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Decision in case 1064/2015/JAP on the European Commission’s rejection and recovery of costs claimed under an FP6 grant agreement
Thursday | 22 June 2017
The case concerned the Commission’s rejection and proposed recovery of certain costs related to subcontracted activities in the context of an FP6 grant agreement. Arising from the Ombudsman’s inquiry the Commission decided not to proceed with the recovery of costs totalling almost 87.000 EUR. The Commission explained that it had decided to change its original decision on the basis that the complainant had acted in good faith and in accordance with advice which the Commission had itself given.
The Ombudsman welcomed this new decision; nevertheless, she found it to have been unfortunate that for several years the complainant had the prospect of a major recovery of funds hanging over it.
Decision in case OI/1/2016 on the failure by the European Commission to reply to a request for a legal review of a decision by an EU agency
Thursday | 22 December 2016
The case concerned the failure by the European Commission to reply to the complainant’s request for a legal review of the Education, Audiovisual and Culture Executive Agency’s decision to reject his project from EU funding under the Erasmus+ programme. The Ombudsman inquired into the issue and found that the Commission had already replied to the complainant. She therefore considered this part of the complaint as settled by the institution. She also examined the substance of the Commission’s reply and found it comprehensive and reasonable. She therefore decided that there was no maladministration.
Decision in case 1093/2016/JAP concerning the European Commission’s failure to reply to correspondence about problems with the submission of a grant proposal
Thursday | 01 December 2016
The case concerned the Commission’s failure to reply to the complainant’s messages concerning its difficulties with the submission of a grant proposal. Due to technical problems, the complainant was not able to apply through the Commission’s system PRIAMOS. Instead, it submitted its proposal by e-mail, which remained unanswered.
The Ombudsman inquired into the issue and asked the Commission to reply. In its reply, the Commission apologised for not having replied earlier. It said that it could not accept the complainant’s e-mail application because the system had functioned properly and the Commission had not been able to identify any attempts by the complainant to send the proposal via PRIAMOS before the deadline.
Decision in case 1354/2014/ANA concerning the handling by the Innovative Medicines Initiative (IMI) Joint Undertaking of an alleged conflict of interest in a tender procedure
Monday | 04 July 2016
The case concerned IMI's handling of an alleged conflict of interest in the tender procedure for a research project on risks and benefits of a vaccination scheme in Europe.
The complainant, a member of a consortium that took part in the procedure, argued that IMI failed to address whether all the members of an evaluation committee were impartial. The complainant argued that two members had links to the winning consortium, which gave rise to a conflict of interests.
The Ombudsman found that IMI applied the relevant rules correctly and found no evidence of unjust treatment of the proposal from the complainant's consortium. Therefore, the Ombudsman found that there was no maladministration concerning this aspect of the complaint. The Ombudsman further considered whether experts in a conflict of interest situation with one proposal should be allowed evaluate a competing proposal. The Ombudsman found that, as the rules followed by IMI were drawn up by the European Commission, no further inquiries into this question are justified within the context of this specific complaint.
Partial refusal to give public access to Clinical Studies Reports relating to the approval of a medicinal product (Humira) for the treatment of Crohn's Disease
Friday | 10 June 2016
Decision on own-initiative inquiry OI/3/2014/FOR concerning the partial refusal of the European Medicines Agency to give public access to studies related to the approval of a medicinal product
Friday | 10 June 2016
This inquiry is concerned with how the European Medicines Agency (EMA) should deal with requests for public access to documents containing information on the safety and efficacy of medicines. The specific focus is on the right of public access to three clinical study reports on Humira, a widely sold anti-inflammatory drug.
In 2013 EMA decided to grant public access to these reports. However, the pharmaceutical company that sells the drug (AbbVie) took court proceedings against EMA which had the effect of blocking the proposed release of the reports. In 2014, before the conclusion of the court proceedings, EMA and AbbVie made an out-of-court agreement by which EMA would grant public access to redacted versions of the reports. The Ombudsman contacted EMA to check whether the redactions were justified. Following this check, the Ombudsman was not convinced that all of the redactions were in fact justified. The Ombudsman then began an inquiry, on her own initiative and in the public interest, into EMA's approach to the granting of public access.
In the course of the inquiry it emerged that EMA, in response to other public access requests for the same reports, had released much fuller versions of them. Nevertheless, certain redactions remained.
The Ombudsman accepted that some of these redactions were justified (because of the need to protect personal data). But she was not convinced that other redactions, made to protect commercial interests, were justified. In these latter instances, the Ombudsman took the view that there was likely to be an overriding public interest in disclosure. As a general observation the Ombudsman noted that, where the information in a document has implications for the health of individuals (such as information on the efficacy of a medicine), the public interest in disclosure will generally defeat any claim of commercial sensitivity. Public health should always trump commercial interests.
In closing the inquiry, the Ombudsman recognised that EMA has now made very significant progress with its proactive transparency policy, effective since January 2015. However, in relation to some specific portions of the reports, the Ombudsman questioned EMA's continued reliance on the protection of commercial interests. With a view to promoting systemic improvements, the Ombudsman made several suggestions to EMA as to its future practice in this area.
Decision of the European Ombudsman closing the own-initiative inquiry OI/8/2013 concerning the Executive Agency for Small and Medium-sized Enterprises (EASME)
Thursday | 14 April 2016
The Executive Agency for Small and Medium-sized Enterprises (EASME) manages a number of EU programmes for the European Commission, including part of the Horizon 2020 Research and Innovation Framework Programme, COSME, LIFE and EMFF[1].
The Ombudsman opened an own-initiative inquiry asking the EASME to consider establishing a procedure that would allow applicants who are dissatisfied with the way calls for proposals have been handled to turn to an independent Redress Committee. She made two draft recommendations asking the EASME to 1) establish an evaluation review procedure for applicants who respond to calls for proposals under the Horizon 2020 programme and 2) establish a similar review procedure for applicants who respond to calls for proposals launched under the other EU programmes. The Ombudsman recommended that the review procedure should cover cases where applicants put forward claims of (i) procedural errors, (ii) factual errors or (iii) a manifest error of assessment. The EASME accepted both draft recommendations and took timely and appropriate measures to implement them. The Ombudsman commended the EASME for its response. She also made two further remarks to improve the review processes, suggesting that the EASME make clear to applicants that the review of alleged "procedural shortcomings" can also cover manifest errors of assessment.
Decision of the European Ombudsman in case 697/2014/MG concerning the alleged duty of the European Commission to recover funds from an EU project partner
Wednesday | 17 February 2016
The case concerned the Commission's decision not to accept certain costs declared by a partner to a project funded by the EU. The Commission's decision meant that its final payment to the consortium was reduced by the sum that this partner had received by way of pre-financing. The coordinator argued that it was the Commission's duty to recover the funds incorrectly paid to the partner in question.
The Ombudsman found that the Commission had handled the issue correctly as it could have initiated a recovery only had there been a debt towards the Union. The distribution of financing among project partners is a question of a different nature, in which the Commission has no obligation to intervene. The Ombudsman therefore found no maladministration by the Commission.
Decision of the European Ombudsman closing the inquiry into complaint 1019/2014/PHP concerning the European Commission's duty to ensure that the selection procedure for a fellowship programme complied with the UN Convention on the Rights of Persons with Disabilities
Tuesday | 03 November 2015
The case concerned the complainant's unsuccessful application for a fellowship position under the European Holocaust Research Infrastructure project, funded by the Seventh Framework Programme for Research. The complainant, a deaf researcher, complained to the Commission that the decision not to admit him to the fellowship programme was discriminatory and infringed the UN Convention on the Rights of Persons with Disabilities. The Ombudsman inquired into the issue and found no maladministration by the Commission. She has therefore decided to close the case.
Commission's handling of a grant agreement under the 7th Framework Programme
Wednesday | 07 October 2015
Commission's handling of a grant agreement under the 7th Framework Programme
Tuesday | 06 October 2015
Reply from EASME to further remarks in the European Ombudsman's decision closing her own-initiative inquiry OI/8/2013/OV
Wednesday | 30 September 2015
Decision in case 48/2015/ANA on the European Food Safety Authority's alleged infringement of the complainant's procedural rights as regards a scientific opinion
Wednesday | 23 September 2015
The complainant, Rubinum, a Spanish producer/distributor of animal feed additives, complained to the Ombudsman that EFSA had infringed its procedural rights in the context of the drafting of an EFSA Scientific Opinion which led to the Commission banning Toyocerin, a feed additive used to fatten farm animals.
The Ombudsman inquired into the issue and asked the complainant to clarify its allegations. On the basis of this inquiry, the Ombudsman found that there was no maladministration on the part of EFSA in this case.
Decision in case 254/2014/PMC concerning the European Commission's role in relation to CAPITA-ERANET, a network of European research authorities
Thursday | 09 July 2015
The complaint concerned the Commission's role in relation to CAPITA, a network of six European countries' research authorities encouraging transnational research cooperation. CAPITA received EU funding to support its coordination of research programmes. The complainant raised concerns that CAPITA's selection of projects to be funded might not have been made in a transparent, fair and impartial manner. The Ombudsman found that the Commission has a duty to act where recipients of EU funding do not fulfil their obligations. However, in this case the Ombudsman considered that the Commission acted appropriately in satisfying itself that the projects had been selected in a transparent, fair and impartial manner and that there had not been any misuse of EU funding on the part of CAPITA. She thus closed the case with a finding of no maladministration.
Decision of the European Ombudsman closing the inquiry into complaint 1078/2013/EIS against the European Commission
Tuesday | 07 July 2015
The case concerns the Commission's handling of an infringement complaint regarding the Italian authorities' approach towards recognising foreign qualifications of engineers. The complaint arose from the failure of the Italian authorities to recognise an intermediary qualification leading to a final qualification. The Commission found that the Italian authorities failed to comply with the relevant law in the complainant's case. However, since there was no consistent and general administrative practice contrary to EU law, it decided not to open infringement proceedings against Italy. The Ombudsman inquired into the issue and found that the Italian authorities' refusal to take the Commission's position concerning the complainant's case into account indicated a systemic issue that would have merited the Commission's intervention, without waiting for future problems of that kind to arise. She thus made a friendly solution proposal suggesting that the Commission resume its investigation of the complainant's infringement complaint. Since, in its reply to the Ombudsman's friendly solution proposal, the Commission (i) explicitly stated that the decision of the national authorities in the complainant's case was wrong, and (ii) committed itself to pursuing the matter should any other similar cases be brought to its attention, the Ombudsman concluded that there was no maladministration and closed the case.
Opinion of EMA in relation to public disclosure of Clinical Studies Reports relating to Humira
Monday | 02 February 2015
Decision of the European Ombudsman closing the inquiry into complaint 1962/2013/JN against the European Commission
Tuesday | 20 January 2015
The case concerned the fairness of the recovery by the European Commission of part of its financial contribution to the complainant, a company, in the context of an EU funded project. The Commission admitted that it had made some errors in its calculation of the amount to be recovered, and apologised. It also waived part of its claim for "liquidated damages", considering that it would be disproportionate. In these circumstances, the Ombudsman considered that there was no on-going maladministration and took no further action.