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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.

Décision dans l’enquête d’initiative OI/7/2018/JF portant sur l’absence de réponse d’une Délégation de l’UE à la correspondance concernant un projet d’assistance technique dans le domaine de la santé

Friday | 03 May 2019

1. Le 10 novembre 2017, le plaignant a écrit à la Délégation au sujet du projet susmentionné. N’ayant pas reçu de réponse après un an, le plaignant a saisi la Médiatrice européenne. 2. L'équipe du Médiateur chargée de réaliser l’enquête a contacté la Commission européenne. La Délégation a ensuite répondu au plaignant le 18 avril 2019. 3. Une réponse ayant désormais été envoyée, cette plainte est r...

Decision of the European Ombudsman in her strategic inquiry OI/4/2016/EA into how the European Commission treats persons with disabilities under the Joint Sickness Insurance Scheme for EU staff

Thursday | 04 April 2019

In 2015, a UN Committee found that the health insurance scheme for EU staff members, the Joint Sickness Insurance Scheme (JSIS), does not comply with the UN Convention on the Rights of Persons with Disabilities (UNCRPD). The committee recommended that the JSIS be revised to offer comprehensive coverage for disability-related health needs.

After receiving complaints from staff members, who had encountered problems getting their own or their family members’ medical expenses fully reimbursed, the Ombudsman conducted a strategic inquiry. She found that the failure of the European Commission to take any effective action in response to the committee’s recommendation amounted to maladministration. She thus recommended that the Commission revise the rules governing the JSIS. She also made a number of suggestions to the Commission relating to how the needs of persons with disabilities are covered under the JSIS, as well as on the need to train staff and properly consult stakeholders to ensure the JSIS reflects the needs of persons with disabilities.

The Commission replied, stating that it will revise the rules governing the JSIS and will take action to follow up on most of the Ombudsman’s suggestions.

As the Commission has accepted her recommendation, the Ombudsman closes her strategic inquiry. Given the importance of the issue, she asks the Commission to report back within six months on the implementation of the recommendation. The Ombudsman also confirms her suggestion on the need for the Commission to review its 2004 rules on accommodating the needs of staff with disabilities.

Decision of the European Ombudsman in her strategic inquiry OI/3/2017/NF on how the European Commission manages ‘revolving doors’ situations of its staff members

Thursday | 28 February 2019

The European Commission has a particular responsibility in relation to securing the highest possible standards of administration in the EU institutions. The Commission has generally high standards in the areas of ethics and transparency, however an ongoing and complex challenge - affecting many public administrations - is the so-called ‘revolving doors’ issue.

This inquiry was about how the Commission manages the ‘revolving door’ career moves of its staff, that is, where staff members leave to take up positions externally, for example in the private sector, or where individuals join the Commission particularly from the private sector. This may give rise to concerns about conflicts of interest, where inappropriate use is made of access and confidential information that assists in the lobbying of former colleagues in the EU civil service in the interests of external employers or clients.

The Ombudsman’s inquiry found that, at a systemic level, while its practices generally comply with the rules governing EU staff, more can be done to make those rules become more effective and therefore meaningful. New rules introduced in September 2018 provide greater clarity on what activities are prohibited and what subsequent employment activities need to be authorised. These rules need to be fully utilised and potentially improved.

At a technical level, the Commission has made good progress since the Ombudsman closed her first inquiry in this area. It should, however, examine whether it can take a more robust approach to preventing or dealing with serious cases of conflict, especially in the small number of cases of senior staff who leave for the private sector.

The Ombudsman also calls on the Commission to publish more information, and on a more regular basis, about senior staff who leave the Commission.

Finally, the Ombudsman urges the Commission to follow-up on the good transparency practices she has identified and shared with 15 other EU institutions, bodies, offices and agencies. This includes publishing information on former senior staff members’ lobbying bans directly on the Transparency Register. This would give the public a better picture of the hiring practices of lobbyists in the EU.

The Ombudsman closes the inquiry, encouraging the Commission to continue to lead by example but to take a more robust approach in its assessment of senior staff who leave the EU civil service. The Ombudsman also makes several detailed suggestions for improvement.

The Ombudsman also commits to a follow-up inquiry in 2020, looking more closely at how the Commission manages cases regarding a certain number of specific Commission departments (DGs).

Decision of the European Ombudsman closing her strategic inquiry OI/6/2017/EA on how the European Commission ensures that persons with disabilities can access its websites

Thursday | 20 December 2018

The Ombudsman looked into how the European Commission ensures that its websites and the online tools it makes available are accessible for persons with disabilities.

The Ombudsman asked the Commission about its use of accessible formats (like ‘easy-to-read’), how it enables users to provide feedback on accessibility, and what training it provides for staff members on accessibility issues.

The Ombudsman is satisfied that the Commission has taken steps to enhance the accessibility of its websites and online tools, and that it is committed to further improvements. It is important that these commitments are implemented in practice and that the Commission commits to taking further steps. She therefore closes her inquiry with six suggestions for improvement.

Decision in strategic inquiry OI/2/2017/TE on the transparency of the Council legislative process

Tuesday | 15 May 2018

This strategic inquiry concerned the transparency of discussions on draft legislation in the preparatory bodies of the Council of the EU (the ‘Council’).

In order for European citizens properly to exercise their democratic right to participate in the EU’s decision-making process, and hold those involved to account, legislative deliberations must be sufficiently transparent.

When the 28 Member State governments in the Council formally adopt EU legislation, meetings and any legislative discussions are public. However, before the Council reaches a formal position, discussions take place in more than 150 preparatory bodies. It is at this level that most changes to draft legislation are proposed and compromises between Member States are sought.

However, preparatory bodies do not meet in public. Citizens can exercise their democratic right to follow legislative discussions only by accessing records of these discussions. This requires that legislative discussions in preparatory bodies be properly documented and that timely access to the relevant documents be easily available.

Against this background, the Ombudsman opened this strategic inquiry in March 2017. She put specific questions to the Council, launched a public consultation and inspected legislative files of the Council.

The Ombudsman found that the Council’s current practices constitute maladministration. She specifically criticised the Council’s failure to record systematically the identity of Member States taking positions in preparatory bodies, and the widespread practice of restricting access to legislative documents while decision-making is ongoing (the so-called ‘LIMITE’ marking).

On 9 February 2018, the Ombudsman made three specific recommendations and several suggestions to the Council on how to improve the transparency of its legislative process.

The Council did not reply to the Ombudsman recommendations within the legally-prescribed timeline of three months. The Ombudsman therefore closed the case, confirming her findings, her recommendations and her suggestions for improvement. A Special Report to the European Parliament will follow.

Decision of the European Ombudsman in her strategic inquiry OI/6/2014/NF concerning the composition and transparency of European Commission expert groups

Tuesday | 14 November 2017

Abstract The EU has the responsibility and challenge of proposing and agreeing policy and legislation which affects over 500 million Europeans. The development of policy, including policy that gives rise to proposals for new EU legislation, is one of the main tasks of the European Commission. While the Commission relies heavily on its internal expertise and experience in this work, it also relies ...

Decision of the European Ombudsman setting out suggestions following her strategic inquiry OI/5/2016/AB on timeliness and transparency in the European Commission’s handling of infringement complaints

Thursday | 14 September 2017

Effective application of EU law is essential to ensuring the Union’s credibility. To check that Member States correctly transpose and implement EU law, the European Commission is tasked — in its role as “guardian of the Treaties” — with investigating alleged infringements.

Complaints lodged by citizens, organisations and businesses are an essential source of information for the Commission on possible breaches of EU law. Complainants, however, sometimes struggle to understand that infringement procedures are not always the best way to solve their individual problem. They also find it difficult to accept that the Commission enjoys discretionary powers to open or not to open an infringement procedure at the end of its investigations.

After receiving a range of complaints about the Commission’s handling of these cases, the Ombudsman opened a strategic inquiry to investigate whether there were underlying systemic problems. The inquiry concerned the Commission’s handling of infringement complaints under what is generally referred to as the “EU Pilot” system, which structures the informal stage of infringement proceedings. The purpose of “EU Pilot” is to conduct an informal dialogue with Member States to remedy breaches of EU law at an early stage and avoid resorting to formal infringement procedures. The inquiry covers: (i) the Commission’s duty to reach a timely decision, (ii) information to complainants and (iii) information to the public about EU Pilot cases.

The Ombudsman found that handling infringement complaints quickly under “EU Pilot” has been a challenge for Commission departments. The Commission has recognised these problems and adopted a new strategy in January 2017, according to which it will improve its management of infringement proceedings notably by focusing on systemic and serious breaches of EU law. At the same time, the Commission updated its procedures for handling relations with complainants.

The Ombudsman welcomes the fact that the Commission has made efforts to address the problems that gave rise to this inquiry. She believes, however, that the Commission can make further improvements. The Ombudsman therefore closes her inquiry with 8 suggestions to which the Commission should have regard in order to further improve its relations with complainants and to enhance the transparency of its actions.

Decision of the European Ombudsman closing own-initiative inquiry OI/2/2016/RH concerning delays by the European Commission in processing files on the reproductive toxicity of chemical substances

Tuesday | 18 July 2017

This own-initiative inquiry concerned delays in the handling, under Regulation 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), of files covering the potential reproductive toxicity of 216 chemical substances.

One of the main aims of REACH is to improve the protection of human health and the environment from the risks posed by chemicals. The Regulation seeks to attain this objective by requiring companies to generate information on the chemicals they produce or import. REACH also promotes alternative methods for the hazard assessment of substances in order to reduce animal testing.

A backlog of cases within the European Commission has built up since 2011 due to disagreement over which type of test companies should be asked to perform. The Commission decided to postpone decisions on these cases until a newly-available and preferred test method was adopted and related guidance issued by the European Chemicals Agency (ECHA).

The Ombudsman opened the inquiry in February 2016 to help ensure that the decisions on the pending cases are taken as rapidly as possible. A fully functioning testing regime, generating new data and filling information gaps on the hazard effects of chemicals, is of huge importance if REACH is to achieve its full potential. This is particularly the case for reproductive toxicity as concerns about, and lack of information on, effects on reproduction were among the main points at issue in the lead up to REACH. The fact that ECHA cannot move forward on any of the pending files until the Commission completes the ongoing procedure further emphasises the need to move quickly. Taking decisions within a reasonable period is also an important general principle of good administration.

The inquiry revealed that, while a range of self-imposed deadlines were set, and missed, throughout the process, the Commission has — in view of the complexity of the issues and the unusually high number of cases it had to handle with limited resources — made particular efforts to ensure legally sound decision-making, administrative efficiency and buy-in from all stakeholders. The Ombudsman welcomes the progress made by the Commission since she opened her inquiry. The inquiry also identified a systemic shortcoming in terms of a lack of incentives for registrants to update their files, despite an obligation to do so. This issue should be addressed in the current evaluation of REACH.

Decision of the European Ombudsman setting out suggestions following her strategic inquiry OI/6/2016/AB on the Commission's Special Advisers

Friday | 16 June 2017

This strategic inquiry looks into the European Commission’s rules and practices for ensuring that its Special Advisers do not have conflicts of interest.

The Commission appoints Special Advisers to give policy advice to Commissioners on a part-time basis. As many Special Advisers will continue to work outside the Commission during their term as Special Advisers, robust rules and practices are necessary to ensure that no conflicts of interest arise between these outside activities and their work as Special Advisers. This is all the more important given the high-level access and influence enjoyed by Special Advisers.

The Ombudsman commends the Commission on the procedural improvements the Commission has itself made to deal with certain issues. She is also pleased that the Commission has replied positively to a number of suggestions made by the Ombudsman during her inquiry. In closing this inquiry, the Ombudsman concludes that the Commission could further strengthen its practices in a number of respects. These include: adopting a more proactive approach to its assessment of conflicts of interest; using more effective ‘mitigating measures’ to address risks that arise; and enhancing citizens’ access to information on Special Advisers.

The Ombudsman closes her inquiry by making 10 suggestions to the Commission.