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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

Tisdag | 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 januari 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.

Beslut i ärende 1832/2014/TN - Beslut i ärende 1832/2014/TN om Europeiska kommissionens hantering av potentiella intressekonflikter i Scenihrs arbetsgrupp för tandamalgam

Torsdag | 17 december 2015

Ärendet gällde påstådda intressekonflikter i kommissionens vetenskapliga arbetsgrupp vid utarbetandet av ett yttrande om hur säkert och effektivt tandamalgam och andra tandlagningsalternativ är. Ombudsmannen undersökte ärendet och fann att kommissionens bedömning av arbetsgruppsmedlemmarnas oberoende och lämplighet inte utgjorde något administrativt missförhållande i detta ärende.

Ombudsmannen tog tillfället i akt att kommentera några mer generella aspekter av ärendet. Ombudsmannen underströk hur viktigt det är att säkerställa att de experter som arbetar med kommissionens vetenskapliga kommittéer tillhandahåller vetenskaplig rådgivning som är oberoende och objektiv. Även intrycket av att den vetenskapliga rådgivningen kanske inte är oberoende och objektiv kan åsamka stor skada. Mot denna bakgrund måste kommissionen inte bara se till att den vetenskapliga rådgivningen är helt oberoende och objektiv, utan också skingra varje rimligt tvivel om rådgivningens oberoende och objektivitet.

Ombudsmannen anser därför att det är viktigt att kommissionen inrättar mycket tillförlitliga förfaranden för att se till att experterna redogör för samtliga sina intressen. Kommissionen bör göra en noggrann bedömning av samtliga dessa intressen och genomföra dessa förfaranden med största möjliga öppenhet. Ombudsmannen noterar därför med stor tillfredsställelse att kommissionen håller på att utarbeta riktlinjer för att hantera intresseförklaringar från ledamöter, externa experter och ad hoc-experter som deltar i de vetenskapliga kommittéernas verksamhet i syfte att på ett öppet sätt förklara hur bedömningen av experternas intressen går till. Ombudsmannen har uppmanat kommissionen att hålla henne underrättad om hur arbetet fortskrider och om de slutliga riktlinjerna.

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.

Beslut i ärende 174/2015/FOR om kommissionens påstådda underlåtenhet att undersöka intressekonflikter i samband med antagandet av en rapport om säkerheten när det gäller att ta ut PIP-bröstimplantat

Tisdag | 27 oktober 2015

Undersökningen gäller en påstådd intressekonflikt hos en ledamot i en av Europeiska kommissionens vetenskapliga kommittéer som fått i uppdrag att utarbeta en rapport om riskerna med att ta ut PIP-bröstimplantat.

Under 2010 upptäcktes det att en fransk tillverkare av medicinsk utrustning (PIP) sedan år 2001 i strid med lagen tillverkat och sålt bröstimplantat tillverkade av industrisilikon, i stället för medicinskt silikon. PIP-skandalen ledde till att PIP-implantat förbjöds och till att en chef på PIP fängslades. Uppskattningsvis 400 000 kvinnor världen över blev offer för PIP-skandalen.

2012 gav kommissionen sin vetenskapliga kommitté för nya och nyligen identifierade hälsorisker i uppdrag att utarbeta en rapport om säkerheten för PIP-implantat. Fokus låg på huruvida kommissionen borde rekommendera kvinnor med PIP-implantat att i förebyggande syfte ta ut dessa på kirurgisk väg.

Den klagande, en icke-statlig organisation som företräder offer för PIP-skandalen, var missnöjd med flera av slutsatserna i den vetenskapliga kommitténs rapport från 2014. Den klagande hävdade att en ledamot i en arbetsgrupp som bistod kommissionens vetenskapliga kommitté befann sig i en intressekonflikt och inte borde ha deltagit i utarbetandet av rapporten. Därför ansåg man att rapporten borde dras tillbaka. I denna undersökning hanteras endast frågan om den påstådda intressekonflikten. De vetenskapliga slutsatserna i rapporten behandlas inte.

Ombudsmannen undersökte ärendet om en påstådd intressekonflikt och fann att den berörde experten till en början inte hade redogjort för alla sina intressen. På kommissionens uppmaning tillhandahöll han dock uppgifter som visade att han inte befann sig i en intressekonflikt. Ombudsmannen drog slutsatsen att kommissionen gjorde rätt i att, efter att ha granskat dessa nya uppgifter, konstatera att experten inte befann sig i en intressekonflikt.

Ombudsmannen fann emellertid att den klagande hade rätt i att vara bekymrad då det visade sig att kommissionen till en början inte hade de uppgifter som krävdes för att bedöma expertens oberoende ställning. Ombudsmannen lämnade därför förslag till förbättringar när det gäller hur kommissionen samlar in och analyserar sådana uppgifter.

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

Tisdag | 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

Tisdag | 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.