European Union (Withdrawal Agreement) Bill

Debate between Baroness Brinton and Lord Warner

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

[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.