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EMA/327522/2025

When the EMA pressures researchers.

Seven days to delete data. A written commitment never to use it. Then requests to access our scientific code.

EMA letter · 9 Oct 2025 Access request · 16 Oct 2025 EMA correspondence · Dec 2025 – Jan 2026
  1. June 2021

    We publish our study and its reproducible code

    We publish the study “Pharmacovigilance of COVID-19 Vaccines”, together with the Pfizer.ipynb notebook on Google Colab. This code reproduces the calculations from data consulted on the EMA portal.

  2. 9 October 20255:42 pm

    The EMA demands data deletion and a written commitment

    We receive letter EMA/327522/2025, electronically signed by Alexis Nolte and sent by his assistant. The Agency considers that the script gives access to “non-public” information, including the Worldwide Unique Case Identifier (WWUID) and the country of occurrence. It requests their deletion and written confirmation before 16 October 2025.

    The EMA was not only asking us to delete files. It also demanded a written commitment about their future use and dissemination, worded as follows.

    “I confirm that any non-public data originating from the EudraVigilance system which may be or may have been accessed or downloaded by me […] have been safely and permanently deleted and have not been and will not be disclosed, copied, distributed, reproduced, used, made public, or exploited by myself or any third parties.”Letter EMA/327522/2025, p. 2 — excerpt
    Read the letter
  3. 16 October 20259:17 am · EMA deadline

    On deadline day, a request to access our code

    On the very day of the deadline set in the EMA’s letter, a request to access the Pfizer.ipynb notebook arrives from a personal Gmail account, in the name of Irene Montero. It concerns the code that reproduces our calculations.

    A request targeting our calculation code arrives on the very day the EMA expects our written commitment to delete. We are asking in what capacity this access was requested.

    See the 16 October request
  4. 22 December 2025

    A new request from a personal account

    A new request to access the same file reaches us from a personal Google account. In its later reply, the EMA will state that this request came from its Data Protection Officer, Sabine Brosch.

    According to the correspondence, the Agency was closed from 22 December 2025 to 5 January 2026.

  5. 25 December 2025

    We refuse and ask for explanations

    We refuse access and ask the EMA why a personal account was used to request access to our research.

  6. 7 January 2026

    We follow up with the EMA

    Having received no reply, we renew our request for explanations, copying a journalist. The EMA acknowledges receipt the next day.

  7. 23 January 2026

    The EMA’s official reply

    The Agency confirms that its Data Protection Officer wanted “to understand what information remained accessible”. It explains the use of a personal account by Google’s sign-in requirement for access requests.

    Read the correspondence
Freedom of research · EU law

We ask that the grounds and conditions of these interventions be examined. Several legal questions deserve a documented answer:

Scientific freedom

Article 13 of the Charter of Fundamental Rights of the European Union protects freedom of research. On what basis, and with what proportionality, could this deletion be demanded?

Expression and information

Article 11 of the Charter protects freedom of expression and information. Which restrictions on keeping and disseminating research results were legally justified?

Traceability and personal accounts

Which institutional rules governed these access requests? Who authorised them, and in what capacity?

These questions are not a statement of guilt nor an established criminal qualification. We ask for them to be examined and for public answers on any responsibilities.

We did not give in.

We refused to comply with an order to delete scientific data, or to sign a commitment barring us from using and disseminating it.

We believe scientific research must not be placed under the supervision of the institutions it helps to examine and hold to account.

We refuse to accept that researchers can be pressured for carrying out scientific work whose methods and results are reproducible.

We have chosen to make public the letters, the requests to access our code and the timeline of events.

We did not delete our work. We did not abandon our research. We did not give in.

This website is our answer.

Emmanuelle DarlesVincent Pavan