The publication of the first European Union list of Critical Medicines, in December 2023, and the formation of the Critical Medicines Alliance, in April 2024, marked significant moments in the EU's strategy to improve access to critical medicines in Europe.

In recent years, the vulnerability of the EU’s supply has been exposed – from the impact of the COVID-19 pandemic and the war in Ukraine on supply chains viability, to disruptions to certain medicines such as antibiotics due to changing infection patterns combined with supply chain consolidation in the winter of 2022.

Gaps in access to critical medicines persist, making EU and national reforms essential to resolve systemic issues, remove barriers to access across the region and secure the EU’s role in global health leadership.

In this context, positive steps have been made. In October 2023, the European Commission’s communication titled “Addressing critical shortages of medicines in the EU” recognized the urgency of securing supply chains for essential medicines. It introduced a series of short- and long-term actions aimed at strengthening access to critical medicines, including the creation of the Critical Medicines Alliance and announcement of the future Critical Medicines Act.

In July 2024, following her re-election, Commission President Ursula von der Leyen proposed the upcoming Critical Medicines Act as part of her mandate, to combat shortages of critical medicines and equip the European Health Union with diversified supply chains, equal access to treatments and foster greater resiliency.

At Viatris, we welcome such progress, and we’re committed to playing our part in helping bridge access gaps across Member States.

Our commitment:

Our vision in Europe is ambitious: to secure access to critical medicines, so that patients in every EU country have access to the medicines they need, when they need them. This vision motivates our continued involvement in the Critical Medicines Alliance and collaborative efforts across the healthcare ecosystem.

Working as part of the Critical Medicines Alliance, we are focused not only on tackling short-term supply chain challenges but also on proactively anticipating and mitigating future risks by playing our part to build a more sustainable market environment and leveraging the strength of our supply chain. We are the right partner for this work because:

• We are one of the main providers of critical medicines in European markets, supplying approximately half of the 216 molecules listed on the EU Critical Medicines List. We are also one of the largest suppliers of off-patent medicines across Europe.
• In Europe, we have a supply track record above 90% and we benefit from a robust global supply network that every minute provides 270 packs of critical medicines to European patients.
• In 2023 alone, we distributed more than 140 million packs of critical medicines in the EU, ensuring citizens had access to essential treatments across major therapeutic areas.
• In the Critical Medicines list, our portfolio spans 11 major therapeutic areas, with significant weight on anti-infectives. We supplied over 61 million packs of medicine in 2023 to prevent and treat infections, including vital antibiotics.
• We are also principal providers of medicines for diseases of the cardiovascular and nervous systems, with 26 million and 22 million packs distributed, respectively.
• On top, 9 out of 10 of Europe’s designated critical medicines are off-patent (including generics and branded medicines), based on recent analysis by IQVIA – Medicines for Europe. Off-patent medicines have doubled access to treatment in chronic disease areas, and they represent 70% of treatments dispensed in Europe while accounting for only 30% of healthcare costs⁶.

Our recommendations:

In this context, policy measures that secure the economic viability of off-patent medicines are critical for stable and sustained access to treatments.

Fostering supply security requires a multi-faceted, coordinated approach that advances collaboration between stakeholders, industry and policy leaders at European and national levels.

As Viatris advances our collaborative efforts through the Critical Medicines Alliance and beyond, it's essential to consider strategic policy reforms that can further enhance access to critical medicines across the European Union.

The following top 5 policy recommendations are designed to address the multifaceted challenges within the pharmaceutical supply chain, so that all Europeans have timely access to essential medicines.

• Reinforce the global pharmaceutical supply chain: We believe that secure, reliable access to medicines is best supported by a diverse and agile global supply chain designed to respond quickly to evolving needs. No country can make every medicine it needs, and no medicine is made in every country. Global, diversified supply chains help offset risks and build resiliency, increasing access to affordable medicine. Free trade agreements and international trade cooperation focusing on removal of trade barriers, regulatory cooperation and procurement policies awarding investments in supply security can be efficient tools to improve competition and diversification of suppliers.
• Avoid unilateral and costly measures that undermine access across Europe: Protecting patient access is essential, but national stockpiling is not the answer to promote regular supply in the market. In fact, such measures can put access at risk, by inadvertently undermining access to critical medicines in other locations. Instead, we need to work together. Encouraging diversified manufacturing, increasing demand predictability for Marketing Authorisation Holders (MAH), preventing disproportionate penalties to MAH, introducing the possibility of adjusted pricing in duly justified cases and Most Economically Advantageous Tender (MEAT) criteria are more efficient in addressing the root causes of supply shortages.
• Improve Critical Medicines market measures: High volume, low margin off-patent critical medicines are especially impacted by policies that limit the ability of companies to adjust prices to accommodate increases in production and regulatory costs and keep up with annual inflation rates. Consideration is needed for new policies that evaluate the ability to adjust prices to account for increased production and supply costs, so that production remains viable, and companies remain competitive. On top of this, procurement systems can have a direct impact on supply security and can endanger it by contributing to market consolidation and reducing medicines’ economic viability. To secure supply, procurement systems should instead reward companies that invest in supply security, applying criteria beyond price and awarding contracts to multiple winners.

• Embrace regulatory reform: Digitalization, simplification of shortage reporting and cost reduction: Current regulatory requirements for critical medicines add complexity to supply chains and cost, such as country specific packaging and labelling. Harmonizing pack formats and introducing electronic patient leaflets would go a long way to reduce manufacturing complexity and increase movement between countries in the event of disruptions. Likewise, the simplification of shortage reporting would reduce cost and complexity, facilitating quicker responses and more effective coordination between industry, regulators and healthcare providers.
• Clearly foresee the impact of new regional regulation on Critical Medicines: The impact of increasing obligations for MAH under pharmaceutical, chemical and environmental legislations should be considered with respect to the economic viability and availability of critical medicines. New regulations should aim to strike a careful balance between ensuring access and imposing new requirements on pharmaceutical companies. Proper impact assessments on patient access to medicines is required before new regulation is implemented.