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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

Miércoles | 04 octubre 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

Martes | 18 abril 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

Viernes | 15 enero 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.

Decisión en el asunto 1832/2014/TN - Decisión en el asunto 1832/2014/TN sobre la gestión por la Comisión Europea de posibles conflictos de interés en el grupo de trabajo del CCRSERI sobre la amalgama dental

Jueves | 17 diciembre 2015

El asunto se refería a supuestos conflictos de interés en el grupo de trabajo científico de la Comisión Europea encargado de preparar un dictamen sobre la seguridad y la eficacia de la amalgama dental y sus alternativas. La Defensora del Pueblo investigó el asunto y no observó mala administración en la evaluación por la Comisión de la independencia y la idoneidad de los miembros del grupo de trabajo.

La Defensora del Pueblo aprovechó la ocasión para comentar determinados aspectos más generales del caso. Destacó la importancia de garantizar que el asesoramiento científico prestado por los expertos que trabajan con los comités científicos de la Comisión sea independiente y objetivo. Incluso la percepción de que tal asesoramiento científico pudiera no ser independiente y objetivo podría resultar muy perjudicial. Por ello, la Comisión debe velar no solo por que el asesoramiento científico sea totalmente independiente y objetivo, sino también por que quede despejada cualquier duda razonable sobre esa independencia y objetividad.

La Defensora del Pueblo considera que es importante que la Comisión ponga en marcha procedimientos sólidos para garantizar que los expertos declaren todos sus intereses. La Comisión debe analizar detenidamente todos estos intereses y realizar todos estos procedimientos de la forma más transparente posible. Por lo tanto, la Defensora del Pueblo acogió positivamente la decisión de la Comisión de redactar unas «Directrices para la gestión de las declaraciones de intereses de los miembros, expertos externos y expertos ad hoc que participan en las actividades de los Comités Científicos», en las que se explique de forma transparente cómo se realiza la evaluación de los intereses de los expertos. La Defensora del Pueblo pidió a la Comisión que la mantenga al tanto de la evolución del proyecto y de las directrices definitivas.

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

Miércoles | 18 noviembre 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.

Decisión en el asunto 174/2015/FOR sobre la presunta falta de investigación, por parte de la Comisión, de conflictos de intereses relacionados con la apr obación de un informe sobre la seguridad de la retirada de implantes mamarios PIP

Martes | 27 octubre 2015

La investigación se refiere a un supuesto conflicto de intereses de un miembro de un comité científico de la Comisión Europea encargado de elaborar un informe sobre los riesgos de retirar implantes mamarios PIP.

En 2010 se descubrió que una empresa francesa de productos sanitarios (PIP) había fabricado y vendido ilegalmente, desde 2001, implantes mamarios fabricados con silicona de grado industrial, en lugar de silicona de grado médico. El escándalo de PIP provocó la prohibición de los implantes PIP y el encarcelamiento de un ejecutivo de la empresa. Se calcula que 400 000 mujeres de todo el mundo fueron víctimas del escándalo de PIP.

En 2012, la Comisión Europea pidió a su Comité Científico de los Riesgos Sanitarios Emergentes y Recientemente Identificados que preparase un informe sobre la seguridad de los implantes PIP, prestando especial atención a la cuestión de si la Comisión debería recomendar la retirada quirúrgica preventiva de los implantes PIP.

El demandante, una ONG que representa a las víctimas del escándalo PIP, se mostró insatisfecho con varias conclusiones del informe del Comité Científico de 2014. Alegó que uno de los miembros de un grupo de trabajo que ayudaba al Comité Científico de la Comisión estaba en situación de conflicto de intereses y que no debería haber participado en la redacción del informe. Por lo que solicitó que se retirase el informe. La presente investigación se refiere únicamente al supuesto conflicto de intereses. No analiza las conclusiones científicas del informe.

La Defensora del Pueblo investigó la cuestión del supuesto conflicto de intereses y descubrió que el experto en cuestión no había declarado inicialmente todos sus intereses. Sin embargo, cuando la Comisión le pidió que presentase la información pertinente que probase que no estaba en situación de conflicto de intereses, este así lo hizo. La Defensora del Pueblo determinó que la Comisión había llegado correctamente a la conclusión, una vez examinada esta nueva información, de que el experto no estaba en situación de conflicto de intereses.

No obstante, la Defensora del Pueblo constató que el demandante tenía razón al mostrarse preocupado al averiguar que la Comisión no tenía inicialmente la información necesaria para garantizar la independencia del experto. Así pues, la Defensora del Pueblo realizó sugerencias de mejora sobre el modo en que la Comisión recaba y analiza dicha información.

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

Viernes | 09 octubre 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

Jueves | 17 septiembre 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

Viernes | 11 septiembre 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

Martes | 30 junio 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

Martes | 16 junio 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

Martes | 28 abril 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.