LONDON – The U.K. government told the industry to maintain its readiness for a no-deal Brexit Tuesday, as it was forced to ask the EU for another extension after failing to get a revised withdrawal bill through Parliament.

Following a briefing from ministers on Tuesday, Steve Bates, CEO of the Bioindustry Association (BIA), said he expected to receive a letter confirming the Oct. 31 deadline has been pulled – but that no-deal planning should be continued.

The industry was told to hold onto the stockpiles of the three months' supply of medicines and other health supplies it was instructed to build, and to accelerate preparations for new customs regulations.

For its part, the government said it will maintain freight contracts it has put in place to expedite medicines imports in the event of a no-deal Brexit.

Bates said the situation "is clear as mud, as usual." The latest twist in the saga came after Prime Minister Boris Johnson failed to get a parliamentary approval for revised withdrawal agreement he negotiated to replace that of his predecessor, Theresa May, which was voted down three times.

Parliament agreed to the alternative negotiated by Johnson being put before it, but voted against the proposed timetable, which would have allowed only three days of debate on the complex legal agreement.

That left Johnson, who had said the U.K. would leave on Oct. 31, "do or die," forced to request more time. The EU has extended the leaving date to at least Jan. 31, in what it termed a "flextension." That means if Parliament votes through the withdrawal agreement before then, an orderly Brexit can happen sooner.

The prospect is unlikely, however, because after repeated prevarication, all the main political parties have agreed to a general election in early to mid-December. Parliament will not be sitting during the election campaign, and with Christmas intervening, even if Johnson were to win a majority, there will be scant time to bring the withdrawal agreement back.

"There is now the looming prospect of an election, so more uncertainty. We will have to prepare again for a new deadline," said Bates. "We will be looking at a rerun of the same for January 31, with a general election, then Christmas, so only a few weeks and not much chance of significant change."

Even if the withdrawal agreement negotiated is voted through Parliament in the new year, there will remain the possibility of no-deal crash-out from the EU at the end of 2020, if a new trade EU/U.K. trade deal is not signed off by then.

Johnson deal complicates drug regulation

The main sticking point over May's deal was how to keep open the border between the Republic of Ireland and Northern Ireland, which is the only land border between the EU and the U.K.

The sleight of hand introduced in Johnson's renegotiated deal to do that, thus avoiding checks on the island of Ireland, is for Northern Ireland to be legally part of the U.K. customs union, whilst at the same time, there will be customs checks on goods coming into Northern Ireland from the U.K., and vice versa.

That did not go down well with unionist politicians in Northern Ireland, who want the province to remain fully a part of the U.K. Ten members of the pro-Brexit Northern Ireland Democratic Unionist party, who have been propping up Johnson's minority government, withdrew their support.

As Bates noted, the proposal of a border in the Irish Sea also has implications for drug regulation. The Medicines and Healthcare products Agency (MHRA), the regulator for both Northern Ireland and the rest of the U.K., would in this new deal have to operate under two jurisdictions, with EMA rules in Northern Ireland and U.K. rules in the U.K.

Given that, it is hard to see that the U.K. would be a pure third country to the EU in terms of medicine regulation. For example, the MHRA could not oversee drugs regulation in Northern Ireland if it does not have access to EU databases on clinical trials applications, pharmacovigilance and medicines verification.

"There now needs to be a detailed technical discussion on how this would operate," said Bates. "This is a new issue which we will pick up with colleagues in Brussels."

Bates was speaking at the last of a series of government-funded events around the U.K. the BIA has staged to help members prepare for the Oct 31. withdrawal date. In snap polls of members at these events, most said they expected the Oct. 31 deadline to be postponed. "You have been proved right," Bates said.

The government has ordered coins minted to celebrate the Oct. 31 withdrawal from the EU to be melted down and put the £100 million (US$128.6 million) Brexit communications campaign on hold. No deal contingency plans activated on Monday were deactivated Tuesday.

While frustrated that deadlines for leaving the EU have come and gone – on March 29, and now at the end of this month – Bates insisted the effort that has gone into preparations is not redundant. "It's unlikely the shape a no-deal Brexit will change much in 90 days, or by the end of next year," he said.

There is now a "repository of no-deal knowledge" that BIA will curate for future reference. "It will be useful if we have to dig this out the other side of Christmas, or at the end of 2020," said Bates.

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