Medical Devices (Northern Ireland Protocol) Regulations 2021

Lord Bethell Excerpts

Monday 12th July 2021 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Medical Devices (Northern Ireland Protocol) Regulations 2021.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, the statutory instrument that we are discussing today relates to the regulations for medical devices within Northern Ireland. It reflects the application of EU regulation 2017/745 on medical devices, which I will hereafter refer to as the EU medical devices regulation, under the terms of the Northern Ireland protocol. As noble Lords will be aware, the protocol agrees to continue applying certain EU rules in Northern Ireland to recognise the unique status of Northern Ireland within the UK and to uphold the Belfast/Good Friday agreement. It is important to remember that this instrument does not apply the EU medical devices regulation within Northern Ireland. That legislation took automatic effect in Northern Ireland from 26 May this year, under the terms of the Northern Ireland protocol.

The EU medical devices regulation contains some flexibility areas, where states have the discretion to make policy decisions and adjustments. This instrument therefore makes provisions to apply in Northern Ireland where it serves to align Northern Ireland policy with Great Britain. This is to deliver the Government’s commitment to the pragmatic implementation of the Northern Ireland protocol. In creating the provisions in this instrument, we are minimising the impact on economic operators and the public in Northern Ireland, as the Northern Ireland protocol pledges.

The Medical Devices Regulations 2002, hereafter referred to as the 2002 regulations, will continue to be the relevant regulations for in vitro diagnostics in Northern Ireland, and will operate alongside the EU medical devices regulation and this instrument on the regulation of medical devices and active implantable medical devices.

I shall give some background. This instrument achieves the Government’s commitment to align Northern Ireland with Great Britain, where permitted, in four areas. First, it implements national adjustments for Northern Ireland in areas where the EU medical devices regulation grants member states the ability to make national policy decisions. This has been done in a way that will align with policies in place in Great Britain. Secondly, it sets out the fee structures that keep fees aligned with those applied in Great Britain. Thirdly, it sets out the enforcement regime for activity and violations under the EU medical devices regulation in Northern Ireland. Lastly, it makes amendments to existing regulations, to take account of the application of the EU medical devices regulation in Northern Ireland.

I will first describe areas of national flexibility where this instrument makes provision to change default positions under the EU medical devices regulation to maintain Northern Ireland policy with that of Great Britain. The Government currently permit the remanufacturing of single-use devices, which the EU refers to as reprocessing, so long as the remanufacturer adheres to strict requirements. The default position of the EU medical devices regulation is not to permit remanufacturing unless there is national legislation in place to support it. This instrument does just that. This means that the remanufacturing of single-use devices can continue to take place in Northern Ireland, as well as in Great Britain, so long as requirements under the relevant legislation are followed.

The instrument also introduces provisions so that the MHRA can continue requiring custom-made devices, ranging from dental appliances to orthopaedic moulds, to be registered before being placed on the Northern Ireland market. Provisions are also contained in this instrument that uphold our national requirements for clinical investigations, which are crucial for ensuring that the safety of participants is protected. They do so by maintaining the MHRA’s ability to authorise clinical investigations for all risk classes of medical devices before they can commence. Furthermore, it upholds the requirement for all clinical investigations for custom-made devices to be subject to MHRA assessment. The Government remain committed to delivering improvements to patient safety, and this instrument means that we can respond proactively to any concerns.

By amending the Consumer Rights Act 2015 and the Medicines and Medical Devices Act 2021, this instrument provides the MHRA and district councils in Northern Ireland with inspection powers and powers to serve enforcement notices for breaches of the EU medical devices regulation within Northern Ireland. This will ensure that the MHRA has the enforcement powers it needs to ensure patient safety is prioritised and high standards are maintained for the people of Northern Ireland.

The MHRA charges fees to cover the costs associated with certain aspects of the regulation of medical devices. This instrument details fees which may be charged for activity under the EU medical devices regulation in Northern Ireland, keeping them identical to those charged in Great Britain under the 2002 regulations for similar services. This upholds the Government’s commitment to ensure that there are no disadvantages to economic operators in Northern Ireland as a result of the Northern Ireland protocol. This instrument does not introduce any fees for new requirements under the EU medical devices regulation.

Finally, this instrument makes technical amendments to other legislation, including the 2002 regulations, to reflect the application of the EU medical devices regulation within Northern Ireland. This will ensure the regulatory landscape operates effectively in Northern Ireland. Officials in the Northern Ireland Executive have been kept informed of the progress of this instrument and I am hugely grateful for their continued collaborative approach. As the nature of the changes in this instrument are technical in many instances, the impacts of the instrument do not meet the threshold for impact assessments, hence these are not provided.

In conclusion, this instrument upholds the Prime Minister’s commitment to the Northern Ireland protocol and to minimise the impact on the activities of economic operators and the public in Northern Ireland. The significance of our public healthcare system has never been clearer than during the Covid-19 outbreak, and this instrument will ensure that the UK’s exceptional standards of safety are maintained within Northern Ireland. This is something we must support. I commend the regulations to the Committee.

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

The noble Lord, Lord Hunt of Kings Heath, has withdrawn, so I call the next speaker, the noble Lord, Lord McColl of Dulwich.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, as a responsible Government, it is absolutely imperative that we deliver on the Northern Ireland protocol and do so pragmatically to minimise the impact on the activities of economic operators and the public in Northern Ireland. As was intimated by the noble Baronesses, Lady Thornton and Lady Brinton, we are trying to find a way through. I believe that this instrument achieves that and, in doing so, ensures that high standards for patient safety are maintained throughout the United Kingdom.

I assure the noble Baroness, Lady Hoey, and other noble Lords who asked similar questions that the Government are fully committed to a system of medical device regulation that prioritises safety and safeguards public health. As such, the department has sought to minimise any disruption to patients and industry by providing consistency in policies where that is possible and ensuring a functioning statute book for the regulation of medical devices in Northern Ireland.

My noble friend Lord McColl asked about an advisory body. No formal advisory body is currently planned, but we will take his suggestion on board. NHS Digital is working with industry on a surgical devices register and, as such, is extremely engaged with industry in the manner to which he alludes. On the matter of deadlines, I agree with him about the importance of high service levels, but that is best left for management, not for secondary legislation. Compensation is covered in a large number of fora, including the courts, and is best left there.

I reassure my noble friend Lord Lansley about the Government’s commitment to unfettered access. As set out in the Government’s Command Paper of 20 May 2020, the UK’s approach to the Northern Ireland protocol ensures unfettered access to Great Britain for Northern Ireland businesses. It protects the territorial integrity of the UK by safeguarding Northern Ireland’s place in the UK’s customs territory and keeps goods flowing between Great Britain and Northern Ireland, applying measures that help to maintain food supplies and, of course, the flow of medicines. This includes access for medical devices from Northern Ireland businesses that are CE or CE-and-UKNI marked. The CE or CE-and-UKNI marking applies to Northern Ireland now and after June 2023.

My noble friend Lord McColl asked about mesh. We wholeheartedly commit to demonstrating to the patients and families who have shared their experiences during the Cumberlege review, and to anyone else who has suffered, that we have learned from them and are changing and improving because of what they have told us. The SI focuses on implementing the EU medical devices regulation in Northern Ireland under the specific powers of the European Union (Withdrawal) Act 2018, which would not extend to making changes to the regulations to respond to my noble friend Lady Cumberlege’s review. The Medicines and Medical Devices Act 2021 provides the powers for future regulations that have patient safety at their heart, and we are reflecting on the lessons from the Cumberlege review for future regulations. We will consider questions on the responses.

The points made by the noble Lord, Lord Dodds, on the 300 manufacturers are extremely well made. I reassure him that we are committed to implementing the protocol, but we must do so in a way that is sensible, balanced and attuned to the unique circumstances of Northern Ireland. As the noble Lord has already noted, my noble friend Lord Frost and the Secretary of State for Northern Ireland have recently made public statements on the Northern Ireland protocol. The Government are carefully considering next steps and will set out their approach to Parliament before the Summer Recess.

I reassure the noble Lords, Lord Dodds and Lord Empey, and the noble Baronesses, Lady Hoey and Lady Ritchie, that the Government are committed to adopting a pragmatic approach to regulatory divergence, seeking to minimise the impacts wherever it is possible to do so. I cannot emphasise enough that the changes contained in this instrument are essential to delivering on that commitment. The instrument does so by providing consistency between regulations in Northern Ireland and Great Britain where we are not constrained by the EU medical devices regulation. The instrument also ensures that when a medical device complies with the EU medical devices regulation and is a qualifying Northern Ireland good, it can be placed on the market in Great Britain without needing to meet any further regulatory requirements.

The noble Lord, Lord Empey, asked about future regulation. I reassure him that for a two and a half year period after the end of the transition period, devices compliant with EU medical devices regulation and EU in vitro diagnostics regulation can be placed on the Great Britain market as part of the UK’s acceptance of EU-regulated CE goods.

In answer to the noble Baroness, Lady Thornton, the UK will be consulting shortly on the future of Great Britain’s medical device regulations which will include a review of the elements of EU medical devices regulation and EU in vitro diagnostic devices regulation which benefit patient safety and patient access. Work on the future Great Britain regulatory regime will explore any risks around regulatory divergence between Great Britain and Northern Ireland.

To the noble Baroness, Lady Brinton, as I said in my opening remarks, by keeping the fees in Northern Ireland the same as those charged for equivalent activities in Great Britain under the 2002 regulations, this instrument ensures that there are no financial deterrents which may cause any disadvantage for Northern Ireland manufacturers or those carrying out clinical investigations.

By way of summing up, I thank noble Lords for their valuable contributions to this debate. I reassure all noble Lords that as a Government we are fully committed to ensuring that patient safety in all parts of the UK is prioritised and that high standards are maintained within Northern Ireland. I am enormously grateful for the support shown by many noble Lords for these measures, and I commend these draft regulations to the Committee.

Motion agreed.