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Medicines

Launch of new medicines in UK face two-year delay post-Brexit, MPs told

The launch of new medicines in the UK may be delayed by two years after Brexit as it is “relegated” in the global medicines market, MPs on the House of Commons Health Committee were told on 12 December.

The predicted delay will also have a “significant” knock-on effect on the UK’s involvement in clinical trials.

“If medicines are going to be delayed by two years, then standards of care will change. And if your comparator is unlikely to be available in the UK, why would you set up a clinical trial here?” Leslie Galloway, chair of the Ethical Medicines Industry Group, a trade association for life science companies, told MPs.

Galloway was giving evidence to the committee’s ongoing inquiry into the impact of Brexit on the medicines supply chain, and on medicines and devices regulation.

Galloway’s warnings were endorsed by Steve Bates, chief executive of the BioIndustry Association, the trade association for the sector. He said he was worried that, post-Brexit, the UK would no longer have access to new medicines — including generic products — which would have “implications for the NHS”.  

Funding streams — from both the private and public sectors — essential to maintain a “vibrant life sciences sector” were also at risk, according to Bates.

Uncertainty over the future regulation of medical devices because of Brexit was creating anxiety in the sector, Suzanne Halliday, head of medical devices at the British Standards Institution, told MPs.

A no-deal Brexit would be “devastating for patients” in terms of access to new medical devices. “It could mean no access to any [new] medical devices after March 2019,” she admitted.

Some device manufacturers were already moving their manufacturing out of the UK to Switzerland and to Ireland, she revealed.

At the same time drug companies were also moving their marketing authorisation to “mainland Europe” because of Brexit, Galloway added. “They will not come back to the UK,” he warned MPs.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20204114

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