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 (Withdrawal) Bill

Baroness Jolly Excerpts

Committee: 8th sitting (Hansard - continued): House of Lords
Monday 19th March 2018 Lords Chamber

[Lord Warner]

My Lords, I shall bring the Committee back to terra firma with this amendment, which is tabled in my name and that of the noble Baroness, Lady Jolly, and the noble Lords, Lord Hunt of Kings Heath and Lord Patel. This amendment inserts a new clause on public health and requires that:

“In carrying out their duties and functions arising by virtue of this Act, a Minister of the Crown or a public authority must have regard to the principle that a high level of human health protection must be ensured in the definition and implementation of all policies and activities”.


The language of the amendment draws on Article 168 of the Lisbon treaty and has the advantage of existing legal precedent and interpretive guidance on which to draw when determining its meaning. It does not preserve our law in EU aspic because it would be for UK courts to decide the specifics in future individual cases. In doing so, they would be able to draw on pre-Brexit legal precedents. Putting the amendment in the Bill would give a clear signal to EU members that the UK remains committed to maintaining our public health agenda to the high standards we have established together.

Disease is no respecter of international borders, and public health is best protected when the international community operates to established and well-understood high standards. The amendment goes much further than the power placed on the Secretary of State for Health under the 2006 National Health Service Act, as amended by the 2012 Health and Social Care Act. It places the duty to “do no harm” on the whole of government, including devolved Governments and a wide range of public authorities. In other words, it reminds a wide range of interests that they must continue to protect and do no harm to public health. This seems particularly apposite in the year that our hard-pressed NHS reaches its 70th birthday and its hard-pressed staff face a future of continuing rising demand without the funding to meet it.

The Secretary of State and the noble Lord, Lord O’Shaughnessy, have given various assurances about the Government’s commitment to the UK playing a leading role in promoting and ensuring public health in the EU and around the world. Jeremy Hunt has outlined his commitment to,

“maintain participation in European cooperation on … disease prevention”,

and,

“public health”.

I do not doubt the good faith of those assurances—or of any more that the Minister gives us today—but they rather miss the point. The citizen does not need ministerial assurances but an effective legislative provision to challenge in court the Government, devolved Administrations and public bodies when they fall down on the job of protecting public health.

Although I am not a lawyer, let me try to explain why a legal protection formulated in this way is important when UK courts come to adjudicate on specific cases before them. Here I draw on helpful advice provided by Professor Tamara Hervey, a professor of EU law at Sheffield University. There have been a number of cases in which the high level of protection under EU law for human health in all EU policies and activities has been an important part of the outcome. These include the failed challenges by the tobacco industry to the Standardised Packaging of Tobacco Products Regulations 2015. Here, the high-level protection provisions were used to interpret EU tobacco products law as well as the powers to implement it. It was also used to determine the proportionality standard according to which freedom to trade versus public health is balanced. In particular, much restriction on free trade is legitimate for the purposes of protecting public health, so it helps strike a balance in these contested areas. Perhaps I might quote a passage in the High Court judgment:

“Articles 168 TFEU (on public health) and 169 TFEU (on consumer protection) are especially important. They emphasise how the protection of public health is to be placed at the epicentre of policy making and also how the setting of EU policy is to take account of the work of international organisations (which obviously includes the WHO) and how ‘all’ EU policies must ensure a ‘high level of human health protection’”.


The amendment is not the vague wording that government Ministers have tried to claim in meetings with public health interests. It specifies a very clear consideration that the courts can take into account when considering specific cases. By placing the wording in the Bill, the UK courts would be under no misapprehension about what Parliament expects them to continue doing after Brexit. I hope the Minister will have the good sense not to read out anything in his brief about the wording being vague. It establishes an important legal principle that is not currently provided for in UK legislation but is provided for in EU legal principles.

I am spoilt for choice in terms of future cases where concerned citizens might well ask the courts to intervene because of the action—or, more likely, inaction—of the Government, a devolved Administration or a public authority. As a Londoner, I cite air pollution. In the first five days of 2017, London exceeded the total annual limit for air pollution. Outdoor air pollution is estimated to cause 40,000 deaths in the UK each year. The High Court has slammed the Government for failing to produce an adequate plan to tackle air pollution. To do so, the Government will need the co-operation of the EU after Brexit. The amendment will help keep the Government focused on tackling this killer more effectively. There are other areas, such as unhealthy foods and minimum pricing of alcohol, where this amendment helps, but I do not want to steal the thunder of other colleagues who will probably speak on them regarding the amendment.

In conclusion, I will say a few rather unkind words about why ministerial assurances about good intentions simply will not do. The Government’s track record on public health has been inadequate, as was brought out in this House’s Select Committee report on NHS sustainability. A credible draft obesity plan was put by the Department of Health to No. 10 and emerged with two-thirds removed. It is a totally inadequate response to a crisis. Public health budgets nationally and locally have been cut, despite government protestations to the contrary. On top of all this, the Government’s incoherent and untransparent approach to Brexit, which we have discussed endlessly under the Bill, makes it impossible to give much credence to the assurances of individual Ministers, however well meant they may personally be.

The recent letter to the Times by many public health experts makes it clear that the profession, in the public interest, strongly supports the amendment. That is borne out by the excellent briefing provided by the Faculty of Public Health to me and to many other Members of this House. Here, I say a big thank you to the faculty and to its staff. The extent of support for the amendment is brought out well in the piece in today’s Times. I hope the Minister will have the good sense to accept the spirit of the amendment, but the DExEU approach so far to the Bill does not encourage me to think that he will. I beg to move.

[Baroness Jolly (LD)]

I will speak briefly in support of Amendment 227BD, which is in the name of the noble Lord, Lord Warner, and others, including myself. I add my thanks to the Faculty of Public Health for its support with this amendment. We are all approaching a major crossroads in our political life. Much may well change. Since we joined the EU there has been a huge improvement in our public health. I think that the general public would expect that this rate of change should not be jeopardised.

Some members of the Committee might think that this amendment should be part of a health and social care Bill, but many in this Committee will remember the 2011 Health and Social Care Bill and certainly not wish to revisit it. The EU Withdrawal Bill is where our constitutional stability and certainty will be secured within the UK legal system, so this is where the amendment should sit. Thus, in the current circumstances, this is the appropriate Bill. The British constitution does not exist, as do others, with a single set of principles. If it did, this amendment would be part of it. But it should be enshrined in this Bill, which will be part of the patchwork which forms our constitution.

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.