European Union (Withdrawal) Bill

Lord Sharkey Excerpts

Report: 6th sitting (Hansard): House of Lords
Tuesday 8th May 2018 Lords Chamber

[The Deputy Speaker (Lord Faulkner of Worcester) (Lab)]

I advise the House that if Amendment 70 were agreed to, I would not be able to call Amendments 70A to 70BB because of pre-emption.

[Lord Sharkey (LD)]

My Lords, I declare an interest as chair of the Hansard Society, whose work on delegated legislation will be familiar to many of your Lordships. I will speak briefly in support of Amendment 70—the sifting amendment—to which I have added my name. I will also speak briefly to introduce Amendment 71. The noble Lord, Lord Lisvane, has set out very powerfully the case for Amendment 70—for the sifting committees’ decisions to be binding on Ministers—as has the Delegated Powers Committee in its reports.

When we debated an equivalent amendment in Committee, the Government’s argument against the proposal relied chiefly on their assertion that they were in any case likely to accept the sifting committees’ decisions and that, as the noble Lord, Lord Lisvane, said, ignoring them would be, “hopefully, very rare”. This is a very weak argument. It is not based on principle. It is based on a suggestion of compliance, except in undefined, unexampled and no doubt exceptional circumstances. What it really means, of course, is that the Government, at their absolute discretion, will be able to impose the negative procedure on SIs, denying Parliament the more robust and intensive scrutiny provided by the affirmative procedure.

There is simply no case for allowing the Executive this unfettered and unqualified discretion. If Parliament is properly to exercise its scrutiny function in the face of the tsunami of SIs coming our way, it must be able to decide conclusively which SIs deserve higher levels of scrutiny and which do not. That is the whole raison d’être of the sifting committees: they allow Parliament itself to decide which SIs merit what level of scrutiny.

Not only have the Government demonstrated no real need for this override power, they have not even hinted at any harm that might be done by making the sifting committees’ decisions binding. In any case, throughout this Bill we must guard against the unnecessary transfer of power to the Executive. What the Government propose is such an unnecessary transfer of power. I hope that the noble Lord, Lord Lisvane, will press his amendment to a vote. If he does, we will support him.

I turn very briefly to Amendment 71, which is in my name and those of the noble Baroness, Lady Jay of Paddington, and the noble Lords, Lord Lisvane and Lord Norton of Louth. The Government expect this Bill to generate between 800 and 1,000 SIs. There will be many others generated by other Brexit Bills. As things stand, we have only two options for dealing with these SIs: we can accept them or we can reject them. A regret Motion has no practical effect.

In the past, this House has shown an understandable and very deep reluctance to reject affirmative SIs. We have rejected just six in the past 68 years. We have used our “nuclear option” very infrequently. This entirely understandable reluctance to reject will certainly continue for withdrawal SIs. But given the enormous volume of such SIs and the delicate and sensitive areas they will deal with, this proper reluctance to press the red button will almost certainly lead us to approve marginal cases or cases about which we retain serious misgivings. This would be an unsatisfactory outcome for the quality of created law and potentially damaging to the balance of power between the Executive and Parliament.

Amendment 71 proposes an additional method of dealing with affirmative SIs—and it is an additional method; it does not in any way affect our current powers. We would retain unaltered our powers to approve or reject, exactly as at present. Amendment 71 would simply allow us to do what we so frequently do: to ask the Commons to think again. Where we believe that asking the Commons to think again would be desirable, we simply co-ordinate scrutiny so that the Commons can pronounce first. If it rejects the SI, that is the end of the matter. If it approves, Amendment 71 would allow us to ask the Commons, with reasons, to think again. This mechanism would not frustrate the will of the Commons. If it chose not to reconsider within 10 days, the Lords would be deemed to have approved the instrument.

Amendment 71 would give Parliament more flexibility and room for more discussion in dealing with those SIs where real concern exists but where we are properly reluctant to reject. It simply allows a conversation with the Commons, after which the Commons will decide the matter. I commend it to the House.

[Baroness Neville-Rolfe (Con)]

My Lords, I rise to move Amendment 84 and I am grateful for the support of the noble Baroness, Lady D’Souza. During the passage of the Bill I have raised several issues, all of them designed to ensure that the SIs that will eventually be made under it when it becomes an Act will contain as few errors as possible. This may seem a modest aim, but we are in uncharted waters, and the amount of secondary legislation that will be needed, as has been mentioned, and the little time available to make many hundreds of instruments, taken together with the imperfect nature of human faculties, make error all too likely. One way to minimise this is to consult those with knowledge of and interests in the question at issue. This in turn necessitates publishing draft instruments that can be scrutinised by all. As is so often the case, openness is the best antidote for error.

We have made progress. The Minister has kindly arranged for me to meet officials concerned with agriculture, customs, intellectual property and financial services. It is clear to me that proper plans have been made. A few draft instruments have been published, but things are moving forward at a slow pace. We have made less progress on agriculture than I had hoped; I should declare an interest as chairman of Assured Food Standards Ltd, which operates the Red Tractor scheme. However, this is not the fault of Defra, which seems to be well resourced in this area. One of the serious problems for that department stems from recent rows over devolution, which affects draft SIs in the vital areas of agriculture and fisheries. Defra seems unable to publish drafts without the agreement of the devolved Administrations. This has proved to be an unfortunate state of affairs, which would have been better avoided—but in any case it would be better for everyone in the UK, including the devolved Administrations, if many more specimen drafts were published immediately.

There have been several debates on subordinate legislation and I am glad that the Government have made some very important concessions on scrutiny. Indeed, this very evening they have done so on ambulatory references and arrangements in Scotland. However, the Government have also lost on an amendment in this area, which means that they will be looking at the arrangements again in the House of Commons. That is where I believe Amendment 84 might be useful. It is modest—much more modest than my earlier amendments and those of others—and asks the Government to make public their statutory instruments on GOV.UK 10 days before they are laid. That is all I ask. It would be any 10 days, including parliamentary recesses and festivals.

I would like the Minister to write this into law, perhaps as part of the review of Amendment 31, in the name of the noble Lord, Lord Lisvane, and its consequentials. But if that cannot be, I would like her to undertake to add this provision to government guidance on the making of statutory instruments. As an ex-Minister who has had the embarrassment of having to make new orders correcting past mistakes, I can assure her that future legislators and civil servants would thank her. I beg to move.

--- Later in debate ---

Moved by

[Lord Sharkey]

72: Schedule 7, page 45, line 32, leave out from “contains” to end of line 34 and insert—
“(a) a declaration that the Minister of the Crown concerned is of the opinion that, by reason of urgency, it is necessary to make the regulations without a draft being so laid and approved, and(b) a statement of the grounds for urgency.”

[Lord Sharkey]

My Lords, Amendment 72 would impose measures on the Minister, where he or she was dealing with the urgency procedure in the Bill, for the delaying of “made affirmative” SIs. When we debated this in Committee, I made the point that there was no need, as the Bill is currently constructed, for the Minister to give any explanation for why he or she thought that the instrument should be urgent. I suggested, as Amendment 72 does, that the Minister should explain in writing why the SI should be considered urgent. However, I notice that in Amendment 83N—I am sure that the Leader of the House will explain it in a moment —the Government appear to have recognised the force of the arguments we advanced in Committee, which I have just summarised. In my view, Amendment 83N satisfies the requests we made in Committee and the requirements of Amendment 72. However, I want to ask the Leader of the House a question about where Amendment 83N specifies a failure to give reasons for urgency.

--- Later in debate ---

[Lord Sharkey]

In fact I was thinking of government Amendment 83N—I am sorry that I did not make that clear—which deals with Amendment 72. I was about to ask a question. Amendment 83N says that in the case of a failure of a Minister to give the reasons that he or she should give for urgency, the Minister must write explaining why he has failed to do that. The only thing missing at this point is some indication of when he might write to do that. I ask the Leader of the House to try to help the House by indicating when a Minister should write to indicate his sorrow and apology for not doing what the amendment asked him to do. With that, I beg to move.

[Baroness Smith of Basildon]

My Lords, the amendment is self-explanatory. If urgent regulations have to be laid, having an explanation and clarity from the Minister as to why it is urgent is always helpful. It is fairly simple and straightforward. I hope the noble Baroness will say that she is prepared to accept the amendment.

[Baroness Evans of Bowes Park]

I thank noble Lords for this very brief debate. As I indicated in Committee, the Government have reflected on this point further and decided to table their own amendments to achieve the same aims as the noble Lord’s amendments. The Government have always said that we expect Ministers to use the Bill’s urgent procedure rarely. This might be where, for example, corrections to the statute book are required very close to exit day and where the impact of not making these corrections would be significant.

The Government have always been committed to ensuring an appropriate level of scrutiny is afforded to the Bill’s provisions. I remind noble Lords that the made affirmative procedure still requires debates and potentially votes in both Houses. We have always wanted to be transparent about how this unusual process will work and it is for that reason that we have clarified the time period in which a made affirmative SI must be debated. In response to the persuasive case made by noble Lords in Committee, where the Government choose to use the urgent procedure we are happy to commit in statute to supplementing any declaration of urgency with a commitment to making a statement explaining why this was considered to be appropriate. In response to the question asked by the noble Lord, Lord Sharkey, Ministers will write as soon as is practicable. This is in addition to the obligation to make a statement.

While the Government cannot accept the noble Lord’s amendment for technical reasons, I hope noble Lords will be content to accept those tabled by the Government in its place and that the noble Lord, Lord Sharkey, will feel able to withdraw his amendment accordingly.

[Lord Sharkey]

I thank the noble Baroness the Leader of the House for Amendment 83N and for agreeing with us that it is in fact necessary. With that, I beg leave to withdraw the amendment.

Amendment 72 withdrawn.

European Union (Withdrawal) Bill

Lord Sharkey Excerpts

Committee: 7th sitting (Hansard - continued): House of Lords
Wednesday 14th March 2018 Lords Chamber

Moved by

[Lord Sharkey]

200: After Clause 9, insert the following new Clause—
“Statutory instruments under other Acts of Parliament for the purposes of withdrawal
(1) The Statutory Instruments Act 1946 is amended as follows.(2) After section 9, insert—“9A Instruments relating to the United Kingdom’s withdrawal from the European Union (1) Any statutory instrument under any Act of Parliament containing regulations to make provisions for the same purposes as set out under section 7, 8 or 9 of the European Union (Withdrawal) Act 2018, is subject to the same parliamentary procedure as an instrument made for the same purposes under a power provided for in those sections.(2) Subsection (1) applies instead of the parliamentary procedure set out in any Act under which the instrument is made.(3) For the purposes of this section—“the same purposes as a power provided for in those sections” means—(a) under section 7, regulations which make such provision as the Minister considers appropriate to prevent, remedy or mitigate—(i) any failure of retained EU law to operate effectively, or(ii) any other deficiency in retained EU law,arising from the withdrawal of the United Kingdom from the EU;(b) under section 8, regulations which make such provision as the Minister considers appropriate to prevent or remedy any breach, arising from withdrawal of the United Kingdom from the EU, of the international obligations of the United Kingdom; and(c) under section 9, regulations which make such provision as the Minister considers appropriate for the purposes of implementing the withdrawal agreement if the Minister considers that such provision should be in force on or before exit day;“exit day” has the same meaning as in section 14 of the European Union (Withdrawal) Act 2018.””

[Lord Sharkey]

My Lords, I declare an interest as chair of the Hansard Society, whose work on delegated legislation will be known to many noble Lords. I will be brief in dealing with what is essentially a simple procedural proposal.

The issue is delegated legislation. This has already been the focus of a lot of debate, much of which has consisted of expressions of anxiety about the likely number of instruments; about the range of the powers that they confer; about timing; and about Parliament’s ability to conduct proper scrutiny. There are varying estimates of the number of SIs that the Bill will produce. The noble Lord, Lord Callanan, said in his letter of 20 February that it will be between 800 and 1,000. Our own EU Justice Sub-Committee thinks it may be 5,000, as the noble Earl, Lord Kinnoull, noted on Monday. What is clear is that the number will be very large. The noble Lord, Lord Callanan, estimates that 20% to 30% of those SIs will trigger the affirmative procedure. That estimate is no doubt based on the rules for categorisation set out in the Bill, and will certainly prove to be an underestimate once the sifting committees get to work.

As has been noted, the SIs will give the Government an extraordinary and quite unprecedented range of powers. They will enable the creation of criminal offences without primary legislation, as the noble and learned Lord, Lord Judge, has explained to us; they will allow law-making by tertiary legislation; and they will allow Ministers and, apparently, 109 others largely unfettered discretion to range across the statute book. All this presents a formidable challenge to Parliament when it comes to effective scrutiny. The Government seem to recognise—a bit—that the situation is unprecedented and requires special care. They have written some constraints into the SI-generating clauses, but not enough and not wide enough. These constraints do not, in any case, address the problem of sufficient and effective scrutiny.

We will come to proposals for dealing with the scrutiny problem when we reach the group beginning with Amendment 237 on Monday. These amendments will enable the House to debate how it might adapt our current SI scrutiny system so that we may deal effectively with the avalanche of SIs coming our way. There are at least three schemes for us to consider. But whatever system of scrutiny the House finally settles on, it should apply to all SIs generated by this Bill. The same system, whatever it turns out to be, should also apply to all other SIs, whatever their parent Act, if they are to be used for the purposes of maintaining a coherent and functioning statute book on withdrawal from the EU. It would be quite wrong, for example, to have a rigorous system of scrutiny of SIs generated by this Bill and a less rigorous system for SIs used for withdrawal purposes generated by existing Acts.

This is not a theoretical concern. We know that the Government intend to use SIs generated by existing Acts when they consider that to be appropriate, or perhaps even necessary. The Solicitor-General made it clear in his speech on day 2 of Committee in the House of Commons that that is what the Government would do. In response to that, Amendment 200 sets out to create a common minimum standard of scrutiny. It simply requires that, no matter their provenance, all SIs with the same withdrawal purposes should be subject to the scrutiny procedures we finally agree on SIs generated by this Bill. It does this by making the appropriate amendment to the Statutory Instruments Act 1946, and by specifying in language taken directly from this Bill what “withdrawal purposes” means.

In a brief conversation about this amendment with the noble Lord, Lord Callanan, and his officials, they reminded me that this amendment could not bind future Acts. That had occurred to us. Any future Act could, of course, write its own rules for withdrawal SI scrutiny, or indeed for anything else. But, if that happened, the Government would have to explain to Parliament why one type of scrutiny was appropriate for SIs generated by the withdrawal Bill, with another for SIs with the same purpose generated by subsequent Bills. We should have one minimum standard of scrutiny for any withdrawal-purposed SI, and this amendment is aimed at doing exactly that. Whatever scrutiny standards we eventually adopt for SIs arising out of this Bill, they should be the minimum standard applying across all similarly purposed SIs, wherever they come from, and whatever their parent Act. I beg to move.

[Lord Hope of Craighead (CB)]

There is a good deal to be said for the amendment moved by the noble Lord, Lord Sharkey, when one bears in mind the power given in each of Clauses 7, 8 and 9 to make any provision that could be made by an Act of Parliament under regulations made under these clauses. Of course, one can look back to an existing Act, which could be amended by the exercise of this power, for a purpose related to the Brexit arrangements. If one takes an existing Act—one can visualise all sorts of situations when that might arise—it would seem right that the same procedure should apply if the amendment is made for the purposes which one sees in Clauses 7, 8 and 9.

For future Acts I can see there is a problem, because one cannot control a future Parliament, but as far as the past is concerned I respectfully suggest that there is a lot to be said for the amendment.

--- Later in debate ---

[Lord Callanan]

My Lords, I first thank the noble Lord, Lord Sharkey, for tabling this amendment so that we can have a discussion about this and for the extremely courteous discussion that he had on this matter with me and my officials.

Many of us here today are opposed, in general, to making sweeping fixes to the whole statute book through one Act. Indeed, that is the cause of many of the concerns about the powers in this Bill, and an issue that the noble Lord, Lord Sharkey, addresses with his amendment. I am therefore wary of inadvertently undermining the delicate and proportionate balances struck within other Acts between haste and scrutiny. The need to deal with the detail of how the Acts differ from one another is, however, what makes these Henry VIII powers necessary.

Nothing in this Bill directly changes the scope or functioning of other delegated powers. The exceptions that this Bill provides are that, within the context of and with the scrutiny attached to the original powers, they can be used to amend retained direct EU law. The Bill also clarifies that it lifts any implied EU-related restrictions from exit day, a necessary consequential step to our leaving the EU’s legal architecture. It is right and proper that, within their context and limits, other powers can be used for the same purposes as Clauses 7, 8 and 9. This amendment, if it is broadly constructed by the courts, could render moot any debate that this House has had or is having on scrutiny provisions in other Bills. This also extends to exit-related Bills and, in this field alone, this could catch the trade, sanctions and customs Bill.

It is I think best to let the sleeping dogs of my noble friend Lord Strathclyde lie, so I shall skate over the very concerning question of how financial privilege would apply under this amendment to the powers to correct deficiencies in the customs Bill.

I call noble Lords’ attention back to the crucial importance of the ability to exercise the powers in the sanctions Bill at speed and the additional information requirements added to that Bill. Even if parallel changes were to be made to this Bill, these would be tailored to the specifics of this Bill.

I stress the Government’s commitment to proper scrutiny of the powers under this Bill; they are a unique, time-limited solution to a unique problem. None of this, however, should be a reason to render irrelevant any specificities of scrutiny that this House has insisted on in other Acts. I therefore urge the noble Lord to withdraw his amendment.

[Lord Sharkey]

As I listened to the noble Lord, I could not help thinking that we were talking entirely at cross purposes. The House has yet to decide on exactly what method of scrutiny we shall use and how we will amend existing methods—if we do at all—when we consider this Bill. That is not the issue for this evening; that is for Monday’s discussions.

This amendment simply says that whatever we decide is the appropriate method of scrutiny, all other SIs, no matter where they come from, should be subject to the same level and procedure of scrutiny. That is all it does. It does not interfere with anything else, or any workings of the parent Act, apart from the scrutiny procedure itself. It leaves the parent Act entirely untouched in every possible sense. The Minister is greatly overcomplicating what the situation will be. I accept that there may be cases with other Acts where the Government prefer not to have more rigorous scrutiny applied to the SIs generated by those Acts, but that is part of the point of tabling the amendment in the first place. I will withdraw it now, especially at this time of night, but I suspect we will return to this subject on Report. I beg leave to withdraw the amendment.

Amendment 200 withdrawn.

European Union (Withdrawal) Bill

Lord Sharkey Excerpts

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

In responding to the amendment, the Government need to put on record that they fully intend to adopt the CTR when it comes into force and that they clearly understand the implications of it for the UK’s ability to lead on clinical trials. I beg to move.

[Lord Sharkey (LD)]

My Lords, my noble friend Lady Jolly has added her name to this amendment, but unfortunately she cannot be in her place today. She has asked me to speak in her stead, and I am delighted to do that. I declare an interest as chair of the Association of Medical Research Charities and of the Specialised Healthcare Alliance, which campaigns on behalf of people with rare diseases. Both these organisations have a direct interest in this amendment.

As the noble Lord, Lord Patel, made clear, the UK has a tremendous record in medical research, in both basic blue-sky research and in translation into treatments. We live in a golden age for medical research, and this golden age is driven very largely by the UK, by efforts in our universities and in our hospitals. There are many reasons for this pre-eminence: world-class university research, world-class medical institutions, the unique NHS system and a funding structure unlike anywhere else in the world, where medical research charities contribute £1.6 billion each year to research, sitting alongside public and private funding.

All this makes our medical research achievement one of the undoubted successes of the United Kingdom. This success has a simple and direct consequence: it produces very significant improvements in health and well-being and very significant improvements in our ability to cure and to treat disease. The chief mechanism by which research turns into cures or treatments is the mechanism of clinical trials.

The UK has long been, and remains, attractive to the pharmaceutical industry, for example, because of the NHS’s ability to run extensive clinical trials. The UK has been able to recruit the very best researchers—again partly because of the NHS. Another reason why clinical trials in the UK are important to researchers, as the noble Lord, Lord Patel, made clear, is our alignment with the other 27 EU states under the existing EU clinical trials directive of 2004.

This alignment is absolutely critical. It allows wide and varied datasets, it creates standard procedures and protocols, and it makes research into rare diseases possible. This last point is of huge importance. Some diseases, very often serious diseases, are so rare that there is not available in any one country a sufficient number of patients for research to take place. But because we are aligned across the EU by the 2004 directive, we can and do find sufficient numbers across 28 countries to carry out effective research.

Pancreatic cancer is a case in point. This is one of the hardest cancers to treat and has an appallingly low survival rate. Just 1% of people diagnosed with pancreatic cancer in England and Wales survive for 10 years or more. The European Study Group for Pancreatic Cancer recruited more than 700 patients from the UK, Germany, Sweden and France to a large-scale clinical trial. The results showed that an extra 13% of the patients on the trial lived for five years when given the tested combinations of chemotherapy and drugs. This is a huge result for patients and for the future of pancreatic cancer treatment, all made possible by, and only because of, the ability to run trials across 28 countries under a common regime. I should add here that the European Study Group for Pancreatic Cancer is led by an outstanding team at Liverpool University.

The 2004 clinical trials directive has proved invaluable. But it has also proved to have many deep and fairly obvious flaws, which we in the UK have been instrumental in trying to correct. After the introduction of the directive, the number of applications for clinical trials fell by 25% between 2007 and 2011, administration costs rose by 98% and delays in actually launching a clinical trial rose by 98%. All this was recognised in 2012 when, with a great deal of UK lobbying, work began on a revision to the directive.

This revision became, in 2014, the new EU clinical trials regulation, referred to in the amendment before us. As the noble Lord, Lord Patel, said, the benefits of the new regulation are straightforward: it speeds up the process for launching new clinical trials; it establishes a more proportionate regulatory regime, with much less red tape; it recognises the concept of co-sponsorship of trials; it simplifies the rules for critical multicountry trials; and it streamlines reporting requirements. This means faster and cheaper trials, faster results and faster delivery of any benefits to patients. All these are of course very good things.

Although the new regulation was agreed in 2014, it was estimated that it would apply only from 2017-18. That was to allow time to get in place the mechanisms needed to make it work properly. But this application date, as has been mentioned, has been delayed yet again, and the EU now says that the regulation will come into force in the second half of 2019. This presents the problem that the amendment addresses. The Bill assumes that we will have left the EU on 29 March 2019, so the new regulation will not be incorporated by this Bill into UK law. Without the amendment, though, the old directive will be, or could be, incorporated. Either way, that means we will not be aligned to the new regulation when it comes into force in the second half of 2019. We will not be part of a group of 28 member states when it comes to conducting clinical trials; we will be a group of one outside a group of 27. The consequences of that for clinical trials in the UK would be disastrous, as they would for UK medical research, for research in the NHS and for our attraction as a research base for pharmaceutical companies.

The amendment of the noble Lord, Lord Patel, takes no political stance and no view about the merits or otherwise of Brexit. It simply says that the Government must not incorporate the old, defective clinical-trials-directive-derived legislation into UK law before the Government have reported to both Houses about the costs and benefits of adopting the new EU clinical trials regulation.

I entirely support the amendment and believe it to be necessary, but I also believe it does not go far enough in ensuring that we are compliant with the new regulation from the day that it applies. That is what we need, not just to protect existing trials but to make certain that we are part of the new regime, which after all we were instrumental in creating. I very much hope that the Minister will take the amendment as the beginnings of a conversation about how to adopt or realign with the new regulation on day one of applicability, and I hope that he will be able—on Report if not today—to make a firm commitment to aligning the UK with the new regulation from the day that it becomes applicable.

[Viscount Ridley (Con)]

My Lords, I have added my name to this amendment. Unlike many amendments to the Bill, this one really is intended to be helpful to the Government and the Bill. Unlike many, it has a genuine point to make and is not merely an excuse to filibuster. Unlike some speeches in support of the amendments, when I say I shall be brief I shall mean it.

As the noble Lord, Lord Patel, says, the Prime Minister’s speech 10 days ago removed the need for lots of amendments to the Bill. In saying that we intend to join or align with the European Medicines Agency if possible, I think she has effectively indicated that the amendment is welcome. However, it is worth pressing the point briefly to get clarity. The background, as the noble Lord, Lord Sharkey, has said, is that the EU passed a disastrous clinical trials directive in 2004, destroying much of a thriving British clinical trial industry almost overnight—a crown jewel of our world-leading biomedical sector. It was not one of Brussels’ finest hours. None the less, the UK remains the leader in Europe and one of the leaders in the world in discovering, developing and testing new treatments for diseases, thanks to our strong pharmaceutical industry and our superb academic sector.

The UK’s MHRA—I shall not spell it out; we know what it stands for—in particular has been instrumental in designing and delivering a robust regulatory environment across the EU, providing an attractive and harmonised framework for clinical trials. It is the senior agency relating to the EMA. This includes reviewing the shortfalls of the clinical trials directive and putting its considerable expertise towards drafting the new clinical trials regulation that is coming along to undo some of the harm done by the 2004 directive.

We have already agreed to the CTR in full but, as the noble Lord, Lord Patel, says, due to a minor delay we risk not only failing to adopt its vastly improved principles in data sharing and expedience but, in the process, losing alignment with our European partners on vital shared research. The CTR will be applied in late 2019, as opposed to this year as originally planned. It will therefore not be covered by the EU withdrawal Bill as it stands. The resulting uncertainty is already having an effect. Clinical trials can run over many years and require significant planning. Uncertainty is already having consequences.

The Government have sent out strong signals that the UK should be a leading centre for the life sciences through the life sciences industrial strategy and associated sector deal. Aligning with the CTR and allowing collaboration to continue to underpin the UK’s thriving research sector will help the Government to achieve that ambition. I and many others are rightly concerned about new regulations that could come in during the implementation period that the UK will have no say in. The clinical trials regulation is categorically not one of those. It was devised with enormous input from British research expertise, was fully agreed to by British representatives in the EU and is regarded as a significant step forward for the governance of cross-national clinical trials. So I hope the Minister will be able to reassure us and the vital biomedical sector in this country by clarifying that we will align with the CTR, as implied by the Prime Minister 10 days ago.

European Union (Withdrawal) Bill

Lord Sharkey Excerpts

Committee: 5th sitting (Hansard - continued): House of Lords
Wednesday 7th March 2018 Lords Chamber

[The Deputy Chairman of Committees (Lord Haskel) (Lab)]

My Lords, if this Amendment is agreed, I cannot call Amendments 72 or 73 because of pre-emption.

[Lord Sharkey (LD)]

My noble friend Lord Tyler has added his name to Amendments 71, 116, 253 and 257. Unfortunately, he is unwell and unable to be in his place today. He has, however, advised me —extensively—to rely heavily in my remarks on the report of the DPRRC published on 1 February. As I am sure that Members will know, the report was highly critical of this Bill. It noted that:

“The Bill confers on Ministers wider Henry VIII powers than we have ever seen”,


and went on to discuss some of these powers in detail. The first it examined was the use in the Bill of “appropriate” instead of “necessary” as a test for action by secondary legislation. The committee pointed out that this gives the Minister much wider discretion than the Government’s White Paper commitment not to make major changes to policy beyond those necessary to ensure continued proper functioning of the law after we leave the EU. Instead of a test based on objective necessity, the Government have substituted the much wider and entirely subjective test of the Minister’s judgment about what he or she considers appropriate. The Government must explain why they have abandoned the White Paper commitment. It would help us to understand their reasoning if the Government could also provide the House with concrete and substantive examples of where a test of necessity may fail to produce continued proper functioning of the law.

I am sure that when he does this, the Minister will want to acknowledge and deal with paragraphs 8 to 10 of the DPRRC report, which concluded, via a worked example, that a proper test of necessity does not prevent his choosing between possible solutions when the “necessary” threshold is in fact met. I am sure that he will tell the House why he disagrees with the DPRRC’s recommendation in paragraph 12, which simply says:

“The subjective ‘appropriateness’ test in clause 7 should be circumscribed in favour of a test based on objective necessity”.


As the DPRRC remarked, the Bill is packed with Henry VIII clauses, and it might be worth remembering what actually happened when the Minister’s predecessors, Thomas Cromwell and Lord Audley, presented the original Henry VIII power, the Bill of Proclamations, to Parliament. Historians have disagreed about Cromwell’s motives but not about what the Bill sought to do—to make the King’s proclamations enforceable as law by the courts. Both Houses of Parliament saw the evident dangers in this and both resisted. The eventual outcome, the Act of Proclamations, was a heavily revised version of the original Bill. It showed Parliament’s strength of feeling on the issue and its skill in avoiding direct confrontation with the King. In those days, the penalty for defying the Executive was a little sharper-edged than a visit from the noble Lord, Lord Strathclyde. In the end, Parliament passed the Bill but amended it to ensure that the provisions for enforcement would be wholly unworkable—and so it proved.

I am not suggesting exactly the same approach, but I do suggest that we take the same view as our predecessors about giving wide, direct law-making powers to the Executive. We should do what Parliament did in 1539—we should resist.