Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

Baroness Wheeler Excerpts

Wednesday 2nd December 2020 Lords Chamber

[Baroness Wheeler (Lab)]

I thank the Minister for introducing the regulations, and other noble Lords for their contributions and key questions on these two important instruments. I also thank my noble friend Lord Blunkett for the speech he decided not to make. As noble Lords have said, it is timely to discuss these instruments now, as we take stock of the Medicines and Medical Devices Bill Committee discussions and outcomes, await Report dates and deliberations, and meanwhile continue the so far helpful discussions on a number of key issues taking place between the Minister, ourselves and other noble Lords involved with the Bill.

For the record, the Bill has changed substantially as a result of government amendments agreed in Committee —not by consensus among participants, as we normally would have expected, but by the Government’s insistence that it was necessary to agree the amendments in Committee to comply with the requirements and timescales for consultation on the Bill with the Department of Health in Northern Ireland and the Northern Ireland Assembly.



We are now working our way through the “new” Bill to assess the full impact of this departure from established procedure and, in particular, the response from the Government to the deep concerns of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee on the use of delegated powers across a range of provisions in the Bill. I note that the Government have not formally responded to these committees, as is also usual practice, other than broadly commenting in the course of their response on individual proposed amendments, or in general correspondence from the Minister in his letter to Peers of 13 October and to the noble Lord, Lord Lansley, of 18 October. Can the Minister tell the House if he plans to respond to the committees, explaining not only how their concerns have been addressed but by which specific government amendment? This information is pretty crucial to all involved as we continue to discuss the Bill with Ministers prior to Report.

The regulations today are confirmed through the affirmative procedure instruments. I would be grateful if the Minister can today confirm that the Government will use this procedure in all regulations on human medicines and medical devices, as also promised in his letter of 13 October.

We have had a good, if short, debate on these SIs, which are long, complex and technical, but which we recognise as a necessary step towards ensuring that people are kept safe when using medicines and medical devices after the end of the implementation period for exit from the EU. I will not repeat the content and purpose of the regulations, which have been well explained by the Minister and other noble Lords and also documented in the very helpful Explanatory Notes and Library briefing, and by the most helpful summary of all, in my view, the Commons Minister Edward Argar’s bullet-points letter of 20 October. In the main, the key issues are the ones we have closely examined in Committee, and which continue to be under discussion.

I want to reinforce and add to the questions raised by some noble Lords. First, on the landmark Cumberlege report, I referred earlier to the helpful discussions taking place on the implementation of this vital review, in particular the establishment of a patient safety commissioner. The Minister referred to these discussions, but he knows that a clear statement of commitment from the Government is needed on this and is long overdue. Can he update the House further on the progress of the discussions? The Minister in the Commons promised strengthened regulations to do more to protect patients, and to use the powers in the MMD Bill for this. He said that plans are in development which will take into consideration both international standards and global harmonisation in the establishment of our future system. I look forward to further information from the Minister about these budding plans and the timescale for when we can expect information and consultation on them.

My noble friend Lord Blunkett touched on the powers of the MHRA in relation to vaccines, and the powers generally in the Bill. There have been deep concerns about how the MHRA is to be staffed and resourced to meet the huge challenges of its future role as the UK regulator of all medicines coming into Great Britain and Northern Ireland. It is a much respected body, but its capacity and expertise will need to be hugely expanded to meet its new obligations and duties. The £13 million in additional funding from the Government up to the end of March 2021 will, I suspect, be just a pump-priming starter. Can the Minister tell the House the planned annual budget for the MHRA up to the end of year three of its operation under its extended remit?

The conformity assessment—the UKCA mark—will be available for industry to use for medical devices placed on the market in Great Britain from the end of the transition period. Is the Minister confident that manufacturers have been given sufficient time and guidance to prepare for the UKCA marking?

What assessment have the Government made of the impact these new regulations could have on the number of approved medical devices in the next few years? According to GlobalData’s pipeline products database, there are more than 17,000 active medical devices currently in the pipeline, with approximately 42% of these devices in the early stages of development. The high proportion of products being developed in the EU and UK indicates that a vast majority of devices will be caught in transitioning approval processes, which may lead to a temporary decline in the volume of approved devices—and, indeed, to the delays that noble Lords have talked about. Many companies are already struggling with the demands of the medical device regulations, including the increased costs. Does the Minister share my concern that this, coupled with the additional authorisation process required to reach the UK market, may lead to delays or deter companies from selling their products in the UK altogether?

Under these regulations, the UK will continue to recognise the CE marking on medical devices and in vitro diagnostic devices which have demonstrated their conformity with EU regulatory requirements, until July 2023. Will the UKCA marking be recognised by the EU? Can the Minister confirm whether the EU falsified medicines directive, referred to by the noble Baroness, Lady Bennett, will apply in the UK after Brexit? If not, packs of medicine intended for the UK that are not compliant with the directive may not be lawfully dispensed in Northern Ireland.

The complexities businesses face are considerable and have been exacerbated by the Northern Ireland protocol, which requires companies seeking marketing authorisation to be able to sell a new medicine in the UK to continue to follow EU procedures in respect of Northern Ireland. Can the Minister confirm whether a single marketing authorisation will suffice or whether new companies will have to obtain a double “EU plus UK” marketing authorisation to sell throughout the UK?

For those of us deeply concerned about the risks of regulatory divergence on medicines and medical devices between Great Britain and Northern Ireland, can the Minister tell the House about the specific work that is being done, in response to the Bill and these regulations, to mitigate the adverse consequences of possible divergence in the medium and longer term? One has to look only at the timely and expert analysis of the noble Lord, Lord Patel, of the MHRA guidance on this issue in Committee to see that there are key issues that remain unclear and unresolved, and deep confusion around how the dual systems will work in the future.