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Showing 1 - 20 of 245 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.

Recommendation of the European Ombudsman in case 452/2018/AMF on the European Commission’s failure to disclose information on the existence of EU Pilot dialogues and to publish proactively Member State reports on the implementation of the Fisheries Control Regulation

Wednesday | 19 June 2019

The case concerns a refusal by the European Commission to give an environmental NGO general information about discussions between the Commission and Member States regarding their potential non-compliance with the EU’s Fisheries Control Regulation. The complainant also asked the Commission to publish proactively Member State reports on how they implemented the Fisheries Control Regulation.

The Ombudsman considers that the Commission is wrong not to provide the complainant with the information it requested and makes a recommendation in that regard. The Ombudsman also suggests that the Commission proactively publish Member State reports on the implementation of the Fisheries Control Regulation.

Decision in case 1946/2018/KR on how the General Secretariat of the Council informs the public about meetings that the European Council President and members of his private office have with interest representatives

Tuesday | 18 June 2019

The case concerned a request by a non-governmental organisation to the General Secretariat of the Council of the EU (GSC) to make public information about all meetings held between interest representatives and the President of the European Council, as well as members of his private office (‘cabinet’).

The General Secretariat of the Council replied to the complainant that while it is under no legal obligation to maintain a record of the meetings of the President or the cabinet members with external stakeholders, it is committed to publishing relevant information about meetings in a structured and proactive manner.

During the inquiry, the Ombudsman found that information on the meetings held by European Council President Tusk with interest representatives is made public. However, no information is available about any meetings that may take place between members of the President’s cabinet and interest representatives.

The Ombudsman closed the inquiry making several suggestions aimed at improving the information that the GSC makes public.

Decision in case 476/2018/EA on the information made available by the European Commission about an ‘expert group’ on defence research

Friday | 22 February 2019

The case concerned the information made available by the European Commission about the As-If Programme Committee for Defence Research, which advises the Commission on defence research. The complainant contended that the information on the Commission’s register of ‘expert groups’ was not up-to-date.

The Ombudsman found that the Commission had updated the register by adding the agendas and minutes of several meetings held by the Committee in 2017 and 2018. However, the minutes of one meeting were still missing, as well as comments submitted by participants to previous meetings. The Ombudsman made a proposal for a solution to the Commission to address these issues and to take measures to avoid delays in updating the register in the future.

As the Commission updated the register by adding meeting agendas and minutes, and made a commitment to avoid future delays, the Ombudsman considers that matter as settled. The Commission has also agreed to assess what in terms of participant comments and other background documents can be published on the register. The Ombudsman invites the Commission to report back within three months on the measures it has taken.

Closing note on the Strategic Initiative with the European Commission on the negotiations on the UK withdrawal from the EU (SI/1/2017/KR)

Monday | 11 February 2019

The withdrawal of the United Kingdom from the European Union has serious and wide-ranging implications for millions of EU citizens and businesses. They should, to the appropriate extent, be kept informed about developments in the withdrawal process, as well as the subsequent process for deciding upon the future relationship between the EU and the UK.

The European Commission has been mandated by the European Council to represent the EU in the negotiations leading to the withdrawal of the UK from the EU. Weeks before the UK invoked Article 50 to begin the process, the Ombudsman suggested practical ways to President Juncker to ensure appropriate transparency throughout the negotiations, and to secure the necessary input from citizens and others. The Ombudsman also wrote to the Secretary General of the Council of the EU.

The level of transparency achieved thus far has been very high, when compared to for example international negotiations that the EU has conducted in the past.

This transparency has served to enhance the legitimacy of the Commission and the EU in these negotiations. It has also helped keep the EU united as all key stakeholders were informed at every step. As the Ombudsman said in her letter of March 2017, the EU side could only benefit from transparency, as the reality of the negotiations sets in on the UK side.

The Ombudsman also notes the early call of the European Parliament for “full transparency”[1] in the negotiations.

The Ombudsman now encourages the European Council and European Commission to continue to ensure that the future relationship negotiations are as transparent and participative as possible.

Decision in case 1830/2017/SRS on how the European Commission’s Scientific Committee on Health and Environmental and Emerging Risks (SCHEER) selects external experts to provide scientific advice

Friday | 08 February 2019

This case concerned how the European Commission’s Scientific Committee on Health and Environmental and Emerging Risks (SCHEER) selected experts to take part in a working group, which drafted an opinion on the use of non-human primates in research.

The complainant argued that the procedure to select the experts was not transparent and that the Commission had not ensured a plurality of views within the working group. It argued, in particular, that the working group did not include a sufficient number of experts on the alternatives to non-human primates in research.

The Ombudsman found that SCHEER did not exceed its broad margin of discretion in selecting experts in this case and that the process was sufficiently transparent. The Ombudsman therefore concluded that there was no maladministration.