HDA UK Media And Political Bulletin – 2 June 2017

Media Summary

Regulatory guidance for industry to prepare for the UK’s withdrawal from the EU
European Medicines Agency, 31 May 2017

The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies prepare for Brexit. The Q&A document covers centralised procedures, the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs), companies’ manufacturing and batch release sites. The EMA is preparing a series of additional guidance documents which will be published on its website in due course. Companies are therefore advised to check the EMA’s dedicated webpage regularly.

EU pharma agency warns of post-Brexit levies
Financial Times, Sarah Neville, 1 June 2017

The European Commission has warned that medicines made in Britain will be treated as imports by the EU in the event of a “cliff-edge” Brexit. They also caution that the life sciences sector will face a series of new regulatory obligations. A document issued jointly by the Commission and the European Medicines Agency also states that UK companies may have to set up some operations related to drug safety and approval within the EU to ensure their products comply with European requirements. Additionally, authorisation to sell a drug within the European Economic Area would have to be given by at least one member state’s regulatory body. The paper is a reminder of the issues that will arise if Britain and the EU struggle to reach agreements on regulation of various sectors post-Brexit.

Pharma firms told to plan for ‘hardest of Brexits’
The Daily Telegraph, Iain Withers, 2 June 2017

Unless a swift regulatory deal is struck with Brussels, the UK pharmaceuticals sector has been told to prepare for a “crisis” Brexit scenario of drastically reduced access to European markets and hundreds of millions of pounds of restructuring costs. The Association of the British Pharmaceutical Industry (ABPI) told The Daily Telegraph that new regulatory guidance published by the European Medicines Agency (EMA) this week posed a risk to UK pharmaceutical jobs and to public health on both sides of the Channel. The EMA paper also warned that the UK will face a sharp rise in regulation and stringent checks on medicine exports from March 30, 2019.

Parliamentary Coverage

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Full Coverage

Regulatory guidance for industry to prepare for the UK’s withdrawal from the EU
European Medicines Agency, 31 May 2017

EMA and the European Commission publish first in a series of Q&As for companies.

The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies to prepare for the United Kingdom’s withdrawal from the European Union. The guidance relates to both human and veterinary medicines.

The questions-and–answers document concerns information related to the location of establishment of a company in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies’ manufacturing and batch release sites.

EMA is preparing a series of further guidance documents which will be published on its website in due course. Companies are advised to regularly check EMA’s dedicated webpage on the consequences of Brexit.

This first questions-and-answers document follows the publication of the European Commission/EMA notice to marketing authorisation holders of centrally authorised medicines for human and veterinary use on 2 May 2017.

Pharma firms told to plan for ‘hardest of Brexits’
The Daily Telegraph, Iain Withers, 2 June 2017

THE UK pharmaceuticals sector has been told to prepare for a “crisis” Brexit scenario of drastically reduced access to European markets and hundreds of millions of pounds of restructuring costs unless a swift regulatory deal can be struck with Brussels.

Trade body the Association of the British Pharmaceutical Industry (ABPI), which lobbies for the 60,000-strong sector, told The Daily Telegraph new regulatory guidance published by the European Medicines Agency (EMA) this week posed a risk to UK pharma jobs and to public health on both sides of the Channel.

The EMA – one of the two EU regulatory bodies based in the UK that is expected to move to the continent – issued a paper detailing how firms should prepare for Brexit. It advised UK-based firms to move hundreds of roles and functions to an EU member state ahead of Brexit to maintain their rights to sell medicines in the common market.

The paper also warned that the UK faced a sharp hike in regulation and stringent checks on medicine exports from March 30, 2019. Dr Virginia Acha, executive director of research, medical and innovation at ABPI, estimated the costs of taking up the EMA’s guidance would run to “hundreds of millions of pounds”.

But she cautioned that the EMA document outlined only one scenario, “the hardest of hard Brexits”, and highlighted the “critical importance” of politicians, regulators and companies working to strike a compromise deal.

The EMA is currently based in London’s Docklands and employs around 900 people.

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