Robert Palmer QC and Khatija Hafesji successfully defend MHRA in Francovich damages claim

21 Feb 2020

Bioplus Life Sciences and Ors v Secretary of State for Health [2020] EWHC 329 (QB)

Bioplus Life Sciences claimed Francovich damages against the MHRA for losses suffered over a 9-year period, during which time the MHRA had regulated Bioplus’s drug Dolenio as a medicinal product requiring a marketing authorisation, but not competitors’ equivalent products (which were being sold as food supplements).

Bioplus had already established in a prior judicial review claim that this disparate treatment was unlawful, and now sought damages.

The matter was listed for a preliminary issue hearing on the sole question of whether the Medicinal Products Directive imposing regulatory and supervisory obligations on Member States entailed the grant of rights to individuals such as the Claimant, so as to provide the necessary foundation for a Francovich claim. Mrs Justice Eady held that they did not, and therefore dismissed the damages claim in its entirety. She found that the claim went no further than establishing the Claimants’ interest in the Defendant’s compliance with its obligations under the Directive (an interest which had given them standing to bring their successful judicial review proceedings), but otherwise the Claimants did not benefit from any individual right to be protected against the consequences of the MHRA’s failure to classify products materially identical to Dolenio as medicinal products.

Robert Palmer QC and Khatija Hafesji acted for the MHRA.

The judgment is here.