Exiting the European Union (Medicines)

Philippa Whitford Excerpts

Tuesday 19th February 2019 Commons Chamber

[Jackie Doyle-Price]

I appreciate the hon. Gentleman’s point. Perhaps I can reassure him by emphasising that the UK is committed to establishing a far-reaching science and innovation pact with the EU to facilitate the exchange of research and ideas, so we continue to maintain the competitiveness to which he refers.

In bringing forward these proposals, we have been determined to establish our pattern of regulation from outside the EU if need be, but as much as possible we wish to continue with business as usual. We will continue to engage with the sector to maintain competitiveness, because we fully appreciate the value of the life sciences sector to our economy.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Paragraphs 7.6 and 7.7 of the explanatory notes highlight that the EU makes information public and transparent. They talk about the MHRA doing that, but they do not mention that the MHRA would be publishing data within the upcoming EU system.

[Jackie Doyle-Price]

The regulations are determined to facilitate transfer with not only EU bodies, but internationally. We fully recognise that in bringing forward the regulations we are operating in an international landscape. The regulations are designed to facilitate that co-operation, as well as to establish the MHRA as the lead regulator. It is worth noting that, within the current system, the MHRA is the lead. In terms of the regulation we are transposing, rather less is coming to the MHRA given the existing ownership it has in this field.

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[Dr Philippa Whitford (Central Ayrshire) (SNP)]

As we all know, Europe is the biggest research network in the world—bigger than China and America; and the UK and, within the UK, Scotland have been major beneficiaries. As the shadow Health Minister mentioned, the EMA provides a single licensing system, and countries outside Europe that are not major economies, such as Canada and Australia, face a delay of six months to a year in accessing and licensing new drugs. The EMA is not just a licensing body, however; it also funds and promotes research, particularly into rare conditions and childhood diseases.

Europe created the comprehensive trial regulation system with the clinical trials directive in 2001 and the good clinical practice directive in 2005. As mentioned, however, in 2014 a new directive introduced the EU clinical trials information system and the new trials regulation system, which will be under the control of the EMA when it comes into force next year. The system will provide a single portal for sponsors to register, collaborate and analyse their work and will provide work spaces for authorities and a public site that will tell patients what trials are going on and what their benefits are. It will also contain the EudraVigilance database on medicinal products that are not yet licensed, which is critical during initial trials.

The MHRA will take on the full role of clinical trial regulation, including legislative functions currently carried out by EU bodies, which will obviously mean additional work and costs for the MHRA. I welcome the Government’s commitment to align closely with the new European regulations, but this is not the same as being part of a single collaborative system. I note that the UK Government plan to recognise sponsors in the EEA, since EEA states will be recognised as approved countries—this is one of the amendments made—to minimise upheaval, but that means there will not be any compulsion to have a legal representative or lead researcher here in the UK.

Clinical trials sponsors must report any suspected unexpected serious adverse reactions—SUSARs, as they are known—to the EU database. They can currently do that from the United Kingdom, in a straightforward fashion. Similarly, any SUSARs registered elsewhere in Europe are entered in the database, so that concerns are highlighted at the earliest point during trials. Many of us will remember safety trials carried out on human subjects that resulted in major damage. It is critical that the UK does not operate in a vacuum.

Before licensing, particularly in the early stages of safety, dosage or phase 1 trials, investigational medicinal products are used. Those products are unlicensed, and, as the Minister said, they must be certified by a qualified person based in the EEA. If they are made in the EEA or in a third country, that is critical. For IMPs made in a third country, the importer must have a manufacturing and importation authorisation, and must ensure that a qualified person certifies the products before supplying it.

Unfortunately, the regulations mean that bringing a drug into the UK for the purpose of a Europe-wide trial and exporting an IMP to Europe from a UK pharmaceutical firm will introduce bureaucracy. It is bizarre to claim that there will be no additional bureaucracy. The regulations merely describe the extra licences that will be required. The MHRA will publish data on UK trials, but there is no promise that they will also be posted on the EU trials information system.

Simply creating something separate will not replace our collaboration across Europe. We are seeing duplication, obstruction and expense. I am sorry to say that those are all the enemies of collaboration—and that defines the loss that is Brexit.

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[Jackie Doyle-Price]

I thank all hon. Members who have participated in this debate, which has demonstrated how vital it is that we make sure the legislative underpinning of clinical trials continues safely, as the hon. Member for Washington and Sunderland West (Mrs Hodgson) outlined in her opening comments. That is by far our biggest priority: we need to continue business as usual, and to value our important pharmaceutical and life sciences sector and guarantee people’s safety.

I will try to address some of the points made today. The hon. Lady mentioned the clinical trials regulation and what it would mean in terms of adoption by the UK if it was implemented after March 2019. We expect the clinical trials regulation to be implemented in late 2020, and the MHRA, the National Institute for Health Research and the NHS have been working towards the implementation of that regulation since it was agreed in 2014. The withdrawal agreement Bill will give effect to the implementation period in domestic law and will allow EU regulations to continue to apply directly in the UK for this time-limited period. If the clinical trials regulation comes into force during the implementation period, as it is currently expected to, we would expect to apply that to the UK. If however we leave without a deal—this is why we have these regulations—the CTR will not be in force in the EU at that time so will not be incorporated into UK law on exit day; however, we intend to align, where possible, with the CTR without delay when it does come into force, subject of course to the usual parliamentary approvals. But that alignment will happen after 29 March 2019.

The two key elements of the regulation that are outside the UK’s control and that this instrument does not therefore cover are the use of the shared central IT portal, as mentioned by the hon. Member for Central Ayrshire (Dr Whitford), and participation in the single assessment model, both of which will require negotiated UK-EU agreement regarding UK involvement post-Brexit. This reiterates the wish expressed by the hon. Lady and shared by me that it would be far preferable if we can leave the EU with a deal. Sadly, experience tells us that these things always go to the wire, but let us hope we get a resolution sooner rather than later.

The hon. Lady also mentioned patient safety. Currently a sponsor can report a suspected unexpected serious adverse reaction—SUSAR—during the course of a clinical trial through the EU database. Similarly, all SUSARs originating outside the UK where the sponsor has an ongoing trial in the UK involving the same medical products currently must be entered on the EU database, and we will clearly need to find a way of entering that so we can share such information and have arrangements for holding it on the MHRA database.

[Dr Whitford]

Does that mean that that ability is not there if the UK leaves without a deal, for April of this year?

[Jackie Doyle-Price]

Being brutally honest with the hon. Lady, and perhaps more honest than some are in this debate, I do not think we can dictate terms to our EU partners; I think we can look forward to having constructive working arrangements with them and it is in all our interests to do so, but ultimately we would have to seek agreement about this. At this stage this SI can only really cover the things that are in the gift of this Government, and a lot will rest on good co-operation after the event, which again means it would be much more preferable to leave with a deal.