Patents (Amendment) (EU Exit) Regulations 2018

Debate between Lord Clement-Jones and Lord Warner

Wednesday 6th February 2019 Lords Chamber

[Lord Warner (CB)]

My Lords, I raised several concerns about this SI in Grand Committee, as the Minister recognised. As he knows, these were the result of briefings from the BIA and the ABPI, with which I am glad to say he has had further meetings. However, since his meetings both these organisations have provided me with further briefing about their continuing concerns.

Before turning to these concerns, I will briefly place them in the wider context of the damage done by Brexit—and the Government’s conduct of it—to our highly successful life sciences industry. This damage could make Nissan and Sunderland look like small beer if we are not careful. From the Prime Minister down, the Government have shown a poor appreciation of the damage being done to this sector: the loss of the EU medicines regulator from the UK; the loss of investment opportunities in the UK; the missed opportunities for collaborative international joint research, development projects and clinical trials; the drain from the UK of talented overseas scientists; and the likely loss of a growing amount of our own homegrown scientific talent.

To this litany of casual vandalism the Government have now added a statutory instrument which, if it were used in the case of our exiting the EU with no deal, would reduce the protection of exclusive intellectual property. The problem is caused by the SI’s approach to supplementary protection certificates—SPCs—which are a key part of the intellectual property protection framework for pharmaceutical research. SPCs are intended to give a period of exclusivity from inherent risks in the development of new pharmaceutical products. But the industry’s trade bodies—both the BIA and the ABPI—are convinced that, in the real world that they occupy, the SPCs as structured in this SI are fundamentally flawed.

In their view—the exact opposite of the Minister’s—this flaw reduces the period of exclusivity for drugs authorised in the UK, because the start of the period for exclusivity in the UK is backdated to a drug’s earlier authorisation in the EU. They are losing a bit of their exclusivity period. The chief executive of the ABPI put this extremely well:

“Britain is internationally renowned for its strong IP framework and this has made it an attractive home for investment from all industrial sectors, including pharmaceuticals. We’re concerned that these measures are a step backwards and seriously undermine the strong life sciences sector that we’ve worked so hard to build over the past 70 years”.


These views are shared by the BIA.

The problem has arisen in large part from the Government’s failure to consult properly on these regulations at the outset—as has been shown to be the case in other no-deal SIs, as we have already discussed. I drew the Minister’s attention in Grand Committee to the inadequacies of that consultation process, and I am pleased to see that he seems to have accepted some of that and tried to rectify matters through proper discussion with the ABPI and the BIA. I congratulate him on taking that particular initiative.

I think that the Minister will be pleased to know that I do not intend to bang on further about past misdemeanours. Instead, I ask him to give the industry two clear-cut assurances about the future conduct of the Government. First, I would like to hear it from him, on the record, that the Government recommit to the UK’s status as a world leader in safeguarding intellectual property and commit to make no further erosions of the UK intellectual property framework; and, secondly, that the Government commit to a specific review of the intellectual property legislation being introduced through statutory instruments as part of the no-deal Brexit planning. The reason for that second one is, frankly, that the industry is very sceptical about whether the Government will just drop these proposals if there is a deal. Ministers in the Government need to understand that they have lost a lot of the confidence of this sector. The time has come for them to start to rebuild that confidence in an industry which is vital for this country’s future.

[Lord Clement-Jones (LD)]

My Lords, the noble Lord, Lord Warner, has expressed the impact on the life sciences industry extremely effectively and eloquently, and I do not wish to repeat anything of what he said. Quite apart from the damning quote from the chief executive, Mike Thompson, the key sentence that I saw in the ABPI’s briefing was:

“The signal the Government has sent to global pharmaceutical companies large and small is that the UK will be less committed to IP protection after Brexit than it has been to date”.


For a major industry to consider that seems extremely damning.

As the noble Lord, Lord Warner, pointed out, the Minister said that it is correct to raise these issues and he is keen to start exploring them, so there is some intention now to have some consultation post the SI rather than proper consultation before it. I think we are looking forward to hearing a bit more of a concrete proposal from the Minister with regard to what precisely is planned.

The Minister’s six and a half-page letter, as we must now call it, dealt with the question of participation in the unified patent court, as set out in the White Paper last autumn. I made the point in Committee that if the UP convention is ratified by Germany and comes into force ahead of our exit date, the UK will need to work out how to remain a member of the UPC or withdraw from the systems, which could have significant impacts on business. In that context, I questioned in Committee whether the UK will have to acknowledge the supremacy of EU law and the ECJ as part of the signing up process. In his letter, the Minister advises that,

“when ruling on domestic cases, UK courts will not be bound to follow decisions of the UPC, or rulings of the European Court of Justice applied by the UPC”.

The last time we discussed this SI, I brandished a 39-page opinion on the subject, so I am rather baffled by the advice that the IPO and the Minister have received in those circumstances, if we have signed up to the unified patent court agreement. I would very much like to hear a bit more clarification on that subject from the Minister.

Patents (Amendment) (EU Exit) Regulations 2018

Debate between Lord Clement-Jones and Lord Warner

Monday 14th January 2019 Grand Committee

[Lord Clement-Jones (LD)]

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.

[Lord Warner]

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.

[Lord Clement-Jones]

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?

European Union (Withdrawal) Bill

Debate between Lord Clement-Jones and Lord Warner

Committee: 6th sitting (Hansard): House of Lords
Monday 12th March 2018 Lords Chamber

[Lord Warner]

My Lords, I have added my name to the amendments and agree entirely with what the noble Lord, Lord Stevenson, said. I do not intend to traverse the same ground as him and may not be quite as helpful to the Prime Minister as he has been.

I want to add a dimension on data protection from the perspective of someone who has been a Minister and a senior civil servant. It is very easy for even the most well-intentioned Minister to overlook the importance of data protection and privacy to some of our fellow citizens when we are trying to push through what is seen as a measure of great collective benefit. We have seen how easy it is for free-speech arguments to trump individual privacy considerations. In the rush to secure medical advances through research, it is easy to see people who are nervous of giving their medical history to a researcher they do not know as Luddites to be overruled. That is why the Data Protection Act 1998 was a landmark Act. It calls on bureaucracies to stop and think and to become more thoughtful about citizens’ rights to privacy and individual data protection. Since that Act, case law has extended those protections in many cases. We do not want any backsliding, and there are plenty of powerful interests who would backslide if these legal protections were diminished. It is for similar reasons that the successor to the 1998 Act needs to be fully protected following our departure from the EU, and that protection needs to be set out clearly in this Bill. This is even more the case given that the Government have set their face against protecting the transfer into UK law of the Charter of Fundamental Rights, which contains privacy provisions.

As I said on an earlier amendment on clinical trials, we need overtly to protect existing rights and provisions important to our fellow citizens from casual vandalism later. That means being sceptical about assurances from Ministers, even the Prime Minister, in relation to this Bill and relying on future actions to preserve safeguards. We have to put more guarantees in the Bill before it leaves this House, as I said on Amendment 84. I want before I sit down to draw the attention of those who were not present for the debate on that earlier amendment to two important points made respectively by the noble and learned Lords, Lord Judge and Lord Mackay. My noble and learned friend Lord Judge, as I understood him, ventured the view that the new EU regulations of concern under Amendment 84 could be added to Clause 7(7). That seems to give support to this amendment. If we went down that route, we would be doing exactly the same for data protection issues as for clinical trials. That suggests that there is scope in the Bill for specific EU regulations to be given particular protection where it is considered of such importance to the rights and safeguards of citizens.

Similarly, on the same amendment—I would need to read Hansard to check that I understood it correctly—the noble and learned Lord, Lord Mackay of Clashfern, made a contribution that was extremely helpful to the Minister, who, if I may put it delicately, was in a little trouble over that amendment. He suggested that, where there were new provisions and some ambiguity about whether the full protections would be safeguarded, it would be open to this House and the Government to consider putting a list of regulations requiring special protection in some form in this Bill.

If that course of action commended itself to the Government before Report, I would respectfully suggest that data protection should be on that list as something that will be given particular protection. I think there is a very strong case, as the noble Lord, Lord Stevenson, has argued very convincingly, to give some special protections in the Bill to data protection. Regardless of whether this amendment is precisely the right wording, or whether there is another way of doing it, I think that the noble Lord has made the case, just as I think that we made the case earlier this afternoon on clinical trials regulations. I think the Government need to think, in the way that the noble and learned Lord, Lord Mackay of Clashfern, was saying, about the kinds of issues that merit that kind of protection if we are to safeguard well-earned citizens’ rights and protections that have built up over time.

[Lord Clement-Jones (LD)]

My Lords, it is a pleasure to follow the noble Lord, Lord Warner, and speak to Amendment 88 and the other amendments in this group. I very much support the words and the very comprehensive introduction that was given by the noble Lord, Lord Stevenson. It is vital to many key sectors—manufacturing, retail, health, information technology and financial services in particular—that the free flow of data between ourselves and the EU continues post Brexit with minimum disruption. With an increasingly digital economy, this is critical for international trade. TechUK, TheCityUK, the ABI, our own European Affairs Sub-Committee and the UK Information Commissioner herself have all persuasively argued that we need to ensure that our data protection legislation is treated as adequate for the purpose of permitting cross-border data flow into and out of the EU, post Brexit.

Fears were expressed in Committee and eventually the Data Protection Bill was amended on Report and at Third Reading to show that some principles, at least, were incorporated in the Bill, despite the fact that the European Charter of Fundamental Rights will not become part of UK law as part of the replication process in this Bill. The noble Lord, Lord Stevenson, quoted the Prime Minister’s recent Mansion House speech, a speech that I am sure will be quoted many times, when she said that,

“we will need an arrangement for data protection. I made this point in Munich in relation to our security relationship. But the free flow of data is also critical for both sides in any modern trading relationship too. The UK has exceptionally high standards of data protection. And we want to secure an agreement with the EU that provides the stability and confidence for EU and UK business and individuals to achieve our aims in maintaining and developing the UK’s strong trading and economic links with the EU. That is why”—

this is exactly what the noble Lord, Lord Stevenson, said—

“we will be seeking more than just an adequacy arrangement and want to see an appropriate ongoing role for the UK’s Information Commissioner’s Office”.

Whether or not something more than adequacy will be available—the noble Lord, Lord Stevenson, also dealt with this—depends on the EU, which states quite clearly, in paragraph 11 of its recent draft negotiating guidelines:

“In the light of the importance of data flows in several components of the future relationships, personal data protection should be governed by Union rules on adequacy with a view to ensuring a level of protection essentially equivalent to that of the Union”.


I have slightly more extensively quoted paragraph 11 of the recent guidelines, but the difference between those two statements is notable. Both the statements recognise the fact, as many of us emphasised in this House during the passage of the Data Protection Bill, that the alignment of our data protection with the EU is an intensely important issue. There will be a spotlight on the question of whether we meet an adequacy assessment by the European Commission, which I think we all agree is necessary and essential.

As I said on Report and at Third Reading of the Data Protection Bill, the Government added a new clause designed to meet the adequacy test in future, yet this Bill also gives Ministers power to make secondary legislation to amend any retained EU law, which would include laws governing data protection rights. So the Government could give with one hand and take away with the other. This amendment, as the noble Lord, Lord Stevenson, emphasised, is exactly designed to avoid a situation where our data protection law does not meet the adequacy test, to the great disadvantage of our digital economy and other sectors. Set against this danger, it cannot be necessary or desirable to exercise any of the powers in Clauses 7, 8 and 9 to repeal any part of our data protection legislation, which we have so carefully crafted and adopted. These are probing amendments but I certainly hope the Minister can give us the necessary assurance to make sure that such amendments do not reappear on Report.