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.