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Showing 1 - 20 of 106 results

Decision in case 874/2020/MIG on how the European Commission dealt with a complaint about how the Commission Vice-President for Democracy and Demography responded publicly to critical media coverage

Friday | 26 March 2021

The case concerned a complaint to the European Commission raising concerns about how the Commission Vice-President for Democracy and Demography had responded publicly to critical media coverage, notably comments she had made during a Croatian call-in TV show. The complainant considered that the Vice-President’s statements were not compatible with her obligations as a Commissioner, and was dissatisfied with how the Commission responded to the concerns raised in her complaint.

The Ombudsman found that the Vice-President’s statements could be understood as meaning that the media should not broadcast or publish critical comments about public figures. The fact that the statements were perceived as such is clearly reflected by the public response, including this complaint and the subsequent media coverage on the incident. Therefore, the Ombudsman found that the statements were inappropriate.

Following the incident, both the Vice-President and the Commission expressed their strong support for freedom of expression and freedom and pluralism of the media. The Vice-President further clarified that it was not her intention to undermine the independence of the media.

While welcoming these clarifications, the Ombudsman regrets that neither the Commission nor the Vice-President issued an apology in relation to the incident. That could have gone some way towards acknowledging the public disquiet over the remarks.

The Ombudsman closes her inquiry, calling on the Commission to remind Commissioners of the need to exercise due caution when making public statements.

 

Decision in joint cases 1570/2018/JF-JN and 1973/2018/JF-JN on how the European Commission approves substances used in plant protection products (pesticides)

Monday | 30 November 2020

This inquiry concerned how the European Commission approves ‘active substances’ used in pesticides. In particular, the Ombudsman looked into the Commission´s practice of approving active substances for which the European Food Safety Authority (‘EFSA’) - the EU body in charge of the scientific safety assessment - said that it identified critical areas of concern or that it identified no safe use. The Ombudsman also revisited the Commission´s practice of approving substances for which additional data confirming their safety is needed.

The Ombudsman set out in detail to the Commission why she considers that its current practices raise concerns. While the Commission maintained that its practices comply with the applicable legal provisions, it listed changes and improvements it has made to address the issues raised. Specifically, it informed the Ombudsman of several measures that should improve the approval process and increase its transparency.

The Ombudsman is now closing this inquiry with three suggestions to the Commission to ensure that it approves substances based only on uses that have been confirmed to be safe by EFSA, that the approval process is fully transparent and that its use of the confirmatory data procedure is further restricted. Bearing in mind the commitment by the Von der Leyen Commission to take action to reduce by 50% the overall use of – and risk from – chemical pesticides by 2030, the Ombudsman expects that the Commission will follow up satisfactorily on her suggestions.

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.