Air Passenger Rights and Air Travel Organisers’ Licensing (Amendment) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Adonis

Tuesday 12th February 2019 Lords Chamber

[Lord Warner (CB)]

My Lords, I had not intended to speak in this debate, and I do not really wish to be added to the Minister’s list of troublemakers. However, I want to emphasise the point made by the noble Lord, Lord McNally, at the end of his speech. I do this as someone who always tries to cheer up his Februaries by reading the travel supplements in the Sunday newspapers. This Sunday’s newspapers were glowing about places where, if I hurried, I could actually book the hotel, the flight or even the two flights that I might need to get to the place. These changes might be in separate countries. I scanned through the travel supplements of both the Sunday Times and the Times on Saturday and could see nothing about whether people’s summers might be disrupted in any way whatever.

[Lord Adonis]

I am very grateful to the noble Lord for giving way. He probably is not—but he may correct me—a regular listener to Spotify. If he were, he would know that Spotify is now running ads advising people to take precautions in the event of a no-deal Brexit. The precaution that they should take is to log on to the GOV.UK website, where information is available on what arrangements will be made in the event of no deal. In respect of travel, which we are discussing this afternoon, it says that you should check with your carrier. So having gone through the GOV.UK website, you are then expected to go to your carrier. When I logged on to the British Airways website to find out what passengers should do in respect of no deal, it said that you should refer to GOV.UK, on the grounds that the Government are setting up what should happen. I say in response to what the noble Lord, Lord McNally, said about a public information campaign that millions are being spent on a public information campaign which tells the public precisely nothing except to be very, very concerned.

[Lord Warner]

My Lords, I am an old-fashioned ex-Minister who usually used the media to project messages if I wanted the public to read them. We might do something in a newspaper or we might do something on a broadcaster. The only streaming I am aware of is from my nose, sometimes, during the winter, so I am not a great Spotify fan. I was trying to make the point that any member of the public who had read the Sunday supplements and was thinking about booking a holiday and had then turned on the parliamentary channel and listened to this debate might have second thoughts about doing so. The Government do not seem to have done anything to give the public any serious pause for thought before they took out their chequebook or electronically transferred their money to reserve their holiday for this year.

Will the few members of the Minister’s department who are left after dealing with the problems that the noble Lord, Lord Adonis, spelled out earlier engage in a proper public information campaign using more of the traditional channels, to tell the people who are booking these holidays—who, in many cases, tend to be from the upper age groups with high disposable income—what dangers they may face in the coming months of 2019 if they peak too early in their summer bookings?

[Lord Adonis]

My Lords, I think it was Seneca who said that anger is a form of temporary madness, which is an injunction that I usually observe, but it is very difficult when wading through these no-deal regulations not to be genuinely angry at what the British state is about to inflict on the British public if this comes to pass. It is not just the known facts about a no-deal Brexit, which are bad enough; it is, as has come through this debate, all of what Donald Rumsfeld called the known unknowns. We do not know the precise litany of catastrophes and problems that there will be down the line, but we know that they will be there. We know that there will be problems with the exchange rate; there will be problems with dodgy carriers which seek to game the system; there will be problems, as the noble Lord, Lord Balfe, said, with changes in regulations over time. It will be no surprise when all this happens; this is what should be expected in the evolution of legislation and behaviour of private and public sector organisations.

We also know, taking the point made by the noble Lord, Lord Balfe, and my noble friend Lord Foulkes, that the state machine, even before no deal has happened, is overwhelmed by preparations for Brexit. I can tell the House as a former Minister in the best department of state, the Department for Transport—I know this because people tell me—that most of the staff at the Department for Transport are being allocated to special contingency duties and units in the case of no deal. They are the units that will be needed to keep the ports operating and to deal with the fact that the M20 will become the largest car park in Europe. Can noble Lords imagine what the switchboard of the CAA will be like once any of these contingencies comes to pass?

That point is important for these debates because from what the Prime Minister said this afternoon, it is clear that she will take this down to the wire. Her strategy is clear: she will present the next version of her deal, with some tweaks to the Irish backstop, to Parliament after the European Council on 21 March, offering a “take it or leave it” vote on her deal or no deal. I hope that Parliament will be strong-minded and realise that there is a third option: seeking an extension to Article 50 without adopting her deal. That is the situation we will face.

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

Debate between Lord Warner and Lord Adonis

Wednesday 6th February 2019 Lords Chamber

[Lord Adonis (Lab)]

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

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

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

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

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

The letter then lists the organisations. It continues:

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


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

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

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

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

[Lord Warner (CB)]

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

Patents (Amendment) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Adonis

Wednesday 6th February 2019 Lords Chamber

[Lord Adonis (Lab)]

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

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

[Lord Warner]

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

[Lord Adonis]

I understand the significant point that the noble Lord makes.

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

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

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

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

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

Occupational and Personal Pension Schemes (Amendment etc.) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Adonis

Tuesday 15th January 2019 Lords Chamber

[Lord Adonis]

My Lords, I do not accept that for a moment. The whole basis on which we engage in no-deal planning is fundamental to these regulations. If no-deal planning does not have the authority of the House of Commons—and it appears from the vote last week that the other place is not prepared to contemplate no-deal planning—why on earth are we detaining the House at huge length in making clearly unsatisfactory arrangements? They have not been properly consulted on and are leading to regulations that are not properly drafted, in pursuit of a contingency that will not arise. I flatly disagree with the noble Lord.

We are the subordinate House, but it appears that leading Members of the House of Commons are concerned with these affairs. The amendment last week which led to a majority against no-deal planning was a cross-party amendment tabled by Nicky Morgan and Yvette Cooper, two very senior Members of the House of Commons. In moving it, Yvette Cooper said:

“I have heard some say that they want the imminent threat of no deal to persuade people to back the Prime Minister’s deal, if not now, then later. But brinkmanship in Parliament is not the way to resolve this and get the best deal for the country. This is too serious for us to play a massive Brexit game of chicken”.—[Official Report, Commons, 9/1/19; col. 263.]


I entirely agree with that statement and so did a majority. That leads to a huge question mark over the validity and legitimacy of all this no-deal planning and puts a particular duty on this House to see that we do not pass regulations which have been inadequately consulted on, inadequately drafted and inadequately scrutinised in pursuit of a deadline artificially imposed by the Government. The Government have the power to change it if they wish, because the European Union (Notification of Withdrawal) Act 2017, which the noble Lord just referred to, gives them the power to change the exit date and unilaterally revoke Article 50. It also does not appear to have the confidence of the House of Commons in the first place. I hope noble Lords will in no way be dissuaded by the ardent partisans of a no-deal Brexit from giving these regulations the scrutiny which they not only deserve in respect of those affected by them, but which we have a duty to give them if we are to follow the will of Parliament as expressed by the House of Commons.

[Lord Warner]

My Lords, I am not going to continue the discussion about our previous experiences of SIs. I just have a question that I want to put to the Minister on this set of regulations, prompted by the helpful remarks of the noble Baroness, Lady Drake. To what extent, if any, would this set of regulations require pension funds to shift their investment strategies, which could be deleterious to the beneficiaries of those pension funds?

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

Debate between Lord Warner and Lord Adonis

Monday 14th January 2019 Grand Committee

[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?

--- Later in debate ---

[Lord Adonis]

Not content.

[Lord Warner]

Not content.

Patents (Amendment) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Adonis

Monday 14th January 2019 Grand Committee

[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.

--- Later in debate ---

[Lord Adonis]

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

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

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

[Lord Warner]

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

--- Later in debate ---

[Lord Warner]

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

[Lord Adonis]

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

[Lord Henley]

The exclusivity point is for another regulation on the MHRA.

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

Debate between Lord Warner and Lord Adonis

Monday 14th January 2019 Grand Committee

[Lord Warner (CB)]

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

[Lord Adonis]

Who are the trusted individuals?

[Lord Warner]

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

Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019

Debate between Lord Warner and Lord Adonis

Wednesday 9th January 2019 Grand Committee

[Lord Warner]

I think it is, but I am trying to be kind to the Minister after what I suspect has been a rather exhausting and tiresome afternoon for her. This requires the Government to be absolutely sure that the safeguards in place now will not be diluted in any way as far as patients are concerned as a result of these regulations. She and the Government have to be sure, as the noble Baroness, Lady Barker, said, that if there is an incident it will not undo all the good will that has been built up in the last 15 years or so.

[Lord Adonis]

The noble Lord has been a Minister and has had to deal with these issues. Could he give his own reflections to the Grand Committee on the issues to do with disruption at ports and airports that might impact on the extensive research and patient treatment that takes place under these provisions? If there was serious disruption, what impact does he think it would have on the communities affected?

[Lord Warner]

If the Government cannot guarantee the easy transfer of pieces of material of one kind or another that are vital for medical research, you end up with a loss of public confidence in medical research and the ethical considerations surrounding that. It starts to jeopardise the ability of world-class scientists to do the research that at the end of the day benefits patients across the country and indeed across Europe.

[Lord Adonis]

My Lords, I did not care greatly for the Deputy Chairman’s intervention in reading the Standing Orders out to us. I think your Lordships are well aware of the requirements for us to be relevant in our remarks, and I do not believe that anything has been said in the Grand Committee today that is not relevant to the direct issue of no-deal planning, which is the precise issue involved in each of these regulations. It is not just relevant but it is our duty to point out—in the way that the noble Lord, Lord Deben, did in his remarks—the big issues to do with the practicality of these arrangements as well as the legal and moral basis on which they are being taken forward, given that the House of Commons, the primary elected body that establishes law and policy, has directly voted against no-deal preparations as recently as yesterday, in a huge Division after a very controversial debate. When I read to him the remarks of Yvette Cooper, the former Labour Cabinet Minister who moved the amendment endorsed by the House of Commons, I think that it was extremely relevant.

We all have great respect and increasing sympathy for the Minister. She is having to assume responsibility for a Government of which she is a distinguished part but only one part. She is in an invidious position in having to reply, but she has not been able to do so because there is no reply to the fundamental issue of why are we considering these regulations at all when it is unclear whether they can be implemented and when the legal basis for them is so shaky and, in my view, unsustainable because, crucially, it depends on the will of the House of Commons, which only yesterday expressed its will emphatically in a huge Division: that it did not want to see no-deal preparations continue—[Interruption.] I am sorry. My noble friend is making an entrance. I thought it might be another intervention from the Chair.

As each of these orders come up for consideration by the House, we need to point out that the Grand Committee believe that the arrangements being put in place are not practical in the time period envisaged for them—now barely two months—and that we will not be satisfied unless the Government can give us some account. The Minister has not been able to say whether there is a satisfactory legal basis for these arrangements to be brought forward, given the view the House of Commons has now expressed. I would welcome that as the Minister did not respond to those remarks in respect of the previous statutory instrument; I hope that she will in her remarks on this one.

The remarks of my noble friends Lord Winston and Lord Warner are acutely concerning. They have huge expertise in this area and have raised very serious concerns about the impact on patients and research in the event that the Government attempt to go down the course envisaged by these regulations. The Grand Committee would welcome the Minister’s views on these issues. I note that we are not talking about a peripheral issue in respect of the NHS and patients. There are about 5,000 imports of tissues and cells from the EU alone in a typical year. This is not my area of expertise, but that is clearly a huge area of our national life which acutely affects a very large number of individuals. That includes 600 imports of stem cells and 3,000 imports of bone products. The UK imports donated sperm primarily from commercial sperm banks in two places—the United States and Denmark—so one of the two principle areas from which we import is in the European Union and will be directly affected. The Minister may be able to confirm figures I have seen saying that Denmark is the principle location from which we import donated sperm and will be hugely affected.

I come back to the fundamental issue I raised in the last debate, to which the noble Baroness was not able to give a satisfactory answer: what happens in the case of serious disruption. I invite the Minister to say more about the word she used in our last debate: “prioritised”. The Government clearly think that there may be serious disruption or there would not have been the attempted simulation of a lorry jam; Chris Grayling could not even organise a lorry jam that worked but a simulation of a lorry jam was attempted on Monday none the less. The Government would not be attempting simulations of lorry jams if they did not think that a lorry jam would be one of the consequences of no deal. I have worked closely with civil servants for many years. They are very conscientious and they feel, correctly, under a duty to see that proper preparations are made for serious contingencies that might arise in respect of policies put forward.

The Grand Committee and the House should take careful note of the fact that this is not any Project Fear done by me or any fantasies from the noble Lord, Lord Deben. The Government are conducting contingency exercises of lorry jams, which means that the port of Dover is effectively impassable for long periods, and we were told yesterday by the junior Transport Minister, the noble Baroness, Lady Sugg, that the port of Ramsgate is being dredged—we are still trying to find out how this dredging is taking place and what the contracts are—so that further no-deal preparations can be made for after the end of March. We now know what the likely disruption can be at the airports, because many of us were trying to get out of Gatwick before Christmas and the drone completely disrupted all the traffic out of the airport.