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 his 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 the plans for an EU regulation on Health Technology Assessment (HTA) were discussed (since January 2017);

(ii) minutes and other reports of these meetings;

(iii) all correspondence (including emails) between DG SANTE officials and/or representatives (including the Commissioner and his Cabinet) and representatives of companies and/or industry associations (including consultancies/law firms acting on their behalf), or patients groups, in which the plans for an EU regulation on Health Technology Assessment were discussed (since January 2017).

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

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 HTA file? 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 HTA file, is currently being handled.

Yours faithfully,

Rachel Tansey

Santé et sécurité alimentaire

3 Attachments

Dear Ms Tansey,

 

Please find enclosed an advance copy of our reply letter to your request
for access to documents that was registered under the reference GestDem
2018/5417.

 

The original signed letter will be sent to you by registered mail with
acknowledgement of receipt.

 

The annexes are sent to you by email only.

 

Kind regards,

 

 

HTA Secretariat
[1]cid:image001.png@01D1E29C.515F9850

European Commission
Directorate-General for Health and Food Safety – DG SANTE

Unit B4 – Medical products: safety, quality, innovation

Rue Froissart 101, 09/43

B-1049 Brussels/Belgium

 

References

Visible links

Dear Health and Food Safety,

Thank you for your response to parts i) and ii) of my request. In your reply letter of 29 November 2019, you stated that "As soon as the consultations have been concluded, you will receive a second reply letter containing the assessment of the documents identified under the scope of part (iii.) of your request." I would like to inquire when I can expect your second reply letter and documents relating to part iii) of my request?

Since my original request (GestDem 2018/5417) was submitted on 12 October 2018, nearly three months ago, I'd kindly ask you to consider this matter with some urgency.

I look forward to hearing from you.

Yours faithfully,

Rachel Tansey

Santé et sécurité alimentaire

3 Attachments

Dear Ms Tansey,

 

Please find enclosed an advance copy of our second reply to your request
for access to documents that was registered under the reference GestDem
2018/5417.

 

The original signed letter will be sent to you by registered mail with
acknowledgement of receipt.

 

The annexes are sent to you by email only. Due to the high volume of
documents, we will send you the annexes in separate emails.

 

Kind regards,

 

 

HTA Secretariat
[1]cid:image001.png@01D1E29C.515F9850

European Commission
Directorate-General for Health and Food Safety – DG SANTE

Unit B4 – Medical products: safety, quality, innovation

Rue Froissart 101, 09/43

B-1049 Brussels/Belgium

References

Visible links

Santé et sécurité alimentaire

2 Attachments

Dear Ms Tansey,

 

Please find attached the first batch of documents.

 

Kind regards,

 

 

HTA Secretariat
[1]cid:image001.png@01D1E29C.515F9850

European Commission
Directorate-General for Health and Food Safety – DG SANTE

Unit B4 – Medical products: safety, quality, innovation

Rue Froissart 101, 09/43

B-1049 Brussels/Belgium

References

Visible links

Santé et sécurité alimentaire

2 Attachments

Dear Ms Tansey,

 

Please find attached the last batch of documents. In total, you should
have received three (3) emails with attachments.

 

Kind regards,

 

HTA Secretariat
[1]cid:image001.png@01D1E29C.515F9850

European Commission
Directorate-General for Health and Food Safety – DG SANTE

Unit B4 – Medical products: safety, quality, innovation

Rue Froissart 101, 09/43

B-1049 Brussels/Belgium

 

References

Visible links

Dear Health and Food Safety,

Thank you very much for sending the documents comprising the response to part iii) of my request. I can confirm that I received three emails, with the reply letter, list of documents, and two annexes containing documents 1-54.

Yours sincerely,

Rachel Tansey