Medicines and Medical Devices Bill

Debate between Baroness Penn and Lord Brougham and Vaux

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

I call the noble and learned Lord, Lord Mackay of Clashfern. He is not there. The noble Baroness, Lady Jolly, is not with us either so I call the noble Baroness, Lady Penn.

[Baroness Penn (Con)]

My Lords, before I speak to the helpful debate we had on this group of amendments, I should like to make a correction to my response to an earlier grouping. At the time, I said that all adverse incidents with medical devices are available online on the MHRA’s website. I would like to correct this: adverse incidents with medical devices will be published online on the MHRA’s website as part of the plans to deliver increased transparency and in line with developing future legislation enabled by the powers in the Bill. However, it is not presently the case.

Turning to our present debate, I thought it might be helpful first to address the current arrangements for the regulation of medicines, veterinary medicines and medical devices in Northern Ireland. Responsibility for medical device regulation is reserved in respect of the whole of the UK. However, Part 1 of the Bill, relating to human medicines, and Part 2, on veterinary medicines, deal with transferred matters in relation to Northern Ireland. Clauses 1 and 8 set out that regulations in relation to Northern Ireland can be made either by the Secretary of State acting jointly with the Northern Ireland department or by the Northern Ireland department. This has always been the case; however, the MHRA and the VMD regulate these areas UK-wide on a day-to-day basis. After the end of the transition period, with regard to both human and veterinary medicines, as well as medical devices, under the terms of the Northern Ireland protocol, Northern Ireland will continue to follow the acquis.

Amendment 119 in the name of the noble Baronesses, Lady Thornton and Lady Ritchie of Downpatrick, seeks to ensure that, in making regulations under the Bill, the Government must minimise and mitigate the potential for regulatory divergence between Great Britain and Northern Ireland. Along with Amendment 120 in the names of the noble Lord, Lord Patel, and my noble and learned friend Lord Mackay of Clashfern, Amendment 119 seeks to establish a requirement for the Secretary of State to report to Parliament on areas of divergence between Great Britain and Northern Ireland.

I completely understand that these probing amendments seek to ensure that Parliament has proper sight of how medicines and medical device regulation develops in the future, particularly in relation to any differences between Great Britain and Northern Ireland. That is right and proper. Noble Lords will be aware, however, that the amendment in the name of my noble friend the Minister, on reporting obligations, means that the Government must already provide Parliament with a report every two years. This sits alongside the separate amendment to Clause 41 in my noble friend’s name, which requires a public consultation on any regulatory change to be made under the Bill.

That new reporting obligation on the operation of regulations made by the Secretary of State under Clauses 1(1), 8(1) and 12(1) is both forward and backward-looking. It must include any concerns raised or proposals for change made by anyone consulted by the Secretary of State in the preparation of the report, and the response to these. That may include advance notice of further regulatory change that the Secretary of State is proposing to make.

These reports, along with the public consultation on regulations under the Bill, would be the right place to deal with any issues of possible regulatory divergence raised. It would therefore be duplicative to require the Secretary of State to lay additional reports specifically on regulatory divergence for medicines and medical devices.

Noble Lords also asked a number of practical questions on how regulation will operate in Great Britain and Northern Ireland after the end of the transition period, which I will also address. The noble Baroness, Lady Wheeler, asked who would be responsible for any possible divergence between the Great Britain and Northern Ireland regulatory systems. I can reassure her that the MHRA and the VMD, reporting to their respective Secretaries of State, will continue to regulate human and veterinary medicines and medical devices for the whole of the UK, and will continue to ensure that patients and animals in Northern Ireland, just as in Great Britain, receive the safe and effective medicines and devices they need.

The noble Baroness, Lady Ritchie, asked specifically about the interaction between the UK Government and the Northern Ireland Executive on issues relating to future regulation of medicines and medical devices. I can reassure the noble Baroness that officials in the Department of Health and Social Care meet officials in the Northern Ireland Executive every two weeks to discuss the Bill and regulation of medicines and devices, and that a strong working relationship exists.

Robin Swann MLA has also given consent for the medicines day one-readiness statutory instrument, laid on 20 October, to be made by the Secretary of State for Northern Ireland as well as for Great Britain. We will continue to engage with the Northern Ireland Executive as plans for the future regulatory environment for devices and medicines develop.

The noble Lord, Lord Patel, also raised the approach to the day one readiness after the end of the transition period on which the MHRA has based its guidance to industry. I can reassure the noble Lord that, as I have just said, those regulations have been laid before Parliament, and we expect to debate them in early December.

Those regulations also require that from 1 January 2021, marketing authorisation holders must transmit all global serious reports of adverse drug reactions directly to the MHRA, to ensure that the agency has access to the totality of the information, to assess safety issues. This links to the noble Lord’s point on pharmacovigilance. I can reassure him that, following the end of the transition period, the MHRA will continue to be responsible for pharmacovigilance across the whole of the UK, and will use common processes for the assessment of safety issues in Northern Ireland and Great Britain.

Covid-19: Gig Economy

Debate between Baroness Penn and Lord Brougham and Vaux

Thursday 22nd October 2020 Lords Chamber

[Baroness Penn (Con)]

My Lords, a huge amount of support is going into the Government’s plan for jobs, which has a focus on improving the amount of training and retraining available where people wish to take it up. That support is there. The entire plan is worth around £30 billion and will be in place to help those unable to find work in the current circumstances.

[The Deputy Speaker (Lord Brougham and Vaux) (Con)]

My Lords, the time allowed for this Question has now elapsed.