My Lords, I rise to move Amendment 9 and speak to Amendment 11 in my name on the Marshalled List. Even since Committee stage began in your Lordships’ House last Wednesday, the Brexit world has shifted again and is doing so even today. The Prime Minister has had her summit at Chequers and my own leader is posing a serious challenge to the Government. We have to wonder how many millions are following the detail of hard Brexit; soft Brexit; tariff-free access; managed divergence or even ambitious managed divergence; hard and soft borders; regulatory alignment; cake philosophy, which is something to do with cherry-picking and having your cake and eating it; the three baskets theory, which I understand is a bit like the cake philosophy, only it is three choices; transition or implementation; and, finally, a bespoke economic partnership.
The media is full of it. The Westminster bubble and the chatterati—from which I do not exclude myself—talk of little else. That is because it is important to our nation’s future and our prosperity, or otherwise. However, I will propose one amendment, and speak to another, on matters which do not at present feature in the headlines or in the huge and momentous agenda being discussed in your Lordships’ House, but which do affect millions of citizens in the UK and the EU, including every Member of this House. These amendments affect all who work and travel in Europe; who buy medicines and take for granted the supply and availability of the most up-to-date, clinically approved remedies.
Like millions of UK citizens, I have been on holiday and travelled all over the EU. Most often, my summer holidays have been in France with my children. Every year while my children were growing up we had at least one ear infection, sometimes a dose of tonsillitis and, one memorable year, an adult with Bell’s palsy. The wonderful Dr Duterte in Brantôme came to know us quite well over 25 years. My son lived in Brussels for five years and, although mostly healthy, he and we thankfully did not need to worry ourselves about his access to healthcare. An important part of a stress-free holiday with a mother with chronic obstructive pulmonary disease was knowing, with confidence, that the oxygen supply would be waiting in the house—free, like in the UK. I tell these everyday stories precisely because they are so ordinary. It is the experience of millions of us: the package holidays; the weekends; the hen parties in Barcelona; the stag dos in Amsterdam and elsewhere; the conferences in all sorts of places. We and our fellow citizens are accustomed to travelling with ease and confidence. The ease with which people can do what they are used to doing is a matter which will colour how they judge whether Brexit is succeeding and whether it has been worth while.
Amendment 9 concerns the EU reciprocal healthcare arrangements which allow citizens of EU and EEA nations, as well as Switzerland, to access health and social care services while in any other of these nations, on the same basis as a resident of that nation would at no or low cost. The schemes include the EHIC, the European healthcare insurance card, which provides access to state-provided healthcare for short-term visitors; and the SI scheme, which, for example, allows ongoing access to health services for people working abroad and social care services for individuals such as pensioners
living abroad. This is important for workers, students, the retired and holidaymakers, and, as I said, it affects millions of us.
Post Brexit, the UK could lose access to these arrangements, depending on the final outcome of ongoing negotiations between the EU and the UK Government. So far, the two parties have agreed that UK pensioners already living in the EU will be able to use the SI and EHIC schemes post Brexit, but no deal has been reached on wider access to them. Losing access to these arrangements would have a significant impact in a number of areas. This is one area where some progress seems to have been made but, as with many other matters, there is some uncertainty about what will happen after Brexit. The latest joint EU-UK document on the Brexit talks in November said that citizens who live in another EU country on the day that the UK leaves will still be eligible for the same healthcare as citizens and will still be able to use the EHIC scheme when visiting another EU country. This includes citizens who work or study in another country or are retired there. However, agreement has not been reached on whether the EHIC would be available to those who travel to, or go and live in, another EU country after the UK has left the bloc. It would seem that the EU wants discussions on that to be included in the negotiations on the future relationship between the UK and the EU, which will come only after sufficient progress has been made on the divorce issues.
Our amendment seeks to prioritise the negotiation of continued access to existing EU reciprocal healthcare schemes, or the creation of comparable alternatives. We need to fully assess the impact which loss of access to the schemes might have on patients and health services. For the UK, this approach would ensure continuity of care for its citizens living abroad and ease of access for UK citizens visiting the EU or EEA and avoid increased demand on and costs for the NHS.
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For the EU this approach would secure access to reciprocal healthcare for EU citizens visiting or residing in the UK and maintain ease of travel for UK visitors to the EU, including holidaymakers. Should there be a failure to agree a withdrawal agreement by March 2019, access to reciprocal healthcare arrangements for UK citizens and residents within the EU and EU citizens and residents within the UK would end. This could lead to significant disruption for those individuals’ healthcare arrangements, an increase in the cost of insurance and uncertainty regarding accessing healthcare abroad. Moreover, the NHS may face a drastic increase in demand for services, which would increase its costs and place greater pressure on doctors and clinical staff because the UK citizens living in, or visiting, the EU would be required to return to the UK for treatment or purchase expensive healthcare or travel insurance, thus increasing pressure throughout the whole system. This is an issue on which it is very important that there is certainty, and that we know what will happen in March 2019.
I turn to Amendment 11. For some time now, it has not been possible to develop a new medicine in one country. This is a global industry and you need to run
your clinical trials everywhere. Patients in the UK can access EU-wide trials for new treatment, particularly for rare diseases and in relation to children. Should the UK find itself unable to access this network, there may be an impact on the high-quality research in which we get involved, to say nothing of the funding of that research at UK institutions. From the clinicians’ point of view, participating in trials means that they get to know and experience the use of medicines under development. A lack of engagement, however, means that they can miss out and will know about the advantages and disadvantages only once an approval has been given. At present, gene therapies, cell therapies and all the oncology therapies are regulated at a European level. This is the cutting edge of drug therapy. For example, around 70% to 80% of the drugs under development are biologically based, and for many of those the work is often initiated here in the UK. We really are at the forefront of this work. Antibodies and DNA were discovered here but we cannot do clinical trials just in the UK because they require a larger pool of patients, particularly with rare diseases. It is important therefore that we have a wider network and the funding to keep those trials moving. As we negotiate our exit from the EU, all this seems in jeopardy.
The UK’s strong science base, world-leading universities and an NHS which provides a huge patient database and source for trials mean that we could possibly try to go it alone. However, even if we develop and produce approved medicines on our own, it will be difficult for us to break into an EU market from a regulatory point of view. As we are not the largest market in terms of sales, and if we cannot ensure that we run trials, we will slip down the list of where companies want to do their work. Therefore, as the UK negotiates a new relationship with the EU, significant challenges must be overcome, not just to ensure the stability and continued growth of the UK’s pharmaceutical industry but to ensure that patients can continue to access the medicines they need. Ensuring close co-operation on medicines and continued collaboration in clinical trials is crucial.
The clinical trials regulation—CTR—that the UK was heavily involved in developing will harmonise the assessment and supervision process for clinical trials via a central EU portal and database being set up by the European Medicines Agency. Implementation, however, has been pushed back because of delays in the establishment of the EU portal and database, meaning that it will be implemented in 2019 rather than this year. The CTR therefore will no longer be automatically captured by the EU (Withdrawal) Bill and the Government’s planned response remains unclear despite what the Minister said in a letter to my noble friend Lady Hayter on 26 January, which provided some comfort in this area. We have tabled this amendment because we think it is vital that Ministers set out a strategy that will ensure the mutual recognition of medicines and clinical devices licensed in both the UK and the EU and will resolve the issue of the European Medicines Agency and the portal and database which will be so important for the development of these medicines. Like Amendment 9, this amendment seeks to ensure that the European Communities Act 1972
is not repealed until the Secretary of State has set out a strategy for the continued mutual recognition of medicines and clinical devices licensed either in the UK or in the EU.
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.