Healthcare (International Arrangements) Bill
Baroness Blackwood of North Oxford ExcerptsTuesday 12th March 2019
(6 years ago)
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Viscount Bridgeman (Con)
My Lords, I am privileged to follow my noble friend Lord O’Shaughnessy, and I am sure that Peers from all sides of the House will have been impressed by the thoughtful letter which the Minister has sent to us all. In it, there are a number of concessions, which will be subject to later amendments in this debate. The insertion of a sunset clause is a valuable safeguard, as are the requirements that arrangements are limited to a public authority, and the statutory duty to report to Parliament on an annual basis. All of these are important concessions. Finally, on the Henry VIII clause, the Minister’s letter refers to removing the powers in the Bill to make regulations containing consequential amendments to primary legislation. Individual healthcare waits for nobody.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
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.
Baroness Thornton
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.
Lord Hope of Craighead (CB)
My Lords, I think that the noble Lord is right in saying that we are establishing a precedent, but I have been looking at the word “example”, and wonder whether the Minister has examples of this kind of legislation being used elsewhere. I cannot think of any. I examined the withdrawal Bill, which was very wide-ranging, and as far as I can recall this phrase does not appear in it even though it contains many provisions about delegated legislation. It would, therefore, be helpful to me if it was demonstrated that this is not the kind of precedent that has been described. In general, however, I congratulate the Minister and her Bill team on going a very long way to meet our objections in later parts of the Bill. I am, however, worried about this bit of it and would like to be reassured.
Baroness Blackwood of North Oxford
My Lords, I thank the noble Lord, Lord Marks, for tabling Amendment 3 and the noble Baroness, Lady Thornton, for Amendment 5, both of which seek to place limits on the powers in the Bill.
I will first address the noble Baroness, Lady Thornton, the noble Baroness, Lady Jolly, and the noble and learned Lord, Lord Judge, on Amendment 5, and clarify the purpose of Clause 2(2). We have had some debate about this already but this will be helpful. Clause 2(2) is intended to be an illustrative list of examples of the type of provision that may be included in regulations made under Clause 2(1). It is not itself intended to be a delegated power. The intention has always been to be prudent and transparent in the use of the delegated legislation, and the list was included to be helpful, by demonstrating the types of provision that the regulation-making powers at Clause 2(1) could enable, in order to effectively implement international healthcare regulations in the same way as under reciprocal healthcare regulations. This is not uncommon in primary legislation.
The list is reflective of the kind of provision already included in our current, more comprehensive, reciprocal healthcare arrangements with the EU, and it is intended as a guide to how the powers in Clause 2(1) can be exercised. Regulations under this clause need to be able to do everything that they might need to do to provide healthcare outside the UK, or to give effective agreement. I described in some detail during our debate on this clause in Committee why each of the descriptive lists were included and what they would be used for.
This amendment could mean that future Administrations would be unable to effectively implement reciprocal healthcare agreements with the EU, individual member states or other countries. The reason for this, which has already been alluded to in the debate, is that we have not yet concluded those negotiations and so it is not possible to rule out what we may need to provide for in regulations to give effect to an agreement. In addition, it would not be appropriate to circumscribe in the Bill the Government’s negotiating mandate with the EU, EU member states or countries outside the EEA and Switzerland.
The examples in Clause 2(2) are not exhaustive, but they are useful pointers to aid understanding of how Clause 2(1) is capable of being exercised. I think they have served their purpose, given that we have had such robust debate about them. They offer additional transparency and assistance in understanding how the regulation-making powers in Clause 2(1) would work for the purpose of implementing reciprocal healthcare agreements. This is not an unusual statutory construction; there are examples of where regulation-making powers are accompanied by illustrative lists of what may be included in regulations in order to provide assistance in the understanding of what the powers are capable of doing. As to whether those illustrative lists include the words “for example”, I have an example from Clause 11(2) of the Automated and Electric Vehicles Act 2018, which states:
“Regulations under subsection (1) may, for example—”,
include paragraphs (a), (b) and (c). That is perhaps a helpful example for the noble and learned Lord, Lord Hope.
As this important policy area continues to develop and progress both in the EU and outside the EU, it is appropriate for the Government to be able to respond to protect the continuity of care of those already in receipt of reciprocal healthcare, as well as to explore whether we would like to extend it to others. Were we to accept this amendment, it would, as I said on the previous group, restrict the implementation of reciprocal healthcare arrangements to current processes. That is clearly inappropriate when implementing dynamic agreements in which there are two parties.
Regulations under Clause 2(1) need to be able to do everything they might need to do to provide for healthcare outside the UK or give effect to a healthcare agreement. One small example of why it is right that the Government retain the ability to do this is developments in IT or new technology. As technological change continues to gather pace, it is right that the Government should be able to make the best use of those changes and ensure the most effective and efficient systems for the people accessing these arrangements. That is why we might need to bring in another regulation-making power. I hope the noble Baroness, Lady Thornton, as a former Health Minister, would agree that technology has the power to change the way people access healthcare and can make a real difference in people’s lives, especially perhaps those who are restricted from accessing healthcare because of long-term conditions or distance from services.
While the illustrative list at Clause 2(2) does not expressly make reference to this matter, it may well be necessary to make arrangements to ensure that the most effective and efficient technological processes and systems are incorporated into the implementation of future reciprocal healthcare agreements. The Government are working, through this Bill, to ensure that we have the necessary ability to implement future international healthcare agreements with both EU and non-EU countries.
Amendment 3 in the name of the noble Lord, Lord Marks, speaks to concerns about the breadth of the powers in the Bill. Clause 1 follows a long line of general payment powers found in primary legislation, further to the Public Accounts Committee’s concordant that government expenditure should flow from a specific Act of Parliament. It is a free-standing payment power and needs to be so. Notwithstanding that, we have deliberately chosen to include a power in Clause 2(1) that can be used to support the exercise of the payment power. Therefore, it is not possible for the Government to accept this amendment. Indeed, the DPRRC recognises that general payment powers are not delegated powers.
As I said in my response to this amendment in Committee, the Bill is making good progress through Parliament but clearly will not have Royal Assent until later this month. So, with the best will in the world, we will not be able to lay regulations until the summer. However, in the undesirable, unprecedented situation of no deal, we may need to use these powers before then. That would be specifically for a scenario concerning citizens’ rights agreements with the EFTA states and with Switzerland, which will protect reciprocal healthcare for people living in those countries on exit day, or in other specified cross-border situations.
It is good news that we have operative agreements in the context of no deal, as they will guarantee healthcare for those covered by them. It is likely, though, that we will need to use the power in Clause 1, together with Clause 4, to temporarily implement those agreements. We cannot therefore accept the amendment because we would not be able to protect the healthcare arrangements of people in those countries. We will bring forward further detail in coming weeks when we can be clearer about bilateral agreements, and on the need for any further arrangements. I hope that noble Lords will agree that the Government must have the ability to provide for people at this unprecedented time. I emphasise that stand-alone funding powers such as those in Clause 1 that operate without the need for delegated legislation are not unusual—so this is not being brought in simply because of a no-deal situation.
I have listened carefully and considered the comments of noble Lords about concerns about the scope and breadth of the power. That is why we have sought to address concerns about it, with a large package of amendments to which I have already referred. We have specifically limited the delegated powers and the scope of what can be done under the Bill, and provided additional parliamentary scrutiny mechanisms and greater transparency.
Finally, I will speak to government Amendments 6, 7 and 8. They are in direct response to the concerns raised that regulations under the Bill could be used to confer functions on anyone, anywhere. It is understandable that noble Lords raised the possibility that the regulation-making powers in Clause 2 could be extended to confer functions on private bodies. There is not and has never been an intention to confer functions on private bodies in order to implement reciprocal healthcare arrangements. This was always the case but, given the concerns raised, we are taking action to make this clear.
The proposed government amendments limit Clause 2 to the operation of Clause 2(1) to ensure that any conferral or delegation of functions may only be to a “public authority”. The definition of “public authority” is a person who exercises a function of a public nature. This ensures that public bodies maintain autonomy over how services are procured, contracted and delivered. When making regulations to implement such healthcare agreements, we wish to confer relevant functions on appropriate public bodies according to their part, giving them clear legal responsibility and an operating mandate. Our amendment does not prohibit us from doing this.
I therefore hope that noble Lords will withdraw or not move their amendments.
Lord Marks of Henley-on-Thames
My Lords, I shall seek leave to withdraw my amendment, because I feel very much under pressure from what the Minister has just said. It is the case that the free-standing power is needed, as she said, because of the delay that there has been in order to ensure that the payment power can be used before regulations can be laid. My amendment would therefore imperil the continuation of our current European arrangements. I feel under pressure because it the wrong way to do this. It is a great shame that this legislation was not introduced timeously, but I do not wish to divide the House on my amendment and I beg leave to withdraw it.
“(6) No regulations may be made under subsection (1)(a) or (b) after the end of the period of five years beginning with exit day.”
Baroness Blackwood of North Oxford
My Lords, the Bill’s delegated powers and their global application have been a source of spirited debate since this Bill’s introduction, and noble Lords have rightly given considerable scrutiny to this matter. A number of amendments were tabled in Committee, including those by the noble Baronesses, Lady Thornton and Lady Jolly, the noble Lords, Lord Patel, Lord Kakkar and Lord Marks, and the noble and learned Lord, Lord Judge. This issue has concerned Peers across the House. I am pleased to say that the Government have listened carefully and tabled an amendment that significantly curtails the scope of the delegated powers in the Bill.
Amendment 9 directly addresses the concerns raised by restricting the exercise of the delegated powers, and, as we have already discussed, limits the global scope. The Bill is intended to support the implementation of comprehensive reciprocal healthcare arrangements with countries within and outside the EU, and to implement possible future partnerships. It was drafted to fulfil this purpose in a number of different scenarios, and that remains the Government’s intention, but we have listened closely to the points raised by Peers both inside and outside of this Chamber, as well as to the views of the DPRRC and the Constitution Committee, and concluded that the regulation-making powers that can be used to set up schemes for unilateral healthcare overseas should be time-limited.
The powers in Clause 2(1)(a) and Clause 2(1)(b) would primarily be needed, in the event of a no deal, to mitigate any detrimental effects of a sudden change in healthcare access for UK nationals living in the EU. These powers would be required in the event that reciprocal arrangements are not in place. Our aim remains to reach an agreement on reciprocal arrangements, but as a sensible Government, we need to plan for all eventualities.
In the unprecedented event of leaving the European Union with no deal, we would need to have the option of establishing support mechanisms for people in exceptional circumstances where there would be a serious risk to their health should any member state not agree to maintain reciprocal healthcare. However, we have listened, and want to ensure that while the Government have the ability to provide for people in this unprecedented time, we are still respectful of the constitutional roles of Parliament and the Executive. In response, we feel that the delegated powers that implement healthcare arrangements outside of reciprocal healthcare agreements with other countries should be sunsetted.
During the five years before the sunset, we will retain the flexibility to deal with exit scenarios using regulations under Clause 2(1) as appropriate. These powers can be used to offer UK nationals reassurance and certainty, which we intend through this Bill. After the sunset, making use of the regulation-making powers under Clause 2(1) would be limited to Clause 2(1)(c) only, which provides the Government with a mechanism to give effect to future complex global healthcare agreements. However, it is important to state that this amendment will mean that it is not possible for the Secretary of State to set up any long-term scheme to unilaterally fund mental health treatment in Arizona or hip replacements in Australia, as has been suggested. Of course, this is not something a reasonable Government would intend to do, but I am happy to provide that reassurance. However, we would want to remove any perceived risk regarding this power, and that is the intention of this amendment.
In tabling the amendment, the Government have sought to clarify the intended use of the important powers in Clause 2(1)(a) and (b). This represents a significant restriction of the Government’s use of delegated powers, in direct response to concerns raised by parliamentarians across this House. It also represents a significant check on the global scope of the Bill. On that basis, I beg to move.
Lord Lansley (Con)
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?
Baroness Thornton
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.
Baroness Blackwood of North Oxford
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.
Baroness Blackwood of North Oxford
My Lords, I now turn directly to the Henry VIII powers of the Bill. As noble Lords know well, the inclusion of the consequential Henry VIII power in the Bill has been the subject of animated debate both inside and outside this Chamber. The Government have been listening closely to these concerns in the Chamber but also in the reports from the DPRRC and the Constitution Committee. In response, we have tabled Amendments 18, 19, 20, 24 and 25, which is a significant step and addresses these concerns directly.
This group of amendments removes Clause 5(3) and amends Clause 5(4). As a result, it will now not be possible to make consequential amendments to primary legislation using regulations made under the Bill.
I want to be clear that the consequential Henry VIII powers were initially included as a future-proofing mechanism. They were never free-standing and we had envisaged using them in only a limited set of circumstances. As negotiations have not yet concluded and the terms of any agreements are not yet settled, there may be situations where it would be appropriate to amend primary legislation. This is why the power was included. We cannot rule out that we may want to amend primary legislation to give effect to a reciprocal healthcare agreement in future, and the lack of such a future-proofing mechanism limits our ability to ensure that the statute book in future is as coherent as it can be.
However, we want to alleviate any fears that we are taking powers which are not absolutely necessary in this Bill. As such we are prepared to take the significant step of removing the entire Henry VIII consequential powers in Clauses 5(3) and (4).
In addition, the Government have listened carefully to the concerns about the list of persons who can lawfully process data as a part of implementing new reciprocal healthcare arrangements under the Bill. To facilitate greater parliamentary scrutiny on this issue, the Government have tabled Amendment 20, which subjects any regulations that add to the list of persons authorised to process data for the purposes of the Bill to the draft affirmative procedure, which we have already debated. This would allow Parliament the opportunity to scrutinise authorised persons handling sensitive patient data, while equally ensuring that the Government can guarantee that future agreements are administered in the most efficient and effective way possible.
I hope that your Lordships will view these amendments, together with the other government amendments, as a genuine and significant effort to reduce the scope of powers in this Bill and respond to the concerns raised by this House concerning the use of Henry VIII powers. On that basis, I commend the amendments to the House.
Lord Judge
My Lords, I have already spoken warmly about the efforts by the noble Baroness, Lady Blackwood, and referred to us having a little touch of Blackwood in this House. Let it continue. I should like what has happened today to be habit-forming.
Baroness Thornton
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?
Baroness Blackwood of North Oxford
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.
Brexit: Import of Radioisotopes
Baroness Blackwood of North Oxford Excerpts(6 years ago)
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Baroness Symons of Vernham Dean (Lab)
My Lords, I beg leave to ask a Question of which I have given private notice.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
My Lords, the Government have been working very closely with the Royal College of Radiologists and the pharmaceutical industry to ensure that the NHS has robust contingency plans in place so that patients can continue to have access to medicines, including medical radioisotopes, whatever the EU exit outcome. Yesterday, the Royal College of Radiologists published sensible and pragmatic guidance to specialist NHS clinicians, which the Government support, to ensure that all necessary operational planning has taken place before 29 March.
Baroness Symons of Vernham Dean
My Lords, the Royal College of Radiologists, the British Nuclear Medicine Society and the UK Radiotherapy Board have all stated categorically that Brexit, particularly a no-deal Brexit, will mean delays in the supply of imported radioisotopes, which are so vital to the diagnosis and treatment of cancer patients. I too have read the guidance the Minister referred to, but does she agree that all these authorities are not convinced anti-Brexiteers trying to sensationalise the position? They are experienced and skilled in prolonging and saving the lives of cancer patients and they are clear that a no-deal Brexit will put already vulnerable patients at risk, while an extension of Article 50 will improve matters considerably. Does she further agree that while these authorities are making this point, if there were no other reason than that, the risk to people who may be diagnosed or may already have cancer is reason enough to take no deal off the table now?
Baroness Blackwood of North Oxford
I thank the noble Baroness for this. It is a very important question that she has raised. The Government’s first priority is to ensure continuity of care and patient safety, no matter the outcome of EU exit. That is why we have been putting important medical supply and contingency plans in place for the unlikely event of a no deal, even though that is not the Government’s plan.
The guidelines issued by the Royal College of Radiologists were in response to the plans from two major suppliers, representing at least 80% of the market, which have arranged contracts for air freight capacity to commence this month for the supply of radioisotopes. It is important to note that many isotopes already use air freight, and their deliveries will see no change in their arrival arrangements. Of course, the supply in these routes is relevant because radioisotopic materials have a short half-life, and therefore these changes, although minor, will have an impact on clinical pathways.
It is absolutely right for the Royal College of Radiologists to put some guidelines in place, and we have been working closely with it, the Department of Health and NHS England to offer clinics practical advice in allowing adjustment in their clinical processes. We do not expect any patient harm to arise from this, and the changes in clinical pathways and practice are expected to be minor and short-lived. We do not expect any delays or increased waiting times to arise from this; this is straightforward, practical advice to support clinics in adapting to changes in delivery times.
I hope that is a reassuring Answer for the noble Baroness, and that it has clarified what was, I think, some sensationalist media reporting of the advice.
Baroness Walmsley (LD)
My Lords, it is not this House that needs reassurance but doctors and consultants, who are feeling the need to reduce their treatment lists next month because they simply do not trust the Prime Minister to avoid a no-deal Brexit. The reason for that is because she adamantly refuses to take it off the table, despite the fact that, as a negotiating tool, it is about as much use as a chocolate fireguard. The other side knows that she cannot use it; when will she take off the blinkers?
Baroness Blackwood of North Oxford
I 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.
Baroness Thornton (Lab)
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?
Baroness Blackwood of North Oxford
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.
Lord Ribeiro (Con)
My Lords, the EU Home Affairs Sub-Committee looked at this matter and debated it in a take-note debate in July last year. At the time, I flagged up the importance of developing a new generation of alpha- and beta-emitting isotopes for cancer treatment in helping to mitigate the problems of importation. The then Minister, my noble friend Lord O’Shaughnessy, reassured the House that quite a lot of work was indeed going on with regard to proton beam treatment, that the Christie Hospital would be starting that very soon—that was last year—and that another unit was on the go. So there are alternative provisions for cancer treatment with proton beam therapy. None the less, there is an issue about what would happen in a no-deal Brexit as regards the gap between what we currently receive and what we are able to provide. Can the Minister say anything about when we can expect these new systems to come on stream? It is a challenging question, so she may wish to write to me on that.
Baroness Blackwood of North Oxford
I thank my noble friend for that helpful question. I assure him that both the Christie and UCL proton beam programmes are well under way, and we can be proud of our world-leading programmes in cancer proton beam therapy. I cannot give him an exact progress update on that, so I shall write to him on it. However, he is absolutely right that we must make sure that we progress those programmes, as well as ensuring that our supply of imported radioisotopes remains protected during the Brexit period.
Lord Warner
My Lords, to what extent does the Minister consider that patients will be put at much greater risk in a no-deal scenario if a large number of oncologists up and down the country take the view that they cannot rely on the supply of medical isotopes and therefore start a programme of delaying access to an assessment and treatment by them? Does she consider that the Government cannot give these assurances because they do not know what the behaviour will be of individual clinicians who require the isotopes to treat their patients?
Baroness Blackwood of North Oxford
One of the reasons why we worked so closely with the Royal College of Radiologists to provide the guidance, as well as working closely with NHS England to communicate to the NHS, is to ensure that reassurance has been sent out through the system with regard to the arrangements which have been made for medical supplies so that those concerns can be allayed and to ensure that clinical pathways are not disrupted. For that reason we do not expect any patient harm to arise from this, and changes to clinical pathways and practice are expected to be minor and short lived.
European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2018
Baroness Blackwood of North Oxford Excerpts(6 years ago)
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Baroness Blackwood of North Oxford
That the draft Regulations laid before the House on 20 December 2018 be approved.
Relevant document: 12th Report from the Secondary Legislation Scrutiny Committee (Sub-Committee B)
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
My Lords, the Government recognise the important contribution made by regulated health and care professionals, including those trained in the EEA and Switzerland. This statutory instrument ensures that professionals with EEA or Swiss qualifications have a clear route to seek recognition of their qualification when the UK leaves the EU.
Following the UK’s exit from the EU, directive and treaty rights under the Treaty on the Functioning of the European Union will no longer apply to the UK in the event of no deal, save to the extent that they have been introduced by UK domestic legislation. Parts of domestic legislation implementing the directive will not operate effectively after exit day and there would be no clearly lawful route for holders of EEA and Swiss health and care qualifications to be registered to practise in the UK. This instrument amends professional legislation in the UK to ensure that a system for the recognition of professional qualifications continues and that professionals with EEA and Swiss qualifications will have a clear and lawful route to seek recognition of their qualifications after exit day.
Arrangements for the recognition of professional qualifications within the EU are provided for by the directive on the recognition of professional qualifications. If UK domestic legislation is not amended, many of the directive’s provisions will still be part of UK law after exit day. However, they will not function properly and in some cases will be inoperable. For example, regulators may lose the ability to recognise certain EEA and Swiss qualifications. This would mean, as I have said, that health and care professionals who want to work in the UK will not be able to do so. Changes to domestic legislation, which implements the directive, are therefore needed to ensure that recognition of EEA and Swiss qualifications can continue in the unlikely event of a no-deal exit.
The UK has been a major beneficiary of the arrangements that European directives have put in place on this matter. Since 1997, more than 77,000 EEA and Swiss qualifications in the automatic professions of doctors, nurses, midwives, dentists and pharmacists have been recognised in the UK. By contrast, fewer than 7,000 UK qualifications have been recognised in the EEA and Switzerland. Directives have supported the recruitment of skilled professionals to the UK’s health and care sector, so it is important that arrangements are in place to allow for the continued registration of such professionals if the UK leaves the EU in a no-deal scenario.
This instrument deals with the recognition of EEA and Swiss professional qualifications in the UK. It has three main effects. First, it puts in place arrangements for the recognition of EEA and Swiss professional qualifications that are currently automatically recognised. Secondly, it ensures that applications for recognition that are ongoing at exit day can be completed under the current legal arrangements, as far as practically possible. Finally, it removes provisions that are not possible or desirable to maintain in the event of a no-deal Brexit.
I will take some time to set out exactly what the instrument does. It puts in place new arrangements for the recognition of EEA and Swiss professional qualifications that are currently automatically recognised by UK regulators. Such qualifications will become acceptable overseas qualifications. These qualifications will continue to be recognised without additional testing, other than checks on language skills and where there are concerns about applicants’ fitness to be registered. The regulations give UK regulators a new power to stop the automatic recognition of a qualification by seeking designation of that qualification if so desired. This is not currently possible under the directive, and this important additional measure will enhance public protection. Such a designation will be subject to Privy Council consent.
The Government have been asked whether they will set out in guidance the criteria to be applied by regulators when seeking designation of a qualification. We do not intend to do so. UK health and care professional regulators currently set the standards for UK qualifications. In our view, therefore, they are best placed to identify whether there is a case for designating a qualification as not comparable to these standards on the grounds of public safety. UK regulators will be able to seek designation of any qualification that is currently automatically accepted but about which they have concerns. It will be the responsibility of the regulators to present 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 UK professional qualification. The arrangements for the continued recognition of automatic qualifications will be reviewed by the Secretary of State for Health and Social Care two years after these regulations come into force.
These regulations also enable qualifications that are not currently covered by the automatic system to be considered by the relevant UK regulator and compared with the equivalent UK standard, as is currently the case. The regulations enable applications which have been made before exit day to be concluded under the current arrangements, as far as practically possible. This instrument also enables 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 or Swiss-trained healthcare professionals practising in the UK, but we do not think that that is a genuine problem. Just 160 professionals are registered on a temporary and occasional basis. Professionals practising on such a basis will not lose their registration on exit day; they will instead be able to practise until their registration expires, which may be for up to 18 months. At that point they will be able to seek full registration in the same way as any other holder of an EEA or Swiss qualification.
Finally, this order removes obligations and administrative arrangements that will no longer apply to the UK regulators, operate effectively or be desirable to maintain when the UK leaves the EU. These include: the removal of the requirement to share information through the European Commission’s internal market information system, IMI, to which UK regulators would no longer have access; the ending of arrangements that allow professionals to practise in the UK using an EPC, which relies on having access to IMI; and the removal of the requirement on UK regulators to set professional education and training standards that comply with standards set in the directive. This provides UK regulators with greater flexibility to set education and training standards that meet the needs of the health and care sector in the UK.
These regulations put in place a system for the recognition of EEA and Swiss professional qualifications if the UK exits the EU without a deal. It also ensures that those applications that are in process on exit day will be concluded under the current arrangements, as far as practically possible. On that basis, I beg to move.
Baroness Blackwood of North Oxford
I thank your Lordships for what I think we can call a robust debate. I will start by discussing the designation criteria, which were at the core of the questions from the noble Baronesses, Lady Thornton, Lady Jolly and Lady Hayman, and the noble Lord, Lord Hunt, and are central to this SI. It is important to set out the differences between the current system and what future recognition might look like under the SI. Obviously, we understand that this would happen only in a no-deal scenario, which the Government very much wish to avoid.
To clarify, the current system is based on automatic recognition of EEA and Swiss qualifications, as listed in Annexe 5, with eligibility based primarily on an applicant’s nationality rather than where the qualification was gained. In future recognition, eligibility would be based solely on whether the individual holds a relevant EEA or Swiss qualification. UK regulators would therefore be able to apply for designation of an individual EEA/Swiss qualification as well. That is where the concept of flexibility comes from, which so upset my noble friend Lord Deben. Some aspects of the directive would no longer apply to the UK, so some of the ways in which the directive applied previously—such as on hours, which have previously been used to determine qualification—might no longer be appropriate in determining whether a qualification has been met.
This flexibility in setting standards should be welcomed. Indeed, we noted that Charlie Massey, the chief executive of the GMC, has previously raised concerns about the training of some individuals we had to accept under this automatic recognition process. For example, he raised concerns about family doctors in Italy before the Health and Social Care Select Committee. The General Dental Council has also raised concerns about the quality of some Romanian and Spanish dental qualifications. Under the new proposals, we would be able to raise such concerns through the designation process. They would go to the Privy Council because that is already the normal process through which UK regulators designate qualifications in the UK system. The process proposed under this SI is the standard UK process for establishing professional qualifications.
Moving on to how this would work, the instrument enhances the UK regulators’ powers to protect the public by designating as no longer acceptable EEA and Swiss professional qualifications that they are currently obliged to accept automatically. As I said, the grounds for designating a qualification will be determined by the UK regulator, which is best placed to make such decisions. The UK regulator will be able to seek designation of any individual professional qualification about which it has concerns. The most likely basis for such a designation will be that a qualification does not meet the standard of UK qualifications. We do not expect the approaches to designation to vary significantly between regulators as they have a shared objective of protecting, promoting and maintaining the health and safety of the public—and long experience of doing so. Therefore, the reasons for seeking designation and evidence supplied in support of designation are expected to be largely consistent. As I said, Privy Council consent must be given for a qualification to be designated. This standard system has been used previously.
The Government have been asked whether they will set out guidance on the criteria to be applied by regulators when seeking designation of a qualification. We do not intend to do so because we believe that the most likely basis for designation will be a qualification not meeting the standard of equivalent UK professional qualifications. We think that UK regulators, not the Government, are the authority on standards for healthcare professionals practising in the UK. They set the standards for UK health and care professional qualifications and are therefore best placed to understand if there is a case for designating a qualification. As I said, the Privy Council has a well-established role in overseeing the UK’s health and care professional regulators. For some regulators, including the GCC and GOsC, it approves UK qualifications and the appointment of council members. Its new role in approving applications for the designation of EEA qualifications is simply an extension of its existing role.
Costs and the impact assessment were referred to by a number of noble Lords but particularly exercised my noble friend Lord Deben. I am afraid that we have gone into the costs in some detail, despite the concerns he raised. He will know that UK regulators operate on a full-cost-recovery basis and set registration fees that meet the cost of processing applications. The cost to regulators of moving to the new system is considered negligible because it mirrors the current system, as far as possible, for at least two years—we intend to review that, once the regulations come into force. Should the regulator incur additional cost, it will be able to recoup it through fees. We estimate the total cost to regulators on the automatic system—including the NMC, the GMC, the GPhC and the GDC—to be £250,000 per year and an additional £60,000 for recruitment costs in the first year of these regulations coming into force. This could raise registration fees by an average of 27 pence per registrant per year for the regulators to recoup additional administration costs. We have costed the impact and believe the assessment to be reliable. That is why we have the GMC’s support; it believes that the impact assessment is reasonable and that it can cope with the impact.
I want to address concerns raised about temporary workers. I know that the noble Baroness, Lady Jolly, wanted to re-raise this even though I tried to address it in my opening speech, as the noble Baroness, Lady Thornton, acknowledged. As we said, we do not think that the removal of this group of registrations will cause concern as only 160 professionals are registered on a temporary and occasional basis. Professionals practising on such a basis, even in that small group, will not lose their registration on exit day; they will be able to practise until their registration expires, up to 18 months later. At that point, it will be open to them to seek full registration in the same way as any other holder of an EEA or Swiss qualification. It is important to note that the number of joiners from the EEA has remained steady at around 2,050 a year since 2016. In 2017-18, doctors joining the register from non-EEA and UK routes made up 32.4% of the total, while EEA applicants made up 16.2%. We are confident that the impact on that point will be manageable but we will keep a close eye on it and ensure that it is kept in check.
Moving on to the question about the IMI, raised by my noble friend Lord Deben and the noble Baroness, Lady Jolly, it is absolutely right that if the UK leaves the EU without a deal, we will no longer have access to EU systems, including the IMI system which gives us access to the exchange of information about healthcare professionals. The regulators are aware of this and they are preparing for it. It is important that this instrument will mean that they will not be required to put in place new procedures for the recognition of EEA qualifications and that any costs involved with the loss of the IMI system are unavoidable in the case of no deal. Such costs depend on a number of factors. While we would like to see continued access to the IMI system, it is worth bearing in mind that the registration of international health professionals takes place with non-EEA registrants without access to IMI. We have managed to ensure that that happens safely, effectively and efficiently. However, we will do our utmost to ensure that we consider other means to replace IMI that comply with the GDPR, such as standard contractual clauses. I hope that reassures noble Lords on that point.
Perhaps I may go on to answer the questions raised by the noble Lord, Lord Crisp, and the noble Baroness, Lady Jolly, on Spanish nurses and nurses from the Republic of Ireland. There is an issue on this point and I recognise the concerns that have been raised. There will be no change as a result of these regulations in the way Irish and Spanish qualifications are accepted, but at this point the Spanish regulator has said that it will not recognise the UK practice of Spanish nurses. This is a matter for the Spanish body, but we are continuing to discuss as a matter of urgency how EU regulators will recognise UK practice and qualifications, so that it does not matter which we are taking up.
As regards Ireland, the regulations ensure the continued recognition of Irish professional qualifications in Northern Ireland for at least two years after exit day and will allow professionals practising under temporary and occasional registration status to continue to do so until that registration expires. We are making sure that health and care practice across the island of Ireland is maintained smoothly and continuously. This has been a priority for the Government.
With those comments, I hope I have addressed the main concerns raised by noble Lords and given reassurance on those points. On that basis, I beg to move.
Lord Warner
My Lords, can the noble Baroness give me some answers to the points I raised about guidance being given in the event of no deal and exit on 29 March? First, how are the Government going to communicate that guidance to all the interested parties in the time available? Secondly, I asked about the status of these SIs in the event that the Article 50 period is extended beyond 29 March but there still being no deal. Does that mean that after that period, these SIs would come into effect when the period of exit is established post 29 March? Thirdly, what happens to these SIs if there is a deal? Does the present status carry on, with these SIs being put into limbo and therefore not introduced?
Baroness Blackwood of North Oxford
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.
Baroness Thornton
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.
European Qualifications (Pharmacists) (Amendment etc.) (EU Exit) Regulations (Northern Ireland) 2018
Baroness Blackwood of North Oxford Excerpts(6 years ago)
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Baroness Blackwood of North Oxford
That the draft Regulations laid before the House on 6 December 2018 be approved.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
My 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.
Baroness Thornton (Lab)
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.
Lord Lea of Crondall (Lab)
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?
Baroness Blackwood of North Oxford
That was quick. I thank noble Lords for their contributions. The points made by the noble Lord, Lord Lea, are indeed important and concerning. I will arrange for the specific points he has raised to be answered in writing. On the issues regarding this SI, I would like to reassure him that since August 2017 my department has engaged closely with the PSNI and colleagues in Northern Ireland in developing this instrument. These have been technical discussions relating to the proposed amendments to legislation and how they could impact the provision of healthcare services. The department has regularly communicated with stakeholders and colleagues in the devolved Administrations to ensure that their comments on the draft legislation were central to the development of the regulations. There were regular discussions between my officials and each health and care regulatory body to ensure that this reflected operational performance in country. I hope that reassures the noble Lord.
I move on to the questions raised by the noble Baroness, Lady Thornton. We do not have figures for pharmacist registration in Northern Ireland, so I will have to write to her on that. On the general point regarding the numbers of pharmacists and the role they play in Northern Ireland, she is absolutely right. The Government recognise the important contribution to Northern Ireland made by regulated pharmacists, including those from the EEA and Switzerland. That is exactly why we are bringing forward this instrument today, to maintain a simple procedure for recognising EEA and Swiss pharmacy qualifications to help ensure that EEA and Swiss trained pharmacists can be registered to practice in Northern Ireland after exit day should there be no deal, even though we do not want that to happen. It puts in place after exit day a system of recognition similar to the current system, which is why we think it is workable. It allows applications made before exit day to be concluded under current arrangements as far as possible, and allows individuals practising under temporary and occasional status or under the European professional card to continue to do so until such registration expires. For that reason, we think this should have no impact on the numbers of pharmacists operating in Northern Ireland.
I think I have answered the questions raised, and I hope that has reassured noble Lords. On that basis, I commend the regulations to the House.
General Food Law (Amendment etc.) (EU Exit) Regulations 2019
Baroness Blackwood of North Oxford Excerpts(6 years ago)
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Baroness Blackwood of North Oxford
That the Grand Committee do consider the General Food Law (Amendment etc.) (EU Exit) Regulations 2019.
Relevant document: 17th Report from the Secondary Legislation Scrutiny Committee (Sub-Committee B)
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
My Lords, I thank noble Lords for their consideration of the draft regulations—the General Food Law (Amendment etc.) (EU Exit) Regulations 2019, the General Food Hygiene (Amendment) (EU Exit) Regulations 2019, the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 and the Contaminants in Food (Amendment) (EU Exit) Regulations 2019.
The Government’s priority is to ensure that the high standards of food safety and consumer protection we enjoy in this country are maintained when the UK leaves the European Union. These instruments are crucial to meeting our objective of a functioning statute book on exit. They are made under the powers in the European Union (Withdrawal) Act 2018 to make necessary amendments to the overarching food regulations so that we can continue to protect public health from risks that may arise in connection with the consumption of food. These instruments correct deficiencies in those regulations.
I wish to be clear that no policy changes are made through these instruments, nor is there any intention to make any at present. These instruments propose a transfer of responsibilities to UK entities to support a UK-centric regulatory regime. Responsibilities incumbent on the European Commission are designated to Ministers in England, Wales and Scotland, and to the devolved authority in Northern Ireland.
The European Food Safety Authority, EFSA, is the EU body that provides scientific advice on food safety. These regulations designate EFSA responsibilities to the food safety authority. This will be the Food Standards Agency, the FSA, in England, Wales and Northern Ireland, and Food Standards Scotland, which has a close working relationship with the FSA. The draft instruments being considered today will ensure that the following key EU regulations on food and feed safety and hygiene will function effectively on exit day.
Regulation 178/2002 lays down the fundamental principles that underpin food law and the essential requirements that food and feed businesses must comply with, as well as describing certain functions to be carried out by EU institutions. A key principle set out in the legislation is that food placed on the market must be safe to eat. It also provides for other fundamental safety and hygiene requirements, including rules and expectations on traceability. It establishes a requirement for open and transparent public consultation if food law is revised.
Regulation 852/2004 contains the basic food hygiene requirements for all food businesses. It sets out the general requirements for the hygienic production of foodstuffs through the provision of effective and proportionate controls throughout the food chain to the final consumer.
Regulation 853/2004 relates to the specific hygiene rules for products of animal origin, and Regulation 854/2004 relates to the organisation of official controls for products of animal origin. These specific hygiene rules set out the requirements and specific health standards for establishments on land or at sea for slaughtering, processing, storing or transporting products of animal origin.
The regulations on chemical contaminants protect consumers by ensuring that they are protected from the adverse effects of exposure to contaminants that may be present in food. Chemical contaminants may be present in food from the environment or as a result of growing conditions. The legislation sets out maximum limits for certain contaminants in food and provides a clear legal basis on which enforcement action may be taken, where necessary, to protect consumers by facilitating the removal of unsafe food from the food chain.
These instruments do not introduce any changes in how food businesses are regulated or managed. They do not introduce extra burdens and therefore provide continuity and clarity for businesses and continued protection of consumers’ interests. It also means that non-compliances can continue to be addressed in the same way. These will ensure a robust system of controls that will also underpin UK businesses’ ability to trade both domestically and internationally.
It is also important to note that the devolved Administrations have provided their consent for these instruments. Furthermore, we have engaged positively with the devolved Administrations throughout the development of these instruments. This ongoing engagement has been warmly welcomed. A full public consultation indicated support for the proposed approach to retained EU law for food and feed safety and hygiene. These instruments therefore constitute a necessary measure to ensure that the important food safety regulations will continue to work effectively after exit day. On that basis, I beg to move.
Baroness Walmsley (LD)
My Lords, I thank the Minister for introducing these SIs, which replace references to the EU in regulations with references to the UK, and as such are relatively innocuous. The first question I want to ask was raised in Grand Committee last Wednesday by the noble Lord, Lord Rooker, who is in his place. Is the Minister satisfied that all relevant regulations on these important food safety matters have been copied over into the SIs we are discussing today? The noble Lord found some SIs where some important matters had not been copied over. Perhaps he has spotted something which I have not in these regulations, and we will hear from him in due course.
Secondly, the general food law SI, the general food hygiene SI and the contaminants in food SI allow only one hour for a single officer in a local authority to familiarise himself or herself with the new regulations and disseminate the information to staff and stakeholders. I wonder whether it is a coincidence that they will have to do it on April Fools’ Day, the first working day after Brexit. The problem is that cuts to local authority funding have meant that some authorities no longer have any full-time food and feed officers to take charge on this issue, so who is going to do it, and who is going to pay for it? How can they do it in only one hour? Is this not just a covert way of ensuring that an impact assessment does not need to be produced? All those who responded to the consultation claimed that this cannot be done in so short a time and will certainly cost more than the Government estimate, and the Government have not offered to cover these costs. How did the Government reach the conclusion that the implementation time for businesses would be so staggeringly short?
The food hygiene SI allows a 21-month implementation period for food labelling changes from EU to GB or UK, but even here, the industry has concerns that some small businesses may struggle to comply. Other respondents to the consultation raised concerns that a common framework across the whole of the UK has not been properly addressed. The NFU pointed out that some farm holdings cross borders and animal feed moves across the Welsh and Scottish borders frequently. Is the Minister satisfied that devolution issues have been settled to the satisfaction of the Welsh and Scottish Governments?
Thirdly, can the FSA and its Scottish equivalent, the FSS, fulfil their additional responsibilities? Do they have enough staff and resources? Can the Minister respond to these concerns? Other respondents are concerned about how the Government intend to provide a suitable replacement for the risk-management function for food safety currently undertaken by the European Food Safety Authority. Can the Minister say what is being done about this? The whole of the food safety regime is based on risk management, and it is far from clear who will be responsible for this after Brexit and whether they have adequate resources. The National Pig Association is keen to retain a close working relationship with the EFSA to ensure that we in the UK receive food problem alerts in good time to take effective protective action against livestock diseases coming to us from the continent. This will also be a concern for other livestock producers. Can the Minister say what arrangements for this have been put in place?
I hope I will be forgiven for straying slightly beyond these SIs to some relevant matters, and I hope the Minister will find my comments useful for the future. If we are to leave the EU, the Government have always said that there is no danger of reducing our food standards and that, on the contrary, it gives us an opportunity to improve them. That is why I am surprised we have heard nothing yet of the Government’s plans to do that. One thing I would have wanted to improve in the common agricultural policy is to link food production and trade policies to the better dietary health of the European population. So here is a challenge for the British Government. They can start with two things, which I put down as markers for the future. First, they should ban the use of nitrites in processed meats, such as bacon and ham, in favour of other processes which have not been designated as carcinogenic by the World Health Organization, as nitrites have been, but which preserve meat just as well and protect it from botulism just as effectively.
Secondly, they should introduce supply-side regulations to reduce the UK population’s intake of free sugars by two-thirds to comply with the Scientific Advisory Committee on Nutrition’s recommendations, which make clear that overconsumption of sugar is responsible for the crisis of obesity, diabetes and all their associated preventable diseases, and for tooth decay in children, which is responsible for most of their hospital stays. Agricultural and trade policy are central to the supply of sugar, and amendments could be effective in changing the market for sugar before it even reaches the consumer. Reformulation programmes, sugary drinks tax and nudges towards behaviour change have their place, but we could make a greater and faster change if we addressed the supply side.
Once they have got all the relevant SIs about retained EU law through Parliament, will the Government look at these two opportunities as a matter of urgency? Has the Minister had any discussions or made any representations from her department to the rest of Government about such measures, as we move into the years after Brexit?
Baroness Blackwood of North Oxford
I thank all noble Lords for their contribution to this debate on my first SI. I think it is quite unusual for your first SI to involve two former chairs of the independent body that you are in part debating. I shall do my best to tread appropriately carefully.
I shall respond to some of the questions asked by the noble Baroness, Lady Walmsley, about why the instruments deal specifically with these questions and do not think beyond Brexit. I am sure she will know, having experience with previous statutory instruments, that the instruments are responding to the fixing power of the European Union (Withdrawal) Act, which is limited to making appropriate changes to prevent, remedy or mitigate failures of retained EU law to operate effectively, so these instruments aim specifically to ensure that food safety and hygiene legislation functions in a no-deal scenario. I state at the outset that we think it is unlikely that the UK will leave without a deal—indeed, it would be very undesirable—but we must be prepared in all scenarios. I wanted to put on record at the beginning why these SIs were drafted in this specific way, although I know she knows that.
To respond to the noble Baroness’s question about whether we are confident that they have all the necessary read-across from EU law into UK law, we have been very careful to review the EU law in FSA policy areas to check that. We believe we have identified all the EU law that needs to have those connections across.
The noble Baroness asked about the consultation, and this was echoed by the noble Lord, Lord Rooker, regarding the responses about the impact on local government. The SIs were very effective, in as much as the FSA did a full public consultation that lasted six weeks. It should be praised for following that route and for engaging with local authorities and industry. It is reasonable to point out that local authorities are under pressure at the moment, but I think the reason why we have come to the view that it will take a relatively brief amount of time to get familiar with the new legislation is that there are no changes to the vast majority of requirements in the read-across. We are therefore confident that the time that has been predicted in the impact statement is sufficient, so we believe that that impact assessment is robust.
In addition, we wanted to discuss the devolved Administrations and consultation there. We are very pleased that Scotland, Wales and Northern Ireland have provided their consent for these instruments. We have worked very closely in developing them. The principles and rules set out in retained legislation in these SIs are intended to ensure that we have the same level of food safety protection throughout the UK, so that we can have a free flow of trade through it to address exactly the concerns that the noble Baroness raised. However, the FSA is not going to leave it there: it will continue that close working relationship with the Administrations of Scotland, Wales and Northern Ireland so we can be confident that in practice it will be possible to make arrangements to operate a framework of food safety regulation across the UK in whatever exit scenario we may face.
I turn to the important series of questions about RASFF risk assessment and management in a potential no-deal scenario, asked by noble Lords with great experience. I know there has already been something of a debate about this in Select Committee with my colleague the Minister, Steve Brine, so I suspect I will repeat some things that he has said—perhaps not so eloquently, but I will do my best.
As the noble Lord, Lord Rooker, rightly said, securing continued access to and participation in the RASFF system after leaving the EU is one of the UK Government’s top food safety priorities. We recognise its importance for UK food safety, but we also recognise the important role that the UK has played in establishing that system. We are proud of that, and would like to continue to play a role. We are pressing for full access to that system in our negotiations with the EU, and I am sure that is what my colleague the Minister said earlier. As he would have said, though, the exact arrangements for participation in RASFF are still a matter for the next phase of negotiations. It is therefore hard to provide any further detail on that, as I know noble Lords will recognise. We recognise the importance of it and of a continued strong relationship with the EU.
In communications back to us, the EU has recognised the important role the UK played in the establishment not only of RASFF but of equivalent food standards bodies in the European Commission, so I think the close relationships we have there will bear fruit. They are not just close relationships at a European Commission level but scientific relationships, which tend to weather political storms a little better than political relationships, if I may say so, so I have a sense of optimism about this. We must be clear that negotiators recognise that there is no precedent at this point for third-country membership of RASFF, but we will continue to make the point that we have an unusually strong contribution to make to it and therefore there is value in us engaging with it.
The mutual benefits are an important element of maintaining food safety for both parties, and we think it is important for the EU, as well as for the UK, that this close trading relationship can continue without compromising confidence in food safety. As the noble Lord, Lord Teverson, pointed out, FSA officials have been working closely on this point with Defra officials to ensure that there is a seamless approach to dealing with the challenge of exit, and that contact is maintained at not only a policy and legal level, but, most crucially, an operational level. That will need to continue as we go through this next period.
I now turn to what will happen in the undesired scenario of no deal, where we may well have to cope without access to RASFF, even if it is in the short term. Noble Lords will have heard earlier today from Heather Hancock, the chair of the FSA, on the plans she has put in place to ensure we have robust protections and operational measures in place to ensure that food safety standards are in no way compromised, no matter what the outcome of EU exit may be. In the first instance, we have ensured that the FSA is increasing the level of engagement with the International Network of Food Safety Authorities, INFOSAN—which, noble Lords will know, is managed jointly by the FAO and the WHO—to provide the UK with an extensive reach for communicating food safety issues to INFOSAN. Indeed, we believe that, with our extensive experience, we have done work to improve the effectiveness of that organisation.
We have to bear in mind that we have effectively been managing food risk from imports from and exports to non-EU countries through some of those bilateral and non-EU routes, so we can have confidence in the effectiveness of the FSA as a world-leading regulator—up until this point, in any case. Nevertheless, there has been no complacency in this. The FSA has put in place a number of measures to strengthen the domestic risk assessment and risk management measures. To do this, it has recruited additional staff involved in risk assessment and risk management, implemented an expanded role for the independent scientific advisory committees, which are now being strengthened by recruiting new experts and establishing three new expert groups, and expanded access to scientific experts who can provide scientific advice and other scientific services to inform our work on a contract basis, including by expanding our register of specialists. It has ensured that it will put in place a slightly new system that is based on current practice but includes: a structured separation of risk assessment and risk management; a new executive advisory committee that draws together officials from government; an expanded role for the independent scientific advisory committees, which, as I have said, have been strengthened by recruiting new experts; and a new process for authorising regulated products, such as food and feed additives, enzymes, flavourings, GM food and feed, and other novel foods.
The noble Lord, Lord Krebs, raised an important question about the independence of the FSA and the role of Ministers. It is right to assure him that the response he received from my honourable friend Steve Brine in Select Committee is right. While food safety decisions will be made by Health Ministers, the FSA and FSS will continue to lead and make risk management decisions during food safety incidents, providing risk management advice to the enforcement authorities, which take action. Of course, this independence is set out by statute. No proposal is in place to change that. All food safety and risk management decisions will be proportionate and evidence-based. They will be based on a package of supporting analysis in line with the fine tradition the FSA has of openness and transparency. We can be proud of the FSA’s tradition of doing that.
I hope I have answered the questions raised. On that basis, I beg to move.
General Food Hygiene (Amendment) (EU Exit) Regulations 2019
Baroness Blackwood of North Oxford Excerpts(6 years ago)
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Baroness Blackwood of North Oxford
That the Grand Committee do consider the General Food Hygiene (Amendment) (EU Exit) Regulations 2019.
Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019
Baroness Blackwood of North Oxford Excerpts(6 years ago)
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Baroness Blackwood of North Oxford
That the Grand Committee do consider the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019.
Contaminants in Food (Amendment) (EU Exit) Regulations 2019
Baroness Blackwood of North Oxford Excerpts(6 years ago)
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Baroness Blackwood of North Oxford
That the Grand Committee do consider the Contaminants in Food (Amendment) (EU Exit) Regulations 2019.
Cannabis: Medicinal Use
Baroness Blackwood of North Oxford Excerpts(6 years ago)
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Baroness Meacher
To ask Her Majesty's Government what steps they are taking to ensure that patients in need of medicinal cannabis are able to access such treatment on prescription.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
My Lords, government officials have been working with colleagues across healthcare and the wider system to ensure that patients can access medicinal cannabis where appropriate. Clinical guidance has been issued by the Royal College of Physicians, the British Paediatric Neurology Association and the Association of British Neurologists. Specialist doctors will consider this before prescribing, but we are clear that the decision to prescribe should be for individual clinicians to make in partnership with patients and their families.
Baroness Meacher (CB)
I thank the Minister for her reply. She will be aware that only about four people have received a prescription for medical cannabis since it became legal on 1 November last year. Doctors have had no training in prescribing cannabis. They need to know the contents, dosages, side-effects and everything else about medical cannabis products. The pressure on doctors with desperate patients whose standard medications are not working or are causing unacceptable side-effects is intense. Doctors urgently need government help. Will the Minister ensure that the medical director of the NHS makes specialist doctors aware of the new guidelines to be launched later this month by the Medical Cannabis Clinicians’ Society, and of the 12-module online training course already available from the Academy of Medical Cannabis?
Baroness Blackwood of North Oxford
I thank the noble Baroness for her question. This is a challenging area, and the evidence base is still developing. However, the Government are working hard to ensure that awareness is increasing, which is why we have asked NICE to develop guidance to be released later this year and have asked HEE to develop a training package to increase knowledge and awareness among health professionals. It is also why officials are working closely with suppliers and importers to ensure that prescriptions are filled when they are given. We understand that there is work to do on this issue and will continue to do so.
Lord Howarth of Newport (Lab)
Will the Minister comment on the issues illustrated in the predicament of a person who has been prescribed the cannabinoid dronabinol, branded as Bedrocan, which is the only medication that has proved effective for her following the failure of 35 different medications previously prescribed to relieve her chronic pain from cervical and lumbar spondylosis? Given that the Chief Medical Officer stated last summer that there is conclusive evidence that cannabis-based products are effective for certain medical conditions, why is this patient still forced to travel to Holland every three months to obtain the medication that her consultant considers essential for her, and why does confusion still reign over licensing procedures? Will the Minister meet me and the person I have mentioned to see if she can introduce some more sense into these arrangements?
Baroness Blackwood of North Oxford
I thank the noble Lord for his question. I am very sorry to hear about the situation he raises and will be very happy to meet him. As far as I can see, there should be no reason for the situation he has outlined. It is up to clinicians to prescribe as they see fit under the guidelines that have been issued.
Baroness Walmsley (LD)
My Lords, when the Chief Medical Officer recommended that cannabis medicines be rescheduled, she produced a report showing that the most rigorous regulatory authorities in the world—those in the US, Australia and Ireland, as well as the World Health Organization—had strong evidence of the benefits of cannabis-based medicines for people with epilepsy. In light of that, it is completely unacceptable that only four licences have been granted. Why are UK patients being deprived of these safe and effective medicines which have fewer side-effects than some licensed pharmaceuticals, such as sodium valproate?
Baroness Blackwood of North Oxford
I 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.
Baroness Thornton (Lab)
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?
Baroness Blackwood of North Oxford
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.
Lord West of Spithead (Lab)
The majority of those guilty of violent terrorist crimes in this country are found to be heavy users of cannabis. When one looks at violent crime outside of terrorism, it seems again—although I do not know the details—that very often the people involved are heavy users of skunk—not the kind of cannabis that we are talking about but the liquid stuff. Are the Government looking at the relationship between the use of these really strong types of cannabis and violent crime, to see whether anything should be done about it?
Baroness Blackwood of North Oxford
The medicines we are speaking about are not skunk. The noble Lord is right that all medicines carry risk, but they can also be beneficial. That is why we have introduced a route to allow medicinal cannabis to be used for those conditions where it will be beneficial. The change in the law allows strict access by specialist doctors who, in making the decisions to prescribe, can ensure that the benefit outweighs the harm to the patient and that the restrictions are line with advice from the ACMD. Any further concerns around the kinds of drugs that the noble Lord is talking about are still strictly controlled by the Home Office and by policing.
Safety of Medicines and Medical Devices
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
My Lords, I congratulate my noble friend Lord O’Shaughnessy on securing this debate and on what I know was a very personal commitment to this subject when he was Minister. I also congratulate the noble Lord, Lord Carrington, on a truly excellent maiden speech. We all recognise the significant contribution to the United Kingdom’s public life by his father, the late Lord Carrington, but I do not think the current noble Lord, Lord Carrington, will have any trouble following in his footsteps.
Indeed, I thank all noble Lords who contributed today. It has been a thoughtful and sobering debate on a really important subject. We should be proud of the world-leading role that UK researchers, clinicians, industry and regulators play in medical discovery and innovative treatment. We are the first country to introduce whole-genome sequencing to routine clinical care, the first in the world to approve Kymriah and the first in Europe to approve CAR T-cell therapy. As the noble Baroness, Lady Masham, rightly said, that is so important for patients with rare or hard-to-treat conditions, because it raises the hope of earlier diagnosis and more targeted treatments. That is at the heart of many of the measures in the long-term plan and the life sciences strategy, which is directed at improving the capacity of our life sciences industry and the NHS to improve the quality of care for patients.
As many noble Lords eloquently pointed out, medical innovation flourishes only on a firm foundation of clear and effective regulation and informed consent. That is not only about patient safety but about giving certainty to researchers and innovations. The noble Baroness, Lady Finlay, and my noble friend Lord Bethell movingly reminded us that there is an innate tension in the need to drive forward the frontiers of medical innovation to offer hope to those with rare and hard-to-treat conditions—perhaps it is appropriate that today is Rare Disease Day. But there is also the need in a complex and universal system such as the NHS to have effective and agile safety and consent systems. However, in that context, it is never an excuse for a patient’s voice not to be heard loudly, quickly and effectively when things go wrong and we must never tolerate any form of gender bias, as the noble Baroness, Lady Jolly, said.
We heard today of some of the successes and strengths of our current systems of regulation for both medicines and medical devices, but we also heard about instances where our regulatory and wider systems could go further. I pay tribute to all those patients, some of whom are here today, who have shared their experiences and have gone on with a resolute determination to campaign for change for themselves and on behalf of others, including groups that my predecessor met and worked hard with, such as INFACT and Sling the Mesh. Many of them have met Ministers and Members of this House and have, with great bravery, told their stories, many of which are heartbreaking for them and their families. To them I say: thank you for your courage and dignity. Please know that your voices are heard not only here today but across government and across the system.
Noble Lords have already debated many aspects of the role of the MHRA to be responsible for the regulatory compliance of medicines and devices. As noble Lords will be aware, no medicine or medical device is entirely risk-free. The possibility of a patient suffering an adverse reaction or incident, although limited, can never be eliminated. That is why the MHRA has powers to take action, including removing products and devices from the market or resisting their use if the risk and benefit profile changes as new evidence emerges. We need to ensure that we are capturing that evidence most effectively.
Recent examples of where the MHRA has made use of those powers include recalling some sartan medicines for high blood pressure and issuing new temporary measures for the uterine fibroid drug Esmya. The MHRA also initiated EU action on valproate and will continue to consider what further restrictions are needed to ensure that valproate is not used in pregnancy. I will return to that in more detail a little later.
The noble Baroness, Lady Finlay, is absolutely right that the MHRA and NICE are indeed working more and more closely together on these matters. I have heard her and others’ points about the use of registries to capture evidence more effectively. We need to consider how that would interact with local care health records, however, and whether they are the most appropriate place to capture that information. I will take that point away and consider it carefully.
I particularly thank my noble friend Lord Bethell for his truly eloquent account. I appreciate his impatience for progress on this matter, so I would like to focus for a moment on the system for regulating devices. As the House is aware, medical devices are not brought to the market in the same way as medicines. The regulation of medical devices is instead governed by three EU directives as part of the pan-EU system of conformity assessment, a system that sets out standards for pre and post-market assessment of medical devices, including categories of device and the role of notified bodies and the MHRA.
However, there is no direct authorisation of devices for the UK or EU markets conducted by the MHRA. Medical devices and the wider medical technology sector form an area of very fast technological innovation, as the noble Baroness, Lady Thornton, pointed out. This means that devices are routinely improved and replaced as technology is developed, with a view to improving patient safety and experiences. It also means that there are comparative limitations on the amount of pre-market assessment that can be conducted for devices—unlike for medicines—given that the evidence of their actual use by patients is critical to the overall assessment of their efficacy. This is why manufacturers, notified bodies and the MHRA conduct ongoing post-market surveillance and vigilance to respond to information about the safety of devices when in use, and take appropriate regulatory action to improve them. This includes issuing medical device alerts to the healthcare service and the restricting and recalling of products. The publication of more data and patient feedback is an evolving process, as more experience is gained from the use of medical devices.
While the overall system seeks to establish a balance between continuous innovation in medical technologies and patient safety, I fully accept that it is not easy to achieve. By its nature, the regulation of innovative sectors must respond with continuous improvement, while the sectors’ systems and processes need to be continuously reviewed in the interests of patient safety. This is something that I know the MHRA and others take seriously, and to which I am personally committed. It is why the UK has played a role in arguing for change at European level in recent years, and why the Government intend to fully align the UK with the new EU medical devices regulations and in vitro diagnostic medical devices regulations, which my noble friend Lord Dundee mentioned. We will do this even though we are leaving the EU institutions because we are confident that doing so will drive system-wide improvement, including to the levels of clinical data that are mandated before products can be placed on the market, the scrutiny placed on notified bodies, the level of post-market surveillance conducted and the traceability of medical devices. We think this will improve the safety of medical devices.
This approach will establish a stronger and improved baseline for any future system change that we implement after our departure from the European Union. We will proactively ensure that innovative technology and processes are utilised by the UK healthcare system where this can enhance the role of the MHRA, including in relation to data, as well as increasing patient safety and confidence. My noble friend referenced a strong example of this: the Scan4Safety pilot, which was conducted in six trusts. We hope to roll that out across all acute trusts in England. I am a strong supporter of this, given that I announced the pilot in the first place.
Despite these changes, I know that there are still patients who feel that their concerns or experiences are not adequately heard or considered by the health system, and that the response has not been agile enough. It is an essential principle of patient safety that the regulatory environment gives sufficient voice to concerns reported by patients, families and campaigners, and that it works alongside them to respond in a rapid, open and compassionate way to resolve issues. I offer my firm assurance now that, as a department, we will be neither complacent in our success nor ignorant of the possible opportunities to improve. Just as the landscape of medicines and medical devices is ever-changing, so too must be the regulatory frameworks in which they are marketed, monitored and used within our healthcare system.
It is this commitment to evolve and ensure that the patient voice is central to our healthcare system that led to the Independent Medicines and Medical Devices Safety Review, chaired by my noble friend Lady Cumberlege and introduced by my noble friend Lord O’Shaughnessy. We have already heard much about it, so I will not go into detail. However, it will be critical to improving our understanding and action on listening to and consulting patients in the UK healthcare system to ensure that informed choices can be made. We expect the review to report later in 2019, with my noble friend Lady Cumberlege’s assistance. As we have heard, I know it has been consulting in a detailed and patient-oriented manner across the UK. I specifically thank my noble friend for her great sensitivity and dedication when listening to patient groups and individuals. I have met her and her team and heard first-hand how she has travelled the country to ensure that those who want their story to be heard have had an opportunity to speak in a sensitive and appropriate environment. She has handled her work with great tact and compassion, and I thank her for all her hard work and dedication.
Baroness Blackwood of North Oxford
Without second-guessing her conclusions, we recognise that we need to look beyond regulation and take a system approach to patient experience, enhancing the culture of improvement and using data to identify and drive required change, as my noble friend Lord O’Shaughnessy and the noble Lord, Lord Hunt, rightly pointed out. As part of this, I note my noble friend’s reference to a new national office of patient safety. That will require much more detailed discussion and consideration in the light of the review’s recommendations, but even at this stage it has much to recommend it.
I shall move on to some of the specific questions about surgical mesh. There has been a detailed debate about it, so I do not want to repeat what has been said. As the noble Lord, Lord Hunt, pointed out, in July 2018 my noble friend Lady Cumberlege recommended that there should be a pause without delay in the use of surgical mesh for stress urinary incontinence. That was supported by the Chief Medical Officer and senior clinicians. It was implemented through a high-vigilance regime of restricted practice and communicated to NHS England trusts. I understand that a similar process is taking place in Wales. I understand the impatience for a full ban, but for some women this may still be the only option for treatment, so it was considered that, while awaiting the outcome of the review, it was the appropriate route to take. The current findings are that the pause has dramatically reduced the number of procedures while we await the findings of the inquiry by my noble friend Lady Cumberlege. This is being kept under very tight scrutiny.
With reference to my noble friend’s specific question on a properly funded and staffed national network of expert mesh removal centres, I can confirm that NHS England has consulted on a service specification. When it is in place, we expect the service specification will cover multidisciplinary team management and complex vaginal mesh removal surgery for women who have complex complications. We are taking extremely seriously the review’s wider interim recommendations and are taking appropriate action in response. We will fully consider the final recommendations on mesh that the review will make later this year. Our primary objective will be to prevent future recurrence of the pain and appalling distress that patients, such as those who have given evidence to the review, experienced. We want to ensure that lessons are learned from their experience that will help us to protect other patients from any further risk of harm.
Turning to valproate, I have tremendous sympathy for the families affected by its use. The Government’s priority is to ensure that women are aware of the risks of this medicine. I therefore agree with my noble friend that the Government’s ambition should be to limit in-utero exposure to as close to zero as possible. Our current goal is rapidly to reduce and eliminate pregnancies being exposed to valproate. This is being supported by a formal pregnancy prevention programme and annual specialist review, as well as clear valproate labelling and packaging. There is also a communication and awareness campaign for healthcare professionals and patients. In response to the question asked by the noble Baroness, Lady Walmsley, all pharmacies have been provided with materials and there have been repeated communications. The General Pharmaceutical Council has written to all pharmacists to remind them of their professional responsibility in providing information to women, while the Royal Pharmaceutical Society and pharmacy bodies have been very active in communicating with their membership and in auditing practice. I recognise that there are still concerns about performance, but action is being taken. Patient input and engagement with members of the patient group, INFACT—who I know my noble friend has met many times—have been invaluable in the feedback process. It remains the responsibility of every healthcare professional involved in the prescribing and dispensing of valproate medicines to make sure that women are aware of the risks and are on a pregnancy prevention programme.
I note the questions posed by noble Lord, Lord Alton, regarding Primodos. They were quite detailed so, if he will allow, I will come back to him in writing.
I hope I have covered the majority of points raised by my noble friends and others in this House. This has been an important debate and I reassure all noble Lords that, as a Government, we are fully committed to a system of regulation for medicines and medical devices which intelligently provides access to new, innovative and world-leading products to improve the lives of millions of patients—especially those with diseases that are rare and hard to treat—while simultaneously protecting UK patients from harm, and ensuring that patient voices are heard loudly and clearly throughout the system if something does go wrong.
I finish by thanking my noble friend Lord O’Shaughnessy and all noble Lords who have participated in the debate this afternoon. It is clear that we are united in our dedication to learning from the experiences of those who have been courageous in speaking out, and in our commitment to protecting and improving the safety of patients who use medicines and medical devices in the UK. I am sure that, if we work together on this matter, we will see not only better medicines, better support and better care for patients but a safer NHS that is more responsive when it needs to be.