In a judgment handed down today (R(Roche Registration Limited) v Secretary of State for Health acting by the Medicines & Healthcare Products Regulatory Agency  EWHC 2256 (Admin)) Carr J found that that the MHRA acted lawfully in an inspection of Roche carried out in autumn 2013.
The inspection followed an earlier inspection of Roche in which the MHRA had made serious findings of alleged non-compliance with Roche’s pharmacovigilance obligations (obligations on pharmaceutical companies to monitor, and to report to the regulators on, potential problems with licensed medicines).
Following those findings, the European Medicines Agency (“EMA”) had started an investigation of Roche under the Penalties Regulation, which provides for the imposition of fines for breach of (among other things) pharmacovigilance obligations.
Roche complained that: (1) the EMA had had no power to issue a letter under Article 8(3) of the Penalties Regulation to the MHRA requesting provision of the report of the re-inspection to it for use in relation to the penalties proceedings; (2) that the MHRA had acted unfairly in not adequately disclosing the purpose of the re-inspection; and (3) that the MHRA had wrongly reported to the EMA that Roche was liable for the default of other Roche group companies and had wrongly assessed its compliance by reference to new obligations in force only after 2012.
The Judge dismissed the application on all points. She held that on the facts Roche was not misled as to the purpose of the investigation or as to the possible use of the report in relation to the EMA’s investigation under the Penalties Regulation. As for the EMA’s letter to the MHRA, although it was not clear that the EMA had power to make that request, the point was immaterial as the report would in any event have been provided to the EMA under other relevant provisions: so it was not appropriate to make a reference to the Court of Justice of the EU. As to the MHRA’s alleged errors in its report, Roche’s real concern was not with the report but with the possibility that the EMA and the Commission (which takes the final decision on penalties) might accept those views in the context of the Penalties Regulation: and (applying Masterfoods) it was not right for the national court to pre-empt any decision by the Commission along those lines either by deciding the matter itself or by making a reference to the Court of Justice. Such a decision could be challenged in the General Court, and that was the appropriate course for Roche to take.