68
Products on the WHO List of Prequalified Products
Earned a Certificate of
Appreciation from U.S. Pharmacopeia
Participate and Hold
Leadership Roles in
>55 Industry Groups
The global nature of the pharmaceutical industry requires tremendous interconnectivity, especially when it comes to inclusive, responsible policies and trade agreements that encourage competition and prioritize patient needs. We continuously advocate for responsible trade policy and work to reduce regulatory burdens that impede access to affordable medicine. Barriers we address include slow approval processes, prolonged patent exclusivity and excessive IP protection. Public and private partners representing the entire healthcare continuum must work together, pooling expertise and resources to determine a collaborative path forward that will best serve patients.
We also work directly with regulatory bodies and trade associations to provide constructive input, raise awareness and propose solutions to challenges experienced by the generic and biosimilars medicines industry.
Addressing AMR requires a comprehensive approach and multi-stakeholder cooperation. An effective response to AMR will tackle challenges such as access to antimicrobials, stewardship measures – including appropriate use and surveillance – and responsible manufacturing. As a global healthcare company, Mylan considers the diverse needs and circumstances of patients and communities across the world by supporting and developing measures to address AMR while taking care to avoid unintended consequences.
Mylan is committed to supplying a diverse range of antimicrobial products including “forgotten antibiotics,” those which are less widely produced and often effective against many resistant bacteria. Access to effective antimicrobials in low- and middle-income countries is a priority for Mylan, as evident in our collaborations with TB Alliance and Otsuka. These programs have allowed Mylan and our partners to increase access to affordable treatment for multidrugresistant forms of TB in high burden countries. Our supply chain supports reliable access to antimicrobials with mechanisms such as rapid-response advanced planningsystems, dual sourcing systems and maintaining safety and strategic stocks. We have comprehensive processes to protect the security of products and safety of patients, including anticounterfeit serialization.
Our approach to stewardship includes healthcare professional (HCP) education, appropriate use packaging configurations, incorporating technology such as mobile apps and conducting AMR surveillance. Mylan supplies a broad portfolio of packaging configurations for various strengths and formulations, including pediatric formulations. Further, we work with pharmacies and support mobile applications, as well as other adaptations such as pictograms, to increase prescription adherence. Our HCP education programs meet the highest ethical standard and reach providers on the front lines of AMR. We monitor AMR through multiple surveillanceprograms which will be published in peer-reviewed journals. In India, Mylan supports a multicenter retrospective study of antimicrobial resistance in intensive care unit patients and operates the Revised National TB Control Programme (RNTCP).
In addition to the AMR Industry Alliance, Mylan advances efforts on mitigating AMR and pharmaceuticals in the environment (PiE) through our national and regional trade associations and collaborations with non-governmental organizations. Recently, we have engaged with the Ministry of Environment, Forest and Climate Change (MOEF) and other agencies in India regarding AMR, and in Sweden we are a founding member of PLATINEA, a multi-stakeholder platform for ensuring the future value of existing antibiotics.
Overcoming Obstacles to Access
In 2018, we continued to work to receive approval on products that for many years were out of reach for patients around the world. Many of these products had no or very limited generic or biosimilar competition, therefore the high cost of these life-saving medications restricted access for patients. Our achievements in improving access to biosimilar medicines and generics through our approvals, regulatory submissions and R&D pipeline demonstrate how we continue to positively impact global public health, enabling patients to have an alternative to high-cost medications and improved access to these important medicines.
Advocating for Change in the U.S.
We continue to advocate for changes to the current structural issues in the U.S. healthcare system that hinder access to generics and biosimilars. For instance, we strongly support the need to ensure that generic and brand products are placed on proper formulary tiers to lower out-of-pocket costs for patients, encourage use of generics and biosimilars, as well as create a much-needed generic and biosimilar tier for specialty products.
Mylan recognizes that water is a scarce resource in many of the communities where our employees live and the company does business. We work proactively to protect water and reduce consumption. While we have made significant headway in reduction at some locations, our water usage in 2017 increased by 3.5% to 3.3 million cubic meters, due primarily to increased global production. We continually look for ways to reduce water consumption, reuse water for non-potable purposes and install technologies that ensure adequate quality wastewater.
We continue to invest in wastewater treatment facilities and look for additional improvements across our operations. For example, we recently installed a state-of-the-art, full-scale wastewater treatment system in our manufacturing facility in Galway, Ireland.