Viatris 2023 Sustainability Report: Breaking Down Systemic Barriers To Access Through Policy Engagement
Over the course of their lifetime, people will likely need many types of medicine, spanning infectious and noncommunicable diseases (NCDs). Accessing all these medicines at the right time, in the right place, can be life changing. Public policies are central factors in determining access to medicines as most often there are systemic issues that need to be addressed for meaningful and lasting improvements. Moreover, policymakers often encounter increasingly complex environments where finding perfect solutions is challenging.
Viatris is a member of ~160 trade associations.
We leverage our global experiences, scientific expertise and operations knowledge to support policymakers in identifying policies that advance access to quality medicines and build systems that sustain availability while minimizing unintended consequences. Because we have operations in countries around the world and a broad portfolio across most therapeutic areas spanning generics, trusted brands, improved versions of existing medicines and novel therapeutics, we have insights into the trade-offs policymakers face when considering how best to develop policies that meet people’s diverse health needs.
Given the breadth of our portfolio and geographic footprint, Viatris is well positioned to support policymakers in identifying opportunities for policy change aligned with advancing access to medicines – not just for one medicine, or one disease, but for all medicines. Taking a systems-level approach to consider policy enablers of access allows us to identify the changes that could facilitate access, not only for one company, but for all seeking to serve the world’s health needs.
Our global policy priorities are to advance access to quality medicines, strengthen resilient global supply and build future access. In 2023, we did this in many ways including:
Advancing Access to Quality Medicines
- Engaged alongside industry partners including the International Generic and Biosimilar Medicines Association (IGBA) in pursuit of regulatory harmonization, including actively contributing expertise to technical working groups of the International Council on Harmonization (ICH). Through IGBA, Viatris has a strong presence on ICH Expert Working Groups (EWGs). Viatris currently represents IGBA on four ICH EWGs, providing our technical expertise to help increase harmonization worldwide for the development and approval of safe, effective, and high-quality medicines.
- Supported the UK’s Windsor Framework, an agreement that helps protect access to medicine post-Brexit.
- In the U.S., Viatris partnered closely with the Center for Research on Complex Generics (CRCG), which facilitates research and collaborations across industry, academia and the FDA to increase access to safe and effective generic drugs, sharing our expertise on topics ranging from complex excipients to drug device combination products.
- Sponsored EURACTIV’s European Special Report to help regulators and other stakeholders understand the causes of medicine shortages and help to build solutions that are targeted and effective, including harmonizing regulatory requirements and replacing paper patient information leaflets with e-leaflets to allow for label changes without the need to repackage products.
Strengthening Resilient Global Supply
- Joined with industry stakeholders and Charles River Associates to assess the interplay of localization policies and access to medicines.
- Working closely with our trade association in Australia, Viatris is helping to drive changes with e-labeling. The Australian regulator has updated its guidance on requiring pack inserts for injectable products administered by a HCP, so Viatris is working to remove paper leaflets where possible and replace them with QR codes on packs.
- Provided feedback to relevant agencies and institutions as they consider solutions to drug shortages.
- Made recommendations to the Australia House of Representatives Inquiry into developing local manufacturing capabilities, including revisions that would better enable generic medicines to be manufactured for export. These changes could improve Australia’s ability to supply critical medicines to countries in need, leveraging its manufacturing capabilities to contribute to global access.
Building Sustainable Healthcare Systems and Future Access
- Actively engaged in the European Pharmaceutical Legislation revision, which proposes to include a focus on creating relevant pathways for repurposed medicines in Europe and continue to engage in dialogue to consider broadening this proposal to include additional types of medicine improvements
- Contributed to the paper “Unlocking barriers to scale Innovative Financing for Universal Health Coverage,” which was launched in 2023 by the U.S. Chamber of Commerce to explore new ways to grow and sustain healthcare financing and highlight the important role the private sector can play in innovative finance mechanisms
- Supported a study by the University of Athens (IPOKE Research Institute) which found that chronic underinvestment in healthcare in Eastern and Southern European countries over the past two decades has resulted in significantly lower healthy life years for the citizens of these countries compared to the rest of the Europe. The impact of Underinvestment on Medicines and Health Services study identifies the urgent need for policy action to tackle health inequalities through increased healthcare investments, fostering a healthier future for all citizens across Europe, and avoiding disruptions in the healthcare and pharmaceutical sector.
- Hosted STRIVE (Striving for Innovation, Value & Excellence in Pharmaceutical Procurement) in partnership with Galen Centre of Health and Social Policy, which brought together participants from government agencies, medical associations, the private sector and other stakeholders to discuss value-based healthcare and value-based procurement in Malaysia
- Worked closely with industry associations in the Philippines including the US-ASEAN Business Council on the expansion of the Primary Care Benefit Package, known as the Konsulta Package. In November 2023, PHILHEALTH approved the inclusion of atorvastatin, celecoxib, and gabapentin (joining amlopidine) in the list of pre-approved medicines under the Outpatient Benefit Package under Konsulta. Now, primary care facilities can prescribe these medications and can be reimbursed under the PHILHEALTH package.
