EU pharma law reform faces further delay

Catherine Drew of Pinsent Masons was commenting after Euractiv reported that an eagerly anticipated announcement on reforms to the EU’s general pharmaceutical legislation has again been delayed.

The EU’s general pharmaceutical legislation was the subject of a review by EU policymakers following publication of the European Commission’s pharmaceutical strategy in November 2020. The Commission said at the time that the aim of the review was to “ensure a future-proof and crisis-resistant medicines regulatory system”.

In its review, the Commission said it was considering potential reform in a wide range of areas including in relation to unmet medical needs; improving access to and affordability of medicines; addressing antimicrobial resistance, ensuring security of supply of medicines, adapting the regulatory approach to account for “novel products”; and environmental challenges.

An announcement on the next steps towards reform was initially expected before the end of 2022. However, Politico first reported last summer that an important impact assessment regarding proposed amendments to human medicines legislation had not been approved by an internal European Commission watchdog, causing delay to the announcement of the reform package

A rescheduled date of mid-March 2023 was subsequently envisaged for the announcement before this too was pushed back to 29 March, but Euractiv has now reported that there has been a further delay and that a Commission spokesperson had told reporters that the announcement will now be made at a “slightly later” unspecified date.

Public policy expert Scott Wright of Pinsent Masons said that prolonged delay could risk the passage of legislative reforms proposed by the Commission prior to next year’s European Parliament elections.

Wright said: “The reason cited for the delay is the ‘busy agenda’ of the College of Commissioners – the body responsible for voting on the legislative proposals. However, this latest delay may call into question whether there will be sufficient time for the European Parliament and Council of Ministers to scrutinise the proposals before next year’s European Parliament elections.”

“There’s an unofficial deadline of February 2024 for the conclusion of inter-institutional talks which will preclude negotiations continuing beyond that point. If the legislative process is not finalised before then, the new Commission and Parliament post-election could look to review, and indeed, amend the work that has been conducted on the legislation to that point,” he said.

Catherine Drew said: “Industry might be frustrated at yet further delays but would rather that the Commission got the proposal right than it is rushed out in a fashion that is incomplete or creates more issues than it solves.”