Actions to secure continuous supply of quality, effective and safe medicines

The ongoing COVID-19 pandemic highlighted existing shortcomings in healthcare systems across the EU: supply chains of both medicinal products and medical devices have been impacted by the crisis, increasing the risks of shortages of essential drugs and equipment and consequently causing treatment delays and disruptions. Hence, the temporary and permanent unavailability of medicines severely affects patients’ health and puts a serious strain on European healthcare systems.

Amid shared concerns on the disruptive impact of shortages, ESIP steps up and suggests a number of recommendations to secure availability and access to essential medicinal products. Although national healthcare systems are responsible to handle medicine shortages in full respect of their specific characteristics, joint efforts could be taken at EU level to increase the resilience and sustainability of healthcare systems.

Overall, ESIP invites to launch a preliminary discussion towards a unified definition of strategically important and essential medicines and active pharmaceutical ingredients (API). Accordingly, ESIP calls for increased transparency across the supply chain, namely for an evidence-based evaluation of supply bottlenecks and for a coordinated reporting system on stocks and shortages across European Member States. Regarding compliance with the current legal framework [I], ESIP calls to introduce mandatory sanctions for marketing authorisation holders who fail to secure supply. With a view to supply, ESIP calls on the Commission to further develop and simplify existing frameworks for joint procurement, beyond COVID-19 treatments. As for demand, ESIP also recommends the establishment of common EU stockpiling system for essential medicines. Finally, and regarding production, ESIP supports a balanced approach between diversification and reshoring back to Europe, as well as the possibility to discuss public production in Europe.

More information is available in our position paper here

On our radar: On September 17, the European Parliament also adopted a Resolution on Medicine Shortages. The resolution, already adopted by the European Parliament’s Committee on the Environment, Public Health and Food Safety, calls to ensure access to safe and affordable medicines, under the upcoming pharmaceutical strategy.

Regarding better coordination between and within Member States, the Resolution calls for further cooperation on stock management and extended use of the joint procurement mechanism. What is defined as “an emergency European pharmacy” reflects ESIP's call for a “European stockpiling system for essential medicines”.

With a view to the EU independence in the healthcare sector, the resolution strongly supports relocation of production, envisaging also financial incentives to persuade companies to produce active pharmaceutical ingredients, medicines and medical equipments in Europe. Included in the resolution is also a call on the Commission to introduce a Directive setting minimum standards forquality healthcare systems in the EU.

The full text of the resolution is available here

[I] DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use. Cfr.