Manufacturing, Politics, Regulatory, UK Biotech

Novartis sounds alarm on unsustainable drug supply chain if no-deal Brexit becomes reality

With the UK parliament no closer to finding a way to agree on a Brexit deal, the heightened prospect of a no-deal divorce has triggered Swiss drugmaker Novartis to urge Britain’s lawmakers to come up with a sustainable way to preserve the pharmaceutical supply chain, saying it has begun stockpiling so UK patients have undisturbed access to the 120 million packs of medicines the company makes for the region each year.

A chaotic no-deal departure could be catastrophic for UK patients, as 73% of pharmaceutical imports come in from the EU, according to a House of Commons report published last year. The EMA, which originally had its main office in London, is shifting the headquarters to Amsterdam this year. “Without a continued relationship, there is a significant risk of the UK being a second-tier state for new and innovative medicines. We conclude that there are no benefits from regulatory divergence…A divergent regime could see extra costs of £45,000 for each new medicine released in the UK, making the UK an unattractive small market for specialised medicines, and risking the loss of access entirely to some products,” the report concluded.

In August 2018, the UK health secretary Matt Hancock asked drug suppliers to keep six weeks worth of medicines stockpiled in addition to their buffer stocks. Earlier this week, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said that in the event of a no-deal, the UK would be no longer be part of the EMA umbrella, and that regulatory submissions for drugs would be made directly to the MHRA.

Major British drugmaker GSK has also taken measures to mitigate the disruption and uncertainty of Brexit. Their contingency plan is focused on their supply chain, and the company is expanding its ability to re-test and certify medicines; amend manufacturing and importation licences; and secure additional warehousing. These changes, GSK estimates, will cost the drugmaker up to $70 million in the next two to three years, it has said.

In its statement on Friday, Novartis said it sought clarity over customs arrangements, both to and from Europe, and to minimize disruption at borders.

Given the complex nature of the supply chain, Government needs to implement a comprehensive continuity plan rapidly that includes relevant departments beyond the Department of Health and Social Care and the NHS, to ensure medicines can reach patients in the event of a no-deal Brexit.


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