European Union (Withdrawal Agreement) Bill

Baroness Blackwood of North Oxford Excerpts

Committee: 2nd sitting (Hansard continued) & Committee stage & Committee: 2nd sitting (Hansard continued): House of Lords
Wednesday 15th January 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, let me say how much I welcome the amendment moved by the noble Baroness, Lady Brinton.

When I had the temerity to raise this issue and all the others raised by the noble Baroness on Monday at Second Reading, I sought information and assurance on a range of healthcare matters. I think we can say that I got the bum’s rush from the Minister when he answered my questions. In fact, he did not answer them at all. I hope we might fare better this evening.

The medical research sector has been clear that continued close co-operation should be a priority in the negotiations. Indeed, the Government have recognised the international nature of the life sciences sector. They are committed to aligning as closely as possible with the European Union clinical trial regulation when it comes into effect, safeguarding vital UK-EU clinical trials. Indeed, the political declaration also refers to continued co-operation with the European Medicines Agency, which would help ensure that patients in the UK have swift access to the newest medicine. However, the political declaration has no legal standing, so the noble Baroness, Lady Brinton, is quite right to repeat in the Committee the concerns expressed by the European Union Committee. As it stands at the moment, we cannot see that the European Medicines Agency will continue to benefit patients in the UK.

For some treatments, those of rare diseases, a single authorisation at EU level is vital in providing for cost-effective licensing and distribution of medicines for small populations. If the UK is outside the EU market and companies are required to pay again for separate MHRA licensing, as well as an appraisal by NICE and equivalent bodies in the devolved nations, there must be real concern that some treatments for rare diseases may become not financially viable to launch in the UK, therefore risking patient access entirely.

I know that the Minister absolutely understands all this, so it is very important that she reassures the Committee that these issues will not just be taken into account but will be part of the negotiations and will be successful.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, I welcome the opportunity to discuss this important issue, and I thank all noble Lords for their, as always, thoughtful and expert contributions. During the Government’s preparations for EU exit, this House has discussed on a number of occasions the great value of the UK’s life sciences industry and the importance of ensuring that it remains—as the noble Lord, Lord Warner, rightly said—one of the most productive health and life sciences sectors in the world. As noble Lords will know, this sector alone contributes over £74 billion a year to the UK economy and employs close to 250,000 people. I contest the argument that it has recently been damaged. A report just today shows our leading position in cell and gene therapies, in which ongoing UK trials represent 12% of global trials and have increased by over 45% in the last year alone. That is in the context of Brexit.

The Committee is right that this is a crucial sector to the delivery of healthcare treatments to patients across the UK and will continue to be so in future. We must get this right. I assure noble Lords that the quality and safety of patient care is paramount in the department’s and our partners’ EU exit plans. This has been visible in our extensive efforts and preparations to ensure that the supply of medicines and medical products into the UK remains uninterrupted following the UK’s departure from the EU. This led to the department’s multilayered approach to put in place in the case of a no-deal exit from the EU. It was a substantial approach, which included work to procure additional freight capacity and to ensure buffer stocks and stockpiling; working closely with industry to improve trader readiness; and collectively helping to ensure visibility in the supply chain and, therefore, much more robustly ensuring continuity of supply processes.

While no-deal planning has been stood down, there is no question but that this work will stand us in good stead going forward, given the strategic importance of the supply of medicines and medical products in all scenarios—as the noble Lord, Lord Warner, pointed out. In fact, we are finding that the learning from this work is already helping us to better manage routine shortages, which are becoming increasingly common globally.

During our preparations for EU exit, we have at all times worked closely with our delivery partners. We are committed to doing so in future. Their support, expertise and hard work have been invaluable and will remain so as we enter the next stage of negotiations.

Turning to the amendment moved by the noble Baroness, I hope noble Lords will understand that we cannot accept this proposed new clause. The amendment was originally proposed in the other place and was not accepted there. I do not want to impute motive, but following debate, the sponsor in the other place chose not to move his version of the amendment to a vote there.

I wish to reassure the Committee on some of the questions raised, because it remains our objective to work closely with our EU friends, as we do at present, to ensure that patients continue to have access to safe and effective medicines and reap the rewards of our new relationship with the EU. Our overarching aim for medicines and medical devices regulations at the end of the implementation period is underpinned by the following commitments, which I have given before: patients should not be disadvantaged, which speaks to questions raised around rare diseases in particular; innovators should be able to get products to the UK market as quickly as possible; and the UK should continue to play a leading role in promoting the health of the public. We are in a better position than some of the countries—

[Lord Davies of Stamford]

All this is fine PR speak. All these principles sound splendid, but what are the Government actually going to do? The answer cannot be simply, “We will stay close to the European Medicines Agency.” Does that mean that we will leave that agency, not leave it or have some new, structured relationship with it?

[Baroness Blackwood of North Oxford]

As always, the noble Lord gets to the point. As my noble friend Lord Callanan said, the exact relationship with agencies will be subject to negotiation. I have set out the core principles which will be part of our negotiation, and I would also point out the key assets which we bring to the table. The MHRA has real expertise in many areas —licensing of medicines, pharmacovigilance, clinical trials regulation—and already provides benefits to patients across the UK and the EU.

Regarding the points on clinical trials, raised by the noble Baroness, Lady Brinton, as part of EU exit negotiations, we are working to ensure that we will continue to have the best possible environment to support clinical trials. Our overall aim is to ensure not only that patients in the UK have access to the best and most innovative medicines but that we improve UK trials applications—so that they continue to be authorised by the MHRA and ethics committees, as they are now—and that the UK’s ability to participate in multinational trials will not change. We will also have a simpler way of allowing a single application to a single national decision in the UK, which we have been working on very hard.

The Government have set out the key principles of the UK’s negotiations with the EU in their manifesto, and as part of the political declaration. However, as has been said this evening in response to similar amendments, a statutory negotiating objective in primary legislation, as proposed in this amendment, is neither necessary nor the constitutional norm. We cannot accept a statutory reporting requirement either, but the Government will support this House in fulfilling its crucial role of scrutinising the actions of the UK Government during negotiations. The Prime Minister committed at Second Reading in the other place that Parliament will be kept fully informed of the progress of these negotiations. We will have many challenging and robust debates in this place as well, where your Lordships will hold us fully to account on the progress of those negotiations with the EU.

It is important to note that our approach to negotiations with the EU in this area is set out in the political declaration and the Government’s mandate, but this is only one part of our overall support for the life sciences sector. This commitment is also clearly demonstrated through the medicines and medical devices Bill, which was published in the Queen’s Speech and which we will have a lot of debate about in this place. The Bill is to ensure that the UK remains competitive and at the cutting edge of innovation, to the benefit of patients. I look forward to discussing those provisions with the House later this year. I hope that I have reassured the noble Baroness on the Government’s intentions, and on how we intend to take this forward, and on that basis I urge her to withdraw her amendment.

--- Later in debate ---

[Baroness Blackwood of North Oxford]

I apologise to the noble Baroness; I passed over that note in my response to the debate. Where the UK, a member state, an EEA or EFTA state or Switzerland is responsible for the healthcare of those in scope of the social security co-ordination part of the agreement, such individuals will be entitled to reciprocal healthcare cover from their competent country. This includes EHIC cover for people with full social security co-ordination rights under the agreements, and cover for people who have previously worked in the UK, another member state, an EEA or EFTA state or Switzerland before the end of the implementation period. Obviously, the specifics in future will be subject to the negotiations that will be forthcoming. I hope that that answers the noble Baroness’s question, and she will feel that she can withdraw her amendment.

[Baroness Brinton]

I am grateful to the Minister for her comments, and to other colleagues for their contributions. I am particularly grateful to the noble Lords, Lord Warner and Lord Davies, for their expertise, and especially for the intervention by the noble Lord, Lord Davies. The Minister is always courteous, and always gives us her best brief, but I am not reassured at all on the issue of the EMRN, partly because. although there was plenty of talk about trying to maintain the excellence in life sciences, there was no response to the question of how, with only 3% of the pharma market, we would be able to play the same role as we currently do in the EU, with 25%. There was also a complete failure to respond to the major concerns that everybody expressed about patients not being able to access drugs because we suddenly become a very minor player. On that basis, I will withdraw my amendment this evening, but I will consider whether to lay something for Report.

On the other matter, concerning reciprocal healthcare, again, I am not quite as positive as I think the Minister would like me to be. I remain concerned that the phrase “no-deal planning” was mentioned in the context of both parts of my speech. We on this side are concerned about the impact on UK citizens abroad, and on EU citizens here, of the loss of reciprocal healthcare arrangements. That is really worrying. But I am pleased to hear that there is some reliance, at least in the transition period, on the healthcare arrangements Act. I beg leave to withdraw the amendment.

European Union (Withdrawal Agreement) Bill

Baroness Blackwood of North Oxford Excerpts

Report: 2nd sitting (Hansard - continued) & Report stage & Report: 2nd sitting (Hansard - continued): House of Lords
Tuesday 21st January 2020 Lords Chamber

[Baroness Thornton (Lab)]

I thank the noble Baronesses, Lady Jolly and Lady Brinton, for introducing this. As they said, we are basically picking up where we left off in Committee. I was not satisfied with the answer the Minister gave about reciprocal healthcare. As noble Lords have now said, nobody really understands why, when we already have legislation that we considered and passed last March, that does not form part of the negotiation that will take place. I read the letter that the Minister sent to the noble Baroness, Lady Brinton, and it is very confusing.

I will take a more cynical view of this. A year ago, when we had in front of us the Healthcare (International Arrangements) Bill, it had in it five or six Henry VIII powers. It gave the Secretary of State the power to make a deal about healthcare with anybody in the world they might choose, without any recourse to this Parliament or any accountability. This House wisely changed that into the Bill we passed, now the Act, which does what the Government had said they would do. They said they would not add to the policy arrangements in any area. They would take up the European Union policy and translate it into a way that worked post Brexit. That Bill we had before us a year ago did not do that; it extended the powers incredibly.

I fear that we are seeing a repeat of what the Government tried to do a year ago, so I really need to know from the Minister what powers the Government may take—not what will happen between now and December, but what will happen in a year. What will it look like? Will there be any reciprocal healthcare arrangements? Will there be 27 agreements, which is what the Minister was talking to us about a year ago when we were discussing international healthcare and looking at crashing out of the European Union? What has happened to those 27 agreements? Where have they gone?

As my previous noble friend Lord Warner said—he is still my friend—it is only a matter of time until people become very anxious about this, because not only are people working all the way across Europe, but they are going on holiday all the way across Europe. At the moment, the Department of Health and Social Care’s website is really opaque. It does not give us any clarity at all about what might happen.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, it is always a pleasure to speak to the really important issue of reciprocal healthcare, which touches on a lot of UK and EU citizens’ lives. This House has rightly tested this issue robustly and it is right that we consider it today.

The withdrawal agreement Bill guarantees that reciprocal healthcare arrangements, including for pensioners, workers, students, tourists and other temporary EEA or Swiss visitors, will not be affected during the implementation period. During this time, there will be no change to reciprocal healthcare schemes, such as S1 and EHIC, nor to the S2 route which enables planned treatment. Importantly, I can provide assurance that the European Union (Withdrawal Agreement) Bill also guarantees lifelong, reciprocal healthcare entitlements for people so long as they remain within the scope of the citizens’ rights agreements. This includes UK nationals who will have moved to the EU before 31 December 2020, as well as EU citizens who will have become resident in the UK before this time. I hope that that explanation is clearer than my letter.

Last year, as has been mentioned, this House spent a considerable amount of time holding informed and important debates scrutinising the provisions of the then Healthcare (European Economic Area and Switzerland Arrangements) Bill. With the permission of the noble Baroness, Lady Brinton, I will call it HESA. We agreed that this was a key piece of legislation, providing the UK with options to implement any future reciprocal healthcare arrangements, subject to negotiation with the EEA states or with Switzerland after the UK leaves the EU. I understand the desire to know the outcome of these negotiations but, as they are obviously in the future, I am not able to give exact details, other than to say we want to ensure the best possible outcomes.

Following that scrutiny and the assent of Parliament…

[Baroness Altmann (Con)]

I thank my noble friend for giving way. A number of us on these Benches are deeply uncomfortable with what we are being told, as she well knows. We are willing to give the Government the benefit of the doubt and we hope that this trust will be repaid. We are talking about people’s health and lives: there really is nothing much more important. Will my noble friend take this back to the department, or can she assure us that there will be full information available to all citizens so that they know about this risk at the end of 2020 and can make the appropriate decisions? None of us knows what is going to happen after the end of this year.

[Baroness Blackwood of North Oxford]

My noble friend Lady Altmann makes a very important point. We have tried to ensure that the information is available and communicated. I am happy to review the clarity of this information and to do everything we can to improve it. My noble friend is absolutely right. We need for anxiety to be at the lowest level and for people to be prepared as possible. I can assure the House that we are doing everything we can to work in the best interests of UK citizens. We understand that there are many in European countries, as well as in the UK, who are looking at this issue with great concern.

I want to get back to the process of scrutinising HESA. As the noble Baroness, Lady Brinton, said, this established a legal basis for the Secretary of State for Health and Social Care to fund and give effect to future reciprocal healthcare schemes through its provisions for data sharing and making regulations. It is important to cast our minds back to that debate. This is an implementation Bill; it does not concern the status of the arrangements. In addition, the Government are committed to the effective implementation of the citizens’ rights agreement and the healthcare protections that it provides.

Questions have arisen as a result of my letter, including those raised by the noble Baroness, Lady Brinton, last week. I have been asked why there is no mention of reciprocal healthcare in the Bill. This is because individuals within the scope of the withdrawal agreement are entitled to reciprocal healthcare cover from their competent country for as long as they remain so. The rights of EU citizens, EEA, EFTA and Swiss nationals and their family members who reside in the UK before the implementation period, are brought into UK law through Clauses 5 and 6 of the Bill.

I was also asked about Clause 30. This is limited to implementing parts of the agreement on social security co-ordination and to including reciprocal healthcare and EHIC, so it cannot operate in the way in which the noble Baroness was concerned that it might.

Finally, I was asked whether the consequential powers could be used to revert HESA to the original form—with global scope—that it came to this House in. It cannot. The consequential power does not allow for substantive changes to legislation. It will allow the Government to make only smaller, technical amendments for good housekeeping to ensure that legislation is consistent and functions well. It could not be used in the underhand manner that I think the noble Baroness, Lady Thornton, thinks we intend. This would be much too substantial a use of the power; it would not be considered an appropriate use of it.