European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2018

Debate between Lord Deben and Lord Warner

Thursday 7th March 2019 Lords Chamber

[Lord Deben]

I have got it right this time. That is what they say. In every individual case, negligibility may well be the truth, but what is negligible in one case, when added up with a lot of other “negligible” costs, ends up being rather expensive. I am amazed at the number of things you can do with negligible cost. We are filled with these SIs—with all the things that we can do for nothing. I ran businesses, and I have to say that I do not know anything you can do in business which does not cost you something. I would love the Government to explain to me how they are managing to move whole areas of control and regulation over to British regulators without any cost. I would be able to apply that to my businesses and it would be extremely valuable, because all I know is that the moment you change or move anything, it costs money.

I want to know not only how much it costs but whether we have the resources for it. It is also said that we have these organisations that are perfectly capable of doing all this, as if this is an easy thing to do, when in fact it is not only difficult, but if we get it wrong, we are endangering people’s lives. Clearly, we have not worked out what the cost of doing this is; I just do not understand whether we have the human resources and the trained resources to do it. After all, we have shown so far that we cannot run the National Health Service without large numbers of people coming in from outside. I would like to understand whether we can regulate all this without some additional resources, and if so, we ought to know exactly what resources we will need and how much they will cost.

I am sorry that I have to say this to the Minister with such vigour, but it needs to be said; otherwise, this House looks pretty damn stupid. We look as if we are sitting around, having a gentle argument about what is the programme for catastrophe. This is what we are talking about: how a nation decides how to put itself into a very much less favourable position than it is in at the moment. Sometimes people say, “Ah, but Britain will manage—look what it did during the war!” But we did not ask for the war; we did not say that we wanted it. It happened, and we said that we had to fight it. Here we are asking for it, and are seriously sitting around planning for it. We are asked to do that with a degree of politeness and charm, and courtesy and care, when we ought to be very angry indeed that any Government should even suggest that we need SIs like this.

[Lord Warner (CB)]

My Lords, it is a positive delight to follow the noble Lord, Lord Deben, as I have done on a number of occasions in the past few months in debates on other SIs which have been considered in Grand Committee. The one thing I would say about the noble Lord is that he has been masterly in the consistent way in which he has expressed himself. I do not altogether share his high assessment of previous Conservative Governments on costings, but we will let that one pass.

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

Debate between Lord Deben and Lord Warner

Tuesday 15th January 2019 Lords Chamber

[Lord Deben]

I have to say, there are many fates which are worse than death—though I am not quite sure that that is one.

I wonder whether I could go on to the question of consultation. It is very difficult to uphold the argument that there was no need for consultation when you have had to withdraw the SI because, as a result of publishing it, it turns out that there was a need for consultation because a very serious mistake was found in it. If this were the only case—I say this to the noble Lord, Lord Kirkwood—I would be less concerned, but last week and yesterday we found a series of really serious changes which needed to be made which had been brought to our attention by the very industry with which the particular ministry concerned had claimed to have had ongoing and general discussions.

There is, for example, a very major problem for the pharmaceutical industry because there was no such consultation. I do not want to go into detail on that because obviously that is not the subject here, but it is important to say that this is a case where, had there been consultation, there would not have had to have been a second draft of this SI. My noble friend said, “Well, we have changed it”, but she has not. She has not, I think, convinced the House that there might not be something else that needs to be changed. Because you have changed one thing does not mean to say that there will not be any other.

[Lord Warner (CB)]

Will the noble Lord agree with me, having sat through six sets of regulations which have been negatived, that there is a pattern emerging? Does he agree that the pattern is real doubt about whether there are accurate impact assessments and real doubt about whether any worthwhile consultation has taken place with interested parties? I am asking the question because this is of great importance to the House as a whole. There is a continuing assertion that these were minor and technical issues which did not involve a change of policy; but on further investigation, all showed that there were serious concerns about impact assessments, there were changes of policy, and there were great deficiencies in the consultation. As this House in Grand Committee has negatived six sets of regulations, one after the other, one can be excused for being a little sceptical about assertions from the Dispatch Box.

[Baroness Buscombe]

My Lords, if I may be helpful to the House, I think I made it clear to all noble Lords that, because of consultation with the industry concerning this fairly niche area within the pensions industry of cross-border activity with the EU, we learned that one word was wrong within the draft regulations. Therefore, notwithstanding what may have happened with other SIs that noble Lords have been debating in recent weeks, with regard to this SI, one word was out of place and, quite rightly, the pensions industry alerted the department, which withdrew the draft regulations. As the noble Lord, Lord Kirkwood, so helpfully stated, the reality is that this happens. It does not happen on a regular basis. I cannot believe that, when my noble friend was Secretary of State, every piece of legislation he brought forward was perfect the first time round.

Patents (Amendment) (EU Exit) Regulations 2018

Debate between Lord Deben and Lord Warner

Monday 14th January 2019 Grand Committee

[Lord Warner]

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

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

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

[Lord Deben (Con)]

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

[Lord Warner]

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

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


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

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


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

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

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

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

The UK,

“has moved further down the priority launch market”—

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

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[Lord Warner]

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

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

[Lord Deben]

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

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

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

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

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

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

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[Lord Deben]

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

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

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

[Lord Warner]

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

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

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

Debate between Lord Deben and Lord Warner

Wednesday 9th January 2019 Grand Committee

[Lord Deben]

I say to the noble Lord, Lord Adonis, that we have a real issue here because it is very hard for the Minister to have to respond to this situation. Again, I apologise to her for the fact that I feel that I have to speak—because we cannot go on, in the politenesses of this House, ignoring the fundamental problem. The fundamental problem is that we are being led up the garden path in two different ways.

The Deputy Chairman of Committees is perfectly right to refer us to the Standing Orders, but this is central to the discussion that we having on this particular SI. The centrality of it is that, first, we are assuming that this could happen, and the second part of it is that we are assuming that the Government have made proper arrangements that if it were to happen, what is in this instrument is relevant and effective. There is actually a third thing, which goes back to the point made by the noble Lord, Lord Adonis, about whether this is legally possible to happen. That, I think, is a question which is beyond the remit of this Committee but is certainly of very great importance.

[Lord Warner (CB)]

Can I ask the noble Lord a question? I would quite like a response from the Deputy Chairman as well. Two separate arguments are flowing here. One is an argument about whether, in the light of the latest Commons vote on no deal, we should even be discussing that. I can sympathise with the Deputy Chairman’s intervention. However, there is a second issue which keeps coming up: are these changes actually deliverable? We keep coming back to that and it is where I think that not just this Minister but Ministers on the other regulations will have to come clean. If we cannot deliver these things, I would suggest to the Deputy Chairman that that is a relevant consideration. If the propositions in these regulations require a delivery mechanism that we in our judgment feel, on the evidence being presented to us, is not going to deliver what is in these regulations, it is the duty of this Committee to say that to the Government loudly and clearly, no matter how uncomfortable that may be for the luckless Minister who has to present them to us.

[Lord Deben]

It is natural for the noble Lord, Lord Warner, to have put his finger on exactly what I was about to come to as my final point of discussion.

I say to my noble friend that the problem with which we are faced is that this is a statutory instrument that inherently proposes that it could work, that it could be put into operation. The more I look at it, the more it seems quite impossible for the Government to say that it could work. My noble friend has been absolutely honest about this. She has said that she cannot tell what the future will hold. That of course is true for all of us. She has also said that we have her commitment that these things would be prioritised where priority was necessary. That is a commitment which we respect, but the problem with prioritisation is that you have to be able to do it. I do not believe that any of this is in any way deliverable. It is therefore no good us having this sort of fantasy debate.

We are in fairyland, unless that is politically incorrect as a phrase. This is closer to Enid Blyton than anything I have ever been involved in—it is the Faraway Tree, it has nothing to do with reality. When the noble Lord, Lord Winston, makes an intelligent and sensible contribution about some of the problems which occur when you try to transmute something which is to something which is different, so that it is not quite what people may think, actually in a curious way he is being irrelevant. The truth is that none of this is possible. Arguing about whether it is going to be exactly right or not is a further lunacy. We are even further away from it, because we are now introducing rationality into the discussion. That is one thing that clearly cannot be introduced into the entirely irrational basis upon which we are proceeding.

I am the only person sitting on this side, and I know why: nobody can actually go through this exercise without realising what nonsense it all is. What a ridiculous proposal we have before us. Why have we allowed ourselves to get into this position? I am sorry it is my noble friend who is faced with this, but I do not think this House is doing itself any good by conniving in what is manifestly a total nonsense.

I do not believe it is entirely in order to ask people to support the only deal on the tapis. We all have to accept that the deal the Prime Minister has got is the best deal you could get if you wanted a deal like that. It happens to be much worse than where we are, and I certainly would not vote for it if I had the opportunity. I do not think anybody should vote for their constituents to be poorer, because that is what you have to do if you vote for the Prime Minister’s deal. But that is not the point. We have in front of us proposals which cannot be delivered.

I sympathise with my noble friend over the position in which she finds herself, but I hope she and other Ministers—because we will be continuing this discussion today—will go back to the Government and say, “I cannot stand up and defend this stuff any longer, because I am not in the business of defending Enid Blyton. I cannot be asked to do this, it is not fair”. My speech is entirely on the side of the Minister. It is not fair that she should have been put in the position of defending something which is intolerable, because it is not possible. It cannot be delivered. There is no no-deal scenario which does not mean chaos, so there is no point in having legislation which pretends that it will stop a no-deal scenario being chaos. That is inevitable, ineluctable and inextricable from the whole process. Of course, my noble friend will get her SI through—we have a ludicrous system whereby we cannot do things to it—but I ask her to go back to the Government, and she does not even have to tell us if she does, and say that this is not a proper position to put Ministers in, having to argue for what is unarguable, a fairy tale, and an insult to the intelligence of all of us.

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[Lord Warner]

My Lords, I was not intending to speak on this set of regulations, but I was taken down memory lane when I saw what was involved because I was the Minister who took the human tissues legislation through this House in 2004. I want to remind the Minister why that legislation was put in place because it is relevant to a question that I want to ask at the end of what I am going to say. It was put in place because medical research was being jeopardised because of patients’ concerns about the safety, storage and use of human tissue of various kinds. It arose against a background of huge concern about the treatment of human tissues of children at Alder Hey Hospital. I can still vividly remember the parents of those children fixing me with a gimlet stare as I took that legislation through the House.

My question to the Minister therefore backs up to some extent the point that the noble Baroness, Lady Barker, has just made: can the Government guarantee that in these regulations there will be an absolute set of safeguards around the use of human tissue during the period after a no-deal Brexit that will not jeopardise all the good will that has been built up since 2004, which has got patients willing to co-operate in the use of human tissue for medical research?

[Lord Deben]

As the noble Lord asks for a guarantee, could he explain how the Government could make such a guarantee? Surely that is our problem; it is not that the Government would not like to make such a guarantee—I am sure they would—but how could they? Is that not the fundamental problem with which we are faced?

[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.