US Senate Hears Testimony on UK's Parallel Drug Trade Threat

Amid the ongoing controversy over parallel drug imports in the US, and the prospect of the forthcoming Prescription Market Access and Drug Safety Act, a UK-based industry expert has outlined current threats posed by parallel imports. The country is a lucrative market for firms involved in the trade, as prescription drug prices are frequently well above those in other EU member states.

Nevertheless, in testimony given by anticounterfeiting consultant Graham Satchwell to a US Senate committee, it was claimed that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) is finally beginning to acknowledge the safety threat posed by parallel imports. Despite this encouraging sign, the agency is quoted as stating that verifying parallel drug vendors' credentials is "not our duty," and it was noted that enforcement of such credentials inside the European Union (EU) is "sloppy." Existing regulations oblige UK importers to verify that their clients are licensed within the country of the drugs' origin, although there is no single EU agency responsible for their enforcement.

Apart from problems over inadequate or even misleading patient information included with packets of imported drugs, quality fears are paramount in most assessments of parallel imports. A recent UK survey of 300 parallel import drugs identified 25% as "unsafe," with 50 percent failing on other quality grounds. Over 80 percent failed to satisfy inspectors on the basis that the products violated patents.

Generally, the testimony acknowledged that while UK and EU regulations are adequate, practical enforcement is inadequate. Repackaging drugs for export purposes presents a tempting opportunity for counterfeiters, and European regulators simply do not have the capacity to regulate the entire production chain or even order an effective product recall.

Indeed, the MHRA reports that its resources were insufficient to properly manage a tenfold increase in parallel import license applications since 1995, to roughly 30,000. Those supporting Satchwell's claims are likely to agree that any such under-resourcing and bureaucratic deadlock in the US could pose deadly risks to consumers.