Medicines and Medical Devices Bill

Lord Naseby Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, rather like the noble Lord, Lord Lansley, I see this as a group of amendments in two parts. The argument for consolidated legislation from the noble Lord, Lord Patel, was very ably supported by the noble and learned Lord, Lord Mackay, and I very much support it. For those working in the health service or in industry, trying to wrestle with all the elements of legislation that cover health is very difficult indeed, and the case for consolidating legislation every so often is a very powerful one. I very much hope that the Government will take note of this, bearing in mind of course that there have been strong arguments from NHS England for a further NHS reorganisation Bill, which might be coming within a short space of time. On that issue in particular, the reorganisation of the NHS, the need to consolidate legislation following such a Bill becomes very persuasive indeed.

Where I do not really agree with the noble Lord, Lord Lansley, is on his remarks on Amendment 2 and his suggestion of a sunset clause. He argued that the problem with that is that you shut down the powers and therefore the Government need to produce another Bill, because we obviously need a regulatory regime. Sticking to the three years in my noble friend’s amendment would mean that work would have to start within 18 months. That does not argue against the principle of a sunset clause, although there can be debate about the length of time in which the new Bill needs to be enacted.

The fact is that this Bill conveys a huge number of delegated powers to Ministers. In a pungent analysis, the University of Birmingham points out that, while delegated powers may be needed to ensure responsiveness to the EU transition period and to meet the challenges of technology change, they should not be used indefinitely or relied on to implement matters of policy. This is the problem. If we take this Bill and we do not have some changes in the future, Ministers ever after will be able to ram changes to medicines and medical devices regulation through the House, and the amount of scrutiny in relation to secondary legislation is limited.

The Delegated Powers and Regulatory Reform Committee was very clear in criticising Ministers for failing to provide a sufficient justification for parts of the Bill adopting a skeletal approach. The recent report from the House of Lords Constitution Committee also said that it recognises

“that the existing powers to amend these complex regulatory regimes will cease to have effect on 31 December 2020 and that alternative arrangements are required. If the Government is unable to specify the principles according to which it intends to amend and supplement the existing law, the delegated powers in the Bill should be subject to sunset clauses.”

That surely must be right.

At Second Reading the Minister suggested that sunset clauses would emasculate the Bill, and in Committee he said that a sunset clause

“will not change the very good reasons why delegated powers are necessary.”—[Official Report, 19/10/12; col. GC 327.]

I think we come then to the fundamental argument: that many noble Lords disagree with the extent of delegation that is going to be given to Ministers for all time. The only proper defence against that is to agree to the kind of amendment my noble friend has proposed in relation to a sunset clause. For that reason, I very strongly support her.

[Lord Naseby (Con) [V]]

My Lords, in the past I have had the privilege of working with two pharmaceutical companies, a US pharmaceutical company Upjohn and Reckitt pharmaceuticals. I think that as a country we face a unique opportunity at this point caused by Brexit and a situation where we have a major industry which has all the potential to be a world leader. But this point in time is going to go away unless we act. This is a watershed Bill. It creates an opportunity to enhance the role of the UK Medicines and Healthcare products Regulatory Agency. The industry and all of us should want the UK to be an attractive market for investment in medicines, medical devices and therapies for all our UK patients. It creates an opportunity to make significant improvements in UK clinical research environments and, very importantly, it increases the commercial trial activity to make the UK the number one destination for life sciences supporting UK public health.

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[Baroness Andrews (Lab) [V]]

My Lords, it is a pleasure to follow the noble and learned Lord, Lord Judge, and his magisterial assertion of parliamentary sovereignty, which I entirely agree with. I am pleased to support the amendments in the name of the noble Lord, Lord Sharkey; at the same time, I apologise to your Lordships’ House for not having been able to do so in Committee.

In his opening statement on this amendment, the noble Lord made an irresistible case in principle, as well as explaining with great clarity the process by which a super-affirmative order enables effective parliamentary scrutiny in a way that the simple affirmative procedure—however the Government argue it—cannot. In using it, the implementation of this extremely important Bill becomes a less risky and unpredictable affair.

On Second Reading, I said that the Bill was good in many ways but that, as a skeleton Bill, it created unnecessary risks. Despite the Government’s amendments and their very recent and welcome response to the DPRRC’s scathing report—I am very pleased to say I am a member of that committee—they have still not strengthened the process of parliamentary scrutiny in such a way that should satisfy either the DPRRC or this House.

It is worth reflecting that our wrath as a committee was directed as much at the casual flimsiness of the reasons offered and the false dichotomies between primary and delegated legislation that were set up as at the sheer and extraordinary sweep of the powers across the whole fields of medicine and veterinary science. “Free rein” was one of the milder terms the committee used. Failing at least to take the option of a super-affirmative procedure on these delegated powers still in effect gives the Government free rein. We would be able to challenge the statutory instruments but not change them, however strong the grounds, weighty the evidence or serious the anxieties and risks.

It is significant that, in their response to the committee published this week and in their amendments, the Government recognise that there are risks in the breadth of the powers, but to remove those risks they have merely tightened focus, improved transparency in some cases and assured us that those who use the powers will do so with great care. While any movement was welcome, the Government have refused to acknowledge what is right and proper here—as both the noble Lord, Lord Sharkey, and the noble and learned Lord, Lord Judge, have said, and as the committee made clear—which is a way to engage with and not bypass Parliament.

While under many circumstances the affirmative order is accepted as an appropriate level of scrutiny, it is most certainly not in this case, particularly when the Government choose not to accept that the powers were designated as inappropriate in the first place by the scrutiny committee. A super-affirmative order at least gives Parliament the opportunity to press for further thought, advice and amendment as initiated by the Government. As the noble Lord, Lord Sharkey, said, the amendment has been trimmed so that it deals only with significant changes. This is hardly revolutionary; it is in fact the least that one could insist on, but it is significant. It acknowledges that risks persist but can be reduced and that changes are made to prevent perverse consequences. Surely, in a Bill of this significance, that cannot be too much to ask.

The arguments that the process is too long, slow and cumbersome were dealt with by the noble Lord, Lord Sharkey, in Committee and today. They are but the most recent reiteration of the arguments we hear all the time when we put the case for primary legislation in the face of inappropriate delegation, where speed and technical detail are usually deployed frivolously. They are hardly powerful or relevant when considering the scope of these regulations.

I regret to say that, in their short career, this Government have shown in different ways that they do not welcome interrogation and fear scrutiny. A confident Government would welcome both as a way of avoiding mistakes and creating precedents which in Opposition they could not change. This is a modest opportunity to strengthen this Bill and I hope the amendments will secure the support of the House today.

[Lord Naseby (Con) [V]]

My Lords, I disagree with this amendment. I had the privilege of being the Chairman of Ways and Means and Senior Deputy Speaker in the other House from 1992 to 1997—possibly, legislatively, one of the most challenging periods. I certainly found that MPs were highly creative in their interpretation of the rules of debate and in holding the Government to account.

Noble Lords have only to read Erskine May to see that we have two procedures for SIs that are normal and have been with us for decades: the negative procedure, where no amendments can be taken in your Lordships’ House; and the affirmative resolution. The affirmative resolution is not just a weak tool that puts us on the side; it is a very powerful tool if used properly by Members of Parliament and those of your Lordships’ House who take an interest in these matters. They can ensure that the Government of the day have to listen.

Frankly, I find that the super-affirmative procedure does no more, really, than involve an additional stage of scrutiny where Parliament has considered a proposal for a statutory instrument before the statutory instrument is formally presented. Today this procedure is used for statutory instruments that are considered to need a particularly high level of scrutiny. Quite frankly, we have Select Committees, in the other House in particular, dedicated to particular departments, and there is a very active Select Committee on health matters.

In addition, yes, there are some specialised categories of statutory instruments that are used for those particular purposes, and they can be considered under the super-affirmative procedure. But these statutory instruments usually amend or repeal Acts of Parliament. Examples would include legislative reform orders, localism orders, public bodies orders, regulatory reform orders and remedial orders. It is not usual to have them as part of the primary legislative process.

It is time that we as politicians understood that this country will be successful only if we get on and understand the needs of British industry. It has to have some certainty that things are going to proceed at pace, not be delayed even further because some noble Lords feel that they want to have another bite of the cherry. We already had quite enough bites, in my judgment, on this Bill as we worked through it, and it is being done very thoroughly. It has been done in Committee and is being done on Report. But we have to understand that this all adds to delay and, even worse, possible confusion in the commercial world.

I think adequate procedures are already available. All this does is stretch the thing out for very little marginal benefit. I personally will vote against this proposal with enthusiasm.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I must say that I very much disagree with the noble Lord’s remarks. If we want certainty, we need legislation that is well grounded and which has had thorough scrutiny in Parliament. The problem with this Bill is that it essentially gives a blank cheque to Ministers to change the regulatory regime for medicines and medical devices. If this was just to deal with the aftermath of Brexit, that, of course, would be understandable. But it was made clear in Committee and at Second Reading that the Government are wedded to this way of doing legislation. As the Minister said in Committee,

“this is a modern and fast-changing industry … we may still need to preserve our ability to amend and update regulations.”—[Official Report, 19/10/20; col. GC 328.]

The noble and learned Lord, Lord Judge, referred to two of our most distinguished Select Committees. We need to return to what our Constitution Committee said:

“This is a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made … The Government has not provided the exceptional justification required for this skeleton approach.”


As the noble and learned Lord, Lord Judge, has said, the Government have form. We are increasingly seeing the use of skeleton Bills and Henry VIII clauses. We really must come to a point where we say to the Government that we will not put up with this any longer.

I listened to the Minister in the last debate: what did he offer the House in respect of further scrutiny? It seemed to me he offered a debate or two, and that was it. The Government do not have an answer; they are refusing to budge on a principle which I believe is fundamentally wrong.

The noble Lord, Lord Naseby, talked with joy about the effectiveness of affirmative statutory instruments. This is nonsense. I think eight SIs have been defeated in your Lordships’ House in history; the last one led the Government to threaten to abolish the House of Lords. Unfortunately, the affirmative procedure is hardly any better than the negative procedure, and they do not allow this House to really exert any change on the orders going through.

We have to stand up on this matter. It is much more important and much wider than the issue of medicines regulation. I very much support the amendment moved so effectively by the noble Lord, Lord Sharkey.

Medicines and Medical Devices Bill

Lord Naseby Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, this is an interesting debate and I am grateful to my noble friend Lady Thornton. We know that there is a problem with vaccine uptake, which is linked to anti-vaccine sentiment—though not necessarily always.

Looking back over the past few months, I note that there was in November a survey by Savanta ComRes on behalf of ITV News that found that almost 70% of people in the UK would like to receive a vaccination. More recently, in December, the Royal Society for Public Health published a poll showing that 76% of people would take the vaccine but, significantly, that only 57% of people from BAME backgrounds would do so. There was also a lower response among lower-income groups.

No doubt the Minister will give us figures, but my understanding is that the initial results on vaccine uptake are encouraging. However, we cannot be complacent in the face of the pernicious anti-vaccine sentiment around. Even before the pandemic, vaccine hesitancy was described by the WHO as one of the top 10 threats to global health.

We are interested in what the Government are doing. Last month, we debated this issue and the noble Baroness, Lady Evans, the Leader of the House, referred to the work of a central government unit on it. I should like to hear from the Minister about what is happening. We clearly need strong pro-vaccination campaigns, and the majority of people who may be described as vaccine hesitant are not necessarily anti-vaccine. Most people who are hesitant can be persuaded by good public health messages.

However, as my noble friend and other noble Lords have said, there has been a huge amount of misinformation across social media in the past few months. This is obviously cited by survey respondents as an area of concern when it comes to levels of trust in those delivering public health messages. As Scientists for Labour pointed out, since the recovery from the false findings around the MMR vaccine and autism from Mr Andrew Wakefield, the UK overall now ought to be in a good place when it comes to routine vaccine uptake. For example, the HPV vaccine has a consistent uptake of between 80% and 85%, which is an excellent return for a vaccine that is not part of early childhood schedules.

We do not have too much in the way of well-organised anti-vaccine groups, unlike the USA or, indeed, even the Republic of Ireland, so the likelihood is that the UK population will show less hesitancy about recently introduced vaccines compared with other countries. But the level of misinformation out there is high and we have to learn lessons from other recent vaccine scares. Clearly the Government have a huge challenge in making sure that the uptake of the vaccine is as high as possible—which is why I welcome this debate and the amendment, and very much look forward to the Minister’s response.

[Lord Naseby (Con) [V]]

My Lords, I declare an interest in that I am married to a retired general practitioner.

I congratulate the noble Baroness on her proposed new clause. Whether the detail is correct is another matter, but the principle that she is promoting is absolutely right. I make my observations as someone who, before he came into politics, was a senior director in the fifth-largest advertising agency in the world. I was actually handling the UK Government’s COI account—that is, the general one for specific purposes.

I have four observations. First, all misinformation must be refuted immediately, wherever it occurs—whether it is in the main media or other media. That is not just social media; it includes radio, TV, print, posters, et cetera. Secondly, every medical professional body must make it unequivocally clear that disinformation must be refuted. Thirdly, I suggest that all medical outlets should provide a clear statement, in poster format, for hospitals, surgeries, clinics and pharmacies. Fourthly, consideration should be given to how best to communicate with schools, universities and colleges.

In conclusion, we must all remember the terrible harm that was done to the MMR—measles, mumps and rubella—programme, largely by one pioneering rogue doctor. Against that background, I plead with the Minister to ensure that we have a robust new clause and a plan, worked on now so that it can be communicated instantly, if possible.

[Baroness Jolly (LD) [V]]

My Lords, I support this amendment to require

“the Secretary of State to publish a strategy for tackling antivaccination disinformation within one month of the Bill passing.”

The noble Baroness, Lady Thornton, has picked a fascinating, current topic, and the noble Baroness, Lady Bennett of Manor Castle, posed some pointed questions about the quality and effectiveness of the messages. I look forward to the Minister summing up on these points.

Misinformation is not new. I remember websites being used many years ago to persuade parents to ensure that their children had their childhood vaccinations at the appropriate time, and it is paramount that the Government take a robust stance against anti-vaccination disinformation. Research from Oxford University suggests that 12% of the UK population is “strongly hesitant” about taking the vaccine, with a further 16% unsure. Together, that makes 28%, a very significant proportion of the population—over a quarter. We are putting all our efforts into stopping the spread of this virus. This means that if the 28% avoid vaccination, they will run the real and severe risk of catching the virus; not only that, we will run the risk of catching it from them, so undoing all the benefits of the programme.

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There is much in all these amendments. It has been a good debate and I look forward to the Minister’s reply.

[Lord Naseby (Con) [V]]

It is a pleasure to follow my noble friend Lady Cumberlege, who has gone into great detail on these amendments. As far as I can see, these are mainly government amendments, plus some from other parties, and they are all broadly to be welcomed. The question I ask myself is: where are the boundaries to be set?

Very helpfully, the Minister, in his opening statement, explained in some detail the extent of information-sharing outside the UK and gave the example of the safety of medical devices. Having listened to my noble friend and the others who have contributed, I am still not quite sure about Amendments 18 and 20. I can see where they are coming from and can understand what is behind them but on this occasion I will have to listen to the Minister. These are sensitive areas and certainly we in the upper House should listen. I am also not entirely clear from the Minister’s statement at the beginning what the implications of Amendment 22 are. There has already been a good deal of coverage and I will not add to it further.

[Baroness Jolly (LD) [V]]

These amendments relate to the use of data and information sharing. The noble Baroness, Lady Thornton, my noble friend Lord Clement- Jones and the noble Lord, Lord Patel, have put their names to some of them. The noble Lord, Lord Freyberg, outlined clearly in the context of trade and health the power and value of data. Data is a hugely rich source for research but also a hugely valuable commodity, so we need safeguards.

Concern was raised in Committee about the level of protection in the Bill for patient information, as regulations are able to make provision about the disclosure of such information. I am grateful to the Minister for being so willing to look at this again.

The Government have responded in two main ways: with the introduction of a definition of “relevant person”, thereby narrowing the definition of whom data can be shared with, and by defining what is meant by patient information. As the noble Lord, Lord Patel, explained, Amendment 24 in the name of the noble Baroness, Lady Thornton, strengthens the definition of patient information to protect information that could identify a patient, rather than just information that does.

Amendments 18, 36 and 57, led by the noble Baroness, Lady Thornton, and supported by my noble friend Lord Clement-Jones and others, would allow a relevant authority to disclose information to a person outside the UK only where required for the purpose of giving effect to an international agreement or an arrangement concerning the regulation of human medicine, provided it was within the public interest so to do. Those three amendments all pass the test put forward by the noble Baroness, Lady McIntosh of Pickering, concerning public good.

Amendment 20, from my noble friend Lord Clement-Jones, would take the Government’s amendment on patient consent further by ensuring that consent given in relation to identifiable information was informed consent. The noble Baroness, Lady Cumberlege, has just raised the issue. We should not need this. Informed consent should be the default but, as it clearly is not, I support my noble friend’s Amendment 20.

Similarly, Amendment 21, in the name of the noble Baroness, Lady Thornton, would ensure that patient information could be shared by an appropriate authority only if the individual to whom it related had given their explicit consent.

These amendments strengthen the Bill and therefore patient outcomes. I will listen to the Minister to see what plans the Government have to satisfy noble Lords on this group.