Exiting the European Union (Medicines)

Debate between Jackie Doyle-Price and John Redwood

Tuesday 19th February 2019 Commons Chamber

[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.

[John Redwood (Wokingham) (Con)]

Given that our industry is a world leader and a very significant part of the European effort, does the Minister see opportunities in the future for us to have world-class regulation where we lead and differentiate in a way that would strengthen our efforts?

[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.

--- Later in debate ---

[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.

[John Redwood]

Given the great importance of joint venture companies and joint investment and joint activity across the Atlantic, will the Government also be looking at changes in American regulation to see if any of that would be appropriate—or maybe a UK version could be better than both the American and EU ones?

[Jackie Doyle-Price]

My purpose this afternoon is to ensure that we have business as usual post-exit day, and that we can maintain patient safety at that time. I would not want to encroach on any debate beyond that now.

Questions were raised regarding research funding. I should advise the House that before the Brexit vote the UK was involved in more EU-funded science projects than any other country. The UK secured 14.3% of the total share of the funding to date and is the second-highest recipient of grant funding. We are committed to remaining a world leader in science and research, and that is why, in our modern industrial strategy, we have committed to spending 2.5% of our GDP on research and development by 2027. We have invested an extra £7 billion in research and development as a first step towards that.