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European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2018

Volume 796: debated on Thursday 7 March 2019

Motion to Approve

Moved by

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)

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.

Amendment to the Motion

Moved by

At the end insert “but that this House regrets that, in the event of a no-deal Brexit, the additional administrative burdens for many qualifications and the prohibition of European Economic Area temporary and occasional healthcare professionals that are proposed by the draft Regulations could be detrimental to the National Health Service.”

My Lords, I thank the Minister for introducing this instrument with such clarity. The reason I have tabled an amendment to the Motion is to draw attention to the serious concerns that were expressed by the Secondary Legislation Scrutiny Committee in its report in December last year. As the Minister has explained, these draft regulations laid by the Department of Health and Social Care set out the Government’s plans for recognition of EEA and Swiss professional healthcare qualifications in the event of no deal. Yet again we are spending valuable parliamentary time talking through quite large regulations that would not need to be here if the Government had ruled out no deal, to be frank. Here we go again. They need the scrutiny of your Lordships’ House because the Secondary Legislation Scrutiny Committee drew them to our attention, because of issues of public policy that we need to address.

The Government have said that they would not introduce new public policy issues into these orders and Brexit legislation, so we need to ask whether these regulations raise any of those issues. My questions will be focused on the issues that the Secondary Legislation Scrutiny Committee raised in its report.

The first question is about the regulators’ decision-making. The committee asked the DHSC how the UK regulators would make decisions. It was concerned about whether the regulators could set their own criteria for designation and the DHSC confirmed in its response to that question:

“Health and Care regulators are best placed to assess qualifications. Privy Council scrutiny ensures continuity for applicants in the short term whilst providing an inbuilt safety mechanism for removing qualifications that require further testing. The overarching principle behind the designation is the safety of the public—and we will work with regulators to ensure this”.

The question that the Minister needs to address is about ensuring a consistent and fair approach to the decisions by the different regulators, because each regulator will be responsible for the criteria for designation in its area.

That begs the question of how much work is involved and how much extra burden this will put on our regulators, given that the regulations give the UK regulators a discretion to designate EEA and Swiss qualifications as not acceptable in the UK after exit from the EU. The Minister needs to respond on what criteria regulators will apply in designating a qualification as not comparable to UK standards and what steps will be taken to ensure that regulators maintain a consistent and fair approach to their application. I welcome the clarification that there will be no change to the language testing arrangements, because your Lordships’ House has been concerned about that for many years.

The Minister needs to address what the administrative burden on regulators might be. No information on cost or impact is given in the Explanatory Memorandum other than to say that they will be negligible—I try to avoid that word—which seems unlikely. Given that this function requires assessment of where a qualification is not comparable and may impose an additional burden on UK regulators, we need to ask the Minister for assurances that UK regulators will have the administrative capacity and resources to deal with such decisions.

The Minister has addressed temporary and occasional qualifications, but given the number of EEA and Swiss professionals providing healthcare services in the UK on a temporary and occasional basis, she should assure us that there will be no detrimental effect on the NHS as a result of the removal of the right of EEA and Swiss professionals to work on such a basis.

I think that is enough questions for the time being. Other noble Lords will probably draw to the attention of the Minister the views that have been expressed to us by a range of organisations which have an interest in this matter, including the BMA and the royal colleges. I beg to move.

My Lords, I think that there is agreement across this House that we should work to prepare this country as best we can for Brexit and the potential of a disastrous no deal. I welcome this morning’s response from the Home Office Minister in this House that she believes that no deal is unlikely.

A consequence of no deal will be that the UK is no longer part of the automatic electronic alert system between health regulators, which exchanges information on health professionals who are no longer allowed to practise in the country. The NHS is vital for our country and for the lives of our citizens. Our healthcare professionals are the backbone that holds in place the institution that we hold dear. It is imperative that the legislation is effective at retaining a frictionless flow of EEA and Swiss workforce, along with the care that they bring.

There are several areas of concern. I am concerned that impact assessments have not been done in all circumstances in relation to these SIs and that consultation has sometimes been rushed, or that little public consultation or sector consultation has been done. I intend to ask the Minister questions that are thematic. I do not mind if she does not have the time or the information to be able to respond to them today; I am quite happy for the answers to come in a letter, which I would like to be placed in the Library.

A no-deal Brexit would not allow temporary workers, and it is vague when it comes to permanent workers due to a lack of specific evidence about qualifications. I would like some light shed on this. Can the Minister confirm that, in the event of a no-deal Brexit, vital EEA medical workers will not be treated as international medical graduates—IMG—so that they can easily work for our NHS and will not have to endure long and arduous registration processes which in some cases have been known to take up to at least a year? When do the Government plan to provide guidance to healthcare professional regulators on the information required to obtain Privy Council consent to remove a qualification from automatic acceptance should they have patient safety concerns? It is important that this process can be invoked quickly should concerns arise.

How do the Government intend to approach the two-year review of the SI? Will they commit to reform of professional regulators’ legislation to allow the process for registering healthcare professionals who qualified outside the UK to be fair and consistent for all professionals, regardless of where they qualified?

I think the Minister is aware of issues around Spanish and Irish nurses. What conversations are we having with Spanish health services about the gradation of Spanish nurses to ensure that, as long as they stay here, their years working here count towards their time in the Spanish system? I had the privilege of meeting some Spanish nurses working in Taunton. They thoroughly enjoy working here but would be really anxious were this to go, because they would then feel that they would not be able to return home with any credit for the work they have done here. My noble friend Lady Thornton has already covered the issues that the scrutiny committee raised.

Moving away from the healthcare professions, why have the results of the consultation process relating to the Human Medicines (Amendment) regs and the other two SIs we are discussing not been released? Instead, the Government have provided a response that gives little transparency on any key concerns that were raised during the consultation process, or the specific organisations approached. The changes laid out in the SI are wide-ranging and many call for the establishment of new responsibilities, transference of powers or further discussions with EU counterparts. Is it realistic that the industry will be able to handle these changes in the short period remaining before 29 March and during the transition period afterwards? The MHRA does really good work and I assume that it will be taking on this work independently of the EMA, so will the MHRA receive additional funding to support this extra work?

Moving on to the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, noble Lords got very exercised about this issue in the immediate aftermath of the referendum. The impact assessment says:

“Although this contingency legislation aims to help business in their preparations for a no-deal scenario, there is a risk that due to the requirements set out, businesses will not have sufficient time to prepare. In the event of no deal being agreed with the EU before 29 March 2019, the MHRA will have regulatory processes in place so that businesses will have the relevant information to prepare for this scenario”.

Are we to take it from this that if we crash out with no deal on 29 March, not having agreed this with the EU until directly before, the regulatory process will not be in place?

I thank the Minister for listening and, as I said, I am quite happy for her to write if she is not able to respond to all these questions now.

My Lords, some concerns about nursing were raised in the committee by my noble friend Lady Watkins. She cannot be in her place today, but I understand that those concerns largely related to the points the noble Baroness, Lady Jolly, just made about Spanish and Irish nurses who will be disadvantaged by these regulations. The Spanish nurses will be disadvantaged for the reasons just mentioned—their time in the UK will not count towards their qualifications in Spain—and the Irish nurses because, for the first time, they will have to pay a fee for registration. Could the Minister assure us that steps are being taken to do something about those two points? Both of them affect groups of nurses from different countries, but they profoundly affect us. We should remember this in the context of the fact that 33,000 EU nurses are registered in the UK.

I will also make a wider point. Health staffing is one of the most vulnerable of all the Brexit issues—particularly if no deal is put in place. I note in the regulations that there will be a review within two years. However, I suspect a whole range of unforeseen issues will arise in the short term. Could the Minister let us know what arrangements will be in place to monitor those, and what liaison she and colleagues will have with employees, employers and staff organisations to monitor and deal with the issues that arise within that period?

My Lords, I apologise for my discourtesy in not being present at the beginning of this debate. A number of years ago, with the very great help of our noble friend Lord Howe, we secured the requirement from the Commission that healthcare professionals coming to this country from the European Union be subject to language tests before registration, and not the other way round, as in the previous arrangement. Can the Minister confirm that this valuable requirement will be kept in place under the new regulations?

My Lords, I trust that the House heard with great pleasure the Minister’s comments on how major an advantage this whole arrangement in the European Union has been to us. We should not be discussing any of these SIs without reminding people that our membership of the European Union has been a huge advantage to us, and that what we are doing at the moment is picking apart something which is to our advantage, for reasons which are increasingly difficult to understand. We should not allow any of this to go past without constantly reminding the Government that they are leading this country into a position in which it will be poorer and less advantaged than when they came to power. A historic responsibility will lie on their shoulders, and we should remind them of that constantly.

My concern in this whole debate is that we are being asked to discuss this SI under a double falsehood. The first is the argument that we need it because we might crash out of the European Union, but that we need not be too worried because we will not crash out. The second difficulty is that, if we do not crash out of the European Union, we are legislating for a series of things which will be there in the course of further negotiations. Even if what is referred to at the moment as the Prime Minister’s “deal” were to be accepted—and it is manifestly not satisfactory—it is not a deal at all. It is an agreement to go on discussing to get a deal. During that period of time, what we are discussing here will be there in the background. There have been a number of occasions on which Opposition spokesmen have rightly pointed out that the trouble with these things is that if they are in the background while we are negotiating, they have a real effect. We have to take this very seriously.

Nor should we pass over the problem we are presenting ourselves with. We are saying that, to get the best advantage out of this ludicrous foot-shooting activity, we are going to make sure that every European Union national can come to this country to do what we want them to do without there being any difficulty. Of course, we cannot do any of the things that have made that particularly valuable in addition; we are not going to share the information both ways, which is what the European Union enabled us to do. Rather like the noble Baroness, Lady Thornton, I have a real concern that the IMI system will not continue. The idea that you can happily forget about it because it happens to be convenient, and do the things you can do because they happen to be convenient, seems to me an abnegation of responsibility which I find extremely difficult to accept.

The noble Baroness, Lady Jolly, rightly referred to the additional matter of the electronic alert system. We will not be alerted to the very professionals we most want to know about, because we will have decided that, because Britain is so ultimately different from everywhere else, we will not have this association. I know it is not the fault of the Minister, who is having to defend the ridiculous situation in which we find ourselves, but it is for this House to remind people all the time of what this really means.

Then we go on to the fact that these regulations are in conformity with the withdrawal Act, which says that we are not going to use it to create any new legislation, but merely take into national legislation things that would not be in it if we left the European Union without any agreement. The trouble is that this is not actually possible, because we have to have regulators making decisions. They are now going to make decisions under a new regime—in that sense it is a new regime—and I very much want to hear the response to the noble Baroness, Lady Thornton, on how we make sure the regulators make, roughly speaking, the same decisions across the whole range, and how we make sure that those regulators do not make decisions that extend or change the position we are in now. The latter would be contrary to the undertakings given by the Government.

However, the word that I very much worried about when the Minister used it was “flexibility”. She said that no longer being in the European Union would give us a flexibility on the establishment of professional qualifications which we did not have up until now. I do not think that flexibility can possibly be accepted within this SI, because that genuinely changes the position from what it was before. It may be that it is convenient for the Government to talk about flexibility as an advantage. I find it pretty difficult to see what that advantage would be. What would be the point of being flexible in changing our arrangements in such a way that they were out of line with the arrangements of our neighbours, when we rely upon those neighbours for such a high proportion of our professionals? It seems to me that flexibility is one of those convenient words used by the Government and those who believe in Brexit to suggest that there are some advantages hidden here which we have not yet got hold of. I do not think that there are, or that it would be legal for us to use flexibility under this SI, because it is specifically not supposed to introduce into our legislation anything that we have not had up to now.

I am afraid I will move on to something that I constantly say; that there is no impact assessment here. Why is there not? This is the real reason I say to the Minister that this is unacceptable. The reason there is no impact assessment is that the Government want us to believe that there is no impact. It is very inconvenient for the Government to say that the impact is that we will no longer have the advantages we had before leaving the European Union. They ought to be listing those advantages and explaining what the impact on us will be. But they are not doing that, because that would make more and more people aware of the lunacy of the measures we are now taking, and the ridiculous position in which Brexit places us.

But then there is another question. If you do not have an impact assessment, you also do not appear to have any idea about how much it will cost. I am afraid that I am a Conservative, and I am always interested in costs—I like to know how much it costs. I know that that is a disadvantage in the whole Brexit discussion, because the one thing we never get is the cost. It is amazing, is it not? We have a Conservative Government who never talk about the costs of Brexit, which is an absolutely ludicrous position for us to be in. Let us ask ourselves—I repeat the words of the noble Baroness, Lady Thornton—“What burden? What resources? What cost?”

One of my difficulties is that I have had the misfortune to have had to sit through a large number of these SIs, and every time you ask about the cost, the Minister concerned explains—charmingly, and with considerable aplomb—that the costs are negligible.

I have got it right this time. That is what they say. In every individual case, negligibility may well be the truth, but what is negligible in one case, when added up with a lot of other “negligible” costs, ends up being rather expensive. I am amazed at the number of things you can do with negligible cost. We are filled with these SIs—with all the things that we can do for nothing. I ran businesses, and I have to say that I do not know anything you can do in business which does not cost you something. I would love the Government to explain to me how they are managing to move whole areas of control and regulation over to British regulators without any cost. I would be able to apply that to my businesses and it would be extremely valuable, because all I know is that the moment you change or move anything, it costs money.

I want to know not only how much it costs but whether we have the resources for it. It is also said that we have these organisations that are perfectly capable of doing all this, as if this is an easy thing to do, when in fact it is not only difficult, but if we get it wrong, we are endangering people’s lives. Clearly, we have not worked out what the cost of doing this is; I just do not understand whether we have the human resources and the trained resources to do it. After all, we have shown so far that we cannot run the National Health Service without large numbers of people coming in from outside. I would like to understand whether we can regulate all this without some additional resources, and if so, we ought to know exactly what resources we will need and how much they will cost.

I am sorry that I have to say this to the Minister with such vigour, but it needs to be said; otherwise, this House looks pretty damn stupid. We look as if we are sitting around, having a gentle argument about what is the programme for catastrophe. This is what we are talking about: how a nation decides how to put itself into a very much less favourable position than it is in at the moment. Sometimes people say, “Ah, but Britain will manage—look what it did during the war!” But we did not ask for the war; we did not say that we wanted it. It happened, and we said that we had to fight it. Here we are asking for it, and are seriously sitting around planning for it. We are asked to do that with a degree of politeness and charm, and courtesy and care, when we ought to be very angry indeed that any Government should even suggest that we need SIs like this.

My Lords, it is a positive delight to follow the noble Lord, Lord Deben, as I have done on a number of occasions in the past few months in debates on other SIs which have been considered in Grand Committee. The one thing I would say about the noble Lord is that he has been masterly in the consistent way in which he has expressed himself. I do not altogether share his high assessment of previous Conservative Governments on costings, but we will let that one pass.

I do not intend to go into the content of these SIs; I am saving my firepower for the last lot, on which I have quite a lot to say. However, when you look at this lot and the second lot of SIs—which presumably come out of the same department—you see a strange discontinuity between the level of the impact assessments and assessments of risk in this set compared with the second set, on which I will say some complimentary things about the MHRA and what it has done to set out some of the risk assessment. That is lacking in this set of SIs. It will be interesting to know why, coming out of the same stable, these two racehorses have been saddled up in a totally different way.

I will pursue with the Minister some of the issues around process and the status of these SIs in the number of different scenarios which we can foresee, given that we are only 22 days away from the current statutory exit date. We can have as many warm words from the Dispatch Box as you like about there not being a no-deal exit. The truth of the matter is that the legislation on the statute book—at the insistence of the Government, and indeed the Prime Minister—says that it should be on 29 March.

My concerns and questions for the Minister therefore relate to a number of aspects which may change that —we do not know whether they will; a lot of things will turn on what happens next week. For example, we still do not know whether there will be an extension or a deal, or what type of deal there will be. If there is an extension of the Article 50 process, we cannot be sure what impact it will have on the implementation or transition period—whatever you want to call it.

First, what is the status of these SIs in a number of different circumstances? We know that the Government are committing to review these SIs after two years. However, as I understand it, there is no sunset clause in any of these SIs, so we have to take the Government’s word for it that there will be a review in two years’ time. But what happens on 30 March if we exit the EU with no deal? I assume there is an expectation that all these SIs, including the ones we are discussing today, will be brought into effect. I further assume that, somehow or other, the government machine, or agencies acting on its behalf, will issue guidance to all the affected people about what they are expected to do. Can the Minister clarify whether the guidance on those SIs will in fact be issued before 29 March to all the interested parties who will be affected, in particular on the specific SIs we are discussing today?

Secondly, what happens if Article 50 is extended? I will not go into the possibilities, but let us say it is extended beyond 29 March. What happens to these SIs? Is their introduction extended? Do they not come into operation until any new date when there may be an exit day? There could still be an exit day with no deal; because you have extended Article 50, it does not follow that there is a deal. What then is the status of these SIs in the set of circumstances where there is an extension of the Article 50 process to a new exit date?

Thirdly, let us assume that there is some kind of deal, whether the Prime Minister’s deal or something else. Presumably, these SIs lapse. Is that correct, or do they stay on the statute book, given that Parliament will have passed them? How do we explain to the outside world whether it is supposed to take notice of these SIs or whether the status quo continues—which seems to be the Government’s policy for the period of transition or implementation? What is the status of these SIs in those circumstances? How will the Government communicate their status with the wider world if there is in fact a deal? We, and the world outside, need a bit of clarity about what happens to these SIs in some of the foreseeable and possible scenarios, even if there is no no-deal exit on 29 March.

My Lords, it is very tempting to follow the noble Lords, Lord Warner and Lord Deben, in their remarks. I do not know whether the noble Lord, Lord Deben, has studied the document issued by the US Government last week on their requirements for a trade deal, but there is a contrast between what Brexiteers told the public about how easy trade deals would be and the demands of the US Government, which this Government will have to accede to in their desperation to get a trade deal, and their implications for the National Health Service. Apart from anything else, they will mean that voluntary control on prices of branded drugs will go and the market which the Government now want to legislate to remove, amending the Health and Social Care Act 2012, would fall foul of the requirements of the US Government on public services, which are very explicit about the areas they want US corporations to bid for.

As the noble Lord, Lord Deben, said, I wonder how those on the Front Bench feel about being members of a Government which will be excoriated for decades to come, perhaps as was the pre-war Government in the 1930s, for the lack of preparations they made for the disaster into which they are now taking this country. Of course, this SI is a sort of backstop which, it is hoped, will never come into being. But do we really think the vote will take place next week or will it, as some people feel, be postponed yet again to a cliff edge, when there is no guarantee whatever that there will be an agreement to enter talks about an agreement? This order takes on considerable importance.

I should at this point declare my interests as a member of the General Medical Council and a trustee of the Royal College of Ophthalmologists, and say that the GMC welcomes the order on its narrow terms. I should say to the noble Lord, Lord Deben, that it is the GMC’s view that it can administer the new arrangements effectively without additional substantive burdens being placed on its day-to-day operations. I do not know whether that reassures him; I hope it may.

I should like the Minister to comment on one area which is relevant to what my noble friend and the noble Baroness, Lady Jolly, said. It relates to page 9 of the order, where new powers are afforded to regulators effectively to determine what should and should not be comparable clinical qualifications to those gained in the UK. This is clearly of great importance given the way we are going. Instead of the current automatic recognition given to qualifications gained by, for example, doctors, dentists and nurses in another EEA country, the powers allow them to be deemed non-comparable by a regulator if it felt that necessary for patient safety reasons. The order states that the Privy Council would have to approve any such decision by the regulator. On what basis would the Privy Council approve or not approve a request to do so? Without some idea of the criteria to be used, it will be difficult for regulators to adopt the powers in the order in this area with confidence. Do the Government expect to issue guidance to advise regulators on the basis of a Privy Council judgment? Can they do so as quickly as possible, and will they consult the regulators in so doing?

I also declare an interest as having been a member of the General Medical Council until that post was taken up by the noble Lord, Lord Hunt of Kings Heath.

Many of the points I wanted to make have already been made by the noble Baroness, Lady Jolly, and the noble Lord, Lord Hunt. I follow up his point about the ability to remove a qualification from automatic acceptance. When she introduced the SI, the Minister said that the Government would not issue guidelines. If there are no guidelines, one regulator may decide to remove an automatic qualification. The Minister said that it is in the best position to do so, but the SI lays down that there must be approval by the Privy Council. How is the Privy Council to make its decisions and against which criteria? There must either be criteria for the regulators to abide by and the Privy Council to supervise, or you give power completely to the regulator. I do not see how that process has any power or heft without guidelines.

The issue of review after two years has also been raised. There is concern that that review should be wide-ranging, because the process for recognising the qualifications of non-EEA and Swiss medical professionals is not satisfactory at the moment. It can be very long, drawn-out, bureaucratic and take a lot of money and time, as opposed to the streamlined system that we have had with EEA and Swiss nationals, which we are throwing away if we go for a no-deal Brexit. It is really important that that review is wide-ranging and does not leave us at the end with another cliff edge, which is that these health professionals on whom we depend so much become translated into international medical graduates and subject to an extremely unsatisfactory process.

In his wonderful speech the noble Lord, Lord Deben, referred to how the Government say that we will have wonderful flexibility but never quite explain what that is. Actually, the Government have flexibility on international medical graduates, because those procedures are not governed by the European Communities Act or by our membership of the EU. For many years, regulators have wanted to make progress on the issue but have not been given the legislative time or space and policy commitment from the Government so to do.

Alongside this work on EEA graduates, can we make sure that we look at the wider issue of doctors and other medical professionals coming here from outside the EEA? If the overall immigration trends are mirrored in the people coming to this country as medical professionals, we will see fewer EEA medical professionals but more IMG medical professionals coming here. I believe that we are seeing that already. Therefore, how we recognise their qualifications will be even more important.

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.

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?

I apologise to the noble Lord for missing out on my answers to his questions; that was most remiss of me. These SIs come into force only if there is a no-deal exit. Should there be an extension of Article 50, they would not come into force until or if there is a no-deal exit, which is obviously most undesirable and something the Government are seeking to avoid.

On the communication of the effect or implementation of these SIs, they have been developed in close collaboration and consultation with the regulators that would be impacted. They are well informed about their operation, and given that the effect of the SIs is to continue with business as usual as far as possible, we hope that that is the de minimis effect. I shall write to the noble Lord in response to his final question, as I am afraid I have forgotten what it was.

My Lords, I thank the Minister for her extensive response and noble Lords for their interventions and questions on this SI. The indignation and anger of the noble Lord, Lord Deben, has been reflected right across the House. Noble Lords may not express it quite as well as he has, but it absolutely is there. We have just spent an hour and 10 minutes debating this issue. Then there are all the hours of preparation, the cost of civil servants, the cost of our time and, indeed, the worry that all this is causing, not only to us in the Chamber but to millions of people outside. As the noble Lord, Lord Deben, and others have said, the Minister has done the best she can with the hand she has been dealt and answered our questions to the best of her ability. However, this is not where any of us wants to be. On that basis, I shall withdraw my amendment.

Amendment to the Motion withdrawn.

Motion agreed.