Moved by
Lord Bethell
48: After Clause 6, insert the following new Clause—
“Disclosure of information in accordance with international agreements
(1) This section applies to information which a relevant authority holds in connection with human medicines.
(2) The relevant authority may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicines.
(3) The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority—
(a) considers that it is necessary to do so for the purpose mentioned in that subsection, and
(b) is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.
(4) Except as provided by subsection (5), the disclosure of information in accordance with this section does not breach—
(a) an obligation of confidence owed by the person making the disclosure, or
(b) any other restriction on the disclosure of the information (however imposed).
(5) Nothing in this section authorises a disclosure of information which—
(a) contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or
(b) is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.
(6) In this section—
“commercially sensitive information” means commercial information whose disclosure the relevant authority thinks might significantly harm the legitimate business interests of the undertaking to which it relates;
“relevant authority” means—
(a) the Secretary of State, or
(b) the Department of Health in Northern Ireland;
“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018.”
Member’s explanatory statement
This new Clause makes clear that information held by the Secretary of State or the Department of Health in Northern Ireland in connection with human medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.