Regulation of medical devices, clinical trials and medicines in the UK can’t avoid the six-letter word that is Brexit.
We’re still dealing with hypotheticals as the latest deadline for the UK’s withdrawal from the bloc on 31st October looms larger by the day, and the prospect of no deal with the bloc seems more real with Boris Johnson’s recently formed government apparently more open to that particular prospect.
For me, this is illustrated by the government’s preparedness to blame the European Union 27 to not reopen discussions surrounding the Withdrawal Agreement. The EU has repeatedly said the deal can’t be renegotiated, as the Northern Ireland protocol or ‘the backstop’ seems to be a contentious issue for those who championed a Leave vote the most.
Analysis about the integrity of the Good Friday Agreement that the deal is trying to protect can be read by more qualified authors than someone who studied it for a year, and now writes about life sciences.
Brexit as a result touches everything about life sciences and medtech. It was touched upon at the recent ‘Healthcare Disparities’ event I attended at the University of Manchester, that rules, regulations and laws are a contentious issue, but so are the practicalities of a just-in-time supply chain that covers the manufacture of devices and medicines.
During a recent Westminster Health Forum, Julian Maitland-Walker, senior partner at Maitland Walker, covered various aspects during his presentation that would affect suppliers, manufacturers and the NHS over Brexit – questions that are still unanswered less than two months from when the Prime Minister has pledged the UK will withdraw from the EU with or without an agreement.
He did state from the outset that ‘Brexit constitutes a current and continuing disaster for the UK health sector, almost whatever happens. Whether we have a hard or soft Brexit’.
On medicines, Maitland-Walker said: “There are some drugs that are just not available in the UK from the manufacturer or from an importer, and which can only be sourced through parallel trade. If there’s a restriction on parallel trade as a result of Brexit then those will not be available to patients.”
Dr Jayne Spink, chief executive officer, Genetic Alliance UK voiced similar concerns in her presentation focussing on the access UK patients would have to clinical trials, stating: “Our expulsion from the EU medicines regulatory system and the incentives of the centralised processes for medicines approval could result in a diminished opportunity for UK rare disease patients to participate in clinical trials and access new treatments.
“Our best hope is that a mechanism will be found that enables and promotes collaboration and coordination at the level of research and of regulation and of funding.”
Then there’s the question of uncertainty, which isn’t limited to the sectors covered by this publication and its sisters. If Johnson follows through on his pledge, then there will at least be some certainty by the time trick or treaters are out – and industry will likely deliver its verdict on which category the Conservative Party falls into following their handling of the process.
Mitigating any disaster from the fallout of Brexit, Maitland-Walker suggests, will mean closely aligning with the EU regulatory framework.
But the cost will still result in manufacturers going through licensing processes and being more likely to go for the larger European market as opposed to the UK first. The loss of the European Medicines Agency, also highlighted during one of the Healthcare Disparities lectures, means there’s a loss of R&D – and a reliance on government to fill that particular void.
It appears there are two options available. It will either involve close regulatory alignment which, in the short term at least, will be widely regarded as a pointless withdrawal, or an overnight change that could lead to potential wreckage. What joy awaits in the promised land!
