Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, encourages MedTech trade bodies to engage in shaping new government guidance on declaration of payments.
New guidelines will be published by Government to require MedTech suppliers to declare payments made to clinicians, teaching hospitals and research institutions, the MedTech and Innovation Directorate of the Department of Health and Social Care has announced.
The announcement, in a letter to trade associations from the head of the Directorate, David Lawson, follows a consultation on an earlier recommendation in the 2020 Report of the Independent Medicines and Medical Devices Safety Review, (IMMDS) chaired by Baroness Julia Cumberlege.
The guidance will set out best practice for industry to follow; it will advise on which payments should be reported, and in what format, as well as the frequency of reporting.
Over the coming months, DHSC will work in collaboration with stakeholders to develop a comprehensive set of guidelines for industry to follow. Once published, officials will monitor its uptake closely.
Lawson’s letter acknowledges that medicines and medical device trade associations already have codes of conduct in place that set standards for how businesses should engage with researchers and healthcare providers. These supplement professional codes of conduct that healthcare professionals are required to follow. The new guidance will be in addition to these existing codes, but government has stopped short of introducing a new statutory requirement for such declarations, a situation that could change in the future if industry fails to adhere to the new guidance.
This latest announcement adds to the wider programme of work, detailed in the government’s response to the IMMDS report, to address in full, in part, or in principle, seven of the report’s nine recommendations accepted by the previous government. Four of these have already been successfully implemented, including:
- issuing an unreserved apology on behalf of the healthcare system for historic harms to patients,
- appointing the first ever Patient Safety Commissioner in England in respect of medicines and medical devices,
- establishing nine specialist surgical mesh centres, which are in operation across England,
- establishing and working with a Patient Reference Group to help develop the response to the IMMDS Review.
MedTech trade associations should engage proactively with the DHSC to help shape the details of the guidance, and should encourage their members to continue to act responsibly in the future by making only appropriate payments and fully declaring that they have done so.
The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.
