Roche Registration Ltd, R (On the Application Of) v Secretary of State for Health (Rev 2) [2014] EWHC 2256 (Admin)

[2014] EWHC 2256 (Admin)

Case No CO/393/2014

IN THE HIGH COURT OF JUSTICE

QUEEN’S BENCH DIVISION

ADMINISTRATIVE COURT

Venue Royal Courts of Justice, Strand, London, WC2A 2LL

Date 09/07/2014

Before

THE HON MRS JUSTICE CARR DBE

THE QUEEN on the application of

Between

ROCHE REGISTRATION LIMITEDClaimant

THE SECRETARY OF STATE FOR HEALTHDefendant

Acting by his executive agency the Medicines & Healthcare Products Regulatory AgencyDefendant

THE EUROPEAN MEDICINES AGENCY

Interested Party

Mr David Anderson QC and Ms Victoria Wakefield

(instructed by Covington & Burling LLP) for Claimant

Mr George Peretz (instructed by The Treasury Solicitor) for Defendant

Ms Sarah Lee (instructed by EMA Legal Services) for Interested Party

Hearing Hearing dates: 10, 11 and 13 June 2014

Judgment Approved by the court for handing down

Introduction

[1]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 28th January 2014. A “rolled-up” hearing was ordered by Cox J on 21st March 2014.

[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.

[3]The claim arises out of a re-inspection carried out by the MHRA of Roche’s facilities between 29th and 31st October 2013 and on 14th November 2013 in the United Kingdom and of the facilities of an affiliate company, Genentech Inc (“Genentech”), between 18th and 22nd November 2013 in the United States of America (“the Re-Inspection”).

[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 the infringement proceedings; c) thirdly, that the material provided by the MHRA to the EMA under the Article 8(3) requests (and otherwise under the Penalties Regulation) contained a number of fundamental errors of law. These are therefore public law challenges relating to vires, procedural fairness and alleged error of law.

[10]Roche now seeks a declaration that : a) the past and continuing compliance by the MHRA with the EMA’s Article 8(3) requests dated 1st October 2013 and 17th October 2013 is unlawful, as would be compliance with any other such request in the context of the infringement proceedings; b) the MHRA’s conduct of the Re-Inspection was unlawful; c) the transmission of the resulting draft Re-Inspection Report by the MHRA to the EMA for the purpose of use in the infringement proceedings was unlawful; d) the transmission by the MHRA to the EMA of the final Re-Inspection Report for use in the infringement proceedings was unlawful; e) any information or other communication between the MHRA and the EMA in the context of the infringement proceedings in which the views of the MHRA are based on information gained during the Re-Inspection (including the MHRA’s letter to the EMA dated 13th December 2013) was unlawful; f) that the findings of the MHRA in the Re-Inspection Report are unlawful.

[11]A confidentiality order pursuant to CPR 32.13 has been made in respect of the following documents: a) a draft Re-Inspection Report from MHRA dated 8th December 2013; b) a draft Article 10 report from EMA dated 20th December 2013; c) Roche’s substantive comments on the draft re-inspection report dated 18th January and 7th March 2014; d) Roche’s written observations on the draft Article 10 report dated 14th February 2014; e) the MHRA Inspection Action Group summary of the re- inspection dated 9th January 2014; f) the Claimant’s written observations on the draft Article 10 report and the EMA’s final Article 10 report dated 14th April 2014; g) the MHRA’s final Re-inspection report dated 17th March 2014; h) the EMA’s final Article 10 report dated 14th April 2014.

[12]In the event, it has not proved necessary for the purpose of this claim to delve in any detail into the majority of these documents. So far as possible, confidentiality is intended to be preserved below.

B. The legislative framework

[13]The MHRA has the responsibility for pharmacovigilance in relation not only to products authorised in the United Kingdom but also products regulated centrally by the EMA and authorised by the European Commission under the 2004 Regulation. Title IX of the 2001 Directive headed “PHARMACOVIGILANCE”provides materially as follows :

“Article 101 Member States shall operate a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks and their participation in Union pharmacovigilance activities… Each Member State shall designate a competent authority for the performance of pharmacovigilance tasks….. Article 104 The [MAH] shall operate a pharmacovigilance system for the fulfilment of his pharmacovigilance tasks equivalent to the relevant Member State’s pharmacovigilance system provided for under Article 101(1)…”

Article 104

[14]Article 19(1) of the 2004 Regulation provides :

“…The supervisory authorities for pharmacovigilance shall be responsible for verifying on behalf of the Union that the [MAH] for the medicinal product satisfies the pharmacovigilance requirements laid down in Titles IX and XI of [the 2001 Directive]. They may, if this is considered necessary, conduct pre-authorisation inspections to verify the accuracy and successful implementation of the pharmacovigilance system as it has been described by the applicant in support of his application.”

[15]Title XI of the 2001 Directive then provides :

“SUPERVISION AND SANCTIONS Article 111 The competent authority of the Member State concerned shall, in cooperation with the Agency, ensure that the legal requirements governing medicinal products are complied with by means of inspections, if necessary unannounced, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples. This cooperation shall consist in sharing information with the Agency on both inspections that are planned and that have been conducted. Member States and the Agency shall cooperate in the coordination of inspections in third countries. The inspections shall include but not be limited to the ones mentioned in paragraphs 1a to 1f. … 1b.The competent authority of the Member State concerned shall have a system of supervision including by inspections at an appropriate frequency based on risk, at the premises of the manufacturers, importers, or distributors of active substances, located on its territory, and effective follow-up thereof. Whenever it considers that there are grounds for suspecting non-compliance with the legal requirements laid down in this Directive, including the principles and guidelines of good manufacturing practice and good distribution practices referred to in point (f) of Article 46 and in Article 47, the competent authority may carry out inspections at the premises of: (a) manufacturers or distributors of active substances located in third countries; (b) manufacturers or importers of excipients… 1g. Inspections shall be carried out by officials representing the competent authority who shall be empowered to: ... (d) inspect the premises, records, documents and pharmacovigilance system master file of the marketing authorisation holder or any firms employed by the marketing authorisation holder to perform the activities described in Title IX. … 8. If the outcome of the inspection referred to in point (d) of paragraph 1g is that the marketing authorisation holder does not comply with the pharmacovigilance system as described in the pharmacovigilance system master file and with Title IX, the competent authority of the Member State concerned shall bring the deficiencies to the attention of the marketing authorisation holder and give him the opportunity to submit contents. In such case the Member State concerned shall inform the other Member States, the Agency and the Commission. Where appropriate, the Member State concerned shall take the necessary measures to ensure that a marketing authorisation holder is subject to effective, proportionate and dissuasive penalties. Article 111a The Commission shall adopt detailed guidelines laying down the principles applicable to inspections referred to in Article 111.”

Article 111 Whenever it considers that there are grounds for suspecting non-compliance with the legal requirements laid down in this Directive, including the principles and guidelines of good manufacturing practice and good distribution practices referred to in point (f) of Article 46 and in Article 47, the competent authority may carry out inspections at the premises of: (a) manufacturers or distributors of active substances located in third countries; (d) inspect the premises, records, documents and pharmacovigilance system master file of the marketing authorisation holder or any firms employed by the marketing authorisation holder to perform the activities described in Title IX. In such case the Member State concerned shall inform the other Member States, the Agency and the Commission. Where appropriate, the Member State concerned shall take the necessary measures to ensure that a marketing authorisation holder is subject to effective, proportionate and dissuasive penalties. The Commission shall adopt detailed guidelines laying down the principles applicable to inspections referred to in Article 111.”

Article 111

[16]The essence of Article 111 of the 2001 Directive is therefore to ensure that Member States, in co-operation with the EMA, ensure compliance with pharmacovigilance obligations, including by inspections.

[17]The Directive does of course not give the MHRA vires as a matter of United Kingdom law (see Article 288 of the Treaty on the Functioning of the European Union (“the TFEU”)). It is for the Member State to decide as to the form by which it is to be implemented in national law. To that end one turns in Great Britain to the 2012 Regulations.

[18]Regulations 210 and 211 create criminal offences in relation to breach of pharmacovigilance obligations. Part 16 then provides materially as follows : “PART 16 Enforcement

Enforcement in England, Wales and Scotland

[323]-(1) The Secretary of State must enforce or secure the enforcement of these Regulations and the relevant EU provisions “The relevant EU provisions” are defined as meaning the provisions of legislation of the European Union relating to medicinal products for human use, except to the extent that any other enactment provides for any function in relation to any such provision to be exercised otherwise than by the licensing authority. in England, Wales and Scotland. (2). The Secretary of State may make arrangements for either or both of- 325. -(1) An inspector may at any reasonable time enter premises- (a). in order to determine whether there has been a contravention of a provision of these Regulations which the enforcement authority is required or empowered to enforce by virtue of regulations 323 and 324; (2). A person may not exercise a right of entry under this regulation in relation to premises used only as a private dwelling unless 24 hours’ notice has been given to the occupier. … Application for warrant 326.-(1) In a case where this regulation applies, a justice of the peace may issue a warrant authorising an inspector to enter premises, by force if necessary. … Powers of inspection, sampling and seizure

[327]-(1) An inspector may inspect anything mentioned in paragraph (2)- (2). The things mentioned in paragraph (1) are- (g) information and documents relating to the safety of medicinal products…”

Findings and reports of inspections

[331]- (1) If the outcome of the inspection of things referred to in regulation 327(2)(g) (powers of inspection, sampling and seizure: information and documents relating to safety etc) is that the holder of a marketing authorisation or traditional herbal registration does not comply with the pharmacovigilance system as described in the pharmacovigilance system master file, or any provision of Part 11 (pharmacovigilance), the enforcement authority must- (a) bring the deficiences to the attention of the holder; (b) give the holder the opportunity to submit comments; and (c) inform the other EEA States, the EMA and the European Commission … (3). After every inspection carried out in accordance with regulations 325 (rights of entry) and 327 (powers of inspection, sampling and seizure) in connection with medicinal products other than registrable homoeopathic medicinal products, the enforcement authority must report on whether the activities to which the inspection relates comply with such of the provisions mentioned in paragraph (4) as apply to those activities. … (5). The enforcement authority must before adopting the report- (a) communicate the content of the report to the person to whose activities the inspection relates; and (b) give that person the opportunity to submit comments.”

[19]Thus, the Secretary of State has very broad powers to enforce or secure the enforcement of obligations under the EU medicines legislation. Specific powers are then conferred on the MHRA inspectors for the purpose both of enforcing the 2012 Regulations through domestic criminal proceedings and the relevant EU legislation, including the Penalties Regulation.

[20]The Penalties Regulation provides materially as follows :

“COMMISSION REGULATION (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council … Whereas : … (3) Moreover, in view of the provision made by Article 84(1) of Regulation (EC) No 726/2004, under which the Member States are to determine the penalties to be applied for infringement of the provisions of that Regulation or the Regulations adopted pursuant to it and to take the necessary measurers for their implementation, action at Community level should be taken only in cases where the interests of the Community are involved. In that way, the effective enforcement of Regulation (EC) No 726/2004 would be ensured by an appropriate management of the resources available at Community and national level… (6) In order to ensure the effective conduct of the inquiry stage of alleged infringements, the Agency and Commission should have recourse to the competent authorities of the Member States, designated as the supervisory authorities of medicinal products authorised through the centralised procedure by Regulation (EC) No 726/2004, to carry out the necessary measures of inquiry and to obtain information relating to infringements falling within the scope of this Regulation… (8) The decision to initiate an infringement procedure under this Regulation should be taken by the Agency, which should first inform the Commission and the Member States. In the course of an inquiry, the Agency should be empowered to require such information to be supplied as is necessary to detect any infringement. It should also be able to rely on the cooperation of national competent authorities. Any supervisory powers entrusted to the Agency by Community law as regards marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726/2004 may be used by it in the course of the investigation of an infringement… (13) When carrying out an infringement procedure, the Agency and the Commission must ensure the respect of the rights of defence and of the principle of confidentiality in accordance with the general principle of law, and the case-law of the Court of Justice of the European Communities. In particular, the marketing authorisation holder subject to the infringement procedure should have the right to be heard by the Agency during the inquiry stage and by the Commission once it has been notified a statement of objections as well as to access the file compiled by the Agency and the Commission. While the Commission should be entitled to compel marketing authorisation holders to provide the necessary information and documents relating to a presumed infringement, the right to silence in situations where the holder would be compelled to provide answers which may involve an admission on its part of the existence of an infringement, as developed by the Court of Justice should also be respected… CHAPTER 1 GENERAL PROVISIONS Article 1 Subject-matter and scope This Regulation lays down rules concerning the application of financial penalties to the holders of marketing authorisations, granted under Regulation (EC) No 726/2004, in respect of infringements of the following obligations, in cases where the infringement concerned may have significant public health implications in the Community, or where it has a Community dimension by taking place or having its effects in more than one Member State, or where interests of the Community are involved: … 13. recording and reporting of suspected serious adverse reactions and, in the case of veterinary medicinal products, human adverse reactions, as referred to in Article 24(1) and Article 49(1) of Regulation (EC) No 726/2004; … 15. detailed recording of all suspected adverse reactions and submission of such records in the form of periodic safety update reports, as referred to in Article 24(3) and Article 49(3) of Regulation (EC) No 726/2004; 16. communication of information relating to pharmacovigilance concerns to the general public, as referred to in Article 24/5 and Article 49(5) of Regulation (EC) No 726/2004; … Article 3 Cooperation by the competent authorities of the Member States 1. The competent authorities of the Member States shall cooperate with the Agency and the Commission to enable them to carry out their duties under this Regulation. 2. Information provided by the national competent authorities in response to a request from the Agency or the Commission under this Regulation shall be used by the Agency and the Commission only for the following purposes: (a) as evidence for the purposes of applying this Regulation (b) for carrying out the tasks entrusted to them for the authorisation and supervision of medicinal products under Regulation (EC) No 726/2004… CHAPTER II INFRINGEMENT PROCEDURE Section 1 Inquiry … Subsection 2 Measures of inquiry Article 8 Requests by the Agency 1. The Agency may request the marketing authorisation holder to provide written or oral explanations, or particulars or documents. Requests shall be addressed in writing to the marketing authorisation holder. The Agency shall state the legal basis and the purpose of the request, fix a time-limit by which the information is to be provided, which shall be at least four weeks, and inform the marketing authorisation holder of the fines provided for an Article 19(1)(a) and (b) for failing to comply with the request or for supplying incorrect or misleading information. 2. The Agency may request national competent authorities to cooperate in the investigation in the following ways: (a) by performing any of the tasks entrusted to the supervisory authorities by Articles 19(1) and 44(1) of Regulation (EC) No 726/2004; (b) by performing inspections or other supervisory measures in accordance with Articles 111 to 115 of Directive 2001/83/EC and Articles 80 81 and 82 of Directive 2001/82/EC. Requests shall be addressed in writing and shall state the legal basis and the purpose of the request. The time limit for the submission of the reply or the conduct of the measure of inquiry shall be determined by agreement between the Agency and the national competent authority to which the request is addressed, having regard to the specific circumstances of the case. 3. The Agency may ask any natural or legal persons to provide information relating to the alleged infringement. Requests shall be addressed in writing and shall state the legal basis and the purpose of the request, and shall fix a time limit by which the information should be provided, which shall be at least four weeks… Subsection 3 Report Article 10 Content and time limits … Where the Agency considers that the marketing authorisation holder has committed an infringement as referred to in Article 1, the report shall also include an assessment of the circumstances of the specific case in accordance with the criteria set out in Article 18(2)… SECTION 2 Decision-making stage Subsection 1 Procedure Article 11 Statement of objections 1. Where, following a request from the Agency pursuant to Article 10(2), the Commission decides to continue with the infringement procedure, it shall notify in writing to the marketing authorisation holder a statement of objections … Article 12 Right to reply 1. When notifying the statement of objections, the Commission shall set a time-limit within which the marketing authorisation holder may submit to the Commission his written observations on the statement of objections. That time-limit shall be at least four weeks. The Commission shall not be obliged to take into account written observations received after the expiry of that time-limit. … Article 13 Oral hearing 1. Where the marketing authorisation holder so requests in his written observations, the Commission shall give him an opportunity to deploy his arguments at an oral hearing… Subsection 2 Decision and financial penalties Article 16 Forms of financial penalty and maximum amounts 1. Where, following the procedure provided for in Subsection 1, the Commission finds that the marketing authorisation holder has committed, intentionally or negligently, an infringement as referred to in Article 1, it may adopt a decision imposing a fine not exceeding 5% of the holder’s Community turnover in the preceding business year. … Article 18 Principles governing the application and quantification of financial penalties 1. In determining whether to impose a financial penalty and in determining the appropriate financial penalty, the Commission shall be guided by the principles of effectiveness, proportionality and dissuasiveness. 2. In each case, the Commission shall take into consideration, where relevant, the following circumstances: (a) the seriousness and the effect of the infringement … on the one hand, the degree of diligence and cooperation shown by the marketing authorisation holder in the detection of the infringement and the application of corrective action, or during the course of the infringement procedure or, on the other hand, any obstruction by the marketing authorisation holder of the detection of an infringement and the conduct of an infringement procedure, or any non-compliance by the marketing authorisation holder with requests made by the Agency, the Commission or a national competent authority in application of this Regulation; … SECTION 3 Non-cooperation Article 19 Financial penalties 1. The Commission may by decision impose on marketing authorisation holders fines not exceeding 0.5% of their Community turnover in the preceding business year where, intentionally or negligently: (a) they do not comply with a measure of inquiry adopted pursuant to Article 8(1); (b) they supply incorrect or misleading information in response to a measure of inquiry adopted pursuant to Article 8(1); (c) they do not comply with a request for information pursuant to Article 14; (d) they supply incorrect or misleading information in response to a request for information pursuant to Article 14. … CHAPTER III ACCESS TO THE FILE, REPRESENTATION, CONFIDENTIALITY AND TEMPORAL PROVISIONS Article 21 Access to the file … Article 22 Legal representation The marketing authorisation holder shall have the right to legal representation during the infringement procedure. … This Regulation shall be binding in its entirety and directly applicable in all Member States.”

Whereas : CHAPTER 1 GENERAL PROVISIONS Article 1 Subject-matter and scope Article 3 Cooperation by the competent authorities of the Member States CHAPTER II INFRINGEMENT PROCEDURE Section 1 Inquiry Subsection 2 Measures of inquiry Article 8 Requests by the Agency Subsection 3 Report Article 10 Content and time limits SECTION 2 Decision-making stage Subsection 1 Procedure Article 11 Statement of objections Article 12 Right to reply Article 13 Oral hearing Subsection 2 Decision and financial penalties Article 16 Forms of financial penalty and maximum amounts Article 18 Principles governing the application and quantification of financial penalties SECTION 3 Non-cooperation Article 19 Financial penalties CHAPTER III ACCESS TO THE FILE, REPRESENTATION, CONFIDENTIALITY AND TEMPORAL PROVISIONS Article 21 Access to the file Article 22 Legal representation This Regulation shall be binding in its entirety and directly applicable in all Member States.”

C. The Facts

[21]There are four material witness statements addressing the factual background to the claim : a) for Roche : from Dr Peter De Veene dated 28th January 2014 and Mr Nicholas Phillips dated 28th January 2014. Dr De Veene has been the qualified person for pharmacovigilance (“QPPV”) of Roche since June 2011. Mr Phillips has been the head of inspections management at Roche Products Limited since 2007; b) for the MHRA : Dr Anya Sookoo dated 28th February 2014 and Mr Jonathan Rowell dated 10th April 2014. Dr Sookoo is an expert inspector in Good Clinical Practice and pharmacovigilance for the MHRA. Mr Rowell is a senior pharmacovigilance inspector for the MHRA. It was Dr Sookoo and Mr Rowell who carried out the Re-Inspection, with Mr Rowell acting as lead inspector. In a covering letter dated 28th February 2014 the Treasury Solicitor confirmed to Roche’s solicitors that Dr Sookoo’s statement gave “a full and fair account of the factual background to the matters of which [Roche] complain[ed].”Documents were exhibited which it was considered, in accordance with the duty of candour, should be disclosed.

[22]As explained in paragraph 5 above, there are different types of investigation by the MHRA : inspection following the identification by the MHRA of deficiencies which looks at the implementation of CAPAs and inspections requested by the CHMP and inspections for the purpose of the Penalties Regulation. The EMA refers to the first two categories of inspection in a document titled “PROCEDURE FOR THE PREPARATION OF A RISK-BASED PROGRAMME FOR ROUTINE PHARMACOVIGILANCE INSPECTIONS OF MAHs CONNECTED WITH HUMAN CENTRALLY AUTHORISED PRODUCTS”(April 2009) :

“INTRODUCTION According to the [2004 Regulation] the supervisory authorities shall be responsible for verifying on behalf of the Community that the holder of the marketing authorization of the medicinal product for human use...satisfies the requirements laid down in Titles IV, IX and XI of [the 2001 Directive]…The Competent Authority shall ensure, by means of repeated inspections, and if necessary unannounced inspections., that the legal requirements governing medicinal products are complied with… According to the volume 9A, the CHMP, in conjunction with the Competent Authority of the Member State in whose territory the MAH’s QPPV is located and applicable Pharmacovigilance and Inspectors’ Working Parties, will determine a programme for inspection in relation to centrally authorised products. The inspections will be prioritised based on the potential risk to public health, the nature of the products, extent of use, number of products that the MAH has on the EEA market and other risk factors. Based on this, a written procedure that covers the preparation, revision, implementation and supervision of an annual inspection programme is needed…Sufficient resources must be determined and made available to ensure that the designated programme of inspections can be carried out in an appropriate manner. In general, it is anticipated that national inspection programmes will fulfil the need for the routine inspections of this programme and therefore it is expected that the programme described in this procedure focused on CAP products will be achieved mainly through the national programmes. However, there will be situations where these inspections might be specifically requested by the CHMP (eg global PhV sites in third countries). Targeted inspections will also be reflected in this programme as they may replace the need for a routine inspection.”

[23]Roche emphasises that the attitude adopted by Roche (and indeed, it is said, by the pharmaceutical industry generally) in relation to inspections arising out of CAPAs and CHMP requests is one of deferential co-operation and openness. Dr De Veene states that such inspections are regarded as routine pharmacovigilance inspections. He wishes to ensure that Roche lives up to the MHRA’s expectations and to maintain a good and cordial working relationship with the inspectors. The MHRA inspectors expect a MAH to act transparently and frankly. MAHs tend to accept the inspectors’ findings unquestioningly even if such findings are not based on a strict application of relevant legal requirements or guidance. Rather the focus is on CAPAs. The hope is that by acting in this way MAHs can influence the tone and perhaps even the findings of a final inspection report. As set out above, the final report is shared routinely with the EMA and other Member States.

[24]Between 16th and 20th January and 28th February and 1st March 2012 the MHRA conducted a routine inspection of Roche’s headquarters in the UK. On 4th May 2012 it sent a draft first inspection report to Roche which included three serious findings of alleged non-compliance that were classified as “critical” (“the first inspection report”). A “critical” finding is “a deficiency in pharmacovigilance systems, practices or processes that adversely affects the rights, safety or well-being of patients or that poses a potential risk to public health or that represents a serious violation of applicable legislation and guidelines” (as defined in the EMA’s standard operating procedures) .

[25]Roche’s non-compliance related, amongst other things, to the processing of safety data that had arisen in the context of non-interventional programmes (“NIPs”). The MHRA had particular concerns relating to a programme called “Access Solutions” which was run by Genentech. Access Solutions offered doctors and patients in the United States assistance and advice relating to insurance coverage and funding for Genentech’s products which corresponded to many products marketed by the Roche group of companies in Europe. It made use of a number of service providers, including an organisation called McKesson Speciality Arizona Inc (“McKesson”). The MHRA reported that McKesson and Genentech had received reports of adverse events in relation to relevant products and had failed to pass on these reports. The MHRA took the view that this constituted a breach by Roche of its pharmacovigilance obligations under the 2004 Regulation.

[26]On 9th May 2012 the MHRA sent the final first inspection report to the EMA. On 8th June 2012 the Commission requested the EMA to initiate an infringement procedure under the Penalties Regulation.

[27]On 13th June 2012 the EMA sent Roche a request for information under Article 6 of the Penalties Regulation. On 19th June 2012 the EMA wrote to Roche with a list of questions and requests relating to improvements in Roche’s pharmacovigilance system.

[28]On 21st June 2012 the EMA issued a press release in relation to its findings of alleged non-compliance in the first inspection report. It also stated that it was working with national medicines agencies to investigate deficiencies in Roche’s medicine-safety reporting system.

[29]In July 2012 the MHRA decided not to refer its findings to its Enforcement Group with a view to investigating possible criminal offences.

[30]On 19th July 2012 the EMA wrote again to Roche requesting a comprehensive response to questions listed in an attached assessment report. On 23rd July 2012 Roche responded to the EMA’s Article 6 request of 13th June 2012.

[31]On 23rd October 2012 the EMA notified Roche that it was initiating an infringement procedure under the Penalties Regulation.

[32]Between November 2012 and January 2013, the MHRA assisted the EMA and co-operated with it closely in connection with the infringement procedure. It committed to support the EMA in its enforcement activities as was required of it under the Penalties Regulation and in accordance with Article 111(8) of the 2001 Directive. Thus it assisted the EMA with the drafting of a request under Article 8(1) of the Penalties Regulation and discussed with the EMA whether it should conduct a re-inspection to validate Roche’s response to that request. However, the EMA in the event did not make any such request.

[33]On 19th December 2012 the EMA sent the MHRA an Article 8(3) request to which the MHRA responded on 14th January 2013. On 30th January 2013 the EMA sent Roche an Article 8(1) request, to which Roche responded on 5th April 2013, and on 20th March 2013 a second Article 8(1) request, to which Roche responded on 18th April 2013.

[34]On 16th May 2013 the MHRA advised the EMA in the context of the infringement procedure, including as to the type of evidence which might be needed by the EMA and the best plan of action, including whether or not there should be a re-inspection.

[35]In the summer of 2013 James Cooke from the MHRA was seconded to the EMA to assist with the infringement procedure and in the preparation of the EMA’s draft Article 10 report. As already indicated, the EMA had not carried out an infringement procedure before and did not employ its own inspectors or enforcement officers.

[36]Between May and July 2013 Roche wrote several letters to the EMA arising out of the discovery by Genentech of some 1.2 million additional records relating to Access Solutions. On 2nd July 2013 the EMA wrote to the MHRA seeking its view on these newly discovered source documents that might contain safety data. The MHRA responded indicating that the re-inspection timetable needed to be brought forward as a result of the discovery of this new material. It wished to complete an on-site assessment of Roche’s review methods. On 3rd July 2013 Dr Williams of the MHRA put to Mr Rowell proposals for consideration of the additional records. She stated that Roche needed to be asked for more information and could be told of the plan to bring the re-inspection forward. She referred to the fact that Mr Rowell was going to speak to the EMA about the implications for the infringement notice.

[37]On 4th July 2013 Mr Rowell responded to Dr Williams stating that the EMA was consulting with the Commission as to whether the new failures could be added as an addendum to the existing infringement procedure or whether a second infringement procedure should be started :

“…Whatever the way forward, we aim to include theses additional cases in the ongoing infringement process in some way but are seeking advice. We are considering whether the interim re-inspection needs to take place at the US site as these are largely US Programmes and we may also visit some of the vendors Roche says were holding this additional information...”

[38]Further internal MHRA communications were exchanged that day. The view was expressed by Dr Williams that because of the additional records it would not be possible to conclude in July 2013. Ideally a formal CAPA was required. Interim re-inspection might be required in the United States.

[39]On 19th July 2013 the EMA emailed Mr Rowell. The new data would need to be considered in the framework of the public health track. It would not form part of the infringement track :

“ ..As regards the re-inspection, please go ahead as you, as supervisory authority, decides is the most appropriate way forward (regardless of the ongoing infringement procedure)….Depending on the outcome of the re-inspection findings, it will be up to the [Commission] to decide on how to proceed with the re-inspection findings, if at all, during “decision making phase” in the framework of the penalties procedure.”

[40]The MHRA submits that this is clear evidence that the re-inspection was not being carried out for the purpose of the infringement procedure.

[41]On 22nd July 2013 the MHRA sent an e-mail to the EMA requesting that the EMA adopt the Re-Inspection as a CHMP request and wishing “to know the process for triggering a CHMP-requested inspection at the US (Genentech) site”.

[42]On 29th July 2013 the MHRA emailed Dr De Veene about re-inspection :

“…With the public health track coming to an end, MHRA are starting to plan for the Roche re-inspection…this will take place at some point between 18 and 29November 2013…the re-inspection will of course focus on the Non-Interventional Programme remediation project…”

This was, from Roche’s perspective, standard procedure following an inspection where the MHRA had taken the view that there were significant failings.

[43]The MHRA having set the dates for re-inspection for the end of November 2013, on 8th August 2013 the EMA asked the MHRA for a telephone conference to discuss the re-inspection and whether the dates for such inspection could be brought forward to allow the inspection findings to be available in the context of the EMA’s draft Article 10 report. The next day Mr Rowell responded, stating that that was not possible, but the MHRA could aim to provide a comment on the inspection outcome pending the final report.

[44]In mid-August 2013 the EMA sent the MHRA a draft CHMP Inspection request ahead of a telephone conference to discuss the Re-Inspection. The telephone conference took place on 15th August 2013 with a discussion that included discussion of the timing of feedback from the Re-Inspection. A final CHMP Inspection Request was issued on 22nd August 2013. On 29th August 2013 the MHRA wrote to the EMA stating that it had already advanced the UK site inspection as agreed, to allow the MHRA “to provide a summary of the findings for the EMA’s Infringement Regulation report to the Commission”. The EMA responded stating that it would be back in touch in a fortnight “to follow up on specific questions we would like to be included in the inspection….”. There was in fact no such follow up.

[45]On 30th August 2013 the EMA sent Roche formal notification of the CHMP request for inspection, which included the CHMP IREQ (“inspection request”). The inspection request was limited to four centrally approved products, namely Avastin, Bondronat, Bonviva and Zelbora. As set out in volume 9A of the “Rules Governing Medicinal Products in the EU – Guidelines on Pharmacovigilance for Medicinal Products for Human Use”(dated September 2008) (“volume 9A”), focusing on a sample of products is a standard way of dealing with system issues.

[46]Roche states that its understanding was that the Re-Inspection was to serve the dual purposes of meeting the CHMP request and MHRA standard procedure. This was confirmed by MHRA inspectors during a telephone call prior to the Re-Inspection between Mr Phillips and Mr Rowell on 18th September 2013. Roche’s notes of that discussion read as follows :

“Scope Although the CHMP/EMA notification referred to 4 (3) products the lead inspector clarified that the scope of the inspection will be broad and the main focus is the implementation of the CAPA. UK : Global oversight of NIPs US : Access Solutions and other US programs. The MHRA do not plan to visit the NIP vendor McKesson but may ask for phone interviews with selected US NIP vendors.”

UK : Global oversight of NIPs

[47]Roche thus understood that the Re-Inspection would be broader in scope than the four listed products and would focus on CAPAs and remediation efforts since last inspection.

[48]On 1st October 2013 the MHRA received a request from the EMA stated to be under Article 8(3) of the Penalties Regulation. It stated as follows :

“…In the framework of [the investigation] the EMA would like to seek the cooperation of the MHRA in the form of a request for information pursuant to Articles 3(1) and 8(3) of [the Penalties Regulation]…”

REQUEST FOR INFORMATION This letter is a formal request for information made in accordance with Articles 3(1) and 8(3) of Regulation (EC) No 658/2007 which empowers the EMA to seek the cooperation of the national competent authority to enable it to carry out its duties under this Regulation and, specifically, to ask any natural or legal person to provide information relating to the alleged infringement. The information you are requested to provide in reply of this request for information is intended to further assess the circumstances of the case in the light of the criteria set forth in Article 18(2) of Regulation (EC) No 658/2007 for the report to be established by the EMA in accordance with Article 10 of Regulation (EC) No 658/2007. In particular you are requested to provide a response to the following questions: Can you please confirm that your Member State has not adopted any urgent action in accordance with article 20 of Regulation (EC) No 726/2004 as a result of any of the alleged infringements set forth in the article 7 notification letter dd. 23 October 2012 (Annex I); Can you please inform the Agency if your Member State has imposed any prior sanctions, including penalties, on the same marketing authorisation holder on the basis of the same legal grounds and the same facts by reference to the alleged infringements set forth in the article 7 notification letter dd. 23 October 2012 (Annex I). For the purpose of the inquiry the marketing authorisation holder is identified as Roche Registration Ltd with registered office at 6 Falcon Way, Shire Park, Welwyn Garden City, AL71TW, Hertfordshire, United Kingdom, registered at the UK’s company house with no. 03028626 and/or any company or entity belonging to the same mother company or group of companies as Roche Registration Ltd. Can you please inform the Agency on the degree of diligence and cooperation shown by the marketing authorisation holder in the detection of the infringement during the MHRA inspection conducted in January and February/March of 2012, on the one hand, or on the other hand, any obstruction by the marketing authorisation holder of the detection of the infringement during the MHRA inspection conducted in January and February/March of 2012 or any non-compliance by the marketing authorisation holder with requests made by the MHRA during the inspection in January and February/March of 2012. Can you please inform the Agency on the degree of diligence and cooperation shown by the marketing authorisation holder in the application of corrective action following the MHRA inspection conducted in January and February/March of 2012 or on any non-compliance by the marketing authorisation holder with requests made by the MHRA before, during or following the inspection in January and February/March of 2012 as well as in the context of the follow-up inspection to be undertaken by the MHRA in October/November 2013. Please note that the information provided by the MHRA will only be used as evidence for the purpose of Regulation (EC) No 658/2007, as appropriate.” REQUEST FOR INFORMATION

In particular you are requested to provide a response to the following questions:

[49]It can readily be seen that these questions mirror the individual factors identified in Article 18 of the Penalties Regulation.

[50]On 17th October 2013 the EMA sent Roche a third request under Article 8(1) of the Penalties Regulation. The EMA also sent a further request to the MHRA again expressed to be under Article 8(3) :

“ … In the framework of this investigation the EMA would like to seek the cooperation of the MHRA in the form of a request for information pursuant to Articles 3(1) and 8(3) of Regulation (EC) No 658/2007. REQUEST FOR INFORMATION This letter is a formal request for information made in accordance with Articles 3(1) and 8(3) of Regulation (EC) No 658/2007 which empowers the EMA to seek the cooperation of the national competent authority to enable it to carry out its duties under this Regulation and, specifically, to ask any natural or legal person to provide information relating to the alleged infringement. The information you are requested to provide in reply of this request for information is intended to further assess the circumstances of the case in the light of the criteria set forth in Article 18(2) of Regulation (EC) No 658/2007 for the report to be established by the EMA in accordance with Article 10 of Regulation (EC) No 658/2007. We would like to request the MHRA to provide the following documents in relation to the Pharmacovigilance (PhV) inspection, which has been requested by CHMP on 22 August 2013 and that the MHRA will conduct at Roche’s premises in the UK and the USA in October/November 2013: • Preliminary PhV Inspection Report; • Responses received from Roche on the above mentioned report • Final PhV Inspection Report Please note that the information provided by the MHRA will only be used as evidence for the purpose of Regulation (EC) No 658/2007, as appropriate.”

REQUEST FOR INFORMATION

[51]The email covering this request stated that the information was “intended to establish whether certain provisions of [the Penalties Regulation] have been infringed by Roche and to assess the circumstances of the case in the light of the criteria set forth in Article 18(2) of [the Penalties Regulation]. Please note that the information provided will only be used as evidence for the purpose of the [Penalties Regulation].”

[52]An internal MHRA email to the Divisional Director stated : “Don’t worry about this. This would be something we would do as standard with a CHMP requested inspection”.

[53]The MHRA responded in part to the Article 8(3) request of 1st October 2013 on 18th October 2013. In summary, the MHRA had not taken action to suspend Roche medicinal products; no sanctions had been imposed by the MHRA on Roche; Roche had co-operated fully with the inspections in 2012, and had been co-operative during the subsequent public health investigation. Roche had responded to all information requests as far as was possible from available data. The MHRA stated that it would respond to additional questions following the Re-Inspection.

[54]As set out above, the Re-Inspection of Roche in the United Kingdom took place at the end of October and on 14th November 2013 (and so was brought forward as the EMA had requested). Re-Inspection at Genentech took place between 18th and 22nd November 2013.

[55]At the time of the Re-Inspection, as set out in the witness statements of Mr Phillips and Dr De Veene, Roche did not know that the EMA had made Article 8(3) requests of the MHRA.

[56]There was reference to the infringement proceedings in the opening meetings. There is a document prepared by Mr Phillips dated 29th October 2013 headed “Daily/Periodic Inspection Debrief”. The inspection scope is described as “Implementation of CAPA from MHRA PV Inspection 2012”. In the executive summary the following entry appears :

“The lead inspector confirmed that this is a re-inspection due to the critical findings noted from the 2012 PV inspection. CHMP also requested an inspection to verify the extent of CAPA fulfilment. Inspection report will be shared with the member states and EMA. Aspects of the inspection report will be used for the infringement procedure but this is not the primary purpose why they are here.”

[57]Scribe notes for the 29th October 2013 opening session are also available. The following opening exchange is recorded :

“[Mr Rowell] – Scope – Recap on previous interaction and inspection feedback will distribute to EMA as routine information sharing. Report will also be shared with FDA. CAPA status check; NIP data collection progress; new regulation activities; formal response will be provided after the second visit at USA. Preliminary feedback will be provided at the end of the UK visit. [Mr Phillips] – Infringement procedure clarification with regards to findings from MHRA from this Inspection. [Dr Sookoo] – We will just feed into the current infringement process…” [Dr Sookoo] – We will just feed into the current infringement process…”

[58]Mr Phillips’ manuscript notes of the meeting refer to Dr Sookoo stating that the MHRA re-inspection “may”feed into the infringement process. He went on to note the inspectors stating that “parallel action could be taken but would muddy the waters”. Mr Phillips states that when told that aspects of the inspection report would be used for the infringement procedure, he thought this was “almost as an aside”. It is nevertheless common ground that it was said in terms that the MHRA would (or at the very least might) feed into the infringement process.

[59]In response to the letter before action the Treasury Solicitor stated by letter dated 27th January 2014 :

“…the MHRA made it clear to Roche at the start of the re-inspection that the re-inspection was for standard pharmacovigilance purposes. Although Jonathan Rowell, MHRA lead inspector, cannot remember the conversation verbatim, he is clear that he did not suggest that the re-inspection was in any part being carried out for the purposes of the infringement procedure under the Penalties Regulation…”

[60]Roche states that it believed that the Re-Inspection was a normal routine inspection. As a result, according to Mr Philips and Dr De Veene, no special precautions were taken to protect Roche’s position.

[61]A similar position existed at the opening of the Re-Inspection at Genentech on 18th November 2013. Mr Phillip’s executive summary of the opening meeting in the inspection debrief stated :

“The lead inspector confirmed the inspection scope, and that it is to follow-up on the non-compliances noted from 2012 PV inspection, focusing on [NIPs] and a review of the Access Solution program. It is also request by the EMA to verify the extent of CAPA fulfilment. Inspection report will be shared with the member states and EMA and the FDA. The inspection is to follow-up on the public health track and the impact assessment submitted to PRAC and to ensure that the activities implemented by Roche/GNE are comprehensive. Aspects of the inspection report will be used for the infringement procedure…”

[62]The scribe notes for 18th November 2013 read as follows :

“[Mr Rowell] EMA request CAPA follow-up and how CAPAs were addressed by Roche. Inspection report will be shared with FDA…Inspector’s interest in an “open dialogue” is mentioned by [Mr Rowell]…Wishes to follow up on “public health track”

. PRAC wishes to obtain information about NIPs managed by Roche to ensure activities we committed to were addressed comprehensively. Inspectors will share report with EMA/PRAC. EMA may use report for infringement procedure (NB : not further specified how exactly this would be done).” (According to Mr Phillips, the last comment in brackets was made by the scribe because of the lack of clarity from the inspectors as to how information gathered in the re-inspection was to be used. It does not appear that the inspectors were pressed for any further clarification.)

[63]On 19th November 2013 the EMA issued a press release stating that no new safety concerns were identified in relation to the first inspection report.

[64]On 22nd November 2013 Roche responded to the EMA’s Article 8(1) request of 17th October 2013.

[65]On 27th November 2013 Mr Rowell sent a “briefing note” to the EMA, including to the EMA’s legal services, setting out the findings of the Re-Inspection. It recorded two critical, two major and at least 2 minor findings. It went on to make proposals for consideration by the EMA and PRAC for a proportionate approach to inspection and reporting of additional safety data.

[66]On 2nd December 2013 Mr Rowell circulated a draft Re-Inspection Report internally for peer review, stating that he needed to get it out to Roche as soon as possible “so that the EMA can append it to their report to the Commission”.

[67]On 3rd December 2013 Dr Sookoo reviewed the draft stating :

“Given that the report is so important for the Infringement Regulation case, I am going to spend most of the day (and possibly the night) reviewing the report…”

She stated that she had tried to address some of the lawyers’ comments, but that Mr Rowell might wish to think about how to “stress certain points”. In her witness statement Dr Sookoo states that, amongst other things, she bore in mind making the draft clear to all readers, including the EMA’s legal team who were not pharmacovigilance specialists. She wanted to ensure that the findings were communicated clearly. There was no resulting change to the nature or grading of the findings or any other fundamental change.

[68]Dr Sookoo also, on 5th December 2013, informally reviewed parts of the EMA’s draft Article 10 report.

[69]On 8th December 2013 the MHRA sent the initial Re-Inspection Report (“the Re-Inspection Report”) to the EMA, before sending it to Roche on 9th December 2013. The draft report is confidential. But it can be said that it made critical findings of Roche. Roche made comments on 17th January and 7th March 2014.

[70]On 13th December 2013 the MHRA provided the balance of its response to the EMA’s Article 8(3) request of 1st October 2013. It stated that Roche had made its personnel and documents fully available at the Re-Inspection. The MHRA considered that Roche had co-operated fully. But Roche had not been fully diligent in the application of the agreed CAPAs. Examples were given.

[71]On 20th December 2013 the EMA sent its draft Article 10 report to Roche. It was critical of Roche. Roche submitted its comments on the draft Article 10 report on 14th February 2014.

[72]On 19th March 2014 the MHRA sent its final Re-Inspection Report to the EMA (“the final Re-Inspection Report”).

[73]On 3rd April 2014 the EMA sent Roche the final Re-Inspection Report.

[74]On 14th April 2014 the EMA announced that it had concluded its inquiry and sent its Article 10 report (“the Article 10 report”) to Roche, to the Member States and to the Commission for its consideration.

[75]Before leaving the facts, Roche sounds a general note of concern as to the approach adopted to disclosure by the MHRA and the EMA. It says that the full extent of co-operation between the MHRA and the EMA as set out above has only emerged as a result of repeated document requests and of the MHRA’s acknowledgement of its duty of candour. But it is right to record that, for example, only a summary has been given of (and not all documents relating to) the various interactions between the EMA and the MHRA relating to Roche in 2013.

D. Jurisdiction

[76]Various jurisdictional or quasi-jurisdictional issues have been canvassed by the parties.

[77]As the high point, the EMA submits that this Court has no jurisdiction to entertain any of the three grounds of claim.

[78]The MHRA’s position is materially less extreme, namely : a) on ground 1 the MHRA accepts that the Court has jurisdiction to rule that the MHRA’s actions were lawful but not that they were unlawful. Reliance is placed on Foto-Frost v Hauptzollamt Lubeck-Ost Case 314/85 [1987] ECR 4199. Thus there is no jurisdiction to grant the declaratory relief sought. In the event of a concern over the lawfulness of the Article 8(3) requests, this Court could at most make a reference to the Court of Justice of the European Union under Article 267 of the TFEU and under CPR Part 68 (“a reference”). But there is insufficient merit and/or materiality in ground 1 for the making of a reference to be an appropriate course; b) on ground 2, the MHRA accepts that this Court has jurisdiction to entertain the claim; c) on ground 3, the MHRA submits that, whilst this Court has jurisdiction in principle, it should decline to entertain the claim given the principle said to be established in

Case C-344/98

Masterfoods [2000] ECR 1-11369, as applied in Conex Banninger Ltd v The European Commission

[2010] EWHC 1978 (Ch)

, to the effect that the national court should not rule on questions of liability to penalty that are currently before the Commission and in relation to which, if the Commission decides against Roche, Roche has full rights of appeal to the General Court.

[79]It is a curious feature that an interested party should take a more extreme position on jurisdiction than the defendant itself.

[80]Roche submits that underlying all the issues in this case is an important jurisdictional point: are the courts of this country entitled to evaluate whether the conduct of public authorities in this country is lawful in circumstances where those public authorities are acting in support of an investigation by institutions of the EU? It contends that this Court has substantive jurisdiction over all three grounds of claim.

[81]In the alternative, Roche submits that references on grounds 1 and 3 should be made. By the close of the hearing, certainly on ground 3, Roche’s position was that grounds 1 and 3 were “eminently referable”. Whilst always a matter for the Court’s discretion, it would be “sensible”to refer them. Its alternative became effectively its primary case.

[82]It is most useful to address the quasi-jurisdictional issues raised by the MHRA on grounds 1 and 3 separately in their context. But it is convenient to deal now on a general level with the EMA’s headline submission that the national court has no jurisdiction at all, even on ground 2.

[83]In summary, the EMA submits that all grounds fall in an area where there is an exclusive competence in the European Court because : a) the EU courts enjoy exclusive competence to declare the acts of EU institution or agency (such as the Commission or the EMA) unlawful : see Article 4(3) of the Treaty on European Union (“TEU”) and Fotofrost (supra); b) in consequence : i) the national court has no jurisdiction to decide for itself the matters raised in the claim; ii) any declaratory relief which Roche might obtain in a judgment of the national court in relation to the matters raised in the claim would have no effect in relation to the Commission or the EMA.

[84]The EMA submits that there are sound policy reasons why the matters raised in this claim should be left to the European courts. The Penalties Regulation was set up as a system for administrative decisions imposing financial penalties to be taken by the Commission. It is a centralised system. There is a strong public health interest in allowing the system to operate in a smooth and uniform way. The EMA’s position would not leave any lacuna, since there are full procedures with the Penalties Regulation for the protection of fundamental rights. This distinguishes the position from that in Joined Cases C-402/05 P and C-415/05 P Kadi

[2009] 1 AC 1225

, referred to below, where no such protection was in place.

[85]The EMA submits in particular that the Commission has exclusive competence to take decisions in relation to the infringement procedure, subject to review by the EU courts. This is significant because the Commission therefore enjoys the sole right to decide which evidence to rely on in taking its decision, whether any procedural arguments affecting its ability to rely on that evidence are valid and, if so, what the consequences are. The effect of Roche’s arguments is that a national court is able to make decisions which the EMA submits are ones for the Commission to take. It would be to subvert the legislative intention behind the Penalties Regulation for the claim to be entertained. Grounds 1 and 3 rely solely on the correct interpretation of EU law and are matters which the Commission will have to determine, if Roche raises them, in the infringement proceedings. In reality Roche is attacking the validity of the EMA’s actions and prospectively any decision of the Commission.

[86]The EMA submits that the duty of sincere co-operation between national courts and EU institutions precludes national courts from ruling that decisions made by EU institutions are invalid, including in cases where the Commission has yet to take its decision. Reliance is placed on Foto-Frost (supra) and Masterfoods (supra) in particular. The EMA also relies on the obligation of national courts to guarantee the protection of EU law rights for individuals and bodies. It accepts that where national authorities act within the scope of EU law, individuals are entitled to vindicate their EU law rights in the national courts. But that is subject to the limitation imposed by the duty of sincere co-operation under which only the EU courts can rule in relation to the validity of acts or decisions by EU bodies. National law is not applicable in every case (see

Case C-550/70

Akzo Nobel

[2010] ECR I-08301

). Whether it is relevant will depend on the meaning and scope of the particular legislation. In the present case, it was not intended that under the Penalties Regulation the Commission’s powers to rely on infringement proceedings on information provided by national competent authorities which had been obtained through inspections would vary according to differing national procedural rules relating to inspections.

[87]In my judgment, the broad matters relied upon by the EMA may go to the question of how this Court should ultimately exercise its jurisdiction. There is a degree of overlap in the EMA’s submissions and the MHRA’s submissions on that issue and, where appropriate, those submissions are addressed together under each ground of claim.

[88]But I reject the EMA’s general submission that because the EU courts enjoy exclusive competence to declare the acts of an EU institution or agency unlawful and because there is a centralised system created under the Penalties Regulation, the national court does not have jurisdiction to entertain the claim at all. Nor do I accept that the effect of the duty of sincere co-operation owed by national courts or of the obligation to guarantee the protection of EU law rights for individuals and bodies is to denude the national court of all jurisdiction here. The arguments have been rehearsed in detail in writing and orally, but it is sufficient for present purposes for me to address the main points in summary only below.

[89]It is of course not determinative, but nevertheless noteworthy, that in none of the authorities to date has the jurisdiction of the national court been excluded or has it declined its own jurisdiction. In Masterfoods (supra), for example, there was a referral by the Supreme Court of Ireland on a claim to challenge a Commission decision. The CJEU ruled as follows :

“Where a national court is ruling on an agreement or practice the compatibility of which with Articles 85(1) and 86 of the EC Treaty…is already the subject of a Commission decision, it cannot take a decision running counter to that of the Commission, even if the latter’s decision conflicts with a decision given by a national court of first instance. If the addressee of the Commission decision has, within the period prescribed in the fifth paragraph of Article 173 of the EC Treaty…brought an action for annulment of that decision, it is for the national court to decide whether to stay proceedings pending final judgment in that action for annulment or in order to refer a question to the Court for a preliminary ruling.”

[90]Thus, even where there is effectively a challenge to a Commission decision already taken, the national court still has jurisdiction, even if only to stay or make a reference.

[91]The weakness of the EMA’s position is exposed most obviously by reference to the claim on ground 2. That claim seeks to challenge the acts of an authority of the United Kingdom inspecting a British company pursuant to powers conferred by the 2012 Regulations on the basis of a breach of administrative law principles of fairness. The EU courts have no jurisdiction over the MHRA, with the result that, absent jurisdiction here, the MHRA would be amenable to no jurisdiction.

[92]It is common ground that this Court cannot rule that an act of an EU institution is invalid – see Fotofrost (supra). But, at least on ground 2, Roche is not challenging a decision or an act of an EU institution, but merely the acts and decisions of the MHRA. The challenge is to the acts of a domestic body exercising national powers. The basis for that challenge is an alleged misunderstanding by the domestic body of EU law, but there is no reason in principle why the national court cannot interpret and apply EU law. And even if the Court was being invited to rule that an act of an EU institution was invalid, it would still have jurisdiction – either to rule that the act was valid or to make a reference. Nor does the fact that a question of construction may yet come before the Commission necessarily deprive the national court of jurisdiction (though it may limit the national court’s powers).

[93]Roche relies in this context generally on R (Kent Pharmaceuticals Limited) v Director of the Serious Fraud Office

[2003] EWHC 3002 (Admin)

at first instance. There it was held (at paragraph 26) that if certain disclosure had been made by one government department to another in bad faith or for an improper purpose, in the sense of a purpose not within the proper functions of the recipient department, then it would have been reviewable in domestic law on traditional public law grounds. In the European context, reference is made to Kadi (supra). The CJEU was determining whether the court had jurisdiction to consider the lawfulness of what the European Union had done in response to a request from the United Nations, a body over which it had no control. The CJEU determined that it did. In response to the submission that the challenge was effectively an illegitimate challenge to the decisions of the United Nations, the court said this at paragraph 286 :

“In this regard it must be emphasised that, in circumstances such as those of these cases, the review of lawfulness thus to be ensured by the Community judicature applies to the Community act intended to give effect to the international agreement at issue, and not to the latter as such.” and at paragraph 299 : “It follows from all these considerations that it is not a consequence of the principles governing the international legal order under the United Nations that any judicial review of the internal lawfulness of the contested Regulations in the light of fundamental freedoms is excluded by virtue of the fact that that measure is intended to give effect to a Resolution of the Security Council adopted under Chapter VII of the Charter of the United Nations.”

The EMA is right to point out that the facts in Kadi were very different. But it nevertheless provides a useful indication of approach.

[94]I do not accept that the Penalties Regulation lays down a comprehensive set of rules in relation to the collection of evidence by national competent authorities: a) national competent authorities are responsible for inspections and enforcements (see Article 111(1) of the 2001 Directive) and the EMA has no powers in that regard; b) whilst national competent authorities are subject to EU requirements such as the EU Charter when implementing EU law, they are subject also to domestic law, including the normal principles of national administrative law. But even if it did lay down a comprehensive set of rules, that would not of itself deprive the national court of jurisdiction. Nor do I accept that the exclusivity of the Commission’s jurisdiction to take infringement decisions under the Penalties Regulation in some way deprives the national court of the power to adjudicate on the lawfulness of the national competent authority’s conduct.

[95]Finally, there is in my judgment nothing in the obligations of sincere co-operation or of protection of EU rights that advances matters materially in terms of fundamental jurisdiction. The authorities relied on by the EMA are distinguishable on their facts, such as Akzo Nobel (supra), or do not resolve the question of jurisdiction, such as Joined Cases 46/87 and 227/88 Hoechst v Commission;

Case C-94/00

Roquette Freres;

Case C-199/11

Europese Gemeenschap v Otis NV

[2013] 4 CMLR 4

and

Case C-375/07

Heuschen and Shrouff

[2008] ECR I-8691

[96]In summary, and as the MHRA itself accepts, this Court has jurisdiction to entertain the claim. How it should treat the different grounds of the claim substantively falls next to be considered. The position is more nuanced than reflected in the broad question posed by Roche as set out in paragraph 79 above, certainly so far as grounds 1 and 3 are concerned. The question is not so much one of substantive jurisdictional entitlement, but rather a question as to how that jurisdictional entitlement should be exercised. E. The substantive claim E1. Ground 1

E. The substantive claim

[97]As set out above, in October 2013 the EMA made two requests of the MHRA expressly under Article 8(3), to which the MHRA responded in due course. As set out above, the MHRA provided formal confirmations on the regulatory position, reported on Roche’s diligence and co-operation, and provided a copy of the Re-Inspection Report.

[98]Roche contends that the proper legal basis for a request by the EMA to the MHRA is Article 8(2), not Article 8(3). For requests which fall within the scope of Article 8(2), Article 8(2) is the sole and exhaustive way of making such a request. Article 8(2) is wide enough to cover an information-sharing request both in respect of a planned inspection, or one which had been conducted.

[99]The words “natural or legal persons”in Article 8(3) should be read as excluding the national competent authority, here the MHRA. This is because the position relating to the national competent authority is addressed specifically in Article 8(2). The clear structure of Article 8 is that sub-paragraph (1) deals with the MAH, sub-paragraph (2) with the national competent authority, and sub-paragraph (3) with any other (natural or legal) person. This is a logical construction, since the MAH is the target of the investigation, subject to a compulsion to answer (and penalty for non-compliance in Article 19); the national competent authority has domestic statutory powers to investigate the MAH and EU law obligations to transmit that information to the EMA. By contrast a request under Article 8(3) carries with it no compulsion. It appears as a general voluntary evidence-gathering power.

[100]The MHRA asserts that Article 8(3) was a proper basis for the requests. The reason why Article 8(2) refers to national competent authorities and Article 8(3) does not is that matters that may be the subject of requests under Article 8(2) require the exercise of powers only enjoyed by national competent authorities. Secondly, to construe Article 8(2) as providing the only basis on which the EMA could make requests to national competent authorities would be to frustrate the express purpose of the legislation and the broad duties of co-operation. There would be a significant lacuna, since requests under Article 8(2) are limited to requests to perform inspections. Article 8(2) does not cover investigations that take place for public health reasons, that is to say, independently of the purposes of the Penalties Regulation. As to why, if the MHRA is right in its construction of Article 8(3), Article 8(2) is needed at all, the MHRA states that it is there to make specific provision for the EMA to request national competent authorities to exercise powers that only they have. The MHRA points to the wording of Article 14(2) where there is reference to request by the EMA of “the Agency, the national competent authorities or any other natural or legal persons”to provide information (emphasis added).

[101]Roche submits that Article 8(2), read purposively, is clearly broad enough to cover a request by the EMA in relation to ongoing, not just prospective, investigations. Thus there is no procedural lacuna as the MHRA suggests : a) first, Article 8(2)(b) refers to the performance of inspections or other supervisory measure in accordance with, amongst other things, Article 111 of the 2001 Directive. Article 111(1) refers to co-operation in the form of information sharing on planned and past inspections. Thus Article 8(2)(b) is wide enough to cover requests in relation to ongoing inspections; b) secondly, Article 8(2)(b) refers to “other supervisory measures”. The power under Article 8(2) is clearly not a narrow one.

[102]In my judgment, Roche’s point of construction on Article 8 is properly arguable and cannot be dismissed out of hand. The question then arises as to how this Court can and should proceed.

[103]Roche invites it to rule on the question substantively. The MHRA contends that ground 1 clearly engages the principles established in Foto-Frost (supra) with the result that the most that this court could do would be to make a reference.

[104]In Fotofrost there was a challenge to a domestic measure (taken by the Hauptzollamt) which was giving effect to a European measure. That challenge was treated as if it were a challenge to the validity of the European measure. The court ruled as follows :

“11. In its first question the Finanzgericht asks whether it itself is competent to declare invalid a Commission decision such as the decision of 6 May 1983. It casts doubt on the validity of that decision….However, it considers that in view of the division of jurisdiction between the Court of Justice and the national courts set out in Article 177 of the EEC Treaty only the Court of Justice is competent to declare invalid acts of the Community institutions… 14. Those [national] courts may consider the validity of a Community act and, if they consider that the grounds put forward before them by the parties in support of invalidity are unfounded, they may reject them, concluding that the measure is completely valid. By taking that action they are not calling into question the existence of the Community measure. 15. On the other hand, those courts do not have the power to declare acts of the Community institutions invalid. As the Court emphasized in the judgment of 13 May 1981 in Case 66/80 International Chemical Corporation v Amministrazione delle Finanze [1981] ECR 1191, the main purpose of the powers accorded to the Court by Article 177 is to ensure that Community law is applied uniformly by national courts. That requirement of uniformity is particularly imperative when the validity of a Community act is in question. Divergences between courts in the Member States as to the validity of Community acts would be liable to place in jeopardy the very unity of the Community legal order and detract from the fundamental requirement of legal certainty… 18. It must also be emphasized that the Court of Justice is in the best position to decide on the validity of Community acts. Under Article 20 of the Protocol on the Statute of the Court of Justice of the EEC, Community institutions whose acts are challenged are entitled to participate in the proceedings in order to defend the validity of the acts in question. Furthermore, under the second paragraph of Article 21 of that Protocol the Court may require the Member States and institutions which are not participating in the proceedings to supply all information which it considers necessary for the purposes of the case before it… 20. The answer to the first question must therefore be that the national courts have no jurisdiction themselves to declare that acts of Community institutions are invalid.”

[105]Roche points to R (Bredenkamp) v Secretary of State for Foreign and Commonwealth Affairs

[2013] 2 CMLR 10

where Ouseley J held as follows :

“43. The limitation as expressed in Foto-Frost is on the power of a national Court to declare a Community act invalid. It does not prevent a conclusion by a national court that a Community act is valid. The Foto-Frost principle is thus quite narrowly defined. It is not an assertion of some exclusive “competence” in areas which may touch and concern the Community legal order. The more obviously does this apply where the CJEU, whatever its approach to the effect of arguably unlawful Community acts may be, did not suggest that any contributory domestic acts were subject to its exclusive power, nor did the UK Government seek to obtain such a protective ruling from it. It is not suggested that there is some wider principle to the effect that where the act impugned leads to or is undertaken as part of a Community act, it is immune from domestic legal remedy, and a remedy can only be sought in respect of the eventual Community act, and only through the CJEU. The Foto-Frost principle does not prevent a national court ruling on domestic unlawfulness where that may also involve implied or express criticism of Community processes or acts. 44. Instead, the asserted limited approach to remedying wrongs, articulated by the CJEU, leaves the field open, in the interests of justice, to a challenge to what domestic authorities did en route to the enactment of Community decisions. The absence of judicial protection from the ECJ is not a shield behind which domestic courts are allowed by the European legal order to hide from domestic challenge. I accept that the European legal order ought to provide a remedy for its own unlawfulness, but that may not always be precisely co-terminous with possible national unlawfulness, however closely related. 45. Mr Swift accepts that his arguments turn on whether it can now be seen that breach of the Foto-Frost rule is inevitable in the light of the evidence about how the Community decisions came to be made and the UK Government’s role in them. Unless a ruling that a Community act is invalid is the inevitable precursor to success for the claimant, the claim should continue. Therefore, to my mind, the existence of possible analyses which might eventually cause the action to fail, because success would require the national court to rule Community acts to be invalid, cannot help the Defendant at this stage on this preliminary issue, akin as it to a strike out for want of jurisdiction. The action can only fail now if all possible analyses leading to success for the Claimant can be seen inevitably to require such a forbidden ruling.”

[106]In my judgment Bredenkamp does not assist Roche. It is important to note that Bredenkamp involved a challenge to the acts of the Foreign Secretary in the exercise of his prerogative powers. This was emphasised by Ouseley J :

“5. The grounds of this domestic challenge are important. The first challenge is to the proposal by the UK Government in 2009 that the Claimant be listed under the Council Regulation 314/2004... It is alleged to have been irrational because of the contemporaneous UK Government view that the evidence to justify it was “thin”... The Foreign Secretary had also failed to present a fair picture of the material to the Council or Commission in proposing the Claimant for listing… The Foreign Secretary had failed to seek de-listing…”

[107]It is also to be noted that in Bredenkamp recourse from the national court was the only realistic option by then left available to the claimant, who had effectively exhausted his rights in Europe. Even on the facts of Bredenkamp, where there was not an inevitable challenge to the lawfulness of Community acts, Ouseley J described the difference between holding that the Foreign Secretary acted unlawfully on the one hand and not ruling that the Community acts were invalid on the other “may be as gossamer” (at paragraph 55).

[108]In contrast to the position in Bredenkamp, the complaint here is a vires challenge that wholly and necessarily depends on the contention that the EMA had no power under Article 8(3) to issue the requests that it did. The position is much starker than that in Bredenkamp. The “gossamer” thread does not exist at all. Thus the principle in Fotofrost applies and Bredenkamp is distinguishable. Just as the Finanzgericht could not declare unlawful the national measure taken by the Hauptzollamt, so this Court cannot declare the MHRA’s responses to the Article 8(3) requests unlawful.

[109]As for the making of a reference, even though the construction of Article 8(3) is a properly arguable point, it would not in my judgment be appropriate to make a reference.

[110]It is common ground that a court should not grant relief in relation to an error of law where such error is immaterial to the decision complained of. Roche’s complaint is in my judgment at best a technical one and immaterial to the essential conduct complained of. Whilst as a matter of fact the MHRA’s responses to the Article 8(3) requests would not have been sent in the precise form that they were but for the Article 8(3) requests, the material information contained in the responses would have emerged and been provided lawfully to the EMA in any event. Dr Sookoo in her evidence states in terms that the fact, content and scope of the Re-Inspection were not affected by the Article 8(3) requests in any way. The Re-Inspection results would have been provided to the EMA in any event. Mr Phillips endorses her evidence. The possible exception is the MHRA’s response in relation to co-operation. But that response was entirely positive from Roche’s point of view. It is difficult to see how its provision could be said to entitle Roche to any substantive relief.

[111]Quite independently of Article 8 the Penalties Regulation, the MHRA had a ready and lawful basis for the essential co-operation with the EMA of which complaint is made, for example under Article 111 of the 2001 Directive and Article 3(1) of the Penalties Regulation. The issuing of Article 8 requests did not overtake, let alone eclipse, those obligations which continued at all material times. I reject the submission that where there is arguably a specific legal basis for a request, it is not open to the MHRA to rely on a more general one in the context of a legislative regime that is replete with broad and unfettered obligations of co-operation.

[112]In these circumstances, the making of a reference on ground 1 is simply not warranted and I decline to do so. In reaching this decision, I also take into account the public interest considerations which militate against a reference as set out in the context of my consideration of ground 3 below.

[113]For these reasons, I dismiss the claim on ground 1.

E2. Ground 2

[114]Roche summarises its claim on ground 2 as follows : a) Roche is subject to an investigation which has the potential to lead to very large penalties being imposed; c) the MHRA gathered evidence to be used in that investigation; d) it did so without properly alerting Roche to that fact; e) this deprived Roche of the possibility to consult lawyers, exercise its rights and come to an informed view as to its approach; f) there is no possible justification for such an approach.

[115]Roche says it was entitled to timely, clear and complete information as follows: a) it should have been told of the Article 8(3) requests made by the EMA in October 2013; b) it should have been told of the close co-operation between the MHRA and the EMA in respect of the infringement procedure, including the fact that the timing of the Re-Inspection had been brought forward at the EMA’s request and that Mr Rowell was intending to give informal feedback for the infringement procedure; c) it should have been told of the fact that the evidence obtained in, and views formed as a result of, the Re-Inspection could play a critical part in the infringement procedure and in the assessment of the size of any potential financial penalty.

[116]The MHRA instead effectively sidestepped Roche’s important rights under the infringement procedure, for example to silence and legal assistance. Fairness is the gateway to the exercise of those rights which are otherwise rendered valueless. Roche complains that the MHRA took advantage of the culture of cooperation and openness that exists in the context of routine inspections. It expressly encouraged that openness (for example through Mr Phillips’ remarks on 18th November 2013). It is a matter of general concern if anything said or done in the context of a routine inspection, even if self-incriminating, can then be used in quasi-criminal proceedings such as those arising under the Penalties Regulation. It contrasts what it was told about the interrelation between the Re-Inspection and the infringement procedure and the formal content of the letters setting out the scope of the Re-Inspection.

Duty to act fairly

[117]In its grounds of claim and written submissions, Roche put its claim to unlawfulness in a number of ways : a) a breach of Article 6 of the European Charter of Human Rights (“the ECHR”); b) a breach of Article 22 of the Penalties Regulation; c) a breach of the Police and Criminal Evidence Act 1984 (“PACE”); d) a breach of obligations under the Procedure for Conducting Pharmacovigilance Inspections requested by the CHMP; e) a breach of Roche’s rights under

Article 8 of the ECHR

and Article 7 of the EU Charter of Fundamental Rights (“the EU Charter”); f) a breach of the MHRA’s domestic public law obligations not to act unfairly or improperly.

[118]Whether or not some or all of those principles are engaged properly or at all has proved highly contentious, in particular the application of PACE and

Article 6 of the ECHR

and 7 of the EU Charter.

[119]However, what emerged as common ground between the parties is that the MHRA was at all material times under a domestic public law duty to act fairly. In those circumstances, whilst fully reserving its position, Roche did not press for present purposes the additional bases upon which it relies. In the circumstances, I proceed on the basis of the common law duty alone.

[120]Roche relies on R (Kent Pharmaceuticals Ltd) v Serious Fraud Office

[2005] 1 WLR 1302

at appellate level. There the Court of Appeal was considering whether or not the Serious Fraud Office (“the SFO”) had exercised its discretion lawfully under section 3(5) (a) of the Criminal Justice Act 1987 to provide disclosure to the Department of Health which the SFO had obtained under a number of search warrants executed under section 2(4) of the Criminal Justice Act 1987. The Department of Health had commenced civil proceedings against various pharmaceutical companies, including Kent Pharmaceuticals Ltd (“Kent”). Kent challenged the decision to disclose. The Court of Appeal reviewed the authorities supporting the requirement for fair notice or provision of information including the classic statement of the House of Lords in R v Secretary of State for the Home Department ex p Doody

[1994] 1 AC 531

. There the Court was considering what a prisoner sentenced to a life sentence should be told about the judicial view as to the appropriate tariff and the reasons of the Secretary of State for the tariff chosen. At page 560 Lord Mustill said :

“What does fairness require in the present case? My Lords, I think it unnecessary to refer by name or to quote from, any of the often-cited authorities in which the courts have explained what is essentially an intuitive judgment. They are far too well known. From them, I derive that (1) where an Act of Parliament confers an administrative power there is a presumption that it will be exercised in a manner which is fair in all the circumstances. (2) The standards of fairness are not immutable. They may change with the passage of time, both in the general and in their application to decisions of a particular type. (3) The principles of fairness are not to be applied by rote identically in every situation. What fairness demands is dependent on the context of the decision, and this is to be taken into account in all its aspects. (4) An essential feature of the context is the statute which creates the discretion, as regards both its language and the shape of the legal and administrative system within which the decision is taken. (5) Fairness will very often require that a person who may be adversely affected by the decision will have an opportunity to make representations on his own behalf either before the decision is taken with a view to producing a favourable result; or after it is taken, with a view to procuring its modification; or both. (6) Since the person affected usually cannot make worthwhile representations without knowing what factors may weigh against his interests fairness will very often require that he is informed of the gist of the case which he has to answer.”

[121]In the context of the claim by Kent the Court of Appeal stated that in some cases it might not be appropriate or practicable to give notice of proposed disclosure either at all or in time to enable the owner of the documents to have an opportunity to respond. In such a case the designated member of the SFO would not be acting unfairly if he decided to go ahead without giving the sort of notice which in other circumstances would be required. But, having taken the decision to disclose the documents, he would then have to consider whether the owner of the documents should be told what had taken place. At paragraph 29 Kennedy LJ (with whom Chadwick LJ agreed at paragraph 40) stated :

“…It may be that he should not be told in order to protect ongoing investigations, but in my judgment the starting point should always be that the owner of the documents is entitled to be kept informed rather than the reverse. That is what, as it seems to me, fairness demands, not only because the documents are his, subject to his right to confidentiality save in so far as his rights have been curtailed by statue, but also because he cannot exercise his remaining rights in any way unless he knows what is going on. If the matter is approached in the right way it may be that in most cases, for good reason, no notice will be given. That seems to me to be immaterial. What is important is to recognise the approach that fairness demands.”

[122]The MHRA submits that the facts in Kent are far removed from the facts of this case. Whilst that is not to say that relevant statements of principle may not still be helpful, I agree with this submission. Although there was clearly a power in principle on the part of the SFO to disclose to the Department of Health, Kent had no reason whatever to assume that any such disclosure would happen. Thus it needed to be informed so that it had a chance to object. Here, even ignoring what Roche was expressly told, there was not just a power but a duty on the MHRA to share information with the EMA.

[123]Ultimately, what is fair in all the circumstances is a question to be decided on the facts of each case.

Analysis

[124]The starting point is a consideration of the true nature of the Re-Inspection. Roche asserts that the Re-Inspection was carried out for the purpose of evidence-gathering for the infringement proceedings. The MHRA stoutly denies this. It states that the Re-Inspection was a normal public health track investigation which the MHRA would have been criticised for not carrying out, given the “critical” findings in the first inspection report. The MHRA was carrying out its duty to protect public health and safety. As Dr Sookoo and Mr Rowell each confirms in terms (at paragraph 114 of her statement and paragraph 18 of his) :

“… the activities performed by the MHRA during the conduct of the 2013 re-inspection were performed [with a view to/for the purposes of] the protection of public health.”

[125]Roche relies on an internal email from Dr Sookoo to Mr Rowell dated 26th September 2013 where she wrote the following :

“…Have you shared the draft plan with EMA and do you intend to? It would be useful to get some feedback from the legal team on specific issues they wish us to examine. This is a bit of a combination between a “forensic” investigation and a review of current processes, which is unusual for us. We will have to be clear when recording document requests and in making inspection notes, in case of judicial review of any decision the Commission may come to.”

[126]But in her witness statement Dr Sookoo explains at the time of this email she did not recall all of the previous communications about the scope of the Re-Inspection (for example the EMA’s email of 19th July 2013), and was under the mistaken impression that the MHRA inspection team was being asked to do something additional to a routine CAPA review. The comments in the email reflected that incorrect assumption. She states :

“In subsequent discussions with Jonathan Rowell i.e. after this email was sent, Jonathan Rowell clarified to me his understanding of the purpose of the 2013 re-inspection (i.e. CAPA review) and I re-reviewed the scope in the adopted IREQ (which clearly indicates the objectives of the re-inspection) Jonathan Rowell has confirmed that he did not send the draft re-inspection plans to the EMA legal services as I suggested… or ask the EMA legal services for input into the inspection plans… I am clear in my own mind that the purpose of the 2013 re-inspection was only to examine those points included in the IREQ, in particular, the implementation of the CAPA with respect to retrospective review and submission of safety data for specific products for public health purposes. This is the manner in which the 2013 re-inspection was actually conducted.”

[127]Roche did not seek to cross-examine Dr Sookoo (or Mr Rowell) on these (or any) points and in the absence of any direct challenge to that evidence, it is to be accepted. It is in any event consistent with, for example, EMA’s email of 19th July 2013 and the documents, such as inspection plans, setting out the scope of the Re-Inspection and what was said to Roche at the time of the Re-Inspection itself.

[128]Dr Sookoo also deposes (for herself and Mr Rowell) that “the conduct and scope of the 2013 re-inspection was not affected by the additional Article 8(3) requests [of October 2013]. The scope of the 2013 re-inspection had already been agreed in the IREQ adopted in August 2013 and, in accordance with the EMA SOP on reporting of pharmacovigilance inspections, the 2013 re-inspection report would in any case always have been provided to the EMA”. She also states that it was common practice for the MHRA to provide an initial version of the inspection report to the EMA for CHMP requested inspections, before the MAH has provided responses, in order to inform the EMA that the report has been sent to the MAH and in order to indicate that timelines on reporting are being adhered to. There was nothing in the third Article 8(3) request that required any departure from common practice in terms of what was provided to the EMA. Dr Sookoo confirms that at no time during the Re-Inspection did the MHRA inspectors ask any questions or request any documents which were not relevant to the scope of the inspection adopted in the inspection request (“the IREQ”).

[129]Roche relies on the fact that a briefing note was sent by the MHRA to the EMA by Mr Rowell on 27th November 2013 in advance of the Re-Inspection report being finalised. It described the two critical findings identified during the Re-Inspection.

[130]The possibility of the MHRA providing information to the EMA prior to finalisation of an inspection report is in fact recognised in the EMA’s guidance on the procedure for reporting of pharmacovigilance inspections requested by the CHMP :

“3. PREPARING INSPECTION REPORTS … During the conduct of the inspection or preparation of the reports the inspectors may decide to inform EM[A] on particularly urgent critical findings in advance of the circulation of the inspection reports…”

[131]However, Dr Sookoo frankly states that the briefing note was sent for two purposes. It was sent to the chair of the PRAC and EMA colleagues in the Public Health Track due to the concerns raised about the follow-up actions required for health purposes. A proportionate approach to follow-up of the deficiencies was proposed. But it was also sent to EMA colleagues in the Enforcement Track to notify them of the outcome of the Re-Inspection as had been agreed prior to the Re-Inspection.

[132]The sending of this briefing note does not affect my conclusion as to the scope of the Re-Inspection. There is no suggestion that it contained anything that would not have been or was not contained in the ensuing Re-Inspection report. It may be relevant to the ancillary questions of fairness addressed below, but it does not undermine the essential fact that this was a routine inspection.

[133]It follows from the above that Roche was not misled as to the nature of the Re-Inspection. Additionally, because the scope of the Re-Inspection was limited to that identified above, there is nothing surprising in the fact that the formal letter of notification of 30th August 2013 did not go further and mention the infringement procedure, as Roche suggests it should have done.

[134]However, the fact that Roche was not misled as to the nature of the Re-Inspection does not necessarily determine the question of fairness without more. Roche’s broad complaint remains that it was not told (or not told properly) that the findings of the MHRA or documents or material obtained by the MHRA during the Re-Inspection could or would be passed on by the MHRA to the EMA for use in the infringement procedure. It was not told of this during the telephone conversation between Mr Phillips and Mr Rowell on 18th September 2013, for example.

[135]So did fairness in all the circumstances require Roche to be given additional information or information earlier than it was, as Roche alleges?

[136]As a general point, Roche relies on Dr Sookoo’s witness statement (at paragraph 92) where she states :

“I should note at this point that in MHRA inspections that are conducted as part of enforcement investigations, different processes are followed. For example, the MHRA select the personnel to be interviewed and enforcement officers…would attend the inspection. In addition, the investigative purpose of the inspection is clearly explained to the company. This did not happen with the Roche 2013 re-inspection, because it was a re-inspection to examine CAPA implementation and not an inspection conducted for enforcement purposes. However, given the EMA’s guidance…I consider that Roche should not have been in any doubt that the results of the 2013 re-inspection could be taken into account in relation to possible enforcement proceedings such as those under the Penalties Regulation (and, as I explain below, we made that clear to Roche at the outset of the 2013 re-inspection).”

[137]This evidence does not in my judgment advance Roche’s position as an example of what should have happened at the time of the Re-Inspection. First, as I have found, the Re-Inspection was not an enforcement investigation. Secondly, the reference to “enforcement investigations” by Dr Sookoo is a reference to investigations undertaken by the MHRA’s Enforcement Group with a view to possible referral to the Crown Prosecution Service for criminal prosecution thus, for example, engaging Code C of the Police and Criminal Evidence Act 1984.

[138]As already stated, the question of fairness is ultimately one of fact to be decided in all the circumstances. Relevant circumstances here include the following factors : a) first, Roche is and was at all material times a highly sophisticated and resourced commercial organisation acting by personnel expert in the field of pharmacovigilance; b) secondly, a quasi-criminal infringement procedure against Roche was, to Roche’s knowledge, underway under the Penalties Regulation. The ultimate sanction in any infringement proceedings is potentially very significant. The procedure carried with it safeguards, such as the right to silence, the right against self-incrimination and the right to require a warrant. Roche was in fact of course already addressing the infringement procedure under the Penalties Regulation directly, not least because of the EMA’s Article 6(1) request of 13th June 2012 and Article 8(1) requests of 30th January 2013, 20th March 2013 and 17th October 2013. Roche responded to each of these requests, including to the request of 17th October 2013 on 22nd November 2013, that is to say actually over the period of the Re-Inspection; c) thirdly and importantly, Roche can be taken to have known of the relevant legislative background. It can be taken to have known of the MHRA’s obligations to co-operate with the EMA as referred to, for example, in the Penalties Regulation, and, for example, of the obligation on the MHRA to provide the EMA report under Article 111(8) of the 2001 Directive. Under Article 111 of the 2001 Directive the MHRA was required to co-operate with the EMA to ensure that the legal requirements governing medicinal products were complied with and required the MHRA to act in co-operation with the EMA. That co-operation was stated expressly to consist in the sharing of information with the EMA on both inspections that are planned and that have been conducted; d) fourthly, Roche can also be taken to have known of its rights under the Penalties Regulation as referred to in subsection b) above; e) fifthly, Roche was aware at all material times that the MHRA was in fact working with the EMA for the purpose of investigating deficiencies in Roche’s systems, for example from the June 2012 press release; f) sixthly, Roche can also be taken to have known of relevant guidance such as the general guidance in GVP Module III. In the introduction it is stated :

“The objectives of pharmacovigilance inspections are : i) to determine that the marketing authorisation holder has personnel, systems and facilities in place to meet their pharmacovigilance obligations; ii) to identify, record and address non-compliance with may pose a risk to public health; iii) to use the inspection results as a basis for enforcement action, where considered necessary…”

The third identified objective echoes the “Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use” (dated September 2008) (“the volume 9A Guidance”) and which Mr Phillips actually exhibits (at least in part) in his evidence. There at paragraph 2.4 it is stated :

“…The [inspection] results will be used to help [MAHs] improve compliance and may also be used as a basis for enforcement action…”

I am un-persuaded by Roche’s submission that the reference to inspection results being used “as a basis for enforcement action” suggests only that inspection results could be used to commence enforcement proceedings, rather than be used in those proceedings. That is to take too restrictive an approach to the wording of what was in any event only guidance. And the guidance appears in the introduction section for all types of inspection, re-inspections as well as preliminary inspections. There is also no evidence from Roche stating that this was in fact Roche’s understanding at the time. In broad terms Roche can be taken to have known from this guidance that inspection results could be used for enforcement action purposes, including in the context of an already existing infringement procedure; g) seventhly, Roche can be taken to have known of the considerations for the EMA under the Penalties Regulation, including those of co-operation and diligence as set out in Article 18(2)(c). It can also be taken to have known that under Article 10, where the EMA considered that the MAH had committed an infringement, the Article 10 report would include an assessment of the circumstances of the specific case in accordance with the criteria set out in Article 18(2); h) eighthly, Roche was told in terms at the outset of the Re-Inspection on 29th October 2013 that the report would be shared with the EMA, and that aspects of the report would (or at the very least might) be used for the infringement procedure. Dr Sookoo is recorded as saying that the report would (or might) feed into the infringement procedure. On 18th November 2013 it was again stated that aspects of the inspection report would be used for the infringement procedure. The report would be shared with EMA. For the avoidance of doubt, I do not consider there to be any material discrepancy between what was said by the Treasury Solicitor in January 2014, namely that Mr Rowell was clear that he did not suggest that “re-inspection was in any part being carried out for the purposes of the infringement procedure under the Penalties Regulation…”and what is recorded by Roche as having been said by Mr Rowell at the time of the Re-Inspection. He said that the Re-Inspection was routine. Its fruits would be shared with the EMA which would or could use them as part of the infringement procedure; i) finally in this context, it is important to note that Roche has the full right to be heard and the opportunity in the course of the infringement proceedings to make full representations. It can comment as it wishes on any aspects of the Re-Inspection report or results relied on by the Commission with which it disagrees as a matter of law and/or fact. This right includes the right not only to make written observations with supporting evidence (under Article 12 of the Penalties Regulation) but also to call for a confidential oral hearing (as set out in Article 13 of the Penalties Regulation).

[139]Against this background, I turn to Roche’s allegations of failure to inform.

[140]As for the failure to disclose the Article 8(3) requests, these came late in the day and only very shortly before the Re-Inspection. They did not affect the scope or purpose of Re-Inspection. Mr Rowell states that he did not consider it relevant to inform Roche of the Article 8(3) request for the inspection report because it was going to be shared routinely with the EMA in any event, in line with standard practice. (In fact, for CHMP-requested inspections, an inspection report is considered by the MHRA to be the property of the EMA (as is reflected by the fact that the MAH pays the inspection fee to the EMA, not the MHRA). The MHRA would thus not normally release such reports following freedom of information requests, but would rather refer the applicant to the EMA.)

[141]The question of diligence on the part of Roche was always at the heart of the CAPA investigation and the Re-Inspection. Investigation of the question of co-operation added little, if anything, in context. It is also difficult to understand Roche’s suggestion of any disadvantage as a result of not being informed about an Article 8(3) request in relation to co-operation when, on its own case, provision of the information would have made it less, not more, co-operative. In any event, as set out above, the MHRA responded to the EMA in relation to Roche’s co-operation in very positive terms – Roche had co-operated completely. Under Article 18(2)(c) this is of course to Roche’s benefit.

[142]I can therefore see no basis for legitimate complaint that Roche was not informed (at some stage in October 2013) of the Article 8(3) requests made by the EMA of the MHRA on 1st and 17th October 2013.

[143]Recognising perhaps the lateness of the Article 8(3) requests, Roche goes on to submit that it was in any event clear to the MHRA well before those requests that the EMA would be asking it for material from the Re-Inspection. The MHRA had enough, as it were, without the Article 8(3) requests to put Roche on clear notice of the fact that the report on the Re-Inspection would or might be used by the EMA in the infringement procedure. Roche could (and should) have been told that the MHRA was co-operating closely with the EMA and that the timing of the Re-Inspection had been fixed to suit the infringement procedure.

[144]I do not accept the submission that the MHRA was obliged as a matter of fairness to inform Roche in terms on, for example, 18th September 2013, that the MHRA was co-operating closely with the EMA and would provide the EMA with the Re-Inspection report (or an advance briefing note summarising the findings from the Re-Inspection), given the background knowledge and understanding of Roche in any event. Roche knew that the contents of any adverse Re-Inspection Report would reach the EMA. Roche can be taken to have understood the MHRA to be under a duty to co-operate with the EMA. The details of that co-operation were not matters that Roche was entitled to know, let alone did fairness demand that it be told.

[145]Roche’s background knowledge and understanding is well evidenced by the lack of surprise, let alone concern, registered by Roche when told in terms that the Re-Inspection would (or at the very least might) feed into the infringement proceedings. Roche clearly had them in mind at the time of the Re-Inspection. This is a matter of natural common sense, given that it knew that an infringement procedure had been commenced, but is emphasised by the Article 8(1) requests being made of it contemporaneously with the Re-Inspection.

[146]Additionally, if more were needed and Roche’s general background knowledge and understanding were not enough, Roche was told in terms on 29th October (and 14th November) 2013 that the Re-Inspection results would (or at the very least might) feed in to the infringement procedure.

[147]The question then becomes one of timing. Roche complains that it was told this in terms only too late. However, as indicated, Roche must have considered its position in the context of the infringement proceedings in advance of the Re-Inspection. Even at the stage when Roche was told expressly of the intended onward use of the Re-Inspection results, Roche could have asked for time to consult its lawyers, or asked for an adjournment if it had any concerns about its position as a result of this information. Beyond that, it is material to note there was of course a gap of two weeks in the Re-Inspection carried out in the United Kingdom, and then a gap of four days before the Re-Inspection continued in the United States.

[148]Dr De Veene and Mr Phillips depose in some detail to the different approach that they say they would have adopted had they known that the MHRA had agreed in advance to report back to the EMA and that the Re-Inspection was at least partly for the purpose of the infringement proceedings. Dr De Veene was aware that the MHRA would routinely share its final inspection report with the EMA and other Member States in order to avoid duplicative inspections. But he was not aware that the EMA had specifically asked the MHRA to provide feedback from the inspection for the purposes of the infringement proceedings. Had he been aware, he would have approached the inspections less deferentially. He would undoubtedly have sought the advice of Roche’s in-house lawyers and perhaps outside counsel on whether to take a different approach to the re-inspection. He would clearly have taken a different approach when discussing Roche’s obligations in the context of the financial penalties proceedings.

[149]Likewise Mr Phillips states that he would have obtained legal advice on how to prepare and conduct the Re-Inspection. Roche may have requested that its legal representatives were present for inspection activities, in particular during interviews and to oversee the inspectors’ document requests. If Roche had known that each document it prepared and everything that it said in response to the inspectors’ queries would be used in enforcement proceedings, Roche would have wanted the document requests and its responses reviewed by its legal representatives to avoid self-incrimination. Mr Phillips states that Roche would have exercised its right to silence and to the privilege against self-incrimination in appropriate circumstances. It would not have adopted its routine transparent dialogue with the inspectors. Roche would also have allocated additional resource to the inspection, for example, by providing training to its employees, especially those involved in inspection interviews, to inform them of their procedural rights and safeguards. Mr Phillips states Roche would undoubtedly have been more circumspect and considered in its responses for example, regarding the inspectors’ questions relating to the implementation of Roche’s CAPA plan for the 2012 MHRA inspection and the fulfilment of Roche’s deliverables in respect of such plan. He would have challenged a number of the inspectors’ assertions.

[150]Ignoring the dispute as to the purpose of the Re-Inspection, no doubt this is what Dr De Veene and Mr Phillips now believe that they would have done, although it is to be noted that their evidence antedates the evidence from Dr Sookoo and Mr Rowell and further disclosure by the MHRA. But their beliefs do not determine the question of whether the MHRA treated Roche fairly. How Dr De Veene and Mr Phillips chose to respond to the Re-Inspection in circumstances where they knew, not least because they were told in terms, that the Re-Inspection report would (or at the very least might) be fed into the infringement procedure was ultimately a matter for Roche. Given the relevant background, coupled with what Roche was actually told in opening session, it cannot be said that the MHRA unfairly took advantage of Roche or in some way abused the inspection process as Roche suggests.

[151]It is also noteworthy that Roche does not descend to any detail about what precisely it did say or provide that it would not otherwise have said or provided. There is no indication in terms of how Roche says it has been damaged by the alleged unfairness, other than as a matter of principle. And as indicated above, Roche had or has the opportunity in the context both of the Re-Inspection and also the infringement proceedings to advance all arguments that it wished or wishes to. It is also unreal to suggest that on any matter of real concern or significance to Roche in regulatory terms Roche would simply have proceeded in the Re-Inspection without caveat - not only in the context of a routine inspection but particularly in circumstances where Roche knew that the inspection results would (or at the very least might) be fed into the infringement procedure.

[152]Finally, the suggestion that the MHRA ought as a matter of fairness to have informed Roche that the contents of the Re-Inspection report would or might be critical to the infringement procedure is misconceived. In what manner and to what extent the Re-Inspection report might be used was always an unknown. As set out above, Roche can be taken to have known at all times (and before 29th October 2013) that the Re-Inspection report was at its lowest potentially relevant to the infringement procedure. It was also told in terms that the Re-Inspection report would (or at the very least might) be used in the infringement procedure. The scale or manner of use of the Re-Inspection report by the EMA may have taken Roche by surprise. But this is a matter of degree and not principle. Furthermore, I am not necessarily persuaded that the Re-Inspection was “critical” at least to all parts of the EMA’s Article 10 report. The Article 10 report went well beyond the matters identified in the Re-Inspection report.

[153]For all these reasons, and despite the attractive way in which the submissions were advanced on behalf of Roche, I dismiss the claim on ground 2.

E3. Ground 3

[154]Roche advances two broad arguments on ground 3 in support of the contention that the MHRA’s findings in the Re-Inspection Report contained fundamental errors of law : a) only the activities of the MAH are relevant for the purposes of the infringement proceedings and so Roche, which is the MAH, should not be treated as having failed to report information that a service provider to Genentech received but failed to provide either to Genentech or Roche (“the MAH identity point”); b) the MHRA has applied incorrectly new legal standards and guidance which only came into force in July 2012. There is also complaint that the MHRA unlawfully applied guidance to expand Roche’s responsibility under the Penalties Regulation (“the retrospectivity point”).

The MAH identity point

[155]Roche submits that only the activities of the MAH are relevant for the purpose of infringement proceedings under the Penalties Regulation for two main reasons.

[156]First, the MAH is the target of the Penalties Regulation. Any ultimate decision and penalty is in respect of the MAH only. In the absence of express provision enlarging the scope of the MAH’s responsibility, there is no basis for holding the MAH responsible for the acts of others (in particular other group companies, commercial partners or service providers).

[157]Secondly, Article 1 of the Penalties Regulation identifies the obligations in respect of which an infringement may lead to the application of financial penalties. Article 1 cross-refers to the pharmacovigilance obligations imposed by the 2004 Regulation which applied at the relevant time only to the MAH. Reference is made to Articles 23 and 24 of the 2004 Regulation :

“Article 23 The holder of an authorisation for a medicinal product for human use granted in accordance with the provisions of this Regulation shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance… Article 24 1. The holder of the marketing authorisation for a medicinal product for human use shall ensure that all suspected serious adverse reactions to a medicinal product authorised in accordance with this Regulation occurring within the Community which all healthcare professional brings to his attention are recorded and reported promptly to Member States within the territory of which the incident occurred, and no later than 15 days following the receipt of the information. The holder of the [MAH] shall record any other suspected serious adverse reactions occurring within the Community…of which he may reasonably be expected to be aware, and promptly notify the competent authority of Member States in the territory of which the incident occurred and the Agency, and no later than 15 days following receipt of the information. a) The holder of the [MAH]…shall ensure that all suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of any infections agent…and no later than 15 days following receipt of the information… b) The holder of the [MAH]...shall maintain detailed records of all suspected adverse reactions...which are reported to him by a health-care professional… 5) The [MAH] may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised medicinal product without giving prior or simultaneous notification to the Agency…”

Thus the MHRA has erred in law in treating Roche as responsible for the acts of others. Article 24 a) The holder of the [MAH]…shall ensure that all suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of any infections agent…and no later than 15 days following receipt of the information… b) The holder of the [MAH]...shall maintain detailed records of all suspected adverse reactions...which are reported to him by a health-care professional… 5) The [MAH] may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised medicinal product without giving prior or simultaneous notification to the Agency…”

Article 24

[158]The MHRA submits that a purposive interpretation of the phrase “market authorisation holder” is appropriate. It points to the volume 9A Guidance which stated at paragraph 4.2 :

“Reporting time frames… The clock for expedited reporting starts..as soon as the minimum information…has been brought to the attention of any personnel of the [MAH] or an organisation having a contractual arrangement with the [MAH], including medical representatives…”

[159]The MHRA thus submits that the purport of the volume 9A guidance is that the MAH is responsible not just for itself but organisations with which it has a contractual arrangement. The question of the position of group companies also arises. They may not have a contractual relationship with the MAH within the group, but there is no reason why they should be treated differently to a contractor.

[160]But the MHRA entirely accepts that the MAH identity point is an arguable issue and not clear-cut.

The retrospectivity point

[161]It is common ground that the MHRA in the Re-Inspection report referred to and applied legal standards and guidance that did not come into force until July 2012.

[162]Roche contends that the MHRA was wrong in law to do so. The changes introduced in July 2012 are said to be “critical” to its position and Roche should not have been judged against them.

[163]The changes introduced higher standards. By way of example only, Article 107 of the 2001 Directive, applied to centralised products by Article 28 of the 2004 Regulation, was implemented. Pre-July 2012 the reporting obligations and timelines provided for in Articles 23 and 24 of the 2004 Regulation were only triggered by receipt of the relevant information by Roche. There was an obligation to submit reports within 15 days of receipt of the elements for a valid report, but no obligation to follow up valid cases, to seek additional information in the event that the minimum information for a valid adverse reaction report was missing, to seek medical confirmation of reports received from consumer, or to maximise the quality of valid reports. These latter obligations were only introduced in July 2012.

[164]Nor was the MHRA entitled to use guidance such as that contained in the Volume 9A Guidance as a basis for the creation of additional legal obligations. The Volume 9A Guidance was merely a guidance document and did not have the force of law.

[165]The MHRA resists this attack on the merits. It says that Roche’s claim proceeds on the misconception that the MHRA reached any conclusion about liability to penalty. It did not. The Re-Inspection Report focused on the operation of Roche’s pharmacovigilance system as of October/November 2013, and so after the period being considered by the Commission in the infringement proceedings. Thus it was correct not to deal with the legislation pre-dating July 2012.

[166]There are two potential answers to the first point. Roche does not contend that the MHRA was deciding liability, rather it was feeding into the question of liability. Secondly, it is not necessarily right to draw a stark distinction between liability and penalty when, for example, issues of diligence and co-operation are under consideration for sanction purposes. It will be remembered also that Article 18, which identifies the principles governing the application and quantification of financial penalties, nevertheless requires the Commission to take into consideration, amongst other things, the seriousness and effect of the infringement.

[167]As to materiality, Roche can point to the fact that the infringement proceedings address only pre-July 2012 conduct. And on the facts the MHRA in the (draft and final) Re-Inspection Report actually addressed at least in part Roche’s conduct in periods pre-dating July 2012. Thus the application of the later regulatory framework is at least arguably capable of making a difference.

Analysis

[168]In my judgment, both issues raised by Roche on ground 3 are properly arguable.

[169]On that basis Roche’s position is essentially that the national court should not decide these issues (though it has jurisdiction to do so), but should rather make a reference.

[170]Article 267 of the TFEU provides : “The Court of Justice of the European Union shall have jurisdiction to give preliminary rulings concerning : d) the interpretation of the Treaties; e) the validity and interpretation of acts of the institutions, bodies, offices or agencies of the Union; Where such a question is raised before any court or tribunal of a Member State, that court or tribunal may, if it considers that a decision on the question is necessary to enable it to give judgment, request the Court to give a ruling thereon...” d) the interpretation of the Treaties; e) the validity and interpretation of acts of the institutions, bodies, offices or agencies of the Union;

[171]As indicated, Roche does not abandon its contention that the national court could itself determine the issues, pointing to Bredenkamp (supra) (in particular at paragraphs 43 and 44 already set out above) as support for the proposition that there is no obstacle to taking such a course.

[172]But Roche submits that the issues are questions of wide import and significance and ones which fall more naturally to be decided by the CJEU in a context where all interested member states can participate. Thus a reference should be made.

[173]The MHRA’s position is that, were I to find the issues properly arguable, as I do, I should nevertheless not make a reference because of the pending infringement proceedings.

[174]I have come to the conclusion, on the facts of this case, that for the national court to rule substantively on the issues raised by ground 3 would be contrary to the broad principle in Masterfoods (supra) that national courts should endeavour to avoid a risk of reaching conclusions inconsistent with those reached by the Commission or by the EU courts.

[175]In Masterfoods the Commission had already taken a decision, whereas here no decision has yet been taken. But that does not in my judgment alter the substance of the principle. The national courts should endeavour to avoid a risk of reaching conclusions inconsistent with those not only reached but also to be reached by the EU entity. This approach is re-inforced by the fact that the issues raised here have cross-community implications in a major industry in the European Union. The Commission here is seised of Roche’s arguments already.

[176]Any ruling by this Court would not bind the Commission - see paragraph 48 of Masterfoods :

“Despite that division of powers, and in order to fulfil the role assigned to it by the Treaty, the Commission cannot be bound by a decision given by a national court…The Commission is therefore entitled to adopt at any time individual decisions under Articles 85 and 86 of the Treaty, even where an agreement or practice has already been the subject of a decision by a national court and the decision contemplated by the Commission conflicts with that national court’s decision.”

[177]However, the reality of this claim is that Roche’s concern lies not in any statements by the MHRA to the EMA and the Commission, but rather in the possibility that the Commission might accept and act on those views. I refer for example to paragraph 68 of the detailed grounds of claim :

“…It is submitted to be important however that the MHRA should have the benefit of the earliest opportunity of the concluded view of this court as to the lawfulness of its conduct, and that the EMA and/or EU Commission should similarly be able to draw the necessary conclusions for their own procedures under the Penalties Regulation.”

[178]The policy identified in ConexBanninger (supra) is directly on point. There Conex Banninger Limited (“Conex”) sought an anticipatory declaration against the Commission that there was no power to make a tracing order against it. It is important to note that the decision proceeded on the basis that the national court had jurisdiction. Floyd J stated :

“29. Mr Khan, for the Commission, submitted that the English court had no jurisdiction to grant a declaration against the Commission which would pre-empt the outcome of a pending investigation by the Commission. 30. I prefer not to decide this case on the basis of this wide-ranging submission about jurisdiction. Just as the ECJ in IBM reserved the position as to its jurisdiction of the ECJ in relation to a case where the acts of the Commission lacked even the appearance of legality, so also I would reserve the position in relation to the jurisdiction of the English court to grant such a declaration and the range of circumstances in which it might do so. I think that it is necessary to focus on the fact that both the substantive declaratory remedy in the action, and the decision to refer questions to the ECJ are matters over which the court retains a judicial discretion.”

[179]However, Floyd J declined to exercise his discretion so as to make a reference as sought by Conex. He held :

“35. It is therefore essential in my judgment to determine whether there is any realistic prospect that the ECJ will rule in Conex’s favour on either of the two questions posed in the draft reference. 36. Mr Lasok submitted that the principle emerging from IBM and Intel (about declining relief in respect of preparatory acts) was directed solely to the scope of the direct action for annulment. I reject that submission. It seems to me that the ECJ's reluctance to embark on investigations of preparatory acts is based on much more than narrow and legalistic requirements of admissibility of the direct action for annulment. As paragraph 20 of the decision in IBM, which I have quoted above, makes clear, the reluctance is based on the fact that it is undesirable to pre-empt the acts of the EU institutions and to anticipate the arguments on the substance of the case. It is also based on the desirability of not confusing different administrative and judicial procedural stages, and not acting incompatibly in connection with the division of powers. Finally it is based on the requirement for the sound administration of justice. In those circumstances I consider that it is unrealistic to suppose that the ECJ will take a different view of the underlying policy, merely because the issue comes before it through the means of a reference from a national court. 41. I should not, in the exercise of my discretion, refer the questions to the ECJ if I consider, as I do, that the references have no realistic prospect of obtaining for Conex the protection they seek. In those circumstances, and for those reasons, I propose to dismiss the application for a reference to the ECJ.”

[180]Roche accepts that there may be force in the application of the policy referred to in paragraph 36 when justified on the facts of the case, as was clearly the case in Conex. As it was put for Roche, Conexwas making a “blatant attempt” to pre-empt the normal course of the Commission by seeking an anticipatory declaration. But, submits Roche, the facts of this case are quite different.

[181]It is right to say that there are differences on the facts. In this case, the Commission has not yet started its formal proceedings. Nor is the Commission a party to this claim. No anticipatory declaration is sought. The legal issues raised are not specific to the situation of a particular company and are of general interest. The MAH identity point in particular is not fact specific and raises an important point of interpretation of EU legislation of significance.

[182]However, I see no reason to limit the policy considerations identified by Floyd J to the facts of the case in Conex. In my judgment, they are of general application though of course always to be applied appropriately to the facts of any individual case. It is undesirable to pre-empt the acts of an EU institution and to anticipate the arguments on the substance of the case. It is desirable not to confuse different administrative and judicial procedural stages, and not to act incompatibly in connection with the division of powers. This is all consistent with the sound administration of justice.

[183]On the facts of this case, I have come to the conclusion that, applying the principles identified in Masterfoods and Conex, it would be wrong in principle for this Court to pre-empt the decision of the Commission (and ultimately of the General Court on any appeal and thereafter the CJEU if necessary) either by way of substantive ruling or the making of a reference. Unlike the position of the claimant in Bredenkamp, for example, Roche here still has a full range of opportunity to advance its case within the infringement procedure and beyond, if necessary. The appropriate forum and course is for Roche to maintain these arguments before the Commission, as it sees fit, and thereafter to pursue any appeal that it needs or wishes to. A significant factor in my considerations is the fact that issues of public health and safety are engaged. The public interest leans heavily in favour of allowing the regulatory proceedings to take their normal passage as swiftly as possible, without external interference or delay.

[184]For these reasons, I dismiss the claim on ground 3.

Conclusion

[185]I grant permission to Roche to apply for judicial review but, for the reasons set out above, dismiss the claim.

[186]I invite the parties to seek to agree a consequential order reflecting the above and to agree any outstanding matters, including costs, so far as possible.