Module 17 2024

03/12/2024

Transparency: New UK ‘sunshine’ reporting legislation

Publication or disclosure of payments or other benefits provided by:

to:

Health and Care Act 2022 (Part 2)

•‘Information about payments etc to persons in the health care sector’

Manufacturers of healthcare (HC) products (incl assemblers)

Persons providing HC in the UK (incl under arrangements made by a 3P)

Powers to enact Regulations requiring publication or disclosure of payments or other benefits to HCPs/HCOs and others to be specified

Other persons who carry on activities connected with UK HC (to be designated in Regulations)

Commercial Suppliers of HC products (excl supplies as part of provision of HC)

Bites on supply chain for "health care products"

"health care product“

Connected persons to Mfrs or Commercial Suppliers (to be defined in Regulations)

• medicines, medical devices or other products supplied or prescribed in the course of the provision of health care

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

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Transparency: New UK ‘sunshine’ reporting legislation

Department of Health consulted stakeholders, incl industry Q4 2023

Expect statutory disclosure/reporting requirements

Disclosure via a ‘relevant scheme’ may exempt or except from individual publication / disclosure • E.g. Disclosure UK (EFPIA transparency) •Unclear whether multiple ‘relevant schemes’ will be designated, e.g. MTE CEBP reporting

• HCPs and industry

Compliance with industry transparency schemes may alleviate or exempt from the reporting obligations • Risk that Medtech will be expected to meet pharma (EFPIA) reporting requirements Enforcement may not be via the criminal law (to be determined by Regulations)

Financial penalties foreseen for:

• Failure to comply • Provision of information that is materially misleading or false

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

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