Ref. Ares(2019)1054188 - 20/02/2019
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Health systems, medical products and innovation
Medicines: policy, authorisation and monitoring
Head of Unit
Brussels,
SANTE/B5/AL/mmc
sante.ddg1.b.5(2019)1182837
By registered letter with
acknowledgment of receipt
Dear Ms Tansey,
Subject:
Your application for access to documents – Ref GestDem 2018/5864
We refer to your email of 12/10/2018 in which you make a request for access to
documents, registered under the above-mentioned reference number.
We also refer to our e-mail of 29/11/2018 extending the time limit for responding to your
application, pursuant to Article 7(3) of Regulation (EC) No 1049/2001, our previous
letter dated 23 January 2019 and our email dated 14 February 2019.
1.
Scope of your request
In your request, you ask on the basis of Regulation (EC) No 1049/20011 access to:
i) a list of meetings;
(ii) minutes or other reports of those meetings;
(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.
1 Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and
Commission documents (OJ L 145, 31.5.2001, p. 43).
Ms Rachel Tansey
Corporate Europe Observatory
Rue d'Edimbourg 26
1050 Brussels
Belgium
Advance copy by email: xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx
Commission européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel - Belgium. Telephone: (32-2) 299 11 11.
E-mail: xxxxxxxxxxxxxxxxxxxxxxxx@xx.xxxxxx.xx
You indicate that the scope of this request should be considered to concern the period
between April 2017 and May 2018.
(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).
2.
Identification and assessment of the relevant documents
As mentioned in our letter dated 23 January 2019, some documents falling within the
scope of your request originate from third parties, which were consulted. Please find in
annex I the list of documents relating to points iii) and iv) of your request for access to
documents.
3.
Reason for 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.
Pursuant to Article 4(1)(b) of Regulation (EC) No 1049/2001, access to a document has
to be refused if its disclosure would undermine the protection of privacy and the integrity
of the individual, in particular in accordance with Community legislation regarding the
protection of personal data. The applicable legislation in this field is Regulation (EC) No
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 45/20012.
All documents to which you have requested access contain personal data such as names
and surnames of Commission and company's staff.
Indeed, Article 3(1) of Regulation 2018/1725 provides that personal data ‘means any
information relating to an identified or identifiable natural person […]’. The Court of
Justice has specified that any information, which by reason of its content, purpose or
effect, is linked to a particular person is to be considered as personal data.3
2 Official Journal L 205 of 21.11.2018, p. 39.
3 Judgment of the Court of Justice of the European Union of 20 December 2017 in Case
C-434/16, Peter
Nowak v Data Protection Commissioner, request for a preliminary ruling, paragraphs 33-35,
ECLI:EU:C:2017:994.
2
In its judgment in Case C-28/08 P (Bavarian Lager)4, the Court of Justice ruled that when
a request is made for access to documents containing personal data, the Data Protection
Regulation becomes fully applicable5.
Pursuant to Article 9(1)(b) of Regulation 2018/1725, ‘personal data shall only be
transmitted to recipients established in the Union other than Union institutions and bodies
if ‘[t]he recipient establishes that it is necessary to have the data transmitted for a
specific purpose in the public interest and the controller, where there is any reason to
assume that the data subject’s legitimate interests might be prejudiced, establishes that it
is proportionate to transmit the personal data for that specific purpose after having
demonstrably weighed the various competing interests’.
Only if these conditions are fulfilled and the processing constitutes lawful processing in
accordance with the requirements of Article 5 of Regulation 2018/1725, can the
transmission of personal data occur.
According to Article 9(1)(b) of Regulation 2018/1725, the European Commission has to
examine the further conditions for a lawful processing of personal data only if the first
condition is fulfilled, namely if the recipient has established that it is necessary to have
the data transmitted for a specific purpose in the public interest. It is only in this case that
the European Commission has to examine whether there is a reason to assume that the
data subject’s legitimate interests might be prejudiced and, in the affirmative, establish
the proportionality of the transmission of the personal data for that specific purpose after
having demonstrably weighed the various competing interests.
In your application, you do not put forward any arguments to establish the necessity to
have the data transmitted for a specific purpose in the public interest. Therefore, the
European Commission does not have to examine whether there is a reason to assume that
the data subject’s legitimate interests might be prejudiced.
Consequently, we conclude that, pursuant to Article 4(1)(b) of Regulation 1049/2001,
access cannot be granted to the personal data, as the need to obtain access thereto for a
purpose in the public interest has not been substantiated and there is no reason to think
that the legitimate interests of the individuals concerned would not be prejudiced by
disclosure of the personal data concerned.
4
Means of redress
In case you would disagree with the assessment that the redacted data are personal data
which can only be disclosed if such disclosure is legitimate under the applicable rules on the
protection of personal data, you are entitled, in accordance with Article 7(2) of Regulation
1049/2001, to submit a confirmatory application requesting the Commission to review this
position.
4 Judgment of 29 June 2010 in Case C-28/08 P,
European Commission v The Bavarian Lager Co. Ltd,
EU:C:2010:378, paragraph 59.
5 Whereas this judgment specifically related to Regulation (EC) No 45/2001 of the European Parliament
and of the Council of 18 December 2000 on the protection of individuals with regard to the processing
of personal data by the Community institutions and bodies and on the free movement of such data, the
principles set out therein are also applicable under the new data protection regime established by
Regulation 2018/1725.
3
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 em
ail to: xxxxxxxxxx@xx.xxxxxx.xx
Yours sincerely,
[Electronically signed]
Olga Solomon
4
Electronically signed on 19/02/2019 15:46 (UTC+01) in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563