Exiting the European Union (Medicines)

Daniel Zeichner Excerpts

Tuesday 19th February 2019 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

I beg to move,

That the draft Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, which were laid before this House on 23 January, be approved.

Before I discuss the regulations, it is important to reiterate that we wish to retain the closest possible working partnership with the EU to ensure that those engaged in clinical trials can continue to develop innovative and cost-effective treatments and that patients recruited in trials can continue to have timely access to medicines. However, we are bringing forward this legislation to continue preparations for no deal, in case we need to be prepared for that eventuality.

In developing this amending legislation, my Department’s priorities have been to minimise any disruption to ongoing trials and to make sure that the UK regulator can still protect public health and, importantly, that the UK’s biomedical, health and life sciences research sectors can continue to be world-leading. With that in mind, the Medicines and Healthcare Products Regulatory Authority has sought to take a pragmatic and proportionate approach in establishing the new regulatory requirements. Importantly, that has been done through continued close co-operation with stakeholders. After a period of informal consultation in August, the MHRA published an initial proposal, and it followed that up with further consultation. The feedback from that consultation, which received over 170 responses, led to the statutory instrument before us.

Let me bring a few details to the attention of the House. First, wherever possible, we have sought to maintain existing arrangements. Given that the system for clinical trials is currently based on national-level decision making in the EU and globally, we have not had to make any substantial change in some key areas. In particular, on the ability of the UK to participate in multinational trials in the EU or in the rest of the world, there will be no change. Also, the data gained from trials in the UK can still be deposited in international repositories and be accessed by others. I think the House will agree that that reflects our approach, which is to continue multinational co-operation on clinical trials.

In other areas, we have faced a choice regarding the UK’s regulatory requirements. In those instances, we have sought to maintain current arrangements, provided that the regulator still has sufficient ability to protect public health. For example, we will continue to recognise existing approvals, so there will be no need to reapply for both regulatory and ethics approvals. We will have the same information requirements as the EU for any new applications for multi-state trials in the UK. There is also a requirement that a clinical trial sponsor or legal representative for clinical trials in the EU should be based in the EU. That will ensure continuity of the existing clinical trials landscape and maintain the UK as an attractive, open environment in which to conduct clinical trials.

[Daniel Zeichner (Cambridge) (Lab)]

The Minister is making an important speech. Does she recognise industry concerns about the introduction of an extra level of regulation through the proposals for a qualified person requirement? There is a worry that it will make our country a less attractive place to conduct clinical trials, which are, of course, extremely important to my part of the world.

[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.

--- Later in debate ---

[Jackie Doyle-Price]

My objective this afternoon is to make sure we can continue with business as usual on exiting the European Union, but clearly once we have left the European Union that would be open to us. The ethos behind the regulations and the consultation we have had with the sector very much recognises that this is an international market place. We must ensure that in taking forward these requirements we remain competitive.

As I was saying, we will require the same information requirements as the EU for any new applications for multi-state trials in the UK. There is a requirement that a clinical trial sponsor should be based in the EU. There are a few areas where it has been necessary to add a new requirement, as a result of the UK no longer being part of the European regulatory framework, relating to the MHRA putting in place a new national IT system for safety reporting and submissions. In addition, investigational medicinal products, known as IMPs, imported from the European Economic Area will now require an import licence, as they would no longer be part of the single market. As the hon. Member for Central Ayrshire (Dr Whitford) said, they will be overseen by a qualified person to ensure that the products are appropriately certified. That builds on the existing import licensing system, which allows the transport of IMPs direct from the EEA to UK trial sites to continue. Recognising that this is a new system, we have provided stakeholders with a 12-month transition period from exit day before it comes into force.

While not specifically covered in this statutory instrument, I would like to reassure Members that the Government are engaging with organisations running clinical trials to ensure continuity of supply and that drugs continue to be received. The Government are undertaking a comprehensive deep dive into clinical trial supplies to gain detailed understanding of what is required, and are putting place contingency plans in case the sponsors need them. They will include access to the same prioritised shipping routes that will be available for all other medicines.

As I mentioned in response to the hon. Member for Cambridge (Daniel Zeichner), the Government are committed to ensuring that the UK remains one of the best places in the world for science and innovation. Members should note the Government’s commitment to aligning with the EU’s new clinical trials regulation as far as we can, without delay, when it does come into force, subject to the usual parliamentary approvals.

[Daniel Zeichner]

Will the Minister also comment on the concerns raised by organisations such as Cancer Research UK about future pan-European trials, for which it would appear that the sponsor or lead would have to be from within the EU rather than within the UK?

[Jackie Doyle-Price]

As I said in response to earlier questions, the Government’s approach is that this an international marketplace. We clearly want access to the best possible medicines and to ensure that we can continue to co-operate and share that information as best as possible. I fully expect the MHRA to share that information with the European regulators, as it currently does. Regardless of EU exit, the MHRA and partners across the UK healthcare ecosystem are already taking steps to improve the UK clinical trials application process to ensure that it is as seamless as it can be.

In conclusion, in the event of a no deal, these regulations will put in place a pragmatic solution that ensures that the UK’s clinical trials legislation continues to function effectively after exit day. Essentially, we want this to be business as usual following exit, and I commend this statutory instrument to the House.