EU ministers reach consensus on Biotech Act directive

Published on

17/06/2026 - 16:19 GMT+2

The EU health ministers on 16 June approved a common stance on a piece of legislation that accompanies the Biotech Act regulation — Biotech Act I directive.

The directive tweaks two directives on modified micro-organisms (GMMs) and the processing of organs. The aim — to make them more innovation-friendly, reduce administrative burdens and improve cross-border cooperation in organ transplantation, in a desperate attempt to catch up with biotech frontrunners — such as the US and China.

“Since the adoption of those directives significant progress in biotechnology has taken place,” Neophytos Charalambides, the Cyprus health minister, said. “Updating the respective legislations is therefore not only … a logical consequence, but also an ethical imperative,” he added.

Under the Cypriots’ lead, countries tweaked the Commission’s proposed terminology — for example, replacing the term “low-risk GMMs” with “GMMs eligible for an expedited procedure”, capping indefinitely valid consent to place a GMM on the market at up to ten years, and including provisions specifying that in certain cases processing of personal data can be deemed to be in the public interest.

They also gave themselves more time to comply with updated organ transplantation rules from 24 months to 36 months.

While most countries supported the compromise, the debate revealed a familiar fault line in EU biotechnology policy: how to encourage innovation without weakening safety oversight.

Countries stressed the need to protect personal data, preserve national control over transplantation systems and maintain strong ethical safeguards.

The agreement between the capitals means talks with the European Parliament can start once their negotiating position is reached.

For those discussions, the Cyprus minister suggested taking into account the European Data Protection Supervisor's opinion published at the end of May, which "due to his late arrival, could not be fully taken into account,” he said.

As the Cypriot presidency comes to an end, Ireland will take over responsibility for steering the file through the next stage of negotiations with the Parliament.

In the Parliament, the Health (SANT) and Environment (ENVI) committees are working on the file, with European People's Party’s Adam Jarubas and social democrat Marta Temido leading the work.