The Vaccines Procurement Steering Committee & the Joint Negotiation Team

The request was partially successful.

Dear Secretariat General,

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 of the Vaccines Procurement Steering Committee and the Joint Negotiation Team (JNT) with representatives of pharmaceutical companies about Advance Purchase Agreements (APAs) and the purchase of potential vaccines against COVID-19.

- all correspondence (including emails and their attachments) between the Vaccines Procurement Steering Committee and the Joint Negotiation Team (JNT) and representatives of pharmaceutical companies (including Sanofi-GSK, Johnson & Johnson, CureVac, AstraZeneca, Moderna and others) about Advance Purchase Agreements (APAs) and the purchase of potential vaccines against COVID-19.

- a list of all the above-mentioned documents (including dates, names of participants/senders/recipients and their affiliation, subject of meeting/correspondence).

There is a clear public interest in disclosure of these documents. The transparency rules as set out in the Lisbon Treaty oblige the EU institutions to work as openly and as closely as possible to citizens. There is clearly a lot at stake for EU citizens in the vaccine deal negotiations. Citizens have the right to know about these negotiations that are happening on their behalf, involving billions of euros of public money to be spent for the development of vaccines.

Secrecy around the negotiations about the vaccines, moreover, may undermine public confidence in the EU and its handling of the pandemic, but also in the vaccines themselves (with negative consequences for public health beyond the current pandemic).

Blanket confidentiality cannot be the rule for the negotiations about the Covid19 vaccine contracts. Price and other sorts of confidentiality covering commercial aspects of these contracts cannot preclude transparency, for instance around negotiations about liability and other provisions with clear implications for patient safety and the protection of public health.

The currently negotiated contracts for potential covid19 vaccines differ from usual medicines procurement deals. Considerable amounts of public money and public guarantees are invested into the R&D and manufacturing process through the signature of advance purchase agreements between the European Commission and individual pharma companies. APAs essentially constitute insurance policies paid for by taxpayers' money which amongst other guarantee losses sustained by pharma developers. Governments commit in advance to shouldering the cost of certain liabilities sustained by pharma companies throughout the R&D process; by doing so they de-risk it and become co-developers. This makes the need for transparency and public accountability around the negotiations even stronger.

Please note that there is also a clear public interest in the release of the names of the members of the Joint Negotiation Team (JNT). The public has the right to know who is negotiating on the EU’s behalf. Knowing the names of the negotiators is a pre-condition for assessing potential conflicts of interest.

Yours sincerely,

Olivier Hoedeman
on behalf of Corporate Europe Observatory (CEO)
Rue d'Edimbourg 26,
1050 Brussels, Belgium
Tel. +32 (0)2 893 0930

Secretariat General of the European Commission

Your message has been received by the Transparency Unit of the
Secretariat-General of the European Commission.
Requests for public access to documents are treated on the basis of
[1]Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents.
The Secretariat-General will reply to your request within 15 working days
upon registration of your request and will duly inform you of the
registration of the request (or of any additional information to be
provided in view of its registration and/or treatment).
 
 
L’unité «Transparence» du secrétariat général de la Commission européenne
a bien reçu votre message.
Les demandes d’accès du public aux documents sont traitées sur la base du
[2]règlement (CE) n° 1049/2001 du 30 mai 2001 relatif à l’accès du public
aux documents du Parlement européen, du Conseil et de la Commission.
Le secrétariat général répondra à votre demande dans un délai de 15 jours
ouvrables à compter de la date d’enregistrement de votre demande, et vous
informera de cet enregistrement (ou vous indiquera toute information
supplémentaire à fournir en vue de l'enregistrement et/ou du traitement de
votre demande).
 
 
Ihre Nachricht ist beim Referat „Transparenz“ des Generalsekretariats der
Europäischen Kommission eingegangen.
Anträge auf Zugang zu Dokumenten werden auf der Grundlage der
[3]Verordnung (EG) Nr. 1049/2001 vom 30. Mai 2001 über den Zugang der
Öffentlichkeit zu Dokumenten des Europäischen Parlaments, des Rates und
der Kommission behandelt.
Das Generalsekretariat beantwortet Ihre Anfrage innerhalb von
15 Arbeitstagen nach deren Registrierung und wird Sie über die
Registrierung Ihres Antrags (oder die Notwendigkeit weiterer Informationen
im Hinblick auf dessen Registrierung und/oder Bearbeitung) unterrichten.
 
 

References

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1. https://eur-lex.europa.eu/legal-content/...
2. https://eur-lex.europa.eu/legal-content/...
3. https://eur-lex.europa.eu/legal-content/...

ve_sg.accessdoc (SG), Secretariat General of the European Commission

1 Attachment

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

[5]Ares(2020)4818233 - RE: access to documents request - The Vaccines
Procurement Steering Committee & the Joint Negotiation Team - Gestdem
2020/5436

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

Dear Sir,

Thank you for your e-mail of 15/09/2020. We hereby acknowledge receipt of
your application for access to documents, which was registered on
15/09/2020 under reference number GESTDEM 2020/5436.

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 06/10/2020. 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
[6]Privacy statement – access to documents.

Yours faithfully,

 

ACCESS TO DOCUMENTS TEAM (GD)

 

[7]cid:image001.png@01D45409.F767C980

European Commission

Secretariat-General

SG C.1

[8][email address]

 

 

show quoted sections

Secretariat General of the European Commission

1 Attachment

Dear Mr HOEDEMAN,

             

We refer to your requests both dated 15 September 2020 in which you make a
request for access to documents, both registered on the same date under
the above mentioned reference numbers.

 

Your applications are currently being handled. However, we will not be in
a position to complete the handling of your applications within the time
limit of 15 working days, which expires on 06 October 2020.

 

An extended time limit is needed due to internal consultations and a
thorough analysis of your request.

 

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 27 October 2020.

 

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

 

Yours faithfully,

 

SANTE ACCESS TO DOCUMENTS

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

 

 

References

Visible links

Dear Secretariat General of the European Commission,

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

We are filing the following confirmatory application with regards to our access to documents request 'The Vaccines Procurement Steering Committee & the Joint Negotiation Team' (registered on 15/09/2020 under reference number GESTDEM 2020/5436).

The Commission's deadline for responding to our access to documents request expired on 06 October 2020.

The Commission then extended the time limit with 15 working days. The new time limit expired on 27 October 2020. This is now 10 days ago (!) and we have not heard anything from the Commission about the delayed response.

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

Yours faithfully,

Olivier Hoedeman
on behalf of Corporate Europe Observatory (CEO)
Rue d'Edimbourg 26,
1050 Brussels, Belgium
http://www.corporateeurope.org

Secretariat General of the European Commission

Your message has been received by the Transparency Unit of the
Secretariat-General of the European Commission.
Requests for public access to documents are treated on the basis of
[1]Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents.
The Secretariat-General will reply to your request within 15 working days
upon registration of your request and will duly inform you of the
registration of the request (or of any additional information to be
provided in view of its registration and/or treatment).
 
 
L’unité «Transparence» du secrétariat général de la Commission européenne
a bien reçu votre message.
Les demandes d’accès du public aux documents sont traitées sur la base du
[2]règlement (CE) n° 1049/2001 du 30 mai 2001 relatif à l’accès du public
aux documents du Parlement européen, du Conseil et de la Commission.
Le secrétariat général répondra à votre demande dans un délai de 15 jours
ouvrables à compter de la date d’enregistrement de votre demande, et vous
informera de cet enregistrement (ou vous indiquera toute information
supplémentaire à fournir en vue de l'enregistrement et/ou du traitement de
votre demande).
 
 
Ihre Nachricht ist beim Referat „Transparenz“ des Generalsekretariats der
Europäischen Kommission eingegangen.
Anträge auf Zugang zu Dokumenten werden auf der Grundlage der
[3]Verordnung (EG) Nr. 1049/2001 vom 30. Mai 2001 über den Zugang der
Öffentlichkeit zu Dokumenten des Europäischen Parlaments, des Rates und
der Kommission behandelt.
Das Generalsekretariat beantwortet Ihre Anfrage innerhalb von
15 Arbeitstagen nach deren Registrierung und wird Sie über die
Registrierung Ihres Antrags (oder die Notwendigkeit weiterer Informationen
im Hinblick auf dessen Registrierung und/oder Bearbeitung) unterrichten.
 
 

References

Visible links
1. https://eur-lex.europa.eu/legal-content/...
2. https://eur-lex.europa.eu/legal-content/...
3. https://eur-lex.europa.eu/legal-content/...

ve_sg.accessdoc (SG), Secretariat General of the European Commission

[1]Ares(2020)6427281 - RE: Internal review of access to documents request
- The Vaccines Procurement Steering Committee & the Joint Negotiation Team

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

Dear Sir,

Thank you for your email dated 06/11/2020 by which you request, pursuant
to Regulation No 1049/2001 regarding public access to European Parliament,
Council and Commission documents, a review of the position taken by DG
SANTE in reply to your initial application GESTDEM 2020/5436.

We hereby acknowledge receipt of your confirmatory application for access
to documents which was registered on 06/11/2020 (Ares(2020)6426066).

Your application will be handled within 15 working days (27/11/2020). In
case this time limit needs to be extended, you will be informed in due
course.

Please be informed that the answer to your confirmatory application is a
formal Commission decision that will be notified to you by express
delivery. Thank you for providing your contact phone number, so that the
external delivery service can contact you in case of absence.

Please note that the Commission will not use your phone number for any
other purpose than for informing the delivery service, and that it will
delete it immediately thereafter.

Yours faithfully,

Access to documents team (RC)

show quoted sections

Dear ve_sg.accessdoc (SG),

important clarification: rather than "a review of the position taken by DG SANTE", I want the Commission to act on the excessive delay in responding to my access to documents request application GESTDEM 2020/5436. DG SANTE did not take any position yet, but failed to respond within the deadlines outlined in regulation 1049/2001.

Responding that my "application will be handled within 15 working days (27/11/2020)" only makes things worse (adding yet another three weeks delay before getting a response / receiving the documents).

Yours sincerely,

Olivier Hoedeman
on behalf of
Corporate Europe Observatory (CEO)
Rue d'Edimbourg 26,
1050 Brussels, Belgium

http://www.corporateeurope.org
Tel. +32 (0)2 893 0930

Secretariat General of the European Commission

Your message has been received by the Transparency Unit of the
Secretariat-General of the European Commission.
Requests for public access to documents are treated on the basis of
[1]Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents.
The Secretariat-General will reply to your request within 15 working days
upon registration of your request and will duly inform you of the
registration of the request (or of any additional information to be
provided in view of its registration and/or treatment).
 
 
L’unité «Transparence» du secrétariat général de la Commission européenne
a bien reçu votre message.
Les demandes d’accès du public aux documents sont traitées sur la base du
[2]règlement (CE) n° 1049/2001 du 30 mai 2001 relatif à l’accès du public
aux documents du Parlement européen, du Conseil et de la Commission.
Le secrétariat général répondra à votre demande dans un délai de 15 jours
ouvrables à compter de la date d’enregistrement de votre demande, et vous
informera de cet enregistrement (ou vous indiquera toute information
supplémentaire à fournir en vue de l'enregistrement et/ou du traitement de
votre demande).
 
 
Ihre Nachricht ist beim Referat „Transparenz“ des Generalsekretariats der
Europäischen Kommission eingegangen.
Anträge auf Zugang zu Dokumenten werden auf der Grundlage der
[3]Verordnung (EG) Nr. 1049/2001 vom 30. Mai 2001 über den Zugang der
Öffentlichkeit zu Dokumenten des Europäischen Parlaments, des Rates und
der Kommission behandelt.
Das Generalsekretariat beantwortet Ihre Anfrage innerhalb von
15 Arbeitstagen nach deren Registrierung und wird Sie über die
Registrierung Ihres Antrags (oder die Notwendigkeit weiterer Informationen
im Hinblick auf dessen Registrierung und/oder Bearbeitung) unterrichten.
 
 

References

Visible links
1. https://eur-lex.europa.eu/legal-content/...
2. https://eur-lex.europa.eu/legal-content/...
3. https://eur-lex.europa.eu/legal-content/...

ve_sg.accessdoc (SG), Secretariat General of the European Commission

1 Attachment

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

[5]Ares(2020)7142196 - Your confirmatory application for access to
documents under Regulation (EC) No 1049/2001 - GESTDEM 2020-5436 - 1st
holding letter

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

Dear Mr Hoedeman,

We refer to your email of  6 November 2020, registered on the same day, by
which you submitted a confirmatory application in accordance with Article
7(2) of Regulation (EC) No 1049/2001 regarding public access to European
Parliament, Council and Commission documents[6]^[1] ("Regulation (EC) No
1049/2001").

 

Your confirmatory application is currently being handled. Unfortunately,
we have not yet been able to gather all the elements needed to carry out a
full analysis of your request and to take a final decision. Therefore, we
are not in a position to reply to your confirmatory request within the
prescribed time limit which expires on 18 December 2020.

 

We apologise for this delay and for any inconvenience this may cause but
we would like to assure you that we will do our utmost to provide you with
a reply as soon as possible.

 

Yours sincerely,

 

 

María OLIVÁN AVILÉS
Head of Unit

[7]cid:image001.gif@01D13362.41D673C0

European Commission

Secretariat General

Unit C.1 (Transparency, Document Management and Access to Documents)

 

------------------------

[8][1]               Official Journal L 145 of 31.5.2001, p. 43.

References

Visible links
1. file:///tmp/cid:filelist.xml@01D6C4AA.5F70CA00
2. file:///tmp/cid:editdata.mso
3. file:///tmp/~~themedata~~
4. file:///tmp/~~colorschememapping~~
5. https://webgate.ec.testa.eu/Ares/documen...
6. file:///tmp/foiextract20211201-31628-1pdo3xg#_ftn1
8. file:///tmp/foiextract20211201-31628-1pdo3xg#_ftnref1

ve_sg.accessdoc (SG), Secretariat General of the European Commission

1 Attachment

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

[5]Ares(2020)7726566 - Your confirmatory application for access to
documents under Regulation (EC) No 1049/2001 - GESTDEM 2020/5436 - 2nd
holding letter

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

Dear Mr
Hoedeman,                                                                

We refer to your email of  6 November 2020, registered on the same day, by
which you submitted a confirmatory application in accordance with Article
7(2) of Regulation (EC) No 1049/2001 regarding public access to European
Parliament, Council and Commission documents[6]^[1] ("Regulation (EC) No
1049/2001"). We also refer to our holding letter of 27 November 2020.

 

Your confirmatory application is currently being handled. Unfortunately,
the internal consultations are still ongoing in relation to your
request. Therefore, we are not in a position to reply to your confirmatory
request within the prescribed time limit which expires on 18 December
2020.

 

We apologise for this delay and for any inconvenience this may cause but
we would like to assure you that we will do our utmost to provide you with
a reply as soon as possible.

 

Yours sincerely,

 

 

María OLIVÁN AVILÉS
Head of Unit

[7]cid:image001.gif@01D13362.41D673C0

European Commission

Secretariat General

Unit C.1 (Transparency, Document Management and Access to Documents)

 

------------------------

[8][1]               Official Journal L 145 of 31.5.2001, p. 43.

References

Visible links
1. file:///tmp/cid:filelist.xml@01D6D519.09639C30
2. file:///tmp/cid:editdata.mso
3. file:///tmp/~~themedata~~
4. file:///tmp/~~colorschememapping~~
5. https://webgate.ec.testa.eu/Ares/documen...
6. file:///tmp/foiextract20211201-31628-1o4tsoo#_ftn1
8. file:///tmp/foiextract20211201-31628-1o4tsoo#_ftnref1

Dear Secretariat-General (SG),

on December 18th you informed us that "internal consultations are still ongoing" regarding our access to documents request GESTDEM 2020/5436 and that you "are not in a position to reply" within the prescribed time limit", which expired that same day. You announced that you would reply "as soon as possible." In other words: no specific explanation or justification, no new deadline but an indefinite delay.

Our access to documents request was submitted on September 15th and we have still not received a substantive response, let alone received any of the documents we asked for. This is completely at odds with the Commission's obligations under Regulation 1049/2001 (which has clear deadlines for responding) and constitutes maladministration.

Your handling of our request gives us the impression that the Commission has de facto unilaterally decided that the EU's access to documents legislation does not apply to the covid-19 vaccine deals. Our request outlined very clearly the overriding public interest in the disclosure of the documents.

We are deeply disappointed by the Commission's handling of our request and see no other option than submitting a complaint to the European Ombudsman.

Yours sincerely,

Olivier Hoedeman
on behalf of Corporate Europe Observatory (CEO)
Rue d'Edimbourg 26,
1050 Brussels, Belgium

Sg-Acc-Doc@ec.europa.eu, Secretariat General of the European Commission

Your message has been received by the Transparency Unit of the
Secretariat-General of the European Commission.
Requests for public access to documents are treated on the basis of
[1]Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents.
The Secretariat-General will reply to your request within 15 working days
upon registration of your request and will duly inform you of the
registration of the request (or of any additional information to be
provided in view of its registration and/or treatment).
 
 
L’unité «Transparence» du secrétariat général de la Commission européenne
a bien reçu votre message.
Les demandes d’accès du public aux documents sont traitées sur la base du
[2]règlement (CE) n° 1049/2001 du 30 mai 2001 relatif à l’accès du public
aux documents du Parlement européen, du Conseil et de la Commission.
Le secrétariat général répondra à votre demande dans un délai de 15 jours
ouvrables à compter de la date d’enregistrement de votre demande, et vous
informera de cet enregistrement (ou vous indiquera toute information
supplémentaire à fournir en vue de l'enregistrement et/ou du traitement de
votre demande).
 
 
Ihre Nachricht ist beim Referat „Transparenz“ des Generalsekretariats der
Europäischen Kommission eingegangen.
Anträge auf Zugang zu Dokumenten werden auf der Grundlage der
[3]Verordnung (EG) Nr. 1049/2001 vom 30. Mai 2001 über den Zugang der
Öffentlichkeit zu Dokumenten des Europäischen Parlaments, des Rates und
der Kommission behandelt.
Das Generalsekretariat beantwortet Ihre Anfrage innerhalb von
15 Arbeitstagen nach deren Registrierung und wird Sie über die
Registrierung Ihres Antrags (oder die Notwendigkeit weiterer Informationen
im Hinblick auf dessen Registrierung und/oder Bearbeitung) unterrichten.
 
 

References

Visible links
1. https://eur-lex.europa.eu/legal-content/...
2. https://eur-lex.europa.eu/legal-content/...
3. https://eur-lex.europa.eu/legal-content/...

Olivier Hoedeman left an annotation ()

On January 22nd, the European Ombudsman started investigating the European Commission's secrecy around its Covid-19 vaccine contracts with pharmaceutical companies and the negotiations that shaped these contracts. This inquiry was sparked by complaints filed by Corporate Europe Observatory (CEO) against the Commission's handling of this Freedom of Information (FOI) request, as well as a second FOI request for the disclosure of the Commission's contract with AstraZeneca.

ve_sante.c.3(SANTE), Secretariat General of the European Commission

2 Attachments

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    List of Documents Gestdem 2020 5436 and GestDem 2021 0559 FINAL 5.pdf

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    Reply Gestdem 2020 5436 and GestDem 2021 0559 1 4 4.pdf

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Dear Mr Hoedeman,

Please find attached document Ares(2021)1844668 from GALLINA Sandra (SANTE) dated 15/03/2021.

Best regards,
SANTE C3 Secretariat

Olivier Hoedeman left an annotation ()

On June 3rd, CEO wrote to Sandra Gallina (Director-General for Health and Food Safety in the European Commission) to inquire about the Commission’s lack of follow-up on transparency promises made in the context of the European Ombudsman’s inquiry on public access to documents concerning the purchase of vaccines against COVID-19. The letter is online here: https://corporateeurope.org/sites/defaul...

SANTE ACCESS TO DOCUMENTS, Secretariat General of the European Commission

76 Attachments

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    81 Agenda SB Meeting 31 December 2020 Ares 2021 638026.pdf

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    21 Email SB Meeting 19 August 2020 Ares 2020 6522258 Redacted.pdf

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    77 1 Email SB Meeting 23 December 2020 Ares 2020 7896014 Redacted.pdf

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    15 1 Email SB Meeting 7 August 2020 Ares 2020 6522149 Redacted.pdf

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    25 1 Email SB meeting 28 August 2020 Ares 2020 6522316 Redacted.pdf

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    49 1 Email SB 23 October 2020 Ares 2020 6522867 Redacted.pdf

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    63 1 Email SB meeting 20 November 2020 Ares 2020 6958024 Redacted.pdf

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    51 2 Declaration of absence of conflict SB Metting 30 October Ares 2020 6546874.pdf

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    168 1 Notification Letter sent to PfizerBNT informing of the outcome of the award procedure Ares 2021 433162.pdf

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    168 Notification Letter sent to PfizerBNT informing of the outcome of the award procedure Ares 2021 433162.pdf

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    47 1 Email SB meeting 16 October 2020 Ares 2020 6522756 Redacted.pdf

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    63 Agenda SB meeting 20 November 2020 Ares 2020 6958024.pdf

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    13 1 Email SB Meeting 31 July 2020 Ares 2020 6522121 Redacted.pdf

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    87 1 Email SB meeting 08 January 2021 Ares 2021 638066 Redacted.pdf

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    147 2 BioNTech Pfizer Expression of Interest summary by DE Ares 2021 36708.pdf

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    151 6 Draft Indemnification clause BioNTech Pfizer sent to DE Ares 2021 42400.pdf

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    150 5 BioNTech Pfizer COVID19 Vaccine information BNTPFE Ares 2021 42169.pdf

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    149 4 BioNTech Pfizer EoI to the Commission Ares 2021 41184.pdf

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    71 Agenda SB meeting 11 December 2020 Ares 2020 7726309.pdf

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    148 3 Reply to BioNTech Pfizer EoI by the Commission Ares 2021 40997.pdf

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    53 Agenda SB Meeting 06 November 2020 Ares 2020 6549469.pdf

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    153 8 Pfizer BioNTech Indemnification Clause Discussion Ares 2021 43131.pdf

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    59 1 Email SB meeting 13 November 2020 Ares 2020 6685168 Redacted.pdf

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    152 7 Draft TermSheet BioNTech Pfizer Vaccines from DE Ares 2021 42905.pdf

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    49 2 Declaration of absence of conflict Email SB meeting 23 October 2020 Ares 2020 6522867.pdf

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    43 Agenda SB meeting 09 October 2020 Ares 2020 6522618.pdf

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    161 Answer to question 1 in scope of Invitation to tender for procedure SANTE 2020C3043 BN Pfizer Ares 2020 5095180.pdf

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    A List of Documents Gestdem 2020 5436 and GestDem 2021 0559 FINAL 5 xlsx.pdf

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Dear Sir,

Please find attached to this reply the first batch of documents concerning your access to documents requests GESTDEM 2020/5436 and GESTDEM 2021/0559.

Kind regards,
SANTE ACCESS TO DOCUMENTS

Olivier Hoedeman left an annotation ()

ON June 25th, DG SANTE wrote:

"We would like to inform you that, following the note sent to you on 8th June (Ref. Ares(2021)3769005), DG SANTE completed the assessment of a second batch of documents which have been submitted last week to other Commission's services for consultation.

DG SANTE internal assessment of a third batch of documents is also finalised and ready to be sent to other Commission's services for consultation.

We expect to be able to send you a second reply to your access to documents requests registered under GESTDEM 2020/5436 and GESTDEM 2021/0559 in the course of the following weeks.

We would like to apologise again for the delay."

On October 28th, CEO wrote:

"Dear SANTE ACCESS TO DOCUMENTS,

In June you mentioned that a second reply (presumably with more
documents released) would reach me "in the course of the following weeks".

That is now 4 months ago. Could you inform me why this major delay has occurred and when I can expect the second reply?

Yours sincerely,

Olivier Hoedeman
on behalf of Corporate Europe Observatory (CEO)"

HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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    Fair solution proposal GESTDEM 2020 5436 and GESTDEM 2021 0559.pdf

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Dear Mr. Hoedeman,

In reference to your request, please find attached document Ares(2022)117753 from Mr. Wolfgang Philipp, Director (acting) - Deputy Head of HERA, dated 07/01/2021.

Best regards,

HERA Secretariat

Olivier Hoedeman left an annotation ()

Subject: reply to proposal for a 'fair solution
Date: Thu, 20 Jan 2022 17:25:11 +0100
From: Olivier Hoedeman <olivier@corporateeurope.org>
To: HERA-CONSULT-04@ec.europa.eu

Dear Wolfgang Philipp (Acting Deputy Head of HERA),

Thank you for your letter (HERA/KB(2021)8858418) regarding our application for access to documents (GESTDEM2020/5436 and GESTDEM 2021/0559). In your letter you inform us that the application “has now been assigned to the newly established European Health Emergency Preparedness and Response authority (‘HERA’)”. You also make a proposal for a 'fair solution' which is to reduce the scope of our request " to 125 documents out of the 365 documents initially identified". Your suggestion is to grant access "to documents such as agenda, emails, minutes of the Steering Board meetings, and final contracts".

I am afraid we cannot accept the proposal, for the following reasons:

- limiting the scope to cover only documents related to Steering Board meetings and final contracts is seriously at odds with our original request which was for all reports from meetings with pharmaceutical companies and correspondence with these companies about the Advance Purchases Agreements.

- limiting the scope this way is a major step back from what the European Commission has promised the European Ombudsman in the context of the Ombudsman's inquiry last spring (joint cases 85/2021/MIG and 86/2021/MIG). The Ombudsman's decision to close the inquiry was based on the assumption that the Commission would "continue these efforts to deal with the complainant’s access requests promptly and to make swiftly available as many documents as it deems possible, including on its website."

- it is also a major step back compared to was disclosed in the first batch of 80 documents released by DG SANTE in June. This batch included (redacted) correspondence with pharma companies. In your new proposal you appear to want to exclude this from disclosure from now on.

- on June 25th, DG SANTE informed us by email that they had “completed the assessment of a second batch of documents which have been submitted last week to other Commission's services for consultation. DG SANTE internal assessment of a third batch of documents is also finalised and ready to be sent to other Commission's services for consultation. We expect to be able to send you a second reply to your access to documents requests registered under GESTDEM 2020/5436 and GESTDEM 2021/0559 in the course of the following weeks." Unfortunately this second reply has never reached us.
Now, more than six months later, HERA is making a very different proposal, severely limiting the scope of what would be disclosed. The proposal looks like a u-turn compared to previous transparency promises. You refer to “the principle of proportionality” and limiting the work load, but from DG SANTE’s email of June 25th it is clear that the work on assessing at least two other bathes of documents has already been done as this had been sent to other Commission's services for consultation.

I have in December submitted a complaint to the European Ombudsman about the Commission’s failure to fulfil its transparency promises and I will now await the investigation into these matters.

Yours sincerely,
Olivier Hoedeman
on behalf of Corporate Europe Observatory (CEO)

HERA-ACCESS-TO-DOCUMENTS@ec.europa.eu, Secretariat General of the European Commission

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    Reply to Ares 2022 597471 Fair solution proposal GESTDEM 2020 5436 and GESTDEM 2021 0559.pdf

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From: HERA ACCESS TO DOCUMENTS <[email address]>
Sent: Friday, February 4, 2022 9:56 AM
To: hoedeman olivier (CORPORATE EUROPE OBSERVATORY)
<[email address]>
Subject: [Re] reply to proposal for a 'fair solution - Ares(2022)821458

 

 

HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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    26 SB Minutes 28 August 2020 Redacted s.pdf

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    A List of Documents pdf.pdf

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    31 Email SB Agenda 11 September 2020 Redacted s.pdf

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    61 email Steering Board meeting 18 November 2020 Agenda CureVac Redacted s.pdf

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    33 Email Agenda 17 September 2020 Redacted s.pdf

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    62 and 64 and 66 SB Minutes 18 20 24 November 2020 Redacted s.pdf

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    07 Email Agenda SB 10 July 2020 Redacted s.pdf

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    04 Second meeting of the Steering Board 29 June 2020 Minutes Redacted s.pdf

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    1 2 Declaration of absence of conflict Email SB Meeting 18 September 2020.pdf

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    List of Documents Gestdem 2020 5436 nd GestDem 2021 559 II and III batch FINAL.pdf

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    84 and 86 SB Minutes 04 january and 06 January 20201 Redacted s.pdf

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    02 Minutes of the First virtual meeting of the Steering Board 18 June 2020 Redacted s.pdf

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Dear Sir/Madam,

Please find enclosed the reply to your access to documents requests 2020/5436 and 2021/0559.

Best regards,

Access to documents team

HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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    175 APA with Janssen Pharmaceutica 21 10 2020.pdf

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    List of Documents Gestdem 2020 5436 nd GestDem 2021 559 II and III batch FINAL.pdf

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    174 APA with BioNTech Pfizer 17 12 2020.pdf

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HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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    366 SB Minutes 15 January 2021 Redacted s.pdf

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    381 1st Amendment to PA with Moderna 27 06 2021.pdf

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    382 2nd Amendment to PA with Moderna 19 03 2021.pdf

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    379 1st PA with BioNTech Pfizer 17 02 2021 Redacted s.pdf

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HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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    113 2 Annex Confidentiality SB Meeting 25 September 2020 NO REDACTION s ok.pdf

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    108 Scientific Update by AstraZeneca Representatives Safety and efficacy 15 December 2020 Redacted s.pdf

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    94 Scientific Update by CureVac Representatives 3 November 2020 Report and Presentation Redacted s.pdf

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    List of documents 4th Batch merged 30 May.pdf

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    107 European Commission s advisory panel on COVID 19 Invitation letter and report videoconference 20072020 Ares 2021 1077274 v6 Redacted s ok.pdf

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    92 Scientific Update by Sanofi Pasteur Representatives 17 December 2020 Report and Presentation v1 2 Redacted s.pdf

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    103 Steering Board Meeting with Experts from the Scientific Board of France Spain and the Netherlands 27 July 2020 Report of the meeting Redacted s.pdf

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    93 Scientific Update by CureVac Representatives 17 November 2020 Pre Clinical and Clinical Development Data Update Report and Presentation Redacted s.pdf

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    116 1 Draft APA negotiated between AstraZeneca and EvaluationCommittee on 13 08 20 2 email 2 Redacted s ok.pdf

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    99 Scientific Presentation by Johnson Johnson Representatives 4 September 2020 Report and Presentation Redacted s.pdf

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    100 Scientific Presentation by CureVac Representatives 28 August 2020 Report and Presentation Redacted s.pdf

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    107 2 European Commission s advisory panel on COVID 19 Report videoconference 20072020 Redacted s.pdf

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    Partially positive fourth batch 2020 5436 and 2021 0559 FINAL 2022 4349699.pdf

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    107 1 European Commission s advisory panel on COVID 19 Invitation letter Redacted s.pdf

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    98 Scientific Presentation by Sanofi GSK Representatives 9 September 2020 Report and Presentation Redacted s.pdf

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    97 Scientific Presentation by CureVac Representatives 28 September 2020 Report and Presentation Redacted s.pdf

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    96 Follow up Discussion to the Scientific Presentation by CureVac Representatives 7 October 2020 Redacted s.pdf

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    91 Scientific Presentation by AstraZeneca Representatives 5 August 2020 Report and Presentation SAURE II v2 Redacted s.pdf

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HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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    136 follow up questionnaire sent to Astra Zeneca Redacted s.pdf

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    180 Draft Advanced Purchase Agreement negotiated between J J and the Evaluation Committee 28 09 2020 2 Redacted s ok.pdf

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    179 Draft Advanced Purchase Agreement negotiated between J J and the Evaluation Committee 25 09 2020 2 Redacted s ok.pdf

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    117 1 AstraZeneca COVID 19 Vaccine Update on developments sent to the European Commission email rtf Redacted s ok.pdf

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    165 CALL FOR TENDERS SANTE2020C3043 OFFER email 2 of 3 ARES 2021 340593 redacted s.pdf

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    163 Tender submission in 3 emails ARES 2021 340523 redacted s.pdf

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    137 skype meeting with Astra Zeneca 14052020 vaccines Redacted s.pdf

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    136 1 Email follow up questionnaire sent to Astra Zeneca Redacted s.pdf

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    118 AW Draft Term Sheet for Supply of AstraZeneca COVID 19 vaccine AZD 1222 in Europe com E mail 2 Redacted s ok.pdf

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    117 AstraZeneca COVID 19 Vaccine Update on developments sent to the European Commission Redacted s ok.pdf

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    186 Jansen J J COVID 19 vaccine proposal to the EC 1 call 6 05 2020 2 Redacted s ok.pdf

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    133 1 Commission IR 2021111 of 29 Jan 2021 Regulation.pdf

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    185 Jansen J J response to the questionnaire consulted 200506 JVx COVID19 vaccine EC final CLEAN 2 Redacted s ok.pdf

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    133 Commission IR 2021111 of 29 Jan 2021 Redacted s.pdf

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    185 1 Jansen J J response to the questionnaire 2 Redacted s ok.pdf

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    188 6 Jansen J J COVID 19 vaccine proposal to the EC 3 call 10 06 2020 Redacted s.pdf

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    187 email 5 Janssen J J COVID 19 vaccine proposal to the EC 2 Redacted s.pdf

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    126 Call for tenders SANTE2020C3037.pdf

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    183 Draft APA negotiated between J J and the Evaluation Committee technical 06 10 2020 rep 2 Redacted s ok.pdf

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    122 RE Draft Term Sheet for Supply of AstraZeneca COVID 19 vaccine AZD 1222 in Europe comments JNT 3 FR Redacted s ok.pdf

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    182 Draft APA negotiated between J J and the Evaluation Committee technical 02 10 2020 2 Redacted s ok.pdf

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    126 1 Call for tenders SANTE2020C3037 for the development production priority purchasing options and supply Redacted s ok.pdf

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    126 Call for tenders SANTE2020C3037 for the development production priority purchasing options and supply email rtf Redacted s ok.pdf

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    184 Janssen J J Expression of Intrest to the EC re COVID 19 vaccine 2 Redacted s ok.pdf

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    121 Re URGENT info about suspension of clinical trials for COVID 19 vaccine email Redacted s ok.pdf

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HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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HERA ACCESS TO DOCUMENTS, Secretariat General of the European Commission

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Sg-Acc-Doc@ec.europa.eu, Secretariat General of the European Commission

2 Attachments

Dear Sir,

 

Please find attached an advance copy of the reply to your confirmatory
request for access to documents registered under the number GESTDEM
2020/5436.

 

Yours faithfully,

 

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

 

 

References

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