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Decision on the European Medicines Agency's (EMA) refusal of public access to documents relating to the manufacturing of mRNA vaccines against COVID-19 (case 1458/2021/MIG)

Onsdag | 10 november 2021

The case concerned a request for public access to the parts of an application for a marketing authorisation for an mRNA vaccine against COVID-19 containing detailed explanations regarding how the vaccine is manufactured. EMA refused to grant access to the documents because it considered that their disclosure would undermine the manufacturer’s commercial interests and because there was no overriding public interest in disclosing the documents.

The Ombudsman agrees that the information in the requested documents is commercial information under EU law, since knowledge of it would help competing manufacturers. As regards whether there is an overriding public interest in disclosing the documents, while there are reasons why information relating to the safety and efficacy of a medicine (for example the results of clinical trials) should always be disclosed, the same does not normally apply to detailed information relating to how a medicine is manufactured.

In assessing the public interest in the disclosure of the manufacturing information in this case, the Ombudsman notes that EMA does disclose summaries of the manufacturing information.

The Ombudsman recognises the sentiment of the complainant in this case of the wider public interests involved, however she feels these are largely political questions which need be addressed by those politically responsible.

The Ombudsman thus found that EMA’s position was in line with EU case law and closed the inquiry finding no maladministration.

Henstilling om Europa-Kommissionens afslag på aktindsigt i korrespondancen med Danmark i en statsstøttesag, der blev afsluttet i 2005 og vedrørte en beskæftigelsesordning (sag 358/2020/PB)

Onsdag | 10 november 2021

Europa-Kommissionen afslog at give aktindsigt i sin korrespondance med de danske myndigheder i en statsstøttesag, der blev afsluttet for halvandet årti siden. Korrespondancen drejede sig om lovligheden af lovgivning om indførelse af en ordning, der skulle hjælpe ledige med at finde et job. En dansk fagforening anmodede om aktindsigt i korrespondancen.

Kommissionen afslog at give aktindsigt i dokumenterne under henvisning til en "generel formodning for fortrolighed". På trods af to løsningsforslag fra Ombudsmanden nægtede den at undersøge korrespondancen for at afgøre, om der kunne gives aktindsigt i den. Kommissionen mente, at det generelt ville skade tilliden mellem Kommissionen og medlemsstaterne, hvis der blev givet aktindsigt i nogen dele af indholdet af statsstøttesager, selv 15 år efter at undersøgelsen af statsstøtten var afsluttet.

Ombudsmanden bemærker, at det er muligt at anvende "formodningen om fortrolighed", men at der ikke er pligt til det. Formodningen kan afkræftes og skal anvendes strengt, idet der er tale om en undtagelse fra det grundlæggende princip om aktindsigt.

Ombudsmanden har identificeret en række elementer, der viser, at Kommissionen kunne have behandlet begæringen på en mere borgervenlig og serviceminded måde ved at undersøge det begrænsede antal dokumenter, der var tale om, med henblik på at afgøre, om der kunne gives aktindsigt i dem. Blandt disse elementer er den tid, der er gået, det forhold, at dokumenterne ikke indeholder kommercielle oplysninger eller andre tredjepartsoplysninger eller på anden måde følsomme oplysninger, det begrænsede antal dokumenter, det forhold, at de danske myndigheder selv for nylig havde givet aktindsigt i nogle af dokumenterne, og endelig offentlighedens interesse i at få afdækket et eventuelt udbredt misbrug af billig statsstøttet arbejdskraft.

Ombudsmanden henstiller derfor til Kommissionen, at den undersøger de pågældende dokumenter.

Recommendation on the European Commission’s refusal to grant public access to documents concerning compliance with biofuels sustainability criteria under the Renewable Energy Directive (case 1527/2020/DL)

Mandag | 08 november 2021

The complainant, who works in the biofuels sector, stated that he wished to obtain this information to monitor possible widespread fraud in the UCO sector, which may have negative consequences on tropical forests, biodiversity, climate and the EU’s domestic used oil collection and recycling sector.

The complainant sought public access to a list of all countries of origin of used cooking oil (UCO) for the years 2016 to 2019, together with the volumes of UCO feedstock collected for each country for each year, as reported by the voluntary certification schemes for biofuels sustainability to the European Commission under the Renewable Energy Directive.

The Commission said that it did not hold any document corresponding to the complainant’s request.

The Ombudsman found that the Commission held detailed information on the countries of origin and the volumes of UCO collected. That information was not contained in a single document, but rather was spread over a number of documents. Since the complainant was interested in receiving the information requested even if it was not compiled into a single document, the Ombudsman proposed that the Commission should review the documents it does hold containing this information with a view to disclosing them.

The Commission did not accept this solution proposal.

The Ombudsman is both concerned and disappointed with the Commission’s reply. Rather than taking the opportunity to ensure the complainant’s fundamental right of access to documents, the Commission reiterated that it does not hold any documents corresponding to the request and refused to review the documents requested. The Ombudsman cannot but consider that the Commission’s reply demonstrates a deliberate and inexplicable refusal to settle this case. This is particularly worrying in light of the concerns raised over the last years about the environmental impact of the EU’s import of UCO.

Consequently, the Ombudsman concluded that the Commission’s refusal to review the documents amounted to maladministration. She made a corresponding recommendation.

Recommendation on how the European Commission handled a request for public access to documents concerning the quality of medical masks distributed during the COVID-19 pandemic (case 790/2021/MIG)

Fredag | 05 november 2021

The complainant sought public access to documents concerning 1.5 million medical masks which the Commission had purchased at an early stage in the COVID-19 pandemic and which did not meet the required quality standard. The Commission identified 134 documents in total and, while it took ten months to provide a final reply to the complainant, it gave wide public access. The complainant took issue with the Commission’s refusal to give access (to parts of) 12 documents and, specifically, its reliance on the need to protect the commercial interests of the manufacturer concerned.

The Ombudsman found that the information at issue could not reasonably be considered to be commercially sensitive within the meaning of the EU’s rules on public access to documents. She further pointed out that, even if one were to accept that the Commission could reasonably invoke the exemption for the protection of commercial interests, the information at issue concerns products which the EU purchased using taxpayers’ money to protect public health during the most serious global health crisis in over a century. Given that there have been problems with the purchased masks, the Ombudsman considers that there is a strong public interest in knowing what steps were taken to ensure that no faulty masks were brought into circulation and used.

The Ombudsman therefore took the view that the Commission’s refusal of public access in this case constituted maladministration. She recommended that the Commission should reconsider its position with a view to granting significantly increased, if not full, access to the documents at issue.

Decision on the Council of the EU’s refusal to provide full public access to documents related to trilogue negotiations on motor vehicle emissions (case 360/2021/TE)

Mandag | 11 oktober 2021

The case concerned the Council of the EU’s refusal to grant full public access to documents relating to trilogue negotiations between the Council, the European Parliament, and the European Commission on draft legislation for vehicle emissions. The Council granted access to only parts of the documents it identified as falling under the request, arguing that disclosing the remaining parts could undermine the ongoing decision-making process.

The inspection of the documents by the Ombudsman’s inquiry team showed that the redacted parts contain the Council’s strategy for the negotiations with Parliament. These redacted parts had not been shared with Parliament at the time the Council refused access to the complainant.

The Ombudsman acknowledged that releasing this when the negotiations were ongoing could seriously undermine the Council’s negotiating position. As such, the redactions were justified in that context. However, she took the view that, once compromises on these issues had been reached in the trilogue negotiations, the relevant parts of the documents should be disclosed.

In the course of the inquiry, the Council identified three additional documents that it had shared with Parliament ahead of trilogue meetings. The Ombudsman took the view that they constitute important legislative documents, and that disclosing them would enable the public to properly follow the trilogue negotiations and to try to influence the legislative process at this crucial stage. The Ombudsman thus proposed to the Council that it should disclose these three documents. The Council accepted the proposal.

The complainant expressed his dissatisfaction with the outcome, notably as regards the Ombudsman’s assessment upholding the Council’s decision not to disclose certain parts of the documents while the negotiations were ongoing. The Ombudsman thus closed the inquiry, confirming her assessment and setting out in greater detail the conclusions she had reached.