Any disruption to the flu vaccine supply pipeline sparked by “new and complex” customs arrangements in the wake of a Brexit, could have a negative impact on its time critical process, with implications for public health, a pharmaceutical company has warned.
Sanofi, which has already been making arrangements to stockpile its drugs and other medicines, revealed this week that it was also investigating the option of flying in supplies of flu vaccine to ensure it is “available to people within the UK when they need them”.
“Any delays from new and complex customs arrangements could impact this process and have implications for public health”
Managing director of the company’s UK branch, Hugo Fry, highlighted to Nursing Times that flu vaccines, unlike most others, were manufactured specifically each year, as per recommendations from the World Health Organization.
He said that the influenza vaccines were typically ready for distribution in August and September, which he said already left a “limited window” to vaccinate around 25 million people in the UK between October and January.
With Brexit looming, Mr Fry warned: “Any delays from new and complex customs arrangements could impact this time critical process and have implications for public health.”
Under current pre-Brexit arrangements, Sanofi’s main route of vaccine transportation is via ferry from Calais to Dover, he noted.
“However, we are actively assessing and validating alternative routes into the UK to ensure we are able to provide continuity of supply, should the Calais and Dover route become subject to extensive delays,” he told Nursing Times.
“Our priority is to ensure our medicines and vaccines are available to people within the UK when they need them”
“We are also exploring options for air freight, should we need to use it,” he said. “Our priority is to ensure our medicines and vaccines are available to people within the UK when they need them.”
Mr Fry also promised that the pharmaceutical company has “no intention at all to pass any Brexit related costs” to healthcare professionals.
In a further statement, Sanofi explained that its main “priority” was to ensure that people in the UK have “continued access to the medicines and vaccines they need”.
“Sanofi is working to ensure that Brexit does not negatively impact the regulatory capacity, processes and time-frames for new and existing medicines and vaccines reaching European and UK patients and citizens,” the statement said.
The company went on to explain how uncertainties surrounding Brexit negotiations has meant that it has been planning for a ‘no deal’ scenario, following recommendations from the European Federation of Pharmaceutical Industries and Associations (EFPIA), to do so.
Arrangements have also been made for an additional warehouse capacity in the UK to stockpile the medications and vaccines, where global supply allows.
It is also planning to increase UK-based resource to prepare for any changes to customs or regulatory processes, the statement noted.
“We reviewed our stockpiling plans to meet the government’s guidance to increase UK stock by six weeks over existing arrangements”
Sanofi said it welcomed the UK government’s initial guidance in the event of no deal in the Brexit negotiations, which was published back in August 2018.
“As a result, we reviewed our stockpiling plans to meet the government’s specific guidance to increase UK stock by six weeks over existing arrangements for a majority of products, where global supply allows,” the company stated.
Furthermore, Sanofi explained that after additional information was provided by the health secretary in December last year, it was “continuing to do everything [it] can to ensure access to medicines and vaccines whatever the Brexit scenario”.
“This includes duplicating processes, establishing multiple new supply routes and stockpiling in line with the government’s guidance,” it said. “We are confident that these contingency plans will ensure that people in the UK can access the treatments they need after the UK leaves the European Union.”
Sanofi said it was currently in weekly contact with the Department of Health and Social Care to update the government on the status of its stockpiling plans.
“Additionally, the secretary of state has written to the whole NHS to reassure healthcare professionals that they do not need to issue extra prescriptions as stockpiling arrangements are being taken care of by the pharmaceutical industry,” it stated.
As reported by Nursing Times in February this year, crisis planning to prevent the UK being left without sufficient medical supplies in the event of a no deal Brexit was being stepped up as the original deadline day of 29 March, this Friday, loomed.
At the time, health minister Stephen Hammond confirmed that three-quarters of medicines and over half of the clinical consumables such as needles and syringes used here come from or via the European Union.
The main risk to supply was traffic flow problems between the ports of Calais and Dover or Folkestone, he said in a written statement.
In preparation for a no deal, the Department of Health and Social Care made contingency arrangements that it said would kick in after the UK split from the EU.