European Union (Withdrawal) Bill

Baroness Thornton Excerpts

Committee: 2nd sitting (Hansard): House of Lords
Monday 26th February 2018 Lords Chamber

Moved by

[Baroness Thornton]

9: Clause 1, page 1, line 3, at end insert—
“( ) Regulations bringing into force subsection (1) may not be made until the Secretary of State has set out a strategy for seeking to ensure that any citizen of the United Kingdom or of an EU country, who requires health care in a different country of the EU or in the United Kingdom, will be treated as if they live in the country in which they require treatment, with the home country reimbursing the country where care was provided.”

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[Baroness Thornton (Lab)]

My Lords, I rise to move Amendment 9 and speak to Amendment 11 in my name on the Marshalled List. Even since Committee stage began in your Lordships’ House last Wednesday, the Brexit world has shifted again and is doing so even today. The Prime Minister has had her summit at Chequers and my own leader is posing a serious challenge to the Government. We have to wonder how many millions are following the detail of hard Brexit; soft Brexit; tariff-free access; managed divergence or even ambitious managed divergence; hard and soft borders; regulatory alignment; cake philosophy, which is something to do with cherry-picking and having your cake and eating it; the three baskets theory, which I understand is a bit like the cake philosophy, only it is three choices; transition or implementation; and, finally, a bespoke economic partnership.

The media is full of it. The Westminster bubble and the chatterati—from which I do not exclude myself—talk of little else. That is because it is important to our nation’s future and our prosperity, or otherwise. However, I will propose one amendment, and speak to another, on matters which do not at present feature in the headlines or in the huge and momentous agenda being discussed in your Lordships’ House, but which do affect millions of citizens in the UK and the EU, including every Member of this House. These amendments affect all who work and travel in Europe; who buy medicines and take for granted the supply and availability of the most up-to-date, clinically approved remedies.

Like millions of UK citizens, I have been on holiday and travelled all over the EU. Most often, my summer holidays have been in France with my children. Every year while my children were growing up we had at least one ear infection, sometimes a dose of tonsillitis and, one memorable year, an adult with Bell’s palsy. The wonderful Dr Duterte in Brantôme came to know us quite well over 25 years. My son lived in Brussels for five years and, although mostly healthy, he and we thankfully did not need to worry ourselves about his access to healthcare. An important part of a stress-free holiday with a mother with chronic obstructive pulmonary disease was knowing, with confidence, that the oxygen supply would be waiting in the house—free, like in the UK. I tell these everyday stories precisely because they are so ordinary. It is the experience of millions of us: the package holidays; the weekends; the hen parties in Barcelona; the stag dos in Amsterdam and elsewhere; the conferences in all sorts of places. We and our fellow citizens are accustomed to travelling with ease and confidence. The ease with which people can do what they are used to doing is a matter which will colour how they judge whether Brexit is succeeding and whether it has been worth while.

Amendment 9 concerns the EU reciprocal healthcare arrangements which allow citizens of EU and EEA nations, as well as Switzerland, to access health and social care services while in any other of these nations, on the same basis as a resident of that nation would at no or low cost. The schemes include the EHIC, the European healthcare insurance card, which provides access to state-provided healthcare for short-term visitors; and the SI scheme, which, for example, allows ongoing access to health services for people working abroad and social care services for individuals such as pensioners living abroad. This is important for workers, students, the retired and holidaymakers, and, as I said, it affects millions of us.

Post Brexit, the UK could lose access to these arrangements, depending on the final outcome of ongoing negotiations between the EU and the UK Government. So far, the two parties have agreed that UK pensioners already living in the EU will be able to use the SI and EHIC schemes post Brexit, but no deal has been reached on wider access to them. Losing access to these arrangements would have a significant impact in a number of areas. This is one area where some progress seems to have been made but, as with many other matters, there is some uncertainty about what will happen after Brexit. The latest joint EU-UK document on the Brexit talks in November said that citizens who live in another EU country on the day that the UK leaves will still be eligible for the same healthcare as citizens and will still be able to use the EHIC scheme when visiting another EU country. This includes citizens who work or study in another country or are retired there. However, agreement has not been reached on whether the EHIC would be available to those who travel to, or go and live in, another EU country after the UK has left the bloc. It would seem that the EU wants discussions on that to be included in the negotiations on the future relationship between the UK and the EU, which will come only after sufficient progress has been made on the divorce issues.

Our amendment seeks to prioritise the negotiation of continued access to existing EU reciprocal healthcare schemes, or the creation of comparable alternatives. We need to fully assess the impact which loss of access to the schemes might have on patients and health services. For the UK, this approach would ensure continuity of care for its citizens living abroad and ease of access for UK citizens visiting the EU or EEA and avoid increased demand on and costs for the NHS.

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[The Minister of State, Department for Exiting the European Union (Lord Callanan) (Con)]

Let me first thank noble Lords very much indeed for bringing this important topic before the House today. I reassure them that the Department of Health and Social Care is actively supporting my department in its negotiations with the EU, including forming part of the negotiation team where the topic is of direct relevance to healthcare. It is also working closely with its arm’s-length bodies, the territorial offices and others across government in preparing for EU exit under all eventualities.

I will address this group of amendments now but I note that the noble Lord, Lord Warner, who I think is not in his place at the moment, has also tabled an amendment on health to Clause 6. This will be responded to formally when we reach that group and I note his specific interest in the subject.

Amendment 11, in the name of the noble Baroness, Lady Thornton, would delay the repeal of the European Communities Act 1972 until such time as the Secretary of State has set out a strategy for ensuring the mutual recognition of medicines and devices between the EU and UK. The Government have already set out a very clear offer to the EU for the UK to continue to work in partnership in the area of medicines. It is in the interests of patients and the life sciences industry for us to find a way to continue UK-EU co-operation on medical regulation, even if our precise relationship with the EU will by necessity change. Discussions are ongoing and the outcome will form part of our future relationship with the EU. We cannot and should not delay commencement of this Act until those discussions have concluded. The UK’s medicines and medical devices regulator, the MHRA, is a strong leader that will continue to ensure that medicines and medical devices are safe and effective, regardless of the outcome of negotiations and any agreement on recognition in this area. Indeed, it is currently recognised globally as an authority in its licensing and inspections.

In response to the questions from the noble Baroness, Lady Finlay, and the noble Lords, Lord Cormack and Lord Davies, I can be extremely clear that the UK’s preferred outcome is to find a way to continue to co-operate on medicines regulation with the EMA. We have made that extremely clear to the EU. Even though our relationship with the EMA will have to change as we leave the EU, it is in our mutual interests to continue to co-operate and share scientific expertise. We believe that desire is shared by the EU.

[Baroness Thornton]

Can I ask for some clarification from the Minister about his statement about the preferred outcome? What exactly does that mean? If we do not achieve what we want to in that preferred outcome, what exactly happens and what do we do next? What is the timescale for this? That is why the amendment is framed in the way it is.

[Lord Callanan]

It is obviously difficult for me to speculate on what happens if we do not achieve the outcome that we want. As I said, we strongly believe that since we contribute an awful lot of work through the MHRA—something like 40% of the EMA’s work is contributed to by UK authorities—it is in our mutual interests to continue to co-operate. If that is not possible, we will set out an alternative course of action but we believe that it is and should be.

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[Lord Callanan]

The noble Baroness has made some valuable points. On the question of data on EU staff applying to jobs in the UK, if that information is available then we will certainly share it with her.

She asked what happens if there is no agreement. As I said, the MHRA already issues national licences for some 90% of medicines on the UK market. If we are no longer co-operating with the EMA on the regulation of new novel medicines, the UK will ensure that our own procedures do not lead to any delay in patient access to new medicines and are no more burdensome to industry.

The noble Baroness’s point about working with the devolved Administrations is a good one and we will ensure that that happens.

[Baroness Thornton]

My Lords, I thank the noble Baroness, Lady Finlay, who as always is much more qualified than me and indeed most of the House, for her support. I respectfully suggest that the Minister needs to actually talk to some of these bodies about how complicated, difficult and costly it will be if we do not reach an agreement. That needs to be taken into account.

I thank noble Lords for their support across the House for this suite of amendments. The amendment from the noble Baroness, Lady Jolly, is important and—like my own, I hope—very practical. This is about what medicines people buy over the counter, what health supplements they have access to and whether those will change post Brexit.

The noble Earl, Lord Clancarty, tabled Amendment 205, and I thank him for his support for my amendment. He and I want the same thing: we want this scheme, which protects people’s right to healthcare, to continue, and as the noble Lord, Lord Cormack, said, its current form would be the easiest form for it to do so. It is often the case that the noble Lord, Lord Cormack, makes the observation that you wish you had—in this case, about disease knowing no boundaries. He is absolutely right.

My noble friend Lady Blackstone made an eloquent point about cutting-edge research and the importance that that has for children and the rare diseases that they experience.

I do not deny that the amendment from the noble Lord, Lord Stephen, is important. It will be very important that we know what the impact of Brexit has been, not just a year later but ongoing. However, the argument that we are having on the earlier part of this suite of amendments is about what happens in the negotiations and what happens if they fail. It is about the action that we take now.

The noble Lord, Lord Wigley, is quite correct about the uncertainty that has been created for NHS staff in terms of their retention and recruitment. In fact I asked a Question of the Health Minister about precisely that not so long ago. Those figures have been collected by organisations such as the Royal Colleges so we know that the number of nurses coming from Europe in the last year has fallen by, from memory, around 80%. That is a huge drop in the number of nurses prepared to come and work in this country from Europe.

I say to the Minister that we understand—I agree with the noble Lord, Lord Cormack—that this is a difficult time and the Government are in the middle of negotiations. However, it is a long time since the referendum and we are a short time away from falling off the edge of the Brexit cliff, and issues of licensing of medicines and access of citizens to healthcare can none of them brook a two or three-year negotiation after Brexit because of the suffering that would cause and the impact it would have. That is what the amendments concern.

I hope that, between now and the next stage of the Bill, we will make some progress on both those issues. If we do not, we shall return to them. I beg leave to withdraw the amendment.

Amendment 9 withdrawn.

European Union (Withdrawal) Bill

Baroness Thornton Excerpts

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

[Lord Spicer (Con)]

My Lords, I have a tentative question. If it is true that we do not trust our own legal environment with medical research in which, as has been said, we have great expertise, why should we trust ourselves with anything else? Across the whole of the Bill, responsibility is being transferred to this country. Why should we not be able to do that for medical research as much as for anything else?

[Baroness Thornton (Lab)]

This benefits all patient populations, and is particularly important for paediatric and rare cancers—diseases which, precisely because they are uncommon, are among the hardest to research and treat. You therefore need a larger pool than the 66 million people who live in this country: Europe has a combined population of 510 million to draw on. That is nothing to do with trust; it is to do with how clinical trials need to be carried out. You need a larger pool of patients to test these drugs.

I was pleased to add my name to the amendment in the name of the noble Lord, Lord Patel. I raised this issue in my speech at Second Reading and will mention only one additional matter, which is to do with rare paediatric illness; tumour types which affect relatively few people; and rare cancers which translate to over 20% of all cancer diagnoses across the world. If the UK is to make progress on therapies for paediatric and rare cancer, it is vital that we can work closely with EU nations on clinical trials. Cross-border collaboration is crucial to paediatric and rare cancer clinical trials. Some 75% of clinical trials in the EU involve cross-national collaboration, rising to 86% for rare disease trials. As noble Lords have remarked, that is because of the patient population across Europe. We will be doing a huge disservice to our children, and to the cancers which threaten a few of them, if we fall out of this system. It is as simple as that.

The BEACON clinical trial system is an example of how cross-national collaboration is fighting back against rare paediatric cancers. Neuroblastoma is a form of cancer that affects around 100 children, mostly under the age of five, every year in the UK. More than half the children with aggressive forms of the cancer will see it return and, for these children, there are few treatment options left. In 2013, Cancer Research UK scientists and paediatric cancer specialists launched the BEACON-neuroblastoma trial to find the best chemotherapy treatment for children and young adults with recurring neuroblastoma. To do this, it is bringing together clinicians and scientists from 10 European countries and two international consortia, with funding from Cancer Research UK and European partners. It is a fantastic example of successful European collaboration. The rarity of this neuroblastoma and the low number of patients means that trials could not have happened in a single European country. It is vital that this type of cancer trial—

[Baroness Kramer (LD)]

Given the noble Baroness’s expertise on this issue, I wish to ask her a question. As I understand it, medicine is becoming more and more personalised and customised. Therefore, by definition, the pool for a far wider suite of diseases is becoming smaller and smaller because of that much narrower customisation and personalisation. Therefore, the situation with rare diseases today is about to become the norm across a very wide range of diseases. Does the noble Baroness read it that way?

[Baroness Thornton]

I absolutely agree with the noble Baroness. In fact, several noble Lords who are much more expert on this have already mentioned that aspect. The noble Baroness is absolutely right. I do not think I need to say anything more. I think this amendment is the remedy. I hope that the Government will respond positively to it. The case is unanswerable.

[Baroness Ludford (LD)]

My Lords, when she replies, will the Minister comment on the remarks of her noble and learned friend Lord Keen of Elie on 28 February, when we discussed this issue in the context of directives whose implementation date was beyond exit day? The noble and learned Lord addressed this issue, partly because the noble Baroness, Lady Hayter, mentioned regulations. In his reply, he said something rather interesting: namely:

“There are examples of regulations … where we accept that the regulation has come into domestic law but its actual operation is deferred, perhaps until 2020”.


I think that date was given just as an example. The noble and learned Lord continued:

“That regulation … will form part of our domestic law at the exit date, even though the operative provisions come into force only after the exit date”.—[Official Report, 28/2/18; col. 690.]


Will the Minister clarify whether she believes that the clinical trials regulation falls into the category envisaged by the noble and learned Lord, Lord Keen of Elie? If not, why not?

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[Baroness Thornton]

Will the Government therefore consider amending the Bill to allow that to happen?

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[Baroness Goldie]

My noble friend Lord O’Shaughnessy, who is advising me, says that once there is a new regime in Europe, all non-member states will have to make a decision about whether or not to be compliant with that. We hope that in our Brexit negotiations we have made clear—the Prime Minister has emphasised this—the huge importance we attach to these issues. They are massively important and we want to get a positive outcome in the negotiations, but it would be premature at this stage to incorporate into this Bill the anticipated enactment of the new regulation because it might be inert law.

[Baroness Thornton]

I have already written to the Minister asking for a meeting to discuss this issue and have copied the letter to many noble Lords. It is important that we have the meeting before the next stage of the Bill.

[Baroness Goldie]

I am happy, as are my colleagues, to engage in and attend meetings and to listen to the views expressed.

I was going to make an observation about the amendment of the noble Lord, Lord Patel. The noble Lord, Lord Kakkar, made an important point about how we deal with whatever law we will have if this new regulation has not become law when we leave. It is important that we have the flexibility in the Bill to deal with such matters but, under the amendment of the noble Lord, Lord Patel—I am sure it is not intentional—there could inadvertently be a delay in dealing with them as we leave because his amendment stipulates that Clause 7 powers could not make regulations until a report had been laid before both Houses assessing the costs and benefits of adopting the new EU regulation. We do not know when that is coming through. We think it might be March 2020—we do not know—but in the meantime we could be in limbo in trying to do the very things that noble Lords want us to be able to do in respect of the existing law. For these reasons, I urge the noble Lord to withdraw his amendment.

European Union (Withdrawal) Bill

Baroness Thornton Excerpts

Report: 1st sitting: House of Lords
Wednesday 18th April 2018 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I thank the Minister for her very full response to the amendment moved by my noble friend Lord Patel. She has given a powerful reassurance that the important elements of the European clinical trials regulation that can be applied independently of the European Union to improve the situation for the conduct of clinical research in our country will be brought into force. That is vital, as the Minister said, for ensuring that those who plan clinical research can do so with absolute certainty over a period of time prior to implementation. I, for one, am most grateful to her for this reassurance.

[Baroness Thornton (Lab)]

My Lords, I join everyone in thanking the Minister—the noble Baroness, Lady Goldie—and indeed the other Ministers who have been involved in the discussions. I thank them for the meetings we have had. I am sorry that I was not at the meeting the other day, but I thank her for sharing with me what she was going to say today. I am very happy that the Government have recognised the importance of this matter. Who would not be honoured to be on an amendment with the noble Lord, Lord Patel, and the noble and learned Lords, Lord Judge and Lord Mackay of Clashfern, and if they say that they are content, who am I to say that I am not? What will be necessary from now on is for the Government and all of us to reassure the medical professions and the researchers that this is exactly what will happen, so that they can plan with confidence clinical trials for the future.

[Lord Patel]

My Lords, briefly, I thank everybody who has spoken but particularly the Minister for the way in which she presented the solution. I say by the way to the noble Baroness, Lady Thornton, that we used the brains of the two noble and learned Lords for medical knowledge, not their legal knowledge. I thank them, as this will reassure the research communities, pharma and even the EU institutions of our commitment to collaborate with EU nations on clinical trials. I thank the whole ministerial team and I beg leave to withdraw my amendment.