Ref. Ares(2020)1503747 - 11/03/2020
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
The Director-General
Brussels
SANTE.A.1/RM/CG(2020)
Dear Mr Hoedeman,
Subject:
Your application for access to documents – Ref GestDem 2020/0261
We refer to your email dated 14 January 2020 in which you make a request for access to
documents, registered on the same date with the above-mentioned reference number.
We also refer to our letter dated 2 February 2020 extending the time limit for responding
to your request pursuant to Article 7(3) of Regulation (EC) No 1049/20011 (or “the
Regulation”).
1.
Scope of your request
On the basis of Regulation (EC) No 1049/2001, you requested access to:
[Part 1]
‘all reports (and other notes) from meetings between DG SANTE and
representatives of the pharmaceutical industry (companies as well as
organisations such as EFPIA) from December 1st 2019 onwards. This should
include the following companies: Bayer AG, Novartis International AG, Merck,
GlaxoSmithKline, Amgen Inc, F. Hoffmann-La Roche Ltd, Johnson & Johnson,
SANOFI, Pfizer Inc., AstraZeneca, Eli Lilly and Company, and MSD (Europe)
Inc. (Merck Sharp & Dohme).
[Part 2]
all correspondence (including emails) between the DG SANTE and
representatives of the pharmaceutical industry (companies as well as
organisations such as EFPIA) from December 1st 2019 onwards.
[Part 3]
a list of all the above-mentioned documents (including dates, names of
participants/senders/recipients
and
their
affiliation,
subject
of
meeting/correspondence).’
1 Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and
Commission documents (OJ L 145, 31.5.2001, p. 43).
By registered mail with acknowledgment of receipt Mr Olivier Hoedemann
Corporate Europe Observatory
Rue d'Edimbourg 26,
1050 Brussels
Belgium
Advance copy by email: ask xxxxxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
2.
Identification and assessment of the relevant documents
We have identified 12 documents with their respective attachments falling under the scope
of your request.
Having examined these documents under the provisions of Regulation (EC) No 1049/2001
and after having consulted the concerned third parties, we have come to the following
conclusion:
-
Partial access can be given to documents No 1 to 5.03, 5.05, 5.06 and from 5.09 to
11.2 and 12 as their full disclosure is prevented by the exceptions to the right of
access laid down in Article 4 of the Regulation and/or they contain parts that are
out-of-the-scope of your request.
-
Full access can be given to documents No 5.04, 5.07, 5.08 and 11.3.
You will find attached a table listing the identified documents and summarising the
outcome of the assessment carried out on the basis of the Regulation. We understand this
table to correspond to the list you requested in part three of your application.
We enclose a copy of the above-listed documents redacted of the parts which cannot be
disclosed as covered by the exceptions to the right of access laid down in Article 4 of the
Regulation. In addition, parts falling out-of-scope of your request have been removed.
You may reuse the documents requested free of charge for non-commercial and commercial
purposes provided that the source is acknowledged, that you do not distort the original
meaning or message of the documents. Please note that the Commission does not assume
liability stemming from the reuse.
Some of these documents were drawn up for internal use under the responsibility of the
relevant service of the Directorate-General for Health and Food Safety. They solely
reflect the service’s interpretation of the interventions made and do not set out any
official position of the third parties to which the documents refer. They do not reflect the
position of the Commission and cannot be quoted as such.
Documents originating from third parties cannot be re-used without the agreement of the
originators. They do not reflect the position of the Commission and cannot be quoted as
such.
3.
Reasons for partial refusal
Protection of the privacy and integrity of the individual, in particular in accordance with
Community legislation regarding the protection of personal data - Article 4(1)(b) of
Regulation (EC) No 1049/2001
With regard to the documents No 1 to 5.03, 5.05, 5.06, from 5.09 to 11.2 and 12, a complete
disclosure is prevented by the exception concerning the protection of privacy and the
integrity of the individual outlined in Article 4(1)(b) of Regulation (EC) No 1049/2001,
because they contain the following personal data:
-
the names/initials and contact information of Commission staff members not
pertaining to the senior management;
-
the names/initials and contact details of other natural persons;
-
handwritten signatures/abbreviated signatures of natural persons;
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-
other information relating to an identified or identifiable natural person such as the
names, office and phone numbers of the companies’ representatives.
Article 9(1) of the Data Protection Regulation2 allows the transmission of personal data
only while respecting specific conditions specified therein. In your request, you do not
provide any elements that would fulfil these conditions (e.g. you do not establish that it is
necessary to have the data transmitted for a specific purpose in the public interest) and
therefore we conclude that, pursuant to Article 4(1)(b) of Regulation (EC) No 1049/2001,
access cannot be granted to the personal data contained in the requested documents.
In accordance with the above mentioned, partial access is granted to the requested
documents, expunged of personal data.
Protection of the commercial interests of a legal person - Article 4(2), first indent, of
Regulation (EC) No 1049/2001
Documents No 1 and 3 are partially covered by this exception.
Document No 3 contains information extracted from the requests of right holders for
custom authorities to act. This information is confidential and not shared with other
actors than the customs authorities which have been asked to act. Disclosing this
information would undermine the commercial interests of the right holders.
Documents No 1, 2 and 5 contain information or originate from EFPIA. The third party has
been consulted on the documents originating from them in accordance with Article 4(4)
of Regulation (EC) No 1049/2001, in order to assess whether an exception under Article
4 of the Regulation is applicable.
For what concerns document No 1, EFPIA objected to the disclosure of a power point
presentation invoking the argument that their commercial interests would be damaged by
the disclosure of the slides included in said presentation, which represent the background
in draft format to a project that is still ongoing. These slides were not intended for wider
sharing before publication of results of the project on the EFPIA website in the near future.
We consider that releasing these slides prior to the publication of the EFPIA report would
undermine the ability for EFPIA to give publicity to its project with a timing and form of
their choosing and could therefore affect their competitive position in the market.
Documents No 2 and 5 have not been found to contain any commercially sensitive
information.
Therefore, having considered the opinion of the third party, we concluded that the
disclosure of parts of documents No 1 and 3 is prevented by the exception protecting the
commercial interests of a legal person, laid down in Article 4(2), first indent, of the
Regulation.
2 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the
protection of natural persons with regard to the processing of personal data by the Union institutions,
bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No
45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39–98)
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The documents in question are therefore disclosed, expunged of the parts to which the
above-mentioned exception applies.
Protection of the purpose of inspections, investigations and audits, Article 4(2), third
indent, of Regulation (EC) No 1049/2001
Some parts of document No 3 detail information on the basis on which customs
authorities within Member States perform their risk analysis in view of targeting controls
on certain shipments. This information is restricted and not shared with other actors than
the customs authorities. Its disclosure would undermine the purpose of inspections
carried out by customs authorities by providing access to information regarding the
targeting of controls.
Therefore, we concluded that the disclosure of parts of document No 3 is prevented by
the exception laid down in Article 4(2), third indent, of Regulation (EC) No 1049/2001,
protecting the purpose of inspections, investigations and audits. The parts in question
have therefore been redacted from the disclosed document.
4. Overriding public interests
The exceptions to the right of access provided for in Article 4(2) of Regulation (EC)
No 1049/2001 must be waived if there is an overriding public interest in disclosing the
requested document. In your application, you did not submit any grounds concerning a
public interest on the basis of which the interests protected in the regulation would have to
be overridden, and we could not identify any such ground either. In these circumstances, we
have to conclude that there is no evidence of an overriding public interest in disclosure, in
the sense of the Regulation.
5.
Means of redress
In accordance with Article 7(2) of Regulation (EC) No 1049/2001, you are entitled to make
a confirmatory application requesting the Commission to review this position.
Such a confirmatory application should be addressed within 15 working days upon receipt
of this letter to the Secretary-General of the Commission at the following address:
European Commission
Secretary-General
Transparency, Document Management & Access to Documents (SG.C.1)
BERL 7/076
B-1049 Bruxelles
or by email to:
xxxxxxxxxx@xx.xxxxxx.xx
Yours sincerely,
Anne BUCHER
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Enclosures (sent only by email): List of documents identified as under Section 2.
Documents to which partial access can be given, as
identified under Section 2 of this letter.
Electronically signed on 11/03/2020 15:20 (UTC+01) in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563
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