Direct-to-pharmacy (DTP) distribution models are putting the pharma supply chain under stress by circumventing the role of the wholesaler, parallel importers have told the UK regulator.
DTP is also behind the growing trade in exports by UK pharmacists, says the European Association of Euro-Pharmaceutical Companies (EAEPC), in its response to the Medicine and Healthcare products Regulatory Agency (MHRA)’s call for comments on its proposals to strengthen the UK medicines supply chain in light of the growing threat of counterfeit drugs. With price differentials between European markets persisting, and DTP models aiming to close down trade initiated by wholesalers, “it is economically obvious that the incentive to trade moves downstream to a level where the freedom of trade is not hampered by anti-competitive practices of pharmaceutical manufacturers,” says the parallel importers’ trade association.
“The right thing to do, from a clean regulatory perspective, is to enable the wholesale sector to fully play its role of purchasing from manufacturers and selling medicines to pharmacies,” writes EAEPC secretary-general Heinz Kobelt. This would “liberate” the pharmacy profession from the “ever-stricter restrictions imposed by the manufacturers, in the absence of determined and rapid action by the competition authorities,” he suggests, adding that pharmacists wishing to engage in wholesaling activities can of course apply for a wholesale dealer’s license.
To tackle the threat of counterfeit drugs entering the legitimate supply chain, the EAEPC suggests to the MHRA that it should consider restricting intra-European Union (EU) trade in medicines to licensed operators only. They are subject to Good Manufacturing Practice (GMP) obligations and, therefore, are governed by a more stringent set of quality and safety requirements than those operators which are regulated by Good Distribution Practice ((GDP) requirements only. This proposal would not require a change in legislation, simply more stringent interpretation and application of the existing law, and would help to facilitate stricter standards for transport and establishing an audit trail, it adds.
The parallel trade group also suggests to the MHRA that, when a wholesale dealer’s licence is revoked, this should be made public. And, on the Agency’s proposal to introduce a “due diligence” obligation for holders of wholesale dealer licenses and Responsible Persons (RP) to report suspicious incidents and events, it says that the RP should also be able to obtain information from the regulator or the marketing authorization holder in cases where suspicious material might be on the market. “Information channels on safety-related issues should be both ways,” it says.
