Moved by
Lord Kamall
312B: Before Clause 81, insert the following new Clause—
“Information about payments etc to persons in the health care sector
(1) The Secretary of State may by regulations require manufacturers or commercial suppliers of health care products, or connected persons, to—
(a) publish information about payments or other benefits provided by them to relevant persons, or
(b) provide such information to the Secretary of State.
(2) The regulations may make further provision about when and how the information is to be published or provided.
(3) The information may, in particular, include information about—
(a) a payment or other benefit,
(b) the person who provided it, or
(c) the person who received it.
(4) The regulations may make provision permitting or requiring the further sharing, publication or use of the information.
(5) The regulations may impose requirements on manufacturers or commercial suppliers of health care products, or connected persons, about the retention of information relating to payments or other benefits provided by them to relevant persons.
(6) The regulations may—
(a) authorise the Secretary of State to designate as a “relevant scheme” any scheme under which information about payments or other benefits to relevant persons is collected or published by a person other than the Secretary of State, if the Secretary of State considers that the provision of information under the scheme would render compliance with some or all of the requirements imposed by the regulations unnecessary;
(b) create exceptions from requirements to publish or provide information imposed by virtue of subsection (1) where information is provided under a relevant scheme;
(c) if such exceptions are created—
(i) require a person who holds information mentioned in subsection (1) in connection with the operation of a relevant scheme to provide the information to the Secretary of State;
(ii) permit or require the Secretary of State to publish the information.
(7) The regulations may impose requirements on a person mentioned in subsection (6)(c)(i) about the retention of information mentioned there.
(8) The provision for exceptions that may be made by the regulations includes provision authorising the Secretary of State to grant an exception from a requirement imposed by the regulations in a particular case, on grounds specified in the regulations.
(9) The regulations may provide that the disclosure of information under the regulations 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), other than a restriction imposed by the data protection legislation.
(10) Provision made by the regulations may, in particular, be framed by reference to manufacturers or commercial suppliers with a specified connection to the United Kingdom or a part of it.
(11) In this section—
(a) “connected person”, in relation to a manufacturer or commercial supplier, means a person who has a connection, of a description specified in regulations made by the Secretary of State, with the manufacturer or commercial supplier;
(b) “relevant person” means—
(i) a person who provides health care in the United Kingdom or a part of it, whether or not under arrangements made by another person, or
(ii) another person who carries on activities connected with health care provided in the United Kingdom or a part of it and is of a description specified in regulations made by the Secretary of State.
(12) In this section—
“commercial supplier”, in relation to a health care product, means a person who supplies the product otherwise than in the course of providing health care;
“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;
“health care” means all forms of health care provided for individuals, whether relating to physical or mental health;
“health care product” means a medicine, medical device or other product which is supplied or prescribed in the course of the provision of health care;
“manufacturer”, in relation to a health care product, means a person who manufactures or assembles the product;
“payments or other benefits” includes any payment or other benefit—
(a) wherever it is provided,
(b) whether or not it is of a financial nature,
(c) whether it is provided under a contract or otherwise, and
(d) whether it is provided directly or through a third party.”
Member’s explanatory statement
This New Clause would enable regulations to require the reporting and publication of information about payments and other benefits provided to persons in the health care sector by manufacturers and suppliers of health care products.
312C: Before Clause 81, insert the following new Clause—
“Regulations under section (Information about payments etc to persons in the health care sector): enforcement
(1) Regulations under section (Information about payments etc to persons in the health care sector) (1) may make provision for the enforcement of requirements imposed by the regulations, including provision conferring on the Secretary of State the power to impose a financial penalty on a person who, without reasonable excuse—
(a) fails to comply with such a requirement, or
(b) provides information in response to such a requirement that is false or misleading to a material extent.
(2) The amount of the financial penalty is to be specified in, or determined in accordance with, the regulations.
(3) Regulations by virtue of subsection (1) must include provision—
(a) requiring the Secretary of State, before imposing a financial penalty on a person, to give the person written notice (a “notice of intent”) of the proposed financial penalty;
(b) ensuring that the person is given an opportunity to make representations about the proposed financial penalty;
(c) requiring the Secretary of State, after the period for making representations, to decide whether to impose the financial penalty;
(d) requiring the Secretary of State, if the Secretary of State decides to impose the financial penalty, to give the person notice in writing (a “final notice”) imposing the penalty;
(e) enabling a person on whom a financial penalty is imposed to appeal to a court or tribunal in accordance with the regulations;
(f) as to the powers of the court or tribunal on such an appeal.
(4) The provision that may be made by the regulations by virtue of subsection (1) includes provision—
(a) enabling a notice of intent or final notice to be withdrawn or amended;
(b) requiring the Secretary of State to withdraw a final notice in circumstances specified in the regulations;
(c) for a financial penalty to be increased by an amount specified in or determined in accordance with the regulations in the event of late payment;
(d) as to how financial penalties are recoverable.”
Member’s explanatory statement
This New Clause would enable provision to be made for the enforcement of requirements relating to information about payments etc to persons in the health care sector, including through the imposition of civil penalties.
312D: Before Clause 81, insert the following new Clause—
“Regulations under section (Information about payments etc to persons in the health care sector): consent
“(1) Before making regulations under section (Information about payments etc to persons in the health care sector), the Secretary of State must—
(a) obtain the consent of the Scottish Ministers in relation to any provision which—
(i) would be within the legislative competence of the Scottish Parliament, if contained in an Act of that Parliament, and
(ii) is not merely incidental to, or consequential on, provision which would be outside that legislative competence;
(b) obtain the consent of the Welsh Ministers in relation to any provision which—
(i) would be within the legislative competence of Senedd Cymru, if contained in an Act of the Senedd, and
(ii) is not merely incidental to, or consequential on, provision which would be outside that legislative competence;
(c) obtain the consent of the Department of Health in Northern Ireland in relation to any provision which—
(i) would be within the legislative competence of the Northern Ireland Assembly, if contained in an Act of that Assembly, and
(ii) is not merely incidental to, or consequential on, provision which would be outside that legislative competence.
(2) Consent is not required under subsection (1)(c) in relation to any provision if—
(a) a Bill for an Act of the Northern Ireland Assembly containing the provision would require the consent of the Secretary of State under section 8 of the Northern Ireland Act 1998, and
(b) the provision does not affect, other than incidentally, a transferred matter (within the meaning of that Act).”
Member’s explanatory statement
This New Clause requires the Secretary of State to obtain consent of the Scottish Ministers, the Welsh Ministers or the Department of Health in Northern Ireland (as appropriate) before making provision within devolved legislative competence in regulations relating to information about payments etc to persons in the health care sector.