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24 August 2018Big Pharma

No-deal Brexit: MHRA would take on EMA functions for UK

The UK will fall outside of the European Medicines Agency (EMA) in the event of a no-deal Brexit, leaving the Medicines and Healthcare Products Regulatory Agency (MHRA) to take on the functions currently undertaken by the EU for medicines on the UK market.

That was confirmed in the government papers released yesterday, August 23, which provide guidance on how to prepare if there is no deal agreed when the UK leaves the EU in March 2019.

The EMA, which is responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines, is moving from London to Amsterdam in March 2019.

More work is required on the regulatory aspects, and consultations are promised—the MHRA is planning a public consultation in early autumn on some of the key proposed legislative changes to allow the agency to take on the functions.

Additionally, medicines authorised by the EU as centrally authorised products will be converted automatically to UK-authorised products and transitional provisions will cover EU authorisations that are pending on exit day.

The papers stress that negotiations are progressing and a no-deal scenario “remains unlikely given the mutual interests of the UK and the EU in securing a negotiated outcome”. More notices will follow in September.

Dominic Adair, partner at Bristows, explained: “One can already see the problems caused by uncertainty here: what good is preparation time if we don’t know whether there will be a deal or not? Perhaps it is assumed that businesses will be pessimistic and prepare in any event.”

Additionally, the UK government has asked drug makers to ensure they have an additional six weeks’ supply of medicines stocks in the event of delays caused by a no-deal Brexit.

In a letter to pharmaceutical companies, Matt Hancock, health and social care secretary, said that supply chains could be affected by border processes and procedures and that the government is now seeking evidence of the contingency plans through a survey.

Steve Bates, CEO of the UK BioIndustry Association, said that endeavouring to deliver on the stockpiling in less than 200 days will be a “massive challenge" for industry.

He added: “On behalf of patients, we encourage all participants to be as prepared as possible for a scenario [that] industry really does not want, but we should be under no illusions that this will be easy or smooth.”

For Adair, one of the most interesting points in the paper on medicines is the comment from the government on parallel trade.

The government will unilaterally align to the EU/EEA exhaustion regime in order to provide continuity as a short-term measure. This will allow for the parallel trade of products already placed on the EU market by the rights owner or with its consent.

“This ‘no change’ promise is made as a ‘temporary fix’ pending consideration of all options for exhaustion of rights in relation to which a full research programme and consultation is promised. I think this is the first time we have seen statements on exhaustion of rights,” added Adair.

Sister site WIPR reported that although the exhaustion statement was made in the context of the pharmaceutical sector, it seems to apply across all industries, although it is uncertain how long the principle would apply for.

Speaking to WIPR, Bird & Bird associate Tristan Sherliker said that the exhaustion promise suggests the government’s IP policy and plans have been “moving forward behind the scenes in the last few weeks, so we are likely to be seeing the first glimpse of a wider picture”.

Adair concluded: “The default position remains: no immediate change, but consultations will follow. Hence it is impossible to predict the long-term impact of a no-deal scenario. Much will depend on the outcome of the consultations that follow.”

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4 October 2018   The UK’s Medicines and Healthcare Products Regulatory Agency is seeking industry views on a no-deal Brexit scenario.
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8 January 2019   The UK government has published further guidance on the regulation of medicines, medical devices and clinical trials in the event of a no-deal Brexit.
Europe
8 July 2019   The European Medicines Agency has ended a Brexit legal dispute over its Canary Wharf, London headquarters.

More on this story

Big Pharma
4 October 2018   The UK’s Medicines and Healthcare Products Regulatory Agency is seeking industry views on a no-deal Brexit scenario.
Big Pharma
8 January 2019   The UK government has published further guidance on the regulation of medicines, medical devices and clinical trials in the event of a no-deal Brexit.
Europe
8 July 2019   The European Medicines Agency has ended a Brexit legal dispute over its Canary Wharf, London headquarters.