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European Affairs Committee

Protocol on Ireland/Northern Ireland Sub-Committee

Corrected oral evidence: Follow-up scrutiny of the provision of medicines to Northern Ireland under the Protocol

Wednesday 25 January 2023

3.10 pm

Watch the meeting

Members present: Lord Jay of Ewelme (The Chair); Lord Dodds of Duncairn; Lord Empey; Lord Hain; Baroness O’Loan; Baroness Ritchie of Downpatrick; Lord Thomas of Gresford.

Evidence Session No. 2              Heard in Public              Questions 11 - 22

Witnesses

I: Mark Dayan, Policy Analyst and Head of Public Affairs - Trade and Brexit programme lead, Nuffield Trust; Kate Ling; Senior European Policy Manager, NHS Confederation; Dr Alan Stout, Deputy Chair of BMA NI Council.

Examination of witnesses

Mark Dayan, Kate Ling and Dr Alan Stout.

Q11            The Chair: Good afternoon, everybody. Good afternoon to all our witnesses and welcome to this public meeting of the Sub-Committee on the Protocol on Ireland/Northern Ireland. We are continuing our follow-up scrutiny of the provision of medicines to Northern Ireland under the protocol. This follows a short inquiry undertaken by the committee in the autumn of 2021.

Today we are meeting Kate Ling, senior policy manager of the NHS Confederation, Mark Dayan, policy analyst and head of public affairs at the Nuffield Trust, both joining us in person, and Dr Alan Stout, deputy chair of the British Medical Association Northern Ireland, who is joining us remotely. It is good to meet you all. You are very welcome and we very much look forward to your evidence. Thank you for the contributions that you have sent us in advance. They have been extremely helpful.

Would you mind introducing yourselves the first time you speak? It is not that we do not know who you are but not everybody who is listening or reading the transcript afterwards will know exactly who you are. That will be helpful. Today’s meeting is being broadcast and a verbatim transcript will be taken for subsequent publication, which will be sent to you all to check for accuracy. I also refer to the list of members’ interests, as published on the committee’s website.

Welcome to you all. I will ask the first question to get us going. How would you summarise the main issues facing the pharmaceutical industry for medicine supply to Northern Ireland under the protocol as it is currently operating? I will ask Kate Ling to start.

Kate Ling: Thank you. I am here representing the NHS Confederation, which is the umbrella organisation of the health service in Northern Ireland, so they are our members. I am here today to comment on the impact of the protocol on health service providers and the patients who rely on their services. I have done my homework and seen the session that you had last week with members of industry, which was extremely useful.

Our biggest overall concerns about the operation of the protocol—where shall I start? As far as the impact is concerned at the moment, we are reassured because the evidence that we have had, all the feedback that we have from our members in Northern Ireland, has been positive in that patients are continuing to receive the medicines that they need, which is obviously the bottom line, the most important thing. However, I think that this is because of the easements that have been put in place by the EU and the UK. We are very grateful for those because they have enabled supply to continue so that there has not been the impact on the ground that we all feared a year or two ago.

That is good and it is working, but it is only working because of a huge amount of effort that is being put in at a higher level to get these easements in place. A lot of work is being done behind the scenes to ensure that patients and providers are not seeing too much difference on the front line. As you will have gathered from the evidence given by the witnesses, a lot of the pain is being absorbed by the suppliers and the distributors who are describing the extra hurdles and bureaucracy of the difficulties that they are facing. As I said, the important thing is that the medicines are getting through.

Apart from no agreement being reached at all on the impasse over the protocol, our biggest worry for the future is that, in the rush to get a deal done and to get something over the line, the issues about the supply of medicines will perhaps be forgotten about, side-lined or not dealt with properly. We want to see a long-lasting, stable solution to this. We are worried that if something is rushed through there may be an agreement that ends up in another fudge, something half-baked, and that there will still be anomalies or unresolved issues to be sorted out later. We really do not want to see that.

I do not know how specific you want me to be. There are specific outstanding issues, which I know were gone into in great detail last week. There are the issues to do with the falsified medicines directive, complying with those requirements, and the centrally authorised procedure where medicines that are authorised in the EU may not be available in Northern Ireland except by going through the NIMAR procedure that has been put in place.

The Chair: We may come on to some of those issues.

Kate Ling: That is why I am not sure whether you want me to expand in greater detail now or leave that until later.

The Chair: We will come on to it. I ought to have also said at the beginning that we are expecting votes in the House of Lords at about 4.45 pm. Therefore, we will aim to finish at 4.45 pm so that we do not get interrupted by members having to leave.

Thank you very much. That was very helpful. Mark Dayan, would you like to go next?

Mark Dayan: I agree with everything that Kate said. I work for the Nuffield Trust, which is a charitable think tank that studies this among other issues. We did some research into this last year in looking at authorisations and speaking to a few people involved. Kate will have a closer line to her members and I am sure what she is saying is right.

You can separate out the issues that the industry is facing into several categories of when they are coming, which might be helpful. As Kate says, there are the ones that are here now, like customs friction. There are the ones that are linked to the EU’s unilateral actions last year and the end of the year before that. Grace periods on batch testing are running out at the end of next year and they present something of a cliff edge. There is the gradual drifting apart of authorisations in Great Britain and Northern Ireland, which is ongoing but pretty slow with the effect it has. Lastly, there is the possibility of what comes out of talks in April or at another time, which could introduce new options to get medicines legal for use in Northern Ireland but potentially with additional burdens and complexities as well.

There is a range of different time sets going on and, overall, it is quite a picture of constant change in the obstacles to what can be legally marketed there and to physically moving units from Great Britain to Northern Ireland.

The Chair: Thank you. That is very helpful. I will ask Alan Stout from Northern Ireland. Over to you.

Dr Alan Stout: Thanks very much, Lord Chair. Thank you to you and the committee for the opportunity to speak to you this afternoon.

By way of introduction, I am, first and foremost, a GP. I am a practising GP and, as you mentioned, I am deputy chair of the BMA in Northern Ireland and chair of the GP committee, not only in Northern Ireland but also co-chair in the UK. I get a good oversight from colleagues right across the UK. I agree with the others so far.

As a GP, I have a clinical responsibility for absolutely everything that I prescribe but I am only a prescriber, so I put my signature on the bottom of the prescription and then, as if by magic, the medication appears in the patient’s hands and they take it and they follow the instructions. This is very important because as doctors and for our patients we have been immune and very much protected from all of the work that has been going on in the background to protect that position, to maintain the safety in Northern Ireland and to enable our patients to receive their medications.

In answer to your question, I will make two very simple points. One is that the mitigations, the derogations and negotiations have clearly worked. To date we have not had any issue with the supply of medication, disruption to supply chains, safety issues, mass changes or anything along those lines, which is a huge positive. Also, they have prevented us falling off the metaphorical cliff that everybody keeps referring to. We did not fall off that cliff but it has led to yet another cliff edge, and I think the others have mentioned that, which is when the current set of mitigations and derogations run out. That concerns us most: that we may see what we thought was an uninterrupted supply becoming an interrupted supply from that point onwards.

The Chair: Thank you very much. Thank you to all three of you. That is a very good start and we will go into a number of the points that you have raised in more detail as we go through the evidence session.

Q12            Baroness Ritchie of Downpatrick: You are all very welcome. Last week the industry told us about the specific issues that they were experiencing, which were licensing and technical issues, logistics. In view of that and your own professional experiences, how do you think industry has adapted or changed its operating model as a result of the protocol? As you are aware, we were taking evidence from the distributors, the pharmaceutical companies and the middle person.

Kate Ling: I know that the witnesses you had last week gave very detailed descriptions of the way in which they are coping at the moment. As Alan said, they are effectively keeping this away from the front line so that the patients and practitioners are not bearing the brunt of it. I have very close contacts with, for example, ABPI, the pharma industry. It is simply a lot of extra hassle for them. You had the description last week that the products are often stored in Great Britain and then have to be transported over to Northern Ireland but there is new bureaucracy. There are things they have to do that they did not have to do before.

I have had some evidence from the community pharmacists, for example, that it is increasing costs. Carriage charges and costs of transportation are being incurred by the suppliers and distributors and those eventually may feed through into the costs of medicines. I should emphasise that this affects generic medicines more, but I think that there are issues in the longer run for the NHS in that, if it is costing more for companies to warehouse and transport the products into Northern Ireland, it is reasonable to suppose that at some point this will increase costs and service pressures at the other end. It is not a big thing but they also said that there were some increases in waiting times for medicines. There could be a delay. I am not talking about huge delays, but it might be an extra day if you have to get the medication from somewhere in Great Britain to Northern Ireland.

In the conversations that I have had, it is very difficult to separate out the overall difficulties that everybody is having with the global supply chains, which affects everybody equally in the UK. It is difficult to separate those general problems. You will know yourselves that sometimes you go to the chemist and they do not have exactly what you want when you want it or they cannot give you six months’ worth but can only give you three months—that sort of thing. It is difficult distinguishing those normal everyday problems, which have been particularly difficult in the last couple of years, from things that are specific to Northern Ireland.

However, it is clear from the evidence you had last week, and from the conversations that we have had with the manufacturers and distributors, that there is a lot of extra pain and hassle involved in supplying products to Northern Ireland, particularly when they are very small quantities for a small number of patients, when you have to supply separate packaging. It is simply an absolute pain for them. Hence the problem, which you are well aware of, of some companies deciding that it is just not worth supplying the products into Northern Ireland.

Mark Dayan: That is a very good overview of some specific issues. If you zoom out, one thing that has not changed in the industry operating model or has not generally changed is the fundamental fact that Northern Ireland is still supplied mainly through Great Britain. That is important because, when the protocol was written, one of the scenarios we viewed as possible was that there would be a switch around and ultimately Northern Ireland would be supplied through the Republic, with quite a bit of disruption getting from one state to the other. The easements that we have seen so far have enabled that disruption not to happen. However, because the supply still comes predominantly through Great Britain, the risk of that is still there. That is why further changes can still feel like something of a cliff edge.

Dr Alan Stout: I agree with the other two. The simple answer to your question is: they have adapted very well but clearly they feel the pain and the hassle and the logistical difficulties. The supply is being maintained, so they have quite clearly adapted to that.

To elaborate on what Mark said, the biggest supply is through GB. We have always known that and it will most likely continue to be through GB. The biggest single factor that is causing the difficulties and the extra paperwork and so on is the requirement to follow the falsified medicines directive. That is forcing the need for repackaging and everything else. No doubt we will elaborate a little bit on the FMD during the course of this session, but if we were to look to one single solution or one fundamental solution it would be to remove Northern Ireland from the requirements of FMD. That would solve a huge number of the problems that are being faced at the moment.

The Chair: Again, we will come on to that point later. I think it is a very important point.

Q13            Lord Hain: You are welcome and it is good of you to give up your time. I will start with Alan to make sure we do not forget you over there, Alan. We have concentrated on the problems, quite rightly. Do you see any potential benefits of the protocol for the provision of medicines in Northern Ireland? Do you see any prospects of change on the scale of cross-border provision as well?

Dr Alan Stout: It is a good question. There probably is not a direct benefit but the one benefit of the protocol to medicine supply in Northern Ireland is that it has preserved the supply. Through the BMA, we have warned very heavily about the risks that particularly the hardest Brexit possible would have, not only with medicines but also for people with data and other products as well, and the disruption that it would cause to that, simply because of the unique position that Northern Ireland is in.

Lord Hain: Sorry, Alan, to interrupt. Could you explain a little more precisely what you mean about the difference between a harder Brexit and, to that extent, the beneficial effects of the protocol?

Dr Alan Stout: The way I would refer to it is simply one without agreement. That we were forcing it without an agreement with the EU. Clearly the protocol has allowed some of those negotiations, agreements and mitigations to happen and that has protected the supply. The comparator with not having any agreement in place and the difficulties that that would have caused is the main benefit that we can see from the protocol itself. The change to medications through the Republic was projected and it was thought could be a solution, but it has not happened. Again, that is because of the well-established supply chains through GB and also because we will end up with different licensing and regulation with Northern Ireland. We have heard from the pharmaceutical companies that it is because of the size of the market in Northern Ireland that it was not really in their interests to change their major supply chains, certainly for some of the less frequently used medications.

Lord Hain: Without putting words in your mouth, it is better to have the protocol than nothing but there are still problems with the protocol?

Dr Alan Stout: Absolutely. It has shown that the negotiations, the mitigations, the derogations can work. We look at that as a success and simply the past couple of years as a success because we have been able to maintain our supply.

Mark Dayan: I think that Alan is quite right to put that question in the context of what the alternative is. You could say that if we had left the single market but there was no protocol, we would not have these problems but we would have lots of others. Most particularly, we would then have a hard border between Northern Ireland and the Republic. That would cause big problems for the minority of medicines that came in like that and presenting much larger—

Lord Hain: Minority medicines?

Mark Dayan: Yes, most do come from Great Britain. It would cause other problems for the majority of medical devices that come in like that, for service delivery across the border and obviously for many other parts—

The Chair: When you say “medical device”, what is a medical device and what is a medicine?

Mark Dayan: That is a very good question. They are regulated more differently than many people might think. A medicine is something that you ingest and it has a pharmacological effect on you. Physical tools, aids, things used by doctors and so on, are classed as medical devices and they have a very different regulatory system. We have been consistently told, although precise data is quite hard to come by, that the Northern Ireland NHS gets most of its medical devices from the EU, unlike medicines that mostly come from Great Britain. I think that you would have a much bigger problem with that in a—

Lord Hain: If you had had a hard border across the island of Ireland, the medical devices issue would be escalated?

Mark Dayan: Yes.

Lord Hain: You are referring to a hard border across the island rather than in the Irish Sea?

Mark Dayan: As the counterfactual for having the protocol, which you could say creates more of a border in the Irish Sea. On the other hand, if your counterfactual is that we stayed in the customs union or something like it, that could have removed some of the barriers to medicines we have been discussing without necessarily creating any new ones, but obviously that has implications for many other areas of economic and political life for the whole of the UK.

One last possible beneficial effect of the way that the protocol is working now, which is with some pretty heavy edits when it comes to medicines, is that with the NIMAR route it is now notionally possible that Northern Ireland could get some medicines before the EU if the UK approved them first. As far as we can tell, it has not happened very often so far, but notionally that could be the case.

Lord Hain: If the UK approved them first?

Mark Dayan: Yes.

Lord Hain: Could you elaborate on the procedure for those unfamiliar with how this works, including me?

Mark Dayan: In general, for most innovative products, Northern Ireland is functioning as part of the EU system, basically, through the centralised procedure they have. There is now a mechanism—which I know that the representatives of industry discussed with you in a bit more depth—whereby if the UK approves something first and it has not been approved yet in the EU, at least for an interim period it can be approved for Northern Ireland.

Lord Hain: Kate, could we have your take on it?

Kate Ling: Yes. I agree with everything that Alan and Mark have said: that the very existence of the protocol and the subsequent easements have been beneficial. There are some strange anomalies. Northern Ireland’s unique position in adhering to EU rules means that there are circumstances where patients in Northern Ireland could get earlier access to medicines that have been approved by one or the other regulator. Patients in Northern Ireland can enrol in EU-wide clinical trials, for example. There are these areas where the strange position that Northern Ireland is in can be an advantage.

Lord Hain: Do you mean clinical trials in both jurisdictions?

Kate Ling: Yes, without going through any sort of extra hurdles because for those purposes Northern Ireland is following the EU’s rules. I have heard the same thing as Mark and Alan: that the supply route we thought might happen through the Republic of Ireland has not really happened for logistical reasons, and that companies do not seem to have switched their supply and distribution routes. I have heard all sorts of reasons for that, but they would need different packaging, they would need to do things differently, so by and large that has not really happened.

Another rather strange thing—I am not sure if you could call it a silver lining or not—is that several people have said to me that the introduction of the protocol has driven the health departments and industry and NHS to work together much more closely, and it has greatly improved the monitoring and management of the medicine supply chain. That is probably an unintended consequence but it has happened. You could say why could that not have happened before, but it is certainly something that has taken place.

Lord Hain: Just within Northern Ireland rather than together with England, Scotland and Wales?

Kate Ling: I think both. We speak regularly to the health department and the industry in Northern Ireland but also to their counterparts in the NHS in England and the Department of Health and Social Care in England.

Lord Hain: Without taking up too much time, could you give a practical example of how that extra collaboration has manifested itself?

Kate Ling: Simply because they have had to work together. For example, with the introduction of the NIMAR route they have had to work together very closely to ensure that medication that is available in England, which is licensed by MHRA, that whatever people are getting in Great Britain they are also able to access in Northern Ireland. As I said earlier this—

Lord Hain: Would that not have happened before?

Kate Ling: Before Brexit, it would have been automatic that anything that was authorised by the MHRA would be available anywhere in the UK, including Northern Ireland. Now that is not necessarily the case and it means that industry is having to tell the health departments, to supply very up-to-date information on supplies, what they have available, how much of it they have, whether they are in danger of running out of anything, whether there are products that they might not continue to supply into Northern Ireland, for example. There is very close monitoring of the situation to pre-empt any difficulties, and I think that that has been very effective. It has been working very well. It is a lot of extra time and effort for everybody, whether it is the officials in the health departments or the people involved in industry, but it has worked. It has reaped benefits because the patients are still getting the medication.

Lord Hain: There is extra cost and resource.

Kate Ling: Yes, there is the uncosted resource of people’s time and effort, of course, not just actual cost of extra carriage charges or transportation. There is also the time spent filling in forms and doing the documentation and all the discussions that are going on.

Q14            Lord Dodds of Duncairn: Before I come on to the question that I want to outline more directly, can I follow up on a point of clarification? The business of Northern Ireland patients may receive medicines more quickly as a result. Can you explain how that happens, for instance?

Mark Dayan: It would be that the MHRA approved a medicine and then was able, through NIMAR, as has been accepted by the EU in the allowances that they have made, to transfer that authorisation to enable the medicine to be supplied in Northern Ireland at a time when the EU, which otherwise is responsible for that class of medicines, had not done it.

Lord Dodds of Duncairn: Yes. The NIMAR thing is to overcome the problem of the protocol, because the protocol subjects us to EU rules whereas this allows us to continue as it would have previously, just getting British medicines?

Mark Dayan: As Kate said, it could not exist in the old world where there was simply one medicines regulator for all of the UK, including Northern Ireland. If it had been decided for the UK, it would have been decided for Northern Ireland. Of course, that is more complicated because in practice the types of products we are mostly talking about there were decided at EU level before, so there could not have been the UK having a different approval in that area.

Q15            Lord Dodds of Duncairn: Thanks for that. To come on to the question I want to ask, you have dealt with to some extent the impact of the EU’s legislation on medicines, which came into force last year and it was part of their proposals in October 2021 for certain mitigations. It is my understanding that in the current discussions the EU has not tabled anything new on this. It regards this as dealt with. It is a considerable worry and concern to people in Northern Ireland that the cliff edge may be coming—as we heard last week and you have all mentioned this week—with what may happen in December as a result of centralised procedure and all of that.

What happens if in the current negotiations the issue of medicines is not addressed further? How will we cope with the situation where there is no further change to the medicines regime? As I understand it, that is not one of the salient issues that is currently being negotiated. Given that the alternative of sourcing through the EU, the Irish Republic, is not a winner for all the reasons that we know, because of the extra cost and packaging and all the rest, where would that leave us? Mark, do you want to start?

Mark Dayan: I have absolutely no insight into the negotiations, but it clearly was the case that around a year ago the EU accepted essentially that what was likely to happen to medicine supply into Northern Ireland was unacceptable and, therefore, introduced those delays. There has probably been a certain amount of adaptation on the part of industry but there is a very real risk that if we get towards the end of that period of extensions on requirements, like where you test medicines, where the licensing authorisation holder is, and so on, and they simply run out, we will face the same problems essentially that we did then. As you heard from the people in industry last week, there was quite a credible threat of hundreds—maybe four figures—of discontinued medicines, which would have been quite a major problem. If there is nothing agreed in negotiations and no more unilateral extensions, we would face that cliff edge that people have spoken about.

Kate Ling: I have nothing to add to that situation. I take heart from the fact that the easements that have already been introduced show that both sides recognise that it would be morally indefensible for patients to be caught in the crossfire like this, to be treated as chess pieces in a much larger political game. That recognition is clearly there on both sides, which gives me hope that it may be possible to reach a sensible negotiated solution to deal with the issue of supply of medicines.

Lord Dodds of Duncairn: We certainly hope so, yes. Alan, do you want to add anything?

Dr Alan Stout: Yes, I can. What you are describing is a nightmare situation if both sides play hardball and there is no agreement, and that would seriously restrict the supply of medication.

Lord Dodds of Duncairn: Playing hardball assumes that there is a negotiation about this particular issue. My concern is that this is not being properly addressed at the moment.

Dr Alan Stout: I think that that is a good point as well, whether it is hardball or whether it is simply not addressed. I think the “simply not addressed” is the better position because we already have had evidence of how the EU moved and I do not see that they could possibly not extend the current mitigations and derogations that we have. When we talk about hardball, and you said what would we do, what happens next if that was the case, and to reiterate, with the vast majority of our medications coming through GB, the one thing that is creating the problem is the need to meet the requirements of the falsified medicines directive. The question I would ask if we got into that position is: what would actually happen in Northern Ireland if we did not meet the falsified medicines directive and would the EU really fine us? If it did, how much would it be and would we just take the cost of that? The impact is tiny. The reasons behind the falsified medicines directive are for a tiny proportion of medications across the whole of the UK.

Lord Dodds of Duncairn: I think that is a very good point and a good point to move on to the next question because I think it addresses that directly. Thank you, Alan.

Q16            Lord Thomas of Gresford: Mark, in the written evidence from the Nuffield Trust, you refer to a potential landing zone for compromise and agreement. It says, “From a regulatory standpoint, the key outstanding issues are falsified medicines and the authorisations of medicines. A simple extension, potentially indefinitely, of allowances regarding the provisions of the falsified medicines directive could continue to address the former.” Could you explain what these issues are?

Mark Dayan: Yes. Taking the falsified medicines directive first, the issue to some extent is simply the burden of complying with it when the rest of the UK does not have to. Obviously that involves a whole set of activities around computer systems, tags and identifiers on packs of medicine that are still compulsory in Northern Ireland but are not elsewhere in the UK. That is one thing and it is, frankly, trickier to deal with.

I was referring to the added complexity when a medicine is shipped from the EU to Northern Ireland through Great Britain, which is relatively common, of needing to essentially go through all the work of deactivating those security features as it goes into Great Britain and then reactivating them again as it crosses from Holyhead or Stranraer or wherever it might do. The allowance for that reduces a significant amount of the extra bureaucracy involved in sending something to Northern Ireland through Great Britain rather than any part of the EU. The same goes for some of the other areas of time-limited allowances, as we have discussed. In a sense, the fact that for several years it has been considered to be acceptable to make that allowance suggests that it should be possible to explore whether it could be drawn further or even made permanent.

Lord Thomas of Gresford: Would you overthrow the necessity for the falsified medicines directive to apply? Is that the idea?

Mark Dayan: No. I think that might be difficult in full because Northern Ireland in regulatory terms is part of the European medicines market, which is using those features. That could be examined, but my suspicion is that it would be very challenging to negotiate apart from anything else. From the EU’s point of view, this is supposed to be a set of rules that eliminates the risk of fraudulent medicines. Essentially, if you have a part of its single market—which Northern Ireland really is—that is allowed to just not do that, potentially that will raise concerns. However, if they can accept that moving medicines with those features through the UK is not a risk to the stability of the system, that removes at least that part of the extra bureaucracy. We know that in some senses that is feasible and achievable because that is the allowance made so far.

Lord Thomas of Gresford: Can you explain the deactivation and the reactivation? What is the process?

Mark Dayan: I am not the foremost expert on this. You might want to write to some of the people from the industry who gave evidence earlier for more of a description on how they manage this. Essentially, it is very important from the point of view of the code and the tag on the medicines that you log it when it leaves the system, whether that is because it has reached the end of its road, gone to a patient or it is being exported from the EU. On the face of it with Brexit, the medicine leaving the EU to go through Great Britain to Northern Ireland is really being exported out of the single market and then imported back in. The implication of the original directive is that it needs to go through the effort of being deactivated and then put back into the EU system on the other side with its tag and identifier and the updating.

Lord Thomas of Gresford: With different tags and different identifiers?

Mark Dayan: Yes. I am not 100% sure if that is the case.[1]

Lord Thomas of Gresford: There is obviously a lot involved in doing that, a lot of bureaucracy to do all that.

Mark Dayan: Yes, and it adds a new element to the Great Britain to Northern Ireland border or boundary or however you want to put it, another requirement.

Lord Thomas of Gresford: What problems does the centralised procedure throw up at the moment?

Mark Dayan: The centralised procedure is what we were discussing earlier. I do not know if Alan or Kate will have more to say on this, but it is the way that the EU approves things at an EU level when they are for certain diseases, an innovative substance, biological in nature, things like that. Many of the most cutting edge medicines get applied in this way. Within the EU it is once for the entire bloc rather than at national level. This causes a number of problems for Northern Ireland. The first is that because it is done at EU level, whereas the UK’s MHRA is responsible for national drugs in Northern Ireland, the EU itself remains directly responsible for authorising the centralised procedure for pharmaceuticals. That creates not even a risk but a reality of divergence between what is available in the EU and what is available in the UK.

There are some other issues as well that are secondary to that. One that I think was raised in your prior evidence session was around the fact that at the moment the UK is accepting a lot of the EU centralised procedure decisions through what it calls the reliance route. It is not quite rubber-stamping, doing a bit of a check first but basically accepting a lot of what is decided in Amsterdam about which medicines should be approved. The intention is that they will stop doing that in a year. If that is the case, you have genuinely two different approval systems for Great Britain and for Northern Ireland and you could start seeing more of a drift apart with innovative medicines and which ones are allowed to be sold in Northern Ireland versus in England, Scotland and Wales.

Lord Thomas of Gresford: Kate, do you have any comments on these two issues?

Kate Ling: Mark has explained that beautifully, for which I am very grateful. I was puzzled, thinking about all of this. If something is authorised by a centrally authorised procedure by the European Medicines Agency and Northern Ireland is still within the EU’s regulatory regime, what is the problem? Why cannot things just be provided directly into Northern Ireland? Looking at it more closely, as Mark said, it is to do with differences or divergence in the way in which the European Medicines Agency and the MHRA may authorise new treatments. For example, a new medicine could be licensed by the MHRA for different or broader indications than those that the EMA is prepared to authorise it for. You could end up with certain patients who could access that medication under one jurisdiction and not under the other. It is complex but, yes, there are problems there.

On the falsified medicines, this is curious because, as Mark said, if moving medicines into Northern Ireland via Great Britain is not a problem at the moment, because of the derogations—and I do not think that there is any evidence that there has been any safety risk as a result—why would it be a problem in the future? In other words, is the falsified medicines directive addressing a problem that does not really exist in the UK? Clearly there are problems with falsified medicines circulating globally and also within Europe, but I do not think that this is a big problem in the UK.

However, these are the EU’s rules and they are very strict about wanting to make sure that things are as tight as possible and the safety requirements are as tight as possible. Northern Ireland has been caught up in this, and the obvious solution would be to extend the derogation from the falsified medicines directive requirements and make that permanent.

Lord Thomas of Gresford: Alan Stout, do you have a comment? Do these problems impact on GPs?

Dr Alan Stout: Yes, they absolutely do and I will tell you why. I will be very brief on centralised procedure but we are dipping into solutions here, which is a good thing. The simple solution with the centralised procedure is to allow a GB licence to apply in Northern Ireland without us having to follow the different EU licences as well. The FMD is interesting because your initial question to Mark was: would you overthrow the directive for Northern Ireland? I disagree with what he said on that and simply say, yes, of course we would.

I will quantify the reasons that the FMD was introduced. This was back in 2019 and it was presented to the entire UK. The entire UK was going to have to follow the EU regulation on falsified medicines at that stage. These are not my figures; these are the EU figures. On the number of prescriptions or number of drugs involved, 0.005% of drugs were counterfeit in the UK. That accounted to one prescription per day in the entire UK, so it is a tiny number and this is a completely disproportionate way to address it, and we told them at the time it was a disproportionate way.

You asked specifically about GPs. Every GP practice in Northern Ireland has a scanner in a drawer because they felt that they were going to be asked to decommission medicines if we were giving them from a practice. We do not give very many from a practice. Most of them are vaccines and they are not caught up in the counterfeit regime and so on, but it was applying to everything, to all. That is now having the most significant impact on the solution to the medicines supply through GB, to follow these regulations that apply to such a hugely small number of prescriptions.

Lord Thomas of Gresford: In your view, it is completely disproportionate to have this deactivation and reactivation for one prescription in the UK per day?

Dr Alan Stout: Yes, absolutely. I think Kate said it very well: that it has not been applied properly in Northern Ireland over the past 18 months or so, and we are not aware of any significant problems with counterfeit medication coming into Northern Ireland in that period.

Lord Thomas of Gresford: Following up on that, have there been any discoveries of false medicines in Northern Ireland in the last three or four years?

Dr Alan Stout: I could not give you a definite answer on that, but we would be made aware of that at general practice if there was and we have not been made aware of it.

The Chair: Thank you. That was a very interesting discussion.

Q17            Lord Empey: Good afternoon to our witnesses. We are glad to have you with us. It is interesting that the issue of scale has come up again. If I could refer to Alan’s 0.005% and remind him that we had another statistic of 0.0008%, which was the amount of trade coming across the North Channel from Great Britain to Northern Ireland as a percentage of Europe’s GDP. I think the complexity and the scale collide here with these things.

Can you explain how the Northern Ireland MHRA authorised group, the NIMAR, works in practice and is it working effectively? I will start with Alan.

Dr Alan Stout: That is not my field of expertise at all. It tends to be for some of the more specialised drugs and the rare drugs. I know in a previous evidence session a number was supplied for that, which was somewhere short of 100 drugs—I think it was in the 70s. Again, it is small numbers so we are talking about relative figures here, but it has worked quite effectively and in the wider context of things it has not been an issue in supply of medications.

The one thing that is a fear is that it will with time narrow the repertoire of drugs that are available. For any particular drug, there is usually a number of options available and the narrower that repertoire becomes the more problematic it has the potential to become.

Lord Empey: Those patients, even though it is small in number, will be filtered into the system via you and your colleagues. Therefore, you might not happen to have too many of your patients but colleagues are bound to have these patients at some point. You are saying it has not so far manifested itself as a huge issue but it has potential to grow. Mark, how do you react to that?

Mark Dayan: I think that is a good overview of how it may or may not be felt in different parts of the NHS. In the context of the wider options that might be available for the protocol, it can be seen as one step in the direction of the idea floated earlier about GB authorisations applying in Northern Ireland. Essentially, any innovative product that was approved here would be equally available for sale there alongside the ones that the EU itself has authorised. It is a controlled version of that, where GB authorisations can be valid for Northern Ireland but only if they meet certain criteria around there being no alternative, it being necessary for patients, and that it is kept to a list maintained by the MHRA and the Department of Health and Social Care.

It is quite difficult to be precise about this and I am reluctant to give any hard figures, but it certainly covers a minority of all the GB-only authorisations made, probably one, as Alan says, that is focused around often relatively high end, often safety critical drugs, not necessarily super advanced but for things like insulin as well. It is basically a route, part of the package of measures that came in about a year ago that allows some GB authorisations to be used in Northern Ireland.

It works in so far as it enables that to be the case and you have to assume that MHRA is being accurate that there are not alternatives for many of these, in which case it is certainly a very good thing that it is there. I know you received complaints in your last session that it comes with an added level of bureaucracy relative to it simply being the case that all GB authorisations are valid in Northern Ireland, bureaucracy on the part of companies coming through it and on the part of regulators putting it on special lists and so on. It is not necessarily a painless process, but I am sure it has benefits for patients.

Lord Empey: Would you accept that it may be a very small number of cases but, as divergence goes, we already have a degree of sharing of some treatments between Northern Ireland and the Republic? In fact, an ambulance was officially launched today to take children with cardiac issues to Dublin. In theory, they could start off in Belfast with one set of medicines that were prohibited on the other side of the border. It is that sort of awkwardness that we were trying to avoid, but do you see that as an issue?

Mark Dayan: It may be, yes. You have three divergent zones of the EU with its medicines centrally approved, Northern Ireland with the EU ones plus under NIMAR some of Great Britain’s ones, and then Great Britain without the EU ones but with all of the ones that are done domestically. Yes, that could cause problems on both sides because, as you said, there is a certain amount of cross-border service provision on the island of Ireland. As things stand, the biggest issue for industry and supply is on the Northern Ireland to Great Britain front because that is the bigger route for the exchange of products. Yes, absolutely, if this drift continues there will probably be some issues on the Republic to Northern Ireland axis as well.

Lord Empey: Kate, I think this point may have been raised in your written evidence, if I remember. If it was not yours, it might have been Mark’s. Do you see issues with divergence or are you satisfied that NIMAR is working as presently designed?

Kate Ling: NIMAR is working. I checked yesterday with the Department of Health and Social Care in Northern Ireland, and there are currently 162 products on the list. Patients are getting the medication but, as time goes on, the market is likely to get thinner and there is likely to be less choice and less diversity in the range of medications that will be available to patients in Northern Ireland if this trend continues. I think that really sums it up. The regulatory divergence can only increase as time goes on, as more and more products are likely to be authorised differently by the MHRA and by the European Medicines Agency. We think that that would increase the likelihood of companies withdrawing from the Northern Ireland market and, therefore, increase the need for the NIMAR arrangements in future.

Lord Empey: What would you see as the potential for some kind of mutual recognition arrangement, particularly concerning Northern Ireland, to try to avoid that?

Kate Ling: We would like to see that very much. We are starting to get into solutions and what possible compromises could be achieved in negotiations between the UK and the EU. You will know that originally the UK wanted—well, still wants really—that it would be great if medicines could be removed completely from the protocol, but that seems unlikely to happen. We would also very much like a mutual recognition agreement. This is what my organisation, the NHS Confederation, has been calling for throughout so that the two regulators would mutually recognise each other’s decisions.

Failing that, there are solutions that have been mentioned already: a permanent derogation from the falsified medicines directive requirements, UK-wide authorisation from the MHRA for medicines. That would solve the problem with the centrally authorised procedure. You would not need separate licensing for Northern Ireland. In effect, you would be going back to the situation that we had in the past where medicines would be licensed for the whole of the UK. I am quite sure that, with good will and an effort to compromise and to find practical and technical solutions, there are arrangements that could be made.

There are all sorts of possibilities where the UK and the EU could work together to agree some sort of joint marketing authorisation. The EMA and the MHRA could liaise about joint procedures, for example accepting the same evidence, sharing submissions and sharing assessment outcomes. There are all sorts of ways that people could work together sensibly to come up with practical solutions, but it needs the will to do that and the trust on both sides to get down to that level of technical detail and make it happen.

Lord Empey: I think one of our witnesses last week said that even removing medicines from the protocol would not in all cases solve all the problems. Do you accept that?

Kate Ling: I am not sure what problem they think it would not solve. I cannot think offhand.

Mark Dayan: That is a tricky one. It would solve most of the problems we have been discussing today. It would cause new ones on those different axes of divergence we were talking about. You would then have a sharp line instead in between Northern Ireland and the Republic, which is not the predominant route for medicine supply into Northern Ireland but it does happen. I think that some level of exports from Northern Ireland would be affected by that as well. You would essentially resolve most of the issues we are discussing now but you would create others.

Q18            Lord Hain: Kate, you said that in the NIMAR category there would be a reducing availability, as I understood what you said.

Kate Ling: Yes.

Lord Hain: Would that impact elderly people more or any other category of patients?

Kate Ling: From what I have heard, the majority of the medications that are on the NIMAR list at the moment—and I think Alan can possibly confirm whether I am right on this—tend to be more rare and more specialised medicines, for people with rarer conditions. In other words, it is not the bulk of medications that GPs would be prescribing.

Lord Hain: For example, which sort of conditions?

Kate Ling: I could supply that afterwards. I have some specific examples that we have been given, I think particularly some sort of rare cancer treatments. I can supply some information afterwards. We have some specific named products. I would need to check, from the commercial-in-confidence point of view, if it is okay to share those.

The Chair: It would be very helpful if you could. Please check the commercial-in-confidence issue first, but it would be very helpful to us as we write our results.

Lord Dodds of Duncairn: Last week in the evidence, Paul Williams of Teva UK mentioned a number of specific medicines to do with insulin, diabetes treatments, heart disease products, leukaemia, respiratory medicines, Covid, a pretty serious range of conditions and so on. I want to ask you about something else that he said, which was that he believed that the NIMAR system was “bureaucratic, not a long-term solution and not sustainable”. What is your reaction to that, given that that has proved to be extremely useful to plug that gap?

Mark Dayan: It clearly involves some added element of bureaucracy set against that—maybe not entirely possible—system we have discussed, where GB authorisations just apply in Northern Ireland. Whether it is necessarily unsustainable, I do not know. We would probably have to handle more and more as divergence grows greater. There is no particular reason why I think it would have to stop after a particular period of time, but it clearly is the case that the bureaucracy it is generating is not necessarily welcomed by people who would rather have a more straightforward way of doing things.

Dr Alan Stout: I was going to add a couple of extra comments about it, and Lord Dodds was quite right. I was surprised when I heard last week the medications that were mentioned: insulin, Metformin, which is a diabetes drug, and Clopidogrel, which is a blood thinner that is used in heart disease, were three of the ones. I was previously not aware of those. Those are very commonly used drugs. We would be prescribing those every single day. Again, it shows that the medications are working and we have not had a difficulty with those.

Kate gave a number of 162, and I think the difficulty is that it is a growing number of drugs. Because it involves that extra bureaucratic step it is becoming harder to identify which ones—and those three that I have just mentioned are an example of that—are in that route, and that itself is going to become a logistical difficulty with time as that number continues to increase, and it will continue to increase.

The Chair: Thank you very much for that.

Q19            Baroness O'Loan: Lord Empey has taken us into regulatory divergence, and I want to look at the impact of the Northern Ireland Protocol Bill and ask you about the proposed dual regulatory regime and what impact that will have on the supply of medicines in Northern Ireland. Perhaps you could also comment on the impact of future regulatory divergence between Great Britain and the EU, what effect that might have on medicines supplied to Northern Ireland, and how that can be addressed.

Mark Dayan: I will start with the dual regulation. I will go through this quickly, because there are aspects of the second of those that Kate has definitely thought about more.

On the face of it, the dual regulatory regime would resolve many of these problems but potentially give us new ones. It would mean that a GB approval was good enough to use in Northern Ireland. It would take away the issues where there is a cliff edge around batch testing. It would mean that you did not have to do the falsified medicines directive if you chose to use the GB rather than the EU regulatory system. Maybe within that you can already start to see the seeds of some reasons why this would be difficult. For example, you would have to keep your falsified medicines directive scanner, which Alan has described, for the EU regulated medicines that were coming through your pharmacy or wherever, even if you were not using them most of the time, and there would be the equivalent of that all the way down the line.

We have to be ready to interact with two different regulatory systems for essentially the same product. You would imagine that if that was the case some firms would get their products dual listed so that they could be signed off as either. Then there would be some working through as to whether that would work without having to be signed off as both.

Perhaps a bigger issue, apart from that complexity and the duplication of capability that it may require, is the fact that in the much wider context of the Northern Ireland Protocol Bill it just does not seem very acceptable to the EU, which is an important thing to take into account. That is more what I had in mind. For example, in describing the options on the falsified medicines directive, as opposed to whether it might be desirable there is also the question of whether it can be achieved. You might say the same about types of mutual recognition as well.

If this is imposed but not accepted by the EU, it runs the risk of either some sort of wider breakdown in the protocol or of other EU retaliatory actions for breaching it. We have seen that those can also affect medicines and life sciences. For example, the EU has not let the UK properly join its Horizon science funding programme, basically because it is using that as a negotiating tool over the protocol, and there would be that risk to medicines, and medical devices, going between Northern Ireland and the Republic if there was some sort of wider undermining of the protocol.

It would narrowly remove a lot of the barriers that we have spoken about, but it would also generate a lot of extra bureaucracy and potentially undermine some of the reasons why the protocol exists in the first place, which could cause problems, I would say.

Dr Alan Stout: Mark has just given one of the best descriptions I have heard of dual regulation, and I still do not understand it. Therein lies the problem; I am yet to find somebody who properly understands not only what it means but how it would work in practice. It introduces an awful lot more risks, and it has the potential of introducing more bureaucracy. The bottom line with any of this is that it will require compromises, negotiation and pragmatism. I do not see dual regulation as a magic bullet. One of the biggest threats—Mark referred to this quite accurately—is how the industry deals with it. It may pick and choose who it regulates with, who it licenses with and so on. That might expose us even more, with time.

Kate Ling: It is important to make a distinction between the practical impact of the proposed dual regulation system—it could work; I do not think it has ever been tried quite like this—and the political impact that Mark alluded to: the impact on UK-EU relations of passing the Northern Ireland Protocol Bill and enacting its provisions. What sort of retaliation might that incur from the EU—retaliation in the form of possible legal action or simply increased hassle at the borders, like ramping up checks at the borders? We do not know, but that is a very big part of the picture.

From the point of view of the practicalities, this is interesting, and I have had discussions with people in Northern Ireland about it. I do not think that, as Alan said, people on the receiving end would relish having to deal with two different regimes, dealing with possibly two different lots of medication that have been licensed under different routes. How are they supposed to tell the difference?

Having said that, I think it could work. Manufacturers could choose to license their products for sale in Northern Ireland, either by the EU route or the UK route. I have had interesting discussions about the pros and cons of doing that. For example, why would companies decide on one route or the other, and would it be beneficial? Would they apply for both? The EU route would reach a bigger market initially, for example. I thought, “Well, why would you apply for UK-only authorisation if you could sell into the much bigger EU market?” I have heard that the UK route could be attractive if medications were authorised more quickly if they were perhaps authorised for different or broader indications than the EMA authorisation.

An interesting long-term issue to do with regulatory divergence is the extent to which the UK wants to seek better alignment with international standards—in other words, making sure that we are aligned with the regulatory standards applying in the FDA in the United States, for example, or with the East Asia and Pacific countries, because, as you know, we are seeking to accede to the CPTPP trade bloc; I can never remember what that abbreviation stands for.

There are short-term considerations, such as whether it would actually work in practice, and how it would work. There are longer-term considerations, such as what our regulatory trajectory is and in what direction the UK is moving. There is a difficult balancing act here and decisions for the Government and the MHRA to make.

Q20            Baroness O'Loan: We now move to how we can move towards resolution of some of these problems. Kate, you have started to address that, but the question really is: how are the UK and the EU engaging with industry regarding the outstanding issues that require resolution? Have they indicated if and how these issues will be addressed? Has the UK made suggestions? Has the EU made different suggestions?

Kate Ling: I am not sure I am the right person to answer that, in the sense that I am not representing industry. I have very close connections and speak regularly with the ABPI—the Association of the British Pharmaceutical Industry—for example. The NHS Confederation, the ABPI, the ABHI and some of the other organisations involved certainly speak quite regularly to our colleagues in government, and I think they are well aware of our position. That is hopefully feeding through to the negotiators.

We are very disappointed that, under the terms of the trade and co-operation agreement, one of the governance mechanisms is that a medicinal products working group is supposed to have been set up. It has never actually met, we presume for the same sort of reason as the EU not agreeing on UK accession to Horizon Europe. That is a great shame, because the whole point of setting up something like a technical working group is to bring together technical experts. I anticipate that that would include people on the front line—people from industry and people from the health service in Northern Ireland—who could sit down and bang their heads together and come up with practical and workable solutions.

It is something that we have been pushing for. I am a representative for the NHS Confederation on the Government’s domestic advisory group, which is advising on the implementation of the UK-EU agreements. There is also a colleague on it from the British Medical Association and from the ABPI. There are three health sector organisations represented on this group. We have certainly been pushing very hard for this to happen with our Government, and I think the problem is really on the other side; it is an unwillingness from the EU side.

All the organisations that I have mentioned have strong links with our EU-wide counterparts. We belong to associations of similar people across Europe. Those links are very helpful, because we use them to try to encourage our counterparts and our colleagues in the EU to make representations to their politicians and to people in the European Commission and in their member states who can hopefully move things along and influence things. It is quite frustrating that those sorts of technical discussions, which could have been taking place and could have been informing the talks throughout, have not been happening, at least not on a joint basis as set out in the agreement.

Baroness O'Loan: Alan, from the front-line perspective, are there situations in which the BMA and other organisations are engaging with the UK to the benefit of people like you who are in general practice and having to find the drugs, or find alternative drugs, and so on?

Dr Alan Stout: Yes. I 100% agree with what Kate has just said. We have pushed for that medicinal products working group as well. Exactly as she said, that is where the technical and practical solutions come up. These will always be technical and practical solutions, because even when we go down the route of solutions and say, “Could you remove medicines from the protocol all together?”, there are still technical and practical issues with that. When we talk about the GB licence applying in Northern Ireland or the removal of the FMD, again that will need all that technical and practical discussion. So we would very much agree with that. We have been pushing that through the MA and, as Kate mentioned, we also have BMA representation on that group.

Baroness O'Loan: Do you think sufficient is being done by the British Government to enable you to make these contributions, and to enable industry to prepare the solutions for the day when the British-European working group is finally established?

Dr Alan Stout: The simple answer to that is no. I think Lord Dodds also referred to that earlier in his question: that there is no discussion and negotiation going on at the moment. That is why we are fearful of coming to yet another cliff edge. That can be circumvented with those discussions happening now and it becoming much more of a dynamic process than a crisis process, which it may well become.

Baroness O'Loan: Thank you. Mark, is there anything more you would like to say, particularly about how the engagement could be improved?

Mark Dayan: Like Kate, I do not have great insight into government industry relations. In my experience, the Government will certainly be engaging pretty extensively with industry and will have a reasonably good idea of what it thinks would make its life easier.

Baroness O'Loan: What about the other side, the EU?

Mark Dayan: I would have thought that they have a good degree of access and communication with industry in the EU. I do not know whether you would agree with this, Kate, but, to some extent, the points of tension as to why this is a different negotiation are probably more because the solutions offend the principles of one side or the other. At times, they are genuinely untested things that no developed country has tried to do before, even short of the full dual regulatory route, in terms of allowing two different regulatory systems to approve things into one place. I am not sure there is a lack of understanding of whether and why it is difficult for firms.

Baroness O'Loan: Alan, one final question. Is there any engagement between the British medical practitioners and the European medical practitioners? We are exporters of drugs and medical products into Europe, are we not, so is there any discussion there?

Dr Alan Stout: There is. Through the BMA, we have a European office in Brussels and we are involved in quite a number of the European groups. Interestingly, if I was not here today, I would be at the BMA this very afternoon, because that is the subject of another discussion, on the coattails of Brexit, as to how the BMA maintains those links and where we go in the future with them. As we speak right now, yes, there are very close linkages.

Q21            Baroness Ritchie of Downpatrick: A little question. Kate, you referred to an unwillingness, in your perception, on the part of the EU not to participate in discussions regarding solutions. Can you give us further clarification on that?

Kate Ling: It boils down to what Mark said about it being a question of principle, maintaining the integrity of the single market, and it has made that very clear throughout.

I mentioned that I am the NHS delegate to the UK’s domestic advisory group. There is a counterpart body, an EU advisory group, which performs exactly the same function in the EU in advising the European Commission about the implementation of the agreements. Before Christmas, we had a joint meeting of the two advisory groups and the Civil Society Forum, which is a wider thing. It was very interesting. There is a great deal of commonality between the two sides. Incidentally, it is cross-sectoral, so it is not just the health sector.

I think the health sector representatives on both sides are aligned in things that we would like to see. It was made very clear when we had sessions where we were engaging with officials from the European Commission and from the UK mission to the EU that this is a matter of principle. It was very legalistic. The two sides set out their positions, and the atmosphere for compromise did not sound particularly good—put it that way. It is not just in the health sector; you will be aware of all sorts of painful issues about things like bivalve molluscs, and so on.

It is difficult. I do understand where the EU is coming from—how important it is for it to maintain the integrity of the single market, and the unity that it has. It has shown that it can be flexible—we are very pleased about that—with the derogations that are already in place, so I hope that it would not take too much more for some sort of landing ground, some compromise, in the middle to reach a practical solution to eminently practical problems.

Q22            The Chair: Thank you for that. I was going to ask a question that, in a way, all three of you have answered already as we have gone through the evidence session, so I have a different final question. What would you like to do to see a way through the difficulties that we are now in? Are there solutions out there? Is there a relationship between the UK and the EU that you think would help? As Nuala said, you have very helpfully pointed to various solutions to some of the difficulties there are now, but is there anything else you would like to say about that? Mark Dayan is nodding, so he has something to say.

Mark Dayan: Yes, but not that much, because I agree that all the way through the session we have been describing what the concerns might be, if I put it like that. Essentially phase one, which I think would be unambiguously positive, would be to at least lock in as permanent the current level of allowances, or to extend them for more years.

A higher level ambition might be that you start expanding that a bit by removing some of the remaining barriers, which could look like making it easier to put things into something like NIMAR and trying to reach mutual recognition in areas where that will work. I do not think that mutual recognition for authorisations will happen whereby the UK could say, “We approve drug X”, and it then becomes legal, say, in Portugal. But there could be an expanded version of NIMAR for Northern Ireland and the mutual recognition of batch testing, so that you no longer have to worry about whether it is still legal to do it in the UK for Northern Ireland because that counts as part of the EU’s batch testing system anyway. I think those would enhance the level of ease that has been perfected by the current measures. I think that would be a good place to start.

Lastly, this will need to be constantly worked on. It will never just be done, particularly because, as both the UK and the EU keep changing their regulatory systems, each side will generate more and more requirements that tend to clash with each other, so some sort of resolution will have to be found, in the same spirit perhaps of not quite having a dual regulatory regime but making it easier in Northern Ireland to basically fulfil single market requirements while fundamentally working alongside the UK regulatory system, if that makes sense.

The Chair: It does. Thank you. Kate Ling, do you have any final thoughts on ways ahead, or have you said what you want to say?

Kate Ling: I agree with Mark that we could certainly start with extending the existing derogations and easements, making them as permanent as possible. The only bit that is already in the existing agreements is mutual recognition of the manufacturing procedures, the factory inspections. The next step would be inspecting the batches of medicines, as you said. I agree with you that it is very hopeful to assume that we could get to mutual recognition in the long term.

From the point of view of how to do it, there are ways and means; there are governance arrangements that are set out in the agreements between the UK and the EU to manage divergence in a sensible and adult fashion. The Partnership Council has met only once, for example. A lot of these sub-groups and sub-committees and detailed technical arrangements have never been put into practice because of the political impasse. Therefore, we need to get those wheels in motion, particularly as time goes on and the two sides diverge more and more because there is new EU legislation coming in, for example. It is not one-way divergence, is what I mean. It is both ways.

We need to have an ongoing, long-term way of managing that divergence sensibly, and I do not believe that it is beyond human wit to devise sensible solutions. As I said, it is all about trust and good will and getting down to those concrete discussions.

The Chair: Thank you very much. Alan Stout, it is good to let a general practitioner have the final word.

Dr Alan Stout: It can be dangerous, too. I agree with what the others have said. As a broad summary, I think we have to convert this into a process as opposed to a series of events. We have clear evidence of what happens with a series of events as we hit various cliff edges, and the others have covered it very well. This is about an ongoing process. It is about these discussions in the groups, and there is absolutely a way through it all and solutions at the end of it.

The Chair: Thank you very much, and thank you very much to all of you. That has been extremely helpful. It has also been very helpful that you have punctuated the evidence you have given with possible ways ahead. Both sessions that we have had on this subject have been very helpful and complement each other well. Thank you very much indeed for being with us today. We are very grateful to all three of you in Belfast and here in London. Thank you very much.