Exiting the European Union (Medicines)

Part of the debate – in the House of Commons at 5:21 pm on 19th February 2019.

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Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care 5:21 pm, 19th February 2019

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.