(6 years, 9 months ago)
Lords ChamberIt 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.
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.
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.