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Decision in case 709/2015/MDC on the Commission's refusal to grant public access to drafts of the final Impact Assessment Report accompanying its proposal for a Directive amending the Fuel Quality and Renewable Energy Directives

Onsdag | 04 oktober 2017

The case concerned the Commission’s refusal to grant public access to draft versions of an Impact Assessment Report (IAR) on indirect land-use change related to biofuels (ILUC). Disclosure of the documents was refused on the ground that it would undermine the Commission’s decision-making process. The complainant, a group of organisations, considered that it should be granted access to the documents it requested.

The Ombudsman inquired into the issue. She noted that in September 2015, Parliament and Council adopted Directive 2015/1513. That Directive was based on the Commission’s legislative proposal to which the impact assessment report, the draft versions of which were at issue in this case, was attached. The Ombudsman therefore proposed that, in light of these new circumstances, the Commission grant public access to the requested documents. The Commission disagreed, arguing that there had been no maladministration on its part. It however invited the complainant to make a new request for access to documents, in light of the new circumstances. The complainant later informed the Ombudsman that, following a new request for access to documents, the Commission granted access to the documents it had requested. The Ombudsman thus closed the case with a finding that no further inquiries into the complaint were justified. She also pointed out that the Ombudsman is entitled to ask an institution to take into consideration, when responding to a proposal for a solution of the Ombudsman in an access to documents case, new arguments as to why a document should be released.

Decision of the European Ombudsman closing the inquiry into complaint 208/2015/PD concerning conflicts of interests in a Commission expert group on electromagnetic field

Tirsdag | 18 april 2017

The case concerned alleged conflicts of interests concerning members of a Commission working group tasked with reviewing the science on the effects that electromagnetic fields may have on health. The complaint to the Ombudsman alleged that the Commission had not examined properly whether the scientists in the working group had conflicts of interests.

The Ombudsman inquired into the issue. She was satisfied that the Commission had examined the matter properly and that the scientists had no conflicting interests. Thus, there was no maladministration by the Commission. However, the Ombudsman found that the Commission’s procedures could be improved and made some suggestions for improvement.

Decision of the European Ombudsman closing the inquiry into complaint 1582/2014/PHP on the European Commission's handling of authorisation applications for genetically modified food and feed

Fredag | 15 januar 2016

The case concerned delays encountered in the authorisation of twenty applications for genetically modified food and feed. The complainants informed the Commission of their concerns on several occasions. In their view, the Commission's explanations and the persistent delays were unacceptable. Therefore, the complainants turned to the Ombudsman.

The Ombudsman inquired into the issue and found that the delays affecting the twenty applications were not justified. In the course of the inquiry, the Commission dealt with all the pending applications. The Ombudsman concluded, however, that the delays reflected a systemic problem rather than being the result of matters specific to the particular authorisation applications. In closing the inquiry, the Ombudsman found that the delays constituted maladministration on the part of the Commission.

Afgørelse i sag 1832/2014/TN - Afgørelse i sag 1832/2014/TN om Europa-Kommissionens håndtering af mulige interessekonflikter i VKNNPS' arbejdsgruppe vedrørende tandfyldningsamalgam

Torsdag | 17 december 2015

Sagen vedrørte påståede interessekonflikter i Kommissionens videnskabelige arbejdsgruppe, der udarbejdede en udtalelse om tandfyldningsamalgams sikkerhed og egenskaber samt alternativer hertil. Ombudsmanden undersøgte sagen og fandt i den foreliggende sag ingen tilfælde af fejl eller forsømmelser med hensyn til Kommissionens evaluering af arbejdsgruppens medlemmers uafhængighed og egnethed.

Ombudsmanden benyttede lejligheden til at fremsætte bemærkninger til visse mere generelle aspekter af sagen. Ombudsmanden understregede betydningen af at sikre, at den videnskabelige rådgivning fra eksperter, der arbejder sammen med Kommissionens videnskabelige komitéer, er uafhængig og objektiv. Selv opfattelsen af, at en sådan videnskabelig rådgivning måske ikke er uafhængig og objektiv, kan være meget skadelig. Kommissionen skal derfor ikke blot sikre, at en sådan videnskabelig rådgivning er helt uafhængig og helt objektiv, men også, at enhver begrundet tvivl med hensyn til uafhængigheden og objektiviteten af en sådan rådgivning fjernes.

Ombudsmanden mener derfor, at det er vigtigt, at Kommissionen indfører meget solide procedurer, som sikrer, at eksperter afgiver erklæring om alle deres interesser. Kommissionen bør vurdere alle disse interesser omhyggeligt. Den bør gennemføre disse procedurer så gennemsigtigt som muligt. Ombudsmanden ser derfor med meget stor tilfredshed på, at Kommissionen er i gang med at udarbejde "Guidelines relating to the handling of declarations of interests of members, external experts and ad hoc experts involved in the activities of the Scientific Committees" (retningslinjer for håndtering af interesseerklæringer fra medlemmer, eksterne eksperter og ad hoc-eksperter, der er involveret i aktiviteterne i de videnskabelige komitéer), der har til formål at forklare på anskuelig vis, hvordan vurderingen af eksperternes interesser foretages. Ombudsmanden har anmodet Kommissionen om at holde sig opdateret om udviklingen med hensyn til udarbejdelsen og de endelige retningslinjer.

Decision in case 952/2014/OV on the European Food Safety Authority's (EFSA) public consultation procedure for the renewal of the approval of the herbicide glyphosate

Onsdag | 18 november 2015

The complainant, GM-Free Cymru, a Welsh pressure group campaigning to keep Wales free of genetically-modified crops, wanted to participate in the public consultation organised by the European Food Safety Authority (EFSA) on the renewal of EU approval of the herbicide glyphosate (the active ingredient of the commercialised herbicide "Roundup"). Having complained to the EFSA about the complexity of the public consultation procedure, the complainant turned to the Ombudsman. It alleged that the public consultation procedure was not user friendly, since it imposed 1) the mandatory use of an electronic template, as well as 2) the signature of a disclaimer in order to obtain a copy of the Renewal Assessment Report of the Rapporteur Member State. The complainant argued that these requirements discouraged public participation and that EFSA's intention was to minimise, rather than maximise, public involvement.

The Ombudsman asked the EFSA for an opinion on the complaint. The EFSA thereupon took immediate measures to simplify the relevant public consultation procedure. In particular, the EFSA deleted the requirement to accept any terms or conditions before submitting comments and inserted clarifications on how to fill in the template (previously contained in a separate Guidance document) directly into the template itself.

The Ombudsman welcomed the measures taken by the EFSA and found that the EFSA had settled the issue of the signing of the disclaimer. As regards the mandatory use of the template, the Ombudsman found that the EFSA had shown flexibility, and she trusted that it would do likewise in the future.

Afgørelse i sag 174/2015/FOR om Kommissionens påståede undladelse af at undersøge interessekonflikter i forbindelse med vedtagelsen af en rapport om at fjerne PIP-brystimplantater

Tirsdag | 27 oktober 2015

Undersøgelsen vedrører en påstået interessekonflikt hos et medlem af en videnskabelig komité under Europa-Kommissionen, som blev bedt om at udarbejde en rapport om risiciene ved at fjerne PIP-brystimplantater.

I 2010 blev det opdaget, at en fransk virksomhed, der fremstiller medicinsk udstyr, siden 2001 ulovligt havde fremstillet og solgt brystimplantater lavet af silikone af industriel kvalitet i stedet for silikone af medicinsk kvalitet. PIP-skandalen førte til et forbud mod PIP-implantater og fængsling af PIP's direktør. Det anslås, at 400 000 kvinder verden over er ofre for PIP-skandalen.

I 2012 anmodede Europa-Kommissionen Den Videnskabelige Komité for Nye og Nyligt Identificerede Sundhedsrisici om at udarbejde en rapport om PIP-implantaters sikkerhed med særligt fokus på, om Kommissionen burde anbefale forebyggende fjernelse af PIP-implantater.

Klageren, en NGO, der repræsenterer ofre for PIP-skandalen, var ikke tilfreds med de forskellige konklusioner i den videnskabelige komités rapport fra 2014. NGO'en påstod, at et af medlemmerne i en arbejdsgruppe, som hjalp den videnskabelige komité, var i interessekonflikt og ikke burde have deltaget i rapportens udarbejdelse. Man anmodede derfor om at få rapporten trukket tilbage. Nærværende undersøgelse vedrører alene spørgsmålet om den påståede interessekonflikt, ikke de videnskabelige konklusioner i rapporten.

Ombudsmanden har undersøgt spørgsmålet om påstået interessekonflikt og konstateret, at eksperten ikke fra starten havde anført alle sine interesser. Da Kommissionen imidlertid bad ham fremlægge den relevante dokumentation for, at han ikke var omfattet af en interessekonflikt, gjorde han det. Ombudsmanden konkluderede, at Kommissionen med rette efter at have gennemgået den nye dokumentation havde konkluderet, at eksperten ikke var omfattet af en interessekonflikt.

Ombudsmanden konstaterede imidlertid, at klageren med rette var bekymret over at opdage, at Kommissionen ikke fra begyndelsen havde de nødvendige oplysninger til at vurdere ekspertens uvildighed. Ombudsmanden stillede derfor forslag til, hvordan Kommissionen kan forbedre sin indsamling og analyse af sådanne oplysninger.

Decision of the European Ombudsman in case 894/2015/PMC concerning the European Medicines Agency's (EMA) handling of a request for public access to certain clinical study reports

Fredag | 09 oktober 2015

The case concerned a request for public access to a number of clinical study reports held by the EMA concerning a vaccine against hepatitis-A and hepatitis-B. The EMA gave access to the documents, but blanked out certain information in order to protect personal data and commercial interests. While agreeing in general with the EMA that personal data needed to be protected, the complainant argued that the EMA appeared, for reasons of practical ease, to have blanked out entire pages. The Ombudsman found that the EMA had diligently dealt with the complainant's access request. In particular, she made a finding of no maladministration as regards the EMA's decision to blank out personal data, such as the names of authors and co-authors of the reports. Moreover, the Ombudsman considered that there were insufficient grounds for conducting further inquiries into the EMA's decision not to grant access to medical articles and studies which have been published in various scientific and academic journals, given that these publications are easily accessible online.

Decision in case 1506/2014/JAS on the European Commission's handling of a request for public access to a document concerning infringement proceedings against the UK in relation to the treatment of waste water

Torsdag | 17 september 2015

The complainant is a citizen of the United Kingdom who is concerned about whether the sewage treatment plant at Whitburn (UK) complies with the Urban Waste Water Treatment Directive. He complained to the Ombudsman about the European Commission's refusal to grant him public access to a document related to infringement proceedings regarding the United Kingdom's application of the Directive, namely a letter sent by the UK authorities to the Commission in the course of infringement proceedings.

The Commission refused to release the document, arguing that documents relating to ongoing infringement proceedings are covered by a general presumption of non-disclosure. Nevertheless, the Commission provided the complainant with a summary of the document in question.

The Ombudsman inquired into the issue and found that the Commission was justified in refusing to release the document. Therefore, the Ombudsman concluded that there was no maladministration by the Commission.

Decision in case 1606/2013/AN on how the European Chemicals Agency applies rules concerning animal testing

Fredag | 11 september 2015

The complaint, made by a group of NGOs, concerns the position of the European Chemicals Agency (ECHA) regarding the limiting of animal testing. The complainant disagreed with ECHA's position that it could not reject testing proposals involving animals on the grounds that the data could be generated by an alternative method not involving animal tests. These proposals are submitted to ECHA in the context of the procedure leading to the authorisation of chemical substances to be marketed in the EU in accordance with the REACH Regulation.

The Ombudsman's inquiry concluded that ECHA's interpretation of its role was too strict and did not take into account the fact that the avoidance of animal testing was, together with the protection of human health and the environment, one of the guiding principles of the Regulation. The Ombudsman thus proposed to ECHA (i) that it require all registrants to show that they have tried to avoid animal testing and (ii) that it provide registrants with all the information at its disposal which could allow them to avoid animal testing.

ECHA accepted both proposals. It also stated, however, that it needed to hold further discussions with the European Commission and the competent authorities of the Member States as regards the practical consequences of its acceptance of the first proposal. The complainant expressed doubts in this context. The Ombudsman considered that ECHA had settled the matter but asked it to report on how it had implemented her proposals within six months of the date of this decision. The Ombudsman also invited the complainant to monitor the outcome of this case.

Decision of the European Ombudsman closing the inquiry into complaint 995/2011/KM against the European Commission

Tirsdag | 30 juni 2015

The case concerned an infringement complaint submitted to the European Commission in relation to the alleged failure of Germany to implement properly certain provisions of the ePrivacy directive. The complainant turned to the European Ombudsman alleging that the Commission had failed to explain properly the reasons for not commencing an investigation. The Ombudsman inquired into the matter and found that the Commission subsequently provided an adequate explanation in relation to some of the issues raised by the complainant. As regards the issues in relation to which the Commission did not provide an adequate explanation, the Ombudsman closed the case with a critical remark.

Decision of the European Ombudsman closing the inquiry into complaint 2186/2012/FOR against the European Chemicals Agency

Tirsdag | 16 juni 2015

EU law requires companies that produce or import chemicals to collect information on the properties and the uses of these chemicals, and to assess if they constitute a risk to humans or the environment. The companies must submit this information to the European Chemicals Agency (ECHA), which evaluates it. ECHA may require further information from such companies, which may involve further tests being carried out, including tests using animals.

The complainant is an animal welfare campaigner. In 2012, it asked ECHA to give it public access to certain documents relating to the decision-making, within ECHA, on whether certain tests using animals were in fact necessary. ECHA refused. It based its refusal to give access to the documents on the fact that publication of the documents would hinder scientific debate within ECHA.

The Ombudsman inquired into the issue and found that the decision-making process in question had already been concluded. The argument that the process could be hindered by publication of the documents therefore appeared unreasonable. She therefore made a draft recommendation that the documents be released. When ECHA agreed to disclose the requested documents, the Ombudsman closed her inquiry.

Decision of the European Ombudsman closing the inquiry into complaint 240/2014/FOR against the European Commission

Tirsdag | 28 april 2015

The case concerned the alleged lack of public consultation by the Commission regarding a list of energy infrastructure projects that, if eventually approved by the Commission, would be given priority for funding by the Commission. The complainant (an Irish citizen) questioned the extent of the information provided in relation to individual projects on the proposed list and the fact that the Commission had carried out no consultation at local level in relation to individual projects.

The Ombudsman noted that the applicable rules required extensive public consultation on the impact of individual projects, to be carried out by national authorities, when a particular project was at the stage of planning. That public consultation involved the provision of detailed information to the public on individual projects and the organisation of public meetings at local level on individual projects. The Ombudsman does not consider that the Commission's public consultation, on the drawing up of a list of energy infrastructure projects to be given priority for funding by the Commission, should replicate that process. Rather, the Commission correctly chose to ensure that the consultation it carried out had a pan-European focus.

The Ombudsman made a critical remark as regards the failure of the Commission to make a relevant document (the list of projects) available to the public during the consultation period in languages other than English. She also made a further remark that the Commission should seek to use more dynamic means of making its public consultations known to the public.