European Union (Withdrawal Agreement) Bill

Baroness Brinton Excerpts

Committee: 2nd sitting (Hansard continued) & Committee stage & Committee: 2nd sitting (Hansard continued): House of Lords
Wednesday 15th January 2020 Lords Chamber

Moved by

[Baroness Brinton]

36: After Clause 37, insert the following new Clause—
“UK participation in the European medicines regulatory network
(1) It is the objective of an appropriate authority to take all necessary steps to implement an international trade agreement, which enables the United Kingdom to participate fully after IP completion day in the European medicines regulatory network partnership between the EU, the EEA and the European Medicines Agency.(2) A Minister of the Crown must lay before each House of Parliament a progress report on the objective in subsection (1) within 4 months of this Act being passed, and subsequently at intervals of no more than 2 months.”Member’s explanatory statement
This new Clause would require the Government to seek to maintain participation in the European medicines regulatory network as part of its negotiations for the future relationship with the EU.

[Baroness Brinton (LD)]

My Lords, I am moving Amendment 36 as my noble friend Lady Jolly cannot be in her place tonight, given that the arrangements for today changed at very short notice. I thank the noble Lords, Lord Warner and Lord Davies of Stamford, for supporting the amendment.

As a member of the European medicines regulatory network, the UK enjoys a wide range of benefits, including access to a vast network of expertise and the ability to draw on specialists from across member states. It is particularly important in the recruitment of participants for clinical trials, especially for rare diseases. As a lone state we would not have a large enough patient population to carry out meaningful research and produce meaningful evidence. Within the EMRN, the shared reporting of side-effects means that NHS clinicians have instant access to important data regarding the safety of medicines they prescribe to their patients. These benefits cannot be recreated outside this network and if we are to continue to benefit from them, the Government must negotiate continued participation following the UK’s departure from the European Union.

The European Medicines Agency has already relocated to Amsterdam. If we leave the EMRN we will be leaving a body that constitutes 25% of the global pharmaceutical market to be a stand-alone country that makes up only 3% of that market. Pharmaceutical companies will have to submit separate applications to the MHRA to gain UK marketing rights. Evidence shows that countries such as Switzerland, Canada and Australia all receive applications for drug licensing after the EMA, with an average delay of six months. The sad fact is that the UK will not be seen as a priority, and patients will inevitably see delays in accessing new medicines.

There is no way for the Government to replicate the expertise of the EMA and the power of the single market. Therefore, it is essential that the Minister commit to the UK negotiating the MHRA’s full participation in the EMA marketing authorisation on a similar basis to EEA countries’ regulators. Will the Minister confirm that the Government will commit to making this a priority in negotiations? The United Kingdom’s departure from the EMA will damage patients in the UK, who will be collateral damage of our leaving the EU. This is not something that the UK public ever voted for.

Given the discussion on Amendment 34 on more general reciprocal rights, I ask the Minister a further question, of which I have given her advance notice, on the lack of mention of reciprocal health arrangements after leaving the EU. The European Union Committee report, Brexit: the Revised Withdrawal Agreement and Political Agreement, which came out on Friday, notes the lack of any mention of reciprocal health arrangements and says, in the section on mobility on pages 56-57, that clarity is needed on how this will work. Specifically, paragraph 252 says:

“There is no reference in this section of the Declaration to reciprocal healthcare”.


Paragraph 257 says, in bold type:

“We are concerned at the omission of any reference to reciprocal healthcare, including the European Health Insurance Card, as a means of facilitating mobility. We call on the Government to set out, as a matter of urgency, its plans for maintaining reciprocal healthcare arrangements in the context of the future relationship.”

In paragraphs 173 and 174 there is also specific reference to reciprocal healthcare in Northern Ireland and the Republic. I will not repeat it now, but it makes the point that that is vital.

Can the Minister explain why there is no mention of reciprocal healthcare in the Bill and confirm explicitly to the House that the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019, which many of us worked on, provides for such reciprocal arrangements? Perhaps most importantly, can she confirm that the Government will stand by that Act and not amend or repeal it? I beg to move.

[Lord Warner]

My Lords, I support this amendment, to which I have given my name, which has been moved so clearly by the noble Baroness, Lady Brinton. I do so as a former Life Sciences and Pharmaceuticals Minister who has stayed in touch with this sector since my time as a Minister.

The UK life sciences ecosystem has thrived, with an EU pharmaceuticals regulator based in this country and a strong medicines research base working closely with other European researchers. Over the years a strong pan-European research collaboration has grown up, which has benefited UK jobs and NHS patients. Every month, 45 million packs of medicines move from the UK to the EU and 37 million packs come the other way. The pharmaceuticals sector invests more in R&D than any other—20% of all UK business R&D. This is an industry with an annual turnover of £60 billion and exports of £30 billion. It employs 63,000 people, of whom 24,000 are working in high-paid jobs in R&D.

I say this because all of this is now at risk of lasting damage, particularly if there is not enough time to agree a well thought out deal during the transition period. There is now the prospect of a very clunky regulatory system, with companies having to deal with two regulators—the EMEA and the MHRA—if they want market authorisations in both the EU and the UK. The Government are saying that they want the UK market authorisations to be obtained first, but the EU is the bigger market and some companies think that they may end up with shorter IP protection in the larger market if they do what the Government ask. A dual regulatory system is likely to mean higher costs, driving up NHS prices and damaging patient access to new drugs. It will mean fewer joint research projects benefiting from EU funds, and UK-based companies are less likely to find the UK Government replacing the lost R&D funds from the EU. Over time, we may well see fewer clinical trials being done in the UK.

That is why this amendment is important. It offers the possibility of repairing some of the damage done by Brexit to UK life sciences and UK-based pharmaceuticals and biotech companies. We need to do our utmost to restore some basis for extensive collaboration and research work between us and the EU in the life sciences, and we need to do the best we can to make the regulatory processes as smooth as possible if we want people to continue to do pharmaceuticals research in this country. The Government have been slow to appreciate the damage they have been doing over the last three years to this British success story. Passing this amendment would start to repair some of the damage.

--- Later in debate ---

[Baroness Brinton]

Before the Minister sits down, may I tell her that I passed my question about reciprocal healthcare through to the Whips Office? I also asked in my speech whether the Healthcare (European Economic Area and Switzerland Arrangements) Act would remain in place unamended, which would reassure the EU Committee on its concerns at the fact that there is no mention of reciprocal health rights anywhere in the withdrawal agreement.

[Baroness Blackwood of North Oxford]

I apologise to the noble Baroness; I passed over that note in my response to the debate. Where the UK, a member state, an EEA or EFTA state or Switzerland is responsible for the healthcare of those in scope of the social security co-ordination part of the agreement, such individuals will be entitled to reciprocal healthcare cover from their competent country. This includes EHIC cover for people with full social security co-ordination rights under the agreements, and cover for people who have previously worked in the UK, another member state, an EEA or EFTA state or Switzerland before the end of the implementation period. Obviously, the specifics in future will be subject to the negotiations that will be forthcoming. I hope that that answers the noble Baroness’s question, and she will feel that she can withdraw her amendment.

[Baroness Brinton]

I am grateful to the Minister for her comments, and to other colleagues for their contributions. I am particularly grateful to the noble Lords, Lord Warner and Lord Davies, for their expertise, and especially for the intervention by the noble Lord, Lord Davies. The Minister is always courteous, and always gives us her best brief, but I am not reassured at all on the issue of the EMRN, partly because. although there was plenty of talk about trying to maintain the excellence in life sciences, there was no response to the question of how, with only 3% of the pharma market, we would be able to play the same role as we currently do in the EU, with 25%. There was also a complete failure to respond to the major concerns that everybody expressed about patients not being able to access drugs because we suddenly become a very minor player. On that basis, I will withdraw my amendment this evening, but I will consider whether to lay something for Report.

On the other matter, concerning reciprocal healthcare, again, I am not quite as positive as I think the Minister would like me to be. I remain concerned that the phrase “no-deal planning” was mentioned in the context of both parts of my speech. We on this side are concerned about the impact on UK citizens abroad, and on EU citizens here, of the loss of reciprocal healthcare arrangements. That is really worrying. But I am pleased to hear that there is some reliance, at least in the transition period, on the healthcare arrangements Act. I beg leave to withdraw the amendment.

Amendment 36 withdrawn.

European Union (Withdrawal Agreement) Bill

Baroness Brinton Excerpts

Report: 2nd sitting (Hansard - continued) & Report stage & Report: 2nd sitting (Hansard - continued): House of Lords
Tuesday 21st January 2020 Lords Chamber

[Baroness Jolly (LD)]

My Lords, I will be brief. Clause 41 allows Ministers to make regulations that could alter any primary legislation that has been passed prior to the Bill. Such regulations will be made by the negative procedure, effectively giving Ministers carte blanche to do what they will to legislation that is already in statute. Many of us in the health community in your Lordships’ House were recently involved with the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019, which, noble Lords will remember, started life as the Healthcare (International Arrangements) Bill. A number of significant changes were made to that Bill by this House and then approved by the Commons. However, this clause could allow Ministers to revert the Bill to the original, thereby thwarting the will of Parliament, or they could at any time change any component of it, or any other Bill, with the minimum amount of scrutiny. When you think about it, its scope is really quite breathtaking.

In Committee, my noble friend Lady Brinton asked the Minister about a letter that she had left with the Government Whips’ Office and which the Minister had not seen and so was unable to answer in as much detail as usual. Since then the Minister has sent noble Lords a letter outlining the situation, for which we were all very grateful. As well as responding to the amendment, I am sure that other noble Lords will want to press the Minister on the detail of the letter, so that the Government’s intentions are on the record about any proposed changes to legislation relating to healthcare and the EU. I do not intend to press this amendment. I beg to move.

[Baroness Brinton (LD)]

My Lords, the European Union Committee report on Brexit, referring to the revised withdrawal agreement and political agreement, notes the lack of any mention of reciprocal health arrangements and says, in a section on mobility on pages 56 and 57, in paragraphs 252 to 257, that clarity was needed on how this would work. This is one of the reasons that I questioned the Minister in Committee. I am sorry, on both our parts, that the message with that question did not get through, and I thank her for the letter that she sent over the weekend. This is important because the European Union Committee says:

“There is no reference in this section of the Declaration to reciprocal healthcare, including the European Health Insurance Card (EHIC), as a means of facilitating mobility.”


It was that “means of facilitating mobility” that was absolutely critical for the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019. With your Lordships’ permission I will shorten that to “healthcare arrangements Act” rather than repeating the whole thing every time. Can the Minister explain why there was no mention of this reciprocal healthcare, and say explicitly to the House that these arrangements will stand?

Parts of the Minister’s letter were very helpful on specific points relating to those EU citizens living and working in the UK at the moment and UK citizens living and working in the EU. But that is not as broad as the provisions of the healthcare arrangements Act. That is why the committee raised its concerns, specifically using the phrase “means of facilitating mobility”.

The Minister’s letter made a rather odd assertion: that healthcare arrangements are protected by Clause 13 of the European Union (Withdrawal Agreement) Bill, which covers social security systems. Nowhere in Clause 13 is there any reference to healthcare, nor is there any such reference in the healthcare arrangements Act. More worryingly, if she is right and I am wrong, the decision to change arrangements under Clause 13 is at complete odds with the decision arrangements in the healthcare arrangements Act. Clause 13 reinserts the Henry VIII powers that were in the original healthcare arrangements Bill, and both your Lordships’ House and then the Government decided that this was inappropriate. That is why that Bill was changed. It became an Act in April.

Sections 6 and 7 of the healthcare arrangements Act set out clear routes for changes via statutory instruments and reports to Parliament. That Act is transparent and accountable, unlike Clause 13, where responsibility for such decisions is given to the Minister of the Crown and/or a devolved authority. Can the Minister confirm that any arrangements relating to healthcare would fall under Sections 6 and 7 of the healthcare arrangements Act given that they do not relate to social security? This amendment tries to make sure that we have that protection for reciprocal healthcare. I beg to move.