Deficient medicines: new law to strengthen EU autonomy

EU Parliament green light for rules to improve the availability and supply of critical medicines, such as antibiotics, insulin, vaccines and drugs for chronic diseases. "The proposed regulation adopted with 503 votes in favour, 57 against and 108 abstentions," a note explained, "aims to ensure a high level of public health protection for EU citizens, reducing dependence on imports from third countries and strengthening the competitiveness of the European pharmaceutical sector. MEPs demand that national governments and the EU "give priority, in the current budget and in the next multiannual financial framework, to supporting strategic industrial projects located in the EU in order to strengthen its production capacity".

Companies receiving public funding will have to fulfil clear obligations, including the priority of supplying the EU market. According to the Parliament's proposals, the new cross-border joint procurement procedure "will require the participation of at least five EU countries, less than the nine foreseen in the Commission proposal, and apply procurement criteria that favour manufacturers that produce a significant part of critical medicines in the EU". ('Buy European').

The text of the draft regulation also emphasises the possible benefits of such procurement for medicines for rare diseases, antimicrobials and other innovative, high-cost or highly specialised treatments.

To better anticipate and manage shortages, Parliament calls for the establishment of an EU coordination mechanism for national stocks and emergency stocks of critical medicines. MEPs also call for the Commission to be able to arrange, as a last resort, for the redistribution of medicines from a national stockpile to one or more other Member States if a shortage or disruption of supply is detected.

"We have agreed today on clear priorities," commented the measure's rapporteur, Tomislav Sokol (EPP, Croatia), "the coordination of national and emergency stockpiles, the strengthening of the competitiveness of the EU pharmaceutical industry and the fight against shortages of medicines by ensuring their accessibility and availability for European patients. We have also established a clear and strong principle for public procurement: price can no longer be the sole criterion for awarding contracts for medicines. Security of supply, resilience of production chains and manufacturing capacity within the EU must be taken into account. This 'Buy European' approach ensures that public procurement supports reliable suppliers, strengthens the production of medicines in the EU and contributes to long-term security of supply'.