European Medicines Agency: Medicines and Healthcare products Regulatory Agency

(asked on 31st October 2019) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure the maintenance of the relationship between the Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency after the UK leaves the EU; and what assessment he has made of the effect on people with (a) cancer (b) other conditions of changes to that relationship.


Answered by
Nadine Dorries Portrait
Nadine Dorries
This question was answered on 5th November 2019

Our goal is to continue working closely with our European Union colleagues, as we do at present, to make sure patients have access to safe and effective medicines. As set out in the United Kingdom-EU Political Declaration, our priority is to seek a new relationship with the EU that includes close regulatory co-operation for medicines and medical devices. We have always been clear that we wish to explore with the EU the UK’s on-going participation with the European Medicines Agency (EMA) and wider regulatory network, as a part of the future relationship negotiations.

Whatever the outcome of the negotiations, we will set up a regulatory system that protects the best interests of patients and supports the UK life science industry to go from strength to strength. The Medicines and Healthcare products Regulatory Agency, with over 30 years’ experience licensing and monitoring the safety of new medicines, already licences the vast majority of medicines on the UK market.

The Government will ensure that patients are not disadvantaged by the future regulatory regime in order that UK patients are able to access the best and most innovative medicines and their safety is protected. The UK life sciences industry has much to offer in creating, developing, trialling and commercialising medicines that will benefit UK patients and strengthen the ability of the UK to compete internationally.

The Government has taken pragmatic steps to ensure that patients continue to access innovative treatments in the event that the UK leaves the EU without a deal. The Government’s stockpiling regime will minimise any supply disruption in the weeks after leaving without a deal. The Government has set out alternative licensing routes to incentivise companies to continue to apply for licences with a view to approval of a licence at the same time as the EU. This will ensure that patients, including those with the most critical conditions, are not put at a disadvantage with regard to accessing innovative treatment. Further to this, all centrally authorised products that are already approved by the EMA will be converted into UK-only licences after exit unless the licence holder chooses to opt out, ensuring continued supply of innovative treatment onto the UK market.

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