Patents (Amendment) (EU Exit) Regulations 2018

Lord Adonis Excerpts

Monday 14th January 2019 Grand Committee

[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.

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Finally, there are miscellaneous adjustments to the Patents Act 1977, the Patent Rules 2007 and the Copyright, Designs and Patents Act 1988 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 form a small but vital part of ensuring that the intellectual property system continues to function if a no-deal outcome arises. I commend them to the Committee.

[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 Adonis]

My Lords—

[Lord Henley]

I am not giving way.

[Lord Adonis]

I was in the Chamber.

[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.

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[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.

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[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.

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[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.

[Baroness Kingsmill]

The lawyers.

[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.

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[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 Henley]

I will be responding in due course.

[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]

The exclusivity point is for another regulation on the MHRA.

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[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—

[Baroness Kingsmill]

A difference of fact.

[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.

--- Later in debate ---

[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.

--- Later in debate ---

[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.

[Lord Adonis]

Not content.

[Baroness Crawley]

Not content.

[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.

[Lord Adonis]

Not content.

[Baroness Crawley]

Not content.