GPL stakeholder consultation
Dear DG SANTE access to documents team,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting the following documents regarding the ongoing revision of the general pharmaceuticals legislation.
Specifically, I would like to request a list of all stakeholder meetings that have fed into the evaluation and impact assessment process to date - as indicated in section D of the inception impact assessment - as well as the agendas and minutes of these meetings. Where minutes and or/agendas were not created, I would be grateful if this could be indicated.
We include in our request stakeholder consultation activities undertaken by external providers for DG SANTE (i.e. consultation data – meetings, agendas, exchanges – collected by DG SANTE’s external contractors and submitted to SANTE as part of these contracts). Where DG SANTE does not hold this information, please indicate this.
As per Article 4(1)(b) Regulation 1049/2001, please redact the names/initials and contact information of Commission staff members not pertaining to senior management, as well as representatives of stakeholder groups.
If you have any questions or require clarification of the scope of the request, please do not hesitate to contact me. I would be glad to discuss the request and refine its parameters if appropriate. In case it is helpful to have some context, we are seeking to better understand the Commission’s stakeholder engagement processes as part of a research project.
Yours sincerely,
Dr Kathrin Lauber
University of Edinburgh, School of Social and Political Science
Chrystal Macmillan Building
15a George Square
EH8 9LD, Edinburgh
Dear Sir or Madam,
We hereby acknowledge the receipt of your request for access to documents
sent on 05/10/2022 and registered on 05/10/2022 under the case number
2022/5670.
We will handle your request within 15 working days as of the date of
registration. The time-limit expires on 26/10/2022. We will let you know
if we need to extend this time limit for additional 15 working days.
To find more information on how we process your personal data, please see
[1]the privacy statement.
Yours faithfully,
Directorate-General for Health and Food Safety - Access to Documents
European Commission
References
Visible links
1. https://ec.europa.eu/info/principles-and...
Dear Ms Lauber,
A technical problem has prevented replying to your access to document
request (case 2022/5670) within the assigned deadline.
We expect to send the reply before the end of the week. We apologize for
any inconvenience this may cause.
Sincerely,
Unit “Medicines: policy, authorisation and monitoring“
[1]logo-ce-horizontal-en-quadri-jpg24
European Commission
DG Health and Food Safety
Dear Unit “Medicines: policy, authorisation and monitoring“,
Many thanks for letting me know, I look forward to receiving a response later this week.
Yours sincerely,
Dr Kathrin Lauber
Dear Ms Lauber,
Please find attached a message concerning your request for access to
Commission documents registered under the above case number 2022/5670.
Kind regards,
Unit “Medicines: policy, authorisation and monitoring“
European Commission
DG Health and Food Safety
Dear Health and Food Safety,
Many thanks for taking the time to respond to my request for documents 2022/5670. I hereby confirm that this has been received.
Yours faithfully,
Kathrin Lauber
Dear DG SANTE Access to Documents team,
I refer to your letter and enclosed documents, received via the AsktheEU portal on 28 November 2022. Thank you for your assistance in gathering these documents in response to my request EASE 2022/5670. Whilst I understand the exceptions to the right of access laid down in Article 4 of Regulation (EC) No 1049/2001, and accept some of the instances in which these exceptions have been applied to the documents returned, there are some that I feel have been applied inappropriately. I am therefore lodging a confirmatory application and ask that the redactions to the following documents be reviewed.
Please pass this on to the person who reviews confirmatory applications.
(1) On the basis of the exception outlined in Article 4(1)(b), the organisations which meeting participants represent have been redacted in documents 2, 8, 10, 16 and 17. Whilst I understand the need to redact names and contact details of individuals, I would posit that the names of the organisations being represented should remain in these documents.
(2) On the basis of the exception outlined in Article 4(3), almost the entire substantive content of documents 1, 4, 5, 7, 8, 9, 10, 11, 13, 17, 18, 21, 24, 26, 28, 29, 32, 33, 34, 35, 36, 37 and 38 has been redacted. The same applies to documents 39 and 40 which appear to summarise insights from stakeholder workshops held by an external contractor.
I do not feel that your response adequately demonstrated how disclosure of the redacted documents would seriously undermine the decision-making process, or adequately addressed the public interest in fuller disclosure. It is unclear how the publication of stakeholder views would harm the decision-making process, considering that submissions to the inception impact assessment and the public consultation are publicly available. For instance, in document 13 almost the entire substantive content has been redacted despite the indication in the meeting summary that it involves only the participant’s input into the public consultation. Similarly, in document 37, virtually all content is redacted despite an invitation at the end of the document for those receiving it to forward it on to unspecified colleagues (there is no indication that these should be other meeting attendees), again indicating that the material is not especially sensitive.
Even where the views and information contained in the document go beyond those shared through other consultation pathways, I would argue that selectively withholding the information shared with some stakeholders from others, as well as the wider public, is at odds with principles of openness and participation.
In particular, it is unclear why Article 4(3) was not applied consistently across stakeholder groups: meeting minutes relating to interactions with commercial actors were heavily redacted while those relating to interactions with civil society groups were not. Further, while I appreciate that some contents may be particularly sensitive or subject to other exceptions, in your response, you note that the “Commission's services must be free to explore all possible options in preparation of a decision free from external pressure”. As reported in major EU news outlets, much of this pressure originates from those stakeholders whose views and positions were heavily redacted (see, e.g., POLITICO, 'Push for fairer pharma rules hits brick wall of business interests', 2 Sept 2022).
Article 15 TFEU states that “in order to promote good governance and ensure the participation of civil society, the Union's institutions, bodies, offices and agencies shall conduct their work as openly as possible”. It is in the public interest to make such demands and related discussions transparent without delaying this until a decision is made, seeing as the legislation under development will have major implications for the health and wellbeing of European citizens. Those citizens deserve the opportunity to effectively make their views known, which would be helped by having access to the information shared with and by stakeholders.
In light of the above, I would kindly ask you to reconsider your decision. Many thanks for your time.
Your sincerely,
Dr Kathrin Lauber
Dear Sir or Madam,
We hereby acknowledge the receipt of your confirmatory request for case
2022/5670, sent on 16/12/2022 and registered on 20/12/2022.
We will handle your confirmatory request within 15 working days as of the
date of registration. The time-limit expires on 19/01/2023. We will let
you know if we need to extend this time limit for additional 15 working
days.
Yours faithfully,
Secretariat-General - Access to Documents
European Commission
Hello,
We are writing concerning your confirmatory request for access to
Commission documents for case 2022/5670 registered on 20/12/2022.
We are currently working on your confirmatory request. However, we have
not yet been able to gather all the elements necessary to carry out a full
analysis of your request. We will not be able to send you the reply within
the prescribed time limit expiring on 19/01/2023.
Therefore, in line with Article 8(2) of [1]Regulation (EC) No 1049/2001 we
need to extend this time limit by 15 additional working days. The new time
limit expires on 9/2/2023.
We apologise for any inconvenience this may cause.
Kind regards,
Access to Documents Team
Secretariat-General
SG.C.1 Transparency, Document Management & Access to Documents
References
Visible links
1. https://eur-lex.europa.eu/legal-content/...
Dear Ms Lauber,
We are writing to you concerning your confirmatory request for access to
Commission documents for case 2022/5670, registered on 20/12/2022.
On 19/01/2022, we extended the time-limit for replying to your
confirmatory request to 9/02/2023.
Unfortunately, we were not able to send you the reply within this extended
time limit.
However, we assure you that we are doing our best to send a reply to your
confirmatory request as soon as possible.
We regret this additional delay and sincerely apologize for any
inconvenience this may cause.
Kind regards,
Access to Documents Team
Secretariat-General
SG.C.1- Transparency, Document Management & Access to Documents
Dear [email address],
I am writing to follow up on my confirmatory application for access-to-documents request 2022/5670, which was registered on 20/12/22. This request is now 43 days over the statutory time-limit and the original request was made more than five months ago. Could you please confirm when I can expect to receive a response?
With thanks,
Kathrin Lauber
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/...
Dear [email address],
I am writing to follow up on my confirmatory application for access-to-documents request 2022/5670, which was registered on 20/12/22. This request is now 72 working days over the statutory time limit and the original request was made seven months ago. Could you please provide me with an update and confirm when I can expect to receive a response?
Yours sincerely,
Kathrin Lauber
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/...
Dear Health and Food Safety,
Could you please update on the status of this confirmatory application? It was submitted more than six months ago, and the original access to documents request more than nine months ago. Can you tell me when I can expect a response?
Yours faithfully,
Kathrin Lauber
Dear Ms Lauber,
Thank you for your message of 5 July 2023 addressed to DG SANTE on the
status of your confirmatory application 2022/5670. We understand your
concerns about the delay and would like to assure you that we are doing
our best to handle your case as soon as possible. Unfortunately we cannot
commit to a specific timeframe within when the final decision will be
adopted. Please accept our apologies for the inconvenince this delay may
cause to you and thank you for your understanding.
Kind regards
Access to Documents Team
Secretariat-General/SG.C.1
Kathrin Lauber left an annotation ()
Confirmatory application response received on 9 November 2023 via post