Roche Registration Ltd (Claimant/Appellant) v The Secretary of State for Health (acting through the Medicines and Healthcare Products Regulatory Agency)
| Jurisdiction | England & Wales |
| Judge | Lord Justice Sales,Lord Justice McFarlane,Lady Justice Arden DBE |
| Judgment Date | 21 December 2015 |
| Neutral Citation | [2015] EWCA Civ 1311 |
| Court | Court of Appeal (Civil Division) |
| Date | 21 December 2015 |
| Docket Number | Case No: C1/2014/2510 |
[2015] EWCA Civ 1311
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
THE HON. MRS JUSTICE CARR
Royal Courts of Justice
Strand, London, WC2A 2LL
Lady Justice Arden
Lord Justice McFarlane
and
Lord Justice Sales
Case No: C1/2014/2510
The Queen on the application of
Mr David Anderson QC & Ms Victoria Wakefield (instructed by Covington & Burling LLP) for the Appellant
Mr George Peretz QC (instructed by Government Legal Department) for the Respondent
Hearing dates: 1 & 2 December 2015
Introduction
This case concerns the way in which the Secretary of State, acting by the Medicines and Healthcare Products Regulatory Agency ("the MHRA"), acquired information from the appellant ("Roche") and passed that information to the European Medicines Agency ("the EMA") under the EU pharmacovigilance regime which sets out a system for scrutiny for and reporting of harmful effects of drugs when administered to patients. Although the background to this appeal is the pharmacovigilance regime established by EU law, the determination of the appeal itself turns principally on the application of the obligation of fairness under English law and English law principles in relation to the grant of declaratory relief.
The proceedings relate to re-inspections carried out by the MHRA of Roche's facilities in the United Kingdom between 29 and 31 October 2013 and on 14 November 2013 and of the facilities of an affiliate company, Genentech Inc. ("Genentech") between 18 and 22 November 2013 in the USA (together, "the Re-Inspection"). Based on the Re-Inspection, the MHRA compiled a draft and then final Re-Inspection Report.
The information in question in these proceedings, including in the final Re-Inspection Report, has already been supplied to the EMA by the MHRA. The EMA is an EU institution and any ruling that it is acting or has acted unlawfully is a matter for determination by the EU courts rather than by a national court: see Case 314/85 Firma Foto-Frost v Haumpzollamt Lübeck-Ost [1988] 3 CMLR 57. It will be for the EMA to decide what use, if any, to make of the information supplied to it by the MHRA, in relation to the EMA's own public health and enforcement functions under the EU pharmacovigilance regime. However, in the present proceedings Roche seeks declaratory relief regarding the lawfulness of the past conduct of the MHRA.
This court has been much assisted by the clarity with which Carr J in her judgment set out the relevant facts. The parties accepted the accuracy of the judgment in dealing with these matters, subject only to a couple of minor quibbles and an issue regarding what had been said by MHRA representatives and what Roche representatives had understood by this at the commencement of the Re-Inspection meetings in the United Kingdom and the USA. I deal with that issue below. Subject to that, I gratefully adopt the judge's account of the relevant facts.
At paras. [2] and [4]–[10] the judge sets the scene thus:
"2. 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.
…
4. 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 pharmacovigilance system and to audit that system. They are also obliged to monitor suspected adverse reactions to their product and to record and report suspected adverse reactions to their product which are brought to their attention. These are central safeguards for public safety and health purposes. The duty to protect public health exists independently and separately from any disciplinary issues that may arise.
5. Medicines regulators, such as the MHRA, routinely exercise powers under their respective national laws to conduct pharmacovigilance inspections to check compliance with pharmacovigilance obligations. Where deficiencies are identified, the company under inspection proposes and then implements corrective and preventative actions ("CAPAs"). The regulatory body may then re-inspect at a later date to confirm proper implementation. Roche states that it was (and remains) content to comply with such inspections. Additionally, the CHMP routinely requests that national competent authorities conduct inspections in respect of products for which the CHMP is responsible. Roche states that it was (and remains) content to comply with such inspections.
6. The two principal pieces of EU legislation which impose pharmacovigilance obligations on MAHs are the 2004 Regulation and the 2001 Directive. With effect from July 2012 that legislation underwent material amendment, as did the manner in which the EU laws are implemented into UK law. Prior to August 2012 the key national legislation was the Medicines Act 1968 ("the Act") and the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994 ("the 1994 Regulations"). The 2012 Regulations repealed and/or replaced the relevant provisions of the Act and the 1994 Regulations. The pharmacovigilance obligations said by Roche to be relevant to this claim are those pre-dating July 2012, largely to be found in the 2004 Regulation. The Re-Inspection was conducted in late 2013 pursuant to the 2012 Regulations.
7. Roche alleges that, when conducting the Re-Inspection, the MHRA was knowingly gathering evidence in the context and for the purpose of infringement proceedings which have been brought against Roche under the Penalties Regulation (EC) No. 658/2007 ("the Penalties Regulation") ("the infringement proceedings"). These proceedings are of a criminal or quasi-criminal nature and carry a heavy potential financial penalty of up to 5% of Roche's annual EU turnover in the preceding year. It appears that this is the first time that an investigation has been launched under the Penalties Regulation.
8. Article 1 of Chapter 1 of the Penalties Regulation identifies various pharmacovigilance obligations which, if infringed, give rise to a risk of a financial penalty being imposed. Chapter II sets out the " Infringement Procedure" which commences with an " Inquiry" by the EMA which leads to the EMA producing a report which summarises its findings. The " Decision-Making stage" follows next. The European Commission ("the Commission") considers the case and may, having followed the procedure provided for in the Penalties Regulation, adopt a decision imposing a fine. The Penalties Regulation also allows for penalties to be imposed for non-compliance with measures of inquiry. It provides at the outset (by recital 13) that, when carrying out the infringement procedure, the EMA and Commission must ensure the respect of the rights of defence. The MAH must have access to the file of the EMA and the Commission and the right to legal representation. The right to silence must also be respected.
9. The Claimant brings three grounds of challenge:
a) first, that the MHRA provided information to the EMA pursuant to formal requests from the EMA under Article 8(3) of the Penalties Regulation. Article 8(3) did not provide a proper basis for such requests. Accordingly the MHRA's compliance with them was and remains ultra vires;
b) secondly, that the MHRA failed properly to explain to Roche, at the time of the Re-Inspection, that the information was being obtained for use in a criminal or quasi-criminal investigation and that it would be making additional submissions to the EMA for that purpose. Had the MHRA done so, Roche would have been able to consider its position, including by seeking legal advice and representation and by asserting its right to silence and not to incriminate itself. The MHRA's conduct was thus procedurally improper and unlawful. There was no or insufficient procedural protection of Roche's rights in breach of the applicable EU, European Convention of Human Rights ("ECHR") and domestic law standards in the context of...
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