Activities of Mary HONEYBALL related to 2013/0402(COD)
Plenary speeches (1)
Protection of trade secrets against their unlawful acquisition, use and disclosure (A8-0199/2015 - Constance Le Grip)
Amendments (4)
Amendment 57 #
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9a) For the purposes of this Directive, and in accordance with Regulation (EU) No 536/2014 of the European Parliament and of the Council1a, in general the data included in a clinical study report should not be considered commercially confidential once a marketing authorisation has been granted, the procedure for granting the marketing authorisation has been completed or the application for marketing authorisation has been withdrawn. In addition, the main characteristics of a clinical trial, the conclusion on Part I of the assessment report for the authorisation of a clinical trial, the decision on the authorisation of a clinical trial, the substantial modification of a clinical trial, and the clinical trial results including reasons for temporary halt or early termination, in general, should not be considered a trade secret. ________________ 1aRegulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (OJ L 158, 27.5.2014, p. 1).
Amendment 75 #
Proposal for a directive
Recital 23
Recital 23
(23) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, notably the right to respect private and family life, the right to the protection of personal data, the freedom of expression and information, the freedom of the press and the media, the freedom to choose an occupation and right to engage in work, the freedom to conduct a business, the right to property, the right to good administration, access to file and preservation of secrecy of business, the right to an effective remedy and to a fair trial and right of defence.
Amendment 107 #
Proposal for a directive
Article 2 – point 1 – point c a (new)
Article 2 – point 1 – point c a (new)
(ca) its disclosure is not in the public interest or is not required under Union or Member State law.
Amendment 135 #
Proposal for a directive
Article 3 – paragraph 2 – point f
Article 3 – paragraph 2 – point f