My Lords, I shall speak also to Amendment 68. These are probing amendments the purpose of which is to seek clarity not only about the Government’s intentions towards negotiations on the future relationship with the EU, but about the Bill and Clause 6 in particular.
Since Committee started we have seen one tangible example of what leaving the European Union means, because it also means that many European Union institutions are leaving the United Kingdom. When the flags were lowered and folded at the EMA headquarters last week, the director of the Wellcome Trust said that it was:
“A very sad day for the UK, a great day for the Netherlands”,
where the EMA will now have its temporary headquarters. I am fully aware that, in advance of our discussing this amendment today, many decisions have already been made at the EMA. I am also aware that, if we are leaving the European Union, our membership of EU institutions gives rise to significant complexities. However, that does not alter the fact that membership of the EMA is imperative to the United Kingdom’s medicines industry, our patients and consumers of pharmaceuticals.
The EMA is essential to the functioning of the single market for medicines in the EU, and the UK played a pivotal role in that process, not just in hosting the EMA for 23 years but also through the contribution of our scientists and researchers and our regulatory expertise. The agency’s work is vital and will continue to be so, providing EU citizens with effective, safe and high-quality medicines and maintaining a regulatory environment that fosters innovation and development of new medicines. It is vital that the UK continues to have a relationship, and my amendments seek clarity on how the Government see that relationship. We know that we are no longer able to engage as co-rapporteurs for new marketing authorisations applications—this will end regardless of what happens on 29 March 2019, agreement or no agreement. The only way we can stop this is if we continue our
membership of the European Union, which is by far the most preferable of all the options, but on the basis that that will not happen, we also know that from March onwards the UK’s position will be considerably weaker.
Last April, the EU 27 completed the redistribution of the UK’s portfolio of more than 370 centrally authorised products to rapporteurs from the EU 27 plus Iceland and Norway. We know that significant damage has already been done. To put this in context, more than 40 million pharmaceutical packages are exported from the UK to the European Union every month, and more than 30 million are imported into the UK from the European Union. The UK pharmaceutical industry is integrated into the regulatory regime of the European Union, and separating this out has been a very painful process. The question remains: what will the relationship be going forward?
Paragraph 24 of the political declaration states—assuming this is still the Government’s position— the following:
“The Parties will also explore the possibility of cooperation of United Kingdom authorities with Union agencies such as the European Medicines Agency (EMA), the European Chemicals Agency (ECA), and the European Aviation Safety Agency (EASA)”.
What do the Government mean by co-operation? The Bill says—at the moment—that the Government should,
“take all necessary steps … to fully participate … in the European medicines regulatory network”.
It is for the Government to explain the disparity between the two. Why does the political declaration say simply,
“explore the possibility of cooperation”,
when the Bill says that the Government’s objective is full participation in the regulatory network? Why the disparity in language? Was this on the insistence of the European Union, or because the Government did not do what the House of Commons instructed it to do, taking a much stronger position in the Bill, with full participation as their intention?
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On the previous day in Committee, it is fair to say that there was a degree of inconsistency from the Front Bench about the status of Clause 6, so I am happy to give the Government an opportunity to make the position crystal clear. The noble Baroness, Lady Fairhead, said that the Government could not accept this language going forward and that they were,
“reflecting on what should be done”.—[Official Report, 30/1/19; col. 1068.]
She said that there were “legal and technical difficulties” with the language. I am not sure whether she is shaking her head at me—I am quoting from Hansard, so I hope that I am quoting her correctly. If I am not, I will happily correct the record. The Minister also said:
“The Government do not endorse the wording of the amendment”,
which is now in the Bill,
“and consider that the wording has legal and technical difficulties, so we are reflecting on what should be done.”
Later in Committee, the noble Lord, Lord Bates, said:
“My noble friend Lady Fairhead made very clear our hesitation in the other place when this amendment was proposed, but it is now in the Bill. We see the commitment to all necessary steps in relation to the European Medicines Agency. We have been very
clear that we do not wish to see that extended to other agencies, but it is there in the Bill at present”.—[Official Report, 30/1/19; col. 1155.]
Is that still the Government’s position? This is important. The House of Commons clearly instructed the Government, by changing the legislation, that it should have participation in the European medicines regulatory network as its negotiating position. The House of Commons also voted with clarity on the Government’s position on taking out the Northern Ireland protocol from the withdrawal agreement. Both have equal standing; in fact, the change of the Bill has higher standing, but the Government consider both to be mandates.
I am seeking clarity on two points. First, how do the Government see the language of co-operation being made real in practical examples? Does co-operation mean not only that would we be fully aligned, but that we would take all of the regulatory decisions of the European Medicines Agency if we are not a member of it? Would we submit to their licensing and marketing authorisations procedures? Will there be reciprocity in that? How will our separate regulatory bodies interact with the EMA as a third party?
Secondly, what do the Government intend with this Bill? Before we proceed to Report, we need clarity. On that basis, I beg to move my amendment.