Regina v Patel; [2009] EWCA Crim 2311; [2009] WLR (D) 327

CRIME — Medicine, sale of — Marketing authorisation — Importation of counterfeit medical product for which marketing authorisation not held — Onward sale in UK with view to onward sale to Bahamas — Whether product placed on the market — Whether regulatory regime applicable where intended end users outside European Community — Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (SI 1994/3144), Sch 3, para 1

Regina v Patel

Regina v Hussain

[2009] EWCA Crim 2311; [2009] WLR (D) 327

CA: Hooper LJ, Tomlinson, Swift JJ: 12 November 2009

The Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 were not to be construed as prohibiting transactions which were not intended to have the effect, nor had the effect, of releasing a medical product into a distribution scheme which would lead to its sale to end users within the European Community.

The Court of Appeal (Criminal Division) so held when giving reasons for having, on 29 October 2009, allowed appeals by the defendants, Hitendra Patel and Shaan Hussain, against their convictions on 27 and 28 November 2007 respectively in the Crown Court at Kingston upon on Thames of placing on the market a medicinal product without holding a Community or United Kingdom marketing authorisation contrary to para 1 of Sch 3 to the 1994 Regulations.

TOMLINSON J, giving the judgment of the court, said that the facts, in relation to the conviction which the prosecution submitted should be upheld, were that the defendant, a licensed pharmaceutical wholesaler, imported counterfeit Viagra into the UK and sold it to another wholesale dealer for onward sale to a company in the Bahamas. The products were packaged in the manner in which Viagra was sold in the United States, a manner not authorised in the European Economic Area. The issue related to the words “places a relevant medical product on the market” in para 1 of Sch 3 to the 1994 Regulations. The prosecution’s submission was that the touchstone of liability under the Regulations was control, and the defendant no longer had control over the products’ ultimate destination once he had sold them to the other wholesale dealer in the UK and they had thereby been released into the distribution chain in the UK. The submission concentrated on the public health aspect of the legislation at the expense of its other objective, the functioning of the internal market. The Regulations were not to be construed as prohibiting transactions which were not intended to have the effect, nor had the effect, of releasing a medical product into a distribution scheme which would lead to its sale to end users within the European Community.

Appearances: Orlando Pownall QC and Martin Howe QC (instructed by Neumans LLP) for the defendant Patel; Robin Griffiths (assigned by Registrar of Criminal Appeals) for the defendant Hussain; Sandip Patel, Fiona Jackson and Jemima Stratford (instructed by Solicitor, Department of Health) for the prosecutor.

Reported by: Philip Ridd, solicitor.