Patents (Amendment) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Henley

Wednesday 6th February 2019 Lords Chamber

[The Parliamentary Under-Secretary of State, Department for Business, Energy and Industrial Strategy (Lord Henley) (Con)]

My Lords, as with the previous instrument, this was the subject of a wide-ranging debate in Grand Committee on 14 January. Again, I wrote to noble Lords who spoke in that debate to respond to the points raised, and also placed a copy of my six and a half-page letter in the Library. Since the Grand Committee debate, I have held further helpful and constructive meetings with the BioIndustry Association and the ABPI. Let me make it clear that I value those regular contacts and the insight that they bring on behalf of this important industry. I will continue to have discussions with representatives from industry and hear their perspectives as we move forward. As Life Sciences Minister within the department, my door is always open.

In my discussions with the life sciences sector, it has made clear the value and importance of supplementary protection certificates—SPCs—to the industry, and its concerns about the potential for those valuable IP rights to be affected by a no-deal exit. I hear and understand that. The only intention of this instrument is to fix what would break and to do so in a way that preserves the current operation of the law. We are considered to have one of the strongest IP systems in the world and the Government remain fully committed to maintaining that position. That is why we are preserving the status quo so far as possible in a no-deal exit. It is right that we continue to prepare for a no-deal scenario as long as that remains a possible outcome.

One issue raised in Grand Committee, and addressed in my letter, dealt with the approach taken to consultation on this instrument. In my meetings with industry bodies, we had discussions on this point and on why the usual wide engagement by the IPO was not possible on this occasion. The withdrawal Act established the policy direction which this instrument follows: to preserve the existing law at the point of exit and maintain the status quo as far as possible, ensuring a smooth transition for business. As the Government’s consultation principles make clear, a consultation on a policy which is not changing would not be of benefit. Nevertheless, the IPO wanted to ensure that the drafting of the instrument achieved its aims, by getting external views. Therefore, it was decided, consistent with the constraints in place, to carry out a confidential technical review of the drafting. In addition to providing valuable feedback on the drafting, the participants also raised wider concerns, including on the issue of the SPC term.

The recent engagement with industry bodies also touched on this issue, which was raised in Grand Committee by the noble Lord, Lord Warner. As I reassured them in those discussions, the sole objective of this instrument is to fix parts of the retained law that would otherwise break upon exit. Therefore, the changes being made simply ensure that an SPC which is granted the day after exit would be given exactly the same term of protection as it would if granted the day before exit. Without such intervention, term would have to be calculated without any reference to authorisations granted in the UK. Innovators have expressed the view that this intervention should be to rely solely on a granted UK authorisation to calculate term. This would give a longer period of protection if the product comes to the UK later than the EEA. As I set out in my letter, this has the potential to tip the balance between the interests in this area at a time when maintaining the status quo is critical.

I fully understand that innovators have concerns about wider potential effects of a no-deal exit on the regulatory environment; that has come through strongly in my recent discussions. These are legitimate concerns which must be carefully explored, and it is entirely correct that they are raised. Pharmaceutical innovation is a vital part of the UK economy; the companies which research and develop new drugs are some of our most important and valuable, and we benefit greatly from their work. If we end up in a no-deal situation, I am keen to start immediately exploring these issues with innovators and all other interests, and to make progress as early as possible after a no-deal exit.

In conclusion, by preserving the status quo as far as possible in a no-deal exit, I hope that the Government’s aim is clear—to maintain the UK’s highly regarded IP framework and the important protection that it provides. I beg to move.

[Lord Warner (CB)]

My Lords, I raised several concerns about this SI in Grand Committee, as the Minister recognised. As he knows, these were the result of briefings from the BIA and the ABPI, with which I am glad to say he has had further meetings. However, since his meetings both these organisations have provided me with further briefing about their continuing concerns.

Before turning to these concerns, I will briefly place them in the wider context of the damage done by Brexit—and the Government’s conduct of it—to our highly successful life sciences industry. This damage could make Nissan and Sunderland look like small beer if we are not careful. From the Prime Minister down, the Government have shown a poor appreciation of the damage being done to this sector: the loss of the EU medicines regulator from the UK; the loss of investment opportunities in the UK; the missed opportunities for collaborative international joint research, development projects and clinical trials; the drain from the UK of talented overseas scientists; and the likely loss of a growing amount of our own homegrown scientific talent.

To this litany of casual vandalism the Government have now added a statutory instrument which, if it were used in the case of our exiting the EU with no deal, would reduce the protection of exclusive intellectual property. The problem is caused by the SI’s approach to supplementary protection certificates—SPCs—which are a key part of the intellectual property protection framework for pharmaceutical research. SPCs are intended to give a period of exclusivity from inherent risks in the development of new pharmaceutical products. But the industry’s trade bodies—both the BIA and the ABPI—are convinced that, in the real world that they occupy, the SPCs as structured in this SI are fundamentally flawed.

In their view—the exact opposite of the Minister’s—this flaw reduces the period of exclusivity for drugs authorised in the UK, because the start of the period for exclusivity in the UK is backdated to a drug’s earlier authorisation in the EU. They are losing a bit of their exclusivity period. The chief executive of the ABPI put this extremely well:

“Britain is internationally renowned for its strong IP framework and this has made it an attractive home for investment from all industrial sectors, including pharmaceuticals. We’re concerned that these measures are a step backwards and seriously undermine the strong life sciences sector that we’ve worked so hard to build over the past 70 years”.


These views are shared by the BIA.

The problem has arisen in large part from the Government’s failure to consult properly on these regulations at the outset—as has been shown to be the case in other no-deal SIs, as we have already discussed. I drew the Minister’s attention in Grand Committee to the inadequacies of that consultation process, and I am pleased to see that he seems to have accepted some of that and tried to rectify matters through proper discussion with the ABPI and the BIA. I congratulate him on taking that particular initiative.

I think that the Minister will be pleased to know that I do not intend to bang on further about past misdemeanours. Instead, I ask him to give the industry two clear-cut assurances about the future conduct of the Government. First, I would like to hear it from him, on the record, that the Government recommit to the UK’s status as a world leader in safeguarding intellectual property and commit to make no further erosions of the UK intellectual property framework; and, secondly, that the Government commit to a specific review of the intellectual property legislation being introduced through statutory instruments as part of the no-deal Brexit planning. The reason for that second one is, frankly, that the industry is very sceptical about whether the Government will just drop these proposals if there is a deal. Ministers in the Government need to understand that they have lost a lot of the confidence of this sector. The time has come for them to start to rebuild that confidence in an industry which is vital for this country’s future.

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[Lord Henley]

My Lords, first, I repeat that we do not want to move away from the gold standard of IP that we have. Secondly, I make it quite clear that I regularly meet the two organisations referred to, the BIA and the Association of the British Pharmaceutical Industry. The chief executives of both those organisations sit on our Life Sciences Industrial Strategy Implementation Board, so I see them both regularly. I hope that we have a very good relationship and that full and frank discussion is always possible between me and them and between them and the department more generally.

[Lord Warner]

I just want to be clear to the Minister. What representatives of the industry are telling me in the letters and briefings they have sent is that they have interpreted the Government’s behaviour as meaning that they think that the Government is signalling that we are moving away from a gold standard of intellectual property protection.

The reason they say that is that, in this particular case, we will now have two regulators—when we come out of the EMEA, we will have a UK and an EU regulator for pharmaceutical products. I cannot put it any more clearly than this. They are saying that, if you apply for authorisation of a drug under the UK regulator, the period of exclusivity should start from the date of authorisation; it should start not from any authorisation that may have been given by the EU regulator at an earlier date for the drug to be introduced in the EU but from the authorisation when the drug is authorised in the UK. I do not think that I can be clearer than that. There is clearly a fundamental difference of view between the industry and the Government on this issue. No amount of fine words from the Minister is going to conceal that.

[Lord Henley]

My Lords, if the noble Lord, Lord Warner, will allow me, I was trying to say that, first, I want to continue discussions with them and we will do that. I do not believe that we are as far apart as the noble Lord is suggesting; nor do I believe that we are undermining the gold standard in IP that we wish it to achieve.

We do not want to do anything to undermine our large and successful pharmaceutical industry. It is one of the jewels in the crown, and has a turnover of £41.8 billion. I remind the noble Lord that it has seen a large amount of investment in research, particularly since 2016, and considerable new investment from abroad—again, since 2016. This is an industry that is flourishing and will continue to flourish. We believe that the level of investment within that industry that is supported by the SPC system, which ensures that British businesses are compensated for the period of patent loss protection while requesting market authorisation, is very important. Making sure that our law continues to work is therefore important.

The noble Lord, Lord Warner, says that there is a flaw in the SI: he says that there is a policy change. There was considerable debate on the issue in Committee. As I said previously, I do not share the view that there is a policy change here. This instrument keeps in place the existing calculation of SPC duration. At present, it is calculated from the first market authorisation in the EEA, which includes the UK. The instrument ensures that the exact position remains in place after exit and the calculation is the same. It is precisely this kind of deficiency that the withdrawal Act gave Ministers powers to affect.

The noble Lords, Lord Warner and Lord Adonis, then talked about the industry and said that it wants something different. The BIA and the other organisations representing pharmaceutical innovators would prefer the legislation to be changed so that the term of an SPC would be calculated based on only a UK market authorisation. They argue that the exit may lead to industry launching new pharmaceutical products later in the UK and that they may receive later market authorisation than in the rest of the EEA. That would give a period of SPC exclusivity for a longer period than under current laws. I can see why they argue that point: it is perfectly legitimate that they should do so. However, it would be a significant policy change, affecting the whole of the pharmaceutical industry and the NHS. I do not believe that it would meet the Government’s commitment to avoid a cliff edge for businesses by maintaining the status quo, which is what we are seeking to do, on exit day.

I turn now to the commitment that the noble Lord, Lord Warner, sought from me about whether we would commit to a review within two years. As I have already said, I am keen that we immediately start to consult with all those bodies concerned, and more widely—indeed, with everyone that noble Lords can think of—and explore the landscape after a no-deal exit, and also to look at what happens in other events, to make progress on the issues that concern them. As part of those discussions, I am very happy to talk about the timing and scope of any review of the SPC term. The Government have said that they will review the data and market exclusivity arrangements within two years of a no-deal exit—should there be such an exit, and again we have made it clear that we neither expect nor want a no-deal exit—in order to make sure that we remain competitive. I am sure that we can discuss with stakeholders how any review of SPCs would fit in with that work.

The noble Lord, Lord Clement-Jones, asked about unified patent court judgments in the UK. I can tell him that the UPC is an international court and is not part of the UK judicial system. Its judgments are therefore not binding but can be considered, as is the case with any other foreign judgments. That is obviously a matter for the courts.

The noble Lord, Lord Stevenson, also asked about the unified patent court. I can tell him that the unified patent court and the new British patent will commence shortly after Germany ratifies the UPC agreement, although obviously we have no control over what goes on in Germany. Germany’s ratification is currently on hold pending the outcome of a complaint against the UPC to its constitutional court. Finally, I can tell the noble Lord that the London building is indeed ready.

Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Henley

Wednesday 6th February 2019 Lords Chamber

[Lord Henley]

I think that deals with the point about modern technology—but I deal in letters, and mine is six and half pages of A4. I hope we are all talking about the same letter, which I sent on 21 January. I think, and hope, that it dealt with a great many of the points that have been raised.

I shall go through some of the points that came up in the debate. The principal one referred to by the noble Lords, Lord Adonis, Lord Stevenson and Lord Foulkes, is that there has been a failure of consultation—it just has not been good enough. I believe it has been consistent with the approach taken on no-deal legislation across government. The Government’s consultation principles are clear. Consultations should have a purpose. The statutory instruments in question make only those corrections to retained EU law that are necessary to give the UK a functioning statute book in what we have all made clear is the unlikely event of a no-deal exit, and maintain as far as possible the existing domestic position. A consultation on policy change would not have been meaningful as that is not what these instruments do. Again, I set that out in my letter.

I make it clear that there will be full and proper consultation on further changes. All those who have had dealings with the Intellectual Property Office will accept that it has a good record in this respect. It consults properly and will take into account the concerns of all those who have an interest. I give an assurance that the IPO will do that: it will consult and make sure—

[Lord Warner]

Before the Minister sits down, could he address the second leg of the Cabinet Office guidance? Even if we accept that there is a truncated and specialised consultation process, what about publishing the findings of the process, which is a key part of the Cabinet Office rules? Do he and his colleagues accept that if we are to have special arrangements, they should also publish findings of that consultation process?

[Lord Henley]

If there are findings that it is necessary to publish I give an assurance those will be published. If the noble Lord will bear with me, I want to talk about the future and make it clear that the IPO will consult and publish the findings properly so that the noble Lord and others with an interest will know what is going on.

I turn to some of the other points I want to address—I was not about to sit down, because there are other points to be dealt with. The noble Baroness, Lady Kingsmill, asked about long-term certainty for publishers and referred to the letter from the Publishers Association. I repeat what I said in my remarks: the Publishers Association made it very clear that it saw it as vital that these regulations should be on the statute book in the event of no deal.

Justification Decision Power (Amendment) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Henley

Tuesday 22nd January 2019 Lords Chamber

[Lord Warner]

Perhaps I may come back on this, because there is a matter of principle here, particularly following up on what was said by the noble Lord, Lord Pannick. The Minister will recall that we had some fruitful, if somewhat lengthy, discussions in Grand Committee on some of these regulations. We were debating the idea that these were no-deal exit regulations, and there was often a dispute over whether the regulations did or did not change policy. The Government’s view on some regulations was not necessarily shared by other Members of this House, but I think we were inclined to be tolerant on the basis that these were no-deal regulations, rather than regulations that would continue into the future. So is it going to be a pattern now that we will get these regulations, in a number of areas, presented as no-deal regulations, but then find that—lo and behold—there has been a change in policy that has slipped through, with no consultation, and that the regulations will continue into the future? The Minister might want to say that I am showing my customary paranoia on this issue, but it is a serious point that we in this House need to be clear on when we deal with these regulations. Our attitude will be very much conditioned by whether they are no-deal regulations or whether they will carry on into the future.

[Lord Henley]

To make life easier for the noble Lord, I can assure him that the other three regulations—to which I will be speaking later—are purely no-deal regulations. I do not think the noble Lord is paranoid about this—he is quite right to explore these matters. But I want to make clear to him that there is no change of policy in these regulations; we are just trying to make sure that things are okay on 29 March. That is the case, deal or no deal.

I think that that deals with his point and the point made by the noble Lord, Lord Redesdale. I believe therefore that I have answered the questions put before me. I am grateful again to the noble Lord, Lord Grantchester, for his comments.

Transfrontier Shipment of Radioactive Waste and Spent Fuel (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Henley

Tuesday 22nd January 2019 Lords Chamber

[Lord Henley]

My Lords, I have now set that out. These regulations have been to the appropriate scrutiny committees. They have not queried that part of the Explanatory Memorandum, and I do not think I can take the noble Lord any further.

[Lord Warner (CB)]

Can the Minister clarify something for me? He is saying these are no-deal regulations. Do I interpret his remarks as meaning that, if there is a deal, during the implementation or transition period—whichever you want to call it—we could end up, having reached an agreement with the EU, going back to using the Euratom framework to deal with these problems in future? Is that a distinct possibility if there is a deal?

[Lord Henley]

As I think I made clear, in the event of a deal during the transition period we revert to the old 2008 regulations and they remain in effect for the implementation period. Thereafter, it depends on the outcome of the negotiations.

I come to the point raised by the noble Lord, Lord Redesdale, about the cost of some new IT system. All I can say at the moment is that no bespoke IT system is required as a result of the procedures set out in these regulations. The cost relates to administrative working hours.

Finally, I notice the point made by my noble friend Lord Selborne and the noble Lord, Lord Grantchester, about Euratom. We will leave Euratom; that has been made clear and is cut and dried. But obviously we will continue to work with it, as we have made clear on a number of occasions—not least during the passage of the then Nuclear Safeguards Bill, which now seems an awfully long time ago.

Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Henley

Monday 14th January 2019 Grand Committee

[Lord Warner (CB)]

Can I be clear on what the noble Lord is saying? Is he saying that he will move these three regulations en bloc and make his speech on all three, but he expects the rest of us to wait until he formally moves the individual regulations before we speak to them? That does seem to be a slightly “Fred Karno” way of proceeding.

[Lord Henley]

My Lords, obviously I am in the hands of the Committee and I am quite happy to do whatever the Committee finds most convenient. I did not say that I would move all three en bloc; I said that I would move the first one and then speak to all three. That is very different, if the noble Lord follows me. The only point I was making is that there is an understanding that certain things are agreed by the usual channels and that these instruments would be spoken to together. One of the usual courtesies of the Committee, but obviously the noble Lord does not wish to follow that, is that one would have a word with the usual channels, or at least the noble Lord’s noble friend.

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[Lord Warner]

I may be able to help the Minister because I spoke to the IPO this morning about the second set of regulations. It is clear that there was no formal consultation with the trade body representing the companies affected by those regulations. If I were being a little unkind, it sounded as though officials got hold whoever they could to have a chat. To be fair to the IPO, it never made any claim that it had had a formal consultation. I give the Committee that information in relation to the second set of regulations because it may have been the pattern applied to all these regulations. Perhaps the Minister could clarify that.

[Lord Henley]

My Lords, I thought that we were debating the first set of regulations at this stage. We will get on to second set in due course as the noble Lord wishes.

As the noble Baroness, Lady Kingsmill, and I know, there will obviously be changes for businesses as a result of Brexit. There will be different changes for businesses if there is a no-deal Brexit. These regulations are about dealing with the no-deal scenario. The noble Baroness, the noble Lord and all noble Lords would think we were wrong if we did nothing about the possibility of a no-deal Brexit. That is why we are moving a number of regulations at this stage and why we published various technical notices and made them available to industry. That is why the original drafts of the technical notices led to various improvements.

At this stage, we know that business wants, in the main, to have the status quo in the event of a no-deal Brexit, and we hope that it will also have the status quo if there is a deal. We want to see what the deal is first and get that dealt with. However, in the event that it happens, we also have to make provision for there being—

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[Lord Warner]

Before the Minister rises to answer that, I want to put a proposition to him. He gave me a rollicking earlier for talking about my conversation with the Intellectual Property Office in relation to the second lot of regulations, but what it said is relevant to the point made by the noble Lord, Lord Adonis, which is that there was so much security around these “consultations” or discussions—no doubt the concerns about security came from a political direction—that it was difficult for civil servants to have a formal consultation on these regulations. Can the Minister own up to whether that is true?

[Lord Henley]

Again and with all due respect, I think that the noble Lord is possibly misinterpreting what I said.

[Lord Warner]

I did not say you said it; I said the IPO said it.

[Lord Henley]

What I am trying to deal with is the question about how we get a no deal. If there is to be no deal, we want businesses to be in as similar a position to their present one as is possible. I can speak only for the orders that I am dealing with today and tomorrow, but I imagine this will be true of a whole raft of orders coming from other departments. What we are trying to do is put those businesses in a position whereby they can cope as far as is possible with no deal. Meanwhile, as part of the ongoing, sensitive negotiations over the withdrawal agreement—and on this I can assure all noble Lords there will be consultation until the cows come home—we will try to make sure that all these matters can be dealt with. I give an assurance that the IPO has engaged with legal and business stakeholders as far as possible on the drafting of this statutory instrument and what it achieves, and will continue to do so on anything that is needed in the event of a deal—because in the event of a deal, I imagine we will be here again. I look forward to debating these matters with the noble Lords, Lord Warner and Lord Adonis, the noble Baroness, Lady Kingsmill, and others so that we can get it right.

These regulations relate to the no-deal option. We are trying to ensure that in the event of no deal, as with the technical notices we have put out, businesses know what the position will be. Obviously it will be slightly different from where we are at present. That is the inevitable result of no deal. But no deal is still on the table, and until we know that my right honourable friend’s deal has been accepted by another place, I am not in a position to go any further: that is why we want to prepare for the no deal.

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[Lord Henley]

My Lords, I repeat what I said: this is designed, as an exit SI, to deal with leaving without a deal. We want to maintain the status quo and therefore anticipate the impact on business to be relatively small. I will complete what I am going to say before I take interventions.

[Lord Warner]

My Lords—

[Lord Henley]

I am not giving way to the noble Lord until I have finished my point. I have a right to make this speech in my own manner. I will then give way to the noble Lord and to the noble Lord, Lord Stevenson.

I accept that there could be some impact on parallel trade from the UK to the EEA. That will depend on the actions of the EU rights holders and, more broadly, on what the EU chooses to do on the issue of exhaustion. Those decisions are not within the scope of this instrument, so it is not possible accurately to reflect those impacts in the assessment. I now give way to the noble Lord, Lord Warner.

[Lord Warner]

I am grateful to the Minister. I have listened to this for about an hour and he keeps using the same arguments. We are going to come to these issues again on the second SI. If I give him some notice, he may be able to think of some better arguments than those he has used so far. I find it almost impossible to understand what he is saying. If there has been no proper consultation with the industry, how can he say that this has minimal impact on it? That seems to be a contradiction in terms. What is the basis of the Minister’s impact assessment if there has been no formal consultation?

I come back to the point I raised earlier: were not the hands of the civil servants tied, in terms of their ability to talk to people about these issues, before this SI was formulated—a straight yes or no? Were they constrained in their discussions with the affected industries before these SIs were drawn up?

[Lord Henley]

My Lords, I reject any suggestion that officials have been constrained in what they can do. The point I was trying to make is that we are talking about two things. We are talking about what happens in the event of us leaving without a deal. If we do, we need to set certain things in place, which is what these regulations do. Meanwhile, we will continue to negotiate as part of the whole withdrawal process to get the right deal. We will then get the right things in place. At that point, further instruments will no doubt come before the House—I look forward to debating them—and those will follow full, frank and proper consultation with all concerned. There has been a degree of consultation on these regulations, but they deal purely with a no-deal situation.

Patents (Amendment) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Henley

Monday 14th January 2019 Grand Committee

[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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[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.

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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 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.

Trade Marks (Amendment etc.) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Henley

Monday 14th January 2019 Grand Committee

[Lord Warner]

With due respect to my noble friend, I am not so worried about that at the moment. I may become worried when I see the basis on which the consultations are taking place. I think the Grand Committee—and I in particular—would like to see what system the Government are using for consulting on these regulations.

[Lord Henley]

My Lords, I can make it clear that, throughout all these SIs, the Government have been engaged in what one might call a cross-government approach to consultation, to make sure that we get things right. We obviously cannot consult in the way that we would normally do when there is more time. However, as I made clear on the first and second orders, and now this, there has been a degree of consultation between the IPO and others. If the noble Lord will bear with me, I will expand on that in a letter. The important thing is that we are just dealing with the no-deal option here. When it comes to further arrangements, more consultation will obviously be necessary. I know that the noble Lord has particular concerns. He has come to see me and has been talking to my officials. In the event of there being a deal, we will want to make sure that we continue with those discussions to make sure that we get this right.

[Lord Warner]

I am sorry to be difficult, but I am still trying to grapple with this. Are the Government actually leaving it to the civil servants to decide how to do the consultations individually, regulation by regulation? Or is some kind of guidance being used for this raft of regulations? Can we be clear whether there have been any directions or guidance to them, or have they been left to make up their own arrangements according to each set of regulations?

[Lord Henley]

I ought to make it clear that the IPO discusses these matters with DExEU to agree an approach. We want to make sure that there is a similar approach across Government. I can expand on that in any letter I write to the noble Lord. It is not just a matter for this department or that one, as the noble Lord would put it. I am now going wide of my brief, but there is a degree of consistency when dealing with the no-deal regulations to make sure that we get this right. I see that the noble Lord, Lord Stevenson, is itching to get to his feet, so I will give way, but I agree to write to the noble Lord on this point.

Nuclear Safeguards Bill

Debate between Lord Warner and Lord Henley

Report stage (Hansard): House of Lords
Tuesday 20th March 2018 Lords Chamber

[Lord Warner]

I am sorry to interrupt the Minister as he comes to his peroration. Will he answer the question asked by the noble Lord, Lord Hutton, in more detail? Can he give a categorical assurance to this House that there is no risk of Sizewell B closing down as a result of the Government’s failure to put in place all the things that he assured us of by 29 March next year? As he will know, it is of a US design and relies on imported spare parts and maintenance arrangements, and generates about 8% to 10% of the UK’s electricity.

[Lord Henley]

The noble Lord is asking whether that NCA with the United States will be completed. I have given all the assurances I can that it will be and I cannot go any further than what I said in response to the noble Lord, Lord Hutton. With that in mind, what I was trying to make quite clear in what the noble Lord, Lord Warner, described as my peroration was the need for certainty for the industry, and this amendment would remove that certainty. The amendment would create a situation where we are compelled to secure agreements that we do not need and it runs counter to what the Government are doing: creating certainty. Even if this amendment were technically correct, its impact would be to introduce further uncertainty and potential disruption to an industry by casting doubt over establishing the domestic safeguards regime in the long term. I do not believe that can be the intention of the noble Lords who tabled it.

I believe we are on track to provide continuity and that this amendment is not only unnecessary but exacerbates the risks that it seeks to remove. I hope with the assurances I have given, and with the explanation of the weaknesses in the amendment, that the noble Lord will withdraw it.

Nuclear Safeguards Bill

Debate between Lord Warner and Lord Henley

Committee: 1st sitting (Hansard): House of Lords
Thursday 22nd February 2018 Lords Chamber

[Lord Henley]

My Lords, will the noble Lord bear with me? I said that I was going to play a fairly long innings and I want to explain these matters in full. There is no point in the noble Lord interrupting at this stage. I am going through this carefully and slowly in order to explain what we are going to do to make sure that we have the right things in place for when we leave Euratom and the EU in March of next year.

Our intention is for the new domestic regime to exceed the standard that the international community would require from the United Kingdom as a member of the IAEA. It will be run by the Office for Nuclear Regulation which, as the Committee will know, already regulates nuclear safety and nuclear security. We will also be agreeing a new voluntary offer agreement with the IAEA. I believe that we all recognise the special contribution—

[Lord Warner]

I am sorry to interrupt the Minister, but can he say what discussions have actually taken place with the IAEA to get to that point of an agreement before March 2019? What is the plan of meetings for those discussions that have taken place and are planned to take place?

[Lord Henley]

My Lords, discussions have already taken place with the IAEA. We will continue with those discussions to make sure that we are in the right place at the right time. If the noble Lord will bear with me, I will continue with my speech and set these things out in the proper manner.

[Lord Warner]

I understand what the Minister is saying, but none of us has moved amendments this morning that in any way suggest that we would not be leaving Euratom by next year. We have accepted that for the purposes of this debate. We are not slow learners: we do not need to be taken rather slowly through the arguments that we went through last night.

[Lord Henley]

My Lords, I am sorry if the noble Lord feels that he is not a slow learner. At times, I have felt that he and other noble Lords have been a bit slow on these things. That is why I am trying to spell it out very carefully and very slowly and I will continue to do so. I hope to make it clear so that the Committee and the House will understand that we will have the appropriate civil nuclear safeguards regime in place by next year, which is of paramount importance for us at that stage. We have had already considerable discussions with Euratom. There will be further discussions with the IAEA. I will not go into the details but I can no doubt write to the noble Lord in due course.

In a sense, this is an amending Bill. As noble Lords will be aware, it will amend the Energy Act 2013 by creating new powers so that we can put in place regulations that offer detail on the domestic safeguards regime, such as accounting, reporting, control and inspection arrangements. It also creates the limited power that I referred to earlier which we will get to in later amendments, allowing us to amend the Nuclear Safeguards and Electricity (Finance) Act 1978 and others. That power will mean that references in that legislation to existing international agreements can be updated once new international agreements have been reached. We will discuss that in greater detail later on.

I have listened carefully to what has been said on the agreements that we have before us on Amendments 1, 2, 12, 16 and 17. These amendments taken as a group cover the fundamental issue of the United Kingdom’s future relationship with Euratom and our strategy pertaining to this. I fully appreciate the sentiment and the intention behind these amendments. I shall try to address them all.

On Amendment 1, the new clause proposed by the noble Baroness, Lady Featherstone, would require Ministers, when negotiating and concluding the withdrawal agreement, to have regard to the desirability of associate membership of Euratom, and require the Government to report periodically to Parliament the progress to that end. Noble Lords will have heard many times before that there is no such thing as associate membership of Euratom. I made that clear at Second Reading. It is important that discussions on this matter focus on the actual treaty. The concept of associate membership does not exist in the treaty. Given the frequency with which the point comes up, I start my response by reading out exactly what the Government said to the BEIS Select Committee on this point in the autumn:

“There are two different articles in the treaty that deal with the relationship between Euratom and third countries. One of them is Article 101, which enables the community to enter into agreements with third states. That is the one that has been used in the research and training context with Switzerland. That requires a qualified majority vote. The other one is Article 206, which enables the community to conclude an agreement establishing a formal association involving reciprocal rights and obligations. That is the ‘association with’ part, not being an associate member. That requires unanimity.”


It is indeed the case that the Ukraine and Switzerland each have a form of association agreement with Euratom, but those agreements cover only research and training activities. Neither covers nuclear safeguards activities. These countries are not associate members of Euratom. Wanting to maintain a close relationship with Euratom is this Government’s stated objective so we need no persuading on that point. We have already stated very clearly in Statements to the House that the Government will be seeking a close and effective association with Euratom as part of the next phase of negotiations with the EU. We have made clear the desirability of this aim and that it forms part of our negotiation strategy.

I fully recognise the importance of providing clarity on the progress of the Government’s plans for withdrawing from Euratom and our ambitions in respect of a future relationship with Euratom, which the noble Lord, Lord Warner, asked about earlier; it is relevant to Amendments 2 and 16, which I will deal with later.

--- Later in debate ---

[Lord Warner]

Can I amplify something from what the noble Lord, Lord Hunt, said? If the Minister looks at my Amendment 2, he will see that the suggested new subsection (1)(a) refers to,

“a report on the progress of discussions with Euratom on the scope and conditions for a form of association with Euratom”.

It does not talk about associate membership. Listening to what he said about what the Government aspire to sounded remarkably like seeking,

“a form of association with Euratom”.

In clarifying the Government’s intentions for the noble Lord, Lord Hunt, will the Minister explain the difference between what the Government want and the wording in my amendment? I am quite happy to change the wording if it helps the Minister.

[Lord Henley]

I was coming to the noble Lord’s amendment to make quite clear our ambitions for that future relationship and how we see it developing, before I was interrupted first by the noble Lord, Lord Hunt, and then by his noble friend Lord Warner interrupting him. I will now deal with how we want to ensure proper clarity on where we are going. The information I will provide to the Committee particularly relates to Amendments 2 and 16 from the noble Lord, Lord Warner.

The noble Lord will remember that we made a Written Ministerial Statement on 11 January. I am sure that he knows it off by heart by now. It included a commitment to continue to provide quarterly updates—it is information that noble Lords particularly want in this matter—addressing the progress on the wide range of issues relating to Euratom exit. That will include progress on those negotiations, but also on how they will develop into our future relationship with Euratom, as well as progress made by the ONR on establishing the United Kingdom’s domestic safeguards regime. I cannot tell where those negotiations will take place. The noble Lord will have to bear with me. What he wants, as far as I understand it from his Amendment 2 and the other amendments, is a guarantee that information will be provided by the Government. All I am saying is that we have made one Written Ministerial Statement—actually, we have made more than one—and we will continue to do so. That reporting commitment goes far further than the proposed amendment, by keeping Parliament regularly updated on the key issues that have been raised. I hope the Committee will welcome the fact that we will continue to provide further updates on those. The noble Lord, Lord O’Neill, asked for one. There will certainly be one before the Easter Recess.

I turn to Amendment 12 on our future relationship with Euratom. The Committee will be aware that in her speech on 22 September 2017 in Florence my right honourable friend the Prime Minister set out her desire for an implementation period after the United Kingdom has ceased to be a member of the EU. This is now well understood in the EU and I do not think that the amendment is consistent with this position. It remains the Government’s intention to ensure continuity for the nuclear industry and to avoid the possibility of the cliff edge that noble Lords referred to for the industry on exit day.

I hope that the Committee will not need to be reminded that the UK will not be a member after 29 March next year, whether an implementation period can be agreed with the Commission or not. That much is clear. If it is not, I will repeat from page 1 of the letter that the Prime Minister sent to President Tusk:

“I hereby notify the European Council in accordance with Article 50(2) of the Treaty on European Union of the United Kingdom’s intention to withdraw from the European Union. In addition, in accordance with … Article 50(2) as applied by Article 106a of the Treaty Establishing the European Atomic Energy Community, I hereby notify the European Council of the United Kingdom’s intention to withdraw from the European Atomic Energy Community. References in this letter to the European Union should therefore be taken to include a reference to the European Atomic Energy Community”.


In other words, there can be no question of separately attempting to prolong our membership of Euratom beyond the point at which we leave the EU. That is a very different matter from having an implementation period, which is something we are aiming at. That is a period after we have left the EU and Euratom, during which we continue to be covered by the EU acquis. By “acquis” we mean the regulatory framework that applies to EU member states. In exchange, the Government expect that the United Kingdom would be able to continue to benefit from its current access to the EU’s markets for the duration of the implementation period.

Again, I must emphasise that any agreed implementation period is not a way of delaying our departure from Euratom. It is a way of making the transition smooth, rather than sudden. My reason for asking noble Lords not to press their amendments is simple: the amendment does not seek to establish an implementation period after exit; it seeks a transitional period before exit. My honourable friend the Minister for Business and Energy set out on 7 February that there can be no question of separating the situation for Euratom from that of the wider EU. The two are, as we know, uniquely and legally bound. Again, I made that clear at earlier stages.

Finally, I turn to Amendment 17, which seeks to require the Government to lay a strategy for maintaining existing arrangements once the UK withdraws from Euratom and for this to be considered by both Houses before the main substantive provisions of the Bill can be brought into force. As I have said, the Government have made it absolutely clear that they will seek a close and effective association with Euratom in the future. As was mentioned in the Written Ministerial Statement, the Government set out the principles on which our Euratom strategy is based, including to aim for continuity with current relevant Euratom arrangements, to ensure that the United Kingdom maintains its leading role in European nuclear research, to ensure that the nuclear industry in the UK has the necessary skilled workforce, and to ensure that on 29 March 2019 the United Kingdom has the necessary measures in place to ensure that the nuclear industry can continue to operate. In respect of our future relationship with Euratom, we will also seek a close association with Euratom’s research and training programme, including the Joint European Torus and the International Thermonuclear Experimental Reactor projects. We will also want continuity of trade arrangements to ensure the nuclear industry can continue to trade across EU borders, and to maintain close and effective co-operation with Euratom on nuclear safety.

The Committee will be fully aware that the nature of our future relationship with Euratom is part of the next stage of negotiations, which is yet to begin. An implementation period may well be agreed and we hope that it is, but there are no guarantees. In any case, without such a period the United Kingdom will legally leave the EU and Euratom in March 2019. The Bill and the regulations made under it are crucial to make sure that we can establish that domestic nuclear safeguards regime to meet international safeguards and nuclear non-proliferation standards when Euratom’s safeguarding arrangements no longer apply in the United Kingdom. From that point, the United Kingdom will be responsible for its safeguards, including having its own state system of accounting and control.

Nuclear Safeguards Bill

Debate between Lord Warner and Lord Henley

2nd reading (Hansard): House of Lords
Wednesday 7th February 2018 Lords Chamber

[Lord Henley]

My Lords, it is exactly the same as what I have said—as part of our broader negotiations we will obviously want to ensure that, in the words I think I used, a future customs arrangement with the European Union is as frictionless as possible. We understand the importance of these matters. It is as frictionless as it can be at the moment; we want to make sure that that continues. I do not believe that it is strictly relevant to the Bill but it was important to bring the matter up. I am very grateful to the noble Lord, Lord Hunt, for tabling an amendment, which will be discussed, to another Bill, but I want to give assurances that the Government are doing everything we can to make sure that such imports are frictionless, just as their export from Europe will be frictionless and just as they are frictionless in their export from Europe to non-EU countries at the moment. It is a matter of giving assurances as to what the Government can do and I hope that that will help to reassure noble Lords.

[Lord Warner (CB)]

I did not quite understand what the noble Lord was saying in his attempts to reassure us about Euratom’s observatory. As I understand it, the observatory was an important part of smoothing out problems when there were supply issues around radioactive isotopes. Is he saying that the observatory will continue for all those who have the benefit of being in Euratom but those who leave will not have any equivalent benefits and it is impossible for the UK to achieve such access to those benefits?

[Lord Henley]

It is a body set up by Euratom for Euratom, therefore it has an interest in ensuring safe export from the EU. There is no problem of the export of radioisotopes from the EU to non-EU countries. We want to make sure that when we are no longer part of Euratom that continues to be the case. That is why I am trying to give assurances based not only on what is coming out but on what the United Kingdom Government can do at our end. I hope that that will deal with the noble Lord’s problem.

[Lord Warner]

I do not think that that answers the point. The noble Lord is saying that they will go on helping to smooth out the supply to EU countries, but the UK will be left over here somewhere, unable to benefit from that if there is a world shortage of radioactive isotopes. That seems to me to be what he is saying: will he just confirm that that is what he is saying?

[Lord Henley]

I have a sneaking suspicion that the noble Lord is deliberately misunderstanding me. What I am trying to make clear is that we have to deal with not only what we want to import but obviously what is being exported from Europe. Euratom has an interest in what is being exported. Euratom is quite able, through the advice offered by the European Observatory on the Supply of Medical Radioisotopes, to look after the export of such radioisotopes. We have an interest in their export because we will be importing them as a non-EU country in the future. What I wanted to do is to give the noble Lord, if he will accept it, and other noble Lords an assurance that everything that can be done by the Government, and everything that is relevant in the negotiations, is being done to ensure a continued supply from European countries, just as there will continue to be supply from countries such as South Africa, from which we also import medical radioisotopes. I hope I have given sufficient assurance to the noble Lord, Lord Warner, that he will accept that we are doing what we can. As I made clear earlier, I do not think it is relevant to this Bill but I wanted to deal with the concerns raised by the noble Lord, Lord Hunt, and others during the passage of the EU withdrawal Bill.

The powers in the Bill give the existing independent nuclear regulator—the ONR—a new role to regulate nuclear safeguards, alongside its existing role, which it performs very well, regulating the United Kingdom’s nuclear safety and security. The Bill sits alongside other work around our future relationship with Euratom, the IAEA and third countries. Of course, we do not know what the final arrangements will be so we are doing what any responsible Government would do by being ready to put in place a civil nuclear safeguards regime for the United Kingdom through the Bill. I reiterate that although the United Kingdom is leaving Euratom, we will continue to support Euratom and want to see continuity of co-operation and standards and a close future partnership with it. I beg to move.