Health Bill

Debate between Karin Smyth and Jim Allister

Report stage & 3rd reading
Tuesday 8th September 2026 Commons Chamber

[Karin Smyth]

I know that many hon. Members want to talk about the provisions in the Bill covering many important issues. I will therefore speak briefly about two Government amendments relating to medical device licensing and information sharing.

I will first address new clause 94 regarding medical devices licensing, and consequential amendments new clauses 99 to 101 regarding medical devices disclosure. These amendments are about ensuring that Great Britain’s medical devices regulatory framework remains fit for the future. As we know, medical technology is evolving rapidly, particularly in areas such as software and artificial intelligence, while our current framework was designed for a very different technological landscape. This set of amendments establishes the statutory foundation for a future medical device licensing regime, applying to Great Britain only. EU medical devices legislation will continue to apply in Northern Ireland.

Such a regime would require medical devices to be licensed and certain persons operating within the supply chain to hold a licence. By placing the detail in the regulations, the amendment allows us to work with patients, healthcare professionals and the medical device sector to create a regulatory framework that protects patients, supports innovation and strengthens the UK’s life sciences sector.

[Jim Allister (North Antrim) (TUV)]

In the aftermath of the Windsor framework and the damage done to intra-UK trade, section 45B of the United Kingdom Internal Market Act 2020 was passed, which was said to promise that there would be no further export procedures that could impact adversely on trade from Northern Ireland to Great Britain. Yet, in new clause 94, we have such constraints in the imposition of a licensing programme, whereby to bring—I will not say “export”, as it is an internal market—a medical device from Northern Ireland to Great Britain, a licence is needed by the recipient. How is that compatible with section 45B of the United Kingdom Internal Market Act?