EU member states and the European Parliament have reached a provisional agreement on a new “critical medicines act” designed to reduce shortages of key drugs such as antibiotics, insulin and painkillers.
The deal was agreed between the EU Council presidency held by Cyprus and the European Parliament, and takes the form of a new regulation, the Council of the EU disclosed on Tuesday.
The regulation sets out measures intended to improve the security of supply and availability of medicines classed as “critical” across the bloc, including steps to diversify supply chains and strengthen manufacturing capacity in the EU for these medicines and their active ingredients.
“Patients should not have to worry about whether critical medicines such as antibiotics will be available at their pharmacy or hospital,” Neophytos Charalambides, Cyprus’s minister of health, said.
Procurement, stockpiles and orphan medicines
Under the agreement, public bodies buying critical medicines would be required to apply “resilience-related requirements” in procurement procedures, according to the Council of the EU.
EU countries would also be able to take part in collaborative procurement — buying together — for critical medicines and “medicines of common interest.”
The threshold for the number of member states needed to ask the European Commission to procure on their behalf would fall from nine to five under the text agreed by the co-legislators.
On contingency stock requirements, the agreement says they should be transparent and respect “solidarity and proportionality”, and includes measures for member states to share information about such requirements.
The text also clarifies the use of an existing voluntary solidarity mechanism for exchanging data on contingency stocks and allowing countries to reallocate critical medicine products on a voluntary basis when needed.
The scope of the act would be expanded to include certain “orphan medicinal products” — medicines for life-threatening or very serious conditions affecting no more than five in 10,000 people in the EU — in areas including strategic projects and collaborative procurement.
The provisional agreement must still be endorsed by the Council and the Parliament before it is formally adopted following a legal and linguistic review.
