In Blackbay Ventures Limited v Secretary of State for Health, the High Court considered the scope of the "exemption for pharmacies" from the need to obtain medicinal products from holders of wholesaler dealer licences ("WDLs") under the Medicines Act 1968.
Blackbay held a WDL pursuant to which it purchased medicines for the purpose of onward sale through its network of pharmacies. The MHRA suspended Blackbay's WDL for three months on the basis that Blackbay had contravened its WDL by obtaining supplies of medicinal products from persons other than those also holding WDL. Blackbay contended that it operated in two different capacities - namely a wholesale business and a retail pharmacy business - and could therefore purchase medicines from pharmacies who did not have a WDL. It sought to rely on the exemption under the Medicines Act that "the restrictions imposed by… this Act do not apply to anything which is done in a registered pharmacy… and amounts to wholesale dealing, where such dealing constitutes no more than an inconsiderable part of the business carried on by the pharmacist at that pharmacy."
Supperstone J, giving careful consideration to the requirements of and interplay between the Medicines Act 1968 and the relevant parts of the EC Directive 2001/83/EC, held that it is unlawful for the holder of a WDL to obtain supplies from wholesalers without special authorisation (i.e. unlicenced pharmacies). The judgment states that the "...only action which it prohibits is the purchase of medicines from pharmacies without WDLs by pharmacies with WDLs". While pharmacies may exchange small amounts of stock to deal with unplanned shortages, holders of WDLs will contravene the law if purchasing stock from pharmacies with the intention of selling it on in the wholesale market.
The case serves as a timely reminder that all holders of WDLs, irrespective of the purported capacity in which they operate, must only obtain medicines from other WDL holders or from licenced manufacturers for the purposes of wholesale activities.