Considered in Grand Committee
That the Grand Committee do consider the Patents (Amendment) (EU Exit) Regulations 2018.
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.
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?
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.
Unlike other EU IP rights, SPCs granted under the EU legislation take effect at the national level. This means that it will not be necessary to convert or replace existing rights at exit as UK SPCs will continue to be in force. However, it is still important to ensure that the framework remains functionally the same so that the scope of the right is unchanged and users of the system can have confidence in how it operates. The draft instrument therefore makes only technical changes to the retained EU regulations so that the SPC system can continue to operate effectively. For example, the EU regulations currently state that only authorisations which have been granted in accordance with certain EU directives can be used as the basis for an SPC application. After we leave the EU, UK authorisations would not count under this requirement. The instrument therefore makes changes so that the UK authorisations are covered. This will include any authorisations granted centrally by the European Medicines Agency which are converted into national authorisations at exit.
Similarly, the term of an SPC is determined based on the time between applying for patent and the grant of the first marketing authorisation in the European Economic Area. Again, amendments make sure that a UK authorisation can still form part of that calculation so that the term of an SPC is based on a calculation which everyone is accustomed to. Some of the amendments in this area are contingent on changes that will be made to the regulatory regime for medicines in the event of no deal, in particular to the paediatric extension which rewards carrying out additional testing to see if the product can be used to treat children. The transitional provision will ensure that the pre-exit conditions on when the extension can be granted will continue to apply to extensions already approved and applications in progress.
In addition to SPCs, the instrument will make some technical changes in other areas of patent law which are also governed by EU legislation. Where a patent and a plant variety might overlap in the protection they provide, the EU directive on biotechnological inventions allows the holders to seek a compulsory licence if they are unable to agree terms between themselves. The instrument will ensure that the UK transposition of the directive continues to provide that ability to the holders of UK rights. The instrument will also amend EU regulation 816/2006 to retain the ability to obtain a compulsory licence for manufacturing a patented medicine in the UK for export to a country with a public health need. The regulation relates to the flexibilities provided by the WTO TRIPS agreement which the Government continue to support.
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.
The noble Lord 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?
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. I will respond, if the noble Lord would like to stay until the end of the debate, to it at the end of the debate.
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.
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.
I am not giving way.
I was in the Chamber.
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.
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.
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.
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.
No; there is no need for noble Lords to get up. I will sit down and give way to the noble Baroness or the noble Lord when I am ready, but I am entitled to speak and give way as I wish.
We will consult as appropriate on whatever the future regime might be, deal or no deal. We are trying to get things right in the eventuality of there being no deal. It is quite right—
Can the noble Baroness wait just a moment? I am still speaking. It is quite right that we make appropriate contingency plans. I now give way to the noble Baroness, then I will no doubt give way to the noble Lord, Lord Warner, who is itching to get to his feet.
I was actually trying to be a little helpful. In the notes on this matter, there is a little more detail about the consultation than on the previous one. They say a consultation was taken with “informal discussions”—informal is always questionable—
“with a small group of selected individuals with expertise in the relevant areas, or in patent law generally”.
I read that to suggest that the consultation was with lawyers, as opposed to people directly affected by this. I wonder if the Minister could make that clear. If it is with lawyers, they will be looking at it on the basis of the law as opposed to the impact on businesses. Once the Minister has clarified who and what it was, I could then understand the impact. In paragraph 12, the Government assert that there is,
“no, or no significant, impact on business”.
If there has been a proper consultation, that is fine and perhaps one has to accept that impact. But at present an informal discussion,
“with a small group of selected individuals”,
does not sound to me like the kind of consultation that is going to give anybody the possibility of saying there is,
“no, or no significant, impact on business”.
Perhaps the Minister would care to clarify.
May I intervene to be helpful to the Minister? He might wish to consider withholding his remarks about consultation until he has heard what I have to say a little later about the consultation process—if we may venerate it with such a description. I think he might want to hear those before he commits himself too far on what consultation has taken place.
The noble Baroness, Lady Kingsmill, suggested that it was only lawyers who were consulted. There is nothing wrong with lawyers—I speak as one myself—but others were involved too, including a number of business stakeholders, a representative from the BioIndustry Association and other representatives from the pharmaceutical and generic industries. I imagine this will be confirmed by the noble Lord, Lord Warner, when he speaks; I am looking forward to his remarks. All I can say is that that has happened, but obviously the consultations will continue so as to ensure we get the right process for the future, deal or no deal. At the moment we are dealing just with contingency planning should there not be a deal. I think I have moved, and I think I have now sat down.
My Lords, I hope to throw a little light on the subject of consultation during the course of my remarks, which I am afraid will be slightly lengthy. My remarks are based upon a briefing I have received from the BioIndustry Association They relate to its concerns about both the impact and the process by which these regulations were drawn up and consulted upon. Again, I use the term “consulted” in a very loose way.
Before I get down to the business of what the BIA’s concerns are, I want to make a couple of general remarks which came out of our debates in Grand Committee last week about the previous set of regulations, and out of our discussions this afternoon about the first set of regulations. They are two issues which we keep coming back to time and time again. I hope that, for the rest of the proceedings, the Minister might refrain from continuing to run the argument that these documents do not reflect any change of policy. I shall set out the arguments as to why there is a change of policy here. Last week there was a set of policy changes in the regulations that were produced. I understand why there may have been a change of policy, given the circumstances in which these regulations were pursued, but it would be helpful to informed debate for the Government to stop saying that there is no change of policy because there palpably is a change of policy in many of these sets of regulations.
That is request number one to the Minister. The second concerns the Minister saying that somehow these regulations were only hypothetical and relate to a set of circumstances which may not occur. We raised this last week when he was not here and we were dealing with another Minister. The truth is that this is a set of regulations the Government of the day have drawn up and put in the public arena, and they have an impact on the people who may or may not be affected by them. As I said last week, as an ex-civil servant I know that even if these regulations are not used for the purposes for which they have been drawn up, they will be tucked away in a Whitehall cupboard. That is the reality. If we get down to some of these issues subsequent to Brexit day, they will still be there, they will still be a resource which will be drawn upon, and I would be willing to bet a large sum of money that they will be used to some extent in drafting another set of regulations.
The point that we have been trying to make to Ministers, singularly unsuccessfully, is that there are concerns about how they may be used and how the outside world may interpret the Government’s attitude in these areas in the future. That is why it is very important to challenge the Government when there are defects both in the assessment of impacts and in the inadequacy of the consultation process.
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?
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.
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.
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”;
“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.
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?
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—
This is too long.
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.
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.
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.
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.
I take the noble Lord’s point entirely. However, having pointed out the inadequacy of the consultation programme, it also throws into complete disrepute the idea that there was no, or no significant, impact on business or the public sector and they have therefore not bothered to make an impact assessment. When the consultation process has been so manifestly inadequate, it is impossible to say that there has been no impact.
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.
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.
I do not think that I ought to follow the noble Lord down that road because otherwise there will be a complaint that one is somehow not keeping to the fact, but of course what he says is entirely true and I agree with him. However, the point is that we as a Grand Committee must not take any less notice of these SIs on the basis that they might not have to be implemented or indeed even that they probably will not have to be implemented. There are two reasons for that. One is that they could be implemented because that is what we are doing; we are making law. The second reason is the point made by the noble Lord, Lord Warner. In future, even if they were not implemented, in other contexts the fact that we had agreed to them would be used as a mechanism for suggesting that whatever is then being presented is perfectly all right because the Grand Committee of the House of Lords had been through them and they are only repeating them. That is the same kind of argument which says, “We are not actually changing anything”.
That leads me to my third point, which is simply this. If we are unhappy about the nature of the people who were consulted and if we also feel that we ought to know who they were and the circumstances in which the consultation took place, it is also true that we need to question the outcome. It is clear that those who know about it think that this particular SI changes the situation very significantly, but the suggestion is that there are no new obligations or burdens on private, public or third sector bodies and does not require refamiliarisation—a word which I am fascinated to discover and would ask the Minister to explain what it means in order that I get a measure of it. However, if you get the consultation wrong you then get the outcome wrong and therefore you cannot say that there is no need for an impact assessment. The section on impact assessment is thus also very serious.
I direct the Grand Committee to paragraph 12.2:
“There is no, or no significant, impact on the public sector”.
The fact is that if there is no deal and this has to be implemented, there would be a huge impact on the public sector and that impact would be very expensive.
This is another point that I want to raise with my noble friend. There are no costs in this document. We are not told how much it is going to cost. The way to get around that is to say that it is not going to cost very much so, “we do not have to tell you”. However, one of the falsehoods of the whole Brexit argument is the suggestion that we are somehow going to make money out of it, whereas every time you look at any of these things, it means that the United Kingdom is setting up a system to do what historically has been done effectively on a Europe-wide basis. That all costs money and I want to know, as a Member of this House, how much it will cost. It is not acceptable that because we may not have to do it, we do not have to be told how much it will cost.
Perhaps I may further the point that the noble Lord is making. We have now established pretty well that the consultation process was at best flawed but much more likely so limited as not to be taken seriously. From that has come the idea that there is no significant impact, which in turn has led to it being said that no specific action is being proposed to minimise regulatory burdens on small businesses. The weakness of the consultation process at the very beginning has worked its way through to saying, “Bad luck for small businesses”, and indeed, I might say, large businesses.
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.
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.
I entirely agree, but I add to that list the Minister because, like every other Minister, he has to defend all this nonsense. He has to defend a decision which the Government made. The Minister responsible has resigned because he saw what it meant. This Minister has to defend that. I do not think that is fair on Ministers. I do not think it is fair to say to a Minister: “You have to explain why there was no proper consultation; why when it says impact it means ‘impact (none of the important impacts but just those we have chosen)’ and when it says ‘costs’ it gives none because it excludes all the big costs which really matter. So no one can make any decisions about this, but it is all right because it may never be implemented”. I know it is very unpopular with the Whips and with Ministers but frankly, this Grand Committee has got to draw the attention of the public to the fact that these SIs are based on a wholly improper, wholly wrong concept. They are not just a transition operation. They fundamentally change the way in which many industries are going to operate. They fail to list the real costs, they have not consulted those who know and they have done a cosy little arrangement which this House and this Committee should not accept.
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?
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, 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.
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.
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.
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 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.
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.
I will be responding in due course.
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.
What is more, that one person was selected but clearly not trusted.
I was going to leave this to the end and I suspect that any intervention I make will just prolong these proceedings, but for the sake of assisting the noble Lord at this stage, I can assure him that consultation participants on the technical view of the draft instrument included the BIA, the ABPI, the IP Federation, the Chartered Institute of Patent Attorneys, the British Generic Manufacturers Association and the agrochemicals industry.
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.
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.
The exclusivity point is for another regulation on the MHRA.
The exclusivity point is a key element in these regulations, as I made clear. If the Minister looks at Regulation 55, he will see that. I made it absolutely clear—I am not usually noted for obfuscation —that on the subject of exclusivity there was no consultation of the BIA. I cannot be any clearer than that. If the Minister has evidence that the BIA was consulted on the exclusivity point, I would be happy to withdraw that and apologise as graciously as I can, but the information it gave me was that it was not consulted on that point, which is at the core of this set of regulations.
My Lords, I am not sure if it is helpful to continue this discussion. That point is for another regulation, not the ones we are discussing at the moment. We will, no doubt, get to that one—and to that point—in due course. I am not making any accusation that the noble Lord has misled the Committee and I do not think I have misled it. I have made it clear who was consulted and I was hoping I could deal with that in my closing remarks as that might have been a neater and tidier way of dealing with these matters. I will leave it there.
I wonder if the Minister could help me out. I have been listening to the speeches since I came back from the Liaison Committee. In the light of what we have just heard, is the Minister still pressing ahead with this statutory instrument? Would it not be better for him to withdraw it and clear up some of these points before we consider it again?
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.
My Lords, a situation has arisen where there is a serious difference of view, to put it mildly—
A difference of fact.
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.
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.
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, 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 which we can then make as a Grand Committee for who should undertake this responsibility.
I shall pretend to be a Minister and say that I shall look at that very carefully.
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 to 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.
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.
I want to go back to supplementary protection certificates, which has always been an issue of great angst and has always made me happy that my own professional practice was to do with electronics and computer architectures and a long way from drugs—although I am, perhaps uniquely, one of those people who qualify on both sides of the divide between engineers and chemists. It is a difficult issue and therefore there is all the more need for consultation. There are conflicting arguments as to what works legally, what works usefully and economically, and what works simply.
The way it has been done here, the instrument aligns the maximum term for this patent-like right to continue to that which would be applicable in the EEA so that it would all expire at the same time. Was that decision taken to make it simple, in particular because of the decision made about parallel imports, so that you were not having to cross-check whether there were different rights applying at the time of the parallel imports? We have already had a discussion about parallel imports and whether that was a good idea. One comes back to the same situation that we have already visited. I am not sure what the starting point is; I am asking whether it was the decision on parallel imports and whether, if we suggested that perhaps that should be time-limited, even if not in this instrument, we should do something quite quickly to make it so. Would that then adjust what was done by the supplementary protection certificate because it follows that you would? When you come to look at the economic terms, there are lots of things to balance: whether you want a longer term of protection, who is paying for it and what benefits there are to the industry and the country. These are very nuanced and difficult, and there are always protagonists on both sides. Normally, I tend to be one of the protagonists against extensions; you should have to fight hard and justify them. However, that is all the more reason for having a much wider and longer exposure of all these rather difficult issues that one needs to come to grips with. I therefore agree with those noble Lords who have been poking around to see how good the consultation has been because these are serious issues. But, as I said, my question comes back to the fact that it is a bit chicken and egg: was the parallel import decision taken first and did everything else follow from that?
My Lords, we have to conclude after the debate so far that this SI is holed below the waterline and the Minister will have some difficulty in preventing it sinking. He will have to write a pretty good letter by the time this comes to the whole House to see that it goes through when it comes to a vote there. The powerful speech made by the noble Lord, Lord Warner, has exposed the business issues involved in this, I was interested to hear what the noble Lord, Lord Adonis, said about the legal technicalities on this, and of course the impeccable logic of the noble Lord, Lord Deben, and the noble Baroness, Lady Kingsmill, on the consultation and the impact assessment is unassailable. The Minister will therefore have a great deal of difficulty in persuading us to approve these regulations, whether here or, eventually, in the House.
I am grateful to my noble friend who is a patent expert. My expertise in intellectual property extends to trademarks and copyright but it is very useful to have her unpacking of some of these issues as well. What particularly concerns me about the substance of the SI is not just that it is in the eventuality of no deal but that it has all the signs of something that was planned to take effect at the end of the transition period if the Prime Minister’s deal was going to take effect. This looks as if it is a longer-term arrangement. I think it was enshrined in the White Paper, or at least the outlines of it were, and that makes it of particular significance to get right. If there is any kind of deal then I suspect that this is what will be put into effect. It therefore has a double significance and is not just a fix for this purpose which has not been consulted over and which is not acceptable to a major trade body. I have dealt with the BioIndustry Association and I have a great deal of time for it and respect for the expertise that it embodies. The fact that there has not been adequate consultation over something that is potentially a long-term solution makes this even more questionable.
I am sorry to interrupt the noble Lord further but I want to give a bit of support to what he is saying. In my remarks I drew attention to the fact that the MHRA, the UK pharmaceutical regulator, actually tried to suggest to the BIA that it should wait for a review in two years’ time. That looks remarkably like the timetable for the end of the transition period, so I want to give some support to the arguments that the noble Lord is making.
I thank the noble Lord for that intervention because that is exactly the impression that I had got.
To add to the Minister’s woes, I want to go off into a completely different subject that he himself raised at the very beginning: the issue of the Agreement on a Unified Patent Court and the unified patent. The unified patent has come up; the Minister has mentioned it and it was included in the technical note in September. There is a big issue surrounding the Agreement on a Unified Patent Court and the unified patent. If the agreement is ratified by Germany and comes into force ahead of any exit date, the UK will need to work out how to remain a member of the UPC or withdraw from the system, which could have a significant impact on business. Of course at this stage it is not clear if the agreement will come into effect at all, but if it does and if, as a third party country, the UK then wants to take part, is it not clear—I have a 39-page legal opinion on this subject—that we, the UK, will have to acknowledge the supremacy of EU law and the ECJ as part of signing up to the UPC agreement? What kind of “taking back control” for Brexiters will that be?
What advice have the Government received on this matter? I heard what the Minister had to say: he made the very positive statement that we were going to sign up. Have the Government had any further observations on the UPC agreement and the unified patent? How do they envisage UK legislation dovetailing with both systems, assuming that it is ratified?
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.
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 how, 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?
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.
My Lords, I confess that I cannot begin to answer the noble Lord’s question about the Isle of Man, and promise to write on that and the other issues I did not manage to cover. I note what he says about the advice that my department—the Department for Business, Energy and Industrial Strategy—should take from Her Majesty’s Treasury. As with all departments, we always listen carefully to what our colleagues in the Treasury say, and this time will be no exception.
I was not intending to intervene in the middle of the debate, but I did, and so to get back to this question of consultation and how we set about this with these regulations—which I repeat are only to deal with the no-deal possibility—I think the noble Lord, Lord Adonis, would be the first to agree that we would be irresponsible in not having done something should that eventuality arise. I give way to the noble Lord.
The Minister has been very kind and polite, and I am most grateful to him. Talking about the impossibility of dealing with things, I—like the noble Lord, Lord Deben—have some sympathy with him, and even more with his civil servants behind him. In today’s Order Paper, there are 38 affirmative instruments waiting for consideration by the Joint Committee on Statutory Instruments, 65 affirmative instruments waiting for affirmative resolution and 18 proposed negative statutory instruments made under the European Union (Notification of Withdrawal) Act 2017. Is it not irresponsible to be pressing ahead with this, with no proper scrutiny on things such as conservation, animal health, veterinary surgery, pesticides, employment rights, construction products, insurance distribution, maritime transport, motor vehicles, plant health, air quality? I could go on and on. We are rushing them all through. Is that not irresponsible? Is that not a waste of the Minister’s time and the time of the well-qualified people behind him, in anticipation of something none of us really want to happen? Would it not be better if the Minister came to his senses now, withdrew this order and, along with all his other colleagues, said, “We are not going to take any more of these orders through the Grand Committee and the House of Lords because it is a total waste of time and totally irresponsible”?
My Lords, I am always kind and polite to the noble Lord. I know he is a delicate flower and does not want me to be too hard on him.
I appreciate there are a lot of no-deal regulations and that we are asking a lot of the Joint Committee on Statutory Instruments. The noble Lord has served on that wonderful committee, as have we all, and it does a very good job, as do the other committees that have this duty. We are satisfied that they have enough time and resources. I think the House feels that it too has enough time. This can be discussed by the usual channels. We are having a very useful debate this evening and I am looking forward to continuing that process. It is difficult, but equally it would be much more irresponsible not to be moving regulations or producing them for the eventuality that there was a no deal, because the noble Lord will be aware that as a result of Article 50 and various other acts of Parliament that have been through both Houses, if we do not reach an agreement by 29 March, we leave the EU without a deal. This order, the previous order and other orders are designed to provide that certainty businesses need, and we will continue to move the appropriate orders.
Will the noble Baroness let me finish? I will then give way. She must not be quite so enthusiastic.
As is right and proper, we will then move them so that we can be in that prime position.
My Lords, it surprises me that the Minister is not concerned by the extent of the statutory instruments still to be debated, because the question must be asked: why on earth are we rushing through them at this late stage? There have been two years in which we could have been prepared; there were two years when the possibility of a no-deal outcome was on the cards. Why on earth are we and the noble Lord’s civil servants being expected to race through with inadequate research and consultation now at such a late stage when there have been two years when these things could have been prepared?
My Lords, I simply do not accept that point. The fact is that we are doing them now and giving them proper scrutiny, as the noble Baroness, her noble friend and other noble Lords would accept. There will be other opportunities to debate this and other regulations.
One more point very briefly—
My Lords, I am on my feet, and I will give way to the noble Baroness when I wish. I will now give way.
May I just say that we have been at this for getting on for four hours? If we proceed at this pace with the number of statutory instruments that we have still to debate, we will never get through them and there will be a vote before long to say that there will be no no deal. So what is the point of all this? I referred earlier to Alice in Wonderland; it seems even more peculiar.
My Lords, the noble Baroness is getting on to wider questions. I cannot remember whether it is in Alice in Wonderland or Through the Looking Glass, but I am a mere pawn on the chessboard of life. I believe that we are having appropriate discussion on the order and I think that it is right and proper that, since we have started, we should continue. I look forward so to doing and, as I said, there will possibly be other opportunities as well. I think we should continue with that. Others, who may be the kings, queens and bishops, will then discuss what is the proper procedure, but at the moment, we are considering the Patents (Amendment) (EU Exit) Regulations, which relate only to no deal. We do not want to broaden it out to other things; others can discuss that issue.
Let me return to the debate and the consultation. As I made clear earlier, the IPO sought the views of a group of individual stakeholders—I shall not go into the slightly different words that my noble friend cited from different letters—and consulted them in their personal capacity to identify any issues with the drafting and raise any concerns with the approach. As I made clear, legal experts—there is nothing wrong with lawyers; the noble Baroness, Lady Kingsmill, is one of them, as am I—and business representatives were present. It was a helpful and constructive review of the draft and it was understood that the regs were designed to maintain continuity. I repeat for the sake of the record that at that meeting, as I understand it, there were representatives from the BIA, the ABPI, the IP Federation, the Chartered Institute of Patent Attorneys, the British Generic Manufacturers Association and the agrochemicals industry. If I can add to that list and give further details, I will certainly include that in any letter I write to noble Lords.
On letters, I believe—I am open to correction—that in advance of these regulations I wrote to the noble Lord, Lord Stevenson, and to the noble Lord, Lord Fox, from the Liberal Democrat Benches. I do not know whether I should have taken that wider and written to others. I will consider that with each order I deal with, as appropriate. I also make clear, on the lack of consultation, that we were not preoccupied with the deal. The IPO had sufficient resources to take both deal and no deal in parallel. It was necessary across Government to treat no-deal preparations sensitively when we were in the middle of negotiating a proper deal. From the perspective of business, retaining the regulations means that both the process for applying for an SPC and the scope of the right for which it is granted would be the same after exit as before.
I turn to the post-exit concerns of the noble Lord, Lord Warner. I appreciate that after exit day there may be new drivers for policy change. I think it was the noble Lord who talked about the possible time it may take to get a UK authorisation compared to now and the potential effects. I hear the noble Lord’s concerns, but we should understand the issues when the time comes then properly consider the right policy solution at that point. As I have already said, I would expect that to involve the more usual open and constructive discussions with stakeholders and interests in this area that the IPA usually enjoys. I can assure the noble Lord and others that our intention would be to fully engage with the BIA, the IP Federation and other similar bodies.
I just want to clarify for the Minister that the damage to the life sciences will be wider as a result of Brexit, but the point I made in my speech was that it is the result of the approach to exclusivity and SPCs in this set of regulations. It is not a wider set of damage. It is a damage to the industry and the sector arising from this set of regulations.
The noble Lord is right to point to the importance of the life sciences sector, and I am grateful he did. One should also re-emphasise—I would be grateful if the noble Lord would do so—just how important the life sciences industry is to us and what a great state it is in at the moment. The noble Lord will be aware of the recent stage 2 of the sector deal in life sciences that we published along with that sector. I am sure the noble Lord very much welcomed the fact that a major multinational—one based in Brussels, for that matter—announced at that stage that it was investing a further £1 billion over the next five years in research in the UK. Obviously Brexit is not putting off certain parts of the life sciences industry, and I am sure the noble Lord will welcome that.
I do not share the noble Lord’s view that there is a policy change. The SI maintains precisely the current calculation of the SPC duration, and at present it is calculated from the first marketing authorisation in the EEA, which includes the UK. After exit, without the provisions we have set out in this SI, the duration of an SPC in the UK would be calculated from the first authorisation in the EEA—but that would not include the UK. That would be nonsensical and is exactly the sort of deficiency that Parliament gave Ministers carefully limited powers to fix within the withdrawal Act. We believe we are complying with the powers we have within the withdrawal Act. That is what the SI does. It shows that after exit, SPCs within the UK will continue to be calculated from the first marketing authorisation in the EEA or the UK, and the status quo is maintained.
Finally, I turn to the point made by the noble Lord, Lord Adonis, about the Explanatory Memorandum. He said that there was little impact. If a measure has a net impact to business of less than £5 million then obviously a full impact assessment is not required. The £5 million threshold, as the noble Lord will be aware as a former Minister, is set out in the better regulation framework guidance, and measures below the threshold must be accompanied by a proportionate analysis. The analysis is summarised, as the noble Lord will be well aware, in paragraph 12.3 of the Explanatory Memorandum.
I used the word “finally” but, if noble Lords will bear with me, I will have one or two more “finallys”. I turn to the concerns about the unified patent court. We have set out our proposals for the future relationship with the EU, including exploring continued participation in the UPC and the unitary patent. In the political declaration, the UK and the EU have agreed to co-operate in areas of mutual interest relating to intellectual property, including patents. The future of the UPC and the unitary patent will be a matter for negotiation. It is therefore rather too soon to be setting out the further dovetailing legislation.
The noble Lord, Lord Clement-Jones, also set out the points made by the law firm Bristows. We are aware of the point that Bristows has made. The patents legislation contains a number of references to the comptroller and the court, and all those references will be modified in the event of the UPC coming into force. The patents legislation will fully recognise the jurisdiction of the UPC.
I apologise to the Minister but actually it was not the Bristows opinion; the 39-page opinion that I mentioned is actually from Brick Court Chambers, and it is very comprehensive. It makes it very clear that if we are to sign up, or to continue with our intention to sign up, we will have to recognise the jurisdiction of the European Court of Justice and there will be no getting out of that. That is what makes this so ironic in the circumstances.
I look forward to reading the opinion that has emanated from Brick Court Chambers in due course. I was responding, I thought, to the points that the noble Lord had made about Bristows.
That was the noble Lord, Lord Adonis.
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.
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.
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.
I have two points before the Minister sits down. First, I do not think he replied to my point about whether there was any intended alignment with the supplementary protection certificates and parallel import points. The Minister may wish to come back to me on that. Secondly, the unified patent court and its relationship to the ECJ has been mentioned. That is inevitable. The unified patent court is an international court. The European patent is not an EU invention—it is external to it—but it has been agreed under the convention to which the UK is a party that it recognises the judgments of the ECJ. As I understand it, our own Intellectual Property Office would therefore have to take those judgments into account. Whatever convolutions there may be, we will not get away from the influence of ECJ decisions, whether or not the unified patent court comes into being.
My Lords, I will write to the noble Baroness on both those points.
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.
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.
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.
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 Question is that the Grand Committee do consider the Patents (Amendment) (EU Exit) Regulations 2018.
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.