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Pharma industry swamped with no-deal Brexit info, says BIA

Deluge comes just as prime minister hints at delay


The UK pharma industry is being inundated with information on how it will be asked to operate in a no-deal scenario as the Brexit process enters “unprecedented political waters,” says the BioIndustry Association (BIA).

BIA chief executive Steve Bates says in a blog post that there has been a rapid increase in no-deal planning by the government over the last month as UK politicians “continue to discuss various Brexit scenarios – and put off making key decisions.”

The comments came amid a tumultuous couple of days, with rebel MPs resigning from their parties, ministers openly defying government policy, Labour intimating that it might back a second vote on Brexit if its own plans are rejected, and Prime Minister Theresa May – for the first time – conceding that Brexit may have to be delayed beyond 29 March.

“We now expect any ‘meaningful vote’ in Parliament to be delayed until or by 12 March but will watch closely the debate this week in the House of Commons that could force the government’s hand,” says Bates.

Stephen Hammond

Health minister Stephen Hammond

This week, minister of state for health Stephen Hammond provided a written statement on plans to ensure the continuity of medicinal product supply in the event the UK exits the EU without a deal.

After analysing the supply chains of 12,300 medicines, almost half a million devices and clinical consumables, vaccines and essential non-clinical items “we are confident that, if everyone…does what they need to do, the supply of medicines and medical products should be uninterrupted,” he says.

Among the measures taken is medicine stockpiling, along with contracts for additional warehousing to store the products, plus additional ferry and airfreight services. There’s no mention however of a “dire shortage” in EU-compliant pallets in the UK, as detailed in a Guardian report, which suggests this could scupper the import and export goods as the UK currently has a waiver on standards designed to prevent the transmission of pests.

Last week, the government wrote to marketing authorisation holders (MAHs) in the UK to provide operational information about shipping routes between the EU and the UK and the new warehousing, including a registration system that will allow companies to book ferry tickets for the government chartered ferry capacity in the event of no-deal.

There’s grim reading in other documents released by the government this week – after repeated requests by former Conservative MP Anna Soubry – which suggest that the UK economy will be 6% to 9% smaller over the next 15 years in the event of no-deal. They also suggest almost a third of “critical” contingency plans are behind schedule, and reveal that just six of 40 planned international trade agreements have been signed.

Batch testing update

One of the big concerns for industry has been the topic of batch testing, as the European Commission requires that any drugs released into the EU market have testing carried out within an EU member state.

The Commission has confirmed that the process of confirming that every batch of medicines has the correct composition through lab testing will still have to take place within the EU27, However, it does allow some flexibility, according to the BIA,

Specifically, for a “limited time” companies will be able to rely on UK-based testing, provided a batch release site in the EU27 is identified by the MAH by the withdrawal date and a qualified person established in the EU27 supervises the release.

It also says the establishment designated by the third party conducting the quality control testing should be verified by a competent authority of the EU27, including on the spot checks, and all necessary steps should have been taken to prepare the transfer of the quality control testing site from the UK to the EU27.

Article by
Phil Taylor

27th February 2019

From: Regulatory



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