Nuclear Safeguards (EU Exit) Regulations 2018
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The Parliamentary Under-Secretary of State, Department for Business, Energy and Industrial Strategy (Lord Henley) (Con)
My Lords, these regulations set out the detailed legal framework for the United Kingdom’s new domestic civil nuclear safeguards regime after withdrawal from the European Atomic Energy Community, Euratom. The regulations are made under powers set out in the Nuclear Safeguards Act 2018 and in the Energy Act 2013, as amended by that Act. They will replace the current legal framework provided principally by the UK’s membership of Euratom. The territorial extent and application of these regulations is England, Wales, Scotland and Northern Ireland.
The regulations are linked to the Nuclear Safeguards (Fissionable Material and Relevant International Agreements) (EU Exit) Regulations 2018, which we have just considered and passed, and they set out the definitions of “Fissionable Material” and “Relevant International Agreements”.
As explained in my earlier speech on the fissionable material regulations, nuclear safeguards are accounting, reporting and verification processes designed to demonstrate that civil nuclear material is not diverted unlawfully into military programmes. This is distinct, as I made clear, from nuclear safety or security. Our approach is to establish a regime that will be equivalent in effectiveness to that currently provided by Euratom. The regime will operate in a similar way to the existing arrangements, taking account of best practice in UK regulation-making and considering the need to minimise disruption to industry.
These regulations, together with our international agreements, allow the ONR to deliver a safeguards regime that meets our international obligations from day one of exit. The ONR’s capacity and expertise will build over time to be equivalent in effectiveness and coverage to that currently provided by Euratom, by December 2020. This will fulfil our policy intent and is the means by which the UK will exceed the commitments that the international community expects us to meet. Both the Euratom regulation and the nuclear safeguards regulations are structured to require information concerning nuclear safeguards to be supplied to the relevant entity, whether the Commission or the ONR, which the regulator may then forward, as appropriate, to the IAEA.
The Nuclear Safeguards Act 2018 passed through Parliament last year. This Act gives the Secretary of State powers to make regulations giving effect to the UK’s new domestic nuclear safeguards regime following our withdrawal from Euratom. The 2018 Act also empowers the ONR as the regulator for safeguards. ONR already regulates nuclear safety and security.
These regulations establish the requirements on operators of qualifying nuclear facilities. This covers the records an operator is required to keep, together with the forms which they must send to the ONR, including the requirement for an accountancy and control plan. The regulations also set out the provisions for the ONR, as the new safeguards regulator, when it takes on the roles and responsibilities currently provided by Euratom. Offences, transitional provisions and requirements dealing with notifications to the Secretary of State are also set out in these regulations.
The comments received to the public consultation held on the content of these regulations and the previously discussed fissionable regulations were considered and assisted our final policy deliberations. In response, we have introduced a specific commencement date of 1 January 2021, for accountancy and control plans. This gives operators further time to produce those plans. We have introduced a new exemption for certain educational establishments holding very small quantities of qualifying nuclear material. The specific regulations that are subject to an offence now focus on the areas of the regulations where the UK is subject to international obligations.
In addition, we listened carefully to comments on transitional provisions in Schedule 4 and further developed this to support operators and ensure a smooth move from the Euratom regime to the new UK’s safeguards regime. As part of the consultation, we also published an impact assessment for these regulations. A final fit-for-purpose nuclear safeguards impact assessment was published on 29 November 2018.
Good progress has been made on many of the steps required to enable the delivery of a new domestic safeguards regime in the UK. The ONR commenced parallel running of its new IT system alongside Euratom, processing and checking reports received from industry. This will provide the opportunity to identify and make any necessary adjustments before 29 March 2019. The ONR’s recruitment target for the first phase of the domestic safeguards regime has been met: 16 safeguards officers are currently in place, seven more than the minimum of nine required to deliver the regime at the end of March, and four nuclear material accountants have been appointed, giving a total team of 20 in post.
In conclusion, these regulations, together with the fissionable material and relevant international agreements regulations that we just agreed, are vital for the operability of our domestic civil nuclear industry. They will ensure that the Government’s commitment to deliver a new regime that will be equivalent in effectiveness and coverage to that currently provided by Euratom is met, meeting international obligations from day one of exit, building to be equivalent in effectiveness and coverage to Euratom by December 2020. This will exceed in certain respects the safeguards commitments set out in the new bilateral safeguards agreements between the UK and the IAEA. I look forward to hearing from noble Lords in detail on these orders. I beg to move.
Lord Adonis (Lab)
My Lords, we are grateful to the Minister for his introductory remarks. This regulation was debated in the Fifth Delegated Legislation Committee of the House of Commons last Tuesday, and I want to raise an issue that was raised in that debate. The good news, which gives significant resource to Parliament, is that we have the inspectors that we need to ensure the continuity of functions after 29 March, because there had been concerns when the legislation was going through the House that we might not. The Minister gave the figures in his remarks. However, my colleague, Alan Whitehead, the shadow Minister, raised an issue in the Commons that was not replied to by the relevant Minister, Richard Harrington. He said:
“The Minister said both yesterday and today that additional inspectors had indeed been appointed and that the ONR’s recruitment target for the first phase has been met … As I understand the position, we have inspectors in place to carry out inspection to an international standard, but not to the level previously set out in the regime overseen by Euratom. The explanatory memorandum for today’s SI states: ‘It is intended that these agreements … combined with these Regulations, will allow ONR to establish a new regime which will deliver international standards from day one of exit, building, over time, to be equivalent in effectiveness and coverage to that currently provided by Euratom, and which will exceed international standards’”.—[Official Report, Commons, 15/01/19; col. 6.]
This seems to be quite a significant issue and I would be grateful if the Minister could amplify on it in his remarks. I am not familiar with the industry, but at the moment the Government take pride—and therefore, presumably, so does the industry—in the fact that our inspection standards are above international standards.
The Minister in the House of Commons said that the continuity regime after 29 March will enable us to have inspections to the international standard but not to the existing Euratom standard. It is not clear to me, and it may not be to other noble Lords, what the difference is between an inspection to international standards and an inspection to Euratom standards. However, if it is such a good thing for our industry to have an inspection to Euratom standards, presumably that is because we believe that there is some specific public purpose to be gained in having an inspection to that higher level, and that therefore there is some loss to the industry and the wider public interest in having an inspection only to international standards.
This is not my area at all. I do not begin to understand the difference between inspection to international standards and to Euratom standards. The Government’s own impact assessment says that we wish to attain inspection to Euratom standards, but in the event of a no-deal Brexit, we will not be able to do so after 29 March. Since it has been raised in these debates, and since there clearly is a difference, I would be grateful if the Minister could tell the House what the difference is between international standards and Euratom standards, what we will be losing by having inspections only to international standards rather than to Euratom standards, and when we will achieve inspection to this gold standard—the Euratom standard—which apparently we are losing.
Lord Pannick (CB)
My Lords, further to the point made by the noble Lord, Lord Adonis, this is one of the reasons why the Secondary Legislation Scrutiny Committee, under the chairmanship of the noble Lord, Lord Cunningham of Felling, stated in paragraph 14 of its helpful report published on 13 December 2018 that these regulations raise issues of public policy which require them to be drawn specifically to the attention of the House.
At paragraph 11, the committee explains that it asked the department why the Euratom safeguard standards—which are higher than international standards—could not be met on day one after exit. The noble Lord’s department, BEIS, told the committee that:
“ONR aims to have the required capacity and capability to deliver a regime equivalent in effectiveness and coverage to that currently delivered by Euratom by December 2020”.
I imagine that this is a very real concern to the House. Does the Minister accept that on exit day it will not be possible to maintain the standards currently enjoyed under Euratom, and that it will take until December 2020 to do so? If that is the case, does he really think it is acceptable?
Lord Henley
My Lords, we move to a close on the statutory instruments that I have put before the House. I will start by re-emphasising, as I think it is always important to do in debates on nuclear safeguards—which it feels I have been doing for some time—that we are talking about nuclear safeguards, and I defined them earlier. This is nothing to do with either safety or security. We are grateful for the work that the ONR does on those issues and I am sure that, whatever happens, it will continue to do that job. At the moment we are focusing purely on safeguards. I made it clear that additional inspectors would need to be recruited, and I made sure they were there to deliver a safeguards regime that the noble Lord, Lord Pannick, described as “equivalent”. I repeat that: we are looking for equivalence in effectiveness and coverage to Euratom, and the ONR will continue to recruit safeguards staff so that we can reach that.
It would probably also help if I said a little in response to the noble Lords, Lord Pannick and Lord Adonis, about how Euratom standards differ from IAEA standards. I also make it clear that reporting will continue from all operators from day one, as happens with Euratom. There is no change there—that is the equivalence we will look for. We have stated that our intention is to have a domestic nuclear safeguards regime equivalent in effectiveness and coverage to that currently provided by Euratom. That means a level of inspections and other regulatory arrangements that goes beyond the internationally agreed measures applied by the IAEA. Under the UK’s current safeguard agreements with the IAEA, all facilities containing civil nuclear material in the UK are potentially eligible for inspection by the IAEA. It chooses which are designated for inspection; it has designated two UK facilities that it currently inspects. Euratom standards, however, are applied to all civil nuclear material in the UK.
The proposals for a future UK regime are to conduct assurance and verification activities across all civil facilities, and to all other particular locations where there is civil nuclear material, as part of a proportionate and targeted regulatory regime. The new safeguards regulatory regime will cover all qualifying nuclear materials, including fissionable materials, source materials and ores. It is crucial that the UK meets its international obligations following the withdrawal from Euratom. Compliance will underpin those international nuclear trade agreements we referred to earlier—agreements with the USA, now concluded; Canada; Japan, which dates to 1998; and Australia.
Lord Adonis
I am grateful to the Minister, who is helping the House a great deal. Have I understood correctly that at the moment the IAEA inspects—in what it regards as a proportionate inspection regime—two of the UK’s facilities; Euratom inspects them all; and once we leave, only having international standards, we will inspect only some, but what we want to get to, with the Euratom standards, is its current capacity to inspect them all? If I have that right, is not the obvious point that if Euratom thinks it should have the power and ability to inspect them all, the sooner the ONR— which is, as I understand it, our domestic regulator—also has that capacity, the better? If it is not going to be until the end of 2020, let us hope to goodness that nothing happens between now and then.
Lord Henley
The noble Lord is possibly getting confused with safety and security, and thinking not only about nuclear safeguards. We are talking about only three sites, two of which are in west Cumberland—I have forgotten where the third is, but I shall write to the noble Lord. We will continue to be compliant with IAEA standards. I appreciate that, as the noble Lord said, a slightly different safeguards regime—not safety or security—is set out by Euratom. That will take a little longer, which is why we will need not only further inspectors but nuclear accountants. We will be ready to meet the IAEA standards in March and will get up to the Euratom standards on safeguards a little later.
Lord Adonis
The Minister has not addressed the point raised by the noble Lord, Lord Pannick, which is that we will not reach these Euratom standards until the end of 2020. Can he confirm that there will be this 20-month period where we are inspecting only to the international standard and not to the Euratom standard? As for whether it is a higher standard, the Explanatory Memorandum says that the new regime will be,
“building, over time, to be equivalent in effectiveness and coverage to that currently provided by Euratom, and which will exceed international standards”.
The noble Lord, Lord Pannick, must therefore be right when he says that inspecting only to international standards involves a diminution of current inspection regimes, otherwise it would not be the Government’s objective to exceed those standards to reach the Euratom standard.
Lord Henley
I hope that the noble Lord, Lord Adonis, is not trying to frighten the horses; I am sure he would never want to do that. What I am saying is that we are going to meet the very high international standards of the IAEA—there were queries about this during the passage of the Nuclear Safeguards Bill—and that we will be there. We have different standards from Euratom and we will rise to those in due course. I do not see our nuclear safeguards regime being in any way at risk following that, but it is up to the noble Lord to make what he wishes of that.
Lord Henley
I will write to the noble Lord about the precise moment, but we are moving towards that in terms of the extra staff the ONR is seeking to recruit.
Nuclear Safeguards (Fissionable Material and Relevant International Agreements) (EU Exit) Regulations 2018
Lord Adonis Excerpts(5 years, 3 months ago)
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Lord Redesdale (LD)
My Lords, I wrote only one speech to the two SIs, so I will make only one—do I get a sweetie as well? These provisions seem necessary. The Minister mentioned that NCAs had been signed with a number of countries. Does there need to be an NCA with Euratom itself if it is representing European countries? There seems to be no mention of that in the Explanatory Notes.
Obviously, these regulations will need to come into effect, but it is rather unfortunate that we are looking at the demise of the nuclear industry at the moment. Only Hinkley Point C, the last of the new nuclear fleet, may be built, and that is in jeopardy as well.
Lord Adonis (Lab)
My Lords, these are highly technical regulations and all I have to go on in seeking to scrutinise them is the debate that took place in the House of Commons on 14 January. On the issue of bilateral agreements with other nations, which are clearly vital to the handling of this nuclear material, the Minister, Richard Harrington, gave a comprehensive assurance that exactly the same agreements would be in place after 29 March as before. So that concern, which had been raised in the House of Commons, has been met.
However, in his concluding remarks, the Minister said:
“The nuclear safeguards regulations will also require operators to provide additional nuclear safeguards information to the ONR”—
the regulator—
“on qualifying nuclear material, and to the Secretary of State on certain non-nuclear materials”.—[Official Report, Commons, Third Delegated Legislation Committee, 14/1/19; col. 5.]
It was not clear to me whether that is a significant statement or an insignificant statement because it depends on what additional material they will be required to make available to the ONR and the Secretary of State. Can the Minister tell us the nature of the additional information that will have to be made available to the ONR, and why, in the event of no deal, additional information needs to be made available to the ONR over and above what needs to be made available now? Those in the industry who are reading accounts of our proceedings may be quite keen to understand that issue.
Transfrontier Shipment of Radioactive Waste and Spent Fuel (EU Exit) Regulations 2018
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The Parliamentary Under-Secretary of State, Department for Business, Energy and Industrial Strategy (Lord Henley) (Con)
My Lords, this instrument will ensure that the UK maintains high standards for the supervision and control of shipments of radioactive waste and spent fuel in the event of no deal. The instrument will set out a regime to ensure that radioactive waste and spent fuel is not shipped into or out of the UK without prior authorisation from the relevant competent authorities. This is vital in order to protect the public and the environment from the dangers of ionising radiation. The instrument will further ensure that the UK continues to meet its commitments to the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management.
This new instrument is made under powers set out in Section 8 of the European Union (Withdrawal) Act 2018. It is laid to address specific inoperabilities arising from the UK’s withdrawal from the EU and Euratom, and would come into force on exit day only in the event of no deal between the UK and EU. The UK is seeking a wide-ranging nuclear co-operation agreement with Euratom while putting in place the necessary measures to ensure that the UK industry can operate in all scenarios. This particular instrument will revoke the then inoperable Transfrontier Shipment of Radioactive Waste and Spent Fuel Regulations 2008 and replace these with the new 2019 regulations. These new regulations broadly replicate the procedures under the 2008 regulations for the import, export and transit of radioactive waste and spent fuel into and out of the UK, but will reflect the UK’s independence from the Euratom community. The instrument applies to the whole of the UK.
The UK has ceased reprocessing other nations’ spent fuel. The high-level waste arising from the last of these reprocessing contracts will need to be returned to its countries of origin: Australia, Japan, Germany, and Italy. The instrument will allow for the return of this high-level waste and is of strategic importance to the UK in fulfilling reprocessing contracts and supporting the decommissioning and clean-up mission of the Sellafield site. Further, the UK makes around 400 shipments of radioactive waste a year to Euratom member states. The majority of these are contaminated metals for treatment to Germany and Sweden.
The previous 2008 regulations laid down a set of regulatory procedures for transfrontier shipments that take place within the Euratom community, and a separate set of procedures for shipments entering or exiting the community. Following the UK’s withdrawal from the EU and Euratom, the 2008 regulations will become inoperable, as they treat the EU as a single bloc that includes the UK. In order to ensure an operable regime after exit day, the new 2019 regulations will treat Euratom member states and all other countries in the same way. This will result in three operational changes for UK operators shipping to and from Euratom member states.
First, UK operators will need to request authorisation from the relevant competent authority when importing a shipment from Euratom states. The competent authorities are the Environment Agency, Natural Resources Wales, the Scottish Environmental Protection Agency and the Northern Ireland Environment Agency. Secondly, UK operators will need to notify the relevant competent authority of the completion of shipments to Euratom states. Thirdly, when importing from a Euratom state, UK operators will need to provide evidence that they have made an arrangement with the exporter which has been accepted by the exporter’s competent authority. The arrangement would oblige them to take back the radioactive waste or spent fuel if the shipment cannot be completed in accordance with the regulations.
These changes do not affect all of the nuclear industry. At present, six UK operators have authorisations to ship radioactive waste. Officials have estimated the total cost to all impacted industry from these additional steps to be between £1,700 and £6,000 every three years, as well as a minor familiarisation cost for operators of between £100 to £900 each.
Guidance for the new regulations will be published online prior to the coming into force of this instrument. Officials have been engaging regularly with operators who will be affected by the regulations to ensure that business operations may continue with minimal disruption.
This instrument was drafted in collaboration with the devolved Administrations, the UK’s environment agencies, the Office for Nuclear Regulation and the Nuclear Decommissioning Authority. The legislative competence is reserved—however, this collaborative approach recognised that the administrative implementation of the regime is devolved.
All operators affected by these regulations have been informed of changes and more detailed engagement has been undertaken with those involved in regular shipments. Further engagement initiatives have taken place through stakeholder workshops, the Euratom Industry Forum and other industry events.
These regulations are vital to the success of the UK’s decommissioning programme and to the completion of our last reprocessing contracts. Making them would allow the UK to maintain the highest nuclear safety standards, while ensuring that relevant UK operators can continue to operate in a no-deal scenario. I commend them to the House.
Lord Adonis (Lab)
My Lords, as far as I can see from reading the material supporting the regulations, they do not involve any change in the operation of the law. As the Minister says, they have been approved by the devolved authorities, therefore they seem to me straightforwardly technical, but as there is no opportunity on the whole suite of regulations being moved today to raise issues about their management, I want to ask the Minister one question to which I hope he will respond when he replies.
In the original publication of the Order Paper, two further orders were due for debate today: the Conservation of Habitats and Species Order (Amendment) (EU Exit) and the Conservation (Natural Habitats etc.) (Northern Ireland) (EU Exit) Order. They were both on the Order Paper published on 16 January for today, but then they disappeared from the Order Paper published today. When I was preparing for this debate, there seemed to be some controversial issues surrounding those regulations, and they raise significant issues to do with natural habitats.
When the Minister replies—by then he will have been able to be advised by the Box—can he say why those two regulations were withdrawn from debate today, having been on the Order Paper on 16 January for today, what has happened to them and when they will appear before the House? Some of us are having great difficulty tracking the progress of these highly important regulations through the House because they seem to appear on and then disappear from the Order Paper almost at random.
Lord Pannick (CB)
My Lords, I have one question for the Minister. He told the House in the previous debate that these are no-deal regulations. Can he identify for the House which parts of these regulations will not be needed if the Prime Minister’s deal with the EU were to be approved by the House of Commons?
Lord Henley
My Lords, I start with the point made by the noble Lord, Lord Adonis, when he referred to orders that seem to have been removed from the Order Paper. I did not quite catch the details, but I think they related to non-invasive species or something of that nature.
Lord Henley
I do not think that those orders related to my department. The noble Lord will be aware from his time as a Minister that all Ministers answer from the Dispatch Box on behalf of Her Majesty’s Government as a whole, not purely their department. I think he would accept from his experience that very often one is not in a position to know why decisions have been made by another department on what has been withdrawn from the Order Paper and what has not. I think he will accept—this is quite fair—that those who advise me on such occasions would be even less likely to know why orders relating to habitats and the other matters he referred to, which are not relevant to the department I represent on this occasion, are or are not on the Order Paper.
Lord Adonis
I understand the Minister’s point. Will he write to me to let me know the answer and copy in noble Lords so that we understand what is happening? As I said, that business was supposed to be discussed by the House today but it suddenly vanished.
Lord Henley
Either I will write to him or the noble Lord will be aware that fairly soon—when we have finished with my regulations, whenever that will be and whether I get the sweets from the sweetie box referred to earlier—I will be followed by my noble friend Lord Gardiner from Defra, who might be in a better position to advise him on these matters. We will certainly pass that on to my noble friend. I do not think it would help if I did write to the noble Lord on that subject; I leave it to him to make that point later. He also wanted to know—I think this was at the heart of the question from the noble Lord, Lord Pannick—what the regulations will resemble in the event of a deal scenario. These new regulations have been drafted for a no-deal scenario. The old 2008 regulations would have remained in effect for the implementation period if there was a deal. In the event of a deal, the future supervision and control of shipments of radioactive waste and spent fuel will be subject to negotiations with the EU. This may mean that the 2019 regulations never come into force, or come into force in an amended form. I do not think I can take that any further.
Justification Decision Power (Amendment) (EU Exit) Regulations 2018
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Lord Adonis
I am intervening on the Minister before he sits down. Will the organisation called the justifying authority, which I understand is the organisation which takes these decisions, be affected in any way by the regulations, or will it continue in the same way after a no-deal withdrawal as before? This is a very technical area with which I am not familiar, but my reading of the regulations is that there is an organisation called the justifying authority whose decisions at present depend on EU law and the Government are investing those decision-making powers in the same authority but through UK law. Can the Minister confirm that that is the case and that I have understood it properly?
Lord Henley
My Lords, it is complex and technical. There is no one body called the justifying authority; there are a number of different authorities. On certain occasions, it will by my right honourable friend the Secretary of State for Business; on other occasions, if it was a matter relating to health, it could be the Secretary of State for Health. As I made clear earlier, where it was a devolved matter, it could be the devolved Administrations.
Let me give an example to illustrate how a whole range of things are covered—I am thinking of something that has been in the news recently. If prisons wanted to install a new system for examining or scanning prisoners and others as they came through—I believe that that has already been justified—that involves ionising radiation. I shall now add a further complication: one might presume that the Ministry of Justice would be the justifying authority in that matter, but on this occasion it would be the Home Office. In other words, it would have to look at what the risks to people using these things might be and whether the societal benefits that I referred to earlier were greater such that we wanted to install the technology, hence the need for a justifying authority. There are a number of justifying authorities.
Unlike some other regulations that the noble Lord and I have debated, these are both what we could call deal and no-deal regulations. We are just trying to make sure that the right order is in place so that life can continue as before, with the appropriate justifying authority making the appropriate decision.
Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2018
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Lord Henley
Will the noble Lord give way until I complete this sentence? I shall speak also to the Trade Marks (Amendment etc.) (EU Exit) Regulations 2018, which were laid before the House on 28 November. I shall give way to whichever noble Lord wishes to speak first.
Lord Adonis (Lab)
May I ask that these regulations be considered separately? Can the noble Lord also tell us whether they have been debated in the House of Commons? I could not find any reference to a Hansard account of such a debate in the Commons. If they have been, can he give us a reference to the debate?
Lord Henley
My Lords, I am not aware that these regulations have yet been through the Commons, but they will in the usual way in due course. It has been agreed, and it has been advertised on the Order Paper, that we would take these three regulations—
Lord Henley
The noble Baroness and noble Lords opposite are having fun. I will continue.
Lord Foulkes of Cumnock
I have never been addressed in that way before by a colleague, in 26 years in the House of Commons and now 13 in the House of Lords: by someone saying, “Sit down!” in a peremptory fashion. Perhaps if the noble Lord had said, “I am not prepared to give way at this moment”, we would have understood. I was rising to say that if this Minister had any degree of sensitivity at all, and if he had been watching what had been going on on the Floor of the House and in this Committee, he would have seen that we have on a number of occasions challenged these matters being taken together. I have done it myself on three or four occasions on the Floor of the House, and I have done it twice in this Committee. A number of other Members, including my noble friend Lord Adonis, have also raised the issue. If the Minister had been aware, he would have understood that. I have also mentioned it to our Chief Whip and to the noble Lord, Lord Taylor, the Government Chief Whip. If that has not been communicated to the noble Lord, Lord Henley, it is certainly not our fault.
Lord Henley
My Lords, there has been no formal consultation. Obviously, there have been informal discussions, as officials always have, but there has been no formal consultation by me and other Ministers. The Intellectual Property Office—
Lord Henley
Could I finish this point? The Intellectual Property Office has been engaging with businesses across a number of sectors on the implications of exit since the referendum result.
Lord Adonis
Why has there been no formal consultation, given the interests at stake to which my noble friend has just referred? Should these regulations not be withdrawn so that there can be formal consultation and the House can take account of it before we agree the measure?
Lord Henley
It is important that we make sure that we are capable of dealing with no deal. That is why government has taken various actions for a no-deal scenario. At the same time, negotiations should continue on what that deal should consist of to make sure that we get that right. As I made clear, the Intellectual Property Office has been engaging with businesses across the sector and will continue to do so to make sure that we get the right deal that will satisfy the noble Lord and others.
Lord Adonis
Can the Minister tell us what the results of that informal consultation have been? It is important to the Grand Committee that we know what views businesses have expressed to the noble Lord’s department.
Lord Henley
At this stage, I am not in a position to tell the noble Lord the result of that consultation, or those discussions. What I can say is that we will continue to try to get the right deal. That is the important thing—the noble Lord and I might be at one on that point. These regulations are about making sure that, should there be no deal, we are in a position to deal with that side of things—obviously, in no deal, we cannot deal with the other side. We want to be able to deal with those things that are within our control.
Lord Henley
I will give way to the noble Lord in a minute, when I have finished. I can only answer points if I am allowed to complete them as they come up. We will try to get the no-deal provision set up in the manner which is best for business, to the extent that we can deal with no deal. If there is no deal, there will obviously be changes that we have no control of. The noble Baroness and I know that; everyone does. If there is a deal, as I hope, then everything is fine. I doubt that the noble Lord, Lord Adonis, would be happy but then he probably never will.
Lord Henley
That is not a matter for debate on this occasion. We are not discussing that.
Lord Tyler
I am grateful to the Minister, who has been generous in his advice to the Grand Committee, but I have a specific question on the point he has just made. The implication of what he has just said is that his department is already preparing, in parallel, the secondary legislation that will be required if the Prime Minister’s deal does go through. Or is he saying that, if the Prime Minister’s preferred outcome does get the support of Parliament, there will be no necessity for any secondary legislation? This is a very important distinction. If it is necessary to introduce secondary legislation to implement the specific responsibilities of government under the deal that the Prime Minister now prefers, then your Lordships’ House—which is going to have to consider it in due course—should know. On the one hand, we have this set of proposals, which is speculative, but there is something that might conceivably be more advantageous, both for the Government’s business and for the proper consideration of secondary legislation by this House. Is a parallel exercise going on for what the Prime Minister herself says is her preferred and more likely outcome?
Lord Henley
I ask the noble Baroness to refrain from intervening from a sedentary position. What I said is that things will be different, and what we are trying to do is make sure that things will be as good as possible in the event of there being no deal. If there is a deal, I hope we will get the right deal so that we can see continuity for all businesses as far as possible in this area.
If the noble Baroness feels that the subject should be a matter for wider debate, that is what is happening in the Chamber at this very moment on the general subject of Brexit, business and all of that. Here we are dealing with one small point relating to how we ensure, in the event of there being no deal, that the right things are in place. I leave it to the noble Baroness as to whether she wants to go back into the Chamber and give those speeches but, when she does, I hope she will refrain from trying to suggest that I said things that I did not. All I have said is that we want to ensure that we can get things right in the event of there being no deal. That is what we are discussing today.
If I may, I will continue on the question of security of supply. Continuity of existing parallel trade into the UK from other EEA states is important across several sectors, including medicine and food. The maintenance of the current position on exhaustion rights in relation to parallel imports will help to ensure the continuation of supply for such goods as medicines in a situation where there is no deal with the EU.
Lord Adonis
My Lords, paragraph 12.2 of the Explanatory Memorandum to these regulations says:
“There may be some costs to businesses parallel exporting from the UK to the EEA”,
as a result of the regulations. Can the Minister tell us what those costs might be?
Lord Henley
I cannot give a precise figure for those costs. My belief is that they are generally relatively minor, but I will write to the noble Lord with the details.
Beneficiaries include the NHS, which will continue to have the ability to maintain security and diversity of supply of medicines from the EEA, and to source medicines at the best price from within the EEA without being restricted by IP rights. As I mentioned, and as set out in the technical measures published in September last year, this fix is planned to be a temporary measure. The Government are considering options for what exhaustion regime is best for the UK in future while extensive research is under way. I stress that such an important decision should not be rushed. We will ensure that we have a robust evidence base and that full consultation with stakeholders is completed before any decision is made.
The instrument is extremely important to support the movement of goods and the supply of essential commodities such as medicines. It provides—
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?
Baroness Bowles of Berkhamsted (LD)
My Lords, I did not come to Grand Committee today expecting to speak on intellectual property. I am here to do financial services but, since I spent the best part of 40 years as a European patent attorney, it is hard not to intervene a little. I remember very well from when I started my training the famous Wella case on exhaustion of rights and parallel imports from the US, and what would happen when we had the single market and exhaustion of rights within the EU. It was a very complicated subject, a wonderful training ground and, I am sure, a huge earner for the lawyers who dealt with it. As patent attorneys, we tended to stay out of things.
Lord Adonis
My Lords, I thank the noble Baroness for giving way. Could she explain to the Grand Committee—some of us are not familiar with all the details of this—what parallel exporting is and where the additional costs referred to in the Explanatory Memorandum are likely to arise in a no-deal situation?
Baroness Bowles of Berkhamsted
The issue is where something has come from. You could export it under the terms of a licence, but you might have got it from some third country. In the Wella case, it was the US. It became very difficult to determine where the precise shampoo in question had come from and whether it had originated under a legitimate licence or in the US. It could become very difficult to tell when people took off the labels that said where it had come from. Those were the kinds of issues, and I can see that maybe BEIS is trying to avoid replication of some of that vis-à-vis the EEA.
However, the issue of symmetry and asymmetry—which I think is what the noble Baroness, Lady Kingsmill, is referring to—comes up time and again. As a member of Secondary Legislation Scrutiny (Sub-Committee A), I have seen it in, I guess, half the statutory instruments that have come before us. Sometimes you take the symmetrical option, which means you close things down. Where you think the EU’s logical approach will be to close down on it, we close down on it. Then there are asymmetrical cases—which I think this is, and which I think I have seen more of from BEIS—where priority has been given to continuity. The result is that businesses can benefit from knowing where they stand, at least from the UK side, but it may lead to a competitive disadvantage if their exports are not similarly protected. That is an issue.
I wonder why we have a single shot at correcting it in the event of no deal. You could have said that continuity of supply—especially of drugs and so forth—at the point of Brexit is important, and so you will make some provisional means for trade to continue. Then at some point you will have to analyse it and close it down. I have been reading it only very quickly here, but that does not seem to be the approach taken. It looks as if a single shot is fixed in our legislation now, and I think it would give businesses cause for concern. I would have been happier to see some kind of temporary provision put in there, maybe with a sunset clause after three years, by which time we could have sorted things out. Then it would come back in another statutory instrument or in primary legislation for us to say: “Well, okay, what are we going to do? What has the EU done? Have we got some kind of arrangement with them within that three years?” Or are we going to say, “Now we understand a bit better how things have sorted themselves out, we’re going to go for the symmetrical option, not the asymmetrical option”?
I am sure that it is possible within the powers that the Government have given themselves in primary legislation for them to come back and do that, but it would have made things clearer for business and others to have that message put out there in advance, partly to get negotiations going if those were necessary and partly to say, “This is something that you all need to be thinking about”. I would be interested to hear from the Minister how in this instance such arguments have panned out—what has been said on one side, what has been said on the other and whether something is already up the Government’s sleeve to say, “Well, actually, we’ve thought about this and we are going to be coming back in three years’ time”. It would be reassuring to hear that even if in the long term we ended up deciding that it was best to stay with the way this has been adapted now.
Lord Adonis
My Lords, with great consideration, the Minister took a number of interventions on his speech and covered quite a number of points. However, a lot of issues are raised by the Explanatory Memorandum and the Commission note of 6 September 2017, which is the position paper on intellectual property rights, including geographical indications, and which the Treasury made available to me for this debate. I want to press the Minister on a number of points.
The section on the general principles under which intellectual property will be handled in a no-deal scenario, on pages 2, 3 and 4 of the note, all the way through uses “should” rather than “will” in respect of the mutual recognition and enforceability of rights. Perhaps I may go through them because these are all very important points. Under the first general principle, which is intellectual property rights having unitary character within the European Union, the paper states:
“The holder of any intellectual property right having unitary character within the Union and granted before the withdrawal date should, after that date, be recognised as the holder of an enforceable intellectual property right … In the specific case of protected geographical indications, protected designations of origin and other protected terms in relation to agricultural products … this principle should also imply that the United Kingdom puts in place, as of the withdrawal date, the necessary domestic legislation … The implementation of this principle should include, in particular, the automatic recognition of an intellectual property right in the United Kingdom on the basis of the existing intellectual property right having unitary character within the Union”.
Under the second general principle, it states:
“Applications for intellectual property rights having unitary character within the Union … should be entitled to keep the benefit of any priority date in respect of such pending application”,
and that, in respect of applications for supplementary protection certificates for an extension of their duration,
“a person should continue to be entitled to obtain in the United Kingdom a supplementary protection”.
This carries on in respect of a whole number of further rights. The Grand Committee and the House would obviously wish to be assured that those rights will continue, but my understanding is that whether they will crucially depends on what our EU partners do in respect of those rights if we leave with no deal. In respect of all these reciprocal rights and their enforceability, I completely understand that the Government are putting in place the necessary changes to UK law for us to do our part to ensure that rights are enforceable and recognised, but where the EU paper uses “should” in respect of all these rights, can the Minister tell us what is likely to happen after the end of May? What situation does he believe will apply if we leave the European Union without a deal?
I am not an expert like the noble Baroness, Lady Bowles, who may indeed be able to give a view on this, but it seems that we have no control over that at all, and that, crucially and solely, that depends upon the action of the European Union itself. These aspirations—which are set out in the Commission paper of 6 September and in the statements the Minister has made to the Committee about there not being an interruption in the recognition and enforceability of these rights—absolutely crucially depend on what the European Union does after the end of March, not just on what we do. Therefore, a vital issue for the Grand Committee and for the House when it discusses these regulations is to know what we expect the European Union to do. If in fact we have no reason to believe that the European Union will continue to play ball in the mutual recognition of these rights and their enforceability, do not all the concerns that my noble friend Lady Kingsmill raised apply in spades? It does not matter whether we agree to all these regulations and do everything that the Government want; all that could be superseded by an inability to have these rights enforced or recognised because the European Union itself will not undertake to do so after the end of March.
Lord Tyler
I wonder whether the noble Lord has been paying particular attention to Part 2 of the Explanatory Memorandum, which refers to a number of statements made by the then Minister of State for Universities, Science, Research and Innovation, Sam Gyimah. These statements are intended to reassure the Grand Committee and your Lordships’ House in precisely the sort of terms that the Minister is now referring to. I wonder whether the present Minister takes the same view as the previous Minister, or indeed whether the previous Minister has changed his view. To make the statement at paragraph 2.1:
“In my view there are good reasons for the provisions in this instrument, and I have concluded they are a reasonable course of action”,
may well now be out of date, since we all know that that former Minister takes the view that the proposal that a no-deal solution could in any way be appropriate for our country is absolutely absurd. Should there not have been an updating of this note so that the Grand Committee could at least be informed about the current view of the current Minister? I suspect that the previous Minister now takes a different view.
Lord Adonis
The noble Lord makes an extremely important point, and not just in respect of paragraph 2.1. I have before me the whole of Part 2, which has a whole series of statements made by the Minister of State for Universities, Science, Research and Innovation, Sam Gyimah, to the effect that in his view,
“the Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2018 does no more than is appropriate”.
But, as the noble Lord says, that Minister is no longer in office, so it would be appropriate for the noble Lord, Lord Henley, to tell us whether the new Minister for Universities, Science, Research and Innovation also subscribes to those statements. I should also point out to the Grand Committee that Sam Gyimah is no longer the Minister of State for Universities, Science, Research and Innovation precisely because he resigned in protest at both the Prime Minister’s existing deal and the possibility of the Government contemplating no deal.
Not only has there been no consultation on these regulations; the Minister is not even able to tell us whom the Intellectual Property Office spoke to. At the moment, the only person we know the office has spoken to so far is my noble friend Lord Warner—because he phoned it. The Minister was not able to tell us of anyone else who had been spoken to. He told us that, in an inversion of all the established practices, the consultation on these regulations will take place after they have been approved by the House, not before. The Minister who said that these regulations are proportionate and appropriate has resigned. He resigned specifically because he is not prepared to proceed with Brexit or contemplate no deal. There has been no formal consultation with any other partners. The Government cannot tell the Committee who has been informally approached.
We have no statement from the existing Minister of State for Universities, Science, Research and Innovation that these regulations continue to meet the requirements of the EU withdrawal Act. I would be perfectly happy for the Committee to adjourn while we ask Sam Gyimah whether it is still his opinion that these regulations are proportionate and appropriate. I suspect that it is not, given the statements he has made in the media over the last 24 hours about the huge risks, dangers and costs to the country of Brexit, and a no-deal Brexit in particular. It is a no-deal Brexit that the Government are asking the Committee to approve this afternoon.
The other vital point is that, not only do we have good reason to believe that the business community is worried about these regulations and concerned about the costs, but the relevant Ministers no longer even subscribe to the views they gave when the regulations were being drafted. However, we do now have the benefit of the view of the House of Commons on no deal. Last Tuesday, before we considered these regulations, the House of Commons, for the first time, specifically debated and voted on the issue of no deal. In its amendment to the Finance (No. 3) Bill, it rejected the contemplation of no deal by 303 votes to 296. That is not only a majority of seven against no deal; it was one of the largest votes the House of Commons has conducted on Brexit in any respect. The Grand Committee has good reason to believe that these regulations are being brought forward in defiance of the will of the House of Commons, because that House has said that it is not prepared to contemplate no deal.
In the briefing for her speech today, the Prime Minister said that she now thinks that no Brexit is a bigger risk than no deal. I am perfectly prepared to take that risk; some of us think it is well worth taking. Indeed, we are trying to encourage the Government to enter the supremely risky and dangerous territory of no Brexit. We know how risky it is; we do not need to conduct impact assessments because we are in it at the moment and it is a perfectly tolerable state of affairs. The Government describe it as a risk but, in the last 24 hours, the Prime Minister told us that the risk of no deal is declining. That is the Prime Minister’s judgment, and the House of Commons voted only six days ago, by 302 votes to 296, not to have no deal. We have had no consultation whatsoever on these regulations. In the debate on the no-deal proposition last week, the Exchequer Secretary to the Treasury, Robert Jenrick, said:
“As I made clear, the Government do not want or expect a no-deal scenario”.—[Official Report, Commons, 8/1/19; col. 269.]
If the Government do not want or expect a no-deal scenario, it is wholly within their power to rule one out. The Minister, who is an extremely distinguished and effective member of the Government, could make a contribution to that cause today by withdrawing these regulations in response to what appears to be the overwhelming opinion of the Grand Committee.
Lord Clement-Jones (LD)
It looks like we are on, my Lords. There is a great deal that one could say about the way in which the need arises for this SI and indeed for the others in this series. Today my noble friend Lord Tyler has called them “speculative”; last Wednesday I think he was slightly more scathing and called it a possibly wasted exercise, while the noble Lord, Lord Deben, was even more forthright, saying that we could be,
“conniving in what is manifestly a total nonsense”.—[Official Report, 09/01/18; col. 203GC.]
I have some sympathy with that statement, given that no deal, as the noble Lord, Lord Adonis, has explained, is now not the will of the House of Commons. At the same time, though, my noble friend Lord Tyler also referred to the report by the Constitution Committee, The Legislative Process: The Delegation of Powers, which made explicit reference to the critical importance of effective and timely scrutiny of Brexit-related secondary legislation. So I reluctantly accept that we still have to give it proper scrutiny in these circumstances but, whatever the merits of the statutory instruments, the least that we can do is debate them on the Floor of the House in the main Chamber, and I will be supporting that proposition if it is put later.
Each of the statutory instruments is important in itself. Even if they are only preparatory to no deal, in practice they may be indicative of longer-term government and IPO thinking, and may well be intended to take effect even if we have a deal and the transition period comes into effect. I have an enormous amount of sympathy for what my noble friend had to say about the time limitation and the need for a sunset clause, and for what the noble Baroness, Lady Kingsmill, said about it not being explicitly stated that the regulations do not come into effect if indeed there is a deal. There is a large gap in the middle of the regulations.
In the short term, these regulations are a partial solution to the problem of the UK no longer being inside what is called “Fortress Europe” for the purpose of the exhaustion of intellectual property rights. If there is no deal and the exhaustion SI comes into force on exit day, the effect is to implement, as the Minister explained, a modified version of the current regional EEA exhaustion regime. It would ensure that, post Brexit, once a product has been legitimately placed on the market in the EEA, it can continue to be resold into the UK without the rights holder preventing that. What we are doing is unilaterally allowing EU 27 goods already placed in the market there to be exported to the UK. That may be good news for parallel importers but it is not such good news for parallel exporters. It is clear from the Government’s small print that these exporters may well need to seek permission to gain entry into the EU. No wonder it has been called a one-way exhaustion regime.
What are the Government doing to mitigate the situation? It is clear—the discussion earlier elucidated this—that there has not been any formal consultation on this one-way regime. Indeed, it calls into question the statement about the lack of an impact assessment and what the Minister said in his letter about the draft regulations not changing current policy or imposing new liabilities or obligations on any relevant persons. If an exporter has to seek the consent of the rights holder on exporting into the EU 27 after a no-deal Brexit under the regime set out under these regulations, surely that will have a significant impact on that business.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, it might be helpful, as this is the first instrument that the Committee has considered this afternoon, if I remind the Committee that the Motion is to consider the draft instrument and that it will be the subject of an approval Motion before the House in any event, whatever the decision of the Grand Committee. I also remind the Committee that a single voice of not content will negative the Motion.
The Question is that this Motion be agreed to. As many as are of that opinion will say “Content”; to the contrary “Not content”.
Trade Marks (Amendment etc.) (EU Exit) Regulations 2018
Lord Adonis Excerpts(5 years, 3 months ago)
Grand CommitteeRead Full debate Read Hansard Text Read Debate Ministerial Extracts
Lord Henley
My Lords, I am going to complete this sentence and then I will give way to the noble Lord.
The instrument ensures that replacement domestic rights will be provided to those who own EU trademarks on exit day. It gives certainty and confidence to businesses who rely on their trademark rights in the UK. I will now give way to the noble Lord.
Lord Adonis
I am grateful to the Minister. He referred to the fees for filing applications, the very large number that will be pending and those which will need to be converted. An issue of real concern that has been raised by those who have looked at the regulations is what those fees will be and whether the fees for filing converted applications will be the same as the normal trademark application fees. Can he tell the Grand Committee what the position will be in terms of the fees that will be charged?
Lord Henley
My Lords, again, I was going to deal with that at the end. There will in fact be no costs to business associated with our creation of new UK rights. However, because the UK comparable right will be independent of the EU trademark, there will be a charge for businesses in relation to future renewal. Businesses that wish to maintain their protection in the UK will need to renew their UK-comparable trademark at an average cost of some £300 for a registration period of 10 years. Applications for EU trademarks that are pending but not yet registered at exit day will need to be examined under UK law. The normal UK fee, whatever that is, will therefore apply to those applications. We have committed to respect the relevant filing dates for those applications under this instrument.
Lord Henley
My Lords, if the noble Baroness will be patient, the trademark is renewed every 10 years. When it is renewed, a fee will be paid. That does not change.
The instrument provides that these new UK rights will be fully independent UK trademarks which can be challenged, assigned, licensed or renewed separately from the original EU trademark. Such new UK trademarks will, however, retain their original EU filing date and therefore any other relevant dates that were filed as part of the original application.
Finally, there are miscellaneous amendments to the Trade Marks Act 1994 and the Trade Marks Rules 2008 to reflect the fact that the UK will no longer be a member state or a member of the European Economic Area.
In conclusion, these regulations are a small but vital part of ensuring that this part of the intellectual property system continues to function if the no-deal outcome arises. I hope that on this occasion, noble Lords will support the draft regulations. I commend them to the Committee.
Lord Adonis
He has not sat down, in the sense that he is perfectly capable of answering a question before he concludes his remarks.
He again has not dealt with the question of consultation, which as he knows is of huge concern to the Grand Committee. We would be grateful if, before we come to our debate, he could set out what consultation has taken place, so that we can discuss whether we think that consultation has been adequate.
Baroness Bowles of Berkhamsted (LD)
One small point struck me, not having looked at this before we commenced proceedings. I fully understand the transfer of the pending applications and the ability to file a new application and have it allocated the earlier filing date that the European trade mark had. I do not see any legal difficulty with that, but I wonder if there is a legal difficulty in allowing that to claim the priority date of the EU trade mark, in the sense that it would operate under the Paris Convention, which we and many other countries are party to. I used to take great pleasure in reminding the EU that the Paris Convention of 1883 predated the EU treaties and that they sometimes could not do things. But I wonder whether there has been any advice on that, because there is a discontinuity.
To take a parallel example, in the United States, if you file a continuation in part, there are careful rules so that you can ensure that the priority claim can go all the way through in a continuous way. I wonder whether, through the changing from a European office to the UK office, there is a discontinuity here that would mean that priority date was challengeable. If there was a later priority date UK-only national application from an applicant not from the United Kingdom but from another country that was party to the Paris convention, would there be a clash of rights? It is a question that should appeal to lawyers looking at these things. I cannot answer it without having a longer think, so I am asking the Minister whether he can advise me what advice he may have had on that.
Lord Clement-Jones (LD)
My Lords, my noble friend has asked an important technical question, given her long-standing expertise in this area. As with the patent statutory instrument, this does appear to be a solution for trademarks, or to take advantage of the European community trademark. It appears to be a solution devised not just for a no-deal situation, but with a deal or the transition period in mind as well. Again that gives this particular statutory instrument a greater significance because it might be there for some considerable period of time in the event that a deal was reached. Moreover, as the noble Lord, Lord Adonis, has pointed out, similar issues regarding consultation and the impact assessment arise in connection with this statutory instrument as well.
It was interesting to hear what the noble Lord, Lord Deben, had to say about the difference in wording between the different Explanatory Memoranda. Asking a,
“small group of trusted individuals with expertise in trade mark law”,
almost means that the question is asked of people who are not going to give you the wrong answer.
Quite frankly, the really important aspect of this is the impact on business. On the impact assessment, the homework has been done in such a way that it answers the question by bringing the impact under £5 million. I cannot believe that that will be the total cost to business once you have added together all the issues such as the legal advice that will need to be taken and the red tape involved. I know this is a solution that is designed to be constructive but there are inevitably going to be costs. Frankly, the importance of brands being what it is, the actual costs involved to business are going to be quite high. I cannot believe that the figure is not going to be higher than £5 million.
The same issues apply to this statutory instrument as much as they do to some of the earlier ones. However, there are other technical questions. My noble friend has asked one set about the priority date, but another important question is which court will have jurisdiction if the validity of the original EU trademark is challenged in the future. We cannot leave business in a state of uncertainty. Then of course the UK trademark comparable right will be a stand-alone right. Does that mean that in those circumstances an applicant will have to challenge a trademark’s validity both in the UK and in the EU? What is the answer to that? One right derives from another. As a result of that, does someone wishing to demonstrate the invalidity of a trademark have to go to two jurisdictions? If that is not an additional burden on business, I do not know what is.
There are a number of questions to be asked here. We have come back again to the circularity of a quick fix that could have long-term consequences and where the procedure, process, consultation and impact assessment have been grossly unsatisfactory.
Lord Adonis
Before the noble Lord sits down, he has great familiarity with the sector, as does the noble Baroness, Lady Bowles. Does he think there are similar concerns in the sectors affected to those referred to earlier by the noble Lord, Lord Warner, that organisations and companies intimately affected by these regulations have not been consulted because they do not count within the,
“small group of trusted individuals”,
referred to in paragraph 10.1 of the Explanatory Memorandum?
Lord Clement-Jones
I cannot answer that question. I think that these have been drawn up in an attempt to be constructive. I do not think the initial thought was that these were going to create difficulties for business. The trouble is that at the end of the day any business, when it is looking at its intellectual property, is going to prefer to stay in the EU rather than come out, so there is a fundamental aspect of this which is not business-friendly. I can see what the noble Lord is driving at, but this measure is an attempt to be constructive in circumstances where it is very difficult to get a decent result.
Lord Henley
My Lords, I will try to be brief and as always I will offer to write to all appropriate noble Lords. I think the noble Lord, Lord Adonis, knows what I mean by appropriate.
Lord Henley
Appropriate. The noble Lord will be aware that I trust all noble Lords implicitly and explicitly.
On consultation, I again make clear that the IPO has been engaging with businesses on the implications of exit, and in particular on trademarks, since the referendum result. It has also consulted with specific stakeholders on the technical detail of this instrument. It prefers to fully consult whenever possible but, due to the unique nature of EU exit and sensitivities around negotiations at the time of drafting, we felt the best course on this occasion was to limit consultation.
The noble Lord, Lord Clement-Jones, asked what happens if there is a deal and what the point of the regulations are. I repeat that the regulations will only come into force in the event of no deal. If we secure a deal with the EU, the provisions on intellectual property in the withdrawal agreement will come into effect, and that means EU trademarks will continue to have effect in the UK at least until the end of the transitional period. During the transitional period, it is likely that revised regulations will be drafted which will take into account the result of further negotiations reflecting the future economic partnership.
I will touch on possible costs. The noble Lord, Lord Clement-Jones, doubted that the costs could be less than £5 million. The annual revenue cost has been estimated at between £2 million and £2.7 million, based on a 60% renewal rate in the UK between 2008 and 2017. I would prefer to write to the noble Lord in greater detail on that.
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 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.
The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)
The Question is that the Grand Committee do consider the Trade Marks (Amendment etc.) (EU Exit) Regulations 2018.
The Deputy Chairman of Committees
My Lords, I must remind the Grand Committee that a single call of “Not content” has the effect of negativing the Motion. With that in mind, I put the Question again.
Patents (Amendment) (EU Exit) Regulations 2018
Lord Adonis Excerpts(5 years, 3 months ago)
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The Parliamentary Under-Secretary of State, Department for Business, Energy and Industrial Strategy (Lord Henley) (Con)
My Lords, I beg to move that the Committee considers the draft Patents (Amendment) (EU Exit) Regulations 2018, which were laid before the House on 28 November.
Intellectual property plays a vital role in the UK’s knowledge economy, and this will continue to be the case after our departure from the European Union. Ensuring strong and balanced IP protection and enforcement is central to the Government’s aim of encouraging businesses to innovate and develop new ideas and technologies, which forms part of the industrial strategy. Our IP system is consistently rated one of the best in the world.
Lord Adonis (Lab)
I am very grateful to the Minister for giving way. Can he tell us—the same issue came up with the previous regulation—what consultation there has been on the regulation?
Lord Henley
I will answer that in due course. The noble Lord will have an opportunity to speak after my speech, and we might make better progress if I take it in that manner.
The regulations are part of the work being delivered by the Intellectual Property Office to ensure that the IP system for the UK continues to function effectively in the event of no deal being agreed when we leave the EU in March. This is essential to ensure a smooth transition for business and provide maximum certainty and clarity.
The draft instrument before the Committee today uses the powers provided by the European Union (Withdrawal) Act 2018 to address deficiencies in UK patent law which would arise on exit. The majority of UK patent law is domestic in origin or derived from various international agreements, so will not be affected by leaving the EU. Only a few specific areas of patent law are governed by EU legislation, and it is those areas which the draft instrument is intended to address.
I shall focus in particular on supplementary protection certificates, which are a special type of IP rights connected with patents. Noble Lords may recall that SPCs were created in the 1990s by way of EU legislation to deal with a growing issue affecting pharmaceutical and agrochemical products. Before such products can be made available on the market, the regulatory body must be satisfied that they are safe for use in order to authorise them for sale. As this process is extensive and often lengthy, it can stop the innovator enjoying the full period of exclusivity which a patent on such products normally provides. The aim of the SPC system is to limit the effect of that by providing up to five and a half years of additional protection to an authorised product after the expiry of the patents. This arrangement gives the maker of the product more time to recoup the costs involved in research and development, which is especially important in relation to pharmaceuticals.
The association representing British manufacturers in the field, the ABPI, has estimated that bringing a new drug to market costs more than £1 billion. SPCs therefore play an important role in encouraging innovators to develop new and more effective medicines by helping to cover those costs and providing additional revenue to put back into research. The framework for SPCs is set out in EU regulations 1610/96 and 469/2009 which will be retained under the withdrawal Act.
Lord Adonis
Before the noble Lord sits down, he said that he was going to cover the issue of consultation later in his remarks and he urged me not to intervene. He has not covered the issue of consultation at all. Would he care to do so now?
Lord Henley
My Lords, I did not say that and the noble Lord should not put words into my mouth. I said that when I come to respond at the end, I would deal with the point. No doubt the noble Lord would like to intervene to make the point and I have now listened to it. If the noble Lord would like to stay until the end of the debate, I will respond to it them.
Lord Adonis
My Lords, I do not think that that is a satisfactory response at all. Our consideration of this regulation, which we are just about to engage in, crucially depends on the Minister telling us what consultation has taken place. It is not good enough for him to say that he will speak at the end of the debate when we raise the issue. I have raised the issue because I wish to respond, as will other Members of the Grand Committee, to what he has to say about the consultation that has taken place.
Lord Henley
The noble Lord intervened more than once during the previous debate. I had a number of responses to give to him but sadly he did not think it necessary to stay until the end.
Lord Henley
Will the noble Lord sit down? I have not given way to him. The noble Lord can make his point when I have given way.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, it might be for the convenience of the Committee if I were to put the Question so that the debate can then continue.
Lord Adonis
My Lords, I do not think it is for the convenience of the Committee, because the noble Lord has just made a direct allegation that I was not present in my place to listen to his response. The reason is that I was speaking in the debate on the EU withdrawal agreement in the Chamber. I have made the point to the Whips, including on our side, that it is highly unsatisfactory for the debate to be taking place in the Grand Committee on regulations concerning exactly the same matters as are being debated in the Chamber. It is not possible, even for the noble Lord with his considerable abilities, to be present in two places at once. It is because I wished to participate to the debate—it is a discourtesy to the House that I am not able to be present for most of it, because I am fulfilling my duties in the Grand Committee—that I was not here. I hope the noble Lord will withdraw the remark he just made, which appeared to imply—maybe because he was not aware that I was in the Chamber—that I was not fulfilling my duties. After he has noted that I was not here because I was in the Chamber, I think he needs to answer this point to begin with. Otherwise, I will continue interrupting until he actually gives us some information on what consultation took place on this regulation—before we can properly consider it and whether we think the consultation that took place was adequate.
Lord Henley
My Lords, I quite understand that the noble Lord was in the Chamber and therefore not able to be there at the end. I merely made a statement of fact that he was not there and that therefore I was not able to respond to him. I similarly make the quite straightforward statement that I have spoken on this, for which I hope the noble Lord is grateful, and I will respond in due course to the points made. I hope the noble Lord will understand that the wide-scale engagement he would like, as we discussed on the earlier amendment, was not possible on a draft no-deal regulation of this sort. I can give the assurance, as I gave on the previous order—this is the important thing—that there will be a proper consultation in the future. The noble Lord should bear in mind that at the moment we are making sure there is a degree of certainty for businesses in the eventuality that there is no deal.
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 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—
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
The noble Baroness makes an important point. I want to follow this line because if the consultation itself does not cover the industry, and those others whom you would expect to be covered, it is not likely that the Grand Committee can reasonably expect to accept the concept that there is no effect or problem. We can only do that if we are sure that the consultation has been widespread, properly chosen and the rest. Will my noble friend explain who was consulted with, why some people who are obviously necessary consultees were not consulted, on what basis that choice was made and why these were informal discussions? This is surely a very important SI and there should have been formal discussions.
Secondly, there is a problem in all these SIs which we have to remind the Minister of each time. It is suggested that we can allow these SIs to go through because they are very unlikely actually to be used, because they are based on the principle of a no-deal exit from the European Union. That may be true, but it does not excuse us from ensuring that the SIs are as good as they could be. They might be used, unless the Minister is going to say that they are not going to be. At the moment, they could be used and we have to apply the same intellectual rigour to these as we would to any other SIs.
Lord Adonis
The noble Lord is making a powerful point. Did he note the remark made by the Minister in the debate on the last regulation: that the reason why there had not been full and proper consultation on the regulations was because the department was so preoccupied with consulting on and framing arrangements for the Prime Minister’s deal? We are being told that the regulations which we are debating to make provision for no deal, and which the House is expected to approve, are being inadequately consulted on and—as is clear from the remarks of the noble Lord, Lord Warner—inadequately prepared precisely because the Government are so overloaded with making arrangements for the deal. If the Government’s priority is the deal, rather than a no deal, is it not right for them to withdraw these regulations, and the option of no deal? The Minister made the frank admission to the Grand Committee earlier this afternoon that the Government have not had the resources and capacity to conduct proper preparations and consultation for no deal.
Lord Adonis
Before the noble Lord sits down, in the concluding remarks of his extremely powerful speech he referred to part 2 of the Explanatory Memorandum, which is where the Minister makes the appropriateness statement in respect of the scope of the regulations. He noted that the Minister, Sam Gyimah, who made all three statements in respect of the Equality Act 2010, in respect of the regulations being appropriate and in respect of whether they are in order with regard to the legislative powers conferred on the Government by the European Union (Notification of Withdrawal) Act 2017, has since resigned, and because of Brexit, the very policy enshrined in the regulations for which the Minister was giving these authorisation statements.
Further, in his resignation letters and subsequent statements, the Minister has expressed his extremely deep concern about Brexit in principle, and in particular the no-deal Brexit, the very subject of the regulations about which he was making the appropriateness statements which are before the Committee. Would the noble Lord agree that not only is this unprecedented—in my experience and maybe in his—but that it raises a huge concern: should we be proceeding with these regulations at all without either a statement signed by the current Minister and/or Sam Gyimah giving evidence to us on whether the concerns he has expressed about a no-deal Brexit might lead him to review the statements he has made on behalf of the Crown in part 2 of this Explanatory Memorandum?
Lord Deben
I do not want to embarrass any Ministers, including the noble Lord who is here. I want to exclude Ministers, both past and present, for a kind of corporate nonsense which the Government have presented and which is supported by a surprising number of people across the Benches. I think this Committee has a responsibility to say to the Minister, “One could not imagine this in any other circumstances. You could not make it up, as you can see when you read the detail”.
I end by coming back to the words I put before the Committee at the beginning. In one case it was “trusted people” and in the other it was “selected people”. It was not just a joke. It was to point out that whoever had to write this stuff knew perfectly well that it did not add up, and that there was no basis for presenting it except that somehow or other, the Government had to find a way of talking about these issues without telling the public the truth about impact, about cost and about the deprivation which this measure would bring to the British people if it were ever implemented.
Lord Adonis
My Lords, in my now quite long experience of the House I have found that on most occasions when policies are being tested and explained, amendments are being considered and so on, the difference narrows as debate advances. That difference can be eliminated entirely, sometimes because the explanations given by the Government turn out to meet the concerns, sometimes because the Government themselves move to meet the concerns and sometimes because the concerns are misunderstood. That is the general course. Because our job is to scrutinise there may still be resulting differences, but those differences are narrowed, not expanded.
However, a pattern is now emerging in the consideration by the Grand Committee of these no-deal regulations. In almost every case now, as the debate continues the difference widens, for three reasons. The first is precisely the point that the noble Lord, Lord Deben, has made so eloquently, which is that you are expected to believe, in the words of the White Queen in Alice in Wonderland, six impossible things before breakfast before you even consider these regulations. The first suspension of total disbelief that we are expected to entertain is that, all other things being equal in no deal, these regulations will simply make technical changes to govern the fact that we have left the EU with no deal. The problem is that all other things are not equal. The whole ground has shifted underneath the very activities, and the national interest and the companies, that are at stake.
That could not have been clearer than in the remarks of my noble friend—as I continue to call him; I know he now sits on the Cross Benches but he and I were Ministers together for many years so he will always be my noble friend—Lord Warner. I dare say that my noble friend, whom I hold in extremely high regard, knows this sector better than anyone in the House except possibly my noble friend Lord Darzi. He has huge, detailed knowledge from a long period of time as a Health Minister. My noble friend has reported to the House two issues of extraordinary import. The first is that the impact of the actual changes in these regulations will be profound for the industries concerned and for those who need to use their services. The second is that most of those directly concerned were not consulted at all.
That leads to the second big issue that has now arisen time and again in the Grand Committee: the consultation has been exiguous or non-existent despite the fact that the issues concerned are hugely important. The noble Lord, Lord Deben, who is one of the most forensic debaters in the House, noted to brilliant effect the use of the weasel words in respect of consultation in the Explanatory Memorandum regarding the,
“selected individuals with expertise in the relevant areas”,
who the Intellectual Property Office chose to consult.
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.
Lord Adonis
My Lords, my noble friend has made an extremely grave allegation. Would the Minister care to say whether he is correct that precisely one person in one company was consulted about these regulations? I would happily give way to him if he would like to contradict that statement, because it seems to be of immense importance.
Lord Adonis
I think that the Grand Committee will be extremely concerned to have information on this point. If what my noble friend has said is the case, it would be a situation without precedent in my experience: that on matters of significant impact on a major industrial sector, precisely one person in one company has been consulted and the relevant trade bodies were not even given the opportunity to express their views.
Lord Deben
What is more, that one person was selected but clearly not trusted.
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
My Lords, I will continue with these regulations: I have moved them. No doubt the noble Lord will say, as he and other noble Lords have done with other regulations, that he is not happy for them to be considered by this Committee and they can then be considered in another place. However, we are having a useful discussion at this stage, which I want to be part of, and we should complete what we are doing and deal with as much as is relevant to these regulations as we can. I will continue to do that and I will listen to the noble Lord, Lord Adonis, conclude his speech. The noble Lords, Lord Clement-Jones and Lord Stevenson, and other noble Lords will no doubt wish to intervene. I will then respond to that, as is right, proper and normal. It is up to noble Lords to decide where they wish to take things after that. However, we wish to get this through, to provide continued certainty for this body and to assist the whole life sciences industry, the importance of which the noble Lord, Lord Warner, has just reminded the Committee.
Lord Adonis
My Lords, a situation has arisen where there is a serious difference of view, to put it mildly—
Lord Adonis
A difference of fact, as my noble friend has just said, between the Minister and my noble friend Lord Warner, who has just pointed out to me that paragraphs 1 and 2 of Regulation 55 specifically concern exclusivity. This is the precise issue which he said should have been consulted on and on which the companies and trade associations concerned say they were not consulted. I simply note that, but this issue needs to be explored more fully before these regulations go to the House itself, as the situation at the moment is clearly unsatisfactory. The Minister, who is deeply honourable in these matters, would not wish this dispute of facts to be unresolved.
Lord Deben
Is the noble Lord not being a bit unfair to the Minister? Is the real problem here not the word “informal”? The Minister’s problem is that, if you have a formal consultation, you know precisely who was consulted and on what points. As I said in my own speech, if you have this curious thing called “informal” consultation, no Minister is able to answer these questions because you do not know what was said in any of the discussions. That is what is wrong with this consultation mechanism. The noble Lord is being unfair to the Minister, who can only say what is passed on to him, because this was not formal. There was no formal report, so we have no idea and nor does he.
Lord Adonis
The noble Lord makes a very good point. The Minister himself played no part in this process. All he can do is read out messages passed to him by officials. I do not hold him responsible in any way. Nobody was suggesting for a moment that he was personally responsible for engaging in this consultation and has therefore given misleading information to the Grand Committee. The point is that the House needs to know the truth.
I will make one remark on what the noble Lord, Lord Deben, said. He said it is hard to be precise about what happened if conversations took place during informal, as opposed to formal, consultation. However, there is a difference between informal consultation and no consultation whatsoever. The point made by my noble friend Lord Warner is that it appears not that there was informal as opposed to formal consultation, but none whatsoever. No conversations took place between the relevant trade bodies and companies, and the authorities responsible for drawing up these regulations. That is what he said, and it is of huge moment to the House. Using the word “informal” does not excuse these consultations being non-existent, which is the issue before the Grand Committee.
I return to the third thread of concern we have about the whole way in which these statutory instruments are being conducted. First, they depend on us believing the impossible proposition that no deal is not itself going to make a fundamental difference. The second issue we are constantly wrestling with is the inadequate or non-existent consultation. The third is the inability of Ministers to answer the points raised in the debate. That has been a running theme in these discussions. What happens—I dare say this will happen again when the noble Lord, Lord Henley, responds to this debate—is that the Minister restates the case for the statutory instrument that he made at the beginning. He selectively answers one or two points—to give him his due, he has just given a list of organisations that he said were informally consulted; it may or may not be accurate, but we need to establish that—but most of the points raised in the debate are not answered at all by the Minister. To be fair to him, the Minister himself played no part in this consultation and is simply having to read notes given to him by officials, who may themselves have been at some distance from the consultations that took place.
We are then expected to approve these regulations. Because of the inadequate arrangements for the scrutiny of statutory instruments—a point made very eloquently by the noble Lord, Lord Tyler, in earlier debates—we then have no further recourse. We cannot do what happens with primary legislation in this House, which is that we have a Committee stage, we can move amendments and probe the Government further, and the Government are under an obligation to come back to the House with further information. None of that happens. The only recourse we have is to seek to repeat this debate by referring the statutory instrument to the House and hoping—we then have no ability to amend it or to move amendments—that when the Minister comes to make the next speech in the House, he will respond to the points raised in the Grand Committee.
That leads me to an important point about how we handle these statutory instruments when they go to the House. On each of these statutory instruments that we have been debating and doing our best as Members of the Grand Committee to scrutinise, a lot of concerns have been raised but not met by the Government. I see that my noble friend Lord Foulkes is a member of the Liaison Committee and the Procedure Committee. He is a real power in the land in this House. Most of us are never admitted to the inner sanctum of these bodies, but he is. It is extremely important that Ministers write to Members of the House setting out their response to all the issues raised in the Grand Committee before the House comes to debate these regulations, so that we can then properly consider the adequacy of the Government’s further response. Let us consider the vital issue of consultation, which has been raised by my noble friend Lord Warner and on which I do not think the Minister is going to be in much of a position to comment, because he is dependent on notes passed to him by officials who are one stage removed from the consultation anyway. The House would expect a full statement to Members on what happened in the consultation—who was consulted, on what basis, what they said and what the Government’s response was—before this statutory instrument is debated in the House.
We need some mechanism—perhaps it is the Liaison Committee. Perhaps my noble friend Lord Foulkes, who takes on many public responsibilities, should take it upon himself to see that this process is conducted in a timely and adequate fashion before the House debates statutory instruments. I do not know whether my noble friend would be willing to take on that responsibility, but I am volunteering him. Otherwise, he may have a suggestion that we as a Grand Committee can then make for who should undertake this responsibility.
Lord Foulkes of Cumnock
I shall pretend to be a Minister and say that I shall look at that very carefully.
Lord Adonis
In the want of a better solution, I shall recommend to the Government that my noble friend Lord Foulkes should take this on, because on the basis of the debate that we have had so far, we will not have confidence that this procedure will be conducted unless there is an impartial referee to see that it has taken place.
I turn to a new issue of substance in the regulations. Many Members of the Grand Committee will have been briefed, as has my noble friend Lord Warner, by those directly concerned by the issues raised in the regulations and whether, as the noble Lord, Lord Henley, said, they do indeed make minimal changes to the existing regime, allowing for the fact that we are in a no-deal situation. I draw the Grand Committee’s attention to and ask the Minister to respond to arguments being put before Members by Bristows, a law firm which specialises in patent law. It has raised a serious concern about the regulations, specifically the adjudication mechanism. I set that concern before the Grand Committee and hope that the Minister will respond.
Bristows states that the amendments have potential ambiguity in the following respects. They provide that a declaration of invalidity of a supplementary protection certificate may be submitted to the “comptroller or the court”, in the words of the regulation, with the court being the Unified Patent Court if the basic patent is subject to the Unified Patent Court’s jurisdiction under Schedule 4 to the Patents Act 1977. However, under Schedule 4, the UPC has exclusive jurisdiction for invalidity actions of a supplementary protection certificate based either on a unitary patent or a European patent. Therefore, Bristows argues, the court referred to in the context of the “comptroller or the court” in the draft statutory instrument, when interpreted in the light of the Patents Act 1977, will, for those supplementary protection certificates, be the Unified Patent Court.
Further, as stated in Schedule 4 to the 1977 Act, the Unified Patent Court should have exclusive jurisdiction in such cases. “However”, Bristows asks,
“what is the impact of the reference to ‘the comptroller’ in the expression ‘the comptroller of the court’? Does this leave this national UK authority … with jurisdiction as well as the UPC? The natural meaning of the Statutory Instrument … suggests that there remains additional jurisdiction in the hands of the Comptroller as well as the Court … even if this was not intended. In consequence, it may remain possible for SPCs based on unitary patents to be invalidated in the UK”.
This looks to be a serious concern. I freely confess to the Grand Committee that, not being a patent lawyer myself— my noble friend Lady Kingsmill is, so she may be able to add to this—I do not entirely understand the impact of this concern, but Bristows believes it may be serious. The Grand Committee would be very grateful for an answer to Bristows’ concerns when the Minister replies. If he cannot give one in detail today, perhaps he can include it in his written response to Members of the Grand Committee after the debate.
Baroness Bowles of Berkhamsted (LD)
Maybe I should start with the last thing; I understand the point but I have not investigated it myself, so I cannot say whether it is a concern or not. However, the gist of it is that if something is a unified patent it should go to the Unified Patent Court if and when that continues, and, if it is a UK matter, it should be a matter for the UK.
Lord Stevenson of Balmacara (Lab)
My Lords, this has been a good debate that has raised lots of issues. I think the noble Lord, Lord Clement-Jones, is right that there are real questions to be asked here, although I feel that we are experiencing a bit of a split focus here. It is like being part of the film “The Matrix” because there seem to be two different levels of debate going on. There are the particularly narrow questions about the statutory instrument as presented, with which I think there are some substantial difficulties, but there are also the wider issues about why we are doing all this and the way that we are doing it. The noble Lord, Lord Deben, and others have focused on the absurdity of a situation where we are trying to persuade ourselves that, despite our best instincts, despite all the training that we have had here and despite everything that we do every other day of our lives, we are quite happy to sit here and wave this through just because it might not happen. That seems to be Alice in Wonderland rather than “The Matrix”, but perhaps they come together in a curious way which I have yet to experience.
The noble Lord, Lord Clement-Jones, commented on the Unified Patent Court, which is an intriguing area of public policy which has yet to have its full ramifications explained. He is absolutely right that the UK has committed itself to ratifying the UPC and intends to join up. I am sure that the Minister will confirm that when he comes to respond. Of course, with that comes the continuing role of the ECJ, because all judgments of the UPC—although there will be a platform of it operating here in London in property which has already been bought and refurbished in premises on a lavish scale which may not have been seen by the press yet, but I am sure that when they are there will be a bit of a scandal—will be absolutely redolent of the way in which the European continuing engagement will have to operate. That is because so many people hold unified patents and will need to have them defended in ways which are important not only here but in the six other areas where the court will be operating. But that is part of the further discussion and debate along with the consultation issues which I agree need to be bottomed out at some stage, but perhaps not today.
I may just stunt the time taken up by other speakers by looking at the other four SIs which are due to be discussed shortly by the noble Lord, Lord Bates, and others. I am sure that he will have read through and inwardly memorised the rather clever phrasing used by HM Treasury which I recommend to the department as it might wish to use it in the future and thus avoid some of the confusion. It states:
“HM Treasury has not undertaken a consultation on the instrument, but has engaged with relevant stakeholders on its approach to Financial Services legislation under the European Union (Withdrawal) Act 2018, including on this instrument, in order to familiarise them with the legislation ahead of laying … The instrument was also published in draft, along with an explanatory policy note, on 31 October 2018, in order to maximise transparency ahead of laying”.
That is wonderful phrasing and I congratulate the Treasury on having found a way out of an apparently insoluble problem. If it can defeat the noble Lord, Lord Adonis, and his assembled minions, obviously it will be well ahead of the game.
Lord Adonis
My Lords, I am grateful to my noble friend for giving way. Does he not think that the best way of maximising transparency, which is a laudable objective that the Grand Committee shares entirely, would be to have an ordinary consultation under the Cabinet Office procedures of 12 weeks where people can make formal responses? The Government then evaluate those responses and publish their response together with all of the consultation responses before the debate in the House rather than what the noble Lord, Lord Henley, is proposing, which is that the consultation should take place after the House has approved the regulations.
Will he further say, in this new Alice in Wonderland world in which we work where consultations take place after Parliament has agreed the regulations on which we are consulting, how he thinks that Parliament is then intended to take account of the consultation? In the world of the noble Lord, Lord Henley, where we consult on the regulations having passed them, if the result of the consultation with the trusted and selected individuals or the selected and trusted individuals shows that there is a need for further substantial revisions to the regulations, what are we supposed to do? What procedure does my noble friend have in mind for how we then rescind these regulations and produce new ones? Does he not think that it would be better if we could come out of Alice in Wonderland and go to the world that applied before Brexit started, where we had good, orderly government and consulted on major changes to legislation before we brought about those changes rather than afterwards?
Lord Stevenson of Balmacara
My Lords, I regularly spend most of my day with Alice in Wonderland because I think that it is a wonderful place to be. The noble Lord will be surprised to learn that I agree absolutely with every word he has said. The only difference between us is that I do not think I need to repeat it every time.
Finally, I wish to draw two points to the attention of the Government. The first is that we have to be clear about the damage that will be done to the UK’s pharmaceutical industries along the lines of what the noble Lord, Lord Warner, said. I hope that we will get a letter from the Government confirming or denying some of the points which were made in that exchange. Secondly—this is a minor point but it is worth exploring and asking questions about. In paragraph 4.3 there is rather confused wording about—the extent and territorial application of this SI. Although it applies to the United Kingdom, bits of it, which are not specified, do not apply to the Isle of Man. Activities have been taken up so I would be grateful for a side note because this needs to be responded to today.
Lord Henley
I apologise to the noble Lord, Lord Adonis. I will no doubt study, as will my officials, both the Bristows letter and the opinion from Brick Court.
Lord Adonis
Before the Minister sits down, he has very kindly said that he will write to respond to a number of the points that he has been unable to deal with. Those points are going to be crucial for the House itself to consider when this regulation goes to the House, particularly the points about consultation that were raised by my noble friend Lord Warner.
I ask that the Minister sends his reply and full statement in response to the debate to all Members of the House together with a copy of the debate itself because of the very unsatisfactory arrangements under which the proceedings of the Grand Committee are now reported. They are no longer in the main body of Hansard, a change that I find inexplicable. I do not know when it happened. It must have been beyond the oversight of that shrinking violet, my noble friend Lord Foulkes. It would never have happened if he had noticed it; he must have been shrinking on that particular day. If the Minister could send his full response, with the full proceedings of this debate, to all Members of the House it would be extremely useful in informing noble Lords before they consider these important matters.
Lord Henley
I think that the noble Lord would not expect me to respond quite as positively as he wishes. It might be an overuse of paper to write to every Member of the House. I will write to the noble Lord and other appropriate Peers, and make sure that a copy of my letter is, as always, available in the Library. The noble Lord and I understand that procedure well. A copy of this debate will be available in Hansard. Even if it is not the same Hansard in which reports of the Chamber appear, I understand that it is still Hansard and open to all noble Lords to read. If we want to be really modern about these things, it is also available for the noble Lord to read online.
Lord Henley
My Lords, I will write to the noble Baroness on both those points.
Lord Adonis
My Lords, a moment ago the Minister mentioned writing to “appropriate Peers”. I have never before heard a Minister in the House using the phrase “appropriate Peers”, presumably as opposed to inappropriate Peers. I suspect that, in the Government’s view, I am probably an inappropriate Peer. Particularly in the light of my noble friend Lord Warner’s remarks about “selected and trusted” consultees, I hope we are not going to start introducing the concept of selected and trusted Peers who are to be made privy to the Minister’s responses to these debates. I strongly suggest that all noble Lords receive his letter, together with the account of the proceedings of the Grand Committee. If he is not able to give that assurance, will he take this matter up with the Leader of the House and let noble Lords present in Grand Committee today know soon what the Government intend to do on this? I and other noble Lords may wish to take this matter up with the Leader of the House and with my noble friend the Leader of the Opposition. It goes to the rights and privileges of Members when the whole House considers these matters.
Lord Henley
This is one occasion where I can give a categorical assurance to the noble Lord, because he merely asks what I meant by “appropriate”. I define it as meaning that I will write one letter to all noble Lords who have taken part in this debate and make that available in the Library of the House, as is the normal convention. By that means, all those who have taken part in the debate will have a copy of my responses to the noble Lords, Lord Warner, Lord Adonis, or Lord Clement-Jones. It would be easier if I wrote one letter to all “appropriate Peers”; that is, Peers who have spoken in this debate.
Lord Adonis
My Lords, I am grateful to the Minister for seeking to define “appropriate”, but I do not think that Members of the Grand Committee think that his definition is adequate. Our job is to advise the House as a whole, but there may be a feeling in the Grand Committee that other noble Lords should receive this letter so that they are aware of the gravity of the issues raised about the whole future of the life science industry, which the noble Lord, Lord Warner, referred to, and the importance of taking note of those issues before the House comes to consider them.
Lord Henley
I am grateful to the noble Lord, because obviously he always considers what is important to the House. He will no doubt make sure that that letter of mine, which will be available in the Library of the House, is made available to everyone else whom he thinks it is right should see it. I cannot go further than that, but it would not be right to write to every noble Lord on this regulation.
The Deputy Chairman of Committees (Baroness Finlay of Llandaff) (CB)
The Question is that the Grand Committee do consider the Patents (Amendment) (EU Exit) Regulations 2018.
The Deputy Chairman of Committees
My Lords, I must remind the Grand Committee that a single call of “Not content” has the effect of negativing the Motion. With that in mind, I put the Question again. The Question is that this Motion be agreed to.