UK Triggers Brexit: What’s Next for the UK, MHRA and EMA?

Posted 29 March 2017 By Zachary Brennan

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UK Prime Minister Teresa May on Wednesday set in motion the UK’s departure from the EU over the next two years, guaranteeing the European Medicines Agency (EMA) will see some significant changes over the next few years.

One of the biggest changes due to Brexit will be the departure of the EMA’s headquarters from London to another country in the EU (member states will decide the new location), though it’s still unknown where the headquarters will go and how UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and UK experts will continue to work with EMA.

An EMA spokesperson told Focus via email: "EMA is aware that this will set in motion the procedure described in Art. 50 of the Treaty on the Functioning of the EU which details the steps that must be followed in case a Member State notifies the European Council of its decision to withdraw from the Union. In any case, EMA’s processes and procedures in relation to the assessment of medicines will not be affected by the triggering of Art. 50.

"Concerning the future relations between EMA, MHRA and UK’s experts that work with the Agency, the full implications of the UK referendum are unknown at present. No country has ever decided to leave the EU, so there is no precedent for this situation and therefore we will not engage in any speculation," a spokesperson said.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) said in a statement on Wednesday: "EFPIA continues to underscore the importance of alignment between the UK and EU regulatory regimes in order to maintain capacity, processes and time-frames for the introduction of new medicines for patients and avoid divergence and duplication of regulatory standards and practices."

Those views were echoed recently in a UK government report on Brexit’s impact on trade, which urged "the Government to bring forward proposals for future collaborations with the EMA."

EFPIA also called on the negotiators "to make sure that the relocation of the EMA does not impact negatively on regulatory capacity, processes or timeframes for the approval of new, and the maintenance of existing medicines."

Negotiations over the next two years will decide how the UK’s pivot away from the EU will impact its ability to bring new pharmaceuticals and medical devices to market.

The UK BioIndustry Association said in a statement Wednesday: "We are now entering a two-year political negotiation that is likely to result in a period of press speculation, bombast and rhetoric. Early agreement on key issues like the regulation of medicines, the regime to enable non-UK nationals to work and contribute to the UK life science ecosystem, trade, finance support, market and intellectual property rules, would be the best way to ensure speedy and continuing global inward investment into the UK and EU."

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Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Crisis management, Government affairs, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC, MHRA

Tags: Brexit, EMA, MHRA, new EMA headquarters

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