Anagni: The industrial corridor south-east of Rome fills and finishes more vials than most people realise, and it is the kind of site the Union has spent two years deciding it needs more of. Whether it gets them depends on an instrument that has just moved from negotiation into implementation.
The Critical Medicines Act was agreed between Parliament and Council on 12 May after a negotiating session that ran past twelve hours, and it addresses a dependency that the pandemic made visible and that nothing since has resolved. A large share of the active pharmaceutical ingredients used in Union-manufactured generics originates outside Europe, concentrated in a small number of suppliers. For some older antibiotics and oncology products the number of qualified manufacturers worldwide is in single figures. When one plant has a problem, the shortage is continental.
The Act’s central mechanism is the strategic project. Companies that propose to create, modernise or expand production capacity within the Union for medicines on a critical list can apply for designation, and designation brings three things: eligibility for Union funding, permission for national aid that would otherwise be scrutinised under state aid rules, and accelerated administrative procedures. The conditions attached are what make the instrument distinctive. A designated project must prioritise the European market, which in practice means accepting supply obligations in exchange for the support.
That trade is the part the industry has read most carefully. Generic manufacturers have argued for years that the economics of low-margin essential medicines make European production uncompetitive against Asian suppliers, and that no amount of procedural streamlining changes the arithmetic. The Act’s answer is that public procurement should stop awarding on price alone. It introduces security-of-supply criteria into tendering, which is the first serious attempt to make the buying side of the system pay for resilience rather than merely asking for it.
Whether that works depends on national procurement authorities, most of which operate under budget pressure and have spent a decade optimising for unit cost. A criterion that permits paying more for a more secure supply chain is not the same as a requirement to do so, and the Act leaves considerable room for member states to apply it lightly.
The implementation timetable is now the story. Pilot arrangements are expected during this quarter for the categories judged highest risk — oncology products and antimicrobials — with the first strategic project designations following. The critical medicines list itself, and the methodology for deciding what belongs on it, will determine the instrument’s scope more than any provision in the text.
The Act also sits inside an unfinished larger reform. The pharmaceutical package, the general revision of Union medicines legislation proposed in 2023, contains its own shortage-prevention and supply-management provisions and remains in negotiation. The two instruments were designed to interlock, and the sequencing has reversed: the targeted instrument has been agreed while the framework it was meant to supplement is still being argued over. Companies planning investments face a regime that is half settled.
The people who will judge the result are not in Anagni or in Brussels. They are pharmacists explaining to patients that a medicine is unavailable, which happened often enough across the Union last winter to make the political case for the Act unarguable. The test is whether a strategic project designation and a procurement criterion are enough to move a production line back to Europe, and the honest answer is that nobody will know for several years.
