Hae tutkimuksia

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.

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.

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.

Asiassa oli kyse väitetyistä eturistiriidoista komission tieteellisessä työryhmässä, joka valmisteli lausuntoa hampaissa käytettävän amalgaamin ja sen vaihtoehtojen turvallisuudesta ja toimivuudesta. Oikeusasiamies tutki asiaa ja totesi, ettei kyseisessä tapauksessa työryhmän jäsenten riippumattomuutta ja soveltuvuutta koskevaan komission arviointiin ollut liittynyt hallinnollista epäkohtaa.

Oikeusasiamies käytti tilaisuutta hyväkseen ja esitti huomautuksia joistakin asiaan liittyvistä yleisemmistä näkökohdista. Oikeusasiamies korosti, että on tärkeää varmistaa, että komission tiedekomiteoissa työskentelevien asiantuntijoiden antama tieteellinen neuvonta on riippumatonta ja objektiivista. Jo pelkkä epäilys siitä, ettei tieteellinen neuvonta ole ehkä riippumatonta eikä objektiivista, voi saada paljon vahinkoa aikaan. Komission onkin varmistettava, että tällainen tieteellinen neuvonta on täysin riippumatonta ja objektiivista ja että myös kaikki riippumattomuuteen ja objektiivisuuteen kohdistuvat mahdolliset perustellut epäilyt saadaan hälvennettyä.

Oikeusasiamies katsoi näin ollen, että komission on tärkeää ottaa käyttöön hyvin toimivat menettelyt, jotka varmistavat, että asiantuntijat ilmoittavat kaikista sidonnaisuuksistaan. Komission pitäisi arvioida kaikkia sidonnaisuuksia huolellisesti. Sen olisi toteutettava nämä menettelyt mahdollisimman avoimesti. Oikeusasiamies olikin erittäin tyytyväinen siihen, että komissio laati parhaillaan tiedekomiteoiden toiminnassa mukana olevien komitean jäsenten, ulkopuolisten asiantuntijoiden ja ad hoc -asiantuntijoiden sidonnaisuuksia koskevien ilmoitusten käsittelyyn liittyviä ohjeita (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), joissa selitetään avoimesti, miten asiantuntijoiden sidonnaisuudet arvioidaan. Oikeusasiamies on pyytänyt komissiota pitämään hänet ajan tasalla ohjeiden laatimisen etenemisestä ja lopullisten ohjeiden julkaisemisesta.

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.

Tutkimus koskee PIP-rintaimplanttien poistoon liittyvistä riskeistä annetun raportin laatineen Euroopan komission tiedekomitean jäsenen väitettyä eturistiriitaa.

Vuonna 2010 paljastui, että ranskalainen lääkinnällisiä laitteita valmistava yritys (PIP) oli vuodesta 2001 lähtien valmistanut laittomasti rintaimplantteja teollisesta silikonista lääketieteelliseen käyttöön tarkoitetun silikonin sijaan ja myynyt niitä. PIP-skandaali johti PIP:n valmistamien rintaimplanttien kieltoon ja PIP:n toimitusjohtajan vankeustuomioon. PIP-skandaali koski arviolta 400 000 naista eri puolilla maailmaa.

Euroopan komissio pyysi vuonna 2012 kehittymässä olevia ja vastikään havaittuja terveysriskejä käsittelevää tiedekomiteaansa laatimaan raportin PIP:n valmistamien implanttien turvallisuudesta ja keskittymään raportissa erityisesti siihen, pitäisikö komission suositella varotoimena PIP:n valmistamien implanttien kirurgista poistoa.

Kantelija, joka on PIP-skandaalin uhreja edustava kansalaisjärjestö, oli tyytymätön moniin vuonna 2014 annetussa tiedekomitean raportissa esitettyihin johtopäätöksiin. Se väitti, että yhdellä komission tiedekomiteaa avustavan työryhmän jäsenellä oli asiassa eturistiriita eikä kyseisen jäsenen olisi pitänyt osallistua raportin laatimiseen. Kantelija pyysi näin ollen, että raportti vedettäisiin takaisin. Oikeusasiamiehen tutkimus koskee ainoastaan väitettyä eturistiriitaa. Se ei koske raportin tieteellisiä johtopäätöksiä.

Oikeusasiamies tutki väitettyä eturistiriitaa ja havaitsi, ettei kyseinen asiantuntija ollut ilmoittanut alun perin kaikkia sidonnaisuuksiaan. Hän kuitenkin toimitti komission pyynnöstä asiaankuuluvat tiedot osoittaakseen, ettei hänellä ollut eturistiriitaa asiassa. Oikeusasiamies totesi komission todenneen aivan oikein näiden hiljattain toimitettujen tietojen perusteella, ettei asiantuntijalla ollut eturistiriitaa.

Oikeusasiamies katsoi kuitenkin, että kantelija oli ollut aiheellisesti huolissaan havaitessaan, ettei komissiolla ollut aluksi tarvittavia tietoja käsityksen muodostamiseksi asiantuntijan riippumattomuudesta. Oikeusasiamies ehdotti näin ollen parannuksia siihen, miten komissio kerää ja analysoi tällaisia tietoja.

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.

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.

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.

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.

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.