Brexit - What will the impact be?
With less than 100 days to go to Brexit what should the UK Pharmaceutical industry expect?
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Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.
There may not be a great deal in the new UK-EU trade and cooperation deal for the life sciences industry but a new working group could act as the forum for constructive discussions on regulatory cooperation.
Government and industry in the UK are determined to make the best of the Brexit free trade deal, but German medtechs are eager for trade flow practicalities to be prioritized.
In today’s globalized market for medicines, national rules on pricing and access are abundantly shared and more transparent than opaque. In Vivo speaks to the UK branded industry’s negotiator for the latest five-year joint pricing pact with the government, Richard Torbett, who outlines, among other topics, five widely applicable precedents from the talks that can work in “getting to yes” – despite the fractious budgetary climate for health care evident in all major country markets.
Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.
Building more cold chain warehouses, finding alternative sources of medicine supplies, and halting parallel exports to mitigate product shortages. Just some of the ideas for tackling the consequences of a no-deal Brexit scenario put forward by industry representatives at a recent parliamentary committee hearing.
There has been quite a lot of conjecture over whether UK notified bodies would have to cease their CE marking operations on Brexit day, 31 January, or whether they would be able to continue until the end of the EU/UK withdrawal agreement. BSI's Gary Slack explains that BSI, for one, is still open for business.
Although the EU MDR and IVDR will fall outside the scope of new post-Brexit medtech regulations for Great Britain in 2021, the UK MHRA says it has the chance of developing its own world-leading regulatory regime.
As negotiators struggle to reach agreement on the future UK/EU relationship following Brexit, suppliers have been warned to expect major hold-ups next year for medical products crossing the English Channel.
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