As a global leader in pharmaceutical production and R&D, and with a strong heritage in making medicines available to patients around the world, Ireland has a central role in leading the European debate on medicines supply security.
Access to critical medicines is vital for enabling individuals to effectively manage their health challenges and lead fulfilling lives. Whether young or old, most people will require some form of medicine over the course of their lives.
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 per cent of treatments dispensed in Europe while accounting for only 30 per cent of healthcare costs; these figures are similar in Ireland. In this context, policy measures that secure the economic viability of off-patent medicines are critical for stable and sustained access to treatments.
As collaborative efforts begin through the European Critical Medicines Alliance, it’s essential to consider strategic policy reforms that can further enhance access to critical medicines.
· 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 – such as environmental criteria or supply reliability, can enhance supply resilience. In Ireland, these non-price tender criteria should also apply. Additionally, other measures can be considered to guarantee a predictable supply of medicines, such as the procurement process reopening after the entry of the first multisource medicine or using lead times adapted to the product supply characteristics.
· Avoid unilateral and costly measures that undermine access across Europe, like national stockpiling. Policies that may benefit one country, including stockpiling, can have unintended negative impact on access in other countries. For example, the compulsory stockpiling of six months for certain antibiotics currently applicable in Germany equals the total annual consumption of 10 Member States. Medicines that could be used by patients in these countries instead sit idle in warehouses, limiting access.
· Embrace regulatory reform to streamline medicine access. Greater efficiency in regulatory processes could have a large impact on availability of medicines. Digitalisation, harmonisation and simplification of shortage reporting can facilitate a quicker and more effective response to an out-of-stock situation. The use of available epidemiological and market data, like that available in the product tracking database EMVS, can help to manage shortages in a proactive manner; e-leaflet would enable the movement of medicines to where they are needed, enabling medicine product information to be updated electronically to meet the needs of people in different countries.
· Enhance agility and flexibility of global pharmaceutical supply chains. The globalisation 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 diversify risks and build resiliency.
· Clearly foresee the impact of new European regulation on critical medicines. Well-intentioned regulations can have unintended consequences. New regulations, like the Urban Wastewater Treatment Directive, could impose tremendous costs on the off-patent sector, with potential significant impact on medicines availability. Proper impact assessment on patient access to medicines is required before a new complex and costly regulation is implemented.
These conversations on sustained access to critical medicines are taking place within Ireland as well. With the new National Pricing & Supply of Medicines Agreement 2025-7 negotiations shortly beginning, this is the perfect time to discuss solutions to build more stable access to medicines in Ireland.
Building more resilient medicines supply requires collaboration between stakeholders, as well as strategic policy reforms. In Europe, Viatris is one of the leading companies in the off-patent industry; we supply approximately half of the molecules in the EU Critical Medicines List, covering many major therapeutic areas including anti-infectives, cardiovascular and metabolic, and central nervous system. We have a robust global supply network that every minute provides 270 packs of critical medicines to European patients. In Ireland, we supply about half a million packs of critical medicines every year.
As a member of the European Critical Medicines Alliance, and as a longstanding partner to the Irish government on access to medicines in Ireland, Viatris is committed to playing its part in supporting access to critical medicines for all Europeans.
By Artur Cwiok, head of Viatris Europe and executive member of Medicines for Europe, and Enis Otuk, country manager, Viatris Ireland
For more information, see https://www.viatrispolicy.eu/