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Zobrazuje sa 1 – 20 z 390 výsledkov

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)

Streda | 10 novembra 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.

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)

Piatok | 05 novembra 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.