UK counterfeiter sentenced to eight years in jail

A trial of five men accused of distributing counterfeit medicines in the UK has resulted in one of them - Peter Gillespie - being sentenced to eight years in prison after being found guilty of all charges.

The four other men - Gillespie's brother Ian, retired pharmacist James Quinn and associates Ian Harding and Richard Kemp - were all acquitted in the case, which the UK Medicines & Healthcare products Regulatory Agency (MHRA) has described as "the most serious known breach of the UK regulated supply chain of medicines."

Gillespie spearheaded the infiltration of more than two million counterfeit doses of three AstraZeneca products into the UK from China during a five-month period in 2007, with around 900,000 of those doses actually reaching the hands of patients.  To this date around 700,000 doses have never been traced.

The retail value of the counterfeit shipments has been estimated a £4.7m ($7.7m).

The case was particularly insidious as it involved three life-saving drugs - prostate cancer treatment Casodex (bicalutamide), Zyprexa (olanzapine) for schizophrenia and cardiovascular treatment Plavix (clopidogrel) - providing firm evidence that counterfeiters were moving beyond their traditional focus on peddling lifestyle drugs such as erectile dysfunction products via the Internet.

Gillespie was convicted of conspiring to defraud pharmaceutical wholesalers, pharmacists, members of the public and holders of intellectual property rights in pharmaceuticals between January 1, 2006 and June 30, 2007.

He was also found guilty of selling or supplying Casodex and Plavix without a marketing authorisation and of selling or distributing counterfeit Casodex and Plavix along with selling or supplying Zyprexa without a marketing authorisation and of selling or distributing counterfeit Zyprexa between January 1, 2006 and June 30, 2007.

This remains the starkest example of the potential vulnerability of supply chains to counterfeiters in well-regulated markets such as the EU, although the MHRA points out that these cases are exceedingly rare, coming against a background of 850 million prescriptions dispensed in the UK every year. All told, there have been 15 known instances of counterfeit medicines in the UK regulated supply chain since 2004.

The conviction comes shortly after the European Parliament approved a new directive on falsified medicines which contain a number of measures to help make EU medicine supply chains more secure.

The directive - which still needs to be translated into national legislation - will tighten up rules governing traders in medicines, increase controls over active pharmaceutical ingredients imported into the EU, and add a requirement for safety features, such as tamper-evident seals and serial numbers to allow identification of each pack.

MHRA Head of Enforcement, Mick Deats said: "This outcome sends a clear message to those involved, or contemplating involvement in, the manufacture and supply of counterfeit medicines."

"Public health is a matter of public concern and those deliberately putting people’s lives in jeopardy should expect to be vigorously pursued through the criminal courts."