Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Lord Patel

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I am moving the amendment in the name of my noble friend Lady Thornton, which revisits the issue of regulatory divergence between Northern Ireland and the rest of the UK in matters covered by the Bill, and the need for an annual report to Parliament on this matter. The amendment also places an obligation on the Secretary of State specifically to report on plans to mitigate its adverse effects.

The Government will know that there is huge concern on this issue, strongly reflected in our Committee debates through our amendment and an amendment from the noble Lord, Lord Patel, calling for an annual report. The issue was also raised in consideration of the medicines and medical devices statutory instruments before Christmas and in the deliberations on the Northern Ireland protocol and the Trade Bill.

However, I welcome the Government’s amendments in this group to Clause 44, which extend reporting obligations to apply in respect of regulations made by a Northern Ireland department and to regulations under Clause 18 on the health and social care information systems. In particular, Amendment 85 specifies a Northern Ireland department and the Northern Ireland Assembly as an appropriate legislature and relevant authority in relation to regulations made under the Act.

We also welcome the Government’s acceptance of the arguments put forward by noble Lords and the Delegated Powers and Regulatory Reform Committee on the need for parliamentary scrutiny before and after delegated powers are exercised, and the introduction of a two-yearly reporting requirement in large parts of the Bill. I note that government briefings commit to the reports containing a summary of how the regulations have operated over the period under consideration, including any concerns from stakeholders and the Secretary of State’s response, as well as outlining plans for further changes.

I am speaking also on Amendment 78, in the name of my noble friend Lady Thornton, supported by the noble Baroness, Lady Jolly, which in Committee we submitted for inclusion in the provisions under the previous Clause 41 on consultation but which now amends the reporting requirements in Clause 44. Our amendment specifies cohorts that must be consulted in preparation of a report to Parliament, including patients and their representatives, and other key industry stakeholders from healthcare, pharmaceuticals, veterinary and medical research organisations, and healthcare providers and regulators.

Once again, we come back to the importance of ensuring that patients and end users are part of and involved in consultation and reporting relating to existing and potential new medicines, veterinary medicines and medical devices. The stark lessons from the Cumberlege review, the Ockenden review and many other reviews that we have had are that patients’ voices must be heard.

For the record, we feel that the Government’s reporting requirements amendment falls short of providing the reassurances that we sought in Committee, because the relevant authority still has ultimate discretion over whom it consults. This could mean that any report could be skewed or biased by those chosen at the discretion of the Government. That is why our Amendment 78 details the key stakeholders that should be consulted.

In response to that amendment, I am sure that the Minister will come back to the often stock response to the inclusion of specific stakeholders in the Bill, namely that this would be too rigid and burdensome, and would inadvertently rule out contributions from those accidentally not listed. However, in the context of a very complex Bill and the history of often poor communications with stakeholders, I urge the Minister, if she is not happy with our list, to consider a broader amendment at Third Reading that would provide the reassurance that is clearly needed.

I come back to the key issue of regulatory divergence between Northern Ireland and the UK and reporting on this matter. Marketing, authorisation and trading processes on medicines and medical devices between Northern Ireland, the EU and the UK are complex issues, and many remain unclear. The Northern Ireland protocol and the provision for ongoing discussions to resolve key issues mean continued uncertainty for businesses, health services and patients. In this context, an annual rather than a two-yearly report to Parliament would have been more appropriate, particularly highlighting the problems arising from regulatory divergence, and the plans and progress on addressing them.

This is not the time or occasion to go into detail on the issues covered in Committee. However, in Committee the noble Lord, Lord Patel, highlighted many key matters and concerns arising from the MHRA’s guidance on regulating medical devices from 1 January 2021, issued in September 2020, before Committee. I know that the MHRA has been pretty busy of late with the vital Covid-19 vaccination authorisation, but can the Minister tell us when it is envisaged that the MHRA guidance will be updated and reissued?

We have sought and been given reassurances from the Minister that the MHRA’s staffing, resourcing and capacity have been substantially increased to meet its new obligations. It is a much-respected body, but, as we have said, it faces huge challenges under its new role, and we suspect that the £13 million additional funding provided to it by the Government up to the end of March 2021 will be just a pump-priming starter in the light of all that needs to be done. The Minister’s reassurances over the MHRA’s strategic development plans and the Government’s commitment to further funding are welcome, but this is something that we will need to keep a close watch on. I beg to move.

[Lord Patel (CB) [V]]

My Lords, from the outset it has been clear that there was a potential for regulatory divergence in Northern Ireland from the rest of the UK for medicines and veterinary medicines, since they are referred to separately in the Bill as reserved matters in Northern Ireland. However, it has been made clear in the last quarter of 2020 that interaction with the Northern Ireland protocol makes that divergence inevitable for medical devices as well.

Guidance published by the MHRA in October, which I referred to previously, and statutory instruments laid before Parliament in the final months of 2020, set out two different systems of market authorisation and registration, among other issues, and distinguished between the Northern Ireland and Great Britain markets for medical devices and medicines alike. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland, while CE marks will cease to be recognised in the Great Britain market from July 2023 unless the products in question are from manufacturers based in Northern Ireland.

There are essentially two paths for manufacturers based in Northern Ireland to bring a medical device product into the Great Britain and Northern Ireland markets. The first is to go through UK-based approved bodies for their assessment and market authorisation, which will be approved for both the Great Britain and Northern Ireland markets but will not be recognised in the EU. The second is to submit an application to approved or notified bodies in the EEA to gain a CE mark and thus access to the markets of Great Britain, Northern Ireland and the EU without further needing to apply to a UK body for approvals for the Great Britain market.

By contrast, manufacturers based in Great Britain will need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland, but will need to undertake the separate task of setting up an EU-based responsible person and apply separately for a CE mark in the EU. It appears that the recognition of a CE mark on a medicine or device coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. What is not clear is the extent to which this dual system between Northern Ireland and the rest of the UK will diverge in substance.

For these reasons and many others, the Government should clarify the position. The amendment would provide greater transparency on potential regulatory divergence, with a commitment to mitigate it where possible. Of course, I will not be surprised if the Minister does not accept the amendment, and neither do I think the noble Baroness will divide the House on it, but whether we agree with it or not, I hope the Minister will agree that somebody has to have some way to recognise what this divergence will do. Who will that be? Would she agree that this will be needed in due course?