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Showing 1 - 20 of 290 results

Decision in case 2142/2018/EWM on the European Commission’s refusal to grant access to Member State positions on a guidance document concerning the risk assessment of pesticides on bees

Tuesday | 03 December 2019

The complainant, an environmental NGO, made a request for public access to documents containing the positions taken by Member States in a committee dealing with the risk assessment of how pesticides affect bees. The Commission refused access to the documents. It argued that its rules of procedure require that the positions of individual Member States not be disclosed and that public disclosure of Member States’ positions would prevent Member States from frankly expressing their views.

The Ombudsman inquired into the issue and found that the Commission was wrong to refuse access to the documents. She considered that the documents, should benefit from the wider public access granted to ‘legislative documents’. Moreover, she considered that wider public access was needed as the documents contain environmental information. She thus recommended that the Commission disclose the documents.

The Commission has chosen not to follow the Ombudsman’s recommendation. This is disappointing. Transparent decision-making regarding procedures which are of general interest and application is a cornerstone of democracy. This is all the more important when the decision-making relates to the protection of the environment.

The Ombudsman confirms that the Commission’s continued refusal to grant the complainant access to the requested documents constitutes maladministration.

Decision in case 608/2018/VB on the Consumers, Health, Agriculture and Food Executive Agency’s (Chafea) handling of a request to amend a framework partnership agreement

Monday | 21 October 2019

The case concerned the decision of the Consumers, Health, Agriculture and Food Executive Agency (Chafea) to reject a request to amend a framework partnership agreement in the field of health.

The Ombudsman found that Chafea’s decision was reasonable because the complainant was not in a position to produce the necessary documentation proving its partial takeover of rights and obligations from the bankrupt coordinator. Moreover, although the length of time the procedure took was regrettable, the Ombudsman found that the procedure took time mainly because of Chafea’s efforts to find a solution.

The Ombudsman thus closed the inquiry finding no maladministration.

Decision in case 1585/2018/MH on how the European Commission dealt with concerns raised by an Italian region about a steel plant acquisition

Monday | 09 September 2019

The case is about how the European Commission dealt with concerns surrounding the acquisition of a steel plant in Italy. An Italian region complained to the Ombudsman that the Commission had not given it sufficient opportunity to raise its concerns, before approving the acquisition under the EU Merger Rules.

The Commission’s competition department had a call with the complainant before it approved the acquisition. On that call, it gave the complainant reasonable explanations about why its legal concerns were not relevant to the Commission’s assessment. It also became apparent during that call that the complainant was focussing on the environment rather than on competition matters. The Commission thus referred it to the relevant department, in line with the principles of good administration. The complainant then had the opportunity to provide that department with further information on its environmental concerns.

The Ombudsman therefore closed the inquiry with a finding of no maladministration.

Decision in strategic inquiry OI/7/2017/KR on how the European Medicines Agency engages with medicine developers in the period leading up to applications for authorisations to market new medicines in the EU

Wednesday | 17 July 2019

In order to market a new medicine in the EU, ‘medicine developers’ (mainly pharmaceutical companies) must first submit a ‘marketing authorisation application’ to the European Medicines Agency (EMA). EMA evaluates the medicine and adopts an opinion on whether it should be authorised. Prior to submitting an application, medicine developers may seek and receive scientific advice from EMA. These ‘pre-submission activities’ may have some positive consequences for public health. However, it is important to avoid even the perception that the eventual opinions of EMA on medicines were influenced by these earlier interactions.

The Ombudsman carried out an inquiry on her own initiative into these pre-submission activities, as well as the more general transparency of EMA’s work concerning the authorisation of medicines.

The Ombudsman found that EMA should carefully manage the contacts its evaluators have with medicine developers during the pre-submission phase. She also found that EMA should provide greater transparency on its pre-submission activities, with the aim of maintaining public trust in its work. The Ombudsman thus made a number of suggestions for improvement to EMA.

Decision in case 766/2018/PL on how the European Chemicals Agency conducted a consultation on a proposal to restrict lead in gunshot

Tuesday | 16 July 2019

The case concerns how the European Chemicals Agency (ECHA) conducted a consultation of stakeholders on a proposal to restrict lead in gunshot used in wetlands. The complainant took issue with the wording of the questions and the fact that the consultation was available in English only.

The Ombudsman considers that the questions, and the opportunity to send general comments, allowed participants to express their views freely. Regarding languages, however, the Ombudsman found ECHA’s justification for using English only to be inadequate.

The Ombudsman therefore welcomes ECHA’s commitment for the future to consider translating into other languages at least parts of its consultations. Where ECHA restricts the use of languages, it should put in place relevant safeguards such as making available a summary in all EU official languages, making relevant supporting material available in as many languages as possible and, above all, making clear that responses can be submitted in any EU official language. This latter element is a fundamental right.

The Ombudsman closed the case with a suggestion to ECHA to avoid similar problems arising in the future.