AXREM Statement on the disclosure of payments to the healthcare sector consultation
11 October 2023
The Report of the Independent Medicines and Medical Safety Review, chaired by Baroness Julia Cumberledge, was published on 8 July 2020. Titled “First Do No Harm”, the Review was asked to investigate what happened in respect of two medications (1. hormone pregnancy tests known as HPTs and 2. sodium valproate which is an anti-epileptic drug) and one medical device (pelvic mesh implants). None of these medications or devices are in the scope of AXREM.
The Report can be found here: First Do No Harm (webarchive.org.uk)
The Report contained a number of recommendations, one of which was Recommendation 8 which states:
Recommendation 8: Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests and their recognised and accredited specialisms. In addition, there should be mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.
As AXREM member companies provide medical devices, our association members are likely to be included in the scope of this recommendation.
The UK Government’s Department of Health & Social Care have recently issued an open consultation titled “The disclosure of industry payments to the healthcare sector”. The consultation aims to seek views on the possible introduction of regulations mandating the disclosure of industry payments to the healthcare sector and the publication of these payments.
The Consultation can be found here: The disclosure of industry payments to the healthcare sector – GOV.UK (www.gov.uk)
The Consultation wishes to “seek views on the possible introduction of new secondary legislation to place a duty on manufacturers and commercial suppliers of medicines, devices and borderline substances to report details of the payments and other benefits they provide to healthcare professionals and organisations”.
In the Ministerial foreword, Will Quince MP, Minister of State (Minister for Health and Secondary care) states “To build trust and protect the health system from real and perceived conflicts of interest, we must understand and support the important ways in which industry interacts with the healthcare profession. We now wish to understand whether information about these interactions should be accessible to the public to ensure that these do not compromise patient care”.
The requirement for close collaboration between the NHS, Independent Sector and industry is crucial in delivering innovation, new and improved treatments and care pathways which ultimately improve patient outcomes. Game changing innovations created by such close collaboration in AXREM’s Imaging, Radiotherapy & Care areas of participation have produced new technologies in the UK which have improved the lives of patients around the world; CT, Ultrasound and MRI Scanning are just three innovations in the AXREM space which were born out of this close collaboration.
AXREM are pleased that the need for this close collaboration is recognised in the Consultation where it states “The life sciences industry is crucial to the nation’s health, developing innovations in medicines and medical devices that improve citizens’ quality of life across the UK. To achieve this, industry works closely with leading hospitals, clinicians and researchers to develop products and ensure these are used safely and effectively”.
AXREM members have to comply with rigorous public procurement processes to become suppliers to the NHS & the Independent Sector and the products and solutions offered by AXREM members are heavily regulated and certified.
AXREM have a Code of Conduct and our European sister body COCIR has a Code of Conduct which members are bound by and specifically covers any payment for services by healthcare employees. Details of these codes of conduct can be found here:
COCIR_Code_of_Conduct_2020.pdf
These Codes of Conduct have served the procurement of Medical X-Ray Devices well for a number of years and are subject to regular review. These Codes of Conduct were shared with representatives of the Department of Health & Social Care during recent engagements.
AXREM supports open and fair competition, free from bias and inappropriate influence, and which promotes innovation and competitive pricing to ensure value of money is offered to the NHS.
The Consultation states “If we proceed with regulating, we propose to require businesses to publish information about in-scope payments to any registered healthcare professional or any hospital, trust, clinic, health board, pharmacy or surgery, whether in the public or independent sector”.
The intention of the regulation would be that every payment or other benefit that can be expressed as a monetary value should be reported. This would include those payments and benefits made anywhere geographically, directly or indirectly. Examples provided in the consultation include:
- a cash payment to an NHS trust to sponsor an event
- a service provided, such as training on products and procedures relevant to the provision of healthcare, outside of contractual agreements
- payment that goes through a legal person connected with a recipient, for example a charitable foundation
- Where a healthcare professional may use, for example, a company to receive payments on their behalf, the regulations would still require the supplier/manufacturer to declare such payments.
The Minimum thresholds proposed in the consultation “set a minimum threshold of £50 for individual payments if the annual aggregated value does not exceed £500 for that recipient. Businesses would, however, still have to report payments if any recipient received payments and benefits valued at £500 and above in any given reporting year”.
AXREM stresses the need for any new system/process/documentation or reporting requirements required to evidence transparency of payments and/or transfer of benefits under new legislation should be
- simple
- straightforward
- timely
- appropriate to the wide variety of differing segments of healthcare suppliers and products and services provided to the NHS
- applied at an appropriate threshold value to provide meaningful data and reporting
- be at NO COST to participating suppliers should a third-party scheme of self-reporting be adopted
and that any such system/process/documentation DOES NOT present an unnecessary administrative burden to suppliers which could have the unintended consequence of imposing additional costs on suppliers which could increase pricing to cover new reporting requirements, nor should it compromise the critical role that AXREM members play in providing Continuing Professional Development (CPD) to NHS employees through training on equipment and procedures to optimise their use of technologies and regular refresh of this critical knowledge as software updates and new versions and releases become available. Such training, which is a mandatory requirement for AXREM suppliers to maintain their registration and regulatory compliance, SHOULD NOT be in scope of this new legislation.
The Consultation period is now open. AXREM will be formally responding to this consultation consistent with our initial engagement and the principals outlined in this statement.
The scope of those potentially impacted by and who may require to comply with any new prospective legislation is wide, including: public and private healthcare suppliers, suppliers and manufacturers, their business partners/dealers/distributors, medical research and training companies, royal colleges, charity arms of hospitals and others. The scope also includes the healthcare employees and organisations (both NHS & Independent) who are recipients of such payments and whose “personal data would be made public relating to individual healthcare professionals”.
We encourage these groups in scope and NHS & Independent Sector healthcare workers to engage in the consultation process and make their views clear to ensure that any resultant new legislation is practical, workable and meaningful.
The Consultation can be found here: The disclosure of industry payments to the healthcare sector – GOV.UK (www.gov.uk)
The Consultation closes at 11:59pm on 16th October 2023.
ENDS