Pat Breen (Clare, Fine Gael) | Oireachtas source

I move amendment No. 203:

In page 126, between lines 25 and 26, to insert the following:“Amendment of section 15A of Control of Clinical Trials Act 1987

167. Section 15A of the Clinical Trials Act 1987 is amended—

(a) by the substitution of the following paragraph for paragraph (d):

“(d) inspect and copy or extract information from any data including data that constitutes personal data within the meaning of—

(i) the Data Protection Regulation, or

(ii) Part 5 of the Data Protection Act 2018.”,

and

(b) the insertion of the following subsection after subsection (10):

“(11) In this section, “Data Protection Regulation” means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).”.”.