The number of medicines recalled by manufacturers owing to defects has increased by 153% in the UK since 2017, with relaxed regulations during COVID being one possible factor behind the surge.
Official data from the Medicines and Healthcare products Regulatory Agency (MHRA) shows that whereas 68 medicines were recalled in the UK between 1 January 2014 and 1 January 2017, the numbers rose dramatically between 1 January 2020 and 1 January 2023 to 172.
Life Sciences lawyers at Arnold & Porter (London) said there were a number of factors that could be fuelling the increase, but that changes to regulations during the COVID years might have contributed.
Commenting, Jacquleine Mulryne, Life Sciences Partner at Arnold & Porter, said: “COVID may be a factor. Manufacturing operations were substantially impacted by the lockdowns and, given the now global supply chains, this affected many products."
"The MHRA allowed various temporary flexibilities in the regulation of medicines and medical devices to support the supply chain and wider response to COVID-19. In addition, many inspections were delayed during this time, so there was then a catch-up from 2021 onwards. This could have led to an impact or increase in recalls when inspections/operations restarted.”
Other factors include the recall of medicines containing pholcodine, a cough suppressant found in some syrups and Night Nurse. Arnold & Porter notes that “pharmacovigilance” rules were updated in 2012, making the guidance and procedures around medicine safety more robust.
Mulryne said: “These requirements include, for example, signal detection and robust action when safety issues arise. With increase product vigilance by both companies and authorities, an increase in subsequent recalls is likely.”
The presence of nitrosamines, chemicals more commonly found in tobacco products or processed meat, also played a role. This was first discovered in 2018 and has led to some recalls.
Sanctions and court
Although there is no penalty simply because a medicine needs to be recalled, Arnold & Porter points out that safety issues with a medicine can lead to criminal sanctions in the most extreme cases or litigation.
Mulryne says: “Safety issues may lead to a variation, suspension or revocation of the marketing authorisation before the product can be returned to the market — assuming that it’s considered appropriate."
"If necessary, the authorities can bring enforcement action if they believe the regulatory requirements have not been met, which could ultimately lead to sanctions (including a fine or imprisonment of up to 2 years if company directors are personally liable)."
The fact that the company initiated a recall does not change these possibilities, although it may mean the authorities are less likely to bring enforcement action if the company has co-operated with them.
“The recall of a product is often linked to a defect or quality issue. This can lead to potential regulatory action against a pharmaceutical company or product liability litigation by those who may be injured as a result of the defect/issue.”
The law firm urged medicine manufacturers to commit to continued monitoring of a product and amending/updating the product information and procedures to address and minimise any issues that arise.
Mulryne said: “Robust pharmacovigilance systems and communication with the MHRA will hopefully mean that any issues are identified quickly and a recall can be avoided. Ultimately, however, if an issue arises that was not previously known about and puts patient safety at risk, a recall will need to take place.”
