The UK government has begun rushing swathes of emergency legislation through Parliament, which would allow medicines regulation to function in the event of a no-deal Brexit.
The government is using secondary legislation called statutory instruments (SIs) to create a legal framework quickly should the UK crash out of the EU without a deal on 29 March, now just 37 days away.
Plans for a new standalone medicines regulation system were drawn up late last year by the UK’s regulator the MHRA, and replacements for decades of EU legislation have had to be hastily drafted in a matter of months.
SIs have been laid before Parliament covering four key areas: a serious shortages protocol, medicines regulation, clinical trials and medical devices.
This week government ministers have begun the process of gaining rapid approval from MPs in the House of Commons – all the while maintaining that they hope a deal can still be struck to avoid a no-deal scenario, and allow the UK to enter a transition period stretching until at least December 2020.
The UK’s pharma industry organisation the ABPI and its biotech equivalent the BIA continue to call for a no-deal Brexit to be avoided at all costs, but at the same time must take seriously the prospect that this new legislation may have to come into force.
The BIA’s chief executive Steve Bates says it is now clear that a no-deal Brexit would mean total duplication of regulation in the UK outside the EU.
This would mean new red tape and expense for pharma, biotech and medical devices companies, a move which the BIA has always warned would see the UK become a market of secondary importance.
Speaking on the BIA’s latest Brexit webinar on Friday, Bates (pictured) said:
“There is a great deal of detail now in the public domain from the government which shows that they are suggesting expensive duplicative red tape and an impact for NHS patients.”
The BIA chief executive has maintained a matter-of-fact approach to Brexit since the referendum in June 2016, but has also made clear that he sees Theresa May’s choice as being between honouring the ‘will of the people’ and maintaining Conservative party unity versus doing what is best for the country economically.
Among the many SIs, the sector raised particular concerns about new regulations governing supplementary patent certificates (SPCs) last week, and gained assurances that laws would be more carefully re-drafted if the UK does leave without a deal.
Research commissioned by the BIA from the Office of Health Economics (OHE) two years ago suggested that the UK would join nations such as Australia, Canada and Switzerland in a ‘tier two’ of markets after the US, EU and Japan. It found that 45% of marketing authorisation applications submitted to the EMA during 2013-2015 had not been submitted to these three countries by the end of 2016, as well as filings on average 2-3 months later than the EU.
Bates says that in ‘normal times’ such proposals would be strongly opposed by a Conservative party traditionally known for being pro-business, but said Brexit had trumped these considerations.
“We really are in a world upside down position,” he said.
Above all, the BIA and ABPI are keen not to ‘talk down’ the UK life sciences sector, and continue to stress its world leading expertise in academic research, industry R&D, and its burgeoning biotech sector. Last year UK biotech raised more funds than anywhere else in Europe, and just behind the US hubs of Boston, San Francisco and San Diego.
The UK sector is also keen to highlight the incentives government departments such as the Office of Life Sciences (OLS) have created via the Life Sciences Sector Deal.
However it seems very likely that the protracted and chaotic Brexit process will make the UK less attractive to international investment. The news yesterday that Honda will close its UK car manufacturing by 2021 was a major blow, and though Brexit was not the number one reason for its decision, expert commentators say it would have added to the decision.
Any such impact is yet to be seen in life sciences, but the sector is focused on ensuring its medicines can reach UK patients after Brexit, and therefore can’t be seen to be disinvesting in the country before then.
Despite the brinkmanship tactics being employed by Prime Minister Theresa May, there is still a belief that no-deal will be avoided.
Bates is sticking by his recent prediction that the most likely next move will be an extension to the Brexit deadline.
“I still think that we will see before the end of March an extension or a delay to Brexit, and I think that will either be because there is a mooted deal or talks to get to a deal.”
This is the BIA chief executive’s best guess not least because even if a deal is agreed at the eleventh hour by the UK parliament, it still needs to be ratified by the European parliaments and then be turned into UK and EU law – processes for which there is barely any time left.
May is to resume talks with the EU this week, still hoping to secure concessions to reassure the Brexiteer wing of her party on the crucial sticking point of the Irish backstop – even though the EU27 has made it clear nothing new of substance can be offered.
The government is expected to call another Commons vote on the proposed deal next Wednesday 27 February.