I beg to move
That this Assembly recognises the importance of retaining unfettered access to the United Kingdom internal market for medicines and medical devices; notes that 98% of the medicines used in Northern Ireland are supplied from Great Britain; recalls that the barriers to trade in this area, imposed by the protocol on Ireland/Northern Ireland, are yet another reason why the protocol should be replaced; rejects the establishment of regulatory and customs controls on medicines moving between Great Britain and Northern Ireland; highlights that, if established, these arrangements would add cost for businesses and public services, restrict supply and jeopardise patient care across Northern Ireland; regrets that some GB firms have already severed ties with the Northern Ireland market; expresses grave concern that existing grace periods are due to end on 1 October 2021 and 1 January 2022 in the absence of a solution; and calls on the Minister of Health to work with his Executive colleagues to resist strongly disruption to east-west trade for medicines and medical products in all circumstances.
The Business Committee has agreed to allow one hour and 30 minutes for the debate. The proposer of the motion will have 10 minutes to propose and a further 10 minutes in which to make a winding-up speech. All other Members who wish to speak will have five minutes.
I speak on this most serious of issues in the hope that Members across the House will accept the spirit of what I say and the serious nature of the debate. The issue of medicines and medical devices goes to the heart of why I believe that the Northern Ireland protocol is harmful to Northern Ireland citizens. If it does not highlight the protocol's harmful insanity, I fear that nothing will.
The perilous implications of imposing the protocol on Northern Ireland have been well documented. First and foremost, we are all too aware of the economic disruption directly consequent from the implementation of the arrangements. Like many other Members, I have been contacted by hundreds of people giving examples of the burdens placed on consumers, businesses and everyday supply chains. In this brief period, we have witnessed a snapshot image of the long-term unworkability and unfairness of the new arrangement, which, ultimately, impacts on trade across all sections of the UK and draws a dagger across our tried-and-tested market.
Beyond the economic impact, this roughshod arrangement has been thrust upon Northern Ireland with no support from the unionist community. Nothing on the ballot paper or in the result of the 2016 referendum made the protocol inevitable or desirable. Best of all, those in the House who are champions of the protocol portray it as a compromise and a necessary evil to keep the land border open. That is to the detriment of the health of every one of our citizens. What sort of compromise is it? How does accessing medical supplies pose a risk to the EU single market? Historically, Northern Ireland's model of supply has relied on the free movement of supply from Great Britain, and, to that end, it comes as no surprise that 98% of the medicines and medical devices used in Northern Ireland are imported from or via Great Britain.
I am grateful to my friend for giving way. The Member knows that the debate takes place in a context. One of the contexts is that, as a consequence of COVID, we have had to cancel more than 16,000 surgical operations and 320,000-plus people in Northern Ireland are on a waiting list. Does the Member agree that denying those people medicines and access to medical equipment is an act of cruelty?
I will give way shortly. When the grace period ends, all medicines coming into Northern Ireland from Great Britain will be treated as goods entering the EU from a third country and will be subject to additional batch testing and certification. From 1 January 2022, when the grace period ends, all the medicines used in Northern Ireland will have to comply with the EU's falsified medicines directive. That affects the packaging of medicines, and the same requirements will not apply to products marketed in GB. Medicines in Northern Ireland must comply with the European licence and requirements set out by the European Medicines Agency (EMA) while those in GB do not. In addition to those checks, Northern Ireland will allow for EU regulations on vaccines and clinical trials from which we have benefited enormously in recent history. If ever there has been a case for the need for closer alignment on medicines — from paracetamol to vaccines for COVID — it is quite clear that Northern Ireland has benefited immensely.
I pay tribute to the Minister and the vaccination team, headed by Patricia Donnelly, on the efficiency in which the programme was rolled out in Northern Ireland. Can you imagine the disaster if the grace period did not apply and Northern Ireland did not have access to those life-saving vaccinations?
I will give way shortly. I have to get through this. I will have time to come back to you.
We have not seen the impact that the protocol will have on medicines and medical devices because it has been covered over. I welcome the fact that there has been a grace period, but the impact has been masked. When that ends, suffering will be inevitable because of the Northern Ireland protocol. All these measures and barriers to supply for the proposed differentiated arrangements for Northern Ireland will require segregated, complex and costly supply chains.
Throughout the pandemic, we were made abundantly aware of the benefits of unfettered access to the national distribution and supply network through the success of the UK COVID vaccination programme across all regions. That would not have been possible without the existence of the grace period. Some 98% of supplies to the Department of Health come from the mainland and are valued annually at £600 million. Despite that, the protocol would create small and segregated NI-only pools of products with the risk that separate licensing, labelling and customer requirements will prevent medicines, made to GB specifications, being sold in Northern Ireland. My colleague Pam Cameron and I have met many of those GB companies, and they fear the additional burden that this will put on their supply chains. Many of them, I imagine, will look at Northern Ireland as no longer being a place in which they will do business. The British Generic Manufacturers Association (BGMA) has made it clear that that will prevent identical products from being sold to GB and NI, meaning businesses will have to duplicate resources and supply lines, and firms may need to build extra warehousing and hire more staff to ensure that medicines comply with both UK and EU regulations. It simply is not viable in the long term. Given the small margins, that will simply not be sustainable. Some GB manufacturers report that up to 90% of medicines could be at risk of being withdrawn.
Alongside the cost of creating a Northern Ireland-only pool of products, the protocol is likely to impact and prohibit the treatment of specialist illnesses. A headline in the 'News Letter' last week told of specialised cancer drugs not being allowed access to Northern Ireland as a result of the protocol. That is harmful in so many ways, yet parties in the House call for its rigorous implementation. In today's debate, I want Members from those parties to recognise the folly of their words.
I thank the Member for giving way. If the DUP is genuinely concerned about the impact that Brexit will have on health, why do I not hear it talking about the new barriers that EU healthcare workers are facing and the impact that those barriers will have on staffing levels? Why do I not hear the DUP talking about the cross-border health directive? Surely those issues will have an immediate impact on our health service. I would like to hear you talk about that, Mr Buckley, instead of the motion that is in front of us and the inaccuracies that it presents in an attempt to deflect from the protocol. The issue for health is not the protocol. Rather, the fundamental issue is that Brexit is bad for health. That is a Brexit that you voted for —
Thank you. I will finish my point. The protocol is not the issue that is facing health. The issue is that Brexit is fundamentally bad for people's health. That is a Brexit that —
I will happily debate any of the issues that were mentioned by the Member, but today I am talking about medicines and medical devices, 98% of which come from GB and are directly impacted on by the Northern Ireland protocol. The Northern Ireland protocol does not look at those patients with care and consideration. In fact, quite the opposite is the case. Only last week, a constituent told me that the manufacturer of the MS drugs that they need has claimed that the supply line will be disrupted because of the protocol. That is in addition to the threat to the supply and choice that is available to local health and social care services, to access to clinical trials and to exciting new developments in the production of medicines, including vaccine supply. Those will be threatened or, at the very least, slowed down. The reality is that, although the protocol was championed with false promises —
I welcome the opportunity to make some brief remarks outlining the Health Committee's consideration of the issue, before I speak as my party's health spokesperson. At the outset, I point out that the Committee has no agreed position, but I will outline its consideration of the matter to date.
The Committee received a number of Brexit briefings from Department of Health officials, who were joined by Executive Office officials at the most recent briefing, on 15 April 2021. During that briefing, the Chief Pharmaceutical Officer outlined how the pharmaceutical industry currently benefits from a grace period for medicines, which was introduced at the start of January to give the industry a further 12 months to prepare for changes. The Committee has scheduled a further briefing on Brexit-related issues for late June. At that point, it expects a detailed update on the progress that the Department has made on dealing with the issues that have been raised.
I will now make some remarks as the Sinn Féin spokesperson for health. There is no good Brexit for Ireland, North or South. The majority of people here voted against it. Our membership of the EU was a fundamental component of the peace process and formed the foundation of the Good Friday Agreement. The protocol is not perfect, but it mitigates the worst of Brexit. It is an internationally agreed and binding treaty that prevents a catastrophic hard land border.
Brexit itself is the problem. When he moved the motion, the Member talked about drawing a dagger across the throat of long-established markets, but that is exactly what Brexit has delivered. We would not be here debating this issue if the British Government did not go down a path of a hard Brexit with maximum disruption and divergence. The Tories, enabled by the DUP, chose this hard Brexit, and you must both own it. Innumerable opportunities were available to minimise divergence in medicines regulations, as well as in trade and many other areas.
The Members opposite, whose party brought the motion today, may have been fooled, beguiled or bought by the lies of a Tory Government that no more have your interests at heart than they have mine or ours, but we are not fooled, and nor should any Member or party in the House be fooled by the faux outrage and false narrative contained in the motion. Instead, we must concentrate on dealing honestly with the issues that Brexit is raising and will continue to raise. We should recognise that the supply of medicines and medical devices is a complex undertaking, featuring a series of interlinked processes across Europe and the world. Indeed, it is the reality that 70% to 80% of Britain's medicine supply comes via a European border. We need to maximise the potential of the grace period and work in good faith and honestly, Members, with all partners, including Europe, in that effort. Burying our heads in the sand will not help in that regard.
If we want to talk about threats to our health system from Brexit, we could talk about, as has been mentioned, the serious long-term staff shortages in hospitals and care homes that are being exacerbated as a result of the additional red tape around recruiting EU healthcare workers. We could talk about the loss of the cross-border healthcare directive, which is already having an impact, and I am sure, Members, that you are all hearing of constituents who are being impacted by the loss of that directive. Those are also looming crises to our health service, but they are because of Brexit alone and are nothing to do with the protocol. The fact is that Brexit is bad for our health. It is not the protocol that is the problem here; it is the Brexit that the party opposite called for, worked for and connived with English nationalists for against the democratic wishes and interests of our people here in the North.
I call on everyone here today —.
In this distortion of reality, does the Member not recognise that Great Britain has free access to, for example, Tagrisso, which is a treatment for lung cancer? Northern Ireland does not, and why? Because of the protocol. Not Brexit, but the protocol, because the protocol keeps us within the ambit of the European Medicines Agency.
I thank the Member for his intervention, but surely the Member knows that Britain imports 70% to 80% of its medicines from Europe, and up to 90% of its medicines comes from the wider global supply chain. Medicines are not a British issue. I heard reference earlier to the vaccination programme. AstraZeneca, a key vaccine that has helped here, was developed in conjunction with a German and European company, manufactured in Belgium and funded by the European Union. That is where medicines supply and healthcare sit in the world today.
I call on everyone here today to reject this attempt at misinformation and misrepresentation and to reject the motion. Let us set about the real work, Members, of rebuilding our health and social care sector, and let us stop wasting time with the cynical political opportunism and fearmongering from the Members across the Chamber.
First of all, I am somewhat disappointed that none of the amendments to today's motion — I know that several were tabled — was accepted. They would have allowed a greater richness of debate, and people had put down alternative wordings.
OK. To be clear, Mr Deputy Speaker, I did not question any judgement. I expressed regret that they were not accepted. That is not the same thing, and it is disingenuous of my colleague from South Belfast to state otherwise.
Today's motion concerns movement of medicines and medical devices. It is an entirely legitimate subject for debate. I am in no way suggesting that the Members opposite should not debate these issues. However, there is a somewhat insincere decision to frame the issues as having been produced by the protocol. It is as if, somehow, the protocol is sui generis: it came from nowhere. It dropped from space. Perhaps someone in Brussels got in a room with the Alliance Party, the SDLP, Sinn Féin and the Irish Government and they decided to come up with a protocol out of nowhere. The protocol is a response to —.
The protocol is a response to decisions made by the UK Government. They made repeated decisions to break away from the regulatory ambit of the EU single market and to do so in a way that has prompted unfortunate consequences that go far beyond the Northern Ireland protocol. The protocol simply relates to movement of goods. It does not relate to services. Before I come to the specifics of medicines, it is important to say that the vast majority of our economy — 70% — is services. Services are not covered by the protocol, and that is having real-world consequences for healthcare.
The cross-border healthcare directive has been mentioned. The Minister's Department has written to trusts in Northern Ireland to tell them that, if they have any staff engaged in cross-border healthcare work — for example, nurses or doctors who accompany children to get cardiac care in Dublin, or people involved in providing cancer care in the north-west — they now need to be registered on both sides of the border. A vast range of complexities and difficulties has been thrown up by Brexit. Brexit is a disruption of regulation and of how we do a range of things. It is unfortunate, and I wish it were not happening.
It is important that we get a resolution to the issue of medicines and medical products. We are in a grace period, which was agreed long before the end of the transition period last year. It is worth saying again that the transition period should have been extended; that would have given us a long time in which to deal with this and many other issues to do with Brexit, not just in relation to goods and other matters affected by the protocol. The grace period that the Joint Committee agreed late last year is welcome, and I know that the Joint Committee monitors and observes how we deal with movement of medicines and medical devices. It is a legitimate question. It is legitimate for us to engage with the Joint Committee, and I am sure that the Minister's Department will do just that. I am not ideological about this, but it is incorrect and wrong to portray the protocol as the root of all evil when it comes to these matters.
I am sure that the Member has read the protocol. If he has read annex 2 of the withdrawal agreement, he will know that paragraph 20 imposes 11 EU regulations, all of which control medicinal products, and that paragraph 21 imposes five EU regulations that deal with medical devices. With or without grace periods, that is the heart and core of the protocol vis-à-vis medicine. That will not change unless the protocol goes.
Thank you very much, Mr Deputy Speaker.
The Member is right that those directives are applied in Northern Ireland. He wants to upend and remove the protocol and is engaged in legal and political pressure to do so. That would be a very bad thing to happen. The protocol established a Joint Committee, joint consultative working groups and a whole range of other means of engagement with the European Commission and the UK Government for applying the protocol. That has already happened.
If the Member's solution to everything is simply to turn over the table and to throw everything in the air, what good will that do? I say that seriously to some Members opposite. I respect the fact that many of them dislike the protocol on principle, and I do not demean their concerns about it. I have many concerns about Brexit. I am deeply upset that constituents of mine who are EU citizens have to apply for settled status because we do not enjoy freedom of movement in this part of the world any more. We all have to deal with unfortunate consequences of Brexit. I regret the fact that doctors and nurses in Northern Ireland are having to register with Southern authorities simply to provide basic healthcare. These are difficult issues thrown up by Brexit. The right way to deal with them is to engage in productive, constructive —
This debate would not need to be happening if there were no protocol nor a regulatory border down the Irish Sea in place. It is worth placing on record that a number of parties in the Chamber were quite happy to run down to Dublin and go across to Brussels for smiling photo opportunities, and to call on both the Irish Government and the EU to implement the protocol without delay. They were unashamed cheerleaders for the protocol. Indeed, in a letter that the leaders of the Alliance Party, Sinn Féin, the SDLP and the Green Party signed and sent to the Prime Minister in April of last year, they advocated for an EU office in Belfast:
"to ensure the implementation of the Protocol on ... Northern Ireland which you negotiated".
The DUP leadership initially welcomed the concept of a regulatory border down the Irish Sea, describing it as a "gateway to opportunity".
No, thank you.
This opened the door for Boris Johnson to push ahead. By the time that the DUP realised the consequence of its initial welcome and began back-pedalling, it was too late to stop it.
My family have operated a village supermarket for nearly 50 years. We can already see the creeping effects and consequences of the protocol. A large, local wholesaler, which is part of a chain that operates right across Great Britain, previously stocked a huge range of own-label products covering just about every requirement that a shopper could have. Those were quality products with a budget price marking. A shopping basket filled with them would represent a huge saving on a family's weekly food bill. These products are no longer being brought into Northern Ireland because the supplier cannot justify the cost of relabelling the large number of food products in the range to meet EU regulations. That is just one example of the long-term damage being caused to the supply chain of goods coming into Northern Ireland. I could quote a number of similar stories around various products. There is not a single retailer or wholesaler in Northern Ireland that has not been negatively impacted on by the protocol.
This debate, however, is about the supply of life-saving and pain-relieving medicines and medical devices. This issue is extremely worrying. No matter what your opinion on Brexit or the protocol, no one should underestimate the potential impact on our citizens' health and, more importantly, on our NHS and the public's ability to purchase over-the-counter medicines, as we approach the end of the grace period on 1 January 2022 and in the years that follow.
The annual budget for medicines used in Northern Ireland is around £600 million. That figure does not include medical devices. Undoubtedly, the price of medicine will increase because of the protocol. Even a 10% increase in costs to the NHS would inflict a major blow to its budgets. It is money that could be better directed and better used to assist the much-needed restructuring of the NHS and its ability to tackle and reduce the unacceptable waiting lists, which were brought about by the curtailment of health funding over many years by parties in the House. For instance, new drugs to be used in the treatment of cancer could become available for use. While those will become immediately available to patients in Great Britain after professional assessment, the same drugs are not guaranteed to become available in Northern Ireland.
No, I need to finish.
My party has suggested a mitigating solution: that the UK Government legislate to place a duty on suppliers based in Great Britain to provide their goods to all regions of the UK internal market. We think that that would prevent a situation in which producers of medicines and medical suppliers decide, following a grace period, that they will supply their goods only to customers in GB. I know that the Minister and his officials are working hard to pre-emptively cover a range of outcomes brought about by the protocol, from temporary product shortages to major price increases. This is the result of a flawed political deal between the UK Government and European Commission and a clear illustration of why it should be scrapped. Using the safety and welfare of the people of Northern Ireland as some sort of bargaining chip is shameful. We need the certainty that a commitment to a full derogation will provide, and we need it now.
On numerous occasions, I have heard —
I regret that the Alliance Party cannot support the motion, despite the fact that there is much in it that we agree with. It rightly raises a serious issue, but, as is so often the case with the EU referendum, it falls short of providing serious solutions.
Before I proceed, I thank Cathy Harrison, the Chief Pharmaceutical Officer, and her team. As the Chair of the Health Committee said, she has come to the Committee many times to outline the serious issues that they are grappling with, not least during a global pandemic.
While I commend the proposer of the motion for raising the issue, which requires resolution, we again see it raised in a way that is primarily about pretending that the matter is not about Brexit. Specifically, it pretends that the matter is not about the Brexit that was, inevitably, brought about by the DUP's insistence on seeking, at every conceivable turn, while its MPs held the balance of power at Westminster, to distance us from our major trading partner. The DUP likes to talk about our major trading partner being Great Britain, but, from an all-UK perspective, our major trading partner is the European Union and, specifically, the European single market. The DUP fully and intentionally sought to put up barriers to that trade. We are living with the damage.
I want to make a bit of progress. Thank you.
Part of that damage will inevitably involve barriers to cross-border cooperation in health, yet the DUP's only solution is to try to impose a border for goods on the island of Ireland. The existing regulatory body adds to the potential damage to our health system in everything from longer-term workforce planning to mutual recognition of qualifications.
The issue before us is serious. As I said, there is much in the motion with which I agree. While we should not forget that the protocol creates significant opportunity for the local pharma industry and for investment in pharma locally, because it can freely export to both Great Britain and the European Union, it is not realistic to expect a full redirection of medicine imports by October 2021 or January 2022. Therefore, although I fully concur with the final lines of the motion, they do not explain how what they propose may best be done.
Let us turn to solutions. I agree that we will need longer than until October to find an adequate way forward, a fact that is widely accepted for food. The grace period for medicines will need to be extended. We should not use that grace period merely to seek more time to realign supply chains; we need to be better than that.
There are ways in which we could try to eliminate the barriers to imports of medicines from Great Britain, the most obvious of which is for everyone in the Chamber to face the fact that that will involve the UK Government and the European Union coming together and agreeing alignment on standards and regulations. That re-agreement, which is evidently being blocked by the UK Government, would provide at the very least a model on which we could restore the relatively unfettered east-west movement of vital goods. That could be copied for pharmaceuticals. Failing that, we should, as the bare minimum, seek to have HSC Northern Ireland — in other words, our NHS — recognised under a trusted trader agreement in order to demonstrate that there is no risk of a leak into the European Union of medicines that are to be used by the public health service.
We want to see solutions. That will require us to lay identity politics to one side and to engage in practicalities on behalf of everyone here in Northern Ireland. Alliance Party representatives will meet the Cabinet Office this week to discuss those solutions. That is where our focus needs to be.
There is an apocryphal story about an old soldier at the end of the Second World War who did not realise that the Japanese had surrendered and kept on fighting in the jungle for years afterwards. When I hear myself and Matthew O'Toole talk about Brexit, I sometimes think of that as an allegory.
We can fight until doomsday about this issue, but I do not wish to refight the 2016 referendum.
Following on from what another colleague from South Belfast Ms Bradshaw said about the erection of barriers, I think that she will find that one of the major reasons why we are in this situation is the callous and spiteful decision, some time ago, of the European Union to invoke article 16 as a means of seeking to deny the people of this country access to EU vaccines. The Health Minister rightly said:
"Everyone thought that that work was progressing well until the EU triggered article 16 over vaccines. That unnerved and unsettled people, and it has increased the level of concern that we are seeing, especially from the smaller suppliers of medicines and more intricate medical devices."
It is quite clear where the belligerence in this situation has come from, and it has not come from the elected representatives of the people of Northern Ireland or from the Government of the United Kingdom.
I want to make a few points, and then I will give way to you.
This situation demonstrates that the Northern Ireland protocol is bad for your health. Some 98% of all medicines and medical equipment coming into this country come from Great Britain. In that context, it is important that we reflect on the scale of the health challenges that we face. Of course, for the past 14 months, the health service has been focused almost entirely on tackling the threat of COVID-19. As a consequence, 16,000 surgical procedures have been cancelled in this country. More than 320,000 people are on waiting lists, which is one in six of the population. We need the resources. The Minister will say that he needs the money, and I accept that, but we need the resources. It is not simply money and staff that we need but medicines and medical equipment.
I thank Mr Stalford for giving way. There are two fundamental problems. The first is the DUP's support for Brexit. That has been well rehearsed, but I suggest that there is also an existential threat to unionism at the very top of the British Government. It is encapsulated in the quote from Dominic Cummings:
"I do not care if Northern Ireland falls into the effing sea".
I am here to discuss health rather than any existential threats to the Union, but I certainly believe that it would be good to see a bit more unionism put back into the Conservative and Unionist Party. That is a challenge for the Prime Minister to meet over the coming days.
Anything undertaken to deny our people medical supplies is not merely the act of some overzealous bureaucrat; it is a deliberate act of cruel aggression and belligerence towards the people of Northern Ireland.
Those who defend the protocol are supporting the denial of medicines and medical equipment to the people whom they represent. The Member may shake his head as much as he likes and choose to parrot whatever line comes out of Brussels, but the exact consequence of this protocol is that people in East Antrim will not have access to the medical equipment or supplies that they need.
I beg your pardon, sir. The European Commission's cheerleaders can attempt to sugar-coat it any way that they like, but that is the reality on the ground. Northern Ireland is being used by the European Union as a football to kick in order to punish the United Kingdom as a whole for daring to vote to leave its club. That is demonstrated by the fact that 20% of all checks taking place at the EU's borders are conducted on goods crossing the North Channel, a region that represents well below 1% of the European population. What does that demonstrate about the overzealous way in which the European Union conducts itself? We saw it when the EU sought to deny people access to vaccines, we see it in the brutal and heavy-handed way in which it is implementing the checks at the North Channel, and we see it in this latest example of seeking to deny our people medicine and medical equipment.
I cannot: I have 40 seconds. We have already been told by the Health Minister that a request to extend the grace period on medicines has not been agreed. What possible justification can there be for such belligerence beyond spite? The people looking in will see not only the spiteful attitude that has been adopted by the European Union but the roll-out of vaccines in this part of the world as demonstrating the success that our country has had in comparison with the approach that European Union officials have taken on healthcare matters.
I will say the opposite of what Christopher said: Brexit is bad for your health. Colm Gildernew, Sinéad Bradley and, indeed, Matthew O'Toole, in so many words, said that as well. For all its faults, the protocol is there to mitigate the worst impacts of Brexit. I want to correct Christopher: most people in the North did not vote for Brexit. I do not want to reopen that debate, but I want to put that on record.
The protocol is an internationally agreed and binding treaty. Therefore, the notion that 45 votes in the House can do away with it is misleading.
It absolutely is.
I want to bring some facts into the debate. Scotland does not have a protocol, yet, according to Scotland's Health on the Web, there are 37 supply shortage notices in the supply of drugs, including antidepressants and medicines for epilepsy and other such illnesses. It has been completely ignored that the red tape is a result of Brexit, not the protocol. In fact, some British companies have, indeed, relocated to Dublin in order to ensure that there is free flow and that it is via Britain. I think that that is being missed, although I saw that Pam had put something up that differed from what Jonathan said in his outline. The notion that suppliers of medical devices in Britain face many new barriers to trade needs to be challenged, because it is misleading. To be frank, it is hyperbole. Yes: there will not be automatic certification, but there are compliances that need to go through. The fact that that has been omitted — sorry: it has not been fully omitted; at the end of his speech, Jonathan acknowledged that, because of grace periods, the east-west supply has not been impacted yet. However, he then went on to outline the worst-case scenario.
I thank the Member for giving way. I understand, from the logic of the Member's remarks, that Brexit is primarily the problem in the debate. However, does she accept — I have not heard it yet from the party opposite — that the Northern Ireland protocol, in its current form, affects that market far beyond any other element of society in Northern Ireland, with 98% of its market being on the GB mainland? Does she accept the protocol's problems with regard to that aspect?
Thank you. Again, the Member is misleading the House, if I can say so: some 70% of drugs come via Britain; they do not come from Britain. With respect, Jonathan needs to read his research papers.
The issue was the same in the debate about agriculture and businesses. Again, here are some facts: a Manufacturing NI survey found that the majority of businesses accepted the protocol and mitigations. Only 18% of them believed that it should be thrown out completely. That is a fact.
I believe that the Member was at the Committee when the Chief Pharmaceutical Officer, Cathy Harrison, attended. I also acknowledge the work that she and her staff are doing. They are doing absolutely everything.
Even the British Government, in which the Member put so much faith until they shafted him again and again and again, have asked for an extension to the grace period in order to get things through.
Without the protocol, things would therefore be really bad. I understand that, ideologically, the Member has to jump up and down, but, realistically, without the mitigations, things would be much worse. On that basis, we will not be supporting the motion. The Member will not be surprised to hear that, because he has already heard Colm say it.
I welcome the opportunity to take part in the debate. It provides a timely opportunity to remind the DUP and the hard Brexiteers of the responsibility and accountability that they have for the Northern Ireland protocol. Let us look at the facts. The DUP pushed for a hard Brexit in 2017. At its party conference, the then DUP leader, Arlene Foster, said that the DUP would prevent any Brexit deal that would "decouple" Northern Ireland from the UK. That was when the DUP was a kingmaker, but it became a time of intransigence, belligerence, arrogance and telling the Prime Minister how DUP MPs took their tea. It was a time of problem-finding and solution-dodging.
"There cannot be a border down the Irish Sea ... The red line is blood red."
DUP intransigence, belligerence and arrogance continued over subsequent years until, in October 2019, it accepted Boris Johnson's proposal for a regulatory border in the Irish Sea covering goods and agri-food. To sweeten the deal, PM Johnson offered additional funding for Northern Ireland: a little bit of a buy-off. It was as though the people of the North could be bought and sold, like so many rolls of Mr Johnson's wallpaper.
The motion tells us that the Northern Ireland protocol was "imposed" on us and must "be replaced". Has the DUP learnt nothing? The DUP pushed for the hardest Brexit. It rejected every single deal that was going. It was intransigent, belligerent and arrogant with the UK Government. I will take a moment to ask DUP Members this: just exactly what did you expect? What would have been a positive outcome? The protocol is a result of Brexit. The DUP is responsible for the protocol. You are accountable for the protocol. You danced to the tune of a Member for North Antrim while looking to future elections, and you gave in to the unelected bloggers who called on you to make Northern Ireland unworkable until the Irish Sea border was removed. Violence returned to the streets of the North, and then the DUP called for the Chief Constable to resign and called into question the rule of law and order.
The motion before us notes that grace periods are due to end:
"in the absence of a solution".
I suggest to the signatories to the motion that the motion is not a solution. It is evident that there are still outstanding issues with the protocol. Those issues are technical and not political, however. The parallels between the DUP's attitude to the protocol and to the First Minister are really quite telling. It is evident that it is not in solution-finding mode with the protocol.
The Member mentions solution-finding mode. Some of us on this side of the House are often told that we are not as committed as we should be to making Northern Ireland work. Does he not agree with me that the irony is that, in this year, which is important to certain Members of the House, we have unique dual market access, including to half a billion members of the EU single market, and that those who want to make Northern Ireland work should focus on maximising that opportunity?
Thank you very much, Mr Deputy Speaker. I welcome that intervention, which shows a positive outcome that the protocol can deliver. If we were forward-thinking and forward-looking and were out there embracing every opportunity that there is across the world to try to sell ourselves as being ideally placed to be able to work the systems and to be able to deliver jobs and prosperity for the people of the North, it would be a good thing, but all we get is negativity, negativity and negativity from across the Chamber.
An investor would probably run a mile rather than provide jobs for the very people whom you are supposed to be representing.
The lesson needs to be learned and learned well: intransigence, belligerence and arrogance from the DUP placed us in this position. Those who tabled the motion may well have been able to operate a coup and remove their party leader, but intransigence and arrogance will not remove a framework from an internationally agreed act of withdrawal. Let us get the technical problems addressed and leave the politics to the side. We support the part of the motion that states that we all need to have access to medicines, but we do not support the way in which it is proposed to deliver that.
Although the point has been made a couple of times in the debate already, it is fair to say that no one in the Chamber wants to see any disruption to our medicines and medical supplies. You, Jonathan, will know from the Committee that it is an issue that we are all aware of. The problem with the motion is its essence and content. It ignores the glaring reality of why we are at this point. Members across the way have made the point that it is as a result of the protocol, but we are not debating the issue of unfettered access to medicines and medical devices as a result of the protocol. As has been said, the reality is that Brexit is the problem. Brexit is the point. We have been brought to where we are now because of Brexit. The protocol emanated from Brexit. Brexit was the catalyst. Language is changing. When Cathy Harrison gave us a briefing at the Health Committee, she talked about long-term change and a new normal. We have heard all those comments being made. The long-term change that has been identified and to which the industry is trying to adapt has been a result of the process that has flowed from the Brexit referendum.
I thank the Member for giving way. I understand that some Members across the House do not want to take my word for it, but what about the words of Mark Samuels, the chief executive of the British Generic Manufacturers Association? He said:
"Due to the Protocol’s interpretation, the situation has forced our members to review the viability of their ongoing medicines portfolios for Northern Ireland. Without a solution immediately, some manufacturers report that up to 90% of medicines could be at risk of being withdrawn."
Is that not an acceptance that the protocol is a serious issue?
I thank the Member for making that point. I want to bring my remarks back to the word "solution".
We hear about the threats and the 90%. We need to focus on medicines disruption. Carál referenced it earlier in relation to Scotland. The disruption that we see is not unique to the North. If it is not unique to the North, logic tells you that it is not unique to the protocol. Carál mentioned the Scotland example. A committee has been set up to monitor the availability of all medicines across England. As recently as 14 May, that committee revealed that the latest shortage that has been reported is for fluoxetine, which is an antidepressant. The shortage exists for England, Wales and us in the North. It cannot be said that the protocol is causing those shortages; it is bigger than that.
Cathy Harrison has briefed the Health Committee on a number of occasions about the impact that Brexit is having on medicines and supply. Members will know that, every time, we have asked what is being done to address those problems. That is the point that we need to get to. We know that the mitigations thus far have ensured minimum disruption to patients and citizens, and we know that many of the issues that were raised were about the readiness of traders and the short grace periods. It also has to be said that the Chief Pharmaceutical Officer stated that the majority of those issues have been resolved and that they are working through them, albeit on a case-by-case basis, and that, importantly, they have a further enhanced surveillance system in place. That is the important thing that we need to be talking about and keeping checks on. We heard about the potential for slow access to new medicines and delays to the introduction of variations in licensing. The Chief Pharmaceutical Officer has made it clear that that has been given top priority. More importantly, it is part of the ongoing talks between the British and European Union negotiating teams. That is where you will get progress and movement.
We heard about the large programme of work that is being undertaken by our Department of Health, the CPO, the Department of Health and Social Care over in England and by HMRC. An enormous amount of work has been done to reduce the risk to our supply chains. The language that the CPO used at the Committee was that all that work that has been done and is still being done is standing us in good stead in our understanding of supply chains.
We know that our medicine supply chain is being reorientated as we speak, and there is no change in that. That is happening as we speak. We are now working towards this phase of a new normal for a wide range of partners in the industry. The pharmaceutical industry is a broad family, and it is looking at highly complex supply chains from around the world. They are looking at different ideas but are having to make decisions, and they are making decisions already around transporting to the South of Ireland from the North and direct models into the North as opposed to via Britain. That is work that they are used to doing. This is a complex business. Yes, the changes are having to take place, but the important thing for us as MLAs, and people were saying how our constituents might suffer —
— as a result, is that we really need to be careful with our language in the Chamber. Until we see the evidence and the outworkings that our citizens are being impacted, we have a responsibility to be really measured and to focus on progress and solutions.
I oppose the motion, because the Alliance Party did not want the protocol. It is not our protocol; it is the DUP's protocol. We know why that protocol came about. It is the responsibility of a party that chose extreme Brexit, and that is where we are. However, we are a pragmatic party when it comes to issues such as those in the motion. We want to highlight the solutions. Others have been talking about solutions. This has been a debate of two halves: those who are not interested in solutions and those who are interested in promoting solutions. I am clearly on the side of wishing to promote a solution to the problem that we have had and that is set out in the motion. The motion totally fails to outline a meaningful course of action. Furthermore, it fails to set out any realistic way of addressing the problems and issues that we face.
The Alliance Party was first among the parties to engage with the Cabinet Office to find solutions to the protocol. Our North Down MP, Stephen Farry, our Brexit spokesperson, has been engaged extensively on this since the election in 2019. He has been engaging directly with the UK Government, highlighting the issues for the people of Northern Ireland but, crucially and importantly, working on solutions. Dr Farry was one of the very first to float, for example, the UK-EU veterinary agreement to ease Brexit friction across the Irish Sea — an idea that has gained considerable traction across the political landscape, even among DUP Ministers. Dr Farry was one of the first to highlight the potential problems that we might see with medicines in Northern Ireland when the grace period drew to a close. As many have mentioned, the vast majority of medicines into Northern Ireland come from Great Britain, but the fact is that many of them are manufactured in the EU. The grace period on the implementation of rules around medicines imported from the single market has been welcome and should be given more space. However, we must keep medicines flowing long-term. That is in everyone's interest. I believe and have confidence that the UK Government, sitting down with its partners in the EU, will be able to achieve that.
What will not resolve the problem is continued blatant scaremongering. As local representatives, we should engage in good faith and constructively to achieve that resolution. I am delighted that the Health Minister is here to listen to the debate. I want to hear in detail what engagement he has had and what practical activities he has undertaken with the Joint Committee to resolve these problems. There is one person in the room who can tell us exactly what is going on. I do not believe that he will scaremonger; hopefully, he will set out some of the practicalities that he and his Department have been working on to resolve the issues.
Perhaps a trusted trader scheme could be a solution, as medicines do not normally go directly to patients but are prescribed. Essentially, I see no risk of medicines ending up outside Northern Ireland after arriving from the other parts of the United Kingdom. On wider customs issues, the UK Government have invested in the UK Trader Support Service to reduce friction and manage red tape. Businesses are already managing mitigations. We should give them space to support that happening, not trying to undermine that work by scaremongering. We need to support businesses to help them seek stability and reduce frictions. The reality is that the protocol is here to stay. Even Mr Stalford, who engaged with me earlier in the debate, told 'The Nolan Show' that it could be here to stay. Those were his words.
The UK Government have decided that a hard Brexit for the rest of the UK is worth it, so what is the alternative to the DUP proposal? Brexit and the protocol were not the outcomes that my party wanted. Clearly, the backstop, which was vetoed by the DUP, would have provided a much better outcome, but the DUP sank that, which is something that they should reflect on. People are tying themselves in knots, trying to reconcile the fact that they supported a hard Brexit and all the complications that, they were warned, it would bring to Northern Ireland.
There should be some reflection on the number of minutes given to those in favour of the motion as opposed to the number of minutes given to those who are against it.
The motion is a moment of truth for the rigorous implementers of the protocol — Sinn Féin, the SDLP and the Alliance Party — because they are the people who demand rigorous implementation. We are seeing what rigorous implementation means for their constituents and for mine. Under the protocol, the person who is suffering from lung cancer cannot, unlike his fellow citizen in the United Kingdom, have access to a vital life-saving drug like Tagrisso. Why?
I will not give way because I will get no extra time.
Why is that? Because the protocol places us exclusively under EU law and within the orbit of the European Medicines Agency, which has not approved that drug. Therefore, the hapless people of Northern Ireland, courtesy of the protocol and thanks to the rigorous implementers, are in a position where a life-saving drug like that cannot be afforded to them. I hope that the rigorous implementers are proud of themselves —.
On a point of order, a LeasCheann Comhairle. Is it in order for Members to peddle misinformation? My colleague made the point earlier that the problem with medicines also relates to Scotland; it is not an issue that is related to the protocol. The Member in the corner is clearly blaming it on the protocol. Is it in order for a Member to do that?
I make the point because it is absolutely accurate
The people in Scotland have access to Tagrisso. Why? Because they are not bound by the iniquitous protocol. The people of Northern Ireland, including the people in west Belfast who might be suffering from lung cancer, will not have access to it, thanks to the protocol and its rigorous implementation, which Mr Sheehan and others support
I trust that those who vote for the rigorous implementers will see what rigorous implementation means. It means that they put their ideology above their constituents' health. That is what it comes down to: above their health. Shame on them for taking that attitude.
However, it does much more than that. As I said when I intervened earlier, 16 critical EU regulations and directives are implemented by the protocol. That means that never, ever, under the protocol, can any public representative from Northern Ireland have any say in shaping, changing or amending any of them. The transfer of sovereignty that has happened under the protocol means that those laws, which touch on medicines — nothing is more critical to our people — can never now be made in Belfast or London but are to be made in a foreign jurisdiction that is subject to the oversight of a foreign court. That is the protocol in action. You see it in action in what it is doing to our health. It is a death-delivering protocol for cancer patients —
— and that is courtesy of those who want the rigorous implementation of the protocol. It truly is bad for your health.
Thanks to the rigorous implementers, that is the way that they want it to be. Tragically, sadly, their pro-EU ideology is such —
On a point of order, Mr Deputy Speaker. As a person who is suffering from cancer, I take great offence at being told that my vote today may deliver death to people in Northern Ireland. I trust that the Minister of Health will explain exactly what the situation is with life-saving cancer drugs in Northern Ireland. He has a duty and an obligation to explain that and to say that —
Thank you, Mr Deputy Speaker, for the opportunity to respond to the motion and to Members' remarks.
I reassure Members that I and my Department are committed to maintaining the supply of medicines and medical devices in order to meet the needs of people in Northern Ireland. Furthermore, I am committed to ensuring that Northern Ireland citizens continue to have the same access to new medicines and innovative treatments as citizens in the rest of the United Kingdom. As a constituent part of the United Kingdom, we should expect no less.
The Assembly can be satisfied that, as Minister of Health, I am prioritising those issues. Undoubtedly, however, where this issue is concerned, under the flawed protocol, there are challenges. Members should be aware that the Northern Ireland protocol has major implications for the regulation and supply of medicines and medical devices. Under the Northern Ireland protocol, Northern Ireland is obliged to continue to follow EU laws and regulatory processes for medicines and medical devices, but Great Britain is not. Consequently, whereas Great Britain is now subject solely to the regulatory authority of the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), Northern Ireland must follow the European Medicines Agency's (EMA) centralised procedure for medicines authorisation. If there are any differences in medicine licensing decisions or timelines between the two regulators, that creates a risk of divergence between Great Britain and Northern Ireland that must be managed.
We have seen an example of that in recent days with the change to the medicines licence for Tagrisso, which is a lung cancer drug.
I said that differences between the two regulators creates a risk of divergence, so it covers both — North/South and east-west. I do not want to politicise the drug supply.
I want to talk about the example that has been used here today. Tagrisso was already licensed by the MHRA and the EMA under the Northern Ireland protocol, and Northern Ireland follows the conditions of the EMA licence. When a change of licence held by MHRA was approved under Project Orbis, it applied only to Great Britain, leaving Northern Ireland subject to an EMA update, which has not yet happened. However, in order to avoid a delay for Northern Ireland patients, the MHRA, the Department of Health and Social Care in Westminster and my Department worked together with the drug company in order to enable Tagrisso to be available in Northern Ireland for patient use in line with the rest of the United Kingdom while allowing it to be used outside its licence. While the EMA authorisation is being finalised, Tagrisso will be available under compassionate use and judged on a case-by-case basis.
I am grateful to the Minister for giving way. It is to be used on a compassionate basis as a one-off. The principle is that, once we come to next January, we will be tied in irreversibly to the EMA and its approvals, and the approvals of the UK regulatory body will cease to control us. Is that not correct?
Tagrisso has proven to be an example of the complex issues that we currently face and the additional steps and procedures that now need to be managed when there are differences between the decisions of the MHRA and the EMA on medicine authorisation.
On supply, Members will be aware that we currently benefit from a grace period to allow the pharmaceutical industry more time to adapt its systems to comply with the new requirements under the protocol that will come into effect after 31 December 2021. The new requirements will mean that medicines moving from Great Britain to Northern Ireland will be subject to additional batch testing and verification. In addition, all medicines in Northern Ireland will have to have packaging that complies with the EU falsified medicines directive.
I advise the Assembly that the grace period has been successful in mitigating potential risks to Northern Ireland medical supplies. At this time, the Department is, fortunately, not aware of significant risks to patient care because of an actual or proposed diminution in the quality of medicinal products or devices placed on the Northern Ireland market. Certainly, there has been a range of issues involving delays to deliveries of medicines and medical devices as suppliers adapt to new import arrangements. However, the majority of those relate to trader readiness and have been satisfactorily resolved at this stage. My officials continue to offer support and interventions when needed to ensure supplies for patients.
I note Members' concerns about the Northern Ireland protocol, and I agree that the challenges for the pharmaceutical industry and my Department must be addressed and worked through. The Assembly will agree that it is important that those challenges are properly defined. At this time, the true extent of how the protocol will impose barriers to trade is still to be seen, but it should be the policy of all in the House to avoid any barriers.
Since the start of the year, trade has, thankfully, been maintained, and the pharmaceutical industry has adapted to the additional regulatory and import checks required by the protocol when moving goods from GB to Northern Ireland. There is no evidence yet to suggest that patients in Northern Ireland are unable to access medicines that they need or, indeed, any issues with the safety and efficacy of the medicines that are available. However, when the grace period ends, all suppliers will have to comply fully with the requirements of the Northern Ireland protocol, and my Department is aware that companies are planning for potential major changes to their supply arrangements from January 2022. The Chancellor of the Duchy of Lancaster asked for an extension of that grace period, but the EU has yet to agree to that. Members should note that pharmaceutical companies are subject to an obligation to ensure continuous supplies of medicinal products so that the needs of patients in Northern Ireland are met.
I appreciate the Minister's giving way. I agree with him that we need to focus on ensuring that we have a solution to issues with medicines moving from GB to NI. Will he note that Almac, which is one of the biggest pharmaceutical and life sciences companies in Northern Ireland, has a section on its website called:
"The Almac Advantage: unique, unfettered and flexible access to the UK, Europe and beyond" and that this enormous employer and pharmaceutical leader in Northern Ireland believes that it is an advantage for it to have access to both British and EU single markets under the protocol?
I note what the Member says, and I note that the motion states:
"if established, these arrangements would add cost for businesses and public services, restrict supply and jeopardise patient care across Northern Ireland".
That is acknowledged in the motion that we are debating today.
A number of issues were raised. We are aware that price increases are a potential risk, and, if issues emerge, we have systems in place to deal with them.
So far, there is no evidence to suggest an increase in the price of medicines, but that does not mean that that could not change.
The grace period for medicines is a short-term mitigation that has benefited the medicinal supply chain in Northern Ireland. However, to reduce the potential for risks manifesting themselves at the end of the grace period, I assure the Assembly that a number of other mitigations are ongoing.
First, medicines are the subject of ongoing discussions between the UK Government and the EU Commission to reach a negotiated position on implementation of the protocol. Secondly, my Department is working with the DHSC in London at official and ministerial level through direct and regular engagement between the Minister of State for Health and me. The underpinning principles of this work are to ensure that the clinical needs of patients in Northern Ireland are met and that equity of access to medical products is maintained across the United Kingdom. The DHSC has committed to communicating to industry specifically on supplying to Northern Ireland. My officials have requested further clarification from the DHSC regarding the time frame for that guidance.
Thirdly, the DHSC is involved in formal discussions with industry about its plans for the end of the grace period, and my Department also maintains close contact with stakeholders in industry, and officials have frequent meetings with individual companies. In addition to that, officials engage with wider stakeholder groups in the health and social care sector in Northern Ireland, with community pharmacy and with groups representing patients across a range of interests and medical conditions.
I note that the motion:
"calls on the Minister of Health to work with his Executive colleagues".
I assure Members that, throughout this process, I have spoken with the Executive and provided my colleagues with a comprehensive briefing setting out my up-to-date assessment of the situation. I will, of course, continue to do so. My officials also continue to liaise with officials from the Executive Office on related matters.
I conclude by saying that the actions taken by the pharmaceutical industry and the interventions, when needed, by my officials have ensured that there has been no significant reduction in the quality or quantity of medicines and medical devices on the market in Northern Ireland. They have risen to that challenge, and the Assembly will no doubt join me in acknowledging their hard work to date and in thanking them. My Department will continue that work in the coming months to ensure that future access to medicinal products and medical devices is maintained for the citizens of Northern Ireland. My Department has the support of the Department of Health and Social Care in Westminster and the Medicines and Healthcare products Regulatory Agency. I believe that I have clearly demonstrated that all the issues are being given serious attention by my Department and that intensive work is ongoing. I thank Members of the Health Committee for their acknowledgement of the work of the Chief Pharmaceutical Officer, Cathy Harrison, and her team in their dedication to the task.
Neither my Department nor I have created or sought this situation, and we cannot fix it by ourselves. The EU and the UK Government have central roles in finding the way forward. I have sympathy with the concerns expressed by Members.
I thank the Minister for his last few words, when he said that he cannot fix this issue on his own and that it lies between the UK Government and the EU to resolve these matters. I value the intervention of the Department of Health and the Minister on these matters, but the words that the Minister used today are important in acknowledging that we need to work on solutions and that those solutions are achievable between the UK Government and the EU.
I thank the Member for his intervention. I hope that, by demonstrating our interactions with the DHSC and the MHRA and the work by the Chief Pharmaceutical Officer and her team, he will see that we are working on the issue on a case-by-case basis. Many of the theoretical and policy problems that are presented to us need a case-by-case answer. At the end of this, it will be a political solution and agreement. No matter how much policy that departmental officials, the EU or Westminster come up with, the answer will be political.
I thank the Minister for giving way. Will he confirm that all the regulations and directives listed in the protocol that touch on medicinal issues, which include veterinary medicines and medical implements, are beyond the amendment or input of this House and that all legislation touching on those matters as they affect Northern Ireland is now incapable of being made anywhere in the United Kingdom?
The scope of the decisions on this is outwith the competence of the House and my Department. We have a major responsibility to provide input and advice when the Department of Health and Social Care asks for it. We are getting great support from DHSC and the MHRA in recognition of the challenges that are now faced to the supply of medicines and medical devices to Northern Ireland. My deepest regret is that, as Minister of Health in Northern Ireland, I do not have a seat at that table. That is where we could truly identify all the issues that we know of and all the knock-on implications that any change will have. I would value that dedicated and detailed input.
As I was saying, I have sympathy with the concerns expressed by all Members, because this situation is very far from ideal. New layers of complexity and bureaucracy are being created. I appeal to Members to choose their words carefully, however. There are uncertainties and challenges, but every effort is being made by my Department to ensure that the needs of all our patients and people in Northern Ireland are met.
I thank all the Members for their contributions, including the Minister of Health for his response. Without a doubt, this threat to Northern Ireland's medicine supply is an issue that should be debated openly and honestly. I welcome the opportunity that we have had to discuss it.
I am sure that every one of us, when we talk to constituents, says that one of our highest priorities, if not the highest, is health. Our health service is the jewel in the crown of our Union. We all value that free-at-the-point-of-need service: in the past 12 months, more than ever before. It should always be a priority, because our health service keeps us well and saves lives.
Key to the success of our health service is access to medicines and medical devices. In the United Kingdom, we benefit greatly from the very latest treatments and cutting-edge technology, all administered by our amazing front-line healthcare workers. Approximately 98% of medicines and medical products used in Northern Ireland are imported either from or via Great Britain. It is a life-saving supply chain, yet, because of the protocol, that free flow of medicines and medical devices is now under severe threat. Medicines moving from GB into Northern Ireland will be handled as though they are goods entering the EU from a third country. That means that medicines moving into Northern Ireland from GB will be subject to additional batch testing and qualified-person certification.
On 1 January next year, when the grace period ends, all medicines used in Northern Ireland will have to comply with the EU medicines directive. That affects the packaging of the medicines, but the same —.
I will not, thank you.
That affects the packaging of the medicines, but the same requirements will not apply to products marketed in GB. The fact that the EU calls it a "grace period" is in itself an insult.
GB manufacturers that place medical devices on the Northern Ireland market must now appoint an EU- or Northern Ireland-based authorised representative. I have spoken with many suppliers in recent weeks, and they testify to intolerable levels of paperwork and bureaucracy, including issues with couriers and a substantial increase in the cost of doing business with long-standing clients in Northern Ireland. Non-UK manufacturers are now required to appoint a UK-responsible person or a Northern Ireland —.
I appreciate the Member's giving way. I do not dispute that there are issues that we need to address constructively. The Member mentioned the increase in paperwork. Does she accept that, for anyone importing goods into GB from Europe, that enormous European market from which a huge number of medicines are imported into the UK, is also facing a huge increase in paperwork, because that, unfortunately, is what Brexit is?
I thank the Member for his intervention.
Non-UK manufacturers are now required to appoint a UK responsible person or a Northern Ireland-authorised person, who, along with Northern Ireland manufacturers, must register devices with the MHRA before they are placed on the Northern Ireland market. Furthermore, medicines on clinical trial will follow EU regulations in NI but not in GB. With the times that we are in and us having benefited so greatly from the UK vaccination programme, it is significant that Northern Ireland will follow EU regulations on vaccines and Great Britain will not. While Members from some parties want us to follow the European vaccine programme, I think that, once again, we are better with the Union of the United Kingdom and not with the European Union.
The British Generic Manufacturers Association has made it clear that the intolerable and unsustainable position that has been foisted on us at the behest of the EU will prevent identical products from being supplied to GB and NI. It will mean that businesses will have to duplicate resources and supply lines
I will not. Thanks.
Firms may need to build extra warehousing and hire more staff to ensure that medicines comply with both EU and UK regulations, which simply is not viable in the longer term. Given the small margins, that will not be sustainable, and some GB manufacturers report that up to 90% of medicines could be at risk of being withdrawn.
Sadly, the consequences of what the EU is demanding are likely to impact specialist illnesses particularly hard, given that smaller quantities are needed and the cost of creating an NI-only pool of products would be prohibitive. It would also disrupt direct patient supply, especially for nutritional products, such as gluten-free food, infant formula and some personal home-care products. That is in addition to the threat to the supply and the choices available to local health and social care services. Access to clinical trials and accessing new developments in the production of medicines, including vaccine supplies, would be threatened and, at the very least, slowed down.
Who among us feels that that is the best deal and the best for the health and well-being of those whom we represent? The rigorous implementation of the protocol, shamefully demanded by some local parties and the Irish Government, is damaging to the public health of everyone in Northern Ireland. It is not an orange or green or a Leave or Remain issue. It affects everyone. Whilst some Members opposite will no doubt seek to dismiss those issues, their cherished protocol is depriving lung cancer patients here of the same chance of recovery as those in GB. That is absolutely scandalous.
No, thank you.
The invoking of article 16 of the protocol in January ended the facade that Northern Ireland would be treated as a full and equal member of the EU single market. As Brussels considers new export controls on COVID-19 vaccines, there is no guarantee that our Province will escape the fallout. The residual threat to the domestic supply of medicines is one of the most telling examples of why the notion of the best of both worlds is a dangerous myth.
Given that there is already very little direct North/South trade in medicines because of different licensing regimes, there is minimal threat to the EU market or consumers. While the protocol was championed under false pretences, the reality is that medicines and medical devices should never have been in the conversation in the first place. A permanent decoupling of public health from the protocol by the EU and the UK is long overdue. They should pursue a comprehensive mutual recognition agreement on medicines that takes the politics out of it and ensures the free flow of goods across our United Kingdom.
The bottom line and minimum requirement are that medicines that are produced in Great Britain should be able to be legally used in Northern Ireland without additional barriers or hurdles. Quick fixes and tinkering at the edges of the problems will not cut the mustard. There needs to be a meaningful and sustainable replacement of the protocol. It is time that we all recognise the perilous implications for patients, pharmacies and local health services. I ask all those who will go to the doors of constituents over the next 12 months to back up their claims, to make health a priority and to support the motion.
Clear the Lobbies. The Question will be put again in three minutes. I remind Members that they should continue to uphold social distancing and that Members who have proxy voting arrangements in place should not come to the Chamber. Also, it would be preferable to avoid a Division and the use of the Lobbies.
Question put a second time.
Before the Assembly divides, I remind the House that, as per Standing Order 112, the Assembly has proxy voting arrangements in place. Members who have authorised another Member to vote on their behalf are not entitled to vote in person and should not enter the Lobbies. I remind all Members of the requirement for social distancing while the Division takes place. Please ensure that you maintain gaps of at least 2 metres between yourselves and others when moving around in the Chamber or the Rotunda and especially in the Lobbies. Please be patient at all times, observe the signage and follow the instructions of the Lobby Clerks.
The Assembly divided:
Dr Aiken, Mr Allen, Mr Allister, Mrs Barton, Mr Beattie, Mr M Bradley, Ms P Bradley, Mr K Buchanan, Mr T Buchanan, Mr Buckley, Ms Bunting, Mr Butler, Mrs Cameron, Mr Chambers, Mr Clarke, Mrs Dodds, Mr Dunne, Mr Easton, Mrs Foster, Mr Frew, Mr Givan, Mr Harvey, Mr Hilditch, Mr Humphrey, Mr Irwin, Mr Lyons, Miss McIlveen, Mr Middleton, Mr Nesbitt, Mr Newton, Mr Poots, Mr Robinson, Mr Stalford, Mr Stewart, Mr Storey, Mr Swann, Mr Weir, Mr Wells
Tellers for the Ayes: Mr Buckley, Mr Middleton
Ms Anderson, Dr Archibald, Ms Armstrong, Ms Bailey, Mr Blair, Mr Boylan, Ms S Bradley, Ms Bradshaw, Ms Brogan, Mr Catney, Mr Dickson, Ms Dillon, Ms Dolan, Mr Durkan, Ms Ennis, Ms Flynn, Mr Gildernew, Ms Hargey, Ms Hunter, Mr Kearney, Mrs D Kelly, Mr G Kelly, Ms Kimmins, Mrs Long, Mr Lynch, Mr Lyttle, Mr McAleer, Mr McCann, Mr McCrossan, Mr McGlone, Mr McGrath, Mr McGuigan, Mr McHugh, Ms McLaughlin, Mr McNulty, Mr Muir, Ms Mullan, Mr Murphy, Ms Ní Chuilín, Mr O'Dowd, Mrs O'Neill, Mr O'Toole, Ms Rogan, Mr Sheehan, Ms Sheerin, Miss Woods
Tellers for the Noes: Mr Gildernew, Mr Sheehan
Question accordingly negatived.