April 14. 2024. 7:47

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EU pharma reform delayed again due to Commission’s busy agenda


The unveiling of the much-awaited reform of the EU’s regulatory framework for pharmaceuticals has been pushed back to a later date for the third time in just a few months, EURACTIV has learnt.

The revamping of the EU’s general legislation on medicines for human use is the last major health file to be unveiled by the EU executive before the end of the current legislative term in the second half of 2024.

The Commission’s initiative, which will aim at ensuring a future-proof and crisis-resistant medicines regulatory system for Europe, was expected by the end of last year but was then pushed back to mid-March and then delayed again to the end of the month.

In a recent interview with EURACTIV, the EU’s health chief Stella Kyriakides confirmed that the proposal was ultimately set for 29 March.

However, a Commission spokesperson told reporters that the adoption of the revision “will take place slightly later than the date currently indicated in the tentative agenda for forthcoming Commission meetings”.

The spokesperson mentioned the ‘very busy agenda’ of the College of Commissioners – the EU executive’s weekly cabinet meeting tasked with voting on the legislative proposals – in recent weeks as the main reason behind this new postponement.

“This agenda is always indicative and adoption dates of Commission proposals may change anytime, especially when these proposals concern reforms of complex legislations of major importance as is the case for the pharmaceutical legislation that will have an important impact on the health sector for the coming years,” the spokesperson continued.

For now, there is no expected timing for the presentation of the proposal and another indicative date could be put forward already on the next College agenda.

Speaking at a recent event, Kyriakides said the reform is needed as “current rules were put in place in a different era and need to move with the times” in order to address “chronic challenges in this area” and solve problems “that have been highlighted by all for many years”.

However, it appears extremely unlikely that the EU co-legislators – the European Parliament and the EU-27 ministers – will be able to start discussing the proposal in a bid to approve the new rules as there is an unofficial cut-off point for inter-institutional talks around February 2024, meaning that negotiations cannot continue beyond this point.

Commission to seek patient-centred, industry-friendly pharma rules reform

With only a few weeks before unveiling the EU’s revamped framework for pharmaceuticals, Health Commissioner Stella Kyriakides described the main drivers of the much-awaited reform, stressing the importance of finding the balance between patients’ and industry’s interests.