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‘Streamlined’ medicines regulation promised in ‘No Deal’ Brexit scenario

UK would miss out on new EU clinical trial regulations

Brexit

More details about how the UK could function after a potential ‘No Deal’ Brexit have been published today, including medicines supplies and regulation.

Warnings about the huge delays to supply chains and damage to the UK economy are being made across all sectors, but concerns about medicines are particularly high – there are now less than 200 days until Brexit, and a deal is still not in sight.

The growing chance of a No Deal scenario has spurred the government into action, and today it clarified the steps it would need to take in medicines regulation.

Exiting the EU without a deal would mean also exiting the European Medicines Agency’s pan-European (28 EU countries plus Iceland, Norway and Liechtenstein) approval system. This would mean the UK’s regulator the MHRA would have to approve all new medicines for the UK. This will require a change in the law, and the government says a consultation on this will be launched shortly.

New launches

Aside from the potential chaos that would be wrought on the medicines supply chain in the short-term by a No Deal Brexit, it is the long-term consequences of no longer being an EMA member which is causing the greatest alarm in the UK pharma industry.

They and others have warned that this will instantly relegate the UK from being a priority launch market into an ‘also ran’ where new medicine launches are either launched later or not at all, because of the extra expense and administrative burden.

Professor Sir John Bell, a leading UK academic scientist and lead author of the Life Sciences Sector Deal recently indicated he believed the MHRA, using its world-class expertise, could make a success of being a standalone regulator, perhaps as a specialist in areas such as Advanced Therapy Medicinal Products (ATMPs).

However this view is generally not shared in the industry, where there is a growing push for greater regulatory harmonisation, not less.

Fully aware of these warnings, the MHRA has today committed to providing a ‘streamlined approach’ to its marketing authorisation process that would place “no greater burden on industry and ensures that patients can access new and innovative medicines at the same time as EU patients.”

The UK industry nevertheless doesn’t want to find out whether or not the MHRA can fulfil this promise. Its leaders, including the ABPI and BIA are backing the UK’s stated aim for a deal to be struck which would allow the UK to retain ‘associate’ status within the EMEA group.

The question of new medicines approvals is just one of many in a dizzyingly complex regulatory challenge.

Other major undertakings, such as converting EMA-approved medicines into UK approved medicines -a process known as ‘grandfathering’ is also set out in the documents, along with arrangements for packaging and leaflets, Advanced Therapy Medicinal Products (ATMPs) and pharmacovigilance.

Another area of concern for the life sciences sector is the UK losing harmonisation with the EU on clinical trials regulation. The government has confirmed that the existing 2004 Regulations will remain in force, but that its long-awaiting updated version, the new EU Clinical Trials Regulation (CTR) 536/2014 will not be in force in the EU by 29 March 2019, and therefore will not be incorporated into  UK law.

The government says only that it will “align where possible with the CTR without delay when it does come into force, subject to usual parliamentary approvals.”

The final Brexit outcome depends on political decisions in London, Brussels and other EU capitals. European Union leaders meet in Austria next week, and will discuss whether or not to hold a special summit on Brexit in November, as earlier hopes of agreeing a final deal in October now appear less likely.

Read the document here:

How medicines, medical devices and clinical trials would be regulated if there's no Brexit deal

14th September 2018

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