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.

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[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.