Advocating for Access

At a Glance

Partnering to Make a Difference

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.

Fighting Falsified Medicine

We’ve made significant investments in packaging and information technology to enhance product safety. By lowering the likelihood that falsified products will enter our supply chain, we are helping ensure access to high quality medicine. Significant updates to existing policies and procedures were also made as well as the establishment of new procedures to handle the movement and shipping of serialized product. Among these are processes to track and trace serialized products. An internal product safety group helps monitor the supply chain to help ensure it is not breached.

Expanding Serialization

Serialization is fueled by myriad government regulations that require Mylan to track our products along the supply chain and verify their authenticity.

We comply with the U.S. Drug Supply Chain Security Act and the European Union Falsified Medicine Directive. We employ serialization technology such as a 2D matrix on all products. Work also includes the gathering of data from the matrices so that we can identify and manage procedures associated with individual units regarding product picking, packing, shipping, sampling, returns and destructions.

Invested $80M on Serialization Processes

Addressing Antimicrobial Resistance (AMR)

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. Mylan is a signatory to the Davos Declaration on combating AMR and a board member of the AMR Industry Alliance.

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 AMR.

Learn more about how Mylan is addressing AMR

Improving Access and Addressing Obstacles

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.

Air Emissions

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.

Wastewater Management

Site with zero discharge
(ZLD) systems

11

Water Supply,
thousand qubic meters

2015 2016 2017
3,142 3,185 3,298

100%

of Mylan's wastewater genrated in our Hyderabad manufacturing sites utilizes ZLD technology. Mylan began using it in 2009 and today operaters 11 ZLD facilities across India.