UK Health Committee Probes Impact Of No-Deal Brexit On Medicines Supply
Executive Summary
The BioIndustry Association is planning to contribute to a UK parliamentary inquiry into the likely effects of a “no-deal” Brexit on healthcare and medicines supply, and has urged companies to notify the government of the state of their contingency plans.
A UK parliamentary committee is launching an inquiry into the effects of a “no-deal” Brexit, particularly the impact on patients and the health and social care system if the supply of medicines or medical devices is disrupted.
The House of Commons health select committee wants written submissions to the inquiry to be in by Oct. 15, with oral evidence and witnesses being heard at a later date. It particularly wants to hear from patient groups on the “extent of the potential risk to patient care” of any supply disruptions from the EU-27 to the UK, and would like to hear how effectively stakeholders and the government are planning for a no-deal scenario.
The BioIndustry Association plans to make a submission to the committee, its CEO Steve Bates said during a recent Brexit webinar. “They are seeking evidence and we plan to contribute. They will look at the no-deal notices, and we will be inputting into this with the ABPI [Association of the British Pharmaceutical Industry] on members’ behalf,” he said.
The inquiry is a follow-up to an earlier one conducted by the committee on “Brexit: medicines, medical devices and substances of human origin.” The committee identified a range of regulatory issues and called on the government to show how it intended to address them, but industry was not impressed, with the BIA saying it failed to provide the detailed answers necessary for the sector to make plans. (Also see "UK Biotech Not Impressed By Govt’s Response To MPs’ Brexit Concerns " - Pink Sheet, 25 May, 2018.)
“We encourage all participants to be as prepared as possible for a scenario that industry really does not want to see” - BIA CEO Steve Bates
Also on the medicines supply front, Bates noted that the deadline has now passed for pharmaceutical companies that supply the National Health Service from or via the EU to fill in a survey on “Medicines Supply Contingency Planning” in which they were to confirm whether they had a minimum of six weeks’ additional supply “over and above their business as usual operational buffer stocks.”
For products with short shelf-lives that cannot be stockpiled, the Department of Health and Social Care (DHSC) had asked companies to “ensure they have plans in place to air freight those products” and said it would also “consider how the department may support suppliers in making arrangements” for stockpiling and short shelf-life products.” The deadline for responses was Sept. 10.
Now that the deadline has passed, Bates said, the government is following up those companies that have not sent responses, and the DHSC will send a confirmation letter to those that have. He repeated his warning to the government that preparing for a no-deal Brexit would be a “massive challenge” for both industry and the UK regulator, the MHRA, and that “we encourage all participants to be as prepared as possible for a scenario that industry really does not want to see.”
“We are advising members to fill in contingency planning forms,” Bates said, noting that some companies are well prepared for a no-deal Brexit, others have triggered contingency plans, and others are in a wait and see position. Referring to the no-deal “technical notices” issued by the government, he said that “at least now you have some more detail you can chew on – there is quite a lot out there now on what no deal would look like. The big challenge is whether you think there will be a deal and what the timeframe would be. My sense is that people put it at 50:50 before and the odds are going up, but until a deal has been done it is very hard to call that one.”
Bates also noted that industry was still waiting for the launch of a formal consultation by the MHRA and the DHSC on the regulations that they would need to lay down in the event of a no-deal Brexit. “We were promised it in September but we have not seen it yet,” he said, although he added that “I imagine it will come very soon.” The proposed consultation was announced in the technical notice on medicines and clinical trials published in August, which stated that the MHRA would take on the regulatory functions currently undertaken by EU regulators, which would require legislative changes to the Human Medicines Regulations 2012. (Also see "UK's No-Deal Brexit Plans Revealed For Pharma Sector" - Pink Sheet, 23 Aug, 2018.)
He also said that the EMA had held a meeting on Brexit with industry last week, and that a key concern was that the agency was under “considerable strain” because of Brexit and the agency’s forced relocation to Amsterdam. “Agency leaders say they are no longer taking part in forward looking initiatives or international collaborations while they try to keep the basics going and keep the lights on. There is not much flexibility, if any, for companies, and I know that is the experience of BIA members,” Bates declared.
As for the BIA’s activities around Brexit, Bates said that the association's EU Relationship Group With Ministers held a “very useful” meeting on Sept. 13 to look at issues like contingency supply and the technical notices, and that the group will meet again on Nov. 5. He also noted that the European industry association coalition and the BIA/ABPI Brexit Lead Network met on Sept. 18 and 19 respectively.
Political Landscape
Looking at the broader political situation around the Brexit negotiations, Bates noted that the opposition Labour party, which opposes the “Chequers” deal put forward by prime minister Theresa May and is prepared to vote against it in parliament, is now saying that if it does not get a general election it must “support all options remaining on the table, including campaigning for a public vote." The shadow Brexit secretary, Keir Starmer, has also stated that “nobody is ruling out remain as an option.”
Bates said that almost 90% of Labour members support remain, according to YouGov polling, “although the Corbyn leadership is, I think, trying to triangulate between the Labour vote particularly in the north of England that voted for Brexit and cities like London which were vastly in favour of remain. This matters because if Labour can’t support the deal, they will vote for a general election and if they can’t get this, they may vote for a second referendum.”
He also examined the article penned in the Daily Telegraph by Boris Johnson in which the former foreign secretary argues that what is needed are “practical ways of sorting out what are - after all - “basically banal questions of bureaucratic procedure.” The UK, Johnson wrote, “seems to trade very smoothly and effectively with countries that are not in the EU; we used to trade smoothly with France and Germany before we joined the EU, and we can easily do so now.”
Bates said he was “not sure Boris is someone who spends the day looking at licensing requirements for medicines on both sides of channel or the need for batch testing and release. He seems to think this is all straightforward and easy to do. Not one I tend to agree with.”
This, he said, was “a crucial time. There is no progress on the timetable from the UK and the EU, there is some clarity on no deal, but not what we want, and UK politics is still febrile.”
From the editors of Scrip Regulatory Affairs.