(5 years, 8 months ago)
Lords ChamberI thank my noble friend for that Question and pay tribute to the work of the Lord Speaker. I agree with the premise of his Question. Public Health England has attributed the success that we have had, with 92% of people with HIV now diagnosed, 98% of patients receiving treatment and 97% virally suppressed to a combination of HIV prevention, including expanded HIV testing, prompt initiation of antiretroviral therapy after diagnosis, condom provision and PrEP, all of which we will need to build on as we develop plans to achieve zero infections by 2030. He is absolutely right that these will all need to go into development of that plan.
My Lords, it is greatly to be welcomed that science is now leading us to end new transmissions by 2030. But is the Minister aware that women who are HIV-positive are four to five times more likely to develop cervical cancer? I agree with the noble Lord that there is a need for a new strategy. Will the forward plan and investment in public health recognise the need for investment in prevention and early intervention and a package of care for all women living with HIV, which includes going for regular smear tests?
I thank the noble Baroness for her question. She is absolutely right that the key to us making progress is prevention and early intervention and also understanding about any crossover consequences with other illnesses. She is also right that the key is closing the gaps now. In 2017, 43% of diagnoses were made at a late stage of HIV and, although there has been a decline, the largest group diagnosed at late stage were black African heterosexual men and women. It is important that we close those gaps. Some key projects have been working on that through the HIV Innovation Fund so when we bring forward plans for HIV 2030 it is important that we find out how we can close those gaps if we are indeed to get to zero by 2030.
(5 years, 8 months ago)
Lords ChamberMy Lords, I rise to move Amendment 1 and speak to consequential Amendments 2, 12, 13, 14, 45, 46 and 47. The House will realise that these are the same amendments that we discussed in Committee. I am grateful for the support for them that I have received from across the House: from the noble and learned Lord, Lord Judge, the noble Earl, Lord Dundee —who, we learned yesterday, cannot be with us today—and the noble Baroness, Lady Jolly. I like to think that the reason for their support, and that of other noble Lords in Committee, is the amendments’ simplicity in revising the scope of the Bill to deal with the healthcare arrangements for the EU/EEA and not the whole world.
Like other noble Lords, I am very grateful to the Minister for the time and effort she and her team have put into discussing the Bill with noble Lords. We can see from today’s amendments that the Government have listened to concerns expressed during the Bill’s stages. That is to be welcomed. I am afraid, however, that on this issue—the scope of the Bill—we find ourselves some distance apart.
We need to remember that the DPRR Committee noted the Bill’s breathtaking scope and commented that the scope of the regulations could hardly be wider. The committee said that it was one thing to introduce skeletal legislation needed in the event of no EU withdrawal agreement, but that this Bill was as much to do with implementing future reciprocal healthcare arrangements with non-EU countries—indeed, that it went much further than merely giving effect to healthcare agreements and covered the provision of any healthcare by anyone anywhere in the world. It concluded that the powers of the Bill were inappropriately wide and had not been adequately justified by the department.
This view was expanded in many ways by the Constitution Committee, which said that while the exceptional circumstances of the UK’s departure from the European Union might justify legislation containing broader powers than would otherwise be constitutionally acceptable, this did not extend to giving effect to new policy unrelated to Brexit. It concluded that the Bill should be limited to future reciprocal healthcare arrangements with countries that participate in the existing European health insurance card scheme. We agree. These are the tests that need to be brought to bear on the Bill, as was so eloquently expressed by the noble and learned Lord, Lord Judge, in Committee.
During our discussions with the noble Baroness, it was suggested that it would be in some way inappropriate for this House to reduce the scope of the Bill. If the Constitution Committee and the DPRR Committee think that this revision is appropriate, we are bound to give the matter serious consideration. Surely it our job to offer the elected Chamber the opportunity to reconsider the breathtaking scope and powers of this Bill.
Then there are the issues of practicality and policy. On the practicality test, in this pre-Brexit period—and, my goodness, we are now at possibly the most exciting bit, with the discussions that are taking place in the Commons—surely it should be the Government’s priority to ensure that the millions of British citizens currently benefiting from reciprocal healthcare agreements with the EEA and Switzerland, by virtue of our membership of the European Union, continue to do so. The same should be true for European citizens in the UK. A significant proportion of the many UK citizens living in the EU are pensioners, and they will be personally liable for healthcare costs after exit day unless a new agreement with the EU, or new bilateral agreements with individual member states, are in place. It would cost the UK taxpayer more to treat British nationals who have to return home for healthcare.
My Lords, I am grateful to the noble Baronesses, Lady Thornton and Lady Jolly, and to the noble and learned Lord, Lord Judge, the noble Lord, Lord Marks, and the noble Earl, Lord Dundee, who I am sorry could not be with us today, for giving me the opportunity to deal with the important matter of the global nature of the Bill. We have already had a good deal of debate about this during our progress on the Bill, but it is a pleasure to return to it today yet again.
It is important that the Government explain why we believe it appropriate to seek powers which are global in nature. As I mentioned in my response in Committee, the EU Home Affairs Sub-Committee of this House, which is very wise, remarked that:
“Reciprocal healthcare oils the wheel of the day-to-day lives of millions of citizens”,
and brings the,
“greatest benefit to some of the most vulnerable members of our society”.
I am grateful to noble Lords from across the House, not only in the debate today but during the progress of this Bill, who have been clear that there is widespread cross-party support for the current EU arrangements, and for providing the people who rely on these arrangements with the assurance that the Government are taking all the necessary steps to support them in these uncertain times.
We clearly all support the arrangements we have with the EU. It therefore does not seem logical to preclude the possibility of seeking new arrangements or strengthening existing ones outside the EU. Where the Government have a good policy in one place, it seems logical that we should want to extend it to others. Reciprocal healthcare agreements promote tourism and facilitate economic exchange and growth by enabling people to study, travel and work abroad without worrying about their ability to access healthcare, or the cost of doing so. As we have discussed in our debates on this issue, reciprocal healthcare arrangements are particularly important for older people, people such as me with chronic conditions, or people with disabilities, for whom access or costs can be a genuine barrier to travelling.
Reciprocal healthcare agreements enable people to travel overseas for planned treatment, which enables patient choice. One of the genuine benefits of the current EU arrangements is to enable mothers to travel to a home country to give birth close to their families and support networks. That is available only to EU citizens at the moment, not to those from other countries who live here. Our existing arrangements with the EU enable around 1,350 UK residents to receive planned treatment or maternity care in another EU member state. We do not want to be forced to limit choices only to EU countries in the future.
Reciprocal healthcare agreements can also help to support international healthcare co-operation through fostering closer working relationships between countries and states. We can be proud that the UK is a prominent voice in the global healthcare community and is a key driver in global attempts to raise standards of patient safety. We could help to further drive that agenda through developing even stronger relationships with our close partners. I have heard the concerns raised by noble Lords about the costs of these arrangements. Reciprocal healthcare agreements enable countries to reimburse one another on a fair and transparent basis. Noble Lords, particularly the noble Lord, Lord Foulkes, have queried why we cannot simply rely on waiver agreements. Fair reimbursement is the key reason why. Without this Bill, we would be restricted to waiver agreements outside the EU without a way to establish fair and transparent payment and cost-recovery mechanisms.
Agreements with other countries predate the EU and have never been limited to Europe. This is one reason why the concept of restricting the Bill to the EU does not make sense. We have agreements outside the EU now and will continue to have them in the future. The noble and learned Lord, Lord Judge, and my noble friend Lord Ribeiro raised the matter of scope—the countries which the Bill would apply to. As Clause 4 sets out, data can be shared only in accordance with the GDPR and our data protection regulations. This means that no reciprocal healthcare agreement could be reached with a country that does not meet data adequacy standards. Over and above that, as my noble friend rightly noted, this scope would be further narrowed by the need to agree reciprocal healthcare arrangements only with countries that have a compatible healthcare system. This would mean that countries such as Venezuela, raised by the noble and learned Lord, Lord Judge, would simply be out of scope for an international healthcare agreement. Safeguards built into the Bill would be in place.
I make it clear that I have heard the concerns raised at Second Reading and in Committee about the global scope of the Bill and the breadth of the delegated powers. We have taken considerable steps to address the concerns about the breadth of the powers—the root cause of the concern about the global scope. As has already been referred to, we have tabled a large package of concessions, which I worked hard to try to deliver. The first was to remove the consequential Henry VIII powers; I am taken by the terminology for this now being a “Blackwood amendment”. We have limited the ability to confer functions to public bodies. We have provided greater parliamentary scrutiny over regulations relating to data processing and greater transparency over the financial aspects of future reciprocal healthcare policy in the form of an annual report. I hope that this reassures the noble and learned Lord, Lord Judge. We have placed a statutory duty to consult the devolved Administrations where regulations make provision within devolved competence. Finally, and very significantly, we will sunset two of the three regulation-making powers at Clause 2, so that they can be exercised only for a period of five years after exit day. This final amendment means that it is not possible for the Secretary of State to set up any kind of long-term scheme to unilaterally fund mental health treatment in Arizona or hip replacements in Australia, as the DPRRC proposed. In tabling these amendments, we have limited the delegated powers and therefore the scope of what can be done under the Bill around the world. We have also provided additional parliamentary scrutiny mechanisms and greater transparency.
During the debate on Amendments 1, 2, 11, 12, 13, 27, 28 and 29, from the noble Baronesses, Lady Thornton and Lady Jolly, the noble and learned Lord, Lord Judge, and my noble friend Lord Dundee—who cannot be in his place—I have not heard any concerns raised on the fundamental principle of reciprocal healthcare in countries outside the EU. Rather, I have heard the need for reassurance that in implementing agreements with other countries we seek to appropriately cost such arrangements, protect the NHS, and ensure that those countries which we strengthen or make new agreements with have appropriate healthcare systems and are able to process data appropriately. We are firmly committed to all these principles.
When the Bill was debated in the other place, questions were raised concerning the possibility of a reciprocal agreement with Guernsey, which is something we will need to look into following EU exit. This was seen as a positive possibility of the Bill; it is just one example of how our relationships might evolve and how the Bill can offer people new opportunities which they are currently denied under our legislative framework. If the scope of the Bill is limited to matters relating only to EEA countries and Switzerland, the Government would be unable to implement a reciprocal healthcare agreement with countries such as Guernsey where we are able to reimburse one another fairly. We would also be giving up the opportunity to support people, to bring them confidence and comfort outside the EU.
As the UK considers its relationship with the rest of the world, it is appropriate to take this opportunity to consider strengthening our existing agreements while exploring possible agreements with other countries. The powers under this Bill allow us to fund healthcare overseas to support UK nationals who live in, work in, study in, want to visit or give birth in other countries, while ensuring that we also have appropriate scrutiny powers within this Bill. They also allow us to extend similar opportunities to overseas nationals to use the NHS funded by their own country, making the NHS more sustainable and fit for the future. This is what we would be giving up with these proposed amendments.
There has been much debate in this House and outside it about whether there should, in fact, be two separate Bills: one to provide for implementing agreements with EU, EEA countries and Switzerland, and the other at a later date to provide for countries outside that group. I believe that this is the intent of Amendment 4, in the name of the noble Lord, Lord Marks. That would not be an effective use of parliamentary time; it would prove a barrier to the development and implementation of policy in this area that is clearly in the interests of the people whom I have already discussed. I am also not clear how different a different implementing Bill would look, as it would simply be for the implementation of international healthcare agreements and would be rather similar, whether they are for the EU country or for a country in another part of the globe. It seems to be doing the same work twice.
With the Bill, we seek to ensure that we have an implementing mechanism for reciprocal healthcare now and into the future. While it may be appropriate in other policy areas for the Government to seek new primary powers to implement specific, individual international agreements, it is simply not the case with reciprocal healthcare agreements. These agreements are not far-reaching in nature and are very limited in subject matter: they are about reciprocal healthcare. As has already been discussed, the Government already rely on the royal prerogative to enter into these agreements with other countries. This Bill is simply a smarter implementing mechanism for these agreements.
I also have concerns that Amendment 4 risks our ability to effectively implement a future relationship with the EU. Recognising the broader benefits of reciprocal healthcare, we want a long-term relationship with the EU but, as with any area of policy, we must have flexibility as to how we negotiate with the EU and how we arrange our broader relationship with it. EU law evolves and, as we discussed in Committee, there are proposals currently before the European Parliament that would mean that elements of that model might change in the near future. This amendment would prevent the UK from implementing that evolved arrangement even if that was the desired negotiating position of the UK. If we put this on the face of the Bill, we would have no flexibility on how we would do that, including agreements already concluded with Switzerland and the EEA and EFTA states. The noble Lord himself acknowledges in his amendment that flexibility is needed, but through this amendment that flexibility would be difficult to apply in practice.
In relation to all the amendments in this group I firmly believe that, in pursuing future reciprocal healthcare policy with close partners outside the EEA and Switzerland, the Government are providing hope and opportunity to people. Our colleagues and friends in the other place overwhelmingly supported this endeavour. We have introduced significant restrictions on what this Bill can do globally. However, I regret that these amendments would prevent us from being able to look to the future and embrace an opportunity for EU exit. It would be a great shame to miss that opportunity.
I recognise the valuable contributions from many Members of the House on enhancing and improving many elements of this Bill; I thank them for the time that they have given me, but I am unable to accept these amendments. I hope noble Lords will feel able not to press their amendments on that basis.
I thank the Minister for her remarks and for the attention that she has paid to this matter all the way through. Everybody appreciates that enormously. In a way, she has made my argument for me, as has the noble Lord, Lord O’Shaughnessy, because nothing in the Bill says that healthcare agreements have to be reciprocal. In a way, that proves that we do not need an international healthcare arrangements Bill: we need a European Union-EEA healthcare Bill to deal with reciprocal arrangements and do the job that we have in front of us.
I do not accept the argument put by the noble Lord, Lord O’Shaughnessy, tugging at our heartstrings, about the human consequences of this. Actually, there is nothing to stop the Government bringing forward a global healthcare Bill. I am absolutely sure that the Minister and her colleagues, with the help of the noble Lord and others, could get this into the Queen’s Speech in two months’ time, when we could have all these discussions about how it might work. He said that we do not have any disagreements in principle about this. Actually, we do not know whether we have any disagreements in principle about international healthcare because we have not had that discussion: that is the discussion we would have if we were dealing with a Bill that was being consulted upon, going through pre-legislative scrutiny and all those other things that we have been arguing need to happen if we are to have a Bill of the scope that the Minister and her party wish to have.
I thank the noble and learned Lord, Lord Judge, the noble Lord, Lord Marks, the noble Baronesses, Lady Brinton and Lady Jolly, and my noble friends Lord Foulkes and Lord Judd for their support. In particular, I thank the noble Lord, Lord Wilson, who, in his brief remarks got the argument absolutely right yet again. As I was preparing for this, I looked at the agreements we have with Australia and New Zealand, for example. These things are complicated—of course they are— and in a way that is why they deserve and need further consideration. I fear that we are not convinced by the Minister’s arguments and I would like to test the opinion of the House.
My Lords, as I should have done at the beginning of the first group, I thank the Minister for her help and courtesy in discussing this Bill and in engaging with Peers across the House to see how we should proceed with it. I echo the words of the noble and learned Lord, Lord Judge, including his tribute to the Blackwood amendment in respect of Henry VIII powers. As the Minister will have appreciated and has recognised by her actions, there is a real concern about the use of delegated legislation to amend or revoke primary legislation and EU legislation.
Amendment 3 is intended to bring a constitutionally acceptable structure to the Bill. It will ensure that the powers of the Secretary of State can be exercised only within the context of regulations. I will start with a word or two about the other amendments in this group: Amendment 5, on the words “for example”, and government Amendments 6, 7 and 8, which limit the delegation of powers to public authorities.
As we have heard, Clause 2 contains the principal regulation-making powers. We had considerable debate, both at Second Reading and in Committee, about how unacceptably wide those powers are. The use of “for example” at the beginning of Clause 2(2) speaks volumes as to the disrespect shown in the Bill for the proper restriction of ministerial powers. The Delegated Powers Committee and the Constitution Committee have exposed how outrageously broad these powers are.
My amendment is directed at the absence of anything in the Bill that would limit the Secretary of State to exercising his Clause 1 powers only in accordance with regulations. One does not have to read far into the Bill to appreciate that, under Clause 1:
“The Secretary of State may make payments, and arrange for payments to be made, in respect of the cost of healthcare provided outside the United Kingdom”.
This is wholly without restriction. It is this glaring deficiency—the failure to tie the Secretary of State to the exercise of powers in accordance with limitations either in the statute or contained in regulations—that my amendment is intended to cure.
The Minister frankly and commendably, if I may say so, recognised on our first day in Committee that the effect of Clause 1, if not amended in the way I suggest, would be to enable the Secretary of State to make or arrange payments without any regulatory limitation. She justified this untrammelled power—which, frankly, I find frightening—on the basis of urgency. She said that the Bill was unlikely to secure Royal Assent before March, so regulations would not be laid before the summer. If there were no deal, she explained, Ministers might need to use the powers before then. She mentioned—again, frighteningly—sharing data as well as making healthcare payments before the Government had a chance to get regulations passed to deal with these matters “more transparently”, as she put it.
This clause alone, unamended, would justify this country ruling out a no-deal exit and ensuring that our leaving date is delayed. It is an extraordinary travesty of the notion of the United Kingdom Parliament taking back control that we are asked to pass a Bill which involves ceding to Ministers an entirely unconstrained power to pay money out across the world on the sole professed ground that the Government failed to introduce legislation in a timely way, and to permit Ministers to spend public money and make arrangements of great public importance without any parliamentary scrutiny or authorisation.
I turn briefly to the other amendments in the group. Many of us still take the view that their scope is breathtakingly and unacceptably wide. The Government’s proposal to limit possible delegation of the Secretary of State’s powers so that such powers may be conferred only on a public authority is of course welcome; so is the limited five-year sunsetting provision, to which we shall return later, but, taken together, they barely scratch the surface of the massive transfer of unrestrained power from the legislature to the Executive set out in Clause 2. Of course, the sunsetting clause should be more restrictive—at least as restrictive as proposed by the noble and learned Lord, Lord Judge. Again, we will come to that later.
It goes without saying that the ridiculous and offensive restriction-busting words “for example” should be removed, as proposed in Amendment 5. However, the only satisfactory way to restrict the Government’s power to what is necessary and acceptable is for the House of Commons to now accept the amendment we just passed restricting the use of the Bill to replicating the arrangements we have with the EU, the EEA and Switzerland. We hope that it does that.
This Government and future Governments must show more restraint and respect for the proper limits to the scope of delegated legislation. In the Bill, as in others to do with Brexit, they have not done that. It is to be hoped that they return to a wiser path in future.
I thank the noble Lord, Lord Marks, for his exposition, which saves me from exploring yet again the powers in the Bill. I shall speak to Amendment 5, which is a simple amendment but one that we think might be quite clever in its intent. It states that regulations under the Bill can be made only for specific purposes.
When the clause was debated in Committee, noble Lords discussed the nine regulation-making powers mentioned by the noble and learned Lord, Lord Judge, which brought comment from the DPPRC, about the widest possible scope. However, as drafted, Clause 2(2) appears to bestow infinite powers on the Secretary of State to make regulations by virtue of the seemingly innocuous phrase “for example”, which effectively grants the Secretary of State carte blanche to bring regulation forward outside the listed examples in relation to pretty much anything and everything. Just deleting those words will assist with the accountability that needs to be built into the Bill.
Amendment 5, which has the support of the noble and learned Lord, Lord Judge, and the noble Baroness, Lady Jolly, would ensure that regulations can be brought forward under the Act only for the purposes specified. We will, of course, support the Minister in the amendments she has tabled in this group—Amendments 6, 7 and 8 —and I think the combination of our amendment and hers significantly improves the Bill, so I hope she will accept it. I probably need to say that, unless there is a very good reason why she does not want it and why it should not be there, we will seek support from the House for this amendment.
My Lords, we have here a new example of constitution-making. We have now got rid of Henry VIII in this Bill and we have something rather more subtle—not something that that great, mighty ogre could have conceived of for himself.
The new example is:
“Regulations under subsection (1) may, for example”.
Those of your Lordships who were in the House when we discussed the Trade Bill last week will remember another regulation-making power—another blockbuster like this one—only the words used were not “for example” but “among other things”, in relation to regulations under whichever subsection it was. What kind of primary legislation is this? It is really rather alarming. The primary legislation provides:
“The Secretary of State may by regulations”,
do this, that and the other: (a), (b) and (c). Well, fine. The regulations “may” do nine things—there is an amendment to one of them to come later, but this is not relevant to present purposes—specifying just about anything you can think of.
Why do we not say, even in relation to the EU, that the regulation-making power should be defined as widely as it is in Clause 2(2) but not extend further? The reality is that, with these words, in truth there is no limit to the regulation-making power. I find that astonishing, and I suspect that many Members of your Lordships’ House will find that astonishing. So we now have within the terms of the Bill—subject to the Henry VIII point, which is going—in effect an undefined, unconstrained power given to the Secretary of State to make regulations. It will not do.
I listened very carefully to the Minister and I am not convinced, partly because the regulations under Clause 2(2) are very helpful. They give the Government everything they need to take forward the negotiations on reciprocal healthcare, and as the Minister herself said, we have put the regulations in place to help with a no-deal situation, which I hope will not occur. But the noble and learned Lords, Lord Hope and Lord Judge, made the point that those words are, while dangerous might be an exaggeration, certainly not appropriate.
Does the noble Baroness agree that, with “for example”, you may not be extending the jurisdiction of the regulations but actually limiting their range? That is what the Minister was seeking to tell us in her eloquent description of her case. If you say “for example, cows”, you have the example of animals that fall within the range of cows. Without that phrase, some cases would not apply to cows.
I hate to disagree with the noble and learned Lord, Lord Woolf, but the words “for example” expand the list rather than decrease it. That is the point of this amendment. Given the huge weight of regulations that we are dealing with in this House, if something is not included in that list, I am sure that that can be remedied. We are getting very good at remedying those situations. We on these Benches think—and other noble Lords have certainly agreed—that “for example” expands the range and that is not necessary or appropriate, so I beg to move and wish to test the opinion of the House.
My Lords, my noble friend will forgive me if I ask for a point of clarification. If Amendment 9 is passed, after the sunset clause is implemented, powers could only be made in relation to a healthcare agreement. However, Clause 3 says that a healthcare agreement can concern either healthcare provided outside the United Kingdom and paid for by the United Kingdom, or healthcare provided in the United Kingdom with another country paying. It does not require reciprocity. Is that quite the restriction my noble friend was suggesting, since it could still be unilateral, not reciprocal?
I thank the Minister for tabling this sunset clause; she is quite right to do so. I had not thought of the question asked by the noble Lord, Lord Lansley, but it is a good one. However, we support the amendment.
I thank my noble friend Lord Lansley for his question. This power enables a unilateral scheme, so it does not require reciprocity and is intended to be used only in an emergency scenario where a group of individuals are in difficulty. That is why it is appropriate to sunset it in this way.
I thank the House for its support for the amendment and hope that the noble and learned Lord, Lord Judge, will withdraw his amendment on that basis. I beg to move.
My Lords, I had amendments that the Minister responded to at the Dispatch Box and I accepted her explanation at the time. Now I take the point that the noble Lord, Lord Clement-Jones, is trying to raise, that those principles that she enunciated about data protection included the Caldicott principles. As that reassurance was given at the Dispatch Box, I think it will cover the issue.
My Lords, I added my name to the amendment in the name of the noble Lord, Lord Clement-Jones, and I am grateful that he has made the argument so I do not need to repeat it. Of course, I spoke about this in Committee and, like other noble Lords, I was reassured at the time by the explanation given by the noble Baroness, Lady Manzoor. Since then, however, the Bill team has actually made available the Bill data processing factsheet, which is very useful. It explains things in great detail, so I wondered whether it might be a good idea if this was given to everybody involved with this Bill. I do not know whether the noble Lord has seen this, but it is a very useful piece of information. Otherwise, I was satisfied in Committee, and if the Minister answers the questions, I am sure that I will remain satisfied.
My Lords, I thank the noble Lord, Lord Clement-Jones, and the noble Baronesses, Lady Jolly and Lady Thornton, for tabling Amendment 14 and raising the issue of the lawful and responsible processing of data. I start with an apology to the noble Lord, Lord Clement-Jones. My noble friend Lady Blackwood did write to the noble Lord, and I am sorry that he has not yet received the letter. We will endeavour to send him another copy as soon as possible.
As my noble friend Lord O’Shaughnessy said—and I reassure the noble Lord, Lord Patel, that—data sharing is a necessary and crucial aspect of maintaining effective complex reciprocal healthcare arrangements, and the Government are committed to the safe, lawful processing of people’s personal data. There are, as the noble Lord said, safeguards in place in respect of processing personal data for the purposes set out under the Bill, for which the Bill makes express provision. The Bill makes it absolutely clear that it does not authorise the processing of data that contravenes UK data protection legislation.
Data processing will be permitted only for the limited purposes set out in the Bill. Personal data will be processed in accordance with UK data protection law—as the noble Baroness, Lady Thornton, observed—namely, the Data Protection Act 2018 and the general data protection regulation, which will form part of UK domestic law under the European Union (Withdrawal) Act 2018 from exit day.
I assure the noble Lords, Lord Patel and Lord Clement- Jones, and the noble Baroness, Lady Thornton, that the Caldicott principles are an important part of the governance of confidential patient information in the NHS and a guiding mechanism for organisations in how they should handle confidential patient information on a practical level. The NHS is expected to adhere to these principles.
Since 1999, NHS bodies have been mandated to appoint a Caldicott Guardian. These principles are therefore ingrained in the current operation of the NHS and confidential patient data handled by the NHS for purposes in relation to reciprocal healthcare will be subject to these principles. The principles are consistent with the requirements of the GDPR and a breach of the Caldicott principles would most likely amount to a breach of the GDPR and the Data Protection Act 2018. The principles are not intended for statute but are of real practical and operational importance when confidential patient information is processed. This will be the case when confidential patient information needed for reciprocal healthcare arrangements is processed.
It is also worth noting that reciprocal healthcare arrangements will not normally involve the processing of confidential patient information, except in particular circumstances, such as facilitating planned treatment. However, where this information is processed through reciprocal healthcare arrangements under the NHS, it must comply with UK data protection legislation. NHS organisations, as they do now, will be required to adhere to the Caldicott principles. The data ethics framework that the noble Lord, Lord Clement-Jones, mentioned sets out collective standards and ethical frameworks for how data should be used across the whole public sector, as well as the standards for transparency and accountability when building or buying new data technology. Where the framework refers to personal data, it consistently cross-refers to the principles in the GDPR, which is the relevant legislation that policymakers must consider when processing personal data.
Personal data processed for the purposes of reciprocal healthcare arrangements would therefore also take into account the data ethics framework. In addition, from 1 April 2019, the National Data Guardian will be put on a statutory footing and will therefore be able to issue formal guidance and informal advice to organisations and individuals about the processing of health and adult social care data in England. This will provide patients statutory independent oversight of the use of health data, with health bodies being required by law to have regard to the guidance issued by the National Data Guardian. This is another way in which NHS organisations in England which are processing data in respect of reciprocal healthcare will be monitored and personal data can be further protected as necessary.
It is important to note that express reference to these principles in the Bill would not provide any additional protections for personal data or confidential patient information, as the standard of protections required is the same as the existing data protection legislation already provided for in the Bill. I am grateful to the noble Baroness, Lady Thornton, and others for their support in observing this. Furthermore, as I have said, these principles already apply to NHS organisations and will continue to do so in respect of reciprocal healthcare. As a result, it would be inappropriate to put these in the Bill and I am therefore unable to accept the amendment. However, the Government have listened carefully to concerns surrounding the list of persons who can lawfully process data as a part of implementing new reciprocal healthcare arrangements under the Bill and have tabled an amendment on this issue.
Currently, the list of authorised persons under the Bill includes the Secretary of State, Scottish Ministers, Welsh Ministers and a Northern Ireland department, NHS bodies and providers of healthcare. Of course, over time, public bodies change, are reformed and refashioned, and functions are transferred between them in consequence. Clause 4(6)(e) gives the Secretary of State the ability to respond to such changes so that systems can operate efficiently and data can follow in an appropriate and lawful way to enable such operation. We propose, however, subjecting any regulations that add to the list of persons authorised to process data for the purposes of the Bill to the draft affirmative procedure. This would allow Parliament the opportunity to scrutinise authorised persons handling personal data while ensuring that the Government have the ability to guarantee that future agreements are administered in the most efficient way possible.
The Government are firmly committed to the safe, lawful processing of personal data, and to ensuring that patients have enforceable protections under data protection legislation. I hope, given my assurances that any data processing under the Bill would comply with the Caldicott principles and the data ethics framework as appropriate, that the noble Lord will feel able to withdraw the amendment.
The noble Baroness, Lady Thornton, kindly mentioned the factsheet. Of course, if it is useful, we would be very happy to put this in the Library. Officials do a tremendous job and I am very grateful to them. I hope, with the assurance I have given noble Lords, and the fact we are providing greater scrutiny, that the noble Lord feels able to withdraw the amendment.
My Lords, this is a probing amendment to Amendment 16. I am seeking reassurance about the contents of the annual report. I very much welcome the amendment moved by the noble Baroness, Lady Manzoor, which we shall be supporting.
I realise that lists are a dangerous thing to put in a Bill. In proposing her amendment, the noble Baroness covered some of these points. However, it is very important, given the powers that the Bill contains, that information—for example under Clause 2(2)(a) and (b)—must be listed in every annual report by individual countries. We feel that proposed new paragraphs (a) to (f) in our amendment need to be contained within the annual report.
This amendment seeks reassurance that the contents of this report will be consistent with the powers that the Government are seeking in the Bill.
My Lords, I support the amendment moved by the noble Baroness, Lady Thornton. Without repeating our debates at previous stages of the Bill, it would be helpful to have reassurance from the Minister that the content of the list in the noble Baroness’s amendment is exactly the sort of detail we need. It is important to reassure people on exactly how any financial arrangements for healthcare will be made.
My Lords, I am grateful to the noble Baroness, Lady Thornton, for her amendment and to the noble Baroness, Lady Brinton, and my noble friend Lord Lansley for their contributions. I am not sure I want to go down this route. However, if the noble Baroness, Lady Brinton, wants me to write to her to clarify the point she raised, I will certainly do so. From what I have seen, my noble friend Lord Lansley is correct in saying that we have a reciprocal agreement with the countries he mentioned, where money does not exchange hands.
I can reassure the noble Baronesses, Lady Thornton and Lady Brinton, that—as I indicate—the Government have listened to the need for greater transparency in the administration and implementation of reciprocal healthcare arrangements. I welcome the support around the House for our intentions. We understand the importance of presenting this information in a clear and accessible document, which is why we propose to go beyond the current reporting requirements. Our initial commitment to the DPRRC is contained in the amendment that the Government have tabled on this matter.
As I said, the government amendment directly addresses concerns raised by noble Lords. I hope it reassures noble Lords and demonstrates that we have listened to the clear request for increased scrutiny of the use of public money.
The amendment of the noble Baroness, Lady Thornton, would ensure that specific requirements are reported on. The detailed content of the financial report should—and could only—be determined, once reciprocal healthcare agreements have been made and technical and operational details are known. We do not know what these agreements may be in future. If we accepted the amendment, we would be placing a statutory duty on future Administrations to collect and report on data we have not yet agreed to exchange with other countries. This is not appropriate.
Our amendment is a more feasible way of reporting on future healthcare arrangements that does not pre-empt their nature or how they may be implemented, but still allows for transparency and accountability, which the noble Baroness, Lady Thornton, and other noble Lords seek. It is a baseline, and we intend to go further than just reporting on payments, but we cannot provide a statutory obligation to do so.
The Department for Health and Social Care is currently working to ensure that UK nationals can continue to access healthcare in the EU in the same way they do now, either through an agreement at EU level or through agreements with relevant member states. In either case, we will have to agree how eligibility is evidenced, how—and how frequently—that information is exchanged and the reimbursement mechanisms that will govern those new agreements. Such agreements will have to take into account the operational possibilities and limitations of each contracting party to ensure the smooth operation of reciprocal healthcare arrangements. This should include how NHS trusts in the UK can evidence eligibility for the treatment of non-UK citizens in the most efficient and least burdensome manner.
Once those administrative details are known, the Government will be able to speak confidently to the specific measures that can be reported on for each country. There is an annual reporting mechanism in the government amendment to provide such detail. I acknowledge that the amendment of the noble Baroness, Lady Thornton, is well meaning and agree with its spirit, but the level of detail proposed in it could constrain or create unnecessary burden when administering future healthcare arrangements that have not yet been negotiated.
It is in the interest of neither the Government nor Parliament to force unnecessary administrative burdens on the NHS, which the amendment could inadvertently cause. The level of detail required in the amendment may create new reporting requirements on front-line NHS services.
As always, should the noble Baroness wish, the Minister or others from the department would be very happy to meet her to talk further about the issues, once we have a clear understanding of future negotiations and how they progress. I hope I have reiterated the Government’s commitment to accountable financial reporting, and that the noble Baroness and other noble Lords feel reassured on our commitment to ensuring that sufficient and appropriate checks and balances are in place on reciprocal health agreements. I hope she will agree that her amendment, which places a statutory duty on future Administrations to collect and report on data we have not yet agreed to exchange with other countries, is inappropriate. I hope I have reassured her and other noble Lords and she feels able to withdraw her amendment.
I thank the Minister. I said from the outset that this was a probing amendment and I therefore beg leave to withdraw it.
Perhaps I may add a few words to those of the noble and learned Lord, Lord Judge. I was particularly concerned by Clause 5(3), as the noble Baroness may remember, and am delighted to see it removed because, as worded, it gave rise to a lot of problems. Together with the other amendments proposed, there is considerable improvement and I am most grateful.
I tabled an amendment in this group. First, I join the noble and learned Lords and all noble Lords in saying thank you very much to the Government and the noble Baroness for removing these Henry VIII powers, which cause so much heartache in this House—we really do not like them at all. I tabled Amendment 21 because I should like an explanation. Given that our Constitution Committee and the Delegated Powers Committee have several times said that they find the negative procedure rampant in the Bill, and that the British Medical Association has also voiced its concern about legislation being subject to the negative resolution procedure, in the interests of accountability, I need to ask the Minister to explain to the House the justification for negative procedure throughout the Bill. Should it not be subject to the same level of scrutiny as in the European Union (Withdrawal) Act, for example?
I thank the noble and learned Lords for their support for our amendments to Clause 5 and the removal of the Henry VIII operation within the Bill. I shall do my best to continue in the way I have started in this House.
I thank the noble Baroness, Lady Thornton, for her Amendments 21 and 23. The Government recognise that appropriate levels of scrutiny are the hallmark of an effective and responsible parliamentary system and that the processes by which we draft, consider and test legislation must be robust. It is necessary that we look at the nature of the subordinate legislation in the Bill and balance the need for scrutiny against the appropriate use of parliamentary time.
The draft affirmative resolution offers a greater level of parliamentary scrutiny and may be appropriate for particularly significant or sensitive regulations. For example, that is why the Government have agreed that that is appropriate when amending the list of authorised persons able to process data for the purposes of reciprocal healthcare. It is important to understand that, where the UK negotiates a new comprehensive international healthcare agreement, most of the important elements setting out its terms would be included in the agreement itself rather than in the regulations, made under the Bill, that implement it. The regulations giving effect to such an agreement would be much more likely to focus on the procedural, administrative or technical details, such as the types of documents or forms to be used to administer reciprocal healthcare arrangements. Evidence tabled during the course of the Bill’s passage from the Academy of Medical Royal Colleges and the British Medical Association demonstrates that the administration for current arrangements works well. The regulations made under this Bill would be likely to simply provide for the effective and efficient administration of these arrangements.
I thank the Minister for her explanation, which of course I accept. I am sorry I did not speak to Amendment 23 in my name, but it is consequential on Amendment 21. I think we probably just have to be watchful, so I will not move these amendments.
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Lords ChamberI thank my noble friend for his question; he is of course very expert in this area. We want NHS dental services to be attractive for the profession and we remain committed to reforming the dental contract, which should help, but we recognise that there are a range of reasons for contracts being handed back, whether it is retirement, a decision to concentrate on private work or, in some cases, reorganisation of the companies providing the service. It is important that NHS England works with other local dentists to ensure that patients can continue to access dental care. There is a level of concern about recruitment and retention of dentists, and those difficulties need to be addressed by NHS England in its role as the commissioner. It is continuing to ensure that it works collaboratively with the profession and the department is keeping a close eye on this.
My Lords, tooth decay is a major source of health inequalities, as the noble Baroness has acknowledged, with 33% of the most deprived five year-olds having tooth decay, compared with 13.6% of the least deprived. In some parts of the country—the north-west, the West Midlands and Yorkshire—tooth decay rose for the first time in the last 10 years. How much investment will the Starting Well Core scheme have and for how long? When will we learn from the Government whether this has provided the right kind of remedial action for the most deprived children?
I thank the noble Baroness for her question. I shall write to her on the exact amount of investment, but there are some reassuring figures coming forward: 77% of all five year-olds now have no visible decay, compared to 69% in 2008; there has been a fall in the number of extractions per 100,000 finished consultant episodes for the first time in the last decade; and more children accessed dentistry over the last year. All this is reassuring and we are committed to improving access and equality of access to dental care—that is what the Children’s Oral Health Improvement Programme Board, led by PHE, is intended to do. It brings together 20 stakeholder organisations specifically focused on oral health. There is a significant amount of activity targeting exactly the issue the noble Baroness raises.
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Lords ChamberI thank the noble Baroness for her question. This advice has come not from the Prime Minister, but from the Royal College of Radiologists. On the basis of that advice, we know that many services will be unaffected. For other services, the NHS is already working closely with suppliers to minimise the impact of changes to medical radioisotope delivery times, which are expected to be a matter of hours and easily managed by clinics. But it is appropriate that they should be given sensible and practical advice to ensure that patients are protected and that patient safety is maintained to the highest possible standards.
My Lords, in many ways this Question is the just-in-time question of healthcare. We know that our manufacturing industries, particularly the automotive industries, will be affected by Brexit because of the just-in-time nature of their work. This is the just-in-time of cancer care. If you do not have the isotopes the tests do not get done, because the delivery is timed for the morning of an appointment when patients are due to arrive at the hospital—if there is nothing to give them, they then have to go home and wait for another slot.
My question to the Minister, who has done her best to reassure us on this, is: what calculation have the Government made of the risks? Certainly, the organisations which have waved a flag about this are not trying to panic anyone; they have legitimate concerns that they may have to delay treatment and tests because of Brexit. What calculations have the Government made of the risks there would be to people’s lives from delays that may happen as a result of this lack of just-in-time?
I think I answered that in my response to the noble Baroness. We have assessed that we do not expect any patient harm to arise from this, and the changes to clinical pathways and practices are expected to be minor and short-lived. It is one of the reasons why we started working with industry early in the process to ensure that air freight capacity was put in place. It is also why we have been working with the Royal College of Radiologists, NHS England and the department to ensure that the guidance was put in place, so that clinics could be prepared to adapt to these changes in delivery times.
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Lords ChamberMy Lords, this statutory instrument has been brought forward in the absence of the Northern Ireland Assembly which, as noble Lords will be aware, is suspended. We have just debated a complementary instrument which deals with the recognition of other EEA and Swiss health and care qualifications in the UK in a no-deal scenario. My department has worked closely with Northern Ireland Civil Service officials in the development of these regulations and they are the result of positive and collaborative work between the respective departments. Noble Lords will now be familiar with the recognition arrangement for all other EEA and Swiss qualified health and care professionals across the UK, which this instrument seeks to replicate. I will therefore describe only briefly what these regulations do.
This instrument deals with the recognition of EEA and Swiss pharmacist qualifications in Northern Ireland. It has three main effects. First, like the previous set of regulations, it puts in place arrangements for the recognition of EEA and Swiss pharmacist qualifications that are currently automatically recognised. Secondly, it ensures that applications for recognition that are ongoing on exit day can be completed under the current legal arrangements. Finally, it removes a number of provisions which it is not possible or appropriate to maintain in the event of a no-deal Brexit.
The instrument puts in place new arrangements for the recognition of pharmacist qualifications that are currently automatically recognised by the Pharmaceutical Society of Northern Ireland. Such qualifications will become “relevant European qualifications”. As such, they will continue to be recognised without additional testing other than checks of language skills and whether there are concerns about their fitness to be registered.
The regulations give the PSNI a new power to stop the automatic recognition of a qualification by seeking designation of that qualification. This is not currently possible under the directive and is an important additional measure that will enhance public protection. Such a designation will be subject to the agreement of the Department of Health for Northern Ireland.
The Government have been asked whether they will set out guidance on the criteria to be applied by the PSNI when seeking the designation of a qualification. We do not intend to do so. The PSNI will be able to seek designation of any qualification that is currently automatically accepted about which they have concerns. It will be the PSNI’s responsibility to gather the evidence in support of designation. The most likely basis for designation will be that a qualification does not meet the standard of the equivalent Northern Ireland pharmacist qualification and therefore presents public safety concerns. The PSNI sets the standards for Northern Ireland pharmacist qualifications and is therefore best placed to identify if there is a case for designating a qualification as not being comparable to these standards. The arrangements for the continued recognition of automatic qualifications will be reviewed by the Secretary of State for Health and Social Care no later than two years after these regulations come into force.
Qualifications that are not covered by the automatic system are considered by the General Pharmaceutical Council, which regulates pharmacists in Great Britain. These pharmacists can practise in Northern Ireland under a memorandum of understanding between the GPhC and the PSNI. This arrangement will continue, and changes to the GPhC’s procedures in a no-deal exit have been dealt with in the previous order.
These regulations enable applications which have been made before exit day to be concluded under current arrangements as far as practically possible. The instrument also allows individuals practising under temporary and occasional status or under the European professional card to continue to do so until such registration expires. Concerns have been expressed that the removal of temporary and occasional registration will have a detrimental impact on the number of EEA and Swiss trained pharmacists practising in Northern Ireland. I do not accept this. The PSNI does not have any pharmacists registered to practise on a temporary and occasional basis and has never received an application for temporary and occasional registration in Northern Ireland.
The instrument removes obligations and administrative arrangements that no longer apply to the PSNI, operate effectively or are appropriate to maintain when the UK leaves the EU. These include the requirement to share information through the European Commission’s IMI, to which regulators will no longer have access; arrangements that allow pharmacists to practise in Northern Ireland using an EPC; and the requirement on the PSNI to set professional education and training standards that comply with standards set in the directive. This will provide the PSNI with greater flexibility to set education and training standards that meet the needs of the pharmacy profession in Northern Ireland.
These regulations put in place a system for the recognition of EEA and Swiss pharmacist qualifications in Northern Ireland if the UK exits the EU without a deal. They also ensure that applications in progress on exit day will be concluded under current arrangements as far as possible. The regulations ensure a consistent approach to the recognition of professional health and care qualifications across the UK.
My Lords, I thank the Minister for introducing these regulations. These ones are kind of like a double whammy: there are no-deal issues to deal with and no Assembly in Northern Ireland to deal with them.
These regulations are not as complex as the other ones. However, briefings we have received about this in the last week suggest there is some confusion among pharmacists in Northern Ireland about what might happen. The Company Chemists’ Association suggests that the impact of Brexit,
“could lead to a major nationwide shortage of pharmacists available for work”.
There has reportedly been a huge drop in the number of pharmacists registering with the General Pharmaceutical Council since the Brexit vote, with registrations of pharmacists from the EEA falling by 80%—that is generally, not just in Northern Ireland. The Chief Medical Officer for England stated that our pharmacists will be on the front line if there are any shortages. It makes being a pharmacist in the next month or so a pretty daunting prospect.
Concerns are rife, despite the Government stating that they wish to keep free movement of the protected professions and recognising pharmacists’ qualifications. Can the Minister clear up the confusion between pharmacists? Some seem to be saying it will be okay; others say they will fare very badly in the event of no deal. Can assurance be given to pharmacists that their qualifications will be recognised after we exit the European Union? Can the Minister outline the impact she thinks Brexit will have on our pharmaceutical industry and our chemists? In the UK, we depend on our pharmacists as the front line, the people we go to quite often so that we do not have to bother our GP. There seems to be a lot of concern out there that our pharmacists will find themselves in some difficulty.
My Lords, I want to pick up a point made by both the Minister and my noble friend Lady Thornton at the start of her remarks—the lack of an Assembly and how things are dealt with in Northern Ireland. The Minister may not be able to respond to this, but I will put it on the record to see whether someone in government could respond. Is she aware of reports in the press that civil servants in Northern Ireland are increasingly worried about having to take policy decisions? The people then think they should be accountable for the policy decisions, so criticisms are made of civil servants who are making policy decisions. This is certainly not what anybody wanted, but it is inevitable now and has been going on for some time.
This is one of many examples. If there is no way in which the Northern Ireland political parties can be consulted, the way they are behaving is causing an increasingly treacherous situation. I say this to put it on the record and ask for someone in government to respond as to whether they agree that Northern Ireland’s civil servants are in an impossible position in terms of them making policy. Secondly, I ask whether consideration has been given to how far the Civil Service in Northern Ireland circulates this material to political parties and seeks any feedback. Is that also out, in the present situation of no Assembly?
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Lords ChamberAt the end insert “but that this House regrets that, in the event of a no-deal Brexit, the additional administrative burdens for many qualifications and the prohibition of European Economic Area temporary and occasional healthcare professionals that are proposed by the draft Regulations could be detrimental to the National Health Service.”
My Lords, I thank the Minister for introducing this instrument with such clarity. The reason I have tabled an amendment to the Motion is to draw attention to the serious concerns that were expressed by the Secondary Legislation Scrutiny Committee in its report in December last year. As the Minister has explained, these draft regulations laid by the Department of Health and Social Care set out the Government’s plans for recognition of EEA and Swiss professional healthcare qualifications in the event of no deal. Yet again we are spending valuable parliamentary time talking through quite large regulations that would not need to be here if the Government had ruled out no deal, to be frank. Here we go again. They need the scrutiny of your Lordships’ House because the Secondary Legislation Scrutiny Committee drew them to our attention, because of issues of public policy that we need to address.
The Government have said that they would not introduce new public policy issues into these orders and Brexit legislation, so we need to ask whether these regulations raise any of those issues. My questions will be focused on the issues that the Secondary Legislation Scrutiny Committee raised in its report.
The first question is about the regulators’ decision-making. The committee asked the DHSC how the UK regulators would make decisions. It was concerned about whether the regulators could set their own criteria for designation and the DHSC confirmed in its response to that question:
“Health and Care regulators are best placed to assess qualifications. Privy Council scrutiny ensures continuity for applicants in the short term whilst providing an inbuilt safety mechanism for removing qualifications that require further testing. The overarching principle behind the designation is the safety of the public—and we will work with regulators to ensure this”.
The question that the Minister needs to address is about ensuring a consistent and fair approach to the decisions by the different regulators, because each regulator will be responsible for the criteria for designation in its area.
That begs the question of how much work is involved and how much extra burden this will put on our regulators, given that the regulations give the UK regulators a discretion to designate EEA and Swiss qualifications as not acceptable in the UK after exit from the EU. The Minister needs to respond on what criteria regulators will apply in designating a qualification as not comparable to UK standards and what steps will be taken to ensure that regulators maintain a consistent and fair approach to their application. I welcome the clarification that there will be no change to the language testing arrangements, because your Lordships’ House has been concerned about that for many years.
The Minister needs to address what the administrative burden on regulators might be. No information on cost or impact is given in the Explanatory Memorandum other than to say that they will be negligible—I try to avoid that word—which seems unlikely. Given that this function requires assessment of where a qualification is not comparable and may impose an additional burden on UK regulators, we need to ask the Minister for assurances that UK regulators will have the administrative capacity and resources to deal with such decisions.
The Minister has addressed temporary and occasional qualifications, but given the number of EEA and Swiss professionals providing healthcare services in the UK on a temporary and occasional basis, she should assure us that there will be no detrimental effect on the NHS as a result of the removal of the right of EEA and Swiss professionals to work on such a basis.
I think that is enough questions for the time being. Other noble Lords will probably draw to the attention of the Minister the views that have been expressed to us by a range of organisations which have an interest in this matter, including the BMA and the royal colleges. I beg to move.
My Lords, I think that there is agreement across this House that we should work to prepare this country as best we can for Brexit and the potential of a disastrous no deal. I welcome this morning’s response from the Home Office Minister in this House that she believes that no deal is unlikely.
A consequence of no deal will be that the UK is no longer part of the automatic electronic alert system between health regulators, which exchanges information on health professionals who are no longer allowed to practise in the country. The NHS is vital for our country and for the lives of our citizens. Our healthcare professionals are the backbone that holds in place the institution that we hold dear. It is imperative that the legislation is effective at retaining a frictionless flow of EEA and Swiss workforce, along with the care that they bring.
There are several areas of concern. I am concerned that impact assessments have not been done in all circumstances in relation to these SIs and that consultation has sometimes been rushed, or that little public consultation or sector consultation has been done. I intend to ask the Minister questions that are thematic. I do not mind if she does not have the time or the information to be able to respond to them today; I am quite happy for the answers to come in a letter, which I would like to be placed in the Library.
A no-deal Brexit would not allow temporary workers, and it is vague when it comes to permanent workers due to a lack of specific evidence about qualifications. I would like some light shed on this. Can the Minister confirm that, in the event of a no-deal Brexit, vital EEA medical workers will not be treated as international medical graduates—IMG—so that they can easily work for our NHS and will not have to endure long and arduous registration processes which in some cases have been known to take up to at least a year? When do the Government plan to provide guidance to healthcare professional regulators on the information required to obtain Privy Council consent to remove a qualification from automatic acceptance should they have patient safety concerns? It is important that this process can be invoked quickly should concerns arise.
How do the Government intend to approach the two-year review of the SI? Will they commit to reform of professional regulators’ legislation to allow the process for registering healthcare professionals who qualified outside the UK to be fair and consistent for all professionals, regardless of where they qualified?
I think the Minister is aware of issues around Spanish and Irish nurses. What conversations are we having with Spanish health services about the gradation of Spanish nurses to ensure that, as long as they stay here, their years working here count towards their time in the Spanish system? I had the privilege of meeting some Spanish nurses working in Taunton. They thoroughly enjoy working here but would be really anxious were this to go, because they would then feel that they would not be able to return home with any credit for the work they have done here. My noble friend Lady Thornton has already covered the issues that the scrutiny committee raised.
Moving away from the healthcare professions, why have the results of the consultation process relating to the Human Medicines (Amendment) regs and the other two SIs we are discussing not been released? Instead, the Government have provided a response that gives little transparency on any key concerns that were raised during the consultation process, or the specific organisations approached. The changes laid out in the SI are wide-ranging and many call for the establishment of new responsibilities, transference of powers or further discussions with EU counterparts. Is it realistic that the industry will be able to handle these changes in the short period remaining before 29 March and during the transition period afterwards? The MHRA does really good work and I assume that it will be taking on this work independently of the EMA, so will the MHRA receive additional funding to support this extra work?
Moving on to the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, noble Lords got very exercised about this issue in the immediate aftermath of the referendum. The impact assessment says:
“Although this contingency legislation aims to help business in their preparations for a no-deal scenario, there is a risk that due to the requirements set out, businesses will not have sufficient time to prepare. In the event of no deal being agreed with the EU before 29 March 2019, the MHRA will have regulatory processes in place so that businesses will have the relevant information to prepare for this scenario”.
Are we to take it from this that if we crash out with no deal on 29 March, not having agreed this with the EU until directly before, the regulatory process will not be in place?
I thank the Minister for listening and, as I said, I am quite happy for her to write if she is not able to respond to all these questions now.
My Lords, I trust that the House heard with great pleasure the Minister’s comments on how major an advantage this whole arrangement in the European Union has been to us. We should not be discussing any of these SIs without reminding people that our membership of the European Union has been a huge advantage to us, and that what we are doing at the moment is picking apart something which is to our advantage, for reasons which are increasingly difficult to understand. We should not allow any of this to go past without constantly reminding the Government that they are leading this country into a position in which it will be poorer and less advantaged than when they came to power. A historic responsibility will lie on their shoulders, and we should remind them of that constantly.
My concern in this whole debate is that we are being asked to discuss this SI under a double falsehood. The first is the argument that we need it because we might crash out of the European Union, but that we need not be too worried because we will not crash out. The second difficulty is that, if we do not crash out of the European Union, we are legislating for a series of things which will be there in the course of further negotiations. Even if what is referred to at the moment as the Prime Minister’s “deal” were to be accepted—and it is manifestly not satisfactory—it is not a deal at all. It is an agreement to go on discussing to get a deal. During that period of time, what we are discussing here will be there in the background. There have been a number of occasions on which Opposition spokesmen have rightly pointed out that the trouble with these things is that if they are in the background while we are negotiating, they have a real effect. We have to take this very seriously.
Nor should we pass over the problem we are presenting ourselves with. We are saying that, to get the best advantage out of this ludicrous foot-shooting activity, we are going to make sure that every European Union national can come to this country to do what we want them to do without there being any difficulty. Of course, we cannot do any of the things that have made that particularly valuable in addition; we are not going to share the information both ways, which is what the European Union enabled us to do. Rather like the noble Baroness, Lady Thornton, I have a real concern that the IMI system will not continue. The idea that you can happily forget about it because it happens to be convenient, and do the things you can do because they happen to be convenient, seems to me an abnegation of responsibility which I find extremely difficult to accept.
The noble Baroness, Lady Jolly, rightly referred to the additional matter of the electronic alert system. We will not be alerted to the very professionals we most want to know about, because we will have decided that, because Britain is so ultimately different from everywhere else, we will not have this association. I know it is not the fault of the Minister, who is having to defend the ridiculous situation in which we find ourselves, but it is for this House to remind people all the time of what this really means.
Then we go on to the fact that these regulations are in conformity with the withdrawal Act, which says that we are not going to use it to create any new legislation, but merely take into national legislation things that would not be in it if we left the European Union without any agreement. The trouble is that this is not actually possible, because we have to have regulators making decisions. They are now going to make decisions under a new regime—in that sense it is a new regime—and I very much want to hear the response to the noble Baroness, Lady Thornton, on how we make sure the regulators make, roughly speaking, the same decisions across the whole range, and how we make sure that those regulators do not make decisions that extend or change the position we are in now. The latter would be contrary to the undertakings given by the Government.
However, the word that I very much worried about when the Minister used it was “flexibility”. She said that no longer being in the European Union would give us a flexibility on the establishment of professional qualifications which we did not have up until now. I do not think that flexibility can possibly be accepted within this SI, because that genuinely changes the position from what it was before. It may be that it is convenient for the Government to talk about flexibility as an advantage. I find it pretty difficult to see what that advantage would be. What would be the point of being flexible in changing our arrangements in such a way that they were out of line with the arrangements of our neighbours, when we rely upon those neighbours for such a high proportion of our professionals? It seems to me that flexibility is one of those convenient words used by the Government and those who believe in Brexit to suggest that there are some advantages hidden here which we have not yet got hold of. I do not think that there are, or that it would be legal for us to use flexibility under this SI, because it is specifically not supposed to introduce into our legislation anything that we have not had up to now.
I am afraid I will move on to something that I constantly say; that there is no impact assessment here. Why is there not? This is the real reason I say to the Minister that this is unacceptable. The reason there is no impact assessment is that the Government want us to believe that there is no impact. It is very inconvenient for the Government to say that the impact is that we will no longer have the advantages we had before leaving the European Union. They ought to be listing those advantages and explaining what the impact on us will be. But they are not doing that, because that would make more and more people aware of the lunacy of the measures we are now taking, and the ridiculous position in which Brexit places us.
But then there is another question. If you do not have an impact assessment, you also do not appear to have any idea about how much it will cost. I am afraid that I am a Conservative, and I am always interested in costs—I like to know how much it costs. I know that that is a disadvantage in the whole Brexit discussion, because the one thing we never get is the cost. It is amazing, is it not? We have a Conservative Government who never talk about the costs of Brexit, which is an absolutely ludicrous position for us to be in. Let us ask ourselves—I repeat the words of the noble Baroness, Lady Thornton—“What burden? What resources? What cost?”
One of my difficulties is that I have had the misfortune to have had to sit through a large number of these SIs, and every time you ask about the cost, the Minister concerned explains—charmingly, and with considerable aplomb—that the costs are negligible.
I have got it right this time. That is what they say. In every individual case, negligibility may well be the truth, but what is negligible in one case, when added up with a lot of other “negligible” costs, ends up being rather expensive. I am amazed at the number of things you can do with negligible cost. We are filled with these SIs—with all the things that we can do for nothing. I ran businesses, and I have to say that I do not know anything you can do in business which does not cost you something. I would love the Government to explain to me how they are managing to move whole areas of control and regulation over to British regulators without any cost. I would be able to apply that to my businesses and it would be extremely valuable, because all I know is that the moment you change or move anything, it costs money.
I want to know not only how much it costs but whether we have the resources for it. It is also said that we have these organisations that are perfectly capable of doing all this, as if this is an easy thing to do, when in fact it is not only difficult, but if we get it wrong, we are endangering people’s lives. Clearly, we have not worked out what the cost of doing this is; I just do not understand whether we have the human resources and the trained resources to do it. After all, we have shown so far that we cannot run the National Health Service without large numbers of people coming in from outside. I would like to understand whether we can regulate all this without some additional resources, and if so, we ought to know exactly what resources we will need and how much they will cost.
I am sorry that I have to say this to the Minister with such vigour, but it needs to be said; otherwise, this House looks pretty damn stupid. We look as if we are sitting around, having a gentle argument about what is the programme for catastrophe. This is what we are talking about: how a nation decides how to put itself into a very much less favourable position than it is in at the moment. Sometimes people say, “Ah, but Britain will manage—look what it did during the war!” But we did not ask for the war; we did not say that we wanted it. It happened, and we said that we had to fight it. Here we are asking for it, and are seriously sitting around planning for it. We are asked to do that with a degree of politeness and charm, and courtesy and care, when we ought to be very angry indeed that any Government should even suggest that we need SIs like this.
I apologise to the noble Lord for missing out on my answers to his questions; that was most remiss of me. These SIs come into force only if there is a no-deal exit. Should there be an extension of Article 50, they would not come into force until or if there is a no-deal exit, which is obviously most undesirable and something the Government are seeking to avoid.
On the communication of the effect or implementation of these SIs, they have been developed in close collaboration and consultation with the regulators that would be impacted. They are well informed about their operation, and given that the effect of the SIs is to continue with business as usual as far as possible, we hope that that is the de minimis effect. I shall write to the noble Lord in response to his final question, as I am afraid I have forgotten what it was.
My Lords, I thank the Minister for her extensive response and noble Lords for their interventions and questions on this SI. The indignation and anger of the noble Lord, Lord Deben, has been reflected right across the House. Noble Lords may not express it quite as well as he has, but it absolutely is there. We have just spent an hour and 10 minutes debating this issue. Then there are all the hours of preparation, the cost of civil servants, the cost of our time and, indeed, the worry that all this is causing, not only to us in the Chamber but to millions of people outside. As the noble Lord, Lord Deben, and others have said, the Minister has done the best she can with the hand she has been dealt and answered our questions to the best of her ability. However, this is not where any of us wants to be. On that basis, I shall withdraw my amendment.
(5 years, 8 months ago)
Lords ChamberI do not accept the characterisation that the noble Baroness has just given. UK patients are not being denied access to these medications; they are able to access medication via prescription from a doctor who is on the specialist medical register. The Government have acted fast on the review of the best clinical evidence and we are going further with forthcoming NICE guidelines and a Health Education England training package to raise even more awareness.
What troubles me about the Minister’s answer is that NHS England’s guidance says that medical cannabis can be provided only where all,
“other treatment options have been exhausted”,
and where there is, “published evidence of benefit”. We have heard lots of evidence of the benefit this afternoon but we are right to be worried about the research that is allowing that to happen. Why is it not happening quickly enough? Can the Minister describe what level of opiate addiction and which severe side-effects of other medication can be tolerated before medical cannabis is prescribed?
The evidence base for the quality and effectiveness of these products is limited; it is developing. This is why the Government have asked the MHRA to call for a proposal to enhance our knowledge of these medications. However, we have not waited for this; we have introduced a route via unlicensed medications which allows for doctors who are on the specialist register to prescribe for patients. This is the right route; these are the doctors who will understand the conditions mostly likely to benefit from prescription and who are able to make a judgment about the safety and efficacy of medicinal cannabis. It is the route usually used for unlicensed medications and already set up by the MHRA. We want to see more licensed products in this route, however; we call upon industry to invest in more trials and publish the results and full underpinning data to build our knowledge so that more patients are able to benefit.
(5 years, 8 months ago)
Lords ChamberMy Lords, I congratulate the noble Lord, Lord O’Shaughnessy, on initiating this important debate—which, of course, a few weeks ago he would have been answering himself. I declare my interests, which are in the register: my long association with the British Healthcare Trades Association and as a lay member of a clinical commissioning group. I also congratulate the noble Lord, Lord Carrington, on his spirited maiden speech and welcome him to the House. I thank all the organisations which have sent us briefings on this issue, and indeed our own Library. They have been very helpful indeed.
While my sympathies are totally with the mesh campaign, I am not going to refer to it because several noble Lords have spoken about it with enormous passion. My heart is with them but I am going to talk about other issues. In that regard I particularly welcome the contributions of my noble friends Lady Bryan and Lord Hunt. The House is aware that these matters are close to the heart of the noble Lord, Lord O’Shaughnessy, and his record of taking action to deal with issues of safety is to be commended, including the establishment of the commission of inquiry which is being chaired and led so wonderfully by his noble friend Lady Cumberlege. She has given us an up-to-date briefing and, indeed, enormous cause for hope.
This is a good time to reflect on the infrastructure that safeguards the introduction of medicines and devices into the UK as Brexit looms. The noble Earl spoke knowledgeably about this and I am grateful to him for his remarks. Like other noble Lords, I believe that we have a legislative and regulatory structure in the UK which is designed to protect patients and which has been material to the development of Europe-wide regulation from which we have all benefited. Several noble Lords have suggested that it is creaky, which I think is right, and that it has to keep up. That sentiment was well expressed by the noble Baroness, Lady Masham. Following a question posed not so long ago by the noble Baroness, Lady Walmsley, about the protection of patients from counterfeit medicines after the UK has left the EU, it was quite clear from the briefings that arrived in my mailbox that the UK pharmaceutical and biotechnology industry and organisations such as the Association of the British Pharmaceutical Industry and the UK BioIndustry Association are warning that leaving the EU without a deal would increase the risk of counterfeit medicines entering both the UK and EU supply chains.
The first issue that I would like to raise with the Minister is this. She will know that the falsified medicines directive—FMD—was published on 1 July 2011 and the legislation became effective on 8 February this year. It introduces tougher rules to ensure that medicines are safe and that the trade in medicines is rigorously controlled. This directive is being introduced to tackle the counterfeit high-price medicines that are a threat to public health worldwide. Does the Minister agree that a no-deal Brexit is likely to see the UK’s access to EU databases revoked, including the European Medicines Verification System, which is the heart of EU-wide compliance with the falsified medicines directive? Those proposals also present a risk to UK patients as unilaterally revoking FMD legislation in the UK would make the country a target for counterfeiters. Both the bodies involved in this area are very concerned indeed. Post Brexit we need to be assured that keeping fake or fraudulent medicines out of our supply chain is an absolute priority.
In this context, three things are important: making specific reference to the importance of co-operating on the regulation of medicines in the political declaration; making it clear that the UK and the EU will co-operate on protecting citizens from infectious disease and counterfeit medicines; and making it clear that the UK and the EU will agree closer collaboration on science and innovation.
The second issue I wish to raise stems from my support over many years for the British Healthcare Trades Association, which, having been founded in 1917, is one of the UK’s oldest and largest healthcare associations. My connection with the association arises partly because many years ago I met stoma nurses and discussed with them the work they do. I had conversations with them about the design and importance of support for stoma patients. Those conversations led to me getting to know the BHTA and realising that a lot of the devices, innovation and design we have in this country rest with small and medium-sized enterprises, which need our support. The BHTA provides them with the controls and regulatory framework that are so important in their relationship with the NHS and individuals. It deals with class 1 and some class 2 devices.
I also want to ask the Minister about the suppliers of other equipment and devices. The wide availability of medical devices from places such as Argos and through Amazon, and the purchase of apps and other monitoring devices, concern me greatly. Last summer I was sent copies of an Argos leaflet, available in a GP surgery outside London, advertising a whole range of equipment, including monitoring devices available in its stores. There was no suggestion in any of these leaflets that it might be a good idea to get professional advice before forking out on these items. We would want a physio to assess us before using walking aids—sticks and rollators—and to be measured up to make sure that we get the correct ones. A shower stool could be dangerous if you had Parkinson’s or a one-sided weakness or found it hard to stand. You would need an occupational therapist to work out whether you needed a chair with a back or with arms.
While we wish people to take responsibility for preventive care and self-care, and monitoring your own health and progress is to be encouraged, effective self-help is a complex thing. It requires ongoing education and support from health and social care workers. Done well, it is fantastic. I ask the Minister her view of the ease with which people can buy medicines and devices, either online or in places such as Argos. For example, is there any research to inform issues of patient safety, knowledge, usage or whether there are enhanced outcomes in terms of prevention or well-being?
Thirdly, I will briefly mention access to new devices for diabetics. Technology plays a key role in diabetes care, particularly for people with type 1 diabetes but also for people with type 2. Over the last few decades new technologies have transformed that. However, it is a postcode lottery. I ask the Minister: what are the Government doing to ensure that there is fair distribution and access to these very important technologies?
Finally, I think I need to ask the Minister about a recent leak concerning the NHS app, which is designed to be a digital front door, and the fact that it would appear it is not able to connect with any other providers of online GP consultations. The leaked NHS Digital briefing shows that a survey of 32 online consultation suppliers, such as LIVI and Babylon Health, found that none of the technology was able to integrate with the NHS app. This is quite a serious matter, because the NHS Long Term Plan commits to building the app into a single digital front door for patients to,
“provide advice, check symptoms and connect people with healthcare professionals—including through telephone and video consultations”—
all brilliant stuff. This is a serious issue of patient safety. I would like assurance from the Minister, given that she, her predecessor—the noble Lord, Lord O’Shaughnessy—and their boss have embraced this technology with such huge enthusiasm. I hope we are not heading into another technological black hole.
I congratulate all noble Lords on their contributions. This has been an absolutely excellent debate, one that I hope will provide support for those people campaigning on a variety of very important issues around patient safety, and will take the debate forward.
(5 years, 9 months ago)
Lords ChamberMy Lords, this is a very difficult area. I agree with all the noble Baronesses who have spoken, in so far as they stress the problems of trying to identify what one means by “liberty” in this area, particularly regarding mental health. A number of cases have come before the courts, both in this House when it was sitting in its appellate capacity, and in the UK Supreme Court, where I sat and grappled with this problem myself. I support the government amendment which seems much more consistent with the way the Strasbourg court has interpreted Article 5.
There is a great deal of case law that has been developed over the years as to the meaning of “liberty” in its various contexts. The point that comes out very clearly from a case called HL v the United Kingdom—it went to Strasbourg following a decision in this House in a case called R v Bournewood Community and Mental Health NHS Trust—is that account has to be taken of a whole range of factors when you look at the word “liberty” for the purposes of the article. The court says that in the end it will always come down to a question of degree and intensity, regarding whether what has been going on really is a deprivation of liberty or merely a restriction. It is trying to devise a dividing line between these factors that one is searching for in looking for a definition.
The court said it decided not to try to define the world “liberty”, because it was so difficult to find a workable definition that would apply to all circumstances. What you tend to find is the approach that the government amendment takes, of saying what does not fall within the article in a given case, and what does. It is a safer way of proceeding, rather than trying to, as the amendment in the name of the noble Baroness does, lay down in clear terms what the “deprivation of liberty” amounts to. The problem is that if one looks at the way in which that amendment is framed, in future cases the courts are going to find it very difficult to see whether Article 5 is consistent with what is in the amendment. Then there is the problem of the court having to declare an incompatibility, which then has to be sorted out by some further amendment.
The safer and most useful route is to anchor the amendment to Article 5, as subsection (1) of the government amendment does; and then, for the guidance of those who have to deal with these difficult issues, set out some clearly defined areas where they are not at risk of it being said that they are in conflict with the article. I do not find the provisions set out in the subsections that follow difficult to understand.
I thank the noble and learned Lord for allowing me to ask a question about the comments of the Joint Committee on Human Rights and its grave reservations about the formulation which the Government are putting forward.
I am not surprised; we are all grappling with a difficult area. Based on my own experience, and my reading of the Strasbourg decisions, the Government’s approach is the safer one to adopt. Before the noble Baroness stopped me, I was trying to say that there are situations where the use of a double negative is a perfectly intelligible way of proceeding, so that criticism does not seem particularly strong. I suggest that we follow the Government’s approach for the reasons I have given, especially because of the way it anchors the proposed section to Article 5 itself. We are always going to come back to the Strasbourg court and the way it interprets the article. We do not have the final word on this, I am afraid, because of the way the convention is framed, the way we have subscribed to it and the way we apply the decisions of the Strasbourg court.
My Lords, it is a matter of great regret that we have reached this point in the Bill and are still debating the definition of deprivation of liberty. We should have been able to resolve this over the last six months, and we should not be having this discussion. We should have agreed it. The reason we have not agreed it, to put one point of criticism, is stated in the letter from the Joint Committee on Human Rights:
“It is regrettable that there was no time for adequate consultation on the proposed definition”.
I think that is exactly right.
We are where we are, and what we have is a disagreement between our very eminent lawyers—the noble and learned Lords, Lord Hope and Lord Mackay—and those of us who have been looking at and considering the Bill since July last year.
My Lords, I shall speak briefly to Amendment 41A, but first I congratulate the Minister on moving such an enormous group with such coherence. She deserves at least a drink of water, if not a cup of tea. I tabled this small and modest amendment for the sake of completeness. During the passage of the Bill, the noble Lord, Lord O’Shaughnessy, gave us undertakings and assured us that issues to do with independent hospitals would be addressed in the Commons. I congratulate the Government on the fact that indeed they have been. In November, the noble Lord said:
“The Government believe that independent hospitals would benefit from AMCP involvement, and therefore our intention is to bring forward an amendment, or amendments, as required, in the Commons to deal with this issue and make sure that there is such a role for the AMCP in all deprivation of liberty cases”.—[Official Report, 21/11/18; col. 279.]
In some ways the Minister has already partly addressed my concern, which is about the fact that in many independent hospitals most of the patients will be there because of the local authority or the CCG. So the clarification that I am seeking is on whether independence is truly protected when an AMCP is appointed under those circumstances. This amendment seeks to clarify that. The Minister has gone some way towards clarifying that, but I think I need to press her a little on whether that is the case. I declare an interest as a member of a CCG that commissions many of these services. When we are looking at commissioning an independent hospital, should we be the body that also takes the decision about the appointment of an AMCP?
I shall speak very briefly. I welcome very much Amendments 13 and 22 in particular in relation to independent hospitals. In Committee, a number of us raised that issue and were very concerned that independent hospitals, which are often hundreds of miles away from a person’s home, could act as the responsible body and make crucial decisions where perhaps they have a commercial interest in keeping that person on their premises.
With the permission of the current Minister, I will applaud the noble Lord, Lord O’Shaughnessy, because I feel I know that he played a key role in making sure that these amendments found their way into the Bill. The stipulation that the local authority shall be the responsible body is important. Although I understand what the noble Baroness, Lady Thornton, is saying, it seems to be a huge step forward to take the responsible body away from the independent hospital. I would like to feel that local authorities—the professionals dealing with the assessment of such cases—would have a real interest in making sure that those people returned home, if at all possible, as soon as possible. That is what all this should be about.
The other matter I will raise briefly is that of people in domestic settings, where deprivation of liberty is at stake. At our recent meeting with the Bill team we were assured that such cases would be dealt with under this new piece of legislation in the course of the normal care planning process, rather than requiring a reference to the Court of Protection. When an elderly person is caring for a demented husband or wife, the last thing they need is some bureaucratic requirement. This seemed very important, and I was delighted when the Bill team gave us an assurance that this, too, was being dealt with.
There is nothing in the Commons amendments on this, but I wonder whether the Minister could give the House an assurance that it will indeed be the case that people in domestic settings will be dealt with within the local authority planning process, and will not require a reference to the Court of Protection.
(5 years, 9 months ago)
Lords ChamberI thank my noble friend for that question and in particular for raising the issue of stigma. We have put £150 million and extended over 70 services into the community specifically so that services can be more accessible to young girls and boys and so that people can feel free to come forward and seek help where they need it.
It is to be welcomed that the proportion of children with an eating disorder starting urgent treatment within a week or so remains quite high in London, but it is much higher than the rest of the country, according to the data analysed by the Royal College of Psychiatrists. What will the Government do to address what looks like a postcode lottery if your child needs support and help with an eating disorder and you happen to be in Bradford?
I am grateful to the noble Baroness, Lady Thornton, for raising the issue of ensuring that we improve services across the country and do not have a postcode lottery. Since July, NHS England has opened up 126 beds for children and young people in areas of the greatest geographical challenge to ensure that we can address exactly that problem.