COVID-19 Advance Purchase Agreements (vaccine deal contracts)

Response to this request is long overdue. By law, under all circumstances, Secretariat General of the European Commission should have responded by now (details). You can complain by requesting an internal review.

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 contracts with AstraZeneca and other pharmaceutical companies about the purchase of potential vaccines against COVID-19 (Advance Purchase Agreements, APAs).

There is a clear public interest in disclosure of these contracts. 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, but also in the vaccines themselves.

Blanket confidentiality cannot be the rule for the covid19 contracts. Price and other sorts of confidentiality covering commercial aspects of these contracts cannot preclude transparency around 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 even stronger.

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

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)4819251 - RE: access to documents request - COVID-19 Advance
Purchase Agreements (vaccine deal contracts) --- Ref. Gestdem 2020/5437

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 2020/5437.

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
Privacy statement – access to documents.

Yours faithfully,
Access to Documents Team (rc

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

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

1 Attachment

Dear Mr Hoedeman,

Please find attached document Ares(2020)6159174 from GALLINA Sandra (SANTE) dated 30/10/2020.

Kind regards,
SANTE ACCESS TO DOCUMENTS

Dear Secretariat General of the European Commission,

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

I am filing the following confirmatory application with regards to our access to documents request 'COVID-19 Advance Purchase Agreements (vaccine deal contracts)', which was registered on 15/09/2020 under reference number GESTDEM 2020/5437.

Our access to documents request asked for disclosure of “all contracts with AstraZeneca and other pharmaceutical companies about the purchase of potential vaccines against COVID-19 (AdvancePurchase Agreements, APAs).”

In the Commission’s response, Director-General Sandra Gallina mentions that one document has been identified (“Advance purchase agreement signed between European Commission and Astra Zeneca”) and states that “no access can be granted to the requested document” because it “contains information relative to the commercial interests of AstraZeneca”. This, Ms Gallina argues, “could potentially damage the competitive position of the company and the procurement procedures ongoing for the purchase of COVID-19 vaccines if they were made public.”

The Commission rejects that there is an overriding public interest: “After examining your arguments,we do not find that they amount to the identification of a public interest capable of overriding the interest protected by the first paragraph of Article 4(2) of Regulation (EC) No 1049/2001” (protection of AstraZeneca’s commercial interests). The Commission’s response does not contain any information about how the Commission examined our arguments and why these arguments were disregarded. We disagree with the claim that there isn't an overriding public interest in disclosure, a public interest that outweighs the commercial interests of the pharma company. We had referred to numerous examples of this overriding public interest in our FOI request and we do not feel the Commission has seriously addressed our arguments. We therefore ask the Commission to re-assess its decision.

Rather than simply rejecting access to the document as a whole, we would like to ask the Commission to assess which parts of the document can be disclosed. We believe that the Commission must be able to disclose large parts of the contract, with only those parts of the text redacted that contain genuine commercial secrets. In other words we ask the Commission to assess the text of the contract to identify which parts can and should be disclosed in order to respect the public interest in disclosure. Granting partial access is very common in responses to FOI requests. We believe this is the correct way to strike the right balance in terms of the public interest in disclosure versus the protection of commercial interests.

We remind you that Members of the European Parliament have repeatedly asked for more transparency of the Commission’s vaccine deals. MEP Pascal Canfin has on behalf of the European Parliament’s ENVI committee called for five key pieces of information public to be made public:
- the cost structure and price of each vaccine
- the production locations
- the intellectual property arrangements, including non-exclusive labeling
- the liability and indemnification agreements
- agreements regarding access to the vaccines.

Ms Gallina has at several meetings with the ENVI committee underlined the importance of transparency. The blanket rejection of our access to documents request is clearly at odds with these statements. If commercial aspects of the deals cannot be disclosed, confidentiality cannot preclude the publication of sensitive provisions that have patient safety and public health implications such as the liability provisions. If full disclosure is not possible, partial disclosure should be.

We would like to restate our arguments outlining why there is a clear public interest in disclosure of these contracts. We would appreciate the Commission’s explanation of why it would not consider each of these arguments to be sufficient to allow partial disclosure of the contract. We would also appreciate to be informed about any other transparency initiatives the Commission will undertake to enable public and/or parliamentary scrutiny of the Advance Purchase Agreements and when these measures will be put in place.

Our arguments outlined in the access to documents request were as follows:
* 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, but also in the vaccines themselves.
* Blanket confidentiality cannot be the rule for the covid19 contracts. Price and other sorts of confidentiality covering commercial aspects of these contracts cannot preclude transparency around 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 fromusual 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 even stronger.

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

Yours faithfully,

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

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)6641059 - RE: Internal review of access to documents request
- COVID-19 Advance Purchase Agreements (vaccine deal contracts)

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 12/11/2020 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 2020/5437.

We hereby acknowledge receipt of your confirmatory application for access
to documents which was registered on 12/11/2020 (Ares(2020)6640864).

Your application will be handled within 15 working days (03/12/2020). 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

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)7310986 - Your confirmatory application for access to
documents under Regulation (EC) No 1049/2001 - GESTDEM 2020/5437 - 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  12 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 3 December 2020. The new deadline
expires on 4 January 2021.

 

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

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1. file:///tmp/cid:filelist.xml@01D6C985.7E3871B0
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/foiextract20201203-22088-5yw6je#_ftn1
8. file:///tmp/foiextract20201203-22088-5yw6je#_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(2021)159167 - Your confirmatory application for access to
documents under Regulation (EC) No 1049/2001 – GESTDEM 2020/5437

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  12 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 3 December
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 request
within the prescribed time limit which expires on 4 January 2021.

 

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@01D6E5AC.1CFDA990
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/foiextract20210108-19224-1sbigig#_ftn1
8. file:///tmp/foiextract20210108-19224-1sbigig#_ftnref1

Dear Secretariat-General (SG),

on January 4th you informed us that "internal consultations are still ongoing" regarding our confirmatory application regarding our access to documents request GESTDEM 2020/5437 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."

Our access to documents request for the EU's covid-19 vaccine contracts was submitted on September 15th; on November 12th we appealed the Commission's blanket rejection of our request. In our confirmatory application we stressed that there is a clear overriding public interest in disclosure of those parts of the contracts that have patient safety and public health implications. If full disclosure of the contracts is not possible, partial disclosure should be. Since then the Commission twice missed the deadline for responding and now you have announced another delay, this time indefinite, without any specific explanation or justification. This is approach is at odds with the Commission's obligations under Regulation 1049/2001 and its overall duty to be as transparent as possible.

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 4th 2020, the European Commission posted a response to our confirmatory application (arguing that they were not able to respond in time for the deadline that day, announcing a further delay without a new deadline), but unfortunately this was wrongly posted under a different FOI request: https://www.asktheeu.org/en/request/sust...

We have asked the Commission to correct this.

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 focused on documents related to the vaccine negotiations (including notes of meetings and correspondence as well as the names of the members of the Joint Negotiation Team).