wastewater discharge with governing authorities and complies with local discharge limits. Withdrawal and discharge permits are maintained at all sites as required, and all operations sites are periodically audited to ensure compliance with local regulatory and internal standards.

    ZLD systems are wastewater treatment plants that eliminate effluent discharge into the environment. Instead, all wastewater is treated and repurposed back into non-potable applications in our facilities, reducing water usage and significantly reducing environmental impact.

    For more details on ZLD

    Production requirements of our operations – coupled with local regulations and infrastructure – guide the type of water and wastewater management systems and processes we utilize. We continue to implement technologies to manage and reduce the amount of wastewater and effluents from our processes. We use tools from various nongovernmental organizations (NGOs), such as the World Resources Institute, to help perform water risk assessments.

    Mylan is a signatory to the Davos Declaration on AMR and active member of the AMR Industry Alliance’s manufacturing work group, partnering with industry leaders and companies on AMR strategies. We support the Common Antibiotic Manufacturing Framework from 2018. It represents industry’s effort to provide a common methodology to assess potential risk from antibiotic discharges and take appropriate action when necessary*.

    We are also engaged in the Eco-Pharmaco-Stewardship Inter- Association Initiative, a cross-industry collaboration on environmental issues.

    * common-antibiotic-manufacturing-framework

    Additional resources include:

    1. Caldwell, D.J. (2015) Sources of Pharmaceutical Residues in the Environment and their Control, from ‘Pharmaceuticals in the Environment’, 2015, 92- 119 Editor(s): R E Hester, R M Harrison. Royal Society of Chemistry, London, UK.
    2. 2BIO Intelligence Service (2013), Study on the environmental risks of medicinal products, Final Report prepared for Executive Agency for Health and Consumers, pp. 46-47. 3common-antibiotic-manufacturing-framework
For More Information...

As a pharmaceutical company and member of the global community, we are committed to caring for the environment and promoting safe and sustainable operations.

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Our Commitment to Sustainable
Development

The Sustainable Development Goals (SDGs), adopted by all United Nations Member States in 2015, form the basis for collectively creating a better future by addressing fundamental global challenges such as poverty, poor health, inequality and climate change among others. Mylan supports this agenda and believes that companies can play a central role in helping to achieve these development goals.

While we support all 17 SDGs, we have identified nine as most relevant to our business. We place a special emphasis on SDG Number 3, Good Health and Well Being. Our broad and diverse portfolio combined with our long-standing commitment to innovation and partnerships, positions Mylan to make continued contributions toward this goal.

As a global healthcare company, we know our influence and actions impact other goals as well. From ensuring a fair, diverse and safe workplace and upholding a culture of integrity and ethical business practices to supporting local communities and reducing our environmental impact, we are committed to helping lead positive, sustained change.

Sustainable_Development