Maladministration finding could have consequences for health proposals

Last Thursday (27 November), European Ombudswoman Teresa Anjinho found maladministration in the Commission’s failure to respect the standard procedures in preparing new legislation. 

The Commission appears to be in breach of its own ‘Better Regulation’ rules adopted in 2021, under the first von der Leyen mandate. It also appears to be at odds with its institutional agreement with the European Parliament.

The Ombudsman's findings concerned legislation on the environment (Omnibus I), the Common Agricultural Policy (CAP), and countering migrant smuggling; but could equally apply to health files where impact assessments have been set aside in favour of hefty Staff Working Documents (SWD).

MEP Tiemo Wölken (S&D, Germany), who is a member of the European Parliament’s Public Health Committee (SANT), makes it clear that the problem is more widespread and includes many health files, including the Critical Medicines Act, as well as the upcoming Biotech Act, and changes to the Medical Devices and In Vitro Diagnosis Regulations.

In a question to the Commission, Wölken says the Commission is increasingly failing to comply with its obligations under the Better Regulation Guidelines (2021) and the Interinstitutional Agreement on Better Law-Making (IIA-BLM, 2016), which require that all major legislative initiatives likely to have significant impacts be accompanied by an impact assessment (IA).

He points to data from the European Parliamentary Research Service showing that since the beginning of the current Commission mandate on 1 December 2024, 80 ordinary legislative procedure proposals have been submitted, of which only 18 were accompanied by an IA. Of the 62 proposals that lacked an IA, 25 of these had or will have SWDs as analytical substitutes.

Wölken says that the growing reliance on SWDs rather than IAs marks a significant departure from the norms laid down and undermines transparency, accountability, and evidence-based policymaking, thereby weakening trust in the EU legislative process.

The Ombudswoman acknowledged that the Commission would have to respond urgently to different situations, but said that a balance needed to be struck: “Certain principles of good law-making cannot be compromised even for the sake of urgency.”  

On Friday, Commission spokesperson Arianna Podesta said that the better regulation principles do allow for faster adoption processes when urgency demands. However, the Ombudswoman said that the Commission had failed to justify the urgency of the situation and to show their reasoning for deviating from the standard procedure.

With the Biotech Act I and a "targeted simplification" of the EU rules for medical devices and in vitro diagnostics expected on 16 December, it is unlikely that IAs will accompany them, but they will be accompanied by substantial SWDs. However, the Parliament is becoming increasingly uneasy with the Commission's dismissive approach to inter-institutional rules. As scrutiny intensifies, there is mounting pressure to restore full adherence to its own Better Regulation standards and rebuild confidence in the EU’s law-making process.