Wholesale dealer licence holders could face criminal charges if they hoard certain medicines that have been placed under restrictions by the government, new guidance published by the Department of Health and Social Care (DHSC) states.
The guidance, published on 7 October 2019, says the restrictions also prevent licence holders from hoarding restricted medicines.
The DHSC defines ‘hoarding’ as “when wholesale dealers withhold a medicine when it is in short supply”.
The guidance comes a few days after the government issued a list of medicines that cannot be parallel exported from the UK, where companies buy medicines meant for UK patients and sell on for a higher price in another country.
The list of restricted medicines, published on 3 October 2019, contains 19 hormone replacement therapy products.
Wholesale dealer licence holders found to be hoarding medicines on the restricted list could see their licence suspended by the Medicines and Healthcare products Regulatory Authority (MHRA) in the first instance, with persistent hoarding “considered a criminal offence under Regulation 34(1), read together with Regulation 18(1) of the Human Medicines Regulations 2012”, the guidance states.
For medicines not on the restricted list, the Department of Health and Social Care told The Pharmaceutical Journal that hoarding of any medicine that results in the needs of UK patients not being met could still constitute a breach of the regulations and would be considered on a case-by-case basis.
A statement from the Healthcare Distribution Association (HDA) said its member companies are “aware of a few small ‘non-wholesaling businesses’ [that] also hold wholesale dealer’s licences” and “may be offering to buy small amounts of stock from many different locations, such as pharmacies, and then hoard for price gain purposes”.
As a result, the HDA “is calling on the MHRA to consider a more rigorous and transparent enforcement of the obligations on all wholesale dealer license holders in line with good distribution practice legislation”.