On 8 July 2020, Vaughan Gething, MS, Minister for Health and Social Services laid a Legislative Consent Memorandum for the Medicines and Medical Devices Bill currently before the UK Parliament.
A Legislative Consent Memorandum (LCM) is required when the consent of the Welsh Parliament is sought by the UK Government to legislate on an issue which could normally fall within the competence of the Senedd. The provisions within the legislative competence of the Senedd are contained in Clause 16 of the Bill and confer a delegated power on the Secretary of State for Health and Social Care to make regulations for a database of information in relation to medical devices to be established and managed by NHS Digital, which previously had no remit in relation to Wales.
According to the LCM, the purpose of the provision is to improve the safety and standards of medical devices by ensuring that better information can be captured and shared on the performance of implanted devices in order to identify risks of specific devices early on. This would apply to the NHS and private health providers in Wales. By improving the data available on medical devices as part of post-market surveillance, the Medicines and Healthcare products Regulatory Agency (MHRA) will be better able to take action earlier and more effectively as part of their regulation of devices in the UK, including Wales.
It would also mean that in the event of a recall, it would be possible to rapidly identify which devices had been implanted into specific patients. With the establishment of a registry a UK wide information depository holding data on a wider variety of cases reflecting a diverse range of clinical practices would be likely be more effective in generating learning than a smaller Wales focussed body.
The Health, Social Care and Sport Committee will consider the LCM early in the autumn term and report by 22 October.
To inform its consideration, the Committee is seeking views on the provisions in the LCM, including whether you can foresee any particular problems with establishing a database of information in relation to medical devices, as set in Clause 16 of the Bill, and if doing so would meet the stated objective of improving the safety and standards of medical devices.
The deadline for responses is Friday 4 September. Send your views to: firstname.lastname@example.org.
Providing Written Evidence
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Should you wish to speak to someone regarding this consultation, please use the below contact details:
Health, Social Care and Sport Committee
Telephone: 0300 200 6565