European Union (Withdrawal) Bill

Baroness Finlay of Llandaff Excerpts

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

[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]

We would like to retain an arrangement similar to the EHIC if possible. We cannot give any guarantee about what might happen in the next phase of the negotiations.

We welcome the progress made, but we are clear that we want a wider agreement on reciprocal healthcare. I am sure that noble Lords will appreciate that this is not something we can simply legislate for in the withdrawal Bill, but must be negotiated with the EU, which is what we have been doing. We are very clear that we want to protect reciprocal healthcare arrangements.

On 8 December, the UK and EU Commission reached an agreement which delivered on the Prime Minister’s number one priority: to safeguard the rights of people who have built their lives in the UK and EU.

[Baroness Finlay of Llandaff]

I asked the Minister for information about billing across borders to date, because that information must have been available to the Government before they started negotiating over the travel arrangements.

[Lord Callanan]

I will need to write to the noble Baroness with the exact amount of billing, as I do not have those figures in front of me at the moment.

I turn to Amendment 353, tabled by the noble Lord, Lord Stephen. The Government already keep NHS performance and health outcomes constantly under review, including through the NHS outcomes framework, which measures a number of health indicators intended to form an overarching picture of the current state of health and care services in England. We are committed to positive and productive engagement with the devolved Administrations going forward as we seek a deal that works for the entire United Kingdom.

The Secretary of State for Health and Social Care also publishes an annual assessment on the performance of NHS England, including how it has met its mandate from the Government, as well as an annual report on the overall performance of the health service.

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[Lord Callanan]

I thank my noble friend for his comments. A lot of these matters are still to be negotiated in the next phase. We made substantial progress in the first phase, and we will endeavour to ensure that we make good progress to achieve a good working relationship with the EMA and to guarantee the rights of travellers through a system similar to the European health insurance card for those travelling in future. I hope to be able to provide more information on Report.

[Baroness Finlay of Llandaff]

Following on from the comments of the noble Lord, Lord Cormack, could the Minister provide us with data in writing on the numbers of EU staff who have applied for jobs in healthcare in the last 12 months and the numbers of EU staff who have left? We need to have the data rather than bald statements about what is happening based on anecdotes, because it may well be that the Minister is hearing a quite different set of anecdotes from the ones the rest of us are hearing.

Will the Minister also confirm, or not, my interpretation of his comments on the outcome if there is no agreement? Here I return in part to Amendment 11, but to others as well. If there is no agreement with these regulations, will the Government then simply adopt European regulations de facto? I cannot see any other way for our pharmaceutical and biotech industries to continue to function. We need them for our economy, quite apart from needing them to ensure that there is a supply of medical and biotech advances for our patients. It is particularly important because biotech is an emerging field in which to date, within Europe, the UK has been the leader. I should declare an interest here because my son is a senior lecturer in bioengineering and cardiology, so he is involved in some of this ground-breaking work.

It would be helpful for us to know that and whether, in the context of there being no deal, the Government are already establishing dialogue between different Ministers in the devolved Administrations. As the noble Lord, Lord Wigley, has pointed out, there are very real implications for Wales, particularly west Wales—I declare my interest as someone who lives and works there—because we know there are large gaps there. We have to know how the Government intend to behave in the event of there being no deal at all.