153% increase in UK medicine recalls

Relaxed supply chain rules for Covid might have led to increase

The number of medicines recalled by manufacturers due to defects has increased 153 per cent in the UK since 2017, according to new figures, with relaxed regulations during Covid one possible factor behind the increase. 

Official data from the Medicines and Healthcare products Regulatory Agency (MHRA) shows that whilst there were 68 medicines 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 medicine recalls. 

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 lock-downs, and given the now global supply chains, this impacted 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 on recalls, or meant there was an increase in the number of recalls when inspections/operations re-started."

Other factors might also be fuelling the rise in medicine recalls, some of which have been high profile, including the recall of medicines containing pholcodine, a cough suppressant found in some cough syrups and Night Nurse. Arnold & Porter point out 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 where safety issues arise. As such, the vigilance over products, both by companies and by the authorities, increased, and so there would likely also be an increase in subsequent recalls."

Another factor identified by Arnold & Porter as being a possible reason for recalls becoming more frequent was due to nitrosamines, a chemical more commonly found in tobacco products or processed meat. This was first discovered in 2018, and has led to some recalls. 

Sanctions and court

While there is no sanction 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 is considered appropriate given the issue that led to the recall. If considered 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 it is considered that there is personal liability for the directors of the company, for example. The fact 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 cooperated with the authorities.

"Recall of a product is often linked to a defect or issue with the product. 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 any issues are identified quickly and a recall can be avoided. However ultimately, if an issue arises that was not previously known about and this is causing safety issues for patients, a recall will need to take place."