Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Bill [HL]

Debate between Lord Lansley and Lord Alton of Liverpool

Committee stage
Thursday 7th December 2023 Grand Committee

[Lord Alton of Liverpool (CB)]

Can the noble Lord clarify that he would always want that done under the affirmative procedure so that there could be a debate in the House on secondary legislation? I agree with him on the principle that we do not want bits and pieces of primary legislation, but there needs to be some ability to discuss secondary legislation, where appropriate.

[Lord Lansley (Con)]

Some of them are under negative procedures. It is a judgment, not least in this House as our Delegated Powers Committee will advise us on what judgments to make. I would not endorse a blanket affirmative procedure; it must be based on the relative significance of the decisions to be made. Just because something is laid under the negative procedure does not mean that it cannot be prayed against or objected to, but that must rest with the committee.

There is nothing in the current legislation requiring any consultation with the representatives of rights holders in this country before the definition of a qualifying country is extended. I think it would be right for that to be the case; I suspect the representatives of rights holders would welcome it. In giving the Government this wider power, this is a good moment to add this carefully constructed consultation requirement before they bring an order forward. I beg to move.

Medicines and Medical Devices Bill

Debate between Lord Lansley and Lord Alton of Liverpool

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Lord Lansley (Con)]

My Lords, I am glad to have the opportunity to contribute to this important debate, to which I have very much appreciated listening. I want to talk about Amendments 10, 12, 74 and 75, in the name of my noble friend Lady Cumberlege, on which I think I very much follow and share the views of the noble Lord, Lord Kakkar.

We are all agreed about what we are trying to achieve at this stage; the issue is how we go about putting it into effect in this Bill. My first point is on patient safety. In the excellent report of my noble friend Lady Cumberlege and her colleagues, what I read is the imperative to minimise harm and to stop avoidable harm. It is clear in the report that stopping avoidable harm is what is being sought and I am assuming that that is what is meant by the proposition that we must make patient safety a prime consideration. In my view, we are all agreed that patient safety is a consideration above those of availability of medicines and the attractiveness of the United Kingdom as a place for life sciences. I do not object to that; I think that that must be true. Indeed, as a number of noble Lords have said, the achievement of a regulatory regime that properly prioritises the safety of patients is absolutely right.

However, when we think about how we translate that into law, we have to look at all the considerations for a medicines regulator. Let me take two angles on that. First, what do my noble friend Lady Cumberlege and her colleagues expect the MHRA to do? In their report, they say that they expect the MHRA to engage with patients and understand better patient-reported outcomes and patient-reported experiences in order better to be able to assess the benefits and risks of the medicines that it regulates—I emphasise “benefits and risks”, not just risks. In that sense, I want the legislation to tell the MHRA that that is indeed what it should be doing.

Secondly, we start with the medicines regulations that we have from the European Union. To some extent, as noble Lords will have gathered from my incorporation of the phrase “safeguard public health” into Amendment 5, which we debated last week, I think that that proposition enables that consideration by the regulator to be incorporated into its operations. It should be there. Otherwise, how can safeguarding public health be demonstrated if one is not properly assessing both the benefits and risks of new medicines?

Indeed, one of the early paragraphs of EU directive 2001/83/EC on medicines for human use says:

“The concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other”.


The end of the paragraph says that applications for marketing authorisation for a medicinal product must

“demonstrate that potential risks are outweighed by the therapeutic efficacy of the product.”

For this reason I wanted to incorporate safety and therapeutic efficacy in an early draft of my Amendment 5, since both are essential. It is correct to prioritise safety over availability, attractiveness or other considerations, but to attach to patient safety the proposition that it is an overriding consideration seems wrong. It is not an overriding consideration; it is an essential one, alongside the therapeutic efficacy of the current or new intervention being examined, whether a device or medicine.

That is not reflected in the amendment’s language at this stage, entirely due to where we are in Committee: we should understand that and decide how to capture that thought. It might be that we have done it already by capturing the proposition of safeguarding public health—in my view we have. However, we should make safety not an overriding consideration but a primary consideration for the medicines regulator. That is a difference. Perhaps my noble friend Lady Cumberlege and the Minister might like to think hard about how we might reflect that.

Finally, I think Hippocrates would agree. “Do no harm” is of course not in the Hippocratic oath, but it derives from Of the Epidemics, in which he wrote,

“have two special objects in view with regard to disease, namely, to do good or to do no harm.”

The two must be together. The medicines regulatory system must ensure that we can do good through better outcomes for our medicines and devices, but also do no harm.

[Lord Alton of Liverpool (CB)]

My Lords, I support Amendment 12 and the other amendments in the name of the noble Baroness, Lady Cumberlege. In doing so, I also express my support for the amendments in the name of the noble Baroness, Lady Thornton.

At Second Reading I referred to the Primodos scandal. I remind the Committee of my interest as vice-chair of the All-Party Group on Hormone Pregnancy Tests. I know that the Committee will join me in wishing Yasmin Qureshi, Member of Parliament for Bolton South East, the chair of that group, a full and speedy recovery to good health following her discharge from hospital last week, having contracted Covid-19. Ms Qureshi and I have been working with Marie Lyon and the campaign group seeking justice for Primodos victims since 2011.

I am not surprised that the redoubtable and admirable noble Baroness, Lady Cumberlege, has chosen to make, in the words of Amendment 10,

“the safety of human medicines as the overriding consideration”

the standard or battle flag to raise through these amendments. The paramountcy of patient safety is a battle flag to which anyone who has read her compelling report will flock. I concur with the remarks of my noble friends Lord Kakkar, Lady Masham and Lady Watkins of Tavistock on putting the centrality of patient safety at the heart of the Bill, but I also listened carefully to what the noble Lord, Lord Lansley, just said about the use of the word “overriding” and the need to balance conflicting needs. I do not think that there needs to be any conflict between the United Kingdom being a place that upholds patient safety as an overriding concern and a leader in life sciences. However, it might be that the words need to be considered further between now and Report.

Too often after a public outcry over something such as surgical mesh or Primodos, Governments say that they will set up a committee to carry out a review and then everything will be all right. The committee goes away, evidence is gathered and hearings take place. By the time it reports, public indignation and media interest have often moved on to some other injustice. Recommendations are politely acknowledged, those who compiled the report are dutifully thanked and, after promises are made to consider appropriate action, the report is found covered in dust on a basement shelf in a padlocked room in the department, preferably marked “Confidential”, with a get-out clause to tell anyone who inquires, “We can’t say anything because there are legal proceedings pending, but don’t worry, everything will be all right.”

The noble Baroness, Lady Cumberlege, told us at Second Reading that she had learned that attempts were being made to bury her report and to rely on the passage of time, the constant shuffle of ministerial chairs, the comings and goings of elected representatives and the shifting sands of changing priorities to assist in that task. But the people making those attempts made three serious miscalculations. The first is the noble Baroness, Lady Cumberlege. They are significantly underestimating the noble Baroness—a former Minister in the Department of Health and a highly experienced and effective parliamentarian—if they believe that they can bury her report; she will bury them first. Secondly, they have the misfortune of a Bill before Parliament—this one. It provides a legislative vehicle to give effect to some of her central recommendations. Across both Houses, in all parties and none, she has allies who will not be easily bought off. Thirdly, the House knows that it has a duty to act in response. We have heard so many accounts. I listened again to the moving testimony of the noble Baroness, Lady Burt, about victims of mesh. We have an overriding responsibility to act because of the abject failure to protect the public. As legislators we have an overriding duty to ensure that the law protects the public. Manifestly, the law has failed to do that and the amendments seek to put that right.

As we just heard from the noble Lord, Lord Lansley, and from the noble Baroness, Lady Cumberlege, herself, the noble Baroness’s report takes inspiration for its title from the Hippocratic oath: First Do No Harm. I say in parenthesis that the Hippocratic oath should be restored to a central place in the training and teaching of doctors and all those involved in the medical profession. Having systematically and sensitively investigated, winning plaudits from all those with whom she dealt, she found that “avoidable harm” had been caused to women by the drug Primodos—an oral hormone pregnancy test—but also by the epilepsy drug sodium valproate, and by vaginal mesh.

I first raised Primodos a decade ago, in the House in Questions and in letters to the noble Earl, Lord Howe, who we heard from at the beginning of our proceedings, after a Primodos victim, a man called Karl Murphy, had been to see me at my university office in Liverpool. On Primodos, the report laid bare widespread and systemic failings, repeatedly ignored, again and again, for decades. The review rightly concluded that the system was

“disjointed, siloed, unresponsive, and defensive.”

Despite repeated requests—I have written to the noble Lord, Lord Bethell, and tabled Parliamentary Questions —I regret that the Government have so far declined to say how and what redress will be provided. They have also failed to set out clear guidance on how those who have suffered should receive better care and support and, most notably, have failed to set out a timeline.

The Minister could put that right and tell us that there will be no ritual burial of the report. He could tell say why, as the noble Baroness reminded us, we are lagging behind the Scottish Government, who have already started to implement some of the report’s recommendations, notably the crucial appointment of a patient safety commissioner. Perhaps he could also tell us whether the Government will assist the German Government, who have finally set up a similar review after years of refusing to engage with parliamentarians or with Primodos victims in Germany.

At the beginning of this month the leaders of the SNP, the Liberal Democrats, the DUP, the SDLP, Plaid Cymru and the Green Party all wrote to the Prime Minister, urging him to implement the findings of the noble Baroness’s review. They make the point that many mothers who took Primodos, believing it would help their pregnancy, are “now elderly” and have

“lived a life wracked by guilt.”

Yet this was through no fault on their part. They also point out that, as the noble Baroness reminded us, even today sodium valproate is given to women, who are unaware of its potential consequences, with a 50% chance of a baby in the womb being severely damaged if the drug is taken during pregnancy. In their letter, the political leaders point out that 15 patient groups, along with the Royal College of Surgeons, the Royal College of Obstetricians and Gynaecologists, the Royal College of Physicians, the Royal College of General Practitioners and the BMA have all called for the report’s recommendations to be implemented.

Immigration Bill

Debate between Lord Lansley and Lord Alton of Liverpool

Tuesday 26th April 2016 Lords Chamber

[Lord Alton of Liverpool (CB)]

My Lords, the noble Earl just told the House that he believes the Government’s position strikes the right balance. I hope that, in some fairly brief remarks, I can convince the House that that really is not so.

Unfortunately, because of the procedural timetable used in another place yesterday, it is impossible to find in Hansard any reference whatever to the extensive Committee and Report stage debates we had in your Lordships’ House, and the arguments made in favour of the six-month provision incorporated in the amendment passed by your Lordships’ House. It is therefore very difficult to know on what basis the Government have rejected both the six-month amendment and the amendment tabled today, which is an attempt to move a little further in the Government’s direction.

I am, therefore, disappointed that that truncated debate in another place led to the rejection of this proposal. To ask the other place to give further consideration, I have modified the amendment by inserting nine months instead of six. Before turning to its rationale, I declare my non-financial interest as a patron of Asylum Link Merseyside.

The amendment would grant asylum seekers permission to work if their claim has not been determined within the Home Office’s target time of nine months. I will briefly address the arguments made by the Government against the amendment. They have said that the policy will lead to an increase in unfounded applications. In Committee, the noble Lord, Lord Ashton, who is in his place, in responding for the Government repeated their long-held position:

“Earlier access to employment risks making asylum more attractive for those who are otherwise not eligible to work in the UK”.—[Official Report, 20/1/16; col. 851.]

However, the Government themselves have conceded that it “may be broadly true” that,

“there is little hard evidence that the change you propose (to allow asylum seekers to work after six months) would result in more asylum applications”.

So nine months would have even less impact on applications, if that is so. In fact, all the available evidence suggests that permission to work does not act as a pull factor for asylum seekers. That is reflected in the Home Office’s own research, and was confirmed by a review of the 19 main recipient countries for asylum applications in the OECD in 2011, which concluded that policies which relate the welfare of asylum seekers—for example, permission to work, support levels and access to healthcare—did not have any significant impact on the number of applications made in destination countries.

A total of 24 European Union countries allow asylum seekers to work after nine months or less if a decision has not been made on their asylum application, so what I am proposing is hardly revolutionary or without precedent. Twelve of these countries allow asylum seekers access to the labour market after six months or less of waiting for a decision on their claims. Those countries are Austria, Belgium, Cyprus, Finland, Germany, Greece, Italy, the Netherlands, Poland, Portugal, Spain and Sweden. The vast majority of these countries have had these policies in place for many years and none of them has had to change the policy because of any abuse of the asylum route by economic migrants.

In reality, those motivated to come to the United Kingdom for economic reasons are unlikely to make an asylum application and bring themselves to the attention of the authorities on the basis that they might be able to apply for permission to work after nine months. It does not make any sense, if you think about it. Even if this were the case, they would never have an opportunity to do so as the Home Office decides all straightforward claims within six months. Anyone making an unfounded claim for asylum would probably have this dealt with in a matter of weeks rather than months. It should be stressed that applicants cannot manufacture delays by—

[Lord Lansley (Con)]

I am very grateful to the noble Lord for giving way. In response to a Written Question that I tabled in March, I was told that in 2015 of a total of 10,199 asylum claims concluded after six months, fewer than half were well founded. Therefore, the majority of those who are seeking asylum and would therefore be eligible for work after six months on the original amendment would not have made well-founded claims, and so would not have had a reason legitimately to be in this country in the first place.

[Lord Alton of Liverpool]

My Lords, if they do not have legitimate reasons to be here, they will be deported in the normal course of events, so that argument does not stack up against the amendment, which encourages people to work rather than rely on state benefits. In other words, it encourages them to do what the noble Lord and Members on his Benches urge people to do—namely, to use their own efforts and resources to pull themselves up by their bootstraps to play their part in society. The figures that the Government gave me in reply to the earlier debates was that at the end of 2015 more than 3,600 asylum seekers were still waiting for more than six months for an initial decision on their claim, and that was despite the assurance that the noble Lord, Lord Ashton, gave that delays that have happened before have been brought under control.

Returning to my remarks before the intervention, it should be stressed that applicants cannot manufacture delays by not engaging with the process, as they will have their claims refused for non-compliance.

The Government have defended their current policy, which effectively prohibits asylum seekers from working on the basis that asylum seekers are,

“provided with support and accommodation while we determine whether they need our protection and until they have exhausted the right of appeal”.—[Official Report, 20/1/16; col. 843.]

Those words, used by the noble Earl, Lord Attlee, in 2014, were quoted in the Chamber on 20 January. While it is true that asylum seekers are supported, it is highly questionable whether the level of support provided is adequate, as asylum seekers receive just over £5 a day to meet their essential living needs for food, clothing, toiletries and transport to pursue their asylum application. Of course, housing and utility bills are paid for separately for those who need it. An asylum seeker spends an average of around 18 months on Section 95 support. Many asylum seekers who have to survive solely on this level of support for extended periods will suffer a negative impact on their mental and physical health. At the end of 2015, more than 3,500 asylum seekers were still waiting for adjudication and settlement of their cases. In its most recent report on the work of the immigration directorates, the Home Affairs Committee stated that it was,

“concerned that the department may not be able to maintain the service levels that it set itself on initial decisions for new asylum claims within six months. To do so may require further funding and resources”.

Perhaps the noble Earl will comment on that finding in his response.

I have tried to move in the direction of noble Lords who have expressed concern and this is a compromise amendment. It means that the Government would have to significantly miss their target timeframe of six months for making an initial decision on an application before an asylum seeker would be given permission to work. For the small number of people affected, this would be a route out of poverty and an opportunity to restore their dignity by providing for themselves rather than leaving them dependent on handouts from the Government.

Is the current policy fair and proportionate? Is it balanced, in the way that the noble Earl suggested in his preliminary remarks? In Committee, the noble Lord, Lord Ashton, said:

“The Government believe that the current policy strikes the right balance. If a claim remains undecided after 12 months for reasons outside their control, the person can apply for permission to work. That is fair and reasonable policy and is consistent with our obligations under EU law. It also assists genuine refugees”.—[Official Report, 20/1/16; col. 851.]

The question is: does the Government’s current policy strike the right balance? As matters stand, the UK Government effectively prohibit asylum seekers from ever working, because after 12 months they can apply only for jobs on the shortage occupation list, which are the skilled jobs where there is an identified national shortage. Even if an asylum seeker had the requisite skills for such a job, it is unlikely that they would be able to secure it, as they would have to have their existing qualifications recognised and they may well have become deskilled in the year or more that they have been unemployed. An extended period of exclusion from the labour market can have a long-term impact on a refugee’s ability to find employment. It is no wonder that a cross-party parliamentary inquiry into asylum support for children and young people noted, in January 2013:

“Asylum-seeking parents are prevented from working, leaving families dependent on state support. This means parents are left powerless and lose their skills while children are left without positive role models. The Government’s own research has highlighted that this can lead to high levels of unemployment and under-employment once a family gains refugee status”.

I agree with that.

Early access to employment increases the chances of smooth economic and social integration by allowing refugees to improve their English, to acquire new skills and make new friends and social contacts in the wider community. All of this helps to promote community cohesion. The vast majority of asylum seekers want to work and contribute to society. They are frustrated at being forced to remain idle and dependent on benefits. Pulling yourself up by your own bootstraps, reducing reliance on the state and reinforcing the principle that we have a duty to work and contribute to society should appeal to all noble Lords, on whatever Benches they sit. The potential financial savings from allowing asylum seekers to work include reduced asylum support costs and increased tax revenue. In addition, asylum seekers will have increased disposable income which they can then spend in the wider economy. There will also be a number of indirect financial savings for statutory and voluntary agencies, including the avoidance of increased physical and mental health problems and the consequential financial cost to the National Health Service.

In conclusion, granting permission to work to asylum seekers who have been waiting for an initial decision for more than nine months will help to avoid the negative impact on asylum seekers of prolonged, forced inactivity and impoverishment and allow them to contribute to the economy. This will deliver financial savings to the Government and taxpayer, as asylum seekers who are working will not need to be supported. Allowing asylum seekers who have been waiting nine months for a decision on their cases to work has all of the benefits that I have been describing. The original amendment, on six months, was supported in your Lordships’ House. In the absence of a debate in another place on that amendment, it is right for this House to press on with this principle today, to give the other place the chance to consider the merits of the argument properly and come to a considered conclusion. I hope those arguments will commend Amendment 59B to the House. I beg to move.