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; (ii) minutes or other reports of those meetings; and (iii) all correspondence (including emails) between DG SANTE officials/representatives and private companies, industry associations, consultancies or law firms acting on their behalf, or patients groups, pertaining to the “Study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe” conducted by Copenhagen Economics. The scope of this request should be considered to concern the period between April 2017 and May 2018.

In addition, I would like to request (iv) a list of the stakeholders that Copenhagen Economics interviewed in the preparation of its study (cf. page 11 of the study’s Executive Summary refers to “more than 20 interviews with stakeholders” being conducted).

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

Yours sincerely,

Rachel Tansey

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

Dear Health and Food Safety,

Please could you confirm your acknowledgement of my request sent on 12th October 2018 concerning contacts between DG SANTE and industry representatives around the pharmaceuticals incentives and rewards review conducted by Copenhagen Economics? I sent three requests to DG SANTE on that date, via the asktheeu.org platform, and have received two acknowledgements (registered under GestDem 2018/5417 and GestDem 2018/5418), which both appeared to be in reply to my request concerning SANTE-industry contacts around the SPC waiver. As a result, it appears I have had two out of three of my requests acknowledged, but not the third.

I therefore kindly ask you to confirm if this request, concerning contacts between DG SANTE and industry representatives around the pharma incentives review is currently being handled.

Yours faithfully,

Rachel Tansey

Santé et sécurité alimentaire

Dear Ms Tansey,

Thank you for your message dated 2 November 2018.

We can confirm that we have indeed received three requests from you on 12 October 2018.

Your request related to the EU regulation on Health Technology Assessment was registered on 15 October 2018 under the reference number GestDem 2018/5417.
Your request related to manufacturing waivers for Supplementary Protection Certificates was registered on 15 October 2018 under the reference number GestDem 2018/5418.

Due to an administrative mistake, your request related to the "Study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe", which we had also received on 12 October 2018, had not yet been formally registered. This error has been corrected. We can now inform you that your request on the above-mentioned study has been registered under the reference GestDem 2018/5864.

The same extended deadline (i.e. 28 November 2018) applies to all three requests (GestDem 2018/5417, 2018/5418 and 2018/5864).

Kind regards,

SANTE ACCESS TO DOCUMENTS

European Commission
DG Health and Food Safety (SANTE)
Email: [DG SANTE request email]

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Dear Health and Food Safety,

Many thanks for your reply and clarification.

I look forward to hearing from you in due course.

Yours faithfully,

Rachel Tansey

Santé et sécurité alimentaire

Dear Madam,
We refer to your message of 12 October 2018 in which you make a request for access to documents, registered on 8/11/2018 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 expired on 28/11/2018.
An extended time limit is needed as your application part of 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 19/12/2018.

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

Yours faithfully,

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Santé et sécurité alimentaire

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Dear Ms Tansey,

 

Further to the email below concerning your application for access to
documents (Ref. GestDem N° 2018/5864), 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

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Dear Health and Food Safety,

Thank you for your reply of 20 December 2018, in which you noted that a reply to my request (Ref. GestDem N° 2018/5864), had been prepared but still needed to go through the administrative procedure for signature.

Please could you let me know if this reply is now ready, and when I can expect to receive it?

Many thanks.

Yours faithfully,

Rachel Tansey

Santé et sécurité alimentaire

6 Attachments

 
 
 
Our reference: Ares(2019)377993
 
Dear Ms Tansey,
 
Please find attached a letter and its annexes on the above mentioned
subject.
 
Kind regards,
 
Unit “Medicines: policy, authorisation and monitoring“
 
European Commission
DG Health and Food Safety

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Dear Health and Food Safety,

Thank you for your partial reply to my request GestDem 2018/5864, covering parts i) and ii) of my request.
Please could you give me an update of when I can expect your reply to part iii)?

Many thanks.

Yours faithfully,

Rachel Tansey

Dear Health and Food Safety,

With regard to my email of 29 January 2019, over two weeks ago, requesting an update re. when I can expect the reply to part iii) of my request GestDem 2018/5864, I would hereby like to reiterate this request, and ask that your response be treated as a matter of some urgency.

I would also like to point out that my request GestDem 2018/5864 was tabled on 12 October 2018, over four months ago. The European Ombudsman, Emily O'Reilly, has stated that “Citizens need to try access documents while they are still relevant. Information delayed is information denied”. I would therefore like to politely inform you that if I do not hear from you within one week, regarding the second half of your reply to my request GestDem 2018/5864, I will be making a complaint to the European Ombudsman. The Ombudsman's 'fast-track' complaint procedure for access to documents requests includes the provision for complaints to be made in face of delays by EU institutions in releasing documents.

I very much hope to hear from you promptly, and look forward to your response.

Yours sincerely,

Rachel Tansey

Sent: 29/01/19
Dear Health and Food Safety,

Thank you for your partial reply to my request GestDem 2018/5864, covering parts i) and ii) of my request.
Please could you give me an update of when I can expect your reply to part iii)?

Many thanks.

Yours faithfully,

Rachel Tansey

Santé et sécurité alimentaire

1 Attachment

 

Dear Ms Tansey,

 

Thank you for your email. Your request has been processed and we apologize
for the delay to sending you the remaining part of the documents.

 

We can ensure that you will receive them as soon as possible and within a
week time.

 

Yours faithfully,

 

SANTE ACCESS TO DOCUMENTS

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

 

 

 

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Dear Health and Food Safety,

Thank you for your email. I very much appreciate your assurance that I will receive the remaining documents as soon as possible and within a weeks time.

Yours faithfully,

Rachel Tansey

Rachel Tansey a laissé une remarque ()

The response to this request GestDem 2018/5864 is at https://www.asktheeu.org/en/request/dg_s... dated February 20, 2019