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Legal costs

Dear European Medicines Agency,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, we are requesting the following documents:

- Any and all guidelines, policies, instructions, rules, recommendations or regulations of any kind held by the EMA with regards to costs relating to litigation before the General Court of the EU and the European Court of Justice.

In particular - although not exclusively - we are interested in any and all documents related to or regarding:

- How and when the EMA decides whether it relies on external services, may it be external lawyers or other experts, and any considerations and criteria taken into account throughout this decision-making process;
- How the EMA calculates legal costs to be claimed when it wins a legal challenge before the EU court, and any considerations and criteria taken into account throughout this decision-making process;
- How and when the EMA decides to claim these costs, and any considerations and criteria taken into account throughout this decision-making process; or
- Whether the EMA contemplates or establishes limits, reductions or waivers to legal costs, and any considerations and criteria taken into account throughout this decision-making process.

Please don’t hesitate to contact us if you have any doubts or question in regards to this request.

Yours faithfully,

Luisa Izuzquiza, Arne Semsrott
FragDenStaat, Open Knowledge Foundation Deutschland e.V

Anfrage muss klassifiziert werden

  • Datum
    3. Dezember 2021
  • Frist
    24. Dezember 2021
  • 0 Follower:innen
Luisa Izuzquiza
Luisa Izuzquiza (FragDenStaat)
Dear European Medicines Agency, Under the right of access to documents in the EU treaties, as developed in Regula…
An Europäische Arzneimittel-Agentur Details
Von
Luisa Izuzquiza (FragDenStaat)
Betreff
Legal costs [#234455]
Datum
3. Dezember 2021 12:45
An
Europäische Arzneimittel-Agentur
Status
Warte auf Antwort — E-Mail wurde erfolgreich versendet.
Dear European Medicines Agency, Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, we are requesting the following documents: - Any and all guidelines, policies, instructions, rules, recommendations or regulations of any kind held by the EMA with regards to costs relating to litigation before the General Court of the EU and the European Court of Justice. In particular - although not exclusively - we are interested in any and all documents related to or regarding: - How and when the EMA decides whether it relies on external services, may it be external lawyers or other experts, and any considerations and criteria taken into account throughout this decision-making process; - How the EMA calculates legal costs to be claimed when it wins a legal challenge before the EU court, and any considerations and criteria taken into account throughout this decision-making process; - How and when the EMA decides to claim these costs, and any considerations and criteria taken into account throughout this decision-making process; or - Whether the EMA contemplates or establishes limits, reductions or waivers to legal costs, and any considerations and criteria taken into account throughout this decision-making process. Please don’t hesitate to contact us if you have any doubts or question in regards to this request. Yours faithfully, << Address removed >> FragDenStaat, Open Knowledge Foundation Deutschland e.V Luisa Izuzquiza Request Number: 234455 Reply To: <<email address>> Upload large files for this request here: https://fragdenstaat.de/en/request/234455/upload/8509bbb04921d51ca1d3946b99bea8c678158d73/ Post Address: Luisa Izuzquiza << Address removed >> << Address removed >> << Address removed >> << Address removed >> << Address removed >>
Luisa Izuzquiza
Luisa Izuzquiza (FragDenStaat)
Dear European Medicines Agency, On 3 December we sumbitted a request for access to documents related to legal cos…
An Europäische Arzneimittel-Agentur Details
Von
Luisa Izuzquiza (FragDenStaat)
Betreff
AW: Legal costs [#234455]
Datum
6. Januar 2022 14:56
An
Europäische Arzneimittel-Agentur
Status
E-Mail wurde erfolgreich versendet.
Dear European Medicines Agency, On 3 December we sumbitted a request for access to documents related to legal costs when litigating before the General Court of the EU and the European Court of Justice. To date, we have not received an acknowledgement of receipt. Could EMA please acknowledge our request so that it can be processed without further delay? Thank you very much in advance. Sincerely, << Adresse entfernt >> and Arne Semsrott << Adresse entfernt >> Anfragenr: 234455 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/234455/ Postanschrift << Adresse entfernt >> Luisa Izuzquiza << Adresse entfernt >> << Adresse entfernt >> << Adresse entfernt >> << Adresse entfernt >>
Europäische Arzneimittel-Agentur
Dear Sir/Madam **ASK-101904 - Legal costs [#234455] received on 03/12/2021** Thank you for your message and your…
Von
Europäische Arzneimittel-Agentur
Betreff
AskEMA - Acknowledgement to ASK-101904 - Legal costs [#234455]
Datum
12. Januar 2022 12:19
Status
Warte auf Antwort
Dear Sir/Madam **ASK-101904 - Legal costs [#234455] received on 03/12/2021** Thank you for your message and your interest in the European Medicines Agency. Your request has been given the reference number ASK-101904. We will reply to you as soon as we can. For complex queries, it may take longer to answer. In any case we will write back to you within 2 months from the date of receipt. **Please do not reply to this email**, this is an automated response to confirm that we have received your request. If you need to contact us again about the same matter, please use the form on our website and mention the reference number. Kind regards
Europäische Arzneimittel-Agentur
**Re: EMA request reference ASK-104581** **Re: EMA request reference ASK-104142 ( https://servicedesk.ema.europa…
Von
Europäische Arzneimittel-Agentur
Betreff
[EMA Service Desk] (ASK-104581) Legal costs [#234455]
Datum
14. Januar 2022 11:29
Status
Warte auf Antwort
**Re: EMA request reference ASK-104581** **Re: EMA request reference ASK-104142 ( https://servicedesk.ema.europa.eu/jira/browse/ASK-104142 )** Dear Ms. Izuzquiza, Thank you for contacting the European Medicines Agency. Please note that the questions contained in the second part of your request will be handled as requests for information and have been logged in our system with the reference number **ASK-101904 ( https://servicedesk.ema.europa.eu/jira/browse/ASK-101904 )**, you will receive a reply within two months from the date of receipt. Please note that the request for access to documents contained in the first part of the request has been logged in our system with the reference number **ASK-104581 ( https://servicedesk.ema.europa.eu/jira/browse/ASK-104581 )** will be dealt in accordance with the principles and limits established in Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents (the Regulation), as applicable to the European Medicines Agency (EMA) pursuant to Article 73 of Regulation (EC) No 726/2004. Please note that the EMA is currently operating within a business continuity plan to ensure operational continuity during the continuing COVID-19 pandemic. Whilst every effort is being made to process all requests as soon as possible, you should be aware that due to these exceptional circumstances requests cannot be processed immediately and will be dealt in a chronological order from the time they were received. You can find out more information about this in our guidance document under Question 16 linked below: https://www.ema.europa.eu/en/documents/other/guide-access-unpublished-documents_en.pdf ( https://www.ema.europa.eu/en/documents/other/guide-access-unpublished-documents_en.pdf ) This decision is also in line with the principle set out in our policy which states that the Agency will apply the principle of proportionality in order to avoid the core business tasks of the Agency and its performance being jeopardised by the workload related to activities within the Regulation. You will be informed by an ATD coordinator when your procedure starts. Thank you for considering the above. Yours sincerely,
Europäische Arzneimittel-Agentur
Dear Ms Izuzquiza, With reference to ASK-101904 ( https://servicedesk.ema.europa.eu/jir... ), you submitted a nu…
Von
Europäische Arzneimittel-Agentur
Betreff
AskEMA - Response to ASK-101904 - Legal costs [#234455]
Datum
3. Februar 2022 11:02
Status
Anfrage abgeschlossen
Dear Ms Izuzquiza, With reference to ASK-101904 ( https://servicedesk.ema.europa.eu/jir... ), you submitted a number of questions which have been identified as requests for information. We understand that those questions correspond to the matter of EMA’s representation before the Court of Justice of the European Union (namely, the General Court and the Court of Justice) and the recovery of litigation-related costs. In that context, we would like to provide with you the following answers. First question: “*How and when the EMA decides whether it relies on external services, may it be external lawyers or other experts, and any considerations and criteria taken into account throughout this decision-making process*” As a general comment, EMA, as a Union agency, must be presented before the General Court or the Court of Justice (“the EU Courts,” hereinafter) by an agent for each case; the agent may be assisted by an adviser or by a lawyer. This rule is foreseen in accordance with Article 19(1) of the Statute of the Court of Justice of the European Union. In recent years, EMA has not engaged the services of external lawyers or other experts for the purpose of assisting its agents in cases before the EU Courts in cases relating to EU pharmaceutical law and access to documents. Due to the particular expertise that has been acquired internally, recourse to external legal support has not been required. In other areas of EU law, such as staff matters or public procurement, recourse to external representation might be considered on a case-by-case base. Any such decision would be premised on the legal and factual complexity of the case (including, the language of the case) and also financial and budgetary considerations. In order to rely on the services of external lawyers or other experts, the relevant public procurement rules must be taken into account. Second question: “*How the EMA calculates legal costs to be claimed when it wins a legal challenge before the EU court, and any considerations and criteria taken into account throughout this decision-making process*” As a general comment, EMA is bound by the respective rules laid down under Article 140 of the Rules of Procedure of the General Court (GC RoP) and Article 144 of the Rules of Procedure of Court of Justice (CJ RoP) as far as concerns recoverable costs in proceedings. In the situation whereby EMA is successful in a direct action, for example, it may seek to recover any expenses necessarily incurred for the purpose of the proceedings. This includes travel and subsistence expenses of agents and the remuneration of external lawyers. Third question: “*How and when the EMA decides to claim these costs, and any considerations and criteria taken into account throughout this decision-making process*” As a general comment, the unsuccessful party will be ordered to pay the costs relating to the proceedings if they have been applied for in the successful party’s pleadings. A decision as to costs shall be given in the judgment or order which closes the respective procedure. It may be noted that a decision of the EU Courts on the merits of a case will not include a taxation of the recoverable costs. The costs borne by the successful party must be submitted directly to the unsuccessful party. In such a scenario, EMA would be bound by the rules set out under Article 140 of the GC RoP or Article 144 of the CJ RoP. The submission of costs by EMA would typically be submitted following a point in time after the expiry of the deadline for lodging an appeal or following the delivery of an appellate judgment. In the scenario whereby an agreement on recoverable costs cannot be reached between the parties, EMA may submit an application for a taxation of the costs to the relevant EU Court. Fourth question: “*Whether the EMA contemplates or establishes limits, reductions or waivers to legal costs, and any considerations and criteria taken into account throughout this decision-making process*” In general, EMA does not contemplate or establish limits, reductions or waivers to legal costs stemming from proceedings before the EU Courts. In cases, however, involving recourse to external lawyers or experts, the relevant public procurement rules must be taken into account. We trust that this information may of use. If you have any additional questions, please let us know. Sincerely
Europäische Arzneimittel-Agentur
Legal Costs - ASK-104581 Dear Ms. Izuzquiza, Further to our email of 14 January 2022, in which we explained that …
Von
Europäische Arzneimittel-Agentur
Betreff
Legal Costs - ASK-104581
Datum
17. Januar 2024 13:17
Status
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Dear Ms. Izuzquiza, Further to our email of 14 January 2022, in which we explained that the request that you had submitted would be placed in a queue and processed in turn, I write to inform you that we are now in the position to open your request to access “Any and all guidelines, policies, instructions, rules, recommendations or regulations of any kind held by the EMA with regards to costs relating to litigation before the General Court of the EU and the European Court of Justice..” I kindly ask you to you please confirm that you are still interested in receiving the document requested. Upon receipt of your confirmation and not before, we will start processing your request. After your reply we will deal with your request as soon as possible and in accordance with the principles and limits established in Regulation (EC) 1049/2001 regarding public access to European Parliament, Council and Commission documents (the Regulation), as applicable to the EMA pursuant to Article 73 of Regulation (EC) 726/2004. Kind regards,
Europäische Arzneimittel-Agentur
Dear Ms Izuzquiza Further to our email of 14 January 2022, in which we explained that the requests that you had s…
Von
Europäische Arzneimittel-Agentur
Betreff
ASK-104581 - Legal costs - Notification of start of procedure
Datum
6. Februar 2024 10:53
Status
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Dear Ms Izuzquiza Further to our email of 14 January 2022, in which we explained that the requests that you had submitted would be placed in a queue and processed in turn, I write to inform you that we have now opened your request for access to documents for legal costs. We will deal with your request as soon as possible and in accordance with the principles and limits established in Regulation (EC) 1049/2001 regarding public access to European Parliament, Council and Commission documents (the Regulation), as applicable to the EMA pursuant to Article 73 of Regulation (EC) 726/2004. In accordance with the Regulation, you will receive a reply via a secure Eudralink within 15 working days. The Agency may extend this period by a further 15 working days in exceptional circumstances in accordance with the Regulation. Kind Regards,
Europäische Arzneimittel-Agentur
+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency&quo…
Von
Europäische Arzneimittel-Agentur
Betreff
EudraLink - ASK-104581 - Legal costs
Datum
15. Februar 2024 10:13
Status
+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=36fcbd172b14a757fc1c9a5208496854 The package will expire on Wed, 15 May 2024 11:13:36 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

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Europäische Arzneimittel-Agentur
Dear Requester, The decision regarding the document of the above request has just been released to you via a secu…
Von
Europäische Arzneimittel-Agentur
Betreff
ASK-104581 - Legal costs
Datum
15. Februar 2024 10:16
Status
image001.png
435 Bytes
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532 Bytes
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541 Bytes
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5,4 KB


Dear Requester, The decision regarding the document of the above request has just been released to you via a secure Eudralink. Please ensure that you download and save the document before the package expires. Please note that you will need to enter a password to access this Eudralink package. Your unique password takes the following format: ASK-XXXX-YYYY It is the ASK reference number for this request (ASK-XXXX, written exactly as it appears in the subject line ) + the year (-YYYY) in which you submitted your request to the Agency Kind regards,