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MHRA looked into wholesaler hoarding claims, says ex-inspector

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MHRA looked into wholesaler hoarding claims, says ex-inspector

By Neil Trainis

A former medicines distribution inspector who worked at the Medicines and Healthcare products Regulatory Agency for over 16 years has said it investigated concerns that some wholesalers were hoarding supplies of drugs during his time at the regulator and took action but insisted it was “extraordinarily difficult” to gather evidence.

Peter Coombs, who was the MHRA’s good distribution practice inspector between April 2004 and August 2020, told the Sigma conference in the Dominican Republic that the Agency “definitely took action” once it became aware of “a hoarding situation.” However, he did not elaborate on what action was taken.

There have been concerns some wholesalers and wholesale dealer’s licence holders have been hoarding supplies. In October 2020, PSNC representative David Broome also alleged pharmacies were being denied supplies of medicines by certain wholesalers with whom they were not ‘first line’ customers.

When asked by Independent Community Pharmacist if he felt the MHRA investigated those concerns thoroughly enough during his time there, and whether he thought it was doing so now, Coombs said: “I don’t work for them anymore, so you’ll probably have to ask them. The second part of that question was nicely swerved I thought.

“The first bit, did they? Yes. I mean, if inspectors were on site and became aware that there was a hoarding situation going on, absolutely. It was something the MHRA definitely took action about if they became aware of it.

“But, and it’s a big ‘but’, 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, it’s actually extraordinarily difficult to evidence hoarding from a physical inspector’s perspective.”

Coombs, who is now a consultant and director at GDP Pharma Consulting which offers good distribution practice support, said it was possible to obtain evidence of hoarding through “really substantial market surveillance” but insisted there was no guarantee that would allow the MHRA to get proof. 

“Market surveillance is difficult. The MHRA as an organisation does its best with market surveillance but again, it’s very difficult,” he said.

“An awful lot of the stuff is all very commercially sensitive and the Agency does not have visibility of it necessarily. And so, in answer to the question, yes, when they became aware of it, they absolutely did deal with it but on the flipside of that, it’s not that easy to find it.”

Three years ago, Martin Sawer, the executive director of the Healthcare Distribution Association which represents pharmaceutical wholesalers, called on the MHRA to enforce laws governing wholesalers more rigorously and transparently in response to concerns that some wholesale dealer’s licence holders were hoarding supplies.

When contacted by ICP, the MHRA said "these are medicine supply issues that sit with" the Department of Health and Social Care.

 

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