The Medicines and Healthcare products Regulatory Agency’s interim executive director James Pound has insisted it will “proactively take action” when it receives reports that a wholesale dealer’s licence holder is hoarding medicines.

Speaking at the Healthcare Distribution Association’s conference in London yesterday, Pound attempted to reassure community pharmacists across the UK who are struggling to source medicines that the MHRA, which regulates pharmaceutical wholesalers, is closely monitoring the situation.

When asked if the MHRA actively investigates reports of hoarding by visiting a warehouse or an individual who has a wholesale dealer’s licence, Pound told Independent Community Pharmacist: “These things, where we are aware of them, where they are reported to the Agency, is something we would consider.

“There’s two arms to what we (do), whether it’s around inspections or the regulatory side. If it’s something that requires a further response, we have an enforcement unit and we also support that ability.

"As a regulator, we would proactively take action as that information and intelligence is shared with us.”

However, there have been concerns over the MHRA’s ability to gather evidence. In 2023 during the Sigma conference in the Dominican Republic, the MHRA’s former good distribution practice inspector Peter Coombs said it investigated reports of hoarding but conceded it was “extraordinarily difficult” to gather evidence.

“With the complexity of the supply chain, from manufacturer through to wholesale, and what that looks like…you have literally hundreds of thousands of pallet spaces in the warehouse,” he said.

“It’s actually extraordinarily difficult to evidence hoarding from a physical inspector’s perspective.” Coombs was the MHRA’s good distribution practice inspector between April 2004 and August 2020.

Pound did not reveal how many reports the MHRA receives during the year or how often it takes action against individuals or companies.

“Clearly, information and intelligence is helpful in dealing with shortages and it’s something where we all need to work together to make sure patients are able to get their medicines and medical devices thay they need to support their treatment,” he said.

Pound also said the MHRA has changed “some of its processes” to address delays in the approval of wholesale distribution authorisations.

HDA: We want more transparency on use of wholesale licences

The HDA executive director Martin Sawer, who has consistently denied his members have hoarded medicines, said: “Our position is that we have, between our membership, about 15 of the wholesale dealer’s authorisations in the UK and there’s 1,700.

“We would like more transparency as to what those wholesale licences are being used for. So, whether you’re buying or selling, you have an ability to know where and what the product might be going towards what customer.

“I think there’s a lack of transparency in some areas of the WDA world. We only represent a minority of those numbers of licences but we would like more transparency.”

Sawer also said there should be “more openness between supply stakeholders on the why, what and when” if a pharmacy cannot get hold of a product.

He said there was “confusion” over the ‘manufacturer cannot supply’ notification pharmacies receive and insisted clearer and more detailed information should be sent to pharmacy teams. 

The Department of Health and Social Care medicines director Gila Sacks, who was also at the HDA conference, said disruptions to supply can be “tackled early enough and prevented” if all the players in the supply chain “work together” and “updated information” is sent to pharmacies.