Medical Devices (Northern Ireland Protocol) Regulations 2021

Baroness Ritchie of Downpatrick Excerpts

Monday 12th July 2021 Grand Committee

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, I thank the Minister for his explanation of these regulations. I accept what the statutory instrument is intended to do. However, I have some questions, as I want to see streamlined processes with no impediments to the supply of medical devices into Northern Ireland or to those that are currently under construction. There are about 500,000 medical devices, ranging from sticking plasters to dental implants to hip replacements, so they have many forms and functions. We are trying to achieve pragmatic solutions under the protocol to ensure that there are no impediments to their supply.

I have several questions for the Minister. Does the existing legislation on medicines and medical devices, which was approved in Parliament last year, have corresponding legislation in Northern Ireland to ensure that people with particular mesh problems will have a resolution and see an improvement to their health?

Furthermore, on the protocol, what discussions are taking place in the joint committee and the specialised committee with the EU on the exportation issues relating to the transfer of medical devices and medicines, to ensure that they will all continue to be supplied post December 2021? For example, the Royal College of Podiatry and the Ethical Medicines Industry Group are seeking mutual recognition agreements for the supply of those medicines and medical devices post 2021 as part of the protocol. What progress has been made in this regard? What evidence is there of working together to arrive at a long-term solution that avoids unnecessary regulatory complexity and duplication?

Given that the risk of medicines leaking into the EU single market from Northern Ireland in an unregulated manner is very slim, an agreement that permits medicines licensed for use in GB to be supplied to Northern Ireland only without additional checks would deliver on both sides’ needs. What steps are being made in this regard by UK and EU negotiators?

Do the common frameworks on blood safety and quality, on organs, tissues and cells, and on public health intersect with the protocol? What pressure can be brought to bear on the Northern Ireland Executive to sign off on these common frameworks, which deal with technical and policy divergence between Whitehall and the devolved Administrations? I look forward to the Minister’s responses to these issues on this important matter for the people of Northern Ireland.