European Union (Withdrawal Agreement) Bill

Baroness Jolly Excerpts

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

Moved by

[Baroness Jolly]

21: Clause 41, page 40, line 5, at end insert—
“( ) Subsection (2) does not apply to the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019, nor to any regulations made under that Act.”

[Baroness Jolly (LD)]

My Lords, I will be brief. Clause 41 allows Ministers to make regulations that could alter any primary legislation that has been passed prior to the Bill. Such regulations will be made by the negative procedure, effectively giving Ministers carte blanche to do what they will to legislation that is already in statute. Many of us in the health community in your Lordships’ House were recently involved with the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019, which, noble Lords will remember, started life as the Healthcare (International Arrangements) Bill. A number of significant changes were made to that Bill by this House and then approved by the Commons. However, this clause could allow Ministers to revert the Bill to the original, thereby thwarting the will of Parliament, or they could at any time change any component of it, or any other Bill, with the minimum amount of scrutiny. When you think about it, its scope is really quite breathtaking.

In Committee, my noble friend Lady Brinton asked the Minister about a letter that she had left with the Government Whips’ Office and which the Minister had not seen and so was unable to answer in as much detail as usual. Since then the Minister has sent noble Lords a letter outlining the situation, for which we were all very grateful. As well as responding to the amendment, I am sure that other noble Lords will want to press the Minister on the detail of the letter, so that the Government’s intentions are on the record about any proposed changes to legislation relating to healthcare and the EU. I do not intend to press this amendment. I beg to move.

[Baroness Brinton (LD)]

My Lords, the European Union Committee report on Brexit, referring to the revised withdrawal agreement and political agreement, notes the lack of any mention of reciprocal health arrangements and says, in a section on mobility on pages 56 and 57, in paragraphs 252 to 257, that clarity was needed on how this would work. This is one of the reasons that I questioned the Minister in Committee. I am sorry, on both our parts, that the message with that question did not get through, and I thank her for the letter that she sent over the weekend. This is important because the European Union Committee says:

“There is no reference in this section of the Declaration to reciprocal healthcare, including the European Health Insurance Card (EHIC), as a means of facilitating mobility.”


It was that “means of facilitating mobility” that was absolutely critical for the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019. With your Lordships’ permission I will shorten that to “healthcare arrangements Act” rather than repeating the whole thing every time. Can the Minister explain why there was no mention of this reciprocal healthcare, and say explicitly to the House that these arrangements will stand?

Parts of the Minister’s letter were very helpful on specific points relating to those EU citizens living and working in the UK at the moment and UK citizens living and working in the EU. But that is not as broad as the provisions of the healthcare arrangements Act. That is why the committee raised its concerns, specifically using the phrase “means of facilitating mobility”.

The Minister’s letter made a rather odd assertion: that healthcare arrangements are protected by Clause 13 of the European Union (Withdrawal Agreement) Bill, which covers social security systems. Nowhere in Clause 13 is there any reference to healthcare, nor is there any such reference in the healthcare arrangements Act. More worryingly, if she is right and I am wrong, the decision to change arrangements under Clause 13 is at complete odds with the decision arrangements in the healthcare arrangements Act. Clause 13 reinserts the Henry VIII powers that were in the original healthcare arrangements Bill, and both your Lordships’ House and then the Government decided that this was inappropriate. That is why that Bill was changed. It became an Act in April.

Sections 6 and 7 of the healthcare arrangements Act set out clear routes for changes via statutory instruments and reports to Parliament. That Act is transparent and accountable, unlike Clause 13, where responsibility for such decisions is given to the Minister of the Crown and/or a devolved authority. Can the Minister confirm that any arrangements relating to healthcare would fall under Sections 6 and 7 of the healthcare arrangements Act given that they do not relate to social security? This amendment tries to make sure that we have that protection for reciprocal healthcare. I beg to move.

--- Later in debate ---

I know that the noble Baroness tabled the amendment with some of these concerns in mind. I hope that I have answered the questions that have come forward, but this is a routine power to make regulations that are appropriate in consequence of the Bill. I hope that I have answered the way the consequential amendment would be used to respond to the complexity of provisions and the legislative landscape, which we would need to respond to. On that basis, I hope she feels sufficiently reassured to withdraw her amendment.

[Baroness Jolly]

My Lords, we have had an interesting debate that has not, for the most part, been about Clause 41 or the legislation itself, but about health. I guess that that was always what would happen. I am quite happy to withdraw the amendment.

Amendment 21 withdrawn.

European Union (Withdrawal) Bill

Baroness Jolly Excerpts

Report: 2nd sitting (Hansard): House of Lords
Monday 23rd April 2018 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, it is most helpful that the Minister has given a reassurance and further clarified the position. However, I have a lingering concern about what happens if we do not have Article 168 in the Bill. If a trade deal and negotiation end up going to court, something has already gone terribly wrong. The advantage of having this stress on public health in the Bill is to strengthen the arm of the Government to make sure that public health is not inadvertently compromised.

I found a recent review of the Trans-Pacific Partnership Agreement, which looked at the health impact in the context of trade negotiations. Particular areas of concern related to food labelling, alcohol labelling, tobacco control and the cost of medicines. As this House knows, we have a major problem with obesity in this country. If people are to make real, sensible choices over what they are buying, they have to know that food labelling covers all aspects of food safety, including exposure to toxic pesticides, herbicides and so on, and animal husbandry methods, which have been of concern.

Our producers may not want that degree of labelling because it may damage their profits. I can see that in negotiating trade deals there will be, at times, a balance between profits and establishing the trade deal and holding back in some areas because of public health. The same may happen with atmospheric pollution. and so on. So while I fully accept the intention of the Government to make sure that as, in that article, public health protection and health improvement will remain unequivocal and at the centre of things, I have a lingering concern that there may be drift over time and difficulty in negotiations if we do not have this formally in the Bill.

[Baroness Jolly (LD)]

My Lords, I shall speak very briefly. I totally agree with what the noble Baroness has just said. This debate seems very much like the one we had during the passage of the Health and Social Care Bill about parity of esteem for mental and physical health. We were told by the Government that we did not need to have it in the Bill; we could assume that they would treat mental and physical health equally. That patently had not been the case. You might wonder whether they are treated in the same way now but the intention to treat them the same way was put in the Bill and so is on the record. This is very similar. The Government are saying: “We do not need this. You can trust us”. We might possibly trust the current Government. I see no reason why in most instances we should not trust them, but there are Governments coming down the track who may not be as reliable and trustworthy as the current one. So my instinct at the moment is to listen to what the Minister says when he winds up the debate on this amendment, but I would rather that it was in the Bill than not.

[Lord Hunt of Kings Heath (Lab)]

My Lords, this has been a short but very interesting debate. The noble Baroness, Lady Jolly, really put her finger on it when she talked about trust. It seems to me that there are two threads running through the argument. The first is the legal one, about which the noble and learned Lord, Lord Mackay, has spoken so eloquently. Then there is the issue of trust in the Government on public health. In a sense, the two run together.

The Minister is not a Health Minister, and I have to say to him that the reason for the lack of trust is the Government’s record. First they transferred public health in England to local government and then they slashed the budget, which means that even essential public health services are struggling to be performed effectively. Secondly, there is the Government’s reluctance to legislate in the areas of public health, preferring voluntary agreements with the food and drinks industry and so on to deal with things such as alcoholism, obesity and other public health issues. Thirdly, there is the fear about future trade deals—when it comes to it, the Government will be so desperate for trade deals with countries such as the US that public health and farming interests will be swamped by the desperation to reach a deal. That surely is one of the risks.

None the less, this is a debate on the terms of the amendment. I found the Minister’s intervention very helpful. I also found the intervention by the noble and learned Lord, Lord Mackay, helpful. However, this has only just come and I would like time to consider it. The noble Lord, Lord Warner, will make his mind up as to whether he pushes this to a vote tonight. It would be extremely helpful if the Minister would indicate that if we ask for time to look at the detail of his intervention, we could bring it back at Third Reading. That would be a constructive and very helpful outcome to the debate.

European Union (Withdrawal) Bill

Baroness Jolly Excerpts

Committee: 2nd sitting (Hansard): House of Lords
Monday 26th February 2018 Lords Chamber

I am very grateful for the support that these amendments have received from across your Lordships’ House and I hope that the Government will be able to provide sufficient certainty to put millions of our fellow citizens’ minds at rest. I beg to move.

[Baroness Jolly (LD)]

My Lords, I support the amendment on reciprocal health arrangements in the name of the noble Baroness, Lady Thornton, to which I have added my name. I cannot imagine what it must be like to go on holiday to the EU without packing my passport with my EHIC tucked in the middle for security and assurance. I think that I was luckier than the noble Baroness: my children managed to stay well throughout all their holidays.

I am also happy to support Amendment 353 in the name of my noble friend Lord Stephen, Amendment 11 in the name of the noble Baroness, Lady Thornton, concerning medicines and medical devices, and Amendment 205 on the EHIC.

I have Amendment 101 in this group, which is about over-the-counter medicines and devices—all the household names which we have grown up with and which could well be under threat if regulation is not sorted out well in advance of our departure from the EU, should that happen. The intention behind the amendment is to ensure that, on leaving the EU, the UK does not deviate from the existing rules for the regulation and licensing of over-the-counter medicines, medical devices and food supplements. These products are subject to the highest-quality standards and regulations, which the UK, as part of the EU, has helped to deliver over the last 40 years. They ensure that the healthcare products we use are appropriately safe and effective. This amendment seeks to ensure harmonisation and continued collaboration between EU and UK regulators with regard to consumer healthcare products, including hay fever tablets, cold and flu treatments and painkillers—the everyday items that we buy over the counter from our pharmacies and local supermarkets in taking care of our health and well-being to ensure that we continue with our day-to-day activities.

Throughout the manufacture and distribution process, consumer healthcare products face multiple checks and tests by highly skilled, qualified persons in various licensed facilities. They can cross multiple EU country borders throughout this process, yet, due to EU-wide collaboration on regulation, this is a seamless and streamlined process. Leaving the EU puts this process at risk. The UK imports an estimated £1.5 billion-worth of consumer healthcare products from the EU each year. Without harmonised regulatory standards within the EU and without agreeing to mutually recognised inspections and testing after Brexit, we risk having medicines held up at the border while they await retesting for release in the UK. Companies will have to set up new facilities to accommodate this, resulting in duplication, delays and disruption in the supply of basic healthcare products to UK shelves.

Without sufficient assurances that there will be no divergence from existing rules for the licensing and regulation of over-the-counter medicines, medical devices and food supplements, manufacturers will not have the certainty and stability to take action to guarantee the supply chain of these products. Companies have to take these actions now for products that are due to be on our shelves in two years’ time so that there is no delay. Amendment 101 would prevent the Government deviating from these existing trusted regulations and standards. It would lay the necessary legislative groundwork for the regulatory harmonisation required ultimately to put in place the mutual recognition agreements that will guarantee that, post Brexit, we can still access the same consumer medicines, medical devices and food supplements as we can today.

The Government recently launched a campaign to drive more people to their local pharmacy to access self-care for minor ailments and self-treatable conditions. At a time of historically low rates of growth in NHS funding and annual cuts to public health and community pharmacy budgets, it is absolutely vital that public access to healthcare in the UK is not put at risk.

Will the Minister therefore commit to three things? First, will he commit to pursue regulatory harmonisation and mutual recognition agreements, not only for medicines but for medical devices and food supplements, as an objective of the phase 2 negotiations? Secondly, in the event of no deal, will he commit to ensure that UK regulators unilaterally recognise any decisions taken by EU regulators for the foreseeable future? Finally, in the event that there is regulatory divergence following withdrawal, will he commit to ensure that the industry is fully consulted on the period of time it will be given to adjust to the new arrangements, given that the sector body estimates that at least five years will be required to achieve all this? Then, and only then, will there be an assurance that, once the UK has left the EU, there will be no fewer consumer healthcare products on UK shelves and they will be no less safe than they are today.

[Baroness Finlay of Llandaff (CB)]

My Lords, I will address Amendment 11, to which I have added my name. There are a large number of partnership agreements concerning medicines and clinical devices between the UK and Europe, and they are both formal and informal. They are important to our economy, as well as to the health and well-being of our citizens. Amendment 11 seeks to avoid these being ruptured. One of the most important of these international collaborations is of course the European Medicines Agency—the EMA—which provides and co-ordinates licensing, expertise and support for medicines and medical devices throughout the EU. For any pharmaceutical company seeking to license its product across Europe, the EMA is the body through which this is achieved. Our own domestic regulator, the Medicines and Healthcare products Regulatory Agency, operates as a crucial part of the EMA’s regulatory network to ensure frictionless access to medicines for the NHS without delay.

As the Secretary of State for Health and Social Care told the House of Commons Select Committee on Health on 24 January last year, we are one of the EMA’s most important members, overseeing up to 40% of its testing and taking on,

“often the most difficult and challenging cases”,

presented to it for testing and licensing. We have already lost the EMA’s headquarters, and the 900 or so jobs it provided and the economic benefits that came with these, from London to Amsterdam. A greater concern is the potential loss of quality assurance that our membership presently guarantees. For example, the common trademark system allows parallel imports across Europe.

The Healthcare Distribution Association, which represents medicines and medical device suppliers in the UK, has warned that our departure from this framework risks medical shortages and potential increases in the cost of medicines. The Healthcare Distribution Association estimates that the current system saves the NHS more than £100 million a year. Its executive director, Martin Sawyer, has already warned MPs that, when it comes to drugs,

“we take the supply chain for granted”,

and that Brexit could,

“throw a lot of cogs out of a very complicated machine”.

It is a warning worth echoing in this Chamber.

Our current perilous predicament seems to originate from the Government’s refusal to accept that appeals over licensing ultimately go to the European Court of Justice. But the EMA is not officially part of the EU, so there seems to be no constitutional justification for UK leaving it as part of Brexit. Indeed, this position has been put forward by the current chairman of the MHRA, Professor Sir Michael Rawlins, who in evidence to the Lords Science and Technology Select Committee last year stated that not only could the UK technically remain within the current system but that it may even be able to continue to influence new regulations and directives by doing so.

The sole reason that the Government have outlined for voiding their membership of the EMA is that it means accepting the jurisdiction of the European Court of Justice, which deals with legal processes such as licensing appeals. Having identified the jurisdiction of the European Court as one of their negotiating red lines, the Government therefore seem to believe that this renders the continuation of our membership untenable. In short, as is increasingly the case in a number of areas pertaining to Brexit, the Government would appear to be willing to jeopardise the security of our own medicines, drugs and medical devices for our citizens, and the prosperity of industry, for the sake of an ideological inclination.

--- Later in debate ---

[Lord Callanan]

It is obviously difficult for me to speculate on what happens if we do not achieve the outcome that we want. As I said, we strongly believe that since we contribute an awful lot of work through the MHRA—something like 40% of the EMA’s work is contributed to by UK authorities—it is in our mutual interests to continue to co-operate. If that is not possible, we will set out an alternative course of action but we believe that it is and should be.

[Baroness Jolly]

We have a window of about two years in which to get this right. I was talking to the trade bodies for over-the-counter medicine last week and they were saying that a change to make all over-the-counter medicines UK-based would need about a five-year timescale. It is just not doable, so there is an absolute imperative to get these regulations sorted out in pretty short order.

[Lord Callanan]

The noble Baroness makes a powerful point. It is one of our priorities. We have a number of priorities in the negotiations but it is important that we get this one right. The MHRA already licenses nationally 90% of all medicines available in the UK but there is a small percentage regulated abroad, so we need to reach a mutual agreement on that.

Amendment 101, tabled by the noble Baroness, Lady Jolly, would prevent the Government making changes to the licensing or regulation regimes for over-the-counter medicines, to which she just referred. The Government will need to correct deficiencies arising from withdrawal in relation to the regulation regimes for over-the-counter medicines, self-care medical devices and food supplements where the UK’s exit from the EU would result in the retained EU law which governs the regimes being deficient or not operating effectively and where manufacturers of these products would have to adapt to divergent UK requirements, potentially leading to a temporary or permanent withdrawal of their product from our market.

The noble Baroness asked a number of specific questions. The Government have already made it clear that we wish to retain a close working relationship after exit. The Government have been engaging with industry and research charities through the ministerial and industry co-chaired life sciences group, and we will continue to work with that group and industry to ensure adequate notice and sufficient time to implement any changes necessary.

Whatever the outcome of negotiations, the principles which will underpin post-Brexit regulation for this sector will be that patients should not be disadvantaged, that innovators should be able to access the UK market as quickly and simply as possible, and that we will continue to play a leading role in Europe and the world in promoting public health. Over-the-counter products will continue to have an important role in relieving pressure on health professionals and promoting consumer choice to improve public health.

In the event that it is not possible to reach a deal that secures ongoing, close collaboration between the UK and Europe, we will set up a regulatory system in the UK that protects the best interests of patients and supports industry to grow and flourish. I hope that my comments will provide the noble Baronesses, Lady Thornton and Lady Jolly, with the reassurance they need not to press their amendments.

Amendments 9 and 205 were tabled by a number of noble Lords, including the noble Baroness, Lady Jolly, and the noble Earl, Lord Clancarty. The Government recognise how important reciprocal healthcare is to the 190,000 UK pensioners who currently benefit from it, to UK tourists who use the European Health Insurance Card scheme and to EU nationals visiting and living in the UK. This point was powerfully made by the noble Lord, Lord Davies. We want to protect reciprocal healthcare arrangements and have made important progress towards this in this first phase of negotiations. It is the intention of the UK and the EU that the final withdrawal agreement will protect reciprocal healthcare rights for UK citizens resident in the EU on exit day and vice versa on a reciprocal basis.

European Union (Notification of Withdrawal) Bill

Baroness Jolly Excerpts

2nd reading (Hansard - continued): House of Lords
Tuesday 21st February 2017 Lords Chamber

[Baroness Jolly (LD)]

Yesterday, the noble Baroness, Lady Smith of Basildon, spoke of the vision of what was known as the Common Market. My first vote was in 1975, in the referendum to remain in that Common Market. Although I was born in the 1950s, the war still cast a shadow. I was a young woman, newly married to a junior officer in a very, very much larger Royal Navy—one which could certainly cope east of Suez—and the idea of binding states in trade to avoid conflict appealed to me then, as it still does.

Britain’s withdrawal from the EU comes at a time of great global instability. Russia, resurgent and hostile, flies nuclear sorties through UK airspace, harasses NATO’s eastern flank and claims to be seeking a “post-West world order”. The American President expressed ambivalence towards NATO as recently as last Wednesday. Europe has been wracked by a wave of extremist attacks, and the chaos swirling in the Middle East shows no sign of abating. Against this bleak backdrop, the passage of this Bill will set in motion the greatest upheaval of UK foreign, economic and domestic policy in recent history. I submit that the triggering of Article 50 will also have—and, indeed, has had—a profoundly negative effect on the UK’s defence and security.

As I noted last July in this House, Brexit means losing our place in defence institutions such as Europe’s common security and defence framework. Last July, it was clear to us that the loss of access to these important networks might hold unknown risks to our ability to defend ourselves, but last July Donald Trump was not President and NATO did not seem any more at risk than at any time since the end of the Cold War. In difficult times, we must preserve our global alliances and friendships, and yet this Government have failed to provide assurances that they will work to preserve our key security links with the continent after triggering Article 50.

I would be grateful if the Minister could reassure the House that, in this hard-Brexit world, our defence alliances with mainland Europe have not been overlooked. Defence and security should not be bargaining chips to be pushed back and forth across the negotiating table; they are essential commitments which protect our citizens and those of our allies. We cannot allow our withdrawal from the EU to jeopardise or sour our security alliances, and yet the Government’s approach risks doing just that.

It is not just our European alliances that are at risk. Since the 23 June referendum, the pound has fallen by more than 20% against the dollar. At the end of last year, RUSI predicted that if the decline were sustained, the cost of Britain’s defence imports could increase by around £700 million a year. This means, in effect, a 2% cut in the purchasing power of Britain’s defence budget. Last month, a National Audit Office report on the MoD’s equipment plan found that the MoD had already eaten through the £10.7 billion of headroom built into last year’s budget to provide flexibility. That report found that,

“The affordability of the Plan is now at greater risk than at any time since reporting was introduced”—


an effect of the declining exchange rate.

There is, in short, a significant rising threat to the affordability of the defence of the UK. Despite the commitment to spending 2% of GDP on defence, the continuing capability of the British military to meet strategic objectives is far from guaranteed. Just last week, the International Institute for Strategic Studies reported that, in 2016, Britain failed to meet that spending commitment despite the Government’s 2015 pledge to commit at least 2% of GDP for defence for each and every year of this decade. These rising costs might necessitate a revisiting of the 2015 SDSR or else there will be a reduction in expected UK defence capabilities at a time when the world is becoming markedly less secure.

The Government will need to accept that the effects of Brexit on defence will require either a substantial rise in taxes or cuts to vital domestic services. If the UK Government cannot accept these options, they must admit to British citizens that their borders will be less secure and their security more uncertain; they must acknowledge that they have broken their NATO spending commitments at a time when NATO’s future is already uncertain. It is clear that, in just a few months, Brexit and this Government’s Brexit strategy have made the UK less secure and less well defended.

It is not clear, however, that on 23 June last year voters assumed these risks. Leave campaign leaders promised that Britain would reclaim its place on the global stage, yet Brexit has left UK forces less able to defend key interests and has seen the UK diminished within its network of alliances. Brexiteers promised more secure borders, yet our borders are set to become less secure against those who wish to do us harm. They promised us more money for services such as the NHS, but the Government might now have to slash those services if they are to defend our borders and interests in an increasingly unstable climate.

In short, while 52% of voters cast ballots last June for a departure from the EU, they did not vote for that destination. On matters of defence, that destination seems increasingly bleak. My noble friend Lord Paddick and other noble Lords, including the noble Lord, Lord Butler of Brockwell, and the noble Baroness, Lady Neville-Jones, have said that the voters should have a final say.