DG SANTE contacts with industry re. Supplementary Protection Certificates (SPCs) manufacturing waiver

Rachel Tansey made this access to documents request to Health and Food Safety

The request was successful.

From: Rachel Tansey

Delivered

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:

(i) a list of meetings of DG SANTE officials and/or representatives (including the Commissioner and her Cabinet) and representatives of individual companies and/or industry federations (such as, but not limited to, EFPIA and/or its member companies); consultancies or law firms acting for companies/industry groups; and/or, patients groups, at which a manufacturing waiver for Supplementary Protection Certificates (SPCs) was discussed (since June 2016);

(ii) minutes and other reports of these meetings;

(iii) all correspondence (including emails) between DG SANTE officials and/or representatives (including the Commissioner and Cabinet) and representatives of companies and/or industry associations (including consultancies/law firms acting on their behalf), or patients groups, in which a manufacturing waiver for Supplementary Protection Certificates (SPCs) was discussed (since June 2016).

I would be grateful if you could take the Code of Good Administrative Behaviour into account when considering (i) of this request.

Yours sincerely,

Rachel Tansey

Postal Address:
Corporate Europe Observatory
Rue d'Edimbourg 26
1050 Brussels
Belgium

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Health and Food Safety

 

 

Dear Mr Tansey,

 

Thank you for your e-mail dated 12/10/2018.  We hereby acknowledge receipt
of your application for access to documents, which was registered on
15/10/2018 under reference number GestDem 2018/5417.

 

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
07/11/2018. In case this time limit needs to be extended, you will be
informed in due course.

 

Yours faithfully,

 

ACCESS TO DOCUMNETS

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Health and Food Safety

 

Dear Mr Tansey,

 

Thank you for your e-mail dated 12/10/2018.  We hereby acknowledge receipt
of your application for access to documents, which was registered on
15/10/2018 under reference number GestDem 2018/5418.

 

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
07/11/2018. In case this time limit needs to be extended, you will be
informed in due course.

 

Yours faithfully,

 

ACCESS TO DOCUMNETS

 

 

 

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Health and Food Safety


Attachment image001.gif
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Dear Ms Tansey,

 

We refer to your message dated 12/10/2018  in which you make a request for
access to documents, registered on 15/10/2018 under the above mentioned
reference number.

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 on 07/11/2018.

An extended time limit is needed as your application as 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 28/11/2018.

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

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Health and Food Safety


Attachment ATT39215 1.jpg
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Attachment Ares 2018 5814787.pdf
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Our reference: Ares(2018)5814787
 
Dear Ms Tansey,
 
Please find attached a letter on the above mentioned subject.
 
Kindly note that this is transmitted by e-mail only.
 
Kind regards,
 
 
Unit “Medicines: policy, authorisation and monitoring“
 
European Commission
DG Health and Food Safety

show quoted sections

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Health and Food Safety


Attachment ATT51384 2.jpg
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Attachment Ares 2018 5814787.pdf
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Dear Ms Tansey,
 
Further to our letter below concerning your application for access to
documents (Ref. GestDem N° 2018/5418), we are writing to inform you that a
reply has been prepared but still needs to go through the administrative
procedure for signature.
 
Thank you in advance for your understanding.
 
Best regards,
 
Unit “Medicines: policy, authorisation and monitoring“
 
European Commission
DG Health and Food Safety

show quoted sections

From: SANTE PHARMACEUTICALS B5
Sent: Wednesday, November 14, 2018 3:47 PM
To: '[FOI #6014 email]'
<[FOI #6014 email]>
Subject: Your application for access to documents - Ref GestDem N°
2018/5418
 
 
Our reference: Ares(2018)5814787
 
Dear Ms Tansey,
 
Please find attached a letter on the above mentioned subject.
 
Kindly note that this is transmitted by e-mail only.
 
Kind regards,
 
 
Unit “Medicines: policy, authorisation and monitoring“
 
European Commission
DG Health and Food Safety
_____________
This message represents solely the views of its author and cannot be
regarded as the official position of the Commission. It is intended solely
for the person to whom it is addressed and may contain confidential
information. If you have received this message in error, please notify me
as soon as possible.
 
 
 
 
 
 
 
 
 

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Health and Food Safety


Attachment ATT09031 1.jpg
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Attachment Ares 2018 6219530.pdf
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Attachment Ares 2018 6219530 1.pdf
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Attachment Ares 2018 6219530 2.pdf
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Our reference: Ares(2018)6219530
 
Dear Ms Tansey,
 
Please find attached a letter and its annexes on the above mentioned
subject.
 
 
Kindly note that the original of the letter will be sent by post.
 
Kind regards,
 
 
Unit “Medicines: policy, authorisation and monitoring“
 
European Commission
DG Health and Food Safety

show quoted sections

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From: Rachel Tansey

Delivered

Dear Health and Food Safety,

Thank you for your reply, and for the documents that have been sent so far. I look forward to receiving the final part of my request in due course.

Yours sincerely,

Rachel Tansey

Link to this

Health and Food Safety


Attachment image002.jpg
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Attachment Annex I List of documents.xls.pdf
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Attachment Annex II attachment 2.docx.pdf
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Attachment Annex II attachment1.pdf.pdf
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Attachment Annex II email.pdf.pdf
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Attachment Annex III attach 3.pdf.pdf
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Attachment Annex III attachement 1.pdf.pdf
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Attachment Annex III.pdf.pdf
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Attachment Annex V attachment.pdf.pdf
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Attachment Annex VI.pdf.pdf
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Attachment Second partial reply.doc.pdf
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Our reference: Ares(2018)6622688

 

Dear Ms Tansey,

 

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

 

Kindly note that the original of the letter will be sent by post.

 

Kind regards,

 

 

Unit “Medicines: policy, authorisation and monitoring“

 

European Commission

DG Health and Food Safety

show quoted sections

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From: Rachel Tansey

Delivered

Dear Health and Food Safety,

Thank you for the second part of your reply to my request Ref GestDem 2018/5418.

I have noticed that there appears to be several documents missing from your response.

In your letter, you state "Please find in annex I the list of all correspondence related to point iii) of your request for access to documents, and in Annex II, III, IV, V and VI the corresponding documents." I did not, however, receive an Annex IV. According to the List of Documents you provided (Annex I) this should be No. 3 "Email from DG SANTE Services to EUCOPE, 05-04-2018, Ares(2018)182597".

Additionally, in the List of Documents (Annex 1), No. 2 refers to "Email from EUCOPE to DG SANTE Services, Unit B5 and 3 attachments 04-04-2018. Ares(2018)179555" - however I received only two attachments ("Annex III attachement 1" and "Annex III attach 3").

Finally, in the List of Documents (Annex 1), No. 4 refers to"Email from the European Biopharmaceutical Entreprises to DG SANTE and attachments, 18-09-2018, Ares(2018)4980497", but I received only "Annex V attachment" ie not the actual email, Annex V.

Please could you send the missing documents detailed above as soon as possible?

Many thanks,

Rachel Tansey

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Health and Food Safety


Attachment Annex III attach 2.pdf
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Attachment Annex IV.pdf
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Attachment Annex V.pdf
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Dear Ms Tansey,

Please find attached the documents that were missing when sending the reply in December.

Best regards,
SANTE ACCESS TO DOCUMENTS

show quoted sections

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From: Rachel Tansey

Delivered

Dear Health and Food Safety,

Thank you very much for sending the missing three documents.

Yours sincerely,

Rachel Tansey

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Health and Food Safety


Attachment ATT51187 1.jpg
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Attachment 2 more articles to CE.pdf.pdf
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Attachment Annex I List of documents.xls
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Attachment BAYER.pdf.pdf
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Attachment EUROPABIO.pdf.pdf
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Attachment Fw Names of experts to be consulted during the study.pdf.pdf
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Attachment Fwd Prof.Redacted.pdf.pdf
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Attachment GILEAD.pdf.pdf
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Attachment List of interviews 30OCT17 Redacted.pdf.pdf
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Attachment Re CE must interview Redacted.pdf.pdf
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Attachment Re Kind reminder Update on the incentives review.pdf.pdf
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Attachment Re Prescrire s contribution on orphan drugs for SPC study.pdf.pdf
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Attachment Re Update on study Redacted.pdf.pdf
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Attachment Re When can we please talk.pdf.pdf
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Attachment Reply to ESIP.pdf.pdf
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Attachment Updated case study on Gilead s SPC covering TRUVADA in France.pdf.pdf
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Attachment Ares 2019 1054188.pdf
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Our reference: Ares(2019)1054188
 
Dear Ms Tansey,
 
Please find attached a letter and its annexes on the above mentioned
subject.
 
Kindly note that the original of the letter will be sent by post.
 
Kind regards,
 
Unit “Medicines: policy, authorisation and monitoring“
 
European Commission
DG Health and Food Safety

show quoted sections

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