Patents (Amendment) (EU Exit) Regulations 2018

Lord Warner Excerpts

Monday 14th January 2019 Grand Committee

[Baroness Kingsmill (Lab)]

My Lords—

[Lord Warner (CB)]

My Lords—

[Lord Henley]

No; there is no need for noble Lords to get up. I will sit down and give way to the noble Baroness or the noble Lord when I am ready, but I am entitled to speak and give way as I wish.

We will consult as appropriate on whatever the future regime might be, deal or no deal. We are trying to get things right in the eventuality of there being no deal. It is quite right—

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[Baroness Kingsmill]

I was actually trying to be a little helpful. In the notes on this matter, there is a little more detail about the consultation than on the previous one. They say a consultation was taken with “informal discussions”—informal is always questionable—

“with a small group of selected individuals with expertise in the relevant areas, or in patent law generally”.

I read that to suggest that the consultation was with lawyers, as opposed to people directly affected by this. I wonder if the Minister could make that clear. If it is with lawyers, they will be looking at it on the basis of the law as opposed to the impact on businesses. Once the Minister has clarified who and what it was, I could then understand the impact. In paragraph 12, the Government assert that there is,

“no, or no significant, impact on business”.

If there has been a proper consultation, that is fine and perhaps one has to accept that impact. But at present an informal discussion,

“with a small group of selected individuals”,

does not sound to me like the kind of consultation that is going to give anybody the possibility of saying there is,

“no, or no significant, impact on business”.

Perhaps the Minister would care to clarify.

[Lord Warner]

May I intervene to be helpful to the Minister? He might wish to consider withholding his remarks about consultation until he has heard what I have to say a little later about the consultation process—if we may venerate it with such a description. I think he might want to hear those before he commits himself too far on what consultation has taken place.

[Lord Henley]

The noble Baroness, Lady Kingsmill, suggested that it was only lawyers who were consulted. There is nothing wrong with lawyers—I speak as one myself—but others were involved too, including a number of business stakeholders, a representative from the BioIndustry Association and other representatives from the pharmaceutical and generic industries. I imagine this will be confirmed by the noble Lord, Lord Warner, when he speaks; I am looking forward to his remarks. All I can say is that that has happened, but obviously the consultations will continue so as to ensure we get the right process for the future, deal or no deal. At the moment we are dealing just with contingency planning should there not be a deal. I think I have moved, and I think I have now sat down.

The Deputy Chairman of Committees: The Question is, that the Grand Committee do consider the draft Patents (Amendment) (EU Exit) Regulations 2018.

[Lord Warner]

My Lords, I hope to throw a little light on the subject of consultation during the course of my remarks, which I am afraid will be slightly lengthy. My remarks are based upon a briefing I have received from the BioIndustry Association They relate to its concerns about both the impact and the process by which these regulations were drawn up and consulted upon. Again, I use the term “consulted” in a very loose way.

Before I get down to the business of what the BIA’s concerns are, I want to make a couple of general remarks which came out of our debates in Grand Committee last week about the previous set of regulations, and out of our discussions this afternoon about the first set of regulations. They are two issues which we keep coming back to time and time again. I hope that, for the rest of the proceedings, the Minister might refrain from continuing to run the argument that these documents do not reflect any change of policy. I shall set out the arguments as to why there is a change of policy here. Last week there was a set of policy changes in the regulations that were produced. I understand why there may have been a change of policy, given the circumstances in which these regulations were pursued, but it would be helpful to informed debate for the Government to stop saying that there is no change of policy because there palpably is a change of policy in many of these sets of regulations.

That is request number one to the Minister. The second concerns the Minister saying that somehow these regulations were only hypothetical and relate to a set of circumstances which may not occur. We raised this last week when he was not here and we were dealing with another Minister. The truth is that this is a set of regulations the Government of the day have drawn up and put in the public arena, and they have an impact on the people who may or may not be affected by them. As I said last week, as an ex-civil servant I know that even if these regulations are not used for the purposes for which they have been drawn up, they will be tucked away in a Whitehall cupboard. That is the reality. If we get down to some of these issues subsequent to Brexit day, they will still be there, they will still be a resource which will be drawn upon, and I would be willing to bet a large sum of money that they will be used to some extent in drafting another set of regulations.

The point that we have been trying to make to Ministers, singularly unsuccessfully, is that there are concerns about how they may be used and how the outside world may interpret the Government’s attitude in these areas in the future. That is why it is very important to challenge the Government when there are defects both in the assessment of impacts and in the inadequacy of the consultation process.

[Lord Adonis]

My Lords, in the light of what the noble Lord has said, does he not think it extraordinary that paragraph 12.3 of the Explanatory Memorandum says:

“An Impact Assessment has not been prepared for this instrument because … it is designed to maintain the status quo”,


when the point that he is making very powerfully is that the regulation does not maintain the status quo since it envisages a no-deal scenario that, for the industries and businesses affected, is anything but the status quo?

[Lord Warner]

I totally agree with the noble Lord and will set out my reasons for doing so in relation to this particular set of regulations. The concerns that the BIA has about this set of regulations relate to paragraph 55, which is all about the number and date of the earliest of any EEA authorisations which lead to the granting of a UK authorisation. The effect of that setting of the date on the supplementary patents certificates, which are the extensions for patents of medicines that provide additional patient life, is to compensate for the period of market exclusivity lost during the essential regulatory approval process. So the market authorisation sets the date for the five-year market exclusivity arrangements that apply to medicines.

This starts to get a bit complicated so I will keep to the wording of my brief. The SPCs can provide up to five years of extra protection, and the precise period of the additional protection is determined using the first regulatory marketing authorisation date currently within the EEA. The amendment to which I have drawn attention, which is set out on page nine of the regulations, would maintain this EEA-wide stipulation for UK supplementary patent certificates despite the medicine covered by the SPC being subject only to a UK market authorisation—that is, it could not be marketed in the UK until approval by the UK-based MHRA. This would have the SPC’s duration aligned with those granted elsewhere in Europe on the basis of first authorisation in the EEA even if the UK authorisation was much later.

In so far as one understands why the Government are doing it this way, it appears that they are seeking to encourage life sciences companies to launch medicines in the UK at the same time as they launch them in the EU/EEA. The BIA fully understands what the intention is; it just does not agree that it will have the effect that the Government think it will. The BIA says that in reality many of its member companies are saying that the regulation is more likely to delay further the launch of a medicine in the UK and is adversely affecting the global reputation of the UK as a location for the life sciences industry.

[Lord Deben (Con)]

Is not the point that the noble Lord is making rather wider than that? He seems to be saying that if either the Government or the body to which he refers are right, this regulation changes the position in which we are. In other words, we do not need to argue whether it would have this effect in one direction or the other; all that we need to argue, to make the point that I think we are all trying to make, is that it is just not good enough to say, “This regulation doesn’t change the situation”. It manifestly changes the situation whether the Government are right or the BIA is right.

[Lord Warner]

The noble Lord is spot on. That is exactly the point that I am making. I want to develop the argument a bit more and relate it to the problems around consultation, or the lack of adequate consultation. I have a lot of respect for the BIA, particularly following my time as a health Minister when I had a lot of contact with it. It is not an excitable group of people who write and complain to the Government at the drop of a hat but a responsible trade body that any Government of any complexion would do well to take notice of. Moreover, the BIA is concerned about the lack of process and consultation on a regulation that will have a huge impact on its sector and on NHS patients:

“A strong intellectual property framework is essential if the UK wishes to have long-term sustained investment in R&D, remain a globally-attractive location for international investment and grow UK companies in the UK”.


I think we are all agreed that those are desirable things. However:

“Due to other regulatory requirements in the event of ‘no deal’, the exclusivity term for a medicine in the UK would be reduced as a result of the Article 3 amendment”,


in these sets of regulations compared to the rest of the EU. The threat of,

“a shortened data exclusivity period has adversely impacted global companies’ views of the UK”.

Companies have told the BIA—here I will quote what they have actually told the BIA—that a product will,

“never be launched in the UK before the EU”.

The UK,

“has moved further down the priority launch market”—

one company has told the BIA that the UK has moved from the first tier to the third-tier launch market for upcoming new products—and that the international reputation of the UK as a place for global pharmaceutical companies to undertake business has been damaged at the very time Brexit is already having an adverse impact on the UK’s global reputation. These are the points that a very responsible trade body is making about this specific set of regulations.

[Lord Adonis]

My Lords, I think the noble Lord is making a case which is of great concern to the Grand Committee, not least because of the impact on jobs and investment. Can the noble Lord, with his knowledge of this sector over many years, give the Grand Committee some indication of what he thinks the impact might be on investment in the UK in the pharmaceutical sector if the scenario he is envisaging and these no-deal regulations were to take effect?

[Lord Warner]

According to the BIA, which is a cautious body that keeps its finger on the pulse of the sector very well and in my experience always represents that sector extremely accurately, it is concerned about the impact of this approach on patients’ access to new medicines and the effect on jobs of a decline in using the UK for the growth of innovative products in the bioindustry sector. It says:

“Eroding intellectual property protection whilst also seeking global free trade deals sends a signal to industry that the UK Government may further erode protection as it seeks to quickly conclude deals. This would further impact the industry in the UK and future inward foreign investment”.


That is what the industry is saying, it is not what I am saying. I am repeating to the Grand Committee what the sector and the industry are saying, having been involved in this set of regulations. The BIA and the industry are also concerned that the proposal has simply not been properly consulted on:

“The suggestion that the government might take this approach first appeared in a Technical Notice at the end of August”,


2018. The BIA,

“raised concerns with Ministers and the MHRA. The MHRA stated that concerns should be included in responses to their ‘no deal’ consultation which concluded on 1 November (the consultation did not ask specifically about exclusivity)”.

So the Government did not actually consult on the point of exclusivity. That is the view of the trade body which is responsible in this area. This is why I urged a bit of caution on the reassurances that the Minister might want to give until after I had spoken. This is what the industry is saying. The statutory instrument,

“was tabled on 1 December, when follow-up discussions from the consultation were still ongoing. There has been no formal consultation”,

on this issue, which undermines the validity of the regulations.

The sector is saying that it was not consulted on the specific items in the regulations and that is as a result of its contact with the MHRA, the regulator.

In its response to the MHRA no-deal consultations, the BIA, together with the ABPI, stated:

“We are also concerned that the proposal for data and market exclusivity for marketing authorisations is not being consulted on”.


It has made that clear beyond peradventure. I do not know who the IPO spoke to. It may have been one individual company—that is what my intelligence from the BIA suggests. By any stretch of the imagination, it was simply not a proper consultation with the sector that is most affected and which is genuinely concerned that the regulations will have a massive adverse effect on the life sciences industry in this country.

In its response to the consultation, the MHRA stated on 3 January that there would be a review within two years. However, by that time some UK patients will not be able to receive the medicines that they would have if the UK was a member of the EU and there will have been a significant impact on the UK industry as well as on the global industry’s perception of the UK. This is what a responsible trade body is saying has been the effect—

[Baroness Vere of Norbiton (Con)]

This is too long.

[Lord Warner]

I am sorry if I am taking up a bit of time. I have heard longer speeches and I have been interrupted a few times.

[Lord Adonis]

My Lords, I have rarely heard in Grand Committee a speech of greater concern to a major industrial sector and to patients, so I hope that the noble Lord will in no way be influenced by Government Whips telling him to curtail his remarks when those remarks are of such importance to the country.

[Lord Warner]

I am grateful to the noble Lord for his support. I have never been much of a one for taking notice of my own party’s Whips let alone the Government Whips.

The Minister should pause these regulations and conduct a proper consultation before taking them forward. The Government should delay the process until they have heard what the industry has to say about the impact of these regulations on the UK life sciences sector.

[Lord Deben]

My Lords, I am concerned about the consultation element. I am interested in the difference between the wording in this SI and the one that we are going to discuss later. This one says that,

“the Intellectual Property Office held informal discussions with a small group of selected individuals”.

The one that we are going to discuss later says that,

“the Intellectual Property Office held informal discussions with a small group of trusted individuals”.

Does this mean that the selected individuals are not trusted or that the trusted individuals are not selected? This seems like careless drafting, which reveals the fact that there was no proper consultation of any kind.

I say to my noble friend that it is not acceptable to talk about consultation if one of the major bodies concerned was not consulted. It is also not acceptable to talk about consultation when it is informal with selected groups. I run a business and one thing it does is give advice to people. If I said that my advice was based upon a series of people whom I had selected informally, that advice would not be well thought of. I have to say: “These are the people that I have chosen, in order that they should be a broad range, covering all the issues we are dealing with”. I do not select them on any other basis. If my noble friend does not explain on what basis these people were selected, he has to accept that all sides of the House will be other than certain whether it was on the basis of coverage rather than support.

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[Lord Deben]

That is absolutely true. It all adds up to my last point, which I feel is the most important point of all. The Government keep on talking about no impact, but of course in this SI they cover up the fundamental impact, which is that the benefit that used to be enjoyed by those to whom this applies because we were part of the European Union will be removed. That is a huge impact. When the Government talk about no impact, they are really saying that, as long as you confine your activities to the United Kingdom, there will be a little arrangement which will, roughly speaking, be the same as the arrangement that we had in the United Kingdom when we were part of the European Union. That is what we are saying.

That is an entirely different situation, because it means that we do not have the advantages which we had before. I know that that is an integral part of Brexit, and it is one of the reasons why I oppose Brexit so strongly. It is unacceptable not to measure those impacts. It is unacceptable to produce an SI which suggests that there are no impacts when you are saying that if we exclude the biggest impact of all, there are no impacts. That is, at the very best, misleading.

I say to my noble friend that anyone in this country who reads this impenetrable stuff as carefully as we have all tried to will realise that there are two hidden falsehoods in the whole activity. The first is: let us pass it because it will never be used. The second is: when we talk about impacts, we will refuse to talk about the impacts which really matter, which are the impacts which disadvantage British people and make us less able to handle competitive situations, deal with our patients and work in the way in which we can at the moment. We, the Government, are not prepared to measure that because then the public might say, “My goodness, this does not sound a very good idea”. So they do not tell them the figures, the costs or the disadvantages, because it would undermine their position.

[Lord Warner]

I am grateful to the noble Lord and agree with every word he said. Rather more elegantly than I, he made the point I was making about the high impact that these changes, if implemented, would have on British people, jobs, access to medicines and so forth.

In this debate, we are making some fairly serious accusations about the Government and their failure to hold a proper consultation. I hope that the noble Lord will join with me in not allowing that debate to include blaming the Civil Service and the IPO, because they are as much victims as everyone else. They are operating in a system which has not properly allowed them to carry out the consultation that they might have made in normal circumstances. I should not like them, reading Hansard, to think that we are accusing them of dereliction of duty. I hope that he will agree.

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[Lord Adonis]

They turn out to be lawyers. I have nothing against lawyers; my noble friend Lady Kingsmill is a distinguished lawyer. It is fine that lawyers should be consulted, but others should be consulted as well. I do not think it is for the Government to select who should be consulted. We are a democracy where everyone should have that right. Indeed, the Cabinet Office rules on consultation were long laboured over by successive Governments: there should be 12 weeks of consultation on regulations that should be published, and so on. We are told that that cannot happen in the case of these regulations because we do not have 12 weeks. Well, we would if the Government were not engaging in this ludicrous no-deal planning that means that there are not 12 weeks to start with. That argument is entirely circular.

The Explanatory Memorandum looks to me to be worse than my noble friend and the noble Lord have said, on top of these informal discussions with a small group of selected individuals. Incidentally, I may say that the Minister was unable to tell us at the beginning who were they were; he said he was going to tell us when he wound up, so we are still awaiting the names of those selected individuals. They do not appear to have included any of the significant companies and experts that my noble friend Lord Warner knows.

I will repeat this fact because it is of great importance to the Grand Committee: the only person who we know with certainty has been consulted by, and has spoken to, the Intellectual Property Office so far is my noble friend Lord Warner, because he tells us that he phoned them up and gave them his views. There has been no information from the noble Lord, Lord Henley, or from anyone else as to who the others were. We have now a lengthening list of those who were not consulted, but we do not know who was. That is an extraordinary state of affairs for the Committee.

[Lord Warner]

I want to be fair to the IPO. It arranged to have a conversation with me at my request and it was perfectly straightforward. It of course had to preserve the confidentiality of what it had done—after all, it is answerable to Ministers and I would not have expected anything less. My information from the BioIndustry Association is that it thinks that the consultation—in so far as it was a consultation—was with one member, possibly a lawyer, of one company. The consultation is looking fairly thin. It may not be much more than that one member as far as this specific set of regulations is concerned. We do not know the extent to which the IPO accumulated a collection of individuals for a range of regulations—that is quite possible—but by no stretch of the imagination can one see a formal consultation over a longish period, somewhere near the Cabinet Office recommendations, of the industry and sector, because the trade body for this sector was excluded. The Association of the British Pharmaceutical Industry may not have been properly consulted either, but I have not had time to check with it.

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[Lord Henley]

I was going to leave this to the end and I suspect that any intervention I make will just prolong these proceedings, but for the sake of assisting the noble Lord at this stage, I can assure him that consultation participants on the technical view of the draft instrument included the BIA, the ABPI, the IP Federation, the Chartered Institute of Patent Attorneys, the British Generic Manufacturers Association and the agrochemicals industry.

[Lord Warner]

I flatly reject the idea that the BIA was consulted on the exclusivity aspects of these regulations. That is the assurance that I was given by it and I put it on the record in my speech.

[Lord Adonis]

My Lords, we seem to have a serious situation where the Minister has just said that one body of central relevance to these regulations was consulted and my noble friend Lord Warner has flatly denied it. Would the Minister like to elaborate on what he said; otherwise, it might be a matter for other authorities to examine?

[Lord Henley]

The exclusivity point is for another regulation on the MHRA.

[Lord Warner]

The exclusivity point is a key element in these regulations, as I made clear. If the Minister looks at Regulation 55, he will see that. I made it absolutely clear—I am not usually noted for obfuscation —that on the subject of exclusivity there was no consultation of the BIA. I cannot be any clearer than that. If the Minister has evidence that the BIA was consulted on the exclusivity point, I would be happy to withdraw that and apologise as graciously as I can, but the information it gave me was that it was not consulted on that point, which is at the core of this set of regulations.

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[Lord Clement-Jones (LD)]

My Lords, we have to conclude after the debate so far that this SI is holed below the waterline and the Minister will have some difficulty in preventing it sinking. He will have to write a pretty good letter by the time this comes to the whole House to see that it goes through when it comes to a vote there. The powerful speech made by the noble Lord, Lord Warner, has exposed the business issues involved in this. I was interested to hear what the noble Lord, Lord Adonis, said about the legal technicalities on this, and of course the impeccable logic of the noble Lord, Lord Deben, and the noble Baroness, Lady Kingsmill, on the consultation and the impact assessment is unassailable. The Minister will therefore have a great deal of difficulty in persuading us to approve these regulations, whether here or, eventually, in the House.

I am grateful to my noble friend who is a patent expert. My expertise in intellectual property extends to trademarks and copyright but it is very useful to have her unpacking of some of these issues as well. What particularly concerns me about the substance of the SI is not just that it is in the eventuality of no deal but that it has all the signs of something that was planned to take effect at the end of the transition period if the Prime Minister’s deal was going to take effect. This looks as if it is a longer-term arrangement. I think it was enshrined in the White Paper, or at least the outlines of it were, and that makes it of particular significance to get right. If there is any kind of deal then I suspect that this is what will be put into effect. It therefore has a double significance and is not just a fix for this purpose which has not been consulted over and which is not acceptable to a major trade body. I have dealt with the BioIndustry Association and I have a great deal of time for it and respect for the expertise that it embodies. The fact that there has not been adequate consultation over something that is potentially a long-term solution makes this even more questionable.

[Lord Warner]

I am sorry to interrupt the noble Lord further but I want to give a bit of support to what he is saying. In my remarks I drew attention to the fact that the MHRA, the UK pharmaceutical regulator, actually tried to suggest to the BIA that it should wait for a review in two years’ time. That looks remarkably like the timetable for the end of the transition period, so I want to give some support to the arguments that the noble Lord is making.

[Lord Clement-Jones]

I thank the noble Lord for that intervention because that is exactly the impression that I had got.

To add to the Minister’s woes, I want to go off into a completely different subject that he himself raised at the very beginning: the issue of the Agreement on a Unified Patent Court and the unified patent. The unified patent has come up; the Minister has mentioned it and it was included in the technical note in September. There is a big issue surrounding the Agreement on a Unified Patent Court and the unified patent. If the agreement is ratified by Germany and comes into force ahead of any exit date, the UK will need to work out how to remain a member of the UPC or withdraw from the system, which could have a significant impact on business. Of course, at this stage it is not clear if the agreement will come into effect at all, but if it does and if, as a third-party country, the UK then wants to take part, is it not clear—I have a 39-page legal opinion on this subject—that we, the UK, will have to acknowledge the supremacy of EU law and the ECJ as part of signing up to the UPC agreement? What kind of “taking back control” for Brexiters will that be?

What advice have the Government received on this matter? I heard what the Minister had to say: he made the very positive statement that we were going to sign up. Have the Government had any further observations on the UPC agreement and the unified patent? How do they envisage UK legislation dovetailing with both systems, assuming that it is ratified?

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[Lord Henley]

My Lords, the noble Baroness is getting on to wider questions. I cannot remember whether it is in Alice in Wonderland or Through the Looking Glass, but I am a mere pawn on the chessboard of life. I believe that we are having appropriate discussion on the order and I think that it is right and proper that, since we have started, we should continue. I look forward so to doing and, as I said, there will possibly be other opportunities as well. I think we should continue with that. Others, who may be the kings, queens and bishops, will then discuss what is the proper procedure, but at the moment, we are considering the Patents (Amendment) (EU Exit) Regulations, which relate only to no deal. We do not want to broaden it out to other things; others can discuss that issue.

Let me return to the debate and the consultation. As I made clear earlier, the IPO sought the views of a group of individual stakeholders—I shall not go into the slightly different words that my noble friend cited from different letters—and consulted them in their personal capacity to identify any issues with the drafting and raise any concerns with the approach. As I made clear, legal experts—there is nothing wrong with lawyers; the noble Baroness, Lady Kingsmill, is one of them, as am I—and business representatives were present. It was a helpful and constructive review of the draft and it was understood that the regs were designed to maintain continuity. I repeat for the sake of the record that at that meeting, as I understand it, there were representatives from the BIA, the ABPI, the IP Federation, the Chartered Institute of Patent Attorneys, the British Generic Manufacturers Association and the agrochemicals industry. If I can add to that list and give further details, I will certainly include that in any letter I write to noble Lords.

On letters, I believe—I am open to correction—that in advance of these regulations I wrote to the noble Lord, Lord Stevenson, and to the noble Lord, Lord Fox, from the Liberal Democrat Benches. I do not know whether I should have taken that wider and written to others. I will consider that with each order I deal with, as appropriate. I also make clear, on the lack of consultation, that we were not preoccupied with the deal. The IPO had sufficient resources to take both deal and no deal in parallel. It was necessary across Government to treat no-deal preparations sensitively when we were in the middle of negotiating a proper deal. From the perspective of business, retaining the regulations means that both the process for applying for an SPC and the scope of the right for which it is granted would be the same after exit as before.

I turn to the post-exit concerns of the noble Lord, Lord Warner. I appreciate that after exit day there may be new drivers for policy change. I think it was the noble Lord who talked about the possible time it may take to get a UK authorisation compared to now and the potential effects. I hear the noble Lord’s concerns, but we should understand the issues when the time comes then properly consider the right policy solution at that point. As I have already said, I would expect that to involve the more usual open and constructive discussions with stakeholders and interests in this area that the IPA usually enjoys. I can assure the noble Lord and others that our intention would be to fully engage with the BIA, the IP Federation and other similar bodies.

[Lord Warner]

I just want to clarify for the Minister that the damage to the life sciences will be wider as a result of Brexit, but the point I made in my speech was that it is the result of the approach to exclusivity and SPCs in this set of regulations. It is not a wider set of damage. It is a damage to the industry and the sector arising from this set of regulations.

[Lord Henley]

The noble Lord is right to point to the importance of the life sciences sector, and I am grateful he did. One should also re-emphasise—I would be grateful if the noble Lord would do so—just how important the life sciences industry is to us and what a great state it is in at the moment. The noble Lord will be aware of the recent stage 2 of the sector deal in life sciences that we published along with that sector. I am sure the noble Lord very much welcomed the fact that a major multinational—one based in Brussels, for that matter—announced at that stage that it was investing a further £1 billion over the next five years in research in the UK. Obviously Brexit is not putting off certain parts of the life sciences industry, and I am sure the noble Lord will welcome that.

I do not share the noble Lord’s view that there is a policy change. The SI maintains precisely the current calculation of the SPC duration, and at present it is calculated from the first marketing authorisation in the EEA, which includes the UK. After exit, without the provisions we have set out in this SI, the duration of an SPC in the UK would be calculated from the first authorisation in the EEA—but that would not include the UK. That would be nonsensical and is exactly the sort of deficiency that Parliament gave Ministers carefully limited powers to fix within the withdrawal Act. We believe we are complying with the powers we have within the withdrawal Act. That is what the SI does. It shows that after exit, SPCs within the UK will continue to be calculated from the first marketing authorisation in the EEA or the UK, and the status quo is maintained.

Finally, I turn to the point made by the noble Lord, Lord Adonis, about the Explanatory Memorandum. He said that there was little impact. If a measure has a net impact to business of less than £5 million then obviously a full impact assessment is not required. The £5 million threshold, as the noble Lord will be aware as a former Minister, is set out in the better regulation framework guidance, and measures below the threshold must be accompanied by a proportionate analysis. The analysis is summarised, as the noble Lord will be well aware, in paragraph 12.3 of the Explanatory Memorandum.

I used the word “finally” but, if noble Lords will bear with me, I will have one or two more “finallys”. I turn to the concerns about the unified patent court. We have set out our proposals for the future relationship with the EU, including exploring continued participation in the UPC and the unitary patent. In the political declaration, the UK and the EU have agreed to co-operate in areas of mutual interest relating to intellectual property, including patents. The future of the UPC and the unitary patent will be a matter for negotiation. It is therefore rather too soon to be setting out the further dovetailing legislation.

The noble Lord, Lord Clement-Jones, also set out the points made by the law firm Bristows. We are aware of the point that Bristows has made. The patents legislation contains a number of references to the comptroller and the court, and all those references will be modified in the event of the UPC coming into force. The patents legislation will fully recognise the jurisdiction of the UPC.