UK No-Deal Medicines Regulation Under Threat As Brexit Chaos Grows
Executive Summary
Draft regulations on medicines and medical devices could get caught up in the chaos that seems about to engulf the UK parliament as opposition MPs attempt to avert a no-deal Brexit.
The UK government’s decision to suspend parliament for five weeks raises the possibility that draft laws on the regulation of medicines in a no-deal Brexit situation could be rushed through without proper parliamentary scrutiny or even not passed at all before 31 October, industry sources fear.
This week will be a crucial one for the government and lawmakers, as opponents of a no-deal Brexit try to pass legislation preventing such an outcome in the little time remaining before parliament is suspended, or “prorogued,” from 9 or 12 September until 14 October.
The draft legislation, which was released today and is expected to be debated on 3 September, will aim to ensure that the UK does not leave the EU on 31 October without an agreement unless parliament agrees. Hilary Benn, Labour chair of the House of Commons Brexit committee, said the bill would "give the government time either to reach a new agreement with the European Union at the European Council meeting next month or to seek Parliament's specific consent to leave the EU without a deal."
The move is expected to lead to an unprecedented showdown between parliament, where a majority of MPs oppose a no-deal exit, and the prime minister, Boris Johnson, who has said the UK will depart on 31 October “do or die” – ie, with or without a withdrawal deal.
Although the government has said it will look at any legislation passed by parliament, Michael Gove, the cabinet minister responsible for no-deal Brexit planning, has refused to confirm the government will abide by that legislation. The shadow Brexit secretary, Sir Keir Starmer, said: “For ministers not to confirm that this government will accept and comply with legislation lawfully passed is breathtaking.”
Johnson has also threatened that any Conservatives who backed the proposed legislation and voted against the government would have the whip withdrawn and could no longer stand as Conservative candidates in an election. This would have the effect of eliminating the government’s parliamentary majority of one and could make an early general election more likely.
The New Medicines Regulations
In the midst of this chaos it is uncertain what will happen to the existing draft legislation that would allow the UK to run its own freestanding medicines and medical devices regulatory system following a no-deal Brexit.
Earlier this year, the government published two draft “statutory instruments” – the Human Medicines (Amendment etc) (EU Exit) Regulations 2019 and the Medical Devices (Amendment etc) (EU Exit) Regulations 2019. (Also see "How The UK Regulatory System Would Work In A No-Deal Brexit – Part 1" - Pink Sheet, 28 Jan, 2019.)
These are intended to amend the current medicines rules to replicate many of the provisions of existing EU legislation and ensure that the UK medicines regulator, the MHRA, can assume the responsibilities currently undertaken by the EU regulatory network. Areas affected include issuing marketing authorizations for new drugs, incentivizing the development of medicines for children and rare diseases, and operating the pharmacovigilance system.
In July, another draft SI was published: the “Human Medicines (Amendment etc) (EU Exit) (No 2) and the Medical Devices (Amendment etc) (EU Exit) (No 2) Regulations 2019.” This corrected a number of “drafting defects and omissions” in the original amending regulations to “make sure that the published policy in relation to the regulation of human medicines and medical devices in a no deal EU exit scenario is properly reflected in those instruments” and that the regulations are “fit for purpose in a no deal EU exit.” (Also see "UK Brushes Up No-Deal Brexit Legislation " - Pink Sheet, 26 Jul, 2019.)
This latest statutory instrument was originally tabled as a “negative” SI – ie, one that becomes law unless the House of Commons objects – but it was later upgraded to an “affirmative resolution,” which requires approval by both houses of parliament (although neither house can amend it, and can only approve or reject it).
It is not year clear when the SI might come before parliament. The House of Commons confirmed that the SI has been listed in the “Remaining Orders and Notices” part of the future business section of the House of Commons Order Paper, meaning that no date has yet been scheduled for it to be examined.
Given that parliament is to be suspended next week until it resumes on 14 October, a little over two weeks before the Brexit date, there are concerns within industry that the SI may not make it through the parliamentary process because of the lack of time and the amount of other legislation that is supposed to be passed before Brexit.
Alternatively, it could be rushed through with a host of other laws without proper scrutiny of the changes made to the medicine regulations. The fear is that either eventuality could lead to a situation where, in the event of a no-deal Brexit, the industry in the UK is operating in a legally uncertain environment.
'Get Ready For Brexit'
In the meantime, the government has launched a publicly funded “Get Ready for Brexit” advertising campaign that will include television, radio, newspaper and online advertisements advising people to visit the official government Brexit web page to find out what they may need to do in a no-deal scenario. The https://www.gov.uk/get-ready-brexit-check website can be used to find out what individuals or businesses need to do to prepare.
In addition, Her Majesty’s Revenue and Customs (HMRC) has announced that a live webinar will be broadcast each working day from 4 to 13 September to provide “an overview for UK businesses involved in the movement of goods between the EU and the UK” so that they can “find out what you need to know to keep importing and exporting.”
Among other things the webinar will discuss the importance of applying for an Economic Operator Registration and Identification (EORI) number, how to pay the correct customs duty and VAT, how to prepare to make customs declarations, and what “transitional simplified procedures” and “entry summary declarations” are.