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Showing 1 - 20 of 282 results

Decision in strategic inquiry OI/7/2017/KR on how the European Medicines Agency engages with medicine developers in the period leading up to applications for authorisations to market new medicines in the EU

Wednesday | 17 July 2019

In order to market a new medicine in the EU, ‘medicine developers’ (mainly pharmaceutical companies) must first submit a ‘marketing authorisation application’ to the European Medicines Agency (EMA). EMA evaluates the medicine and adopts an opinion on whether it should be authorised. Prior to submitting an application, medicine developers may seek and receive scientific advice from EMA. These ‘pre-submission activities’ may have some positive consequences for public health. However, it is important to avoid even the perception that the eventual opinions of EMA on medicines were influenced by these earlier interactions.

The Ombudsman carried out an inquiry on her own initiative into these pre-submission activities, as well as the more general transparency of EMA’s work concerning the authorisation of medicines.

The Ombudsman found that EMA should carefully manage the contacts its evaluators have with medicine developers during the pre-submission phase. She also found that EMA should provide greater transparency on its pre-submission activities, with the aim of maintaining public trust in its work. The Ombudsman thus made a number of suggestions for improvement to EMA.

Decision in case 766/2018/PL on how the European Chemicals Agency conducted a consultation on a proposal to restrict lead in gunshot

Tuesday | 16 July 2019

The case concerns how the European Chemicals Agency (ECHA) conducted a consultation of stakeholders on a proposal to restrict lead in gunshot used in wetlands. The complainant took issue with the wording of the questions and the fact that the consultation was available in English only.

The Ombudsman considers that the questions, and the opportunity to send general comments, allowed participants to express their views freely. Regarding languages, however, the Ombudsman found ECHA’s justification for using English only to be inadequate.

The Ombudsman therefore welcomes ECHA’s commitment for the future to consider translating into other languages at least parts of its consultations. Where ECHA restricts the use of languages, it should put in place relevant safeguards such as making available a summary in all EU official languages, making relevant supporting material available in as many languages as possible and, above all, making clear that responses can be submitted in any EU official language. This latter element is a fundamental right.

The Ombudsman closed the case with a suggestion to ECHA to avoid similar problems arising in the future.

Decision in case 1128/2018/TM on the European Commission’s webpages on ‘novel foods’ being available in English only

Thursday | 27 June 2019

The case concerned the European Commission’s webpages on ‘novel foods’, types of food that are produced by new methods or have not previously been consumed by humans on a wider scale. The Commission’s webpages include an online application system for businesses seeking authorisation to market a novel food in the EU. The complainant was concerned that these webpages were available in English only.

In the course of the Ombudsman’s inquiry, the Commission started translating information on the authorisation procedure for novel foods into more EU official languages. The webpages were also revised to include the information that applications may be submitted in any EU language. The Ombudsman found that the Commission had taken steps to solve the complaint and closed the inquiry as settled.

Decision in case 860/2018/THH on the European Food Safety Authority’s refusal to grant public access to declarations of interest of middle management staff

Tuesday | 18 June 2019

The complaint concerned the European Food Safety Authority’s (EFSA) refusal to grant public access to declarations of interest of EFSA’s middle management staff. More generally, the Ombudsman also examined how EFSA processes requests for public access to documents.

The complainant requested public access to the declarations of interest of EFSA’s operational management, but was granted access only to the declarations of the Executive Director and four Heads of Department, which were already published on EFSA’s website.

In the course of the inquiry, EFSA adopted a new policy, making publicly available the declarations of interest of its entire operational management. The Ombudsman proposed that EFSA should also make public the declarations of interest of its Chief Scientist, Senior Science Coordinator and Senior Policy Adviser. EFSA agreed to act on this proposal.

In her inquiry, the Ombudsman also confirmed that EFSA has an appropriate system in place to process requests for access to documents.

The Ombudsman closed the inquiry with the conclusion that a solution had been accepted and implemented by EFSA.

Decision in case 537/2019/MIG on the European Medicines Agency’s alleged failure to grant public access to documents

Tuesday | 28 May 2019

The case concerned how the European Medicines Agency (EMA) dealt with a request for public access to documents concerning a medication that is used to treat certain autoimmune diseases and types of cancer.

The Ombudsman found that EMA was, given the large number of documents requested, entitled to split the complainant’s request into two batches. EMA granted partial access to the first batch and was in the process of granting partial access to the second batch.

She thus closed the inquiry finding no maladministration.

Recommendation of the European Ombudsman in case 2142/2018/TE on the European Commission’s refusal to grant access to Member State positions on a guidance document concerning the risk assessment of pesticides on bees

Friday | 10 May 2019

Pesticides are considered to be a contributing factor in the decline of bees in Europe. Following concerns, widely raised, the European Food Safety Authority (EFSA) developed, in 2013, guidance on the assessment of risk of pesticides on bees.

The complaint, submitted by a French civil society group, concerned a request for public access to documents containing the positions of EU Member States on the 2013 EFSA guidance. The European Commission refused access on the basis that the disclosure of Member State positions would jeopardise an ongoing decision-making process.

The Ombudsman found that the documents at issue should, in view of the context in which they were drawn-up and in view of their purpose, benefit from the wider access granted to “legislative documents” under the EU law on public access to documents. Wider access to such documents is crucial to ensure that EU citizens can exercise their treaty-based right to participate in the democratic life of the Union. The Ombudsman also considers that the documents in question contain environmental information, as defined in the Aarhus Regulation. The exception invoked by the Commission to refuse public access to the requested documents must therefore be applied all the more restrictively.

The Ombudsman also found that the Commission has not demonstrated that disclosure of the documents in question would seriously affect, prolong or complicate the proper conduct of the decision-making.

The Ombudsman therefore considers that the Commission’s refusal to grant public access to the positions of Member States constituted maladministration. She recommends that the Commission should grant public access to the requested documents.