Roche Registration Ltd, R (On the Application Of) v Secretary of State for Health (Rev 2)
2014
ADMINISTRATIVE COURT
UK
CORAM
- THE HON MRS JUSTICE CARR DBE
Areas of Law
- Administrative Law
- Civil Procedure
- Human Rights Law
2014
ADMINISTRATIVE COURT
UK
CORAM
AI Generated Summary
In Roche v. Secretary of State for Health, Roche sought judicial review of MHRA's re-inspection, claiming it intended to gather evidence for punitive proceedings without proper notification, infringing on fairness. The court held that the inspections were primarily for public health, the compliance with Article 8(3) requests was legitimate, and Roche had sufficient awareness of potential uses of inspection results. Claims were dismissed across all grounds.
Mrs Justice Carr :
Introduction
This is a claim for judicial review brought by Roche Registration Limited (“Roche”) against the Secretary of State for Health acting by the Medicines and Health Care Products Regulatory Agency (“the MHRA”). The claim was issued on 28 th January 2014. A “rolled-up” hearing was ordered by Cox J on 21 st March 2014.
Roche is a wholly owned subsidiary of Roche Holding AG and is the marketing authorisation holder (“MAH”) of all centrally-approved medicinal products developed and marketed by the Roche group of companies. The MHRA discharges the Secretary of State’s duties and powers as the “ licensing authority ” for Great Britain under the Human Medicines Regulations 2012 (“ the 2012 Regulations ”) which implement Directive 2001/83/EC of the European Parliament and of the Council (“the 2001 Directive”). The European Medicines Agency (“the EMA”) appears as an interested party. The EMA was set up under Regulation (EC) 726/2004 (“the 2004 Regulation”) and is responsible for co-ordinating the scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicines authorised centrally. It includes the Committee for Medicinal Products for Human Use (“the CHMP”), which is responsible for preparing the opinion of the EMA on any question relating to the evaluation of medicines, and the Pharmacovigilance Risk Assessment Committee (“PRAC”), which is responsible, amongst other things, for providing recommendations to the CHMP on any question relating to pharmacovigilance activities for human medicines.
The claim arises out of a re-inspection carried out by the MHRA of Roche’s facilities between 29 th and 31 st October 2013 and on 14 th November 2013 in the United Kingdom and of the facilities of an affiliate company, Genentech Inc (“Genentech”), between 18 th and 22 nd November 2013 in the United States of America (“the Re-Inspection”).
The Re-Inspection related to Roche’s pharmacovigilance system and the extent to which Roche had complied with its reporting obligations. Pharmacovigilance is the science and activities relating to the detection, reporting, assessment, understanding and prevention of adverse effects of a medicine or any other medicine-related problem. The obligation on MAHs, such as Roche, to operate a pharmacovigilance system is a critical element of the system of licensing human medicines in the European Union (“EU”). In broad terms, MAHs are obliged to operate a phar