European Medicines Agency access to documents practices not in line with good administration, says European Ombudsman

The European Ombudsman has criticised two practices that the European Medicines Agency (EMA) applies when handling access to documents requests.

The first concerns EMA’s handling of certain requests for public access to documents by placing them in a chronological queue. In the Ombudsman’s view, this practice does not meet the requirement in the EU transparency regulation that the EU administration handle access requests promptly.

The second practice concerns EMA restricting individuals to a maximum of five requests in the chronological queue at a given time and limiting each of these requests to no more than two documents. This ‘5-2 rule’ is arbitrary and does not take account of the length, complexity, or total number of documents falling within the scope of individual requests. As a result, the Ombudsman found it to constitute maladministration.

The Ombudsman noted that EMA is already taking steps to phase out the chronological queue and asked the agency to report to her on its progress by 30 March 2024.

The Ombudsman’s findings emerged as part of an inquiry into public access to documents concerning a vaccine for infectious bovine rhinotracheitis. (source: ombudsman.europa.eu/photo: europa.eu)

Read more here

Comments

Post a Comment

Popular posts from this blog

Ombudsman inquiry on Commission President’s text messages is a wake-up call for EU

Image
The European Ombudsman inquiry into the Commission’s handling of a request for text messages between its President and the CEO of a pharmaceutical company is a wake-up call for all EU institutions about ensuring accountability in an era of instant messaging. One year after the initial request by a journalist, the Commission has still not clarified whether messages reported to concern major vaccine procurement deals exist and whether the public is entitled to see them. The Ombudsman had asked the Commission, in a finding of maladministration in January, to conduct a more thorough search for the text messages. The Commission’s recent response failed to say whether it had looked directly and correctly for the text messages and if not, why not. While the response recognised that work-related text messages can be EU documents, it reiterated that the Commission’s internal policy is, in effect, not to register text messages. The Ombudsman has closed  the inquiry  and upheld...
Read more

The Title Deed Issue in Cyprus and the "Trapped Buyers" Phenomenon

Image
Article By Giorgos Kazoleas, Lawyer LL.M.  The issue of title deeds in Cyprus and the phenomenon of "trapped buyers" constitutes one of the greatest legal, financial, and social peculiarities of Cypriot real estate law. The Cypriot Peculiarity: Sale Without a Title Deed Under Cypriot law (pursuant to the Immovable Property (Tenure, Registration and Valuation) Law, Cap. 224), legal ownership of a property is transferred and acquired solely upon its registration with the Department of Lands and Surveys and the issuance of the relevant Certificate of Registration (Title Deed). However, a major peculiarity exists: it is entirely legal to sell a property that does not (yet) possess a separate title deed. This typically occurs in new developments (apartment buildings or residential complexes), where the title deed for the plot of land belongs to the developer, but the separate title deeds for each apartment or house can take years to be issued due to bureaucracy, pending ap...
Read more

Greek Administrative Court rules state liable for Covid-19 vaccine side effects due to "excessive sacrifice"

Image
Greece: The Administrative Court of First Instance of Athens, in its decision no. 4202/2025, has ruled that the Greek State is liable for damages sustained by an individual due to side effects following a preventive "COVID-19" vaccination. This landmark decision was issued in a compensation lawsuit filed against the Hellenic Republic. The Case: Seeking Compensation for Vaccine-Related Harm The lawsuit was brought by a plaintiff seeking compensation for material damage and moral harm (non-pecuniary damage), alleging that they suffered severe side effects after their preventive COVID-19 vaccination with a specific vaccine. The initial claim was for €461,835.26, but this amount was subsequently restricted during the proceedings. The plaintiff based their claim on two legal grounds: Article 105 of the Introductory Law of the Civil Code (EισNAK): This article concerns the State's liability for compensation arising from illegal acts or omissions of its organs in the exe...
Read more

European Commission refers Poland to the Court of Justice to protect judges from political control

Image
European Commission decided to refer Poland to the Court of Justice of the EU regarding the new disciplinary regime for Polish judges, requesting an expedited procedure. On 3 April 2019, the Commission launched this infringement procedure on the grounds that the new disciplinary regime undermines the judicial independence of Polish judges and does not ensure the necessary guarantees to protect judges from political control, as required by the Court of Justice of the EU. Specifically, the Polish law allows ordinary court judges to be subjected to disciplinary investigations, procedures and sanctions on the basis of the content of their judicial decisions, including the exercise of their right under Article 267 of the Treaty on the Functioning of the European Union (TFEU) to request preliminary rulings from the Court of Justice of the EU. Moreover, the new disciplinary regime does not guarantee the independence and impartiality of the Disciplinary Chamber of the Supreme Co...
Read more

Following the tragic death of lawyer Ebru Timtik, the CCBE calls on the EU and Turkish authorities to take urgent measures to prevent the death of lawyer Aytaç Ünsal

Image
The Council of Bars and Law Societies of Europe (CCBE) is deeply shocked by the death of Turkish lawyer Ebru Timtik on 27 August after a 238 days hunger strike. Lawyers Ebru Timtik and Aytaç Ünsal, respectively sentenced to 13 and 6 months and 11 years and 6 months in prison, decided to go on an unlimited hunger strike to denounce their unfair trial as well as the unfair trial of several dozens of Turkish lawyers. ( Read more here ) Since 2017, several Turkish lawyers belonging to the Progressive Lawyers Association and the People's Law Office, among which Ebru Timtik and Aytaç Ünsal, have been victims of judicial harassment. These lawyers who have fought for Justice and the Rule of Law have defended, among others, persons considered to be opponents of the Turkish government, families of miners massacred in Soma and Ermenek, populations expelled from their homes as victims of urban transformation, families of citizens killed under torture in police stations and prisons as well as...
Read more

The Delivery Delay Clause in Residential Construction Contracts: Consumer Protection in Cyprus and Europe

Image
By Giorgos Kazoleas, LL.M., Lawyer, Managing Partner at Legal Experts Cyprus The purchase or construction of a new residence is one of the most significant financial and personal decisions a consumer can make. Residential construction contracts or agreements for the sale of property under construction are a crucial and defining element of the entire process, as certain terms they may contain can be detrimental to the buyer. One of the most critical aspects is the contractual delivery time of the project and the provision for delay, through the so-called delivery delay clause. The Delivery Delay Clause: Its Role and Legal Nature The delivery delay clause (also known as a penalty clause in the event of default) is a term usually included in the contract that specifies a predetermined compensation amount that the contractor or seller must pay to the buyer for every day, week, or month of delay beyond the agreed delivery date. The purpose of the clause is twofold: -Compensatory: ...
Read more

Amendment of Articles of Association in Cyprus: Between Corporate Freedom and Abuse of Right – A Comparison with the Corresponding Regulation in Germany

Image
Giorgos Kazoleas, Lawyer in Cyprus The Articles of Association constitute the regulatory framework of a company, governing the internal relations between its members and management. Under Cyprus law, flexibility in adapting this document is vital, but it is not unchecked. The Amendment Process (Section 12 of the Companies Law, Cap. 113) Pursuant to Section 12 of the Companies Law (Cap. 113), a company may amend its articles of association by passing a Special Resolution, subject to compliance with the provisions of this Law and the conditions contained in the Company’s Memorandum of Association. The Company may amend specific articles or its articles of association in their entirety. For the amendment to be valid, a majority of at least 75% of the members present and voting at the General Meeting is required, and the prescribed notice must have been given (typically 21 days, unless otherwise provided for private companies). Subsequently, the company must submit the special reso...
Read more