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Drugs regulator moves to clarify pharma’s position in Brexit negotiations

MHRA tries to allay fears that commerce will grind to a halt next March

Caroline White

Wednesday, 17 January 2018

The medicines and devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has moved to allay fears that cross-border commerce for pharma companies will grind to a halt when Britain exits the EU.
In a statement issued yesterday, the MHRA referred to the Joint Report * on progress made during the first phase of negotiations, published by the European Commission and the government in early December.
The MHRA said: “In the context of ensuring continuity in the availability of goods placed on the market under Union law before withdrawal, the Joint Report makes clear that 'goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight.'”
UK ministers are keen to strike a temporary deal with the EU for a time limited transition period to retain the key benefits of the customs union to ensure that commerce can continue between Britain and EU countries until new arrangements are adopted.
The MHRA emphasised that guidelines issued on 15th December to inform the second phase of negotiations clearly acknowledge Britain’s proposal for a transition period.
“Both parties have recognised the importance of such a period in the interests of providing certainty and continuity to businesses and individuals, and the EU is expected to adopt additional negotiating directives on transitional arrangements in January 2018. The UK expects to be able to rapidly agree the detail with the EU in 2018,” says the statement.
The MHRA goes on to say that the EU is keen to establish a close future partnership with the UK, and that in return “The UK is fully committed to continuing the close working relationship with its European partners, in the interests of public health and safety. Its aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data.”
However, the MHRA says while both sides acknowledge the importance of a transition period, should no deal be struck on this the European Union (Withdrawal) Bill will convert the existing EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework.

The agency would take a “pragmatic” approach, by ensuring the companies had enough time to implement any new requirements and make every effort to ensure “minimum disruption and burden on companies as the UK exits the EU.”
The trade body for pharma, the Association of the British Pharmaceutical Industries (ABPI), said the MHRA’s statement was a welcome update.
It responded: "We share the MHRA and the government’s ambition for patients in the UK and EU to have continued access to best and most innovative medicines through a close working relationship with Europe, underpinned by the strongest regulatory framework and the sharing of data.
"This is an outcome we shall continue to work towards – yet, if such cooperation is unable to be agreed we welcome the MHRA’s intent to take a pragmatic approach. Planning for this scenario does, however, require further detail, and further highlights why a realistic implementation period needs to be urgently agreed.
"For patients and the public there are very real consequences of failing to get this right, and we will continue to work with our members, regulators, governments and the Commission to mitigate these risks. The complex issues surrounding medicines regulation and supply chain need to be front and centre in the second phase of talks."
 *Joint report on progress during phase 1 of negotiations under Article 50 TEU on the UK’s orderly withdrawal from the EU. Presented jointly by the negotiators of the European Union and the United Kingdom of Great Britain and Northern Ireland, December 2017.

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