Meetings with the pharmaceutical industry since March 1st 2020

Astrid Viciano made this Informationsfreiheit request to Gesundheit und Lebensmittelsicherheit

Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

Die Anfrage war erfolgreich.

Dear Health and Food Safety,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

- all reports (and other notes) from meetings between DG SANTÉ and representatives of the pharmaceutical industry (companies as well as organisations such as EFPIA) from March 1st 2020 onwards. This should include the following companies: Bayer AG, Novartis International AG, Merck, GlaxoSmithKline, Amgen Inc, F. Hoffmann-La Roche Ltd, Johnson & Johnson, SANOFI, Pfizer Inc., AstraZeneca, Eli Lilly and Company, and MSD (Europe) Inc. (Merck Sharp & Dohme).
- all correspondence (including emails) between the DG SANTÉ and representatives of the pharmaceutical industry (companies as well as organisations such as EFPIA) from March 1st 2020 onwards.
- a list of all the above-mentioned documents (including dates, names of participants/senders/recipients and their affiliation, subject of meeting/correspondence)

Yours faithfully,

Dr. Astrid Viciano

SANTE-ACCESS-TO-DOCUMENTS@ec.europa.eu, Gesundheit und Lebensmittelsicherheit

1 Attachment

Dear Ms Viciano,

Thank you for your request for access to documents.

Unfortunately, you have not indicated your postal address. This is
necessary for registering and handling your request in line with the
procedural requirements.

Please send us your full postal address at your earliest convenience.
Pending your reply, we reserve the right to refuse the registration of
your request.

Alternatively, you may use directly the electronic form available on the
Europa website:

[1]http://ec.europa.eu/transparency/regdoc/....

 

Best regards,

 

 

SANTE ACCESS TO DOCUMENTS

[2]cid:image001.gif@01D3FF48.374A49E0
European Commission
Health and Food Safety

 

 

References

Visible links
1. http://ec.europa.eu/transparency/regdoc/...

Dear [email address],

Thank you for your response. As you requested, I hereby send you my postal address:

Astrid Viciano
[ADDRESS REDACTED]
[ADDRESS REDACTED]
Germany

Yours sincerely,

Astrid Viciano

SANTE-ACCESS-TO-DOCUMENTS@ec.europa.eu, Gesundheit und Lebensmittelsicherheit

1 Attachment

Dear Ms Viciano

 

Thank you for your access to document request of 18 December 2020. We
hereby acknowledge receipt of your application for access to documents,
which was registered, after receiving confirmation of your postal address,
on 7 January 2021 under reference number GESTDEM 2020/7877.

 

In accordance with Regulation (EC) No 1049/2001 regarding public access to
European Parliament, Council and Commission documents, your application
will be handled within 15 working days. The time limit will expire on 28
January 2021. In case this time limit needs to be extended, you will be
informed in due course.

 

You have lodged your application via a private third-party website, which
has no link with any institution of the European Union. Therefore, the
European Commission cannot be held accountable for any technical issues or
problems linked to the use of this system.

 

Please note that the private third party running the AsktheEU.org website
is responsible and accountable for the processing of your personal data
via that website, and not the Commission. For further information on your
rights, please refer to the third party’s privacy policy.

 

We understand that the third party running the AsktheEU.org website
usually publishes the content of applicants’ correspondence with the
Commission on that website. This includes the personal data that you may
have communicated to the Commission (e.g. your private postal address).

 

Similarly, the third party publishes on that website any reply that the
Commission will send to the email address of the applicants generated by
the AsktheEU.org website.

 

If you do not wish that your correspondence with the Commission is
published on a private third-party website such as AsktheEU.org, you can
provide us with an alternative, private e-mail address for further
correspondence.  In that case, the Commission will send all future
electronic correspondence addressed to you only to that private address,
and it will use only that private address to reply to your request. You
should still remain responsible to inform the private third-party website
about this change of how you wish to communicate with, and receive a reply
from, the Commission.

 

For information on how we process your personal data visit our page
[1]Privacy statement – access to documents.

 

Yours faithfully,

 

 

SANTE ACCESS TO DOCUMENTS

[2]cid:image001.gif@01D3FF48.374A49E0
European Commission
Health and Food Safety

 

 

References

Visible links
1. https://ec.europa.eu/info/principles-and...

ve_sante.b.5(SANTE), Gesundheit und Lebensmittelsicherheit

1 Attachment

Please find attached document Ares(2021)448061 from SOLOMON Olga (SANTE.DDG1.B.5) dated 20/01/2021.

Veuillez trouver ci-joint le document Ares(2021)448061 de SOLOMON Olga (SANTE.DDG1.B.5) daté du 20/01/2021.

Dear DG Santé,

Thank you for your reply concerning my request GestDem 2020 7877. Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting all documents which contain the following information, not only related to Covid-19:

- all reports (and other notes) from meetings between DG SANTÉ and representatives of the pharmaceutical industry (companies as well as organisations such as EFPIA) from March 1st 2020 onwards. This should include the following companies: Bayer AG, Novartis International AG, Merck, GlaxoSmithKline, Amgen Inc, F. Hoffmann-La Roche Ltd, Johnson & Johnson, SANOFI, Pfizer Inc., AstraZeneca, Eli Lilly and Company, and MSD (Europe) Inc. (Merck Sharp & Dohme).
- all correspondence (including emails) between the DG SANTÉ and representatives of the pharmaceutical industry (companies as well as organisations such as EFPIA) from March 1st 2020 onwards.
- a list of all the above-mentioned documents (including dates, names of participants/senders/recipients and their affiliation, subject of meeting/correspondence)

Yours faithfully,

Dr. Astrid Viciano

ve_sante.accdoc(SANTE), Gesundheit und Lebensmittelsicherheit

1 Attachment

Dear Sir/Madam,

Please find attached document Ares(2021)793248 from GARAU Carmen (SANTE.A.1) dated 31/01/2021.

Kind regards,
SANTE ACCESS TO DOCUMENTS

Dear DG Santé,

Thank you for your reply concerning my request GestDem 2020 7877. As you suggest, I will specify my request in order to avoid further delays: I am therefore requesting the documents concerning points 2 (clinical trials), 6 (COVID), 7 (Pharma strategy), and 8 (Orphan and paediatrics), as listed in your letter. Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting all documents referring to the points mentioned above which contain the following information:

- all reports (and other notes) from meetings between DG SANTÉ and representatives of the pharmaceutical industry (companies as well as organisations such as EFPIA) from June 1st 2020 onwards. This should include the following companies: Bayer AG, Novartis International AG, Merck, GlaxoSmithKline, Amgen Inc, F. Hoffmann-La Roche Ltd, Johnson & Johnson, SANOFI, Pfizer Inc., AstraZeneca, Eli Lilly and Company, and MSD (Europe) Inc. (Merck Sharp & Dohme).
- all correspondence (including emails) between the DG SANTÉ and representatives of the pharmaceutical industry (companies as well as organisations such as EFPIA) from June 1st 2020 onwards.
- a list of all the above-mentioned documents (including dates, names of participants/senders/recipients and their affiliation, subject of meeting/correspondence)

Yours faithfully,

Dr. Astrid Viciano

SANTE-ACCESS-TO-DOCUMENTS@ec.europa.eu, Gesundheit und Lebensmittelsicherheit

1 Attachment

Dear Ms VICIANO,

             

We refer to your request dated 18 December 2020 in which you make a
request for access to documents registered on 7 January 2021 under the
above mentioned reference number.

 

We also refer to your reply of 20 January 2021 to our clarification
request of the same date.

 

Your application is currently being handled. However, we will not be in a
position to complete the handling of your application within the time
limit of 15 working days, which expires today on 10 February 2021.

 

An extended time limit is needed as the application concerns a large
number of documents and the documents requested originate from third
parties which have been consulted.

 

Therefore, we have to extend the time limit with 15 working days in
accordance with Article 7(3) of Regulation (EC) No 1049/2001 regarding
public access to documents. The new time limit expires on 3 March 2021.

 

We apologise for this delay and for any inconvenience this may cause.

 

We would therefore appreciate if you could confirm receipt of the present
email by replying to: [1][DG SANTE request email]

 

Yours faithfully,

 

SANTE ACCESS TO DOCUMENTS

[2]cid:image001.gif@01D3FF48.374A49E0
European Commission
Health and Food Safety

 

 

 

References

Visible links
1. mailto:[DG SANTE request email]

Dear [email address],

Thank you for your reply concerning my request GestDem 2020 7877. I have received your e-mail about the further delay of the requested documents. I will then wait for your e-mail with the requested documents until March 3rd 2021. Thank you.

Yours sincerely,

Astrid Viciano

Dear [email address],

I hereby confirm the receipt of your reply, and I await the documents until March 3rd.

Yours sincerely,

Astrid Viciano

SANTE-ACCESS-TO-DOCUMENTS@ec.europa.eu, Gesundheit und Lebensmittelsicherheit

Dear Mr Viciano,

 

We refer to your reply of 02 February 2021, in which you agreed to our
fair solution proposal of 31 January 2021.

However, handling your application, having regard to the volume of the
documents resulting from the initial narrowing down, would still involve
an unreasonable administrative burden and would be disproportionate.
Therefore, we see ourselves obliged to unilaterally restrict the scope of
your application to the amount of 65 documents.

Nonetheless, if the documents we will provide you with our reply will not
satisfy your request you might want to consider to file a new request.

 

We acknowledge that the time limit of your request expires today, however,
we regret to inform you that will not be able to provide you with a reply
within the time-limit, as the management of the COVID-19 crisis at
European level has significantly increased the workload of DG SANTE,
including the handling of a steeply increasing number of requests for
access to documents.

However, please be reassured that we are doing our utmost to provide you
with a reply as soon as possible.

 

Thank you very much for your understanding.

 

Best regards,

SANTE ACCESS TO DOCUMENTS

 

Dear [email address],

Thank you for your reply. Would you please inform me when exactly you will send me the documents requested? Also, it would be important to know how you unilaterally restricted the scope of my application.

Yours sincerely,

Astrid Viciano

SANTE-ACCESS-TO-DOCUMENTS@ec.europa.eu, Gesundheit und Lebensmittelsicherheit

1 Attachment

Dear Mr Viciano,

 

Thank you for your reply and comprehension.

We identified and assessed all documents available at Directorate level,
in the remit of the policy Units in charge of the topics listed in your
reply to our fair solution proposal.

Please find attached a table listing the documents our reply will focus
on.

 

Unfortunately, due to increased workload DG SANTE is facing as a
consequence of the COVID-19 pandemic, we are not in a position to estimate
the administrative delays.

The reply is at the hierarchical scrutiny and it will be sent to you as
soon as signed at the appropriate level.

 

We apologies for any inconvenience this may cause and we thank you once
again for your understanding.

 

Kind regards,

SANTE ACCESS TO DOCUMENTS

 

 

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Dear Health and Food Safety,

Please pass this on to the person who reviews confirmatory applications.

I am filing the following confirmatory application with regards to my access to documents request 'Meetings with the pharmaceutical industry since March 1st 2020'.

Unfortunately, the response to my request is long overdue. I have not received the documents requested in December 2020 until now, even though in the last e-mail I received it said that I would receive them soon (on March 8th). DG Santé by law should have responded by now.

A full history of my request and all correspondence is available on the Internet at this address: https://www.asktheeu.org/en/request/meet...

Yours faithfully,

Astrid Viciano

ve_sg.accessdoc (SG), Gesundheit und Lebensmittelsicherheit

1 Attachment

Link: [1]File-List
Link: [2]Edit-Time-Data
Link: [3]themeData
Link: [4]colorSchemeMapping

[5]Ares(2021)2580295 - FW: Ares(2021)2580159 - Confirmatory
application_GestDem 2020/7877

Sent by ve_sg.accessdoc (SG) <[email address]>. All responses have
to be sent to this email address.
Envoyé par ve_sg.accessdoc (SG) <[email address]>. Toutes les
réponses doivent être effectuées à cette adresse électronique.

 

 

From: ve_sg.accessdoc (SG) <[email address]>
Sent: Friday, April 16, 2021 2:42 PM
To: ask <[email address]>
Subject: Ares(2021)2580159 - Confirmatory application_GestDem 2020/7877

 

[6]Ares(2021)2580159 - Confirmatory application_GestDem 2020/7877

 

Sent by ve_sg.accessdoc (SG) <[7][email address]>. All responses
have to be sent to this email address.

Envoyé par ve_sg.accessdoc (SG) <[8][email address]>. Toutes les
réponses doivent être effectuées à cette adresse électronique.

 

Dear Ms Viciano,

 

We acknowledge receipt of your email of 14 April 2021, by which you submit
a confirmatory application for access to documents related to Gestdem
2020/7877, due to the absence of a reply to your initial application
within the legal deadlines of Article 7 of Regulation 1049/2001.

 

Please note that we were informed by the Directorate-General for Health
and Food Safety, responsible for the handling of your initial application,
that the adoption procedure for the initial reply has been launched.
Therefore, we expect the initial reply to be send to you soon.

 

In this context, we would not yet register your confirmatory application
for absence of an initial reply. Please note that, in accordance with
Article 4(2) of Regulation 1049/2001, you remain free to submit a
confirmatory application within 15 working days, as soon as you receive
the reply to your initial application.

 

Many thanks for your understanding.

 

Kind regards,

 

Access to documents team (cr)
SG.C.1
Transparency
[9]cid:image004.gif@01D4F9CD.7B22B0F0

 

 

References

Visible links
1. file:///tmp/cid:filelist.xml@01D732CF.0452BFF0
2. file:///tmp/cid:editdata.mso
3. file:///tmp/~~themedata~~
4. file:///tmp/~~colorschememapping~~
5. https://webgate.ec.testa.eu/Ares/documen...
6. https://webgate.ec.testa.eu/Ares/documen...
7. mailto:[email address]
8. mailto:[email address]

SANTE PHARMACEUTICALS B5, Gesundheit und Lebensmittelsicherheit

65 Attachments

Dear Ms. Viciano,

Please find attached a letter and its annexes on the above mentioned subject.

Kind regards,

SANTE-PHARMACEUTICALS-B5@ec.europa.eu, Gesundheit und Lebensmittelsicherheit

3 Attachments

  • Attachment

    image001.png

    15K Download

  • Attachment

    declaration applicant to sign docs erroneously sent out annex en 003.pdf

    161K Download View as HTML

  • Attachment

    declaration letter accompanying letter pers data docs erroneously sent out en 003.pdf

    399K Download View as HTML

Dear Ms Viciano,

 

This is a kind reminder of our email of March 30, also attached in this
message, where you were informed of the erroneously released documents
after your request to access to documents. You also received by mail a
declaration letter together with a declaration to sign from your side that
these documents would not be used, disseminated, shared, printed or
processed. As we haven’t still received the signed declaration from your
side, could I kindly ask you to send it by email, in this address, by July
12 at the latest?

 

Thank you in advance,

Kind regards,

 

 

 

Unit “Medicines: policy, authorisation and monitoring“

[1]logo-ce-horizontal-en-quadri-jpg24

 

European Commission

DG Health and Food Safety

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