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Showing 1 - 20 of 296 results

Decision in case 1877/2019/LM on the European Commission’s decision to offset against a previous outstanding debt a payment due to an association participating in a project under the EU’s Horizon 2020 programme

Monday | 23 November 2020

The complainant, a non-profit association, is a partner in an EU-funded project under the EU’s Horizon 2020 programme, which is managed by the Research Executive Agency (REA). It had an outstanding debt to the European Commission, which it was paying back in instalments. The Commission decided to offset the ’pre-financing’ payment, which should have been made to the complainant at the start of the project, against the complainant’s outstanding debt with the Commission. The complainant agreed to continue its tasks under the project, but turned to the Ombudsman to seek an alternative solution.

The Ombudsman found that the Commission was legally obliged to offset the pre-financing payment, and that it informed the complainant and the project coordinator about this in good time. The complainant had willingly chosen to participate in the project under these terms. The Ombudsman therefore closed the case with a finding of no maladministration. However, she made a suggestion for improvement to the Commission and the REA on the need to improve communication with project partners in future cases.

Decision in case 2252/2019/DL on the European Food Safety Authority's refusal to grant access to documents related to the approval of a reasoned opinion on maximum residue limits for pesticides in food

Friday | 30 October 2020

The complainant sought public access to two emails regarding what the complainant considered to be modifications to a scientific opinion on maximum residue limits for pesticides in food.

The European Food Safety Authority (EFSA) refused access to the emails, arguing that they constitute personal data.

The Ombudsman found that one email constituted personal data and that EFSA was justified in refusing access, in line with the EU law on data protection and public access to documents. The other email, however, could not be considered sensitive as its substantive content did not include any private views or personal data. The Ombudsman therefore made a proposal for a solution, asking EFSA to disclose this email, with appropriate redactions of personal data only.  

EFSA accepted the Ombudsman’s proposal for a solution and granted the complainant partial access to the email, only redacting personal data.  

While acknowledging that the complainant remains dissatisfied, the Ombudsman is of the view that EFSA has given a satisfactory response to her proposal for a solution and closes the inquiry.

Decision in case 107/2020/EWM regarding risk minimisation measures, related to pregnancy, set out by the European Medicines Agency for a medicine for treating epilepsy and bipolar disorder

Thursday | 20 August 2020

The case concerned risk minimisation measures, related to pregnancy, that were set out by the European Medicines Agency (EMA) for valproate, a medicine used for treating epilepsy and bipolar disorder. These measures include a so-called ‘pregnancy prevention programme’, which aims to prevent the use of valproate during pregnancy, due to the risks for the foetus and children of those who become pregnant while taking valproate. The complainant considered the wording ’pregnancy prevention programme’ and the terminology used in this programme to be offensive and inappropriate.

EMA adopted the updated risk minimisation measures in 2018, in response to growing concerns about the risks associated with valproate and the failure of measures enacted following a 2013/2014 review by the agency sufficiently to alert relevant healthcare professionals and their patients to the risks attached to taking the medicine in pregnancy,

The widely used medicine, which first came on the market in 1962, has been found to cause malformations in a significant number of foetuses and, in further cases, development problems for children in later life. Despite growing evidence of such risk from the very early days of its usage the medicine continued to be prescribed to women. Some became pregnant while taking valproate, with at times devastating consequences. In 2014, EMA recommended strengthened warnings on the use by women and girls of medicines containing valproate. However, evidence of the medicine being prescribed to women who became pregnant continued, leading EMA to adopt the new risk minimisation measures in 2018.

The Ombudsman acknowledges that, for those who wish to have children, it is a considerable source of distress that medicines they need may pose serious risks to a foetus. She is also mindful of trauma caused to women who became pregnant while taking valproate, and who did not feel sufficiently informed about the risks. The subsequent effects both on them and on their families cannot be underestimated. The Ombudsman considered, however, that EMA has clearly and appropriately explained why it considers the terminology used in the new risk minimisation measures to be proportionate. As such, the Ombudsman concluded that there was no maladministration by EMA. She has however – in the context of EMA’s work in reducing risk - suggested that EMA might further reflect on the serious concerns around the reported failures of General Practitioners in communicating the agency’s multiple warnings about valproate to their patients, and counselling appropriately. This matter falls outside of the Ombudsman’s mandate, but in this regard, the July 2020 UK Independent Medicines and Medical Devices Safety Review contains much that may be relevant. Trust in medical providers is critical in healthcare and the burden of making fully informed choices about medical treatment cannot be left to the patients alone.

Decision of the European Ombudsman in case 1069/2019/MIG on sponsorship of the Presidency of the Council of the European Union

Monday | 29 June 2020

This case concerned corporate sponsorship of the Presidency of the Council of the EU. The complainant considered that the Council should regulate or prohibit such sponsorship. The Council refused to address the matter, arguing that the sponsorship of the Presidency was the sole responsibility of the Member State government holding the Presidency.

The Ombudsman noted that, as the Presidency is part of the Council, its activities are likely to be perceived by the wider European public as being linked to the Council and the EU as a whole. As such, the use of sponsorship by the Presidency entails reputational risks which the Council should address. The Ombudsman therefore recommended that, to mitigate those risks, the Council should provide guidance to the Member States on the issue of sponsorship of the Presidency.

The Council accepted the Ombudsman’s recommendation, announcing its intention to consider issuing best practice guidance to the Member States. The Ombudsman welcomed the Council’s decision and closed the inquiry.