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

Lord Warner Excerpts

Wednesday 6th February 2019 Lords Chamber

[Lord Adonis (Lab)]

My Lords, first, I thank the Minister for his extensive letter to noble Lords responding to the debate in Grand Committee. I have a specific question and will then make some comments on the wider issue of consultation which has bedevilled all our proceedings on these no-deal statutory instruments, because the consultation has been so haphazard and unsatisfactory. My question is in response to the Minister’s opening remarks, when he said that it was “not sensible” to put a sunset clause on the current exhaustion regime. That is a judgment which the Government have made but, since this is clearly a matter of extreme importance to the industry, can he tell us what the view was of stakeholders who were consulted on the issue of the sunset clause? I understand that that issue has bedevilled these proceedings throughout.

On consultation, the Minister’s letter was significant; it accepted that the consultation which had taken place had been in confidence. Having secret consultations which are not open to all relevant people, or all those who wish to take part, particularly from the industries consulted, is contrary to almost all of the principles of public consultation. The Minister’s letter has an extremely convoluted paragraph about how this secret consultation was conducted. It says that the Intellectual Property Office, or IPO,

“identified the relevant representative organisations or businesses it would usually engage with, and who would give a range of views. Because of the confidential nature of the review”—

which was entirely self-imposed by the Government; this did not need to be confidential but could have been an open, public review—

“the IPO then identified and invited 12 individual experts who had previously liaised with the IPO in a role within one (or more) of those relevant organisations”.

The letter then lists the organisations. It continues:

“I believe this is consistent with what I said in my … clarifying remarks about this process during my closing speech; the IPO’s understanding was that these individuals were ‘from’ those organisations but they were, as I clearly said, ‘a group of individual stakeholders’ and the IPO ‘consulted them in their personal capacity’. I therefore also agree with Lord Warner that the organisations themselves were not consulted in the way that would usually happen”.


Reading that twice, one realises the truly extraordinary nature of the consultation which has taken place. The Government have arbitrarily and secretly selected 12 individuals because—to cut to the chase—officials happened to know them and had dealt with them previously. They then chose to consult them, telling Parliament that the consultation process was adequate. However, when pressed, it is clear that these people do not in any respect represent the organisations from which they have come. We are not told who the individuals are and they are not in any way accountable for their advice. We are told that the advice was given individually, but we are not told what it was. When it comes to disputes on major aspects of policy embedded in these regulations, the Government blandly assure us that the decisions they have taken are sensible. In my experience, Governments always think that their decisions are sensible; I have not yet met a Treasury Minister who said that their decisions were not sensible. However, the Government will not even tell us whether the “sensible” decisions they have made reflect the secret consultation that took place before the preparation of the statutory instruments.

Because of the unsatisfactory nature of this whole procedure, we will have to approve this regulation. However, in any normal circumstances, we would not approve a regulation on the basis of a secret consultation with 12 individuals—selected secretly by the Government, whose names we do not know and who are not in any way accountable—when there should be a public consultation. I raise this point not only to highlight the unsatisfactory nature of this, which goes to the heart of all this no-deal planning, but because of the cascade of regulations still to come. Every time your Lordships meet, a plethora of regulations appears before us. In the health Bill, which we debated yesterday —I did not participate, but I read the Bill during the proceedings—there was provision for a whole slew of further regulations, with procedures as yet undecided.

I invite the Minister to respond on this, as I think it is important to get this on the record. Can he give some undertakings that consultation on future regulations laid before your Lordships will be done in an open, transparent way, so that we are not faced again with consultations with secretly selected individuals? As noble Lords will recall, when we were debating one of the instruments, we were told that the individuals were “selected and trusted” respondents—presumably on the grounds that a general public consultation with people who were willing to share their views would not engender trust.

This is not good government. In any circumstances other than this national emergency, I am confident that your Lordships would not agree to process, let alone consent to, regulations on this basis. We need some assurance that, in the time remaining, consultations will be conducted in a proper manner, rather than in the secret, cloak and dagger, totally unaccountable fashion that we have seen in respect to this instrument.

[Lord Warner (CB)]

I want to follow up that point. I remind the Minister that after our rigorous series of exchanges in Grand Committee on these regulations, I took the liberty of submitting a Written Question, which was answered extremely helpfully on behalf of the Cabinet Office by the noble Lord, Lord Young of Cookham. I wanted to check that my memory was correct about the Cabinet Office rules on consultation. Not only do they require 12 weeks—during which people can comment in what is often a helpful way for the Government of the day—but the twin leg to this is that the Government have to publish those responses to their consultation. Not only have the Government, as the noble Lord, Lord Adonis, said, cut out the middleman in their approach to consultation, but by doing it that way they have avoided the commitment to publish the responses to that consultation. So there is a twin problem with the Government’s approach to many of these SIs. I suspect it is going to continue in relation to the Healthcare (International Arrangements) Bill, which contains Henry VIII powers for the Government to produce a lot of SIs. If the Government go on behaving on these SIs in the way that they have behaved on those we are discussing today, they will drive a coach and horses through their own Cabinet Office rules on the way we go in for consultation on legislation.

[Lord Foulkes of Cumnock (Lab Co-op)]

My Lords, I have waited in vain for some Conservative Members to contribute to this debate. When I moved here from the other place, a number of people, including the noble Lord, Lord Strathclyde, who I am glad to see here, told me that the great thing about the House of Lords is its careful scrutiny, the work that it does scrutinising detailed legislation using all its expertise, knowledge and background. That is why I am surprised. We are dealing with a statutory instrument on intellectual property, which a lot of Conservative Members, in particular, must have expertise in. I see the noble Lord, Lord Faulks, who has probably been involved with this in his work in the legal profession. There are others who no doubt could contribute. We have 12 statutory instruments here. I have been at a number of meetings of the Grand Committee, and with the notable, standout exception of the noble Lord, Lord Deben, there have not been any Conservative Members contributing. What has happened to this great scrutiny of the House of Lords? We have had wonderful and important contributions from some of my noble friends, including my noble friends Lady Kingsmill, with her experience in the law, and Lord Winston, when we were discussing the transfer of embryos and other matters. We have heard from the noble Lord, Lord Warner, from the Cross Benches, but no Conservatives. Yet today we have 12 statutory instruments—

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[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.

Patents (Amendment) (EU Exit) Regulations 2018

Lord Warner Excerpts

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.

[Lord Clement-Jones (LD)]

My Lords, the noble Lord, Lord Warner, has expressed the impact on the life sciences industry extremely effectively and eloquently, and I do not wish to repeat anything of what he said. Quite apart from the damning quote from the chief executive, Mike Thompson, the key sentence that I saw in the ABPI’s briefing was:

“The signal the Government has sent to global pharmaceutical companies large and small is that the UK will be less committed to IP protection after Brexit than it has been to date”.


For a major industry to consider that seems extremely damning.

As the noble Lord, Lord Warner, pointed out, the Minister said that it is correct to raise these issues and he is keen to start exploring them, so there is some intention now to have some consultation post the SI rather than proper consultation before it. I think we are looking forward to hearing a bit more of a concrete proposal from the Minister with regard to what precisely is planned.

The Minister’s six and a half-page letter, as we must now call it, dealt with the question of participation in the unified patent court, as set out in the White Paper last autumn. I made the point in Committee that if the UP convention is ratified by Germany and comes into force ahead of our exit date, the UK will need to work out how to remain a member of the UPC or withdraw from the systems, which could have significant impacts on business. In that context, I questioned in Committee whether the UK will have to acknowledge the supremacy of EU law and the ECJ as part of the signing up process. In his letter, the Minister advises that,

“when ruling on domestic cases, UK courts will not be bound to follow decisions of the UPC, or rulings of the European Court of Justice applied by the UPC”.

The last time we discussed this SI, I brandished a 39-page opinion on the subject, so I am rather baffled by the advice that the IPO and the Minister have received in those circumstances, if we have signed up to the unified patent court agreement. I would very much like to hear a bit more clarification on that subject from the Minister.

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[Lord Adonis (Lab)]

My Lords, I want to follow the remarks of the noble Lord, Lord Warner. It is deeply unsatisfactory that the only way we can know the interests of those most intimately affected is if an individual Member of your Lordships’ House relates conversations that they have had to this House. In Grand Committee, the noble Lord, Lord Warner, told us about conversations that he had had but which had not been published because there had been no formal consultation.

The Minister said that he has met relevant stakeholders. We are grateful for that. I hope that, in his reply, he will clarify the issue about the duration of SPCs, particularly for the benefit of those of us who do not follow the detail of what is at stake. I take the noble Lord, Lord Warner, to be saying that a substantive change in the duration of SPCs will take place as a result of these regulations and that this will have a major impact on the industry concerned because of the protection of intellectual property. So this is not, as we have been told all along, a technical issue about rolling over existing regulations. It is a substantive change. This has never been clearly brought out in our proceedings.

[Lord Warner]

Just to be clear, the industry is saying that, because of the way in which the Government have drafted this SI, the period of exclusivity will be less than it would have been in the past. So there is a material change in the financial benefit through the period of protection that was previously given. The industry is worried not just about that aspect but about the signal it gives about whether the Government are going to move away from a gold-standard intellectual property framework. They are worried that this is the first step in this particular direction.

[Lord Adonis]

I understand the significant point that the noble Lord makes.

None of this came out in the Explanatory Memorandum’s summary of the non-existent consultation and secret discussions that took place. The only reason this has come before your Lordships is because of the successive conversations which the noble Lord, Lord Warner, has had with the industry. His point seems entirely reasonable. The industry is concerned as to what this means for the wider protection of intellectual property and the big impact it might have on investment in a crucial national industry. This is not a technical issue; it is fundamental. We were not alerted—in any part of the process leading to these regulations coming before the House—about any of these issues.

The Minister said that, since the Grand Committee debate, he has conducted discussions with industry representatives. We should be grateful that, by calling attention to the lack of consultation, this encouraged the Government to engage in more formal consultation after the instrument was laid. In my day, good government involved consulting about instruments before they were laid, not afterwards. The noble Lord, Lord Warner, and I were in the ancien régime when there was Cabinet Office guidance on 12 weeks’ consultation and publication of consultation results to which the Government gave reasonable responses. In this national emergency, all this no longer applies.

I should be grateful if the Minister could bring out precisely—because it is important that we have it in Hansard—what is the substantive change in respect of SPCs and what is in fact at stake in terms of the lesser protection that will be available for crucial intellectual property in the industry. It is still not clear to me from the remarks of the noble Lord, Lord Warner, but since he is doing such a good job of responding to the debate, he may be able to tell us the scale of the impact that this is likely to have. Are we talking about minor changes, because it is calculating differences in dates at which patents were granted, as I understand it, and whether European and UK patents are granted at different times under the new regime? I should be grateful if the Minister could say more and clarify more.

The other significant point about the regulations is that the consultation was not just secret, in the way I set out in my earlier remarks, but in his introductory remarks the Minister did not address the point made by the noble Lord, Lord Warner: that there is still profound dissatisfaction in the industry. All the Minister told us in his rather—if he will forgive me for saying so—bland opening remarks was that he had met industry representatives. He did not say anything about the content of those discussions or what representations were made to him. We only know about the content of those representations because of the remarks of the noble Lord, Lord Warner. I deduced from his remarks that those representatives are profoundly dissatisfied, think that this will be a diminution of the protection of intellectual property in the industry, are worried about the cavalier way in which this has been done and think it might have a big impact on future investment. These are substantial matters. As I said, in the normal course of events, they would lead us seriously to question what is effectively a proposed change in the law.

If we had a proper legislative process, we would be moving amendments and might require formal consultation to take place. It is deeply unsatisfactory that these big concerns are dribbling out only because of the activity of a few noble Lords independently consulting industry stakeholders and pressing the Government to give us some indication of what they have said, while the Government shield behind a claim that these are technical changes, which is denied by the industry. For the Government to say that the consultations that have taken place are necessarily secret is totally unsatisfactory for such changes.

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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.

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

Lord Warner Excerpts

Tuesday 22nd January 2019 Lords Chamber

[Lord Redesdale (LD)]

My Lords, I am tempted to ask a number of questions to get them out of the way, because most of these regulations follow the same guidelines. My noble kinsman the Minister has already said that they will not come into effect if we remain in the European Union for whatever reason. Can he confirm that that is the case for all the regulations, and then I will not have to ask again?

I have only one question on this regulation, which concerns transparency. The noble Lords, Lord Adonis and Lord Pannick, have already talked about the justifying authority, and reading the SI it is clear that it could be any Secretary of State, but as we are dealing with detriment to health and ionising radiation can the Minister say at what point discussions by the justifying authority would be made public? Under what forum would people be able to find out about the decision-making process?

[Lord Warner (CB)]

My Lords, I had not intended to intervene on this set of regulations, but remarks that the Minister made in answering the noble Lord, Lord Adonis, sparked a thought in my mind, given some of the other discussions we have had on no-deal regulations. The Minister said that these justifying authorities, and presumably these regulations, could be just as relevant if there was a deal as they are for no deal. I thought they were being presented to the House as no-deal regulations. If there is a deal, will these no-deal regulations be abolished and will we start again? Or will they carry on on the statute book if there is a deal and be used as though there were no deal?

[Lord Grantchester (Lab)]

My Lords, the Minister is correct to portray the order before the House today as merely a technical replacement justification power, where “justified” means that the benefit resulting from the practice outweighs the risk and potential health detriment it may cause, under the ionising radiations regulations or the directive. These regulations are a first step towards regulatory approval for any new class or type of practice involving ionising radiation, such as a medical treatment or new nuclear reactor design. These activities are important, and it is important that they are regulated properly. To my mind, they are as needed in any situation as they are needed for exit from the EU. To me it is a straight transposition from an EU-derived power to a UK power to give effect to the UK’s exit in domestic law. There should be no issues with this order.

This is the latest type of Brexit—I am calling it a continuity Brexit—to allow EU-derived legislation to continue to have effect in domestic law, and this order is merely a replica of previous ones. I approve the order today.

I understand that the Government Whips’ Office in the other place has a new sweetie box as a reward system, whereby Ministers are rewarded for each successful continuity order passed before exit day. I trust that the Minister will be rewarded with a bonus issue for this order.

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[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

Lord Warner Excerpts

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

Lord Warner Excerpts

Monday 14th January 2019 Grand Committee

[Baroness Kingsmill]

My Lords, this is not the most sensible way to proceed. Distinct legal issues arise in each of these statutory instruments and it would be much more sensible if they were debated separately. Having sat on this Committee in which these instruments are put forward, I recognise that it is sometimes easier in terms of efficiency to take them all together. However, these instruments give rise to serious, distinct and important issues, and they really ought to be debated separately.

[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.

--- Later in debate ---

[Baroness Kingsmill]

My Lords, we are trying to do our job here. The Minister has confirmed that the regulations potentially put British businesses at a disadvantage, because there will a number of situations where they will not be able to export the goods they currently export. In those circumstances, we need to think carefully about these regulations. Some of the results of the consultation should be made available to us. I know that none of the businesses with which I am concerned has been consulted, including small and large. I would be grateful for some tangible evidence of the results of the consultation. This is important to us; British business will be placed at a significant disadvantage.

[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—

--- Later in debate ---

[Lord Adonis]

My Lords, before the noble Lord sits down, the question that is coming up time and again in the Grand Committee is: why was formal consultation not conducted before rather than after these regulations were made? With respect, the Minister has not given us a satisfactory answer. He said that consultation is taking place on arrangements concerning the deal, but the Government are telling the House that we may have to enter into a no-deal situation in two months’ time, so how can he say that it is more important to consult on arrangements concerning the deal than on no deal? How can he regard that as a satisfactory point to make to the Grand Committee, when we are being asked this afternoon to consider arrangements for no deal? It leads me and other noble Lords to think that we are not in a position to scrutinise these regulations at all if there has been no consultation nor the ability by the noble Lord to tell us who has been informally consulted by the Intellectual Property Office.

[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.

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[Lord Adonis]

Not content.

[Lord Warner]

Not content.

[Baroness Kingsmill]

Not content.

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—

--- Later in debate ---

[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.

--- Later in debate ---

[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.

--- Later in debate ---

[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.

--- Later in debate ---

[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.

--- Later in debate ---

[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.

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

Lord Warner Excerpts

Monday 14th January 2019 Grand Committee

[Lord Warner (CB)]

The noble Lord made an interesting remark a few moments ago about the fact that he had chosen to limit the consultation. I wonder, after the discussions this afternoon and last week, on what basis the Government are operating on consultations? They are clearly not operating on Cabinet Office guidance on consultations. What guidance has actually been given to civil servants on carrying out consultations on behalf of Ministers? I think that the Grand Committee would like to see the basis that the Government are using for consulting on these regulations.

[Lord Adonis]

Who are the trusted individuals?

[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

Lord Warner Excerpts

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

[The Earl of Selborne (Con)]

My Lords, in the draft transition agreement published yesterday the entry on Euratom is in green, which appears to demonstrate that there is some progress being made, apart from any legal complication which might emerge from the woodwork. The Government have committed themselves to a close association with the Euratom research and training programme. The Secretary of State has also committed to report back to Parliament every three months about overall progress on Euratom, with a first update expected before Easter. All so far so good, but this does not change the position that a default clause, such as this amendment suggests, might be sensible.

The only reason I have heard why this amendment will not or cannot be accepted is that, by our own folly, we have already given notice that we are leaving Euratom, come what may. My noble friend on the Front Bench described it as a done deal—which of course it is in terms of the Act we have already passed—but that is not the best of reasons for rejecting this amendment. After all, one Bill can amend a previous Act and if we find that the default position is needed in order to make sure that we do not fall between poles between one Bill and another, I should have thought that a fallback position such as that suggested by this rather sensible amendment would at least be worthy of serious consideration.

I recognise that the assurances given by the Government, and indeed by our Minister here, are helpful so far as they go—I have enumerated them just now—and that the disastrous decision to leave Euratom may ultimately be irreversible, but I will be listening to the Minister’s response to this debate with great care.

[Lord Warner (CB)]

My Lords, I strongly support this amendment. I want to focus on the one issue that will cause me to vote for this amendment if my noble friend puts it to a vote. That is the way that the Government have been playing Russian roulette with our energy security by the ill-considered and ideological rush to leave Euratom without being sure that an equivalent regime is properly in place. The jeopardy this places the UK in is well set out in the latest briefing from the Nuclear Industry Association. The Government are doing a very unusual and risky thing in ignoring the advice of the nuclear industry’s experts simply because of their obsession with the jurisdiction of the European Court of Justice, which, let me remind the House, has never intervened in a Euratom matter during the duration of Euratom’s life.

There is little evidence that it is possible to secure UK accreditation from the IAEA and negotiate a raft of new nuclear co-operation agreements with other countries before exit day. As the NIA briefing makes clear:

“Without access to Euratom’s NCAs and common market, the nuclear new build programme, nuclear could be seriously affected”.


Clearly, a responsible Government would stay in Euratom and not risk the disruption and uncertainty to a critical industry that departure brings, but not this Government. They claim that they will secure an equivalent alternative set of arrangements to membership of Euratom by exit day. Their backstop for failure seems to be that by the end of the transition or implementation period they are trying to negotiate with the EU. Despite yesterday’s upbeat gloss put on the negotiations of a transitional period, no such arrangements have yet been agreed by the Council of Ministers; they may well not be before the Bill leaves this House. Even if they are agreed before Royal Assent they will not provide for a transition period beyond the end of 2020. That may still not be long enough to secure all the new NCAs the UK needs, especially with the United States.

As the NIA briefing makes clear, without these agreements the trade in goods and services to maintain our existing nuclear reactors—these generate 21% of the UK’s electricity—is put in jeopardy, as is the building of new reactors. Sizewell B is particularly vulnerable because it relies on an NCA with the United States, and a new NCA is effectively a treaty, which requires congressional approval.

--- Later in debate ---

[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.

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[Viscount Trenchard]

I accept what the noble Lord says but if you are bound to commit, through the Euratom programmes, to a greater amount of funding for the sector as a whole, that could effectively mean that you were constrained in what you do on your own. I am not saying we would not wish to contribute or to continue to participate, but it would be our decision on whether we participated or not. We would recover the right to make decisions and to apply our research and development funds, which we would then own in so far as they were invested in programmes that we were running independently.

On Amendment 9, I do not see the need for the taxpayer to have to fund a further independent reviewer. The IAEA will ensure that we follow the approved safeguarding regimes, check and verify our safeguards regime and ensure that we work only with verified customers.

[Lord Warner]

My Lords, I support Amendments 7 and 9, and I compliment the Government on Amendment 6. I remind the noble Viscount, Lord Trenchard, that scientific research, in this area or anywhere else, is now overwhelmingly collaborative. If you do not get in the game collaboratively, you find that some of your best researchers and ideas are rapidly transferred abroad to someone else who is much more interested in collaborative research. We have moved on from being a Great Britain that does all this stuff ourselves to being a collaborative, global, international participant in research, including in this area. That is one of the reasons why I support Amendment 7; I think it takes us in the right direction. I am sure that the noble Lord, Lord Broers, whose amendment last night I sadly missed, will want to say a bit about that.

I am really pleased that we have come back to talking about medical isotopes and having a report that keeps Parliament up to date in that area. There is huge concern outside this House about whether the supply chains around medical isotopes will be sufficient to cope with the needs and demands of NHS research and NHS patients.

On Amendment 9, after the last debate that we had before the vote, you would have to be one of life’s perennial optimists—I am not a Liberal Democrat so I do not join that particular club—to believe that everything is going to be okay by March 2019. I suggest to the Minister that he might find it useful to have an independent reviewer who can make independent reports to Parliament to convince sceptical parliamentarians such as me and, I suspect, a few others in this House that good progress is being made on some of the critical issues. That is why I support Amendments 7 and 9.

[Lord Fox]

My Lords, I support Amendment 9, to which my name is appended, and I commend the Government on Amendment 6 and support Amendment 7. I echo the words of the noble Lord, Lord Warner: not even the Liberal Democrats are optimistic enough to imagine that everything is going to be in place in time. That is why we believe this is a helpful amendment to the Government and to the Minister. We heard in the debate on Amendment 3 that the stakes are high in achieving what needs to be achieved in time. I believe, en passant, that for the noble Viscount, Lord Trenchard, to use the cost as a reason for not having something like this in place is a little like trying to save the money that is down the side of the sofa when the whole house is potentially at stake. I suggest that cost is not a reason for not doing this.

The stakes are high. I will not rehearse them again but the Committee has heard scepticism, concern and worry from a vast array of people about whether the finish line can be crossed in time. The Minister—this is in no way reflects scepticism of the Minister himself—has stood up on a number of occasions and said everything is in order and we need not worry. Almost every statement he makes begins with, “I believe”. That is the problem; at this point, to some extent it is difficult to go beyond a belief system. Amendment 9 would put in place an independent voice, someone who was marking the Government’s homework but was not the Government. This is not a question of doing the work of the IAEA; it is a question of following and tracking the Government’s progress in getting to the finish line.

I echo the noble Lord, Lord Warner: this could be very useful for the Government in helping to give reassurance. It would be another voice to prove that the Minister was correct—if he was. When the noble Lord, Lord Hunt, says that this is not an aggressive amendment and not intended to be unhelpful, I know, because I participated in the discussion around this amendment, that it is genuinely not intended to wreck or harm the Bill in any way. It is intended to give support and some further credibility to the argument that things are moving in the right direction.

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[Lord Teverson]

My Lords, I remind Members of what the Euratom treaty says in Article 2(g)—that, in order to perform its tasks, the community shall,

“ensure wide commercial outlets and access to the best technical facilities by the creation of a common market in specialised materials and equipment, by the free movement of capital for investment in the field of nuclear energy and by freedom of employment for specialists within the Community”.

I have not taken the whole of the article, or of part 2(g), into the amendment, but rather the important post-Brexit part, which concerns the free movement of nuclear specialists. I will not make a long speech because I believe that this is self-evident. The Government have an industrial strategy around the nuclear sector: to expand it and for it to be part of where this country goes economically.

We have heard in previous debates that our most important need in the short term is to have a functioning safeguarding authority, whether that is Euratom or—as soon as that stops—our own Office for Nuclear Regulation. We need those bodies, and that body in particular, to function. We have a shortage of qualified people in this area and a shortage of specialists in the industry more generally—although the amendment is, because of the Bill, primarily around safeguarding. Therefore, it must be in the interests of the Bill, and of the country at large, to ensure that we maintain the mobility of those specialists in the nuclear industry and the nuclear sector, so that we maintain this benefit post Brexit and post our membership of Euratom. That is why the amendment is absolutely appropriate to the Bill and is of great importance not just to this sector but to our national security.

I very much hope that the Minister will be able to give a greater reassurance—perhaps higher up on my noble friend Lord Fox’s Richter scale of assurances—than we have received so far that this area will be looked after by the Government, that we will not be browbeaten by the Home Office into having a minimal circulation of specialists, and that this country will benefit from those with the experience and skills that will enable us to perform in this sector, not just in safeguarding but in the nuclear sector more broadly. I beg to move.

[Lord Warner]

My Lords, I have added my name to this amendment because, like the noble Lord, Lord Teverson, I remain concerned about the industry’s access to the workforce that it will need once the UK leaves Euratom. I suggest that the free flow of essential specialist staff could well dry up unless the Government are reasonably energetic in the guarantees that they give them. As the noble Lord, Lord Teverson, said, this is not just a safeguarding workforce issue; it affects the whole sector, as was very well brought out in the Nuclear Industry Association’s briefing. I shall not go into detail on that but it is clear that we need a very skilled workforce coming to this country to help both in maintaining existing reactors and, even more significantly, in building new ones, as well as in the safeguarding area.

With regard to the regular reports that the Government will give to Parliament on progress in the safeguarding area, it is a bit disappointing that we did not manage to get into the Bill a specific reference to the need for an essential specialist workforce. I hope that the Minister will take this suggestion in the spirit in which it is offered, and perhaps he might encourage his officials, when they are producing these reports, to say something about the progress that is being made, particularly with the ONR getting the specialist staff that it needs.

--- Later in debate ---

[Lord Warner]

My Lords, I support the amendment, but I do not expect us to go for our hat trick of votes on it. I speak as someone who had the misfortune to inherit the NHS IT system as a responsibility. I also had some experience in the Home Office of IT systems. Things never work out the way that noble Lords think they will. They are usually delayed and they usually malfunction a bit when they are first introduced and used. My question for the Minister is: has he got a plan B and what is it, if this IT system does not come online to time? At the end of the day, the ONR will still have some responsibilities to discharge. If it does not have the IT system, how will it go about discharging its responsibilities?

[Lord Fox]

Following my noble friend Lord Teverson’s excellent explanation for the reason for this amendment, on the long-named programmes and systems in proposed new subsection (2), can the Minister tell the House whether these are built on existing systems that are being adapted or will they be built from scratch? The Minister may have to write to me in answer. Also, on the nature of the IT companies delivering these, is there competition in delivering systems such as this or is this a very specialist area with a small pool to fish from and not much choice, which of course leads to price escalation?

Nuclear Safeguards Bill

Lord Warner Excerpts

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

[Baroness Featherstone (LD)]

My Lords, I am sure that the Minister, in listening to the Second Reading debate in this House, could not have failed to get the message that leaving Euratom, necessitating the re-creation of its safeguarding capabilities and duties in another body set up to mimic it exactly, is an absurdity and a folly. If he were in any doubt, around 11 pm last night a number of noble Lords—among them, my noble friend Lord Teverson and the noble Lords, Lord Hunt, Lord Warner and Lord Carlile—let him know their opinion of this matter, too.

There was no vote to leave Euratom. Euratom is separate from the EU. Of course, we benefit from our membership, with Euratom regulating the civil nuclear industry, including safeguards for nuclear materials and technology, disposal of nuclear waste, ownership of nuclear fuel, and research and development. Despite our disputing the actual legal necessity of leaving Euratom, the Government are going ahead with the Bill as a failsafe. Amendment 1 seeks to attain associate membership of Euratom. We sought in our original amendment to retain full membership, but, sadly, this was deemed out of scope.

In the Written Statement that the Government laid on 11 January, they said that they want,

“a close association with Euratom”.

But the Government wanting a close association and having one in place are not the same thing, nor have they yet defined what they mean by an association that is “as close as possible”. It would be very helpful if the Minister could indicate what has been said so far about associate membership, and what the answer was during negotiations to date when the suggestion was first put on the table that we want a close association with Euratom, if indeed it was put on the table at all. Was there any problem? It is unimaginable to me that anyone on the other side of the negotiating table would have any problem with us staying in Euratom or, if we are not doing so, having an associate membership. Has the European Commission given its view on this to date?

Our problem with the good intentions of the Government in this regard is that they are undefined, so we want clarity and certainty on this important matter. We want an associate membership that replicates exactly our membership of Euratom—nothing more, nothing less. So what will be required of us in order to have an associate membership? Is it a matter of cost? What would be asked of us, above and beyond what is required now? Amendment 1 has been laid to ensure that the Government, in their negotiations and agreements in accordance with Article 50(2) of the Treaty on European Union, on the future of nuclear safeguards in the United Kingdom must have regard to the desirability of becoming an associate member of Euratom. I am sure—at least, I very much hope and expect—that this will be pretty much at the top of the Government’s list of things to do, if only to avoid the extra works, cost, aggravation and uncertainty in recreating what we have already as a member of Euratom.

So that we can be sure that the Secretary of State is carrying out this duty, the amendment requires that he must lay before both Houses a Written Statement informing us of the progress he is making towards achieving that negotiated outcome. Our preference would be to forestall actually leaving Euratom at all, unless and until such an associate membership is in place. However, as that is apparently not possible, the amendment asks that Statements be made at particular intervals post the Act receiving Royal Assent. If we were to succeed in negotiating an associate membership and effectively remain in Euratom, the rest of the Bill need not apply. I beg to move.

[Lord Warner (CB)]

My Lords, I shall speak to Amendments 2, 12 and 16, which are in my name in this group. We had a good warm-up late last night for this first day in Committee on this Bill, with the Minister’s colleague doing what I thought was a rather good imitation of Geoffrey Boycott: occupying the crease but not showing much flair in his run gathering. In that debate on withdrawal from Euratom that we had in Committee on the European Union (Withdrawal) Bill, it was clear that the mood of the House was that this was a rash and ill-considered action by the Government, and that the Government would do well to reconsider their position on withdrawing from Euratom in the interests of the future of the nuclear industry in the UK. I have little doubt that we will return to this issue during our later consideration of the withdrawal Bill and I do not intend to traverse that ground again today, although I still consider that cancelling the withdrawal from Euratom membership would be the best course of action in the public interest.

Today, I want to focus on two issues that continue to cause concern in the industry and among many of us in this House: first, whether the Government have a credible plan for putting in place an internationally acceptable nuclear safeguarding regime in the UK in time for our departure from Euratom; and, secondly, whether this can be done by EU exit day on 29 March 2019. These two issues are inextricably linked in my view, and that is why I have grouped my Amendments 2, 12 and 16 with the related amendments in this first group. I have to say to the Minister that how the Government respond to amendments on these concerns in this Bill will, I suspect, determine how the House deals with the Euratom issue in the withdrawal Bill. I assure the Minister that that is not a threat but a piece of friendly advice.

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[Viscount Trenchard]

I am well aware that the Government have explained that their policy is to meet Euratom standards, and I am not saying that that would be in any way a bad thing, but I understand that there is a problem over the timescale it would take to reach Euratom standards. Nevertheless, I question whether it is necessary or desirable to meet Euratom standards in full because, as I said, many in the industry consider the IAEA standards better as far as process, procedures and controls are concerned. I think I have now concluded my remarks.

[Lord Warner]

Before the Minister sits down—

[Noble Lords]

Oh!

[Lord Warner]

Well, I am sure the noble Viscount is in the Prime Minister’s thoughts for ministerial office. I am a bit confused about where he is on completing either IAEA-acceptable standards or Euratom standards by 29 March 2019. Is he saying that he accepts that neither of those standards will be met by March 2019, therefore we need a transition period and therefore he supports my amendment on a transition period?

[Viscount Trenchard]

I am saying that I believe it is not possible by March 2019 to achieve the necessary nuclear co-operation agreements with our four key partners, principally, and that therefore we will not be in a position to operate our own nuclear safeguards regime. I believe the ONR could manage to establish recognition of its own nuclear safeguards regime in that timescale, but—because we will not have the NCAs or an agreement with the EU on nuclear in that timescale—I look forward to hearing from the Minister how the Government propose to avoid a cliff edge in the nuclear industry.

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[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 Hunt of Kings Heath]

The Minister is being very helpful. It is the first explanation we have had as to why the Government are leaving. He talked a lot about the influence of the EU over Euratom’s activities, which is no doubt something that we can test and explore. But I do not understand what “close association” means. The Government clearly could not go for a formal association because the relationship would be one in which the EU would set the rules, and we know that the Government have drawn a red line against that. Does “close association” mean that we would basically subcontract the inspectorate from Euratom to work under the auspices of the ONR, with the ONR as the regulator? Does it mean that, despite everything that the Government have said, we hope that we can simply replicate Euratom rules and that it will somehow oversee it, which seems unlikely? Until we know what the Government want to get out of Euratom, it is difficult to know whether the Bill will meet the circumstances if no close association at all is agreed.

[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.

--- Later in debate ---

Tabled by

[Lord Warner]

2: Before Clause 1, insert the following new Clause—
“Review of withdrawal from Euratom
(1) The Secretary of State must, in consultation with relevant interests, by 31 December 2018, lay before both Houses of Parliament—(a) a report on the progress of discussions with Euratom on the scope and conditions for a form of association with Euratom that does not extend to full membership but which minimises the changes to current arrangements for nuclear safeguards; and(b) a report on the legislative changes that would be necessary to introduce arrangements described in paragraph (a).(2) The report under paragraph (1)(a) must cover—(a) the future application of Euratom safeguarding standards;(b) the future of nuclear research and development activities within a Euratom framework;(c) aspects of future working with Euratom members in relation to the civil nuclear supply chain so far as this depends on UK membership of Euratom;(d) the supply to the United Kingdom of medical radioisotopes and their use and disposal so far as this depends on UK membership of Euratom.”

[Lord Warner]

I listened carefully to what the Minister said. I did not hear anything which suggested that there was not still an existential threat to the UK civil nuclear industry. There were some useful nuggets to help me redraft my amendment to make it more compliant with the language that the Government seem to be using—so I shall read Hansard carefully—but I can promise the Minister that I shall be back on Report with an alternative amendment.

Amendment 2 not moved.

Nuclear Safeguards Bill

Lord Warner Excerpts

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

[Lord Judd (Lab)]

My Lords, I strongly support my noble friend and the amendment that he has moved. As I said in our deliberations last night, we must never forget that the issues with which we are dealing have implications not just for us, our children and immediate future generations, but for hundreds and perhaps thousands of years ahead. We have to get it right. There can be no confusion or compromise; there has to be fool-proof action right through, with continuity. There can be no gaps. We must have from the Minister categorical assurances that the Government have in place arrangements that will ensure that continuity when we leave. If we cannot have those assurances, the situation is impossibly grave, because anything can happen in even a short time if the adequate provisions are not there.

One very specific issue on this is that we know, from the Government’s own statements, that for our next generation of nuclear energy we are highly dependent upon expertise from outside the UK, because we do not have the expertise ourselves. What I do not understand is how we can have adequate—indeed, fool-proof—inspection teams working, and how we can have the quality and experience necessary for those teams, if we do not have that quality and experience available to develop our own energy. There seems to be an illogicality here. This is why it is crucial that the Government again have absolutely watertight arrangements about which they can tell the House to cover what happens if we foolishly come out of Euratom.

I have not heard those absolute, categorical assurances, or even begun to hear what the real arrangements will be. This matter is deeply grave. I have great respect for the Minister; I know he is a thoughtful man who will take on board the point being made. It is therefore crucial that this afternoon we have cast-iron evidence that the Government really have the situation under control.

[Lord Warner (CB)]

My Lords, I rise to support this amendment and congratulate the noble Lord, Lord Grantchester, on his drafting skill in producing words that will not inflame the Government or, in particular, the—misnamed—European Research Group and its red lines. The amendment in no way implies that we, the UK, will go back into Euratom, however much most people in this Chamber wish we would. The noble Lord has kept clear of that dangerous territory and I congratulate him on that.

Indeed, there is nothing in the amendment that goes against government policy. The Government say that they aspire to achieving the safeguarding standards of Euratom but by another method than the current set of arrangements. That is all that the amendment tries to do. Indeed, it may help the Government in securing accreditation by the IAEA when it comes to the ONR being recognised as up to snuff in its standards. That accreditation is essential, as many people have said today, for us as a country to secure nuclear co-operation agreements. This is a helpful and well-constructed amendment, which the Government would be well advised to accept.

[Lord O’Neill of Clackmannan (Lab)]

My Lords, I support this amendment. It is not just a question of maintaining the standards that have been established but of putting us in a position where we will be able to meet and address new challenges. I happened to be in Tokyo on the day of the Fukushima disaster and tsunami. I was in the company of a group of nuclear engineers and no sooner had the messages come over the television than they were on their BlackBerrys, communicating with their international colleagues—because there is an international nuclear community—and working out the extent of the damage.

It was shortly after that, on our return, that the Nuclear Installations Inspectorate leadership was appointed to lead the international examination of the Japanese nuclear capability. We were seen to be at the forefront of that. That is a heritage that we want to maintain, and this amendment very succinctly addresses that challenge. It is important, therefore, that the ONR—the successor to the NII—is able to do that. We know that this will have implications for staffing, salaries and for the general financing—which we will come to later—but the point is that it would be desirable to have in the Bill a commitment to maintaining our current position, which is partly due to our membership of Euratom and partly due to the excellence of our inspection and monitoring capabilities.

It is incumbent on the Government, therefore, to give a commitment that they will seek to maintain the quality and standards that we currently enjoy and our capability in contributing to international nuclear safety. This is not something that should be in any way antithetical to what the Government seek to do; the amendment is no reflection on their commitment but it would enhance the Bill and I see no reason why, if not the wording, the spirit of this amendment could not be addressed. As I said in an earlier intervention, the point of Committee stage is to indicate areas of concern and, if the Government are prepared to accept the consensus around this Chamber on the matter, it is incumbent on them to return with the appropriate wording that enables us to proceed. In this instance, we have a very good blueprint from my noble friend Lord Grantchester, as my friend the noble Lord, Lord Warner, has said, for what is required. I do not think the Minister really has anywhere to hide on this issue and I would like to think he will be able to co-operate with us in enhancing the Bill to take account of the dynamic challenges that nuclear safeguards in the future will require.

--- Later in debate ---

Moved by

[Lord Warner]

4: Clause 1, page 2, line 15, at end insert—
“(3A) No regulations may be made under this section unless the Secretary of State has laid before both Houses of Parliament a statement certifying that, in his or her opinion, it is no longer possible to retain membership of Euratom or establish an association with Euratom that permits the operation of nuclear safeguarding activity through its administrative arrangements.”

[Lord Warner]

My Lords, I hope this next amendment will not ensure that we descend into the “end-of-the-pier show”, as we seem to be in danger of doing from time to time. I am very sorry that the Minister has taken the line he has on Amendment 3, and I have no expectations whatsoever that I will get a sympathetic response to Amendment 4.

I want to say a little about why I tabled this amendment. I am genuinely confused as to what the Government want their future relationship with Euratom to be—I simply do not understand. I understand that they want to withdraw from membership, but the Minister talks quite warmly from time to time about having some future relationship. I think “relationship” is probably a safe term to use: we do not talk about “associate membership” or “association”, but a “relationship”. He seems to want that relationship because Euratom provides a comfort blanket in all this. Many in this House are rather desperately looking for some kind of comfort blanket regarding what the situation may be at about 11 pm on 29 March 2019.

The Government’s position is very odd. They are staunchly determined to say that they expect the ONR to be up to meeting the IAEA accreditation standards by that date. However, they are singularly silent about whether that accreditation will actually be achieved in time for us as a country to put in place a series of nuclear co-operation agreements by 29 March 2019. I hope that I can tempt the Minister to say something about that.

--- Later in debate ---

[Baroness Vere of Norbiton (Con)]

My Lords, I thank noble Lords for the opportunity to address this important set of issues around the UK’s future relationship with Euratom. As my noble friend Lord Henley said, the EU and Euratom are uniquely legally joined. Noble Lords will be aware that when we formally notified our intention to leave the EU, we also commenced the process of leaving Euratom. I repeat my noble friend’s assurances, however, that the Government want to maintain the continuity of our mutually successful civil nuclear co-operation with Euratom and other international parties when we leave the EU.

The first half of the proposition of Amendment 4 —that,

“it is no longer possible to retain membership of Euratom”—

has already passed. On 29 March 2017 the Prime Minister notified President Tusk of the United Kingdom’s intention to withdraw from Euratom. We are withdrawing from Euratom but we want a close relationship with it in the future. I believe that it would be deeply irresponsible of Parliament to pass an amendment which, quite explicitly, prevents us from using the powers in this Bill until we have attempted to do exactly the opposite of what the Article 50 letter says we are doing. That leaves the second half of the proposition: that we achieve, “an association with Euratom” that means that it is Euratom rather than our own regulator, the ONR, that carries out safeguarding in the UK after we leave the EU. To reiterate the point made by my noble friend, while the Euratom treaty allows for the conclusion of association agreements that allow third parties to participate in some Euratom activities, these agreements have so far been limited primarily to research and training activities.

This amendment would require us to have explored every avenue and concluded that,

“it is no longer possible”,

before we make regulations to enable the UK’s own domestic regime. That presents enormous timing difficulties and will introduce a risk of the one thing I believe everyone agrees we must avoid—being left with nothing in place from day one of Brexit. I do not believe that the industry would support such a position. We simply cannot await the outcome of the future relationship discussions before we use the regulation-making powers in the Bill. Of course, it may all happen very quickly but, then again, it may not. It would be deeply irresponsible to put ourselves in a position where we cannot exercise the powers in the Bill.

[Lord Warner]

I am sorry to interrupt the Minister’s debut on the Bill. I am trying to make clear that I am not asking the Government to stop proceeding with the Bill; all I am asking them to do is to set out on a piece of paper the nature of their future association and relationship. The Front Bench keeps avoiding that issue. I do not use the words “associate membership”, I use the word “association”. I am willing to change it to “relationship”. What I am trying to get the Government to do is set out how they see their relationship with Euratom—because they have acknowledged that they will have a relationship with it in some way—and what that relationship will cover. If we could get some clarity from Ministers on that, we would not be having these endless discussions about the issue.

[Baroness Vere of Norbiton]

I thank the noble Lord for his intervention. I am on paragraph 11. I have many more paragraphs to go and I hope that in those paragraphs I will be able to keep him very happy indeed.

I understand and share the sentiment of wanting to maintain a close relationship with Euratom. The noble Lord, Lord Warner, mentioned this relationship and it could indeed include any of the things that he mentioned, but they are subject to the negotiations. However, we have already stated very clearly that the Government will seek a close and effective association as part of phase 2 of the exit negotiations with the European Commission. What we cannot accept is that the regulations must await a definitive outcome of talks which are by their nature uncertain in both timing and result. It is therefore vital that we continue to work to enable the set-up of a domestic safeguards regime, and to have ready the bilateral safeguards and nuclear co-operation agreements that we will need to function as a responsible nuclear state from day one of exit.

This approach will reassure the international community that the UK remains committed to nuclear non-proliferation, and will provide clarity to industry that it will continue to be able to move vital materials, parts and expertise once we leave Euratom. There can be no question of waiting until we know the outcome of the negotiations on our future relationship before we can put in place our own arrangements. The implications of not having the right systems operating from when Euratom safeguards arrangements no longer apply are too serious for industry and for our position within the international civil nuclear community.

[Lord Teverson]

Can we actually make this clear? I have not heard anyone in this Committee saying, “Please, Her Majesty’s Government, do not do anything until this thing is finished”. We are not asking for anything to be delayed, we are saying, “Please get on with it”, but we need some information on the way; we have to have some idea of the destination, and Brussels wants some idea of the destination by 22 March and then in October. If it does not happen, what are the contingency plans? We are not asking for anything to not happen now. I do not think the Minister understands that. Did I hear anybody say that?

[Lord Warner]

I put in this provision about regulations only out of sheer frustration because one cannot get any information out of the Front Bench about what that relationship will be. I am not seriously going to stop the Bill proceeding but there is a very high level of frustration across the Committee that the Government cannot explain in any way what relationship they are aspiring to. For example, do the Government want to talk to Euratom about seconding some inspectors to the ONR for a period of time to get it over the hurdle of the transition to a UK regulator? That is the kind of specific thing which it would be quite sensible to discuss. No one is going to stop that. We just want to know what the Government are trying to do.

--- Later in debate ---

[Baroness Vere of Norbiton]

I thank the noble Lord, Lord Teverson, for that interesting question. If it is okay, I shall write to him, because I should like to find out more information about what we are allowed to say at this time.

[Lord Warner]

I beg leave to withdraw the amendment.

Amendment 4 withdrawn.