Medicines and Medical Devices Bill: Legislative Consent Motion

Executive Committee Business – in the Northern Ireland Assembly at 5:30 pm on 16th June 2020.

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Photo of Roy Beggs Roy Beggs UUP 5:30 pm, 16th June 2020

I Call the Minister of Health to move the motion.

Photo of Robin Swann Robin Swann UUP

I beg to move

That this Assembly endorses the principle of the extension to Northern Ireland of the provisions within the Medicines and Medical Devices Bill, as introduced to Parliament on 13 February 2020, dealing with human medicines and veterinary medicines.

Photo of Roy Beggs Roy Beggs UUP

The Business Committee has agreed that there should be no time limit on this debate.

Photo of Robin Swann Robin Swann UUP

Mr Deputy Speaker, I am aware that the Assembly's Standing Order 42(a) provides that a legislative consent motion (LCM) is not normally moved until at least five working days after publication of the Committee report or 20 working days after the date of referral to the Committee. I realise that, in this instance, the provisions of the Standing Order have not been met. However, it is necessary to move the motion today to ensure that the debate takes place before the Medicines and Medical Devices Bill reaches its reporting stage in the House of Commons, which, we were advised, is likely to be on 18 June.

By way of explanation, I trust that Members will appreciate that, in recent times, none of us has been operating in what we would call normal circumstances. As has been the case with the work of the Assembly, the reality is that many aspects of the work of the Northern Ireland Civil Service Departments, particularly my own, have had to be put on hold to prioritise responses to the COVID-19 outbreak. Indeed, work on tackling the outbreak has been the complete focus of all our efforts and energy to date.

The Medicines and Medical Devices Bill has two main purposes. The first is to provide a mechanism for strengthening and maintaining the regulatory system for medicines, both human and veterinarian, clinical trials and medical devices after the UK leaves the European Union. The second is to consolidate the enforcement framework relating to medical devices and to introduce a new civil sanction regime.

From a Northern Ireland perspective, the provisions within the Medicines and Medical Devices Bill that deal with human and veterinary medicines are transferred matters. As such, they fall within the legislative competence of the Northern Ireland Assembly. A legislative consent motion is, therefore, required to allow Westminster to legislate for these provisions.

Matters relating to human medicines are the responsibility of my Department, while those dealing with veterinary medicines are within the remit of my Executive colleague Mr Edwin Poots at the Department of Agriculture, Environment and Rural Affairs.

Those provisions in the Bill that deal with medical devices are reserved matters. As such, they lie outside the legislative competence of the Northern Ireland Assembly. The regulation of medicines, clinical trials and veterinary medicines has been a matter of European Union competence since the UK joined the European Union. The existing legislative frameworks are provided in the following regulations: the Human Medicines Regulations 2012; the Veterinary Medicines Regulations 2013; the Medical Devices Regulations 2002; and the Medicines for Human Use (Clinical Trials) Regulations 2004.

The EU directive relating to medicinal products for human use has been transposed into UK law by the Human Medicines Regulations 2012 with set standards to protect public health and ensure that medicines are safe and effective. The regulations cover the licensing, manufacture, advertising, labelling, distribution, sale and supply of medical products in the UK. They also set rules governing which products can be prescribed, stored and administered by specified professionals in specified settings.

In an equivalent way, the EU clinical trials directive, which regulates clinical trials involving human medicines, is transposed into UK law by the Medicines for Human Use (Clinical Trials) Regulations. 2004. Similarly, the EU directive relating to veterinary medical products has been transposed into UK law by the Veterinary Medicines Regulations 2013, which set out the UK controls on veterinary medicines, including their manufacture, advertising, marketing, supply and administration. Those regulations also set rules governing which products can be prescribed, stored and administered by specified professionals in specified settings.

The UK Government currently have powers to amend those various regulations by means of subordinate legislation, which is made under powers in section 2(2) of the European Communities Act 1972. However, the problem is that by operation of the European Union (Withdrawal) Act 2018, at the end of transition period section 2(2) of the European Communities Act 1972 will be revoked and the powers will no longer be able to be used to allow us to make amendments by subordinate legislation.

It is necessary, therefore, to maintain the ability to amend those regulatory frameworks once the UK has ceased to have recourse to use the section 2(2) power in the European Communities Act at the end of the transition period. It is, therefore, vital that we have a legislative mechanism in place that will provide us with a delegated power to make any changes to the regulation by means of subordinate legislation.

The Medicines and Medical Devices Bill seeks to provide the necessary delegated powers that can be exercised to make changes to the current regulatory framework for medicines, human and veterinary, medical devices and clinical trials by means of subordinate legislation.

In relation to the regulation-making powers in the Bill, I would like to make it clear that clause 41 (4) provides that regulations made by a Northern Ireland Department acting alone are subject to the draft affirmative resolution procedure. That means that they have to be laid before, and approved by, the Northern Ireland Assembly. The exceptions to that are found in clause 41 (7) and (9), which set out when the negative resolution procedure applies. Members will notice that those are limited.

It is important to make the point that the requirement for the draft affirmative procedure will ensure that the Assembly has the proper opportunity to scrutinise and debate any regulations before they are approved. I also wish to highlight that clause 40 requires that before any regulations are made, there has to be consultation with persons who are deemed appropriate. The only exception to the requirement to consult relates to the circumstances where a regulation is required urgently in order to alleviate a threat of serious harm to the health of the general public, or a section of the public.

I am, of course, aware that we need to be mindful of business in Northern Ireland in the context of the EU exit, and the Ireland-Northern Ireland protocol. This is an important issue for our future access to medicines and medical devices, as well as the potential impact on business. In that context, my officials have had ongoing discussions with colleagues in the UK Government about the implications of the protocol. Members will appreciate that those discussions were put on hold because of the need to prioritise our response to COVID-19. However, I fully expect that those discussions will soon begin to gather momentum.

I trust that Members will understand the importance for Northern Ireland to be included in the provisions of the Medicines and Medical Devices Bill. It is vital for us to have the necessary delegated powers to replace section 2(2) of the European Communities Act 1972 and I ask Members to support the motion.

Photo of Colm Gildernew Colm Gildernew Sinn Féin 5:45 pm, 16th June 2020

Ba mhaith liom caint anois ar thuairisc an Choiste Slainte agus tuairimí an Choiste a roinnt libh. I will speak to the Committee's report and summarise the Committee for Health's considerations of this matter. Ar dtús báire, ba mhaith liom mo bhuíochas a ghabháil leis an Choiste Talmhaíochta, Timpeallachta agus Forbartha Tuaithe as a mhachnamh gasta agus as an mhéid a chuir siad leis an tuairisc. I thank the Committee for Agriculture, Environment and Rural Affairs for its prompt consideration of and contribution to the report. I will leave it to my colleague, the Chair of that Committee, to address the issues around veterinary medicines.

The Minister of Health wrote to the Committee for Health on 1 April and advised of the need for the legislative consent motion. The memorandum was laid on 27 May and departmental officials briefed the Committee on 4 June 2020. On 2 June the Committee invited the Committee for Agriculture, Environment and Rural Affairs to submit its views about part 2 of the Bill on veterinary medicines.

Department of Health officials briefed the Committee for Health on the background to the Bill and on the nature of the powers that are to be provided to the Department under Part 1 on human medicines.

As the Minister outlined, and as his officials have advised the Committee, the relevant provisions were essentially of an enabling nature to provide replacement powers to make delegated legislation once section 2 (2) of the European Communities Act 1972 is repealed at the end of December. Members were assured that, on that basis, the regulations that were to be made under the provisions requiring consent will come back to the Committee for consideration in the usual way, and will be subject to the draft affirmative procedure, as outlined by the Minister.

The Committee's attention was drawn to clause 40, which requires consultation prior to the exercise of powers with regard to human and veterinary medicines, except in emergencies, as referenced under clause 6.

The Committee discussed with the officials the scope of the delegated powers, the impact of the EU exit and the protocol on Ireland — North and South — on the matters covered by the Bill; for example, our participation in the North in EU-wide clinical trials. We also discussed North/South and east-west cooperation and regulatory alignment, and the divisions of powers to be exercised in Britain and in the North. Officials confirmed that the delegated powers were needed because human medicine regulations were updated regularly — usually twice yearly — and that such updates directly affect prescribing practices.

Members inquired about the impact of Brexit in relation to this legislation. Officials confirmed that the area of human medicines is included in the protocol as an area of EU legislation, in respect of which the North will continue to apply certain EU standards. When asked about the potential divergence on a North/South basis, officials stated that there was a greater risk of divergence between the North and Britain. They also advised that work was ongoing between the Department of Health, the British Department of Health and Social Care and the Medicines and Healthcare Products Regulatory Agency (MHRA) to reduce that risk.

By way of example, the North will be required to comply with EU standards on falsified medications, whereas Britain would be free to diverge. In relation to clinical trials, officials stated that the MHRA would continue to manage that area and that there is an aspiration to maintain a close link with the EU, although discussions are still at an early stage.

Officials confirmed that issues around the supply of and access to medicines were being addressed as part of preparatory work ahead of implementing the protocol. The Committee enquired whether a detailed list could be provided setting out the limits of devolved authority to legislate in respect of the protocol and British Government powers. Officials advised that that is a complicated field and that a comprehensive list could not yet be provided but that officials are working through the issues. Officials confirmed, however, that all areas of the Bill address matters that have been within the EU’s remit to date.

The chief pharmaceutical officer has confirmed that the implementation of the protocol would have implications for human medicines, but while that work is ongoing, it is separate from the Bill, insofar as the Bill provides replacement delegated powers to continue amending human medicines regulations in line with current practice.

Tá na hoifigigh le pilleadh ar an Choiste amach anseo le huasdáta faoin phrótacal a thabhairt. Officials have undertaken to return to the Committee in due course to provide an update on the implementation of the protocol.

Before closing as Committee Chair, I would like to address the issue of timing. The Health Committee fully acknowledges that the Department of Health has been under tremendous pressure to deal with COVID-19. However, limited early engagement and the late laying of the LCM have necessarily had an impact on the Committee’s opportunity for scrutiny.

The Committee’s deadline to report under Standing Order 42A was 17 June, and today’s debate should have been scheduled to take place at least five working days after that. The Committee was advised by the Department, however, that the House of Commons could schedule report stage as early as 18 June, and that, therefore, debate on the LCM in the Assembly would be scheduled for today.

The Committee has sought to be as cooperative as possible, but it did not have the opportunity to consider taking evidence from stakeholders due to time constraints and the focus on COVID-19.

In view of the lack of detailed prior engagement on the content of the LCM, the short time frame available for scrutiny of the LCM once laid and the importance of the issues connected to the Bill, the Committee decided that it was not in a position to come to a decision on support for the motion. Nevertheless, I trust that the issues raised and the report produced will aid Members in their consideration today.

I would now like to make a few remarks in my capacity as Sinn Féin's spokesperson for health. The widespread uncertainty caused by Brexit is being felt across all aspects of our lives, creating worry about our livelihoods, our health, our education and our futures. The Brexit catastrophe has been foisted upon this society by the worst instincts of extreme British nationalism and inward-looking exclusionary doctrine that threatens our very way of life here in the North. Ní sinne atá ann. Níor chaith pobal an Tuaiscirt vóta ar son Brimeachta. That is not who we are. The people of the North did not vote for Brexit.

Chaith 56% den phobal inár dtoghcheantair vóta le fanacht mar chuid den Aontas Eorpach, agus is sinne a chaithfidh troid ar a son. Some 56% of people across our constituencies voted to remain in the European Union. It is that majority that we are all tasked to represent. As we stumble through the so-called transition period, it becomes clearer that a potential catastrophic crash out from the European Union could lie ahead. What that will mean for our economy is anyone's guess, but we can be certain that there will be few positives for any of us, as the most optimistic forecast is that the already faltering economy of the North could shrink, or will shrink, by a further 3% to 8%.

We know that Brexit, and particularly a crash-out Brexit, and a failure rate means that the protocol will cause widespread disruption to our economy, as our manufacturing base, agriculture, agri-food sectors and all other sectors of our economy could potentially lose access to a market of tens of millions of customers. That will inevitably have an impact on our health service, and that is also a huge concern.

There is no certainty on anything at this point because there is no certainty that the Tory Government in England will even agree to the very agreement that they made with the European Union. That is the ludicrous situation that we find ourselves trapped in despite the fact that we voted no. In other words, we do not know at this stage if the protocol will even be implemented.

We are now caught in a perfect storm as we find ourselves heading into the worst recession in generations. After 10 years of Tory austerity, which has ravaged our public services, we are also faced with the catastrophic disruption of Brexit. Tá seo go dona dár ngeilleagar, dár gcóras sláinte, agus dár bpobal. That is bad for our economy, our health service and our people.

Photo of Declan McAleer Declan McAleer Sinn Féin 6:00 pm, 16th June 2020

At its meeting of 5 March, the Committee considered a letter from the Minister of Agriculture, Environment and Rural Affairs regarding the Medicines and Medical Devices Bill. That letter noted that it is a Westminster Bill, which is predominantly focused on human medicines and medical devices, with one section that deals with veterinary medicines.

The LCM was tabled by the Health Minister and referred to the Committee for Health for consideration. That Committee asked the Agriculture, Environment and Rural Affairs Committee to consider and comment on Part 2 of the Bill as it concerns veterinary medicines. The AERA Committee took oral and written evidence on the four clauses that make up Part 2, which deals with veterinary medicines, on 11 June. The Bill is complex and technical and we have had limited time to scrutinise it. On behalf of the Committee, I want to be clear that, due to time constraints, we have not had the opportunity to fully explore the implications of the clauses, nor have we had time to consult relevant stakeholders.

During our evidence sessions, one of the first things that we asked officials about was the carry-over of the existing regime. We received assurances that, after the enactment of the Bill, the existing regime developed as part of our membership of the EU would remain largely the same.

The provisions of the Bill that deal with veterinary medicines are in Part 2 of the Bill. Veterinary medicines are transferred and, as such, would fall within the legislative competence of the Assembly. The AERA Committee, therefore, considered clause 8, which deals with the power to make regulations about veterinary medicines; clause 9, which deals with manufacture, marketing, supply and field trials; clause 10, which deals with fees, offences, powers of inspectors and costs, and clause 11, which provides an interpretation of Part 2 of the Bill and supplementary provision. We also considered some sections of Part 4 of the Bill, specifically the issues around the making of regulations and the consultation required.

The EU Veterinary Medicines Regulations 2013 were made on a UK-wide basis and will be transposed into domestic law when we leave the EU. DAERA explained that the Bill is essentially an enabling Bill that does nothing in itself but enables amendments to be made by secondary legislation and that it is considered appropriate to retain that flexibility going forward. After the transition period, the Bill will allow DAERA to amend the Veterinary Medicines Regulations 2013, either by DAERA acting alone or jointly with Westminster. The Committee considered the regulation-making powers and is content that any changes to the current regime must be subject to the scrutiny of the Assembly, irrespective of whether they are made by DAERA acting alone or jointly with Westminster. The Committee is also content that most changes will be subject to the affirmative resolution procedure.

The Committee draws attention to clause 9(2). Under the protocol, this Administration must remain aligned with EU regulations on veterinary medicines. However, the explanatory notes on the Bill state that clause 9(2):

“provides the means for making corresponding or similar provision to the new EU Regulations as the UK sees fit.”

We explored that with DAERA officials, who noted that it refers mainly to new EU regulations that will come forward in 2022. As this jurisdiction must adhere to the protocol and remain aligned with the EU, the provision in clause 9(2) was unnecessary and is, in essence, a dormant power. DAERA officials explained that they had indicated to Westminster that they would prefer that it was not included and had asked for it to be removed. DAERA accepts that it is unlikely to happen and indicated to the Committee that it could live with it. Further consideration of the issue by the Committee yielded that the only circumstances in which the provision in clause 9(2) might be used were if the Assembly voted to remove the protocol in four years. However, DAERA officials noted that, even in this scenario, it was difficult to see how that power would be exercised, because, at that point, the 2022 EU regulations would have been incorporated into the veterinary medicine regime.

The Committee is also aware that a common framework is being developed to maintain a consistent and common approach between all four jurisdictions in the area of animal health and welfare issues. It is expected that that will include the regulation of veterinary medicines post-transition, that is after 31 December 2020. The Committee noted that it had not yet considered the common framework and that that left a gap in knowledge that it was unable to address due to a lack of time.

Reference was also made to clause 8(2)(c), especially on the need for clarity on the word "attractiveness". DAERA officials agreed to provide further clarity on that as a matter of urgency. That clarity was received but it was too late to be included in our written report to the Health Committee. However, in an email to the AERA Committee, DAERA stated that it consulted with the relevant Department and the response was:

“It notes that the rationale for the relevant provisions is to ensure that before the regulations are made, consideration is given to matters such as barriers to the market and the need to ensure that the UK remains somewhere that manufacturers want to develop and test human, veterinary medicines and medical devices following the end of the transition period. The UK Department has indicated that the provisions intend to ensure that the whole of the UK can regulate effectively and to reflect the eventual outcome of the UK’s Future Relationship with the EU.”

At the meeting on 11 June, although Committee members were extremely unhappy that they did not have time to fully explore, consult on and scrutinise the LCM, they were content with the LCM as related to the veterinary medicine provisions in the Bill.

My colleague Colm Gildernew touched on many of these issues, but I want to make the point that this has come about as a result of Brexit. We will see a repeal of the 1972 European Communities Act at the end of the transitionary period. That will mean that the Veterinary Medicines Regulations 2013 no longer have to be aligned with the EU. In order for us to avoid a legislative gap here and so that we continue to be aligned with the EU as per the protocol, it is necessary for us to bring in this LCM. As I said, we are not happy with the lack of scrutiny or, indeed, the fact that this is another very unfortunate by-product of a Brexit process that the majority of people here did not accede to or vote for in the first place.

Photo of Pam Cameron Pam Cameron DUP

I support the legislative consent motion. As we continue the processes associated with leaving the European Union, I suspect that we can expect more of these LCMs. They are an important aspect of the legislative process of taking back control. There is little matter of major controversy in the detail of this LCM and, as such, my party and I will support the motion. I intend to highlight only a couple of issues so as to not unnecessarily delay the proceedings of the House this evening.

First, we see the benefits of being able to regulate as an independent nation in an ever-evolving medical world. We see here that, free from EU red tape and bureaucracy, we can now act swifter and more decisively in response to new situations. That can only be a good thing for those who need treatment and those who innovate, research and deliver new products.

I want to address the issues of research relating to medicines and devices. Members will know that, in my South Antrim constituency, we have the world-leading Randox laboratories. This company strives for better and strives to use the world-leading research and development that it has at its disposal at considerable cost to lead in the field of medicines and pharmaceuticals. As we look to recover from COVID-19 and how it has impacted on our economy, we need to support firms like Randox and the many other local companies in this field. We also need to look to support our local universities and private sector to lead in the field of medicines and devices. Opportunities exist; we need to take them and ensure that medicines and medical devices are accessed sooner and safer than ever before.

Finally, patient safety must be at the core of this debate. Patient safety must never be sacrificed; rather, it is my hope that safety will be enhanced and further enshrined by the legislation before us. The Bill has the potential to go further on patient safety than we could under the European Union's framework.

We, as a party, will support the proposal to endorse the principle of the extension to Northern Ireland of the provisions in the Medicines and Medical Devices Bill, as introduced at Parliament on 13 February 2020, that deal with human medicines and veterinary medicines. We believe that it is in the interest of good government and consistency across the UK.

Photo of Colin McGrath Colin McGrath Social Democratic and Labour Party

I appreciate that there is a necessity for this legislative consent motion. I understand from the presentation that was given to us at the Health Committee that officials are aware of the need to have this legislative instrument to be able to make crucial and critical decisions down the line. However, I am somewhat concerned that the impact of the motion will be to leave more questions than answers. When we questioned officials at the Committee, they were unable to tell us what the specific ramifications of the motion could be, and that has led me to the conclusion that I am unable to actively consent to the motion. However, in addressing the need that the officials mentioned to us and outlined, I will not actively block it from proceeding either.

The LCM is needed, ultimately, because of Brexit. Exiting the European Union has a raft of implications that impact on us well beyond the mantra of taking back control. Again, we learn that the impact is more in reality than the simplicity of simply three words.

Many medical devices and, indeed, drugs and other pharmaceutical products are regulated by Europe using the combined knowledge, experience and understanding of 28 countries' medical and pharmaceutical experts. Alas, that will be for us no longer, and the UK will have to try to replicate that work, experience and skill. With the potential of a no-deal Brexit, the ramifications could be that future joined-up working might be in jeopardy. However, again, the key term is "might". It might be; there might be difficulties. Yet again, another industry is subjected to the highs and lows of uncertainty emanating from this badly managed and roughshod Brexit process.

The lack of consultation, which another Member referred to, with the Committee and the fact that its members were not able to engage with the sector to find out what the ramifications of the process would be is not good practice. When we are not able to find out what the impact would be, that is not a good way of making laws or agreeing to other laws.

As a result of all of that lack of clarity, I do not wish to support the LCM, but, due to the issue's importance and urgency and the dire impact that it will have on people and industry, once again, I urge the British Government to —.

Photo of Mike Nesbitt Mike Nesbitt UUP

I thank the Member for giving way. I hear a lot of Members from the far side of the House talk about the lack of best practice, and I get that. However, we have just demonstrated the lack of best practice by approving, retrospectively, lockdown measures being eased. The Executive Office brought, retrospectively, legislation to be approved by the Member's Committee. At the moment, nobody on any of the Statutory Committees is able to fulfil his or her obligation, under section 29(1)(a)(i) and (ii), to advise and assist Ministers of the Executive. We are just not able to do that. I do not think that we should be picking on this Minister on this occasion, because it is now the rule that we seem to be applying.

Photo of Colin McGrath Colin McGrath Social Democratic and Labour Party

I thank the Member for his intervention and wholeheartedly agree. I refer to the previous debate in which I said that every time that I have taken to my feet to speak, I have said that I am unhappy with the process. Should we be giving the critical assessment to this Minister in this place now? Yes. We should be doing it every time that we see laws being put through the Chamber in an imperfect way. I think that to simply sit back and accept that without challenging it means that we are not fulfilling the proper job that we are sent to the Chamber to do.

I think that the best way to sort out all the issues where there is a lack of clarity is for the British Government to swallow their pride and ask for an extension to the transition period, so that proper scrutiny and proper consideration can be given to the impact of rules that are being stuffed through in London, Edinburgh, Cardiff and here. I just do not think that it is perfect at all.

Photo of Paula Bradshaw Paula Bradshaw Alliance

I rise on behalf of the Alliance Party to support the motion, as it is enabling legislation that we will have to pass in some form anyway. As the party's spokesperson on health, my remarks will focus on Part 1, which comprises clauses 1 to 7 and concerns medicines; that is to say, the aspect of the UK Bill that is devolved to Northern Ireland and falls specifically under Health.

This is an enabling Bill that affects matters of significant importance. Naturally, as we know only too well, the supply of human medicines is one of the most important issues that we have to deal with in our roles, and it includes fees, offences and falsification.

The Bill offers clarity about how that will continue to happen and what our role will be. Notably, that is devolved only to Northern Ireland currently, and, for reasons that I will come to, that may prove relevant and useful.

On top of that, Northern Ireland is a world leader in the manufacture and marketing of medicines and in research involving clinical trials, both of which were placed hugely at risk by Brexit. We have already seen pharmaceutical operations shifting over the border to ensure that they are still in the EU. Again, there is an opportunity here to emphasise that there is, at least, the potential that that does not need to happen. In my view, Northern Ireland can potentially, at least, remain a fully regulated supplier to the EU market. We need to be clear that, as the Bill is an enabling Bill, the issue of medicine supplies will remain in our hands. Emergency supplies of medicines is, rightly, handled in a distinct way; ultimately, however, what we are enabling is maintenance of the status quo — world-class regulation combined with local control.

That is not to say that my colleagues and I have no issues with the motion. We are concerned that, as has been mentioned already this evening, current circumstances did not enable proper scrutiny of the legislation and its impact, which, although it is enabling is, nevertheless, specialist. It is frustrating that we have not had enough time to properly engage with the Pharmaceutical Society of Northern Ireland or, indeed, with the pharma sector in general. Nevertheless, relevant future regulations should be subject to appropriate scrutiny and consultation of that nature.

That brings us to exactly what the impact of the UK's withdrawal from the EU legal framework, which is scheduled for the end of the year, will be on the provision and supply of medicines. Notably, paragraph 20 of the Ireland /Northern Ireland protocol of the withdrawal agreement, which applies regardless of any trade deal or extension, makes it clear that the European Community code relating to medicinal products for human use and similar measures, including those on good clinical practice in clinical trials, continues to apply in Northern Ireland. So does the regulation concerning the compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems. Therefore, to a large extent, EU standards will continue to apply to the sector here.

The Bill will present challenges with regard to clinical trials, because we will remain subject to the management of the UK-wide Medicines and Healthcare products Regulatory Agency. I hope that that essentially means that work across the UK, at least with regard to clinical trials, will remain aligned, which is clearly in everyone's interest. That is why we may be glad that the issue is devolved, because there is a challenge, ultimately, of potential east-west divergence in medicines regulation, including falsification. Conversely, it provides a significant potential opportunity for pharmaceutical companies and clinical trials based in Northern Ireland, because, as they will continue to apply most EU standards, products will continue to be exported freely. The benefits of EU single market membership in those sectors will, largely, still apply.

That does not mean that it is anything other than frustrating that we have to take time to deal with the issue at all. This is the unnecessary bureaucracy of Brexit, and there is still no clear benefit from doing any of it. Hard-pressed departmental officials, for example, have had to take up extra time just when they are under extreme pressure with COVID-19 to manage the motion and the consequences of the issues around it. Their time would be far better spent focused on rebuilding and reconfiguring health services without any further complications, potential or otherwise. Therefore, we can see the challenges ahead, arising not from the Bill itself but from the circumstances that make it necessary.

Nevertheless, we must also try to find the opportunities inherent in being able to chart our own path while adhering to the standards of the largest multinational single market in the world. Fundamentally, however, the motion is about approving an enabling Bill that will, as far as possible, leave things as they are on these vital matters, while allowing for the important scrutiny of future decisions on those vital matters to be in the hands of those who are elected to this House. Therefore, the motion has my support.

Photo of Alan Chambers Alan Chambers UUP 6:15 pm, 16th June 2020

I had not intended to speak on the issue, but my party supports the motion. The Chair of the Health Committee rightly reported that, at its meeting, the Committee was unable to come to a conclusion to support the motion. It is only fair to point out that the Committee was split down the middle — 4:4 — on the issue. We cannot, therefore, convey the sense that there was some sort of unanimity in the Health Committee: there was not. The Committee was divided on it.

I want to refer to Brexit. We keep hearing the mantra that Northern Ireland voted against Brexit. I voted to remain; I voted in a UK-wide referendum. It was not a regional headcount, and nobody ever suggested that it was. It was a UK-wide vote, and the nation spoke. As a democrat, I accepted the decision, and I cannot understand why others who call themselves democrats are still in some form of denial.

Photo of Alex Easton Alex Easton DUP

I support the legislative consent motion. The Bill derives from the UK's decision in 2016 to withdraw from the EU. Matters covered by the Bill have been within EU competence for the duration of the UK's membership of the EU, so, basically, we are agreeing to what is already in place.

The Medicines and Medical Devices Bill, which comprises 45 clauses and two schedules, was introduced in the House of Commons on 13 February 2020. Human medicines and veterinary medicines are a transferred matter. The main regulations transposing the EU legislative framework for human medicines were enacted on a UK-wide basis. Once the European Communities Act 1972 is repealed at the end of December 2020, a new power in primary legislation will be required to continue updating or amending those regulations. The Medicines and Medical Devices Bill, therefore, provides replacement delegated powers to the Department of Health in respect of human medicines and to the Department of Agriculture, Environment and Rural Affairs in respect of veterinary medicines. The Bill was described to the Committee as an enabling Bill. In both cases, powers may be exercised by the Minister acting alone or jointly with the Secretary of State. The motion seeks the Assembly's consent, in line with the Sewel convention, for clauses 1 to 11, which deal with human medicines and veterinary medicines, which are transferred matters, to extend to Northern Ireland.

The Committee for Health was briefed on the background of the Bill and on the nature of the power to be provided to the Department. Clause 1 provides the Northern Ireland Department of Health, acting alone or with the Secretary of State, with delegated powers to make regulations in relation to human medicines. Clause 2 deals with the manufacturing, marketing and supply of medicines. It may be used to issue authorisations to manufacture, import or distribute medicines, as well as to regulate advertising, labelling and packaging. Clause 3 addresses falsified medicines. Regulations may be made to help prevent the supply of medicines that falsely represent their source. Clause 4 relates to clinical trials. Powers may also be used for the purposes of the authorisation, notification and reporting of requirements of clinical trials, similar to EU clinical trial regulations. Clause 5 deals with fees, offences and powers of inspectors, and clause 6 gives the Department powers to make regulations providing for the disapplication of human medicines in urgent situations in order to prevent serious harm to public health. The Committee's attention was drawn to clause 40, which requires consultation prior to the exercise of powers in relation to human and veterinary medicines, except in emergencies, as referred to.

Members were assured that the Bill is essentially an enabling Bill. Any regulations to be made under the provisions requiring consent will come back to the Committee for consideration in the usual way. Officials also confirmed that human medicine regulations are updated regularly, usually twice a year. Northern Ireland will be required to comply with EU standards in relation to falsified medications, whereas the rest of the UK will be free to diverge. Officials stated that the MHRA would continue to manage clinical trials. Officials confirmed that issues around the supply of and access to medicines were being addressed as part of the preparation work.

The Health Committee acknowledges that, in recent months, the Department of Health has been under enormous pressure to deal with COVID-19. However, due to the short time available for consideration, the Committee decided that it was not in a position to come to a decision to support the motion. I am disappointed in some of the parties opposite, who could not bring themselves to support this at Committee Stage. I find that strange, because the Committee for Agriculture, Environment and Rural Affairs was able to agree for it to come forward.

I find it strange that we, as an Assembly, cannot agree on regulations and to ensure that the regulations and the safety of our medicines are put forward for the safety of our people. I find it bizarre that we cannot support that at Committee Stage.

Photo of Matthew O'Toole Matthew O'Toole Social Democratic and Labour Party

I am not an expert, I have to say, on medicines regulation or veterinary medicine regulation. Those who think that the UK was taking back control when it voted to leave on 23 June 2016 might want to note that, until fairly recently, there were a lot of experts on medicines and medicines regulation based in the UK because the European Medicines Agency was based in London, in Canary Wharf. London was the headquarters of the regulation of all pharmaceutical production across the European Union, but not any more. It has left. Other capitals bid to host the headquarters, and I think that it was Amsterdam that ultimately was successful. I think that Dublin bid as well. I use that as an example because it is utterly absurd to have Members on the opposite side of the House imply that this is somehow about taking back control or that the LCM and the Bill that it is attached to offer some kind of serious, plausible mechanism for taking back control or that this is in some way some great mechanism for medicines regulation: it is not. This is a mopping-up exercise to ensure that the statute book is not messy. That is what we hope it is, because we do not know. Bluntly, what the legislative consent motion does is give permission to the UK Government to make future regulations that, we hope, will be aligned with regulations that are helpful to, for example, our farming industry and our pharmaceutical industry and, we hope, will be consistent with the fair application of the Ireland protocol.

I am deeply disappointed that we have so little time to debate the motion today. While, as my colleague Colin McGrath said, we will not actively oppose the LCM, to be perfectly honest, there is absolutely no way that I could lend my support to the legislative consent motion. It is also worth bearing it in mind that those who talk about the Sewel convention will also note that the Sewel convention does not have very much by way of practical legal force. If the Assembly decided to withdraw or to withhold its legislative consent, it would not throw the statute book into chaos; it would simply require the UK Government to do what they have done before, which is to just override a devolved assembly or a devolved legislature saying that it does not give its consent. They did that a couple of weeks ago when the Assembly passed a motion calling for an extension to the transition period. They simply ignored us after years of Boris Johnson, Michael Gove and, indeed, their predecessors, some from when I was still working there as a civil servant. I know what they have been saying for the last few years about the consent of this place. We withheld our consent for that, so perhaps the Minister will give us an update.

Following on from Mr Nesbitt's intervention, I do not speak today to get at the individual Minister. He has been working extremely hard on dealing with COVID-19. I do not think that anyone in the House would take that away from him. His work rate is admirable, and his intentions are very good, but the LCM is, I am afraid, something that I cannot actively support. The idea that it is somehow good for Northern Ireland and for the Assembly to simply, like a Potemkin parliament, nod along like dogs at the LCM going through is, I am afraid, pretty rich. While we will not actively oppose it, I am afraid that it is very, very difficult to support.

As several other Members have pointed out, including Declan McAleer, the Chair of the Agriculture Committee, and Colm Gildernew, the Chair of the Health Committee, there are several unknowns in the clauses of the Bill. There are known unknowns, to quote a former US Defence Secretary, in that we do not know how they will interact with the operation of the Ireland protocol, a protocol that, whatever happens in the UK-EU negotiations, will be legally binding on the Assembly at the end of this year. On New Year's Day 2021, unless there is an extension, that protocol will be legally binding on us. Fair play to the Committees for being frank in saying that they have no idea how the Bill will interact with the protocol or the application of it. They do not know, and we do not know what decisions the UK Government will make about diverging on an east-west basis. We cannot pretend that we can simply take the word of the UK Government on east-west divergence. I do not say that as a dig at the UK Government. I do not say that as a kind of nationalist kick at them. I say it because they have done it before, particularly this Government. We know that they have broken faith with politicians here. People in the party opposite should know that. The Prime Minister went to their party conference not so long ago and made them a promise that he later broke. I am afraid, guys, that, if he was willing to break that promise, I would say that officials in the UK department of agriculture — I do not say this to get at officials, because I used to be one — and their Ministers will not hold to all their promises on consistency of regulation.

I will not go through the detailed clauses. I will not oppose the LCM in practice, but I certainly cannot support it. It is deeply depressing that, when it comes to Brexit legislation and Brexit detail, we are squeezing it in at the last on a plenary sitting day when we have been debating other matters. As we come out of the COVID-19 crisis, our biggest priority should be to ensure that we get Brexit legislation right by giving it proper scrutiny. We need to do better, I am afraid.

Photo of Gerry Carroll Gerry Carroll People Before Profit Alliance 6:30 pm, 16th June 2020

Earlier today, I raised concerns about how Bills and other legislation had been repeatedly brought to the House without maximum time for scrutiny or adequate time to answer Members' concerns about issues before the House. Today is a vivid illustration of that precise point. Mr Nesbitt will be glad to hear that this is not just about the Minister here today — or the Ministers — but about a general trend that has been happening throughout the coronavirus crisis.

What we are dealing with today is serious and important stuff. I do not claim to be an expert in medicine or medical devices either, but the manufacturing, marketing and supply of medicines seems to be serious stuff to me. Clinical trials are detailed in clause 4. As we heard on the Health Committee, that clause could provide the possibility of medicinal cannabis trials and other things that activists and campaigners such as Charlotte Caldwell and many others have been campaigning for. We have to approach that with some level of caution, however, and I am certainly cautious. When I hear talk of red tape and bureaucracy, it sounds to me like code for the stripping back of measures that need to be in place to protect the public in clinical trials and in medicine more generally.

I am also concerned, as other Members have indicated, that we are being asked to rubber-stamp an LCM and endorse it without having the full detail to hand, the full detail of what we are voting on and any detailed consequences, intended or unintended. As the Chair said, the Health Committee was asked to make a decision on the LCM and did not, for a number of reasons, the main one being that Committee members — four of them, at least — decided that they had not enough detail on various questions that had been raised. That is serious stuff indeed. For my part, I raised a number of concerns, but the main one was about having a detailed list setting out the limits of devolved authority and what matters would remain in London. The Committee received a report back from the Department. It was advised that this was a complicated field and that a comprehensive list could not yet be provided but that officials were working through the issues. No doubt, the officials are working hard. The Minister is working hard, whatever disagreements I have with him. It not good enough, however, for Members of a legislature to be told, "We don't have the detail to hand on the issues". That is simply not good enough for good practice, for democracy or for Members to cast their vote in a clear, accurate way.

I am also concerned that the memorandum that we received from the Department stated that there was no consultation on the LCM. Of equal concern is the fact that we are told that there are no human rights concerns arising from the legislation. That may well be the case, but how do we know, if we did not consult the people who are involved in human rights work and human rights activism and those who could be — I emphasise "could be" — directly impacted on by the LCM?

Like other Members, I cannot give my consent to the LCM. I will not block it, but I implore the other two Ministers who are in the House, and Ministers across the Executive, to ensure that Departments provide as much detail as possible for any further debates on legislation. It is essential, going forward. Thank you.

Photo of Roy Beggs Roy Beggs UUP

I call Robin Swann, the Minister of Health, to conclude the debate and make a winding-up speech on the motion.

Photo of Robin Swann Robin Swann UUP

I noticed that a number of Members who have spoken expanded the debate on the LCM into the detail and complexity of Brexit without, I think, having read the LCM and what it is meant to do. Although this is the place for that debate, it should be expanded at another time. Tonight, my focus is on the LCM and what it is about to do.

I note those Members who are not able to support the LCM but who will not oppose it. I thank them for taking that decision. I thank all the Members who contributed. I will refer to a number of them.

The Chair of the Health Committee sought assurance on draft affirmative action on amendments to regulations. He has the assurance that was given at the Health Committee and was given in my speech today. So, any changes that have to be made will be done through draft affirmative action. So, the House does have control of what comes out of the LCM. For those who seem to be under the belief that this is solely giving something to the powers in Westminster: it is not. It allows the House to make those decisions. Ms Bradshaw's comment about:

"world-class regulation combined with local control" sums up the thrust of the LCM.

Photo of Edwin Poots Edwin Poots DUP

I thank the Minister for giving way. I indicate my full support for the Minister's actions because there is an element of veterinary medicine to this. The Minister has the support of my Department in bringing forward the LCM. It is the only way forward, and, for those who are suggesting otherwise, there is not another way forward, and they have not proposed another way forward. I will add that we will rely on — I assume on his part, but certainly on ours — expertise that exists in Great Britain that we do not have here, going forward. There is a skills base there, and a quantity of people within that personnel, who are hugely useful to us, in our relatively small pool of people, to deliver on some of these issues. We will continue to have a very close working relationship with the United Kingdom after this is over.

Photo of Robin Swann Robin Swann UUP

I thank the Member for his intervention and the support from his Department.

The Chair of the Health Committee referred also to clinical trials and the importance, as I see it, of Northern Ireland being fully involved. The ramifications of our not being involved in the LCM or the clinical trials were referred to, perhaps by Mr McGrath. The ramifications are actually quite clear. The Member should look to where we are today, with the announcement about a clinical trial that has operated across the United Kingdom for a drug called dexamethasone, an anti-inflammatory drug that has proven to be groundbreaking in how we treat COVID. It has reduced the risk of death for COVID-19 patients on ventilation by as much as 35% and by 20% for patients on oxygen. So, those are the ramifications of Northern Ireland not being involved. It is allowing someone else to do that work and take those risks. It is not where we should be. We should be part of doing that work and benefiting from the results.

Photo of Matthew O'Toole Matthew O'Toole Social Democratic and Labour Party

I thank the Minister for giving way. This is a basic point of information. Does he agree that the Sewel convention, which governs legislative consent motions within the United Kingdom and the devolved legislatures, has no legal force? So, if we did not give our consent to the legislative consent motion, it would not stop the legislation going through Westminster or having binding force in Northern Ireland.

Photo of Robin Swann Robin Swann UUP

With regard to the Sewel convention, my understanding of this specific LCM — and I will get officials to verify it — is that Northern Ireland is the only part of the United Kingdom where this is a devolved authority. It sits slightly outside Sewel because it does not have the same effect on Scotland or Wales; it is not devolved to them. This LCM is solely within our power and our gift, so we can sit outside it.

As I said earlier, when the debate expanded into the wider Brexit point, I am here to discuss this specific LCM. Knowledge of this LCM is what is important in tonight's debate.

With regard to some of the comments from the Chairperson of the Agriculture, Environment and Rural Affairs Committee, and other Members, it is important to note that this is an enabling Bill that allows us to make the decisions. As a devolved Minister and a devolved elected representative, that is where I want to be. The Chair of the Agriculture, Environment and Rural Affairs Committee was right when he noted that this LCM is necessary to bridge the gap once we leave the European Union.

Photo of Colm Gildernew Colm Gildernew Sinn Féin

I understand that the Minister and, perhaps, the Department of Agriculture, Environment and Rural Affairs had requested that the Department of Health in Westminster amended the Bill, at source, thereby potentially obliterating the necessity for an LCM. Can the Minister shed any light on why the Department in Westminster was not minded to adopt that route?

Photo of Robin Swann Robin Swann UUP

As I said in my opening comments, it is about time. It is our understanding this will be moved, at the earliest, on 18 June. It might be delayed by a couple of days but there is no time to do that. The Member makes a valid point but time is against us to make sure that we bring the powers of this LCM and this legislation back into the House, where it should be.

With regard to Mr McGrath's comments on the ramifications, I have covered that around where we are with the devolved powers and being involved in those drug trials and around Paula Bradshaw's comments on further ramifications to our farming industry. When we talk of the recovery in coming out of COVID and the industries that we need and want to support, farming is one of our main industries. The implication of not passing this LCM tonight, either through opposing it or not being able to support it, is something that Members should take note of.

Photo of Colin McGrath Colin McGrath Social Democratic and Labour Party

I just want to point out that the reason we have the LCM is that it is necessary because of Brexit. Therefore, any of the objections to Brexit are the objections to having the LCM. The actual timing of it and the fact that we did not have time in the Committee to consider it is why we are not approving it this evening. It is not that we necessarily disagree with the LCM and what it will do. It is the fact that we have not had the proper time to scrutinise its impact or listen to the sector. The objections on the ground of Brexit are because that is why we actually have the LCM, full stop. There is a difference between the two objections.

Photo of Robin Swann Robin Swann UUP

From the Member's commentary, and that of his party colleagues, I got the feeling that the inability to support this LCM was more to do with a stance on Brexit, rather than anything in the Bill.

Photo of Colm Gildernew Colm Gildernew Sinn Féin

Can I just point out that, as I said in my remarks, the Committee did not oppose the LCM. We pointed to the fact, and acknowledged, that the Department is under pressure. Will you acknowledge that the Department could have laid this LCM with our Committee at an earlier stage and allowed us to give it better consideration?

Photo of Robin Swann Robin Swann UUP

I thank the Chair of the Committee. Maybe he will reflect on the fact that I did not mention the Committee or even his party in my last comment about where I got the feeling of not being able to support this LCM was coming from.

With regard to Mr Carroll’s point about this being serious stuff. Yes, it is. What this allows us to continue to do, as a devolved Assembly, is necessary. It is important to make the point again that the requirement for the draft affirmative procedure will ensure that this Assembly has the proper opportunity to scrutinise and debate any regulations before they are approved. It is not a matter of me, the Department, or even the Minister of Agriculture, Environment and Rural Affairs, under his remit, railroading stuff through.

I take this opportunity to thank the Health Committee and the Agriculture, Environment and Rural Affairs Committee for taking the time to examine the Legislative Consent Memorandum and for their helpful and positive engagement with departmental officials on this matter.

I appreciate that the Committees had to work with a very challenging timescale. I thank them for their patience and understanding and for their cooperation with both Departments. I also thank my Executive colleagues for their support in this matter and for agreeing that a legislative consent motion was necessary. I point out that I had the support of all Executive colleagues in bringing forward this LCM.

I know that some Members hold the view that, as a matter of principle, any legislation that falls within the devolved competency of the Northern Ireland Assembly should, when possible, be made by the Assembly. Whilst I fully agree with that view, it is important to understand that it would not have been possible to progress separate primary legislation for Northern Ireland within a similar timescale. For that reason, I believe that, on this occasion, it is appropriate and, indeed, makes good sense for Westminster to legislate on matters that are devolved to the Northern Ireland Assembly.

In practical terms, new primary legislation is needed to replace the broad regulation-making power that is currently available under section 2 (2) of the European Communities Act 1972, and it is important that Northern Ireland is included in the provisions of the Medicines and Medical Devices Bill. As I stated earlier, the Bill will provide us with the powers necessary to ensure that Northern Ireland can use subordinate legislation to bring forward any necessary amendments to the regulatory regime for human medicines and veterinary medicines. It is also important to reiterate that the Bill is not a new set of delegated powers. It simply replaces one set of powers with another. I consider this to be an important measure that will provide Northern Ireland with the necessary delegated powers to replace section 2(2) of the European Communities Act 1972. I commend the motion to the House.

Question put and agreed to. Resolved:

That this Assembly endorses the principle of the extension to Northern Ireland of the provisions within the Medicines and Medical Devices Bill, as introduced to Parliament on 13 February 2020, dealing with human medicines and veterinary medicines.

Photo of Roy Beggs Roy Beggs UUP 6:45 pm, 16th June 2020

I remind Members that the next plenary sitting of the Assembly will be on Tuesday 23 June.

Adjourned at 6.47 pm.