Securing access to critical medicine

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 pivotal moments in the EU's strategy to improve access to critical medicines in Europe.

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

According to IQVIA and Medicines for Europe study published in April 2024, 9 out of 10’s Europe designated critical medicines are off-patent.[1] In a context where off-patent medicines have doubled access to treatment in chronic disease areas, as the same study highlights, and they represent 70% of treatments dispensed in Europe while accounting for only 30% of healthcare costs, 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.”
Victor Mendonça – Head of Corporate Affairs Viatris Europe

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 patients.

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

Policy action to protect access to critical medicines

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. Measures intended to protect patient access at national level, such as national stockpiling, can inadvertently undermine access to critical medicines in other locations. National stockpiling policies impose additional costs and create artificial increases in demand of critical medicines, impacting companies’ capacity to supply other countries. Whereas a European stockpiling policy can be a tool to address emergency events, it is important to promote alternative, structural solutions that can effectively reduce the risk of shortages in Europe.
  • Improve Critical Medicines availability through procurement and market reforms. Off-patent critical medicines are especially impacted by policies that limit the ability of companies to adjust prices to accommodate increases in production costs and keep up with inflation. New policies that consider the ability to adjust prices to account for increased production and supply cost can enable product to remain viable and companies to remain competitive. Furthermore, procurement systems should reward companies that invest in supply security to support diversity of the production and supply by applying the “Most Economically Advantageous Tender” (“MEAT”) criteria which considers criteria beyond price, and (ii) awarding contracts to multiple winners instead of pursuing a single-winner approach, when it is advisable to secure supply.
  • 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. Increasing MAHs obligations under pharmaceutical, chemical, and environmental legislations should consider the impact on the economic viability and availability of critical medicines. 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. 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.

[1] IQVIA – Medicines for Europe report available here https://www.medicinesforeurope.com/2024/04/10/beneath-the-surface-unravelling-the-true-value-of-generic-medicines/