NORTHAMPTON, MA / ACCESS Newswire / November 4, 2025 / Public policies are central factors in determining healthcare interventions and access to medicines and treatment. Viatris leverages 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 medicine availability while minimizing unintended consequences.
Below are some examples from the work in our global policy priorities: advance access to quality medicines; strengthen resilient, global supply chains; and build future access.
Providing Access to Generic Medicines
Viatris' deep portfolio of generic medicines includes complex and branded generics. These products work in the same way
and provide the same clinical benefits as their brand-name counterparts and may cost less, providing patients and the healthcare system important savings and medicine options which we believe are essential to making healthcare accessible.
With healthcare budgets increasingly stretched thin, governments play a key role in establishing a well-functioning legal, regulatory and market system that enables generic and biosimilar competition to flourish for the benefit for patient access.
Healthy off-patent competition is also critical to patient access. For example, in the next five years, more than 250 medicine patents will expire in the U.K., generating prospective savings to the National Health Service (NHS) - based on current market level of competition in generics and biosimilars - of approximately £18 billion. This is on top of the annual savings of £15 billion from already expired patented products.
Advancing Access to Quality Medicines
In 2024, Viatris worked to advance access in many ways, including the following:
Engaged with U.S. policymakers to provide insights on generic drug market economics, the value of global supply chains and opportunities to enhance supply resiliency. Policies important to patients were ultimately included in Congressional drug shortage proposals, including provisions such as access-supporting changes to the Medicaid Generics Penalty.
Collaborated with Foreign Policy and partners at the 2024 World Health Assembly in Geneva to host the FP Health Forum, a panel emphasizing that individuals
are more than their health conditions and highlighting the need for a holistic approach to prevention, access and care throughout their lives.Supported the British Generic Manufacturers Association in collaborating with the Medicines and Healthcare Products Regulatory Agency (MHRA), to devise a solution for a backlog of pending market authorization applications, which was delaying medicines from reaching the market. MHRA was then able to successfully clear the backlog of more than 1,000 pending applications, improving access for patients.
Led efforts to include language in the State, Foreign Operations, and Related Programs (SFOPS) Appropriations legislation to expand and incentivize regional manufacturing investment to support the PEPFAR program and the fight against HIV/AIDS.
Helped arrange multistakeholder discussions in Sweden to address policy challenges associated with access to antibiotics and promoted legislation and regulatory processes to foster sustainable market conditions conducive to access.
Collaborated with Korea Disease Control and Prevention Agency and the Ministry of Health and Welfare to advocate for changes in the 2024 revision of Korea's tuberculosis treatment guidelines, resulting in improved access to key treatments for nearly all patients in Korea with drug-resistant TB.
Developed, in partnership with the Unified Procurement Authority (UPA) in Egypt, the Pharmaceutical Procurement and Resource Management Program to improve supply chain efficiencies. This program aims to increase the availability of cardiovascular and pain products in government hospitals and expand access for low-income patients.
Strengthening Resilient Global Supply
A global supply chain with facilities across continents is essential for maintaining access to medicine. As stated earlier, no country can make every medicine people need, and no medicine is made in every country. Inputs are sourced globally, produced at scale by experts and securely transported to hospitals and pharmacies worldwide.
In 2024, Viatris worked to ensure the resiliency of this global supply chain by supporting the publication of a report from Charles River Associates and the U.S. Chamber of Commerce to assess how localization policies are affecting equitable access to medicines. The report considered comprehensive solutions to address access barriers including strengthening healthcare systems, fostering regional collaboration, improving security of supply and aligning resources with policies that improve the resiliency of the global supply chain. "Driving Equitable Access to Health Products and Technologies" has been presented to healthcare system leaders around the globe.
Other examples of Viatris' work in this area in 2024 included the following:
Viatris is a member of the EU Critical Medicines Alliance, a European Commission initiative to strengthen the security of medicine supply across the EU. With approximately half of the molecules on the Alliance's critical medicines list in
our portfolio - spanning anti-infectives, cardiovascular and metabolic, and CNS therapies - Viatris plays a pivotal role. We bring proven expertise to the table and are actively driving discussions on supply chain diversification, international cooperation and long-term resilience to safeguard patient access across Europe.Contributed to two white papers published by AmCham and Medicines for Europe on the root causes of shortages and the importance of a resilient global supply chain. Together, these papers helped inform the positioning of the British Generic Manufacturers Association Manifesto for Building a Resilient UK Medicines Industry, which advocates for supportive market conditions that enable medicine affordability and healthcare sustainability.
As a Canadian Pharmaceutical Association (CGPA) member, Viatris actively engaged with a CGPA working group which has partnered with Health Canada, a federal department, to address and detect pharmaceutical shortages and supply chain challenges to increase medication availability for Canadians.
Working alongside the U.S. Pharmacopeia (USP), Viatris helped develop a benchmark standard for supply chain resiliency for injectable medicines. This partnership will establish metrics that encourage adoption of supply chain resiliency standards to mitigate drug shortages and create an evidence-based benchmark tool that allows purchasers of pharmaceuticals to incorporate manufacturer supply chain resiliency measurements into their decision making.
Led a U.S. Congressional advocacy campaign to educate and
inform policymakers on the importance of a global pharmaceutical supply chain for supply resiliency. As a result, policy changes to support patients' uninterrupted access to globally sourced essential medicines were included in key legislation, such as the National Defense Authorization Act (NDAA).
Building Future Access
While Viatris' policy efforts generally focus on advancing access to existing medicines, we also focus on how to build pathways for future access. As health needs continue to evolve, people need new options, whether improvements to existing medicines or novel therapeutics. This could include changes to how the medicine is administered, or to make the medicine last longer, or to combine multiple medicines in a single pill. The opportunities to leverage existing medicines to better address unmet needs are vast and are likely to accelerate as technology advances.
Proper regulatory pathways are needed to enable timely access for patients. Most countries do not currently have regulatory
and market pathways to recognize improved versions of existing medicines. And even if a regulatory pathway exists, market policies need to support the ability for these medicines to compete and demonstrate value - improved versions of medicines are unlikely to reach the market if procurement or dispensing policies treat them as straightforward generic versions of the original medicine.
Viatris in 2024 continued advocating for dedicated abbreviated regulatory pathways for improvements to existing medicines and regulatory frameworks that recognize improvements to existing medicines as a separate category of innovation with equivalent IP protection. In Canada, for example, Viatris engaged in Patented Medicine Prices Review Board (PMPRB) consultations to advocate for a balanced framework that fosters innovation while enabling access. Our comprehensive submissions and collaborations with stakeholders have led to policy changes that create a more predictable and sustainable environment for introducing innovative therapies in Canada.
As the world is changing, staying close to broader shifts at a global scale helps Viatris to consider how policy solutions may also need to adapt for continued access in the future. These shifts include the growing effects of climate change, trade tensions, ongoing conflicts and political shifts in power in the U.S. and elsewhere. Creating the policy environment for access to continue advancing in this shifting landscape is a focus area for Viatris' policy efforts as we move into 2025 and beyond.
With fiscal space constrained and policymakers facing difficult choices, Viatris engages with policymakers to share learnings and highlight opportunities for a more value-based approach to healthcare financing. Examples of this work include:
With the Board of the Generic Association in Hungary, Viatris engaged in consultations with the Hungarian government to discuss the implications that unsustainable pricing policies can have on patient access. These efforts helped lead to the government reversing a claw-back obligation to its original rate amending their policy, helping to foster sustainable market conditions and maintain access to off-patent medicines.
Viatris sponsored a panel in Brazil during the B20 Event on Advancing Healthcare in Latin America. The event included high-level discussions on healthcare advancements in the region, with a focus on value-based healthcare and the socioeconomic burden of diseases.
In collaboration with the Association of Pharmaceutical Companies in Switzerland, Viatris played a key role in driving the "Yes to Medical Supply Security" initiative that advocates for access to the approximately 600 medicines unavailable to Swiss patients.
At the Labour Party Conference in the U.K., Viatris co-hosted a roundtable discussion with the Fabian Society about cost saving strategies for the National Health Service and future healthcare planning.
Collaborating with IGBA to Promote Access to Medicines
Viatris works closely with the International Generic and Biosimilar Medicines Association (IGBA) at all levels to ensure targeted, consistent engagement and messaging on the need for resilient global supply chains, their criticality for sustainable access as well as the importance of high-quality generic medicines.
Viatris helped enable the renewal process with WHO for IGBA's "non-state actor" status as well as IGBA's regular contributions to ongoing WHO technical advisory groups. Viatris has worked with IGBA to contribute to the World Trade Organization - World Intellectual Property Organization capacity building executive training programs on trade, intellectual property and global public health for government officials from low- and middle-income countries - supporting the enhancement of their regulatory systems. Viatris is the founding chair of the IGBA International External Engagement Committee ensuring continued momentum on this important work.
In addition, Viatris supports IGBA's participation in the Executive Program which was launched as part of the collaboration between the WIPO Academy and the WTO Institute of Training and Technical Cooperation in Geneva, Switzerland. This global training initiative provides valuable technical assistance to senior government officials with a focus on the participation of representatives from low- and middle-income countries.
Working for Regulatory Harmonization
Working to create access to medicine for people globally involves working closely with regulatory authorities around the world. Through our Global Regulatory Affairs team, Viatris works to achieve timely health authority approvals. The company helps ensure the compliance of our existing marketing authorizations, labeling and promotional materials and that they are optimized for value throughout a product's lifecycle. In 2024, highlights of this work included the following:
Viatris provided technical support to the Indian Pharmacopeia Commission (IPC) in finalizing some of the IPC's General Chapters, ARVs, COVID-19 related and hepatitis C product-related monographs, as well as toxicological-specific monographs. These contributions have helped ensure that quality product is continuously supplied to patients in India. IPC recognized Viatris' contributions as a member of the Expert Working Group by publishing an Indian Pharmacopeia Addendum which went into effect in July 2024.
In Malaysia, we collaborated with the local health authority to file Xafariv (rivaroxaban) as the first generic under the Facilitated Review Pathway (FRP), leveraging the approval of another stringent regulatory authority (SRA). The collaborative approach led to a streamlined submission process, reduced review time, enhanced understanding of local regulations and a strong working relationship with the health authority.
As a member of the Canadian Generic Pharmaceutical Association's (CGPA) Scientific Affairs Committee, Viatris is leveraging our expertise as the vice- chair of the Complex Molecules Working Group to develop new guidance to share with the regulator Health Canada for complex generics.
View the full Viatris 2024 Sustainability Report.
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SOURCE: Viatris
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