Europe’s Critical Medicines Alliance launches today. This is an occasion to reflect on the policy measures that can further enhance access to critical medicines across the EU.

The European Union is committed to maintaining the availability of safe, effective, and affordable medicines. However, gaps in access to medicines persist. Supply disruptions, including medicine shortages, have contributed to these challenges.

Supply disruptions are a systemic issue – European Union institutions and national regulators are acting, most recently with the Critical Medicines Alliance, to explore measures and strategies to strengthen the supply of critical medicines in the EU, to better prevent and combat their shortages.

In a context where off-patent medicines have doubled access to treatment in chronic disease areas3, as a recent IQVIA – Medicines for Europe study highlights, and they represent 70% of treatments dispensed in Europe while accounting for only 30% of healthcare costs4, policy measures that secure the economic viability of off-patent medicines are critical for stable and sustained access to treatments.

Amidst these challenges, Viatris stands as a committed partner in the Critical Medicines Alliance, driven by our mission to empower people worldwide to live healthier at every stage of life. Access to medicines is not just an initiative for us; it is at the core of our business model. We are Access at Scale – supplying medicines to approximately 1 billion patients globally, every year.

Our vision in Europe is ambitious: to achieve universal access to critical medicines, so that patients in every EU country have access to the medicines they need, without barriers. This vision motivates our continued commitment to the Critical Medicines Alliance and collaborative efforts across the healthcare ecosystem.

Recognizing the complexity of issues underpinning supply reliability, Viatris proactively engages in collaborative efforts to enhance the security and resilience of medicine supply across Europe and beyond.

As one of the leading companies in the off-patent industry across Europe, we play a pivotal role in supplying critical medicines to European patients. We supply approximately half of the molecules in the EU Critical Medicines List, covering major therapeutic areas – anti-infectives, cardiovascular and metabolic, and central nervous system. We supply 141 million packs of these critical medicines to EU countries every year. We have a robust global supply network that every minute provides 270 packs of critical medicines to European patients5.

Our impact extends from regional to national levels, with significant contributions to critical medicine supplies in all Member States.

There are five strategic policy recommendations we believe are critical to further enhance stable, sustainable access to critical medicines across the EU:

• Enhance agility and flexibility of global pharmaceutical supply chains. The globalization of supply chains plays an important role in the development of capacities to improve efficiency and increase access to affordable medicine. Global and diversified supply chains enable flexibility, can help offset risks and build resiliency. No country can manufacture all the medicines they need. As such, the geographical location of individual manufacturing facilities is not a predictor of supply reliability or resilience as supply issues can occur irrespective of the geographical location of a manufacturing plant and are far more influenced by other factors. This short film provides insights into the complex nature of pharmaceutical supply chains.

• Avoid unilateral and costly measures that undermine access across Europe, like national stockpiling. Did you know that the compulsory stockpiling of 6 months for certain antibiotics currently applicable in Germany for example equals the total annual consumption of 10 Member States5 for these medicines? Medicines that could be used by patients in these countries instead sit idle in warehouses. Policies should focus on improving the reliability and resilience of the supply chain rather than on excessive stockpiling in one country that puts at risk patient access in other countries.

• Improve Critical Medicines availability through procurement and market reforms. Procurement systems can have a direct impact on supply security. Rewarding companies that invest in supply security, by applying criteria beyond price and awarding contracts to multiple winners, can enhance supply resilience.

• Embrace regulatory reform to streamline medicine access. Digitalization, harmonization and simplification of shortage reporting can facilitate quicker and more effective response to out-of-stock situation. The use of available epidemiological and market data, like the one available in the EMVS, can help to manage shortages in a proactive manner; e-leaflet would enable movement of medicines to where they are needed.

• Clearly foresee impact of new European regulation on critical medicines. Well-intentioned regulations can have unintended consequences. New regulations, like the Urban Wastewater Treatment Directive, would impose tremendous costs on the off-patent sector, with no consideration of the impact this could have on medicines availability. Maintaining viability of continued production of critical off-patent medicines is fundamental. Proper impact assessment on patient access to medicines is required before a new complex and costly regulation is implemented.

Addressing medicine shortages requires a multifaceted approach involving collaboration between stakeholders and strategic policy reforms. Viatris remains committed to playing its part in supporting access to critical medicines for all Europeans.

We call on European and national policymakers to work together to enact reforms that promote supply security and patient access to essential medicines. Together, we can build a more resilient and sustainable healthcare system that leaves no patient behind.

Learn more: https://www.viatrispolicy.eu/en