HANSARD
Medical Devices (Northern Ireland Protocol) Regulations 2021
- Considered in Grand Committee
- 2:30 pm
- Moved by
- That the Grand Committee do consider the Medical Devices (Northern Ireland Protocol) Regulations 2021.
- 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 noble Lord, Lord Hunt of Kings Heath, has withdrawn, so I call the next speaker, the noble Lord, Lord McColl of Dulwich.
- 2:37 pm
- My Lords, as there are more than half a million of these devices on the market, it is understandable that effective regulation should be in place and workable. It is also clear that most of us will need one of these devices at some time in our life. It is to be hoped that these regulations will give patients more information and choice, and that they will benefit from more up-to-date therapies. I ask the Minister this: what will be the effective way of seeking expert opinions on the wisdom of a proposed new operation that does not necessarily involve a medical device? It would be helpful to have a second opinion on whether it is likely to be feasible and safe.As there are often notoriously long delays in obtaining answers from official bodies, and we are talking about regulations now, has any thought been given to placing a regulation to require answers within a certain time?There has been discussion about a robust financial compensation mechanism to ensure that patients are dealt with fairly and justly for the damage caused by defective devices and by their inappropriate use in certain parts of the body. For instance, the mesh which caused so much damage in operations for incontinence is used widely and safely in hernia operations. Could the Minister tell the Committee who will operate these compensation mechanisms? Who will decide whether compensation is justified and how much to award?
- 2:39 pm
- My Lords, in his introduction, my noble friend the Minister talked about upholding the protocol and upholding the Belfast agreement. I say to my noble friend that the protocol, and what is flowing from it, including what we have before us today, drives a stake through the heart of the agreement because it breaches one of the fundamental principles—but that is an argument for another day.The Minister also referred to enforcement regulations. What we are trying to do here is to circumvent the imposition of rules and regulations on these devices that will be made by the European Union and ratified by the European Parliament as we move forward. We will have no say or role in any of that—neither will the Minister—so we are trying to pretend that we are not simply rule-takers here. We are trying to indicate that we are doing something that will have an impact and minimise the damage. That is basically what this is about.I would like to know from the Minister what the future will hold. The United Kingdom and the European Union basically start off on the same page, because we spent 43 years as part of that union and were involved in all the standards that were set up until this point, but those will diverge over time. I want to know from the Minister what his and the Government’s approach will be if, over time, these regulations start to diverge.We saw on the vaccine issue that the European regulatory regime operated at a much slower pace than our own, here in the United Kingdom. What would be the implications in future if devices were conceived and made available in Great Britain, under whatever rules might apply, but had not been accepted in the European Union? Would people living in Northern Ireland not get access to such devices in future? That is at the core of our concerns over this and a whole range of other items that will arise from the protocol.
- 2:43 pm
- My Lords, I am grateful to my noble friend the Minister for his clear introduction to these regulations. I want to take the opportunity to comment on just one aspect of these arrangements: the processes for a conformity assessment on medical devices placed on the market in Northern Ireland.A European conformity assessment, a CE mark, is to continue to be recognised in the Great Britain market until 30 June 2023. Likewise, the certificates issued by EU notified bodies will continue to be recognised until that date. It seems to me that, if one is a Northern Ireland-based manufacturer of a medical device—the Explanatory Memorandum estimates that there are some 300 such businesses—for the next two years the CE mark should be a sufficient basis for placing a product on the market, whether in the EU, Northern Ireland or Great Britain. I would be grateful if my noble friend were in a position to confirm what I say or correct me.If a Great Britain manufacturer is meeting EU requirements then, from 2023, it will require a UK conformity assessment, but this in itself will not enable its product to be placed on the market in Northern Ireland—hence the references in these regulations to the “UK(NI) indication”, which appears to become of greater significance after 1 July 2023. From that time onwards, British manufacturers will be required to adopt dual marking and conformity assessment through two systems, with the attendant cost and complexity. Obviously, the same is true for non-EU third-country suppliers.At the heart of this problem is the failure of the trade and co-operation agreement to provide for mutual recognition of conformity assessments, given the simple fact that, as my noble friend Lord Empey adverted to, our MHRA undertook 40% of the most significant assessments in the EU. We do not have divergent technical standards; what we have, unfortunately, are divergent political priorities. I personally do not blame Theresa May’s negotiators for our failure to secure that mutual recognition.
- 2:46 pm
- My Lords, I begin by thanking the Minister for his clear explanation of the purposes of this secondary legislation. The statutory instrument is necessary, of course, only because of the Northern Ireland protocol, as the Minister made clear. That protocol means that EU law is applied to Northern Ireland across a wide range of matters without any elected Member of the Stormont Assembly or this Parliament having any vote on the matter.On Friday, in evidence to the Northern Ireland Assembly, the noble Lord, Lord Frost, said that“you need to have broad consensus”to make the protocol work between now and four years’ time,“and the fact we don’t have it is what worries us so much.”He has also said previously, in speaking to the Northern Ireland Affairs Select Committee on 16 June, that“the protocol depends on consent. It is very difficult to operate it if there is not consent and willingness from one segment of Northern Ireland opinion”.I am sure the Minister will confirm his agreement with his ministerial colleague on this vital issue.So we have before us this afternoon a situation where the EU regulation on medical devices entered into force in Northern Ireland directly on 26 May, and Northern Ireland is now subject to the EU regulatory system for medical devices and not the UK one. This statutory instrument is necessary to try to meet the challenges and practical applications of the EU directive applying directly to Northern Ireland. Whatever the mitigations, it would be better in every sense if Northern Ireland were simply in the same regime as the rest of the United Kingdom. Most medical devices, and £600 million-worth of medicines, are brought into Northern Ireland every year, 98% of which are from Great Britain. As has been mentioned, there are 300 operators of medical devices in Northern Ireland affected by this SI.
- 2:50 pm
- Lord Bhatia (Non-Afl) [V]My Lords, the changes that the EU MDR introduces will affect medical device economic operators in Northern Ireland, estimated to be about 300, and any prospective UK notified bodies. This instrument does not implement the EU MDR itself, but updates the statute book to allow us to implement the EU MDR effectively and addresses areas of national decision to align with policy that applies in the rest of the UK. Specifically, these areas of national decision allow for the continued practice of allowing the reprocessing of single-use devices, if reprocessors adhere to the requirements of an original manufacturer. The instrument will also give the MHRA powers to serve enforcement notices for breaches of the EU MDR.The instrument will correct current legislation where required, introduce relevant enforcement provisions and outline the fees structure for Northern Ireland. It will introduce provisions in areas of flexibility allowed for under the EU MDR, to allow Northern Ireland to continue to align with Great Britain policy, where possible.In addition to the 2002 regulations, the instrument also makes amendments to the following retained EU law: namely the Blood Safety and Quality Regulations 2005, to include a reference to the EU MDR alongside the reference to the 2002 regulations; and the human tissue regulations 2007, to include a reference to the EU MDR in order to maintain the scope of the regulations.I believe that this instrument will protect the safety of medical devices that will be used in the UK and Northern Ireland.
- 2:52 pm
- My Lords, I thank the Minister for his explanation. In moving this SI, he made a very brave attempt almost to make it seem as if it is terribly normal and wonderful and no one should be worried about anything in it. In fact, he has made the best of a bad job because, as the noble Lords, Lord Empey and Lord Dodds, said, the reality is that this SI is not something we should even be thinking of discussing, let alone supporting.I accept that some of the moves in it are to make things a little better for the 300 or so device manufacturers in Northern Ireland, and to make it seem—as the noble Lord, Lord Empey, said, it is almost a pretence—as though there is nothing wrong with what is happening. It is particularly sad to say today—and I hope that everyone has had a good Twelfth of July, at the commemoration and celebrations going on in Northern Ireland—that we are in a situation where the protocol is now dividing Northern Ireland from the rest of the United Kingdom, more and more. What we have seen today will be the first of many inevitable divergences, not just in this area of medical apparatus and medical issues but throughout, because we are left in the situation where the European Union is going to make those laws.As has been said by many of us, over and again, and as has been said today by the noble Lords, Lord Dodds and Lord Empey, this is completely undemocratic. No one has been asked about this. From 21 May, we have simply had to take what the European Union has said on this issue. Whether it is right, wrong, good or bad is not the issue; the issue is one of basic democracy and consent. It is even in the Explanatory Memorandum, which talks about allowing“Northern Ireland to continue to align with Great Britain policy where possible.”Who decides “where possible”? It certainly will not be the people of Northern Ireland; it will be when and where it is permitted under the EU.
- 2:56 pm
- 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?