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England and Wales Court of Appeal (Civil Division) Decisions
You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> Roche Registration Ltd, R (on the application of) v The Secretary of State for Health [2015] EWCA Civ 1311 (21 December 2015)
URL: http://www.bailii.org/ew/cases/EWCA/Civ/2015/1311.html
Cite as: 149 BMLR 178, [2015] WLR(D) 543, (2016) 149 BMLR 178, [2015] EWCA Civ 1311, [2016] 4 WLR 46
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ON APPEAL FROM THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
THE HON. MRS JUSTICE CARR
Strand, London, WC2A 2LL |
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B e f o r e :
LORD JUSTICE McFARLANE
and
LORD JUSTICE SALES
____________________
| The Queen on the application of Roche Registration Limited |
Claimant/ Appellant |
|
| - and - |
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| The Secretary of State for Health (acting through the Medicines and Healthcare Products Regulatory Agency) |
Defendant/Respondent |
____________________
(instructed by Covington & Burling LLP) for the Appellant
Mr George Peretz QC (instructed by Government Legal Department) for the Respondent
Hearing dates : 1 & 2 December 2015
____________________
Crown Copyright ©
- This case concerns the way in which the Secretary of State, acting by the Medicines and Healthcare Products Regulatory Agency ("the MHRA"), acquired information from the appellant ("Roche") and passed that information to the European Medicines Agency ("the EMA") under the EU pharmacovigilance regime which sets out a system for scrutiny for and reporting of harmful effects of drugs when administered to patients. Although the background to this appeal is the pharmacovigilance regime established by EU law, the determination of the appeal itself turns principally on the application of the obligation of fairness under English law and English law principles in relation to the grant of declaratory relief.
- The proceedings relate to re-inspections carried out by the MHRA of Roche's facilities in the United Kingdom between 29 and 31 October 2013 and on 14 November 2013 and of the facilities of an affiliate company, Genentech Inc. ("Genentech") between 18 and 22 November 2013 in the USA (together, "the Re-Inspection"). Based on the Re-Inspection, the MHRA compiled a draft and then final Re-Inspection Report.
- The information in question in these proceedings, including in the final Re-Inspection Report, has already been supplied to the EMA by the MHRA. The EMA is an EU institution and any ruling that it is acting or has acted unlawfully is a matter for determination by the EU courts rather than by a national court: see Case 314/85 Firma Foto-Frost v Haumpzollamt Lübeck-Ost [1988] 3 CMLR 57. It will be for the EMA to decide what use, if any, to make of the information supplied to it by the MHRA, in relation to the EMA's own public health and enforcement functions under the EU pharmacovigilance regime. However, in the present proceedings Roche seeks declaratory relief regarding the lawfulness of the past conduct of the MHRA.
- This court has been much assisted by the clarity with which Carr J in her judgment set out the relevant facts. The parties accepted the accuracy of the judgment in dealing with these matters, subject only to a couple of minor quibbles and an issue regarding what had been said by MHRA representatives and what Roche representatives had understood by this at the commencement of the Re-Inspection meetings in the United Kingdom and the USA. I deal with that issue below. Subject to that, I gratefully adopt the judge's account of the relevant facts.
- At paras. [2] and [4]-[10] the judge sets the scene thus:
- Like the judge, this court made a confidentiality order in respect of certain documents before the court. It is not necessary to refer to the detailed content of those documents in this judgment.
- The MHRA has the responsibility at national level 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 so far as material as follows :
- Article 19(1) of the 2004 Regulation provides :
- Title XI of the 2001 Directive then provides :
- The object of Article 111 of the 2001 Directive is to ensure that Member States, in co-operation with the EMA, supervise compliance with pharmacovigilance obligations, including by inspections.
- Since July 2012 the 2001 Directive has been implemented in the national law of the United Kingdom by the 2012 Regulations.
- Regulations 210 and 211 create criminal offences in relation to breach of pharmacovigilance obligations. Part 16 then provides in material part as follows :
- 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 MHRA inspectors for the purpose both of enforcing the 2012 Regulations through domestic criminal proceedings and the relevant EU legislation, including the Penalties Regulation.
- The Penalties Regulation provides so far as material as follows :
- The infringement procedure for the purposes of the Penalties Regulation is set out in detail in Chapter II of the Regulation, entitled "Infringement Procedure". "Infringement procedure" is not itself a defined term, but its meaning appears from the provisions of Chapter II. Recital (13) to the Regulation, set out above, indicates that it is when carrying out an infringement procedure within the meaning of the Regulation that the EMA and the Commission must ensure the respect of the rights of defence and so forth. The Recital does not refer to national competent authorities, and under the scheme of the Regulation it is the EMA and the Commission (not those authorities) which initiate and implement an infringement procedure. The Recital indicates the intention of the EU legislator that the EMA and the Commission should ensure that there is proper protection of the rights of defence of an MAH in the course of the infringement procedure, and Chapter II includes specific protections applicable in the course of the infringement procedure as against the EMA and the Commission to give effect to that objective.
- Section 1 of Chapter II deals with the inquiry stage as follows. Article 5 provides for the EMA to initiate the infringement procedure. Article 6 confers a power for the EMA to request from the MAH any information relating to an alleged infringement. Article 7 states that "The [EMA] shall send written notification of the initiation of an infringement procedure to the [MAH] concerned, to the Member States and to the Commission." Article 8, relating to requests by the EMA, is set out below. Article 9 confers a right for the MAH to be heard by way of written observations before any report under Article 10 is adopted by the EMA and provided to the Commission and others. Under Article 10(2), where the EMA considers that the MAH has committed an infringement, "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) and a request to the Commission for application of financial penalties."
- Article 8 provides:
- Section 2 of Chapter II deals with the decision-making stage. Subsection 1 deals with procedure. Under Article 11, if, following receipt of a report from the EMA under Article 10, the Commission decides to continue with the infringement procedure it has to notify the MAH of a statement of objections setting out the allegations against it and the evidence on which the allegations are founded. Article 12 provides for the MAH to have a right to reply. Article 13 provides for the MAH to have the right to request an oral hearing. Article 15 allows for the Commission to return the case-file to the EMA for a new period of inquiry if additional information is required. Article 14 provides a power for the Commission itself to make requests for information, as follows:
- Subsection 2 of Section 2 deals with "Decision and financial penalties". Article 16 provides that where the Commission finds that the MAH has committed an infringement, it may adopt a decision imposing a fine not exceeding 5% of the MAH's Community turnover in the preceding business year. Article 17 provides that such a decision shall be based exclusively on grounds on which the MAH has been able to comment. Article 18 provides in material part as follows:
- Section 3 of the Penalties Regulation deals with sanctions for non-cooperation. Article 19(1) provides:
- Chapter III of the Penalties Regulation makes provision for access to the file, confidentiality and temporal provisions. Article 21 provides for the MAH to have access to the case file containing evidence of an alleged infringement. Article 22 provides for the MAH to have the right to legal representation during the infringement procedure. Article 23 provides that an infringement procedure must be carried out subject to principles of confidentiality and professional secrecy. Articles 24 to 26 set out various time limits and limitation periods.
- Where the Commission makes a decision imposing a fine, the MAH may appeal on the merits to the General Court of the EU. There is an appeal from the General Court to the Court of Justice of the European Union ("the CJEU"). If the EMA or the Commission have acted unlawfully, or if they seek to rely on evidence where to do so would breach the rights of defence of the MAH, the Charter of Fundamental Rights or any general principle of EU law, the General Court or, as the case may be, the CJEU will be in a position to grant appropriate relief.
- The relevant provisions of the 2001 Directive, the 2004 Regulation and the Penalties Regulation did not change in material ways when these legislative instruments were amended in the course of 2012.
- As appears from the EU legislative framework, Roche will have the benefit of full protection for its rights of defence against the EMA and the Commission in the course of the investigation procedure. There is no possibility of Roche being made subject to a fine by the Commission under the Penalties Regulation without Roche first being subject to the investigation procedure with all the procedural protections which are inherent in that procedure. Nothing done by the MHRA has deprived or could deprive Roche of this protection and the MHRA has no power itself to subject Roche to a fine under the Penalties Regulation.
- The judge refers at [5] and [22] to there being three different types of investigation by the MHRA: (i) inspections following the identification by the MHRA of deficiencies, which looks at the implementation of CAPAs (i.e. under Article 111(1)(b) of the 2001 Directive); (ii) inspections requested by the CHMP, the relevant body of the EMA (i.e. under Article 111(1)(c) of the 2001 Directive); and (iii) inspections for the purposes of the Penalties Regulation (i.e. pursuant to a request under Article 8 of that Regulation). This is not an exhaustive list.
- The MHRA also, of course, carries out routine inspections under Article 111(1): it was such a routine inspection which identified deficiencies on the part of Roche and led to the requirement that CAPAs be implemented, which in turn led to the Re-Inspection to see if they had been. The MHRA may carry out its own enforcement investigations where the EMA is not involved under the Penalties Regulation. In addition, although EU law does not require the introduction of criminal offences in national law to back up the pharmacovigilance regime in the Regulations and the 2001 Directive, the United Kingdom has enacted law to create such offences. This means that, as the judge mentions at [137], in some cases in the United Kingdom a full domestic law criminal investigation may take place, involving the usual protections afforded under the Police and Criminal Evidence Act 1984 ("PACE"). There was some discussion at the appeal hearing of the significance of PACE. Mr Anderson QC for Roche suggested that protections under PACE would be relevant in an enforcement investigation by the MHRA under the EU pharmacovigilance regime, whether instituted of its own motion or at the request of the EMA. However, Mr Peretz QC for the MHRA explained that PACE would only be relevant to a criminal investigation conducted for the purpose of bringing domestic law criminal proceedings.
- The judge's account of the facts continues at paras. [21]-[75]:
- Standing back from the detail, the following are salient features in this case: (i) Roche knew from the MHRA's routine inspection in early 2012 that three serious or "critical" findings had been made against it in relation to compliance with the EU pharmacovigilance regime and knew that the Re-Inspection related to these matters and the corrective action it had been told to take; (ii) on 23 October 2012 the EMA gave formal notification to Roche under Article 7 of the Penalties Regulation that Roche was the subject of an infringement procedure under that Regulation in respect of those matters; (iii) on 22 August 2013, as Roche was aware, the CHMP itself requested the MHRA under Article 111(1)(c) to carry out the Re-Inspection; (iv) the scope of the Re-Inspection was determined solely by reference to what was needed for the MHRA to examine Roche's implementation of the CAPAs and not by any request from the EMA for additional information; (v) Roche was on notice from the terms of Article 111 of the 2001 Directive, from published EMA guidance and from published Commission guidance that the MHRA was bound to share information from the Re-Inspection with the EMA and that such information could provide a basis for enforcement action under the Penalties Regulation; (vi) Roche knew, from the terms of Article 18(2) of the Penalties Regulation, that questions of diligence in implementation of corrective action in the form of implementation of the CAPAs would be relevant to the questions whether a penalty would be imposed under that Regulation and in what amount; and (vii) at the opening of the Re-Inspection meetings in both the United Kingdom and the USA, both attended by Mr De Veene and Mr Phillips for Roche, there was explicit mention by MHRA representatives that information from the Re-Inspection would be sent to the EMA who might use it in the ongoing infringement procedure under the Penalties Regulation.
- This is not a promising factual basis for Roche on which to allege material unfairness by the MHRA in the way it conducted the Re-Inspection. However, Roche contends that there was unlawful unfairness on the part of the MHRA because it did not inform Roche at the time of the Re-Inspection that it had received the Article 8(3) requests of 1 and 17 October 2013 from the EMA and had been co-operating with the EMA in formulating those requests and in bringing forward the timing of the Re-Inspection to assist the EMA in the conduct of the infringement procedure.
- As to the EMA guidance and Commission guidance referred to in point (v) above, Mr Anderson submitted that both sets of guidance should be read as restricted to using information from an inspection or re-inspection as a basis for the commencement of infringement proceedings, but not as evidence which could be used in the course of infringement proceedings as a basis for enforcement action. The judge rightly rejected this submission at [138]. In my view, the guidance makes it clear in each case that information from an inspection or re-inspection may be used for the purposes of enforcement action in the course of infringement proceedings, whether those proceedings are already on foot or yet to be commenced. The language used ("a basis for enforcement action") is wider than the meaning suggested for it by Mr Anderson (whose suggestion was that it should be read, in effect, to say "a basis for the commencement of infringement proceedings"). The language used is apt to cover enforcement action sought to be taken at any stage, including in the course of infringement proceedings already on foot. There is good reason to think this is the true meaning. It makes no sense to draw the distinction proposed by Mr Anderson: the public interest in the EMA and the Commission being in a position to rely on such materials coming to them under Article 111 of the 2001 Directive may be as strong where infringement proceedings are already on foot and the evidence is relevant to those proceedings as it is where the information provided is what triggers the commencement of infringement proceedings in the first place. In both cases, it is very difficult to see why the relevant regulator in the highly sensitive field of human safety in relation to use of medicines should be precluded from making use of relevant information with which it has been provided. Moreover, Article 18(2)(c) of the Penalties Regulation makes it clear that information arising from an inspection or from a re-inspection may be highly relevant to the application and quantification of financial penalties (that is to say, enforcement action) under the infringement procedure, and again, against that background, it would make no sense to interpret the guidance so as not to cover use of information derived from an inspection or re-inspection for Article 18 purposes in the context of an infringement procedure which is already on foot.
- In any event, of greater importance than the EMA guidance and Commission guidance for the purposes of the judge's analysis and the analysis below regarding the application of the MHRA's duty to act fairly is what can reasonably be expected to happen in light of the applicable legislative framework, in particular from the application of the duty of co-operation under Article 111 of the 2001 Directive and from Article 18(2) of the Penalties Regulation. I address this below.
- As to point (vi) above, Mr Anderson emphasised that neither Mr De Veene nor Mr Phillips are lawyers. In consequence, he said, they could not reasonably be expected to pick up and understand the significance of what they were being told at the Re-Inspection meetings; nor did any lawyer attend these meetings on behalf of Roche. Against this, however, Mr Peretz submitted that neither Mr De Veene nor Mr Phillips could be regarded as ingénus in the field of pharmacovigilance. On the contrary, Mr De Veene has been Roche's officially designated QPPV for the purposes of the European pharmacovigilance regime since June 2011, and before that was the deputy QPPV and head of the QPPV office from June 2008. In that capacity Mr De Veene has been responsible for establishing and maintaining Roche's pharmacovigilance system and acts as the primary point of contact for EU and national regulatory authorities in relation to pharmacovigilance-related matters. Mr Phillips has been Head of Inspections Management at Roche since 2007, with responsibility for coordinating and overseeing pharmacovigilance inspections globally.
- It does rather strain credulity that persons as experienced in operating with the pharmacovigilance regime as Mr De Veene and Mr Phillips for a company as large and professionally organised as Roche would be as ignorant of the legislative framework as Mr Anderson appeared to suggest they were. They did not themselves, in their evidence, hold themselves out as being ignorant of that framework. They did not say that they understood the EMA guidance and Commission guidance as bearing anything other than its natural meaning as set out above. Moreover, Mr Phillips' own manuscript notes from the introductory meeting for the Re-Inspection in the United Kingdom on 29 October 2013 include as one of five items under the heading "Introduction" a note of the point that the re-inspection could be relevant to the existing infringement procedure, as material which could feed into that process. It does not appear to have been a matter which went over his head or which was of no interest to him. I think the judge was plainly entitled to find on the evidence before her that Mr De Veene and Mr Phillips "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 …" ([150]).
- Mr Anderson submitted that this court should be prepared to make its own assessment of the facts in relation to this, since all the evidential material available before the judge was equally available before us. The judge had heard no oral evidence.
- However, an appeal will only be allowed where the decision of the lower court was "wrong" or was "unjust because of a serious procedural or other irregularity in the proceedings of the lower court": CPR Part 52.11(3). The latter part of the Rule is not relevant here. In accordance with the usual position under CPR Part 52.11(1), the appeal is limited to a review of the decision of the lower court; there is no good reason to go further and hold a re-hearing. On the material available to us and to the judge, it cannot be said that the judge was "wrong" in relation to her assessment of the relevant facts. It is not sufficient that this court might have reached a different view of the facts if it had started from scratch or had decided to hold a re-hearing. As it happens, however, I agree with the judge's assessment of the facts on this point and generally.
- Having made these points, however, it would not be right to give undue weight to them in the overall context of the case. The main foundation for the judge's rejection of the claim under each Ground was an appreciation of the legislative framework and of the respective roles of the MHRA, the EMA and the Commission within that framework.
- After setting out the facts, the judge dealt with various jurisdictional questions: [76]-[96]. The EMA, as an Interested Party, submitted that the English court had no jurisdiction to entertain any part of the claim. Roche and the MHRA adopted more nuanced positions, which in the end came to much the same thing and was accepted by the judge: the court had formal jurisdiction to consider matters raised, but questions as to how it should exercise its jurisdiction remained to be answered in relation to the substantive claims. The EMA does not appear on this appeal to contest any of this. None of the grounds of appeal nor the respondent's notice relate to this part of the judgment.
- In the next section of the judgment, the judge addressed the substantive claim under each Ground in turn: Ground 1, concerning the significance of the reliance by the EMA upon Article 8(3) of the Penalties Regulation in making its requests to the MHRA of 1 October and 17 October 2013 for information and the request by Roche for a reference to the CJEU under Article 267 TFEU in relation to this ("the Article 8(3) issue"), at paras. [97]-[113]; Ground 2, concerning the duty of the MHRA under English public law to act fairly ("the fairness issue"), at paras. [114]-[153]; and Ground 3, concerning alleged errors of law in the Re-Inspection Report and the request by Roche for a further reference to the CJEU in relation to this ("the errors of law point"), at paras. [154]-[184].
- Under Ground 1, in respect of the Article 8(3) issue, Roche argued that the EMA had no power under Article 8(3) of the Penalties Regulation to make a request for information to be provided by a national competent authority such as the MHRA. Roche says that Article 8 has a clear structure: Article 8(1) governs requests by the EMA for information from the MAH itself; Article 8(2) governs requests made by the EMA directed to a national competent authority; and Article 8(3) is limited to requests made by the EMA directed to anyone else. In this case, for its requests dated 1 and 17 October 2013 to the MHRA, the EMA relied upon Article 8(3); but, on Roche's argument, the EMA had no power under that provision to make such a request. Therefore, Roche submitted, the MHRA had no power to provide the information it did in response to those requests, and the court should so declare. The MHRA, on the other hand, contended that Article 8(2) is not the sole and exhaustive power within Article 8 for the EMA to request information from a national competent authority, and that on its clear wording Article 8(3) also confers on the EMA power to request a national competent authority to provide it with information and so was properly and lawfully invoked by the EMA in its requests to the MHRA.
- The judge held that Roche's proposed interpretation of Article 8 is properly arguable ([102]), with the result that, according to the principle in Foto-Frost, the court would have had to make a reference to the CJEU if a determination on the proper effect of Article 8 were necessary in order for the claim in the national court to be resolved: [103] et seq. Accordingly, Roche's request for a reference to the CJEU could not be dismissed on the basis that its contention regarding the proper interpretation of Article 8 was unarguable. On this appeal, the MHRA by its respondent's notice takes issue with the judgment on this point.
- However, the judge held that it would not be appropriate to make a reference because, as was common ground, a court should not grant relief in relation to an error of law where such error is immaterial to the decision complained of. That was the position here, since the MHRA was obliged to pass all the information it did to the EMA under its general obligations of co-operation with the EMA under Article 111 of the 2001 Directive and Article 3(1) of the Penalties Regulation: [109]-[113]. The judge rejected the suggestion that the issuing by the EMA of requests under Article 8(3) could overtake or eclipse these general obligations. There were also public interest considerations which militated against the making of a reference, including that it would be directed primarily to the lawfulness of the actions of the EMA and it would be undesirable to pre-empt the acts of an EU institution and to anticipate the arguments on the substance of the case ([112] and [182]).
- The judge noted at [110] that the only possible exception, where material was supplied by the MHRA which may not have been covered by the general obligation of co-operation under Article 111 of the 2001 Directive, was information contained in two sentences in the MHRA's letter to the EMA dated 13 December 2013. The sentences stated:
- Those sentences were part of the MHRA's letter in response to the request by the EMA in its Article 8(3) request of 1 October 2013, in which the EMA asked the MHRA to inform it "on the degree of diligence and cooperation" shown by Roche in relation to the implementation of the CAPAs arising out of the inspection in early 2012 and of any non-compliance by Roche in respect of requests made by the MHRA in relation to that inspection and the Re-Inspection.
- As the judge observed at [110], that part of the MHRA's response, regarding co-operation by Roche, was positive from Roche's point of view and she rejected the contention that it would be appropriate to grant any substantive relief by reason of this.
- As to Ground 2 (the fairness point), it was common ground between the parties that this should be addressed on the basis of the domestic public law duty to act fairly. The judge rejected Roche's claim that the MHRA had acted unfairly: [117]-[153]. At [138], set out below, the judge explained the significant aspects of the factual and legal context which led to her conclusion. She also reviewed the evidence in detail and found that the MHRA's purpose in carrying out the Re-Inspection was to comply with its public health obligations under the 2001 Directive and the 2004 Regulation, and that the scope of the investigation and questions in the Re-Inspection were determined accordingly. The Article 8(3) requests "did not affect the scope or purpose of the Re-Inspection" ([140]). Sharing the inspection report with the EMA would be routine, in line with standard practice; and, indeed, as with all CHMP-requested inspections, Roche paid the inspection fee to the EMA, not the MHRA ([140]). Further, "The question of diligence on the part of Roche was always at the heart of the CAPA investigation and the Re-Inspection" ([141]); and at [144] she said:
- At [145]-[146] the judge referred again to Roche's general background knowledge and understanding, adding that if more were needed and that background knowledge was not enough to answer Roche's fairness point (as the judge clearly thought it was), it was also relevant that Roche was told in terms at the commencement of the Re-Inspection meetings in the United Kingdom and the USA "that the Re-Inspection results would (or at the very least might) feed in to the infringement procedure" (a point she again referred to at [150] and [152]). Although Mr De Veene and Mr Phillips gave evidence of their surprise when they discovered the full facts of engagement between the MHRA and the EMA and said they believed they would have behaved differently if given more information by the MHRA about that engagement, the judge observed that "their beliefs do not determine the question of whether the MHRA treated Roche fairly", and "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" ([150]).
- At [151] the judge noted that Roche did not give particularised details about information which it would have withheld from the MHRA if told about the extent of engagement between the MHRA and the EMA, and observed that Roche would have the opportunity in the context of the infringement procedure to advance all its arguments as to whether it was impermissible for the EMA or the Commission to rely on any part of the information provided by the MHRA.
- The judge then turned to consider Ground 3 (the errors of law point). Two alleged errors of law were in issue. The first was whether Roche as MAH was properly to be treated as responsible under the EU regime in respect of information regarding things done by Genentech (at the suggestion of the parties the judge called this the "MAH identity point", but a more accurate label is "the MAH responsibility point"). At points in the final Re-Inspection Report the MHRA referred to things done by "Roche/Genentech" and referred to deficiencies in pharmacovigilance information which had been gathered by Genentech in the USA in the database for the Access Solutions Patient Support Programme. The second was whether the MHRA had inappropriately made criticisms of Roche retrospectively by reference to the more stringent pharmacovigilance obligations introduced in 2012 which were referred to at certain points in the final Re-Inspection Report ("the retrospectivity point").
- Before the judge the MHRA accepted that the extent of an MAH's pharmacovigilance obligations under EU law for the purposes of the MAH responsibility point is an arguable issue which is not acte clair: [155]-[160]. The judge also found the retrospectivity point to be properly arguable ([168]) and regarded it as material, in the sense that it was arguably capable of making a difference to what the MHRA set out in the draft and final Re-Inspection report ([167]).
- However, the judge declined to make a reference to the CJEU: [169]-[184]. This was because she considered that for the national court to proceed to grant declaratory relief would be contrary to a principle which she derived from the judgment of the ECJ in Case C-344/98 Masterfoods Ltd v HB Ice Cream Ltd [2000] ECR I-11369, that national courts should endeavour to avoid a risk of reaching conclusions inconsistent with those reached by the Commission or by the EU courts. Any ruling by the English court would not bind the Commission: see the judgment in Masterfoods at para. 48. Rather, the lawfulness of the Commission's actions could be the subject of proceedings in the EU General Court and the CJEU. It would be undesirable to pre-empt the acts of an EU institution and to anticipate the arguments on the substance of the case; and it would be desirable not to confuse different administrative and judicial procedural powers and not to act incompatibly in connection with the division of powers: [182]. In the judge's view, "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": [183]. The judge noted that Roche still has a full opportunity to advance its case on these issues in the infringement procedure and any EU court proceedings following from that procedure and stated, "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": [183]. Particularly given the public health and safety context, the judge considered that the public interest was "heavily in favour of allowing the regulatory proceedings to take their normal passage as swiftly as possible, without external interference or delay": [183].
- In my judgment, Roche's appeal in relation to Ground 1 should be dismissed. For my part, I would also uphold the judge's decision to decline to make a reference to the CJEU on the Article 8(3) issue on the basis of the MHRA's submission under the respondent's notice, that Roche's argument that the EMA has acted unlawfully in making requests in reliance on Article 8(3) is unfounded, to the acte clair standard. I will deal with these points in turn.
- Declaratory relief in English courts is directed to declaring the rights and obligations of parties in proceedings where there is a proper purpose to be served in doing so. The courts do not give advisory opinions on abstract legal questions.
- In this case, putting to one side for a moment the two sentences in the MHRA letter of 13 December 2013 set out at para. [42] above, the information which the MHRA supplied to the EMA was all information which, by virtue of Article 111 of the 2001 Directive, the MHRA was lawfully entitled and indeed obliged to supply to the EMA. Mr Anderson argued against this proposition by contending that Article 8 is a lex specialis which displaces the operation of Article 111. The judge rejected this suggestion at [111]. In my judgment she was plainly right to do so. There is nothing in the language of either the 2001 Directive or the Penalties Regulation to support Roche's displacement argument, and the important objective of the pharmacovigilance regime of safeguarding public health makes it obvious that the co-operation obligations of the MHRA under Article 111 of the 2001 Directive continue in full force and effect whether or not the EMA happens to have commenced an investigation procedure in relation to some matter from the past.
- Mr Anderson emphasised that the so-called enforcement track is different from the public health track for inspections and sought to suggest that information from the latter cannot be used in the course of an infringement procedure investigation under the enforcement track. I can see nothing in the EU legislation to support this suggestion, and the importance of regulators such as the EMA and the Commission being able to use any relevant information in their possession for the due implementation of the Penalties Regulation to take effective measures to safeguard public health is such as strongly to indicate that the suggestion cannot be correct. That conclusion is reinforced by the fact that the infringement procedure makes explicit provision for relevant procedural protections to ensure than an MAH subject to that procedure is treated fairly in relation to all the evidence relied upon by the EMA and the Commission in the course of it, from whatever source it is derived. But the really important point for present purposes is that the MHRA had an obligation under Article 111 of the 2001 Directive to provide the information in question and had no power to attach conditions when providing it which could bind the EMA regarding what it or the Commission might do with it. What the EMA and the Commission do with the information provided and whether they act lawfully in that regard are not matters for review or determination by the national court.
- What Roche is seeking in the English courts under Ground 1, therefore, is not a declaration regarding the lawfulness of what the MHRA has in fact done, since it is clear that the MHRA has acted lawfully in providing the information in question to the EMA. Rather, Roche seeks declaratory relief that what the MHRA has done lawfully would have been unlawful if the MHRA had only been able to rely on Article 8(3) as the basis for sending the information to the EMA. In effect, this is to seek a declaration that the MHRA could not lawfully have done what it did if Article 111 did not exist.
- In my judgment, this is a clear example of a litigant seeking declaratory relief by way of an advisory opinion from the court. The judge was therefore right to dismiss the claim. Since the claim is for relief which the national court would not grant, it could not be said that it was "necessary" to make a reference to the CJEU, which is the word used in Article 267 TFEU. The true meaning and effect of Article 8(3) is not material so far as resolution of the domestic proceedings is concerned. The answer of the CJEU on the proper interpretation of Article 8(3) is not needed for the purposes of enabling the national court to determine the claim before it.
- Mr Anderson submitted that the regulatory process would be assisted by the domestic court making a reference to the CJEU on the Article 8(3) issue at this stage, so that the EMA, the Commission and Roche could know where they stand on this point as the investigation procedure proceeds, rather than waiting to see what the EMA and the Commission do with the information and, if Roche objects, then waiting for the issue to be argued about in the course of any appeal to the General Court. Neither the EMA nor the Commission joined in this view. The EMA's position, as manifested by its participation in the hearing at first instance, has been to oppose this course.
- In my view there are three answers to Mr Anderson's submission. First, it is beside the point. It does not answer the contention that the judge was right to reject the claim for declaratory relief on the basis that it was not necessary or appropriate for the domestic court to give the advisory opinion being sought from it.
- Secondly, I think the judge was right to say that "It is undesirable to pre-empt the acts of an EU institution and to anticipate the arguments on the substance of the case": [182]. If the English court made a reference to the CJEU, the question posed would be an abstract one, not directed to any actual use made by the EMA or the Commission of the information in question and not directed to any actual dispute between Roche and the EMA or the Commission. There would be a real risk that any answer obtained from the CJEU could be of the "it depends" variety, since no actual facts and no dispute regarding actual use of the information would be before the CJEU. Also, the making of a reference could result in a diversion of attention and energy on all sides from the prompt and diligent implementation of the investigation procedure which is currently on foot. Mr Anderson suggested that the making of a reference would help save time in the infringement procedure, but that is a matter of speculation and we are not in a position to tell whether that is true or not. Thus, far from there being any special circumstances which might induce the domestic court to exercise its jurisdiction to grant some form of advisory declaratory relief, the circumstances are such as firmly to reinforce the judgment that it should not do so.
- Thirdly, I accept Mr Peretz's submission based on R v Ministry of Agriculture, Fisheries and Food, ex p. The Dairy Trade Federation Ltd [1998] EuLR 253 that there are alternative adequate remedies in relation to the complaint in Ground 1 which make it inappropriate for the domestic courts to contemplate the grant of relief in judicial review proceedings. In The Dairy Trade Federation case Dyson J (as he then was) accepted that it was arguable that the creation of a milk marketing scheme was unlawful under EC competition law but refused permission for judicial review on the ground, alongside delay, that there were suitable alternative remedies for the claim: pp. 263G-265A. These consisted in the possibility of a private law claim against the operator of the scheme (Milk Marque), a complaint to the Commission or seeking a reference to the Monopolies and Mergers Commission. As Dyson J held at p. 264C-E:
- Under Ground 1 in the present case Roche's real complaint is that the EMA has relied upon Article 8(3) to make its requests for information when it had no right to do so. That, however, is a matter which by reason of the Foto-Frost principle cannot be resolved by the English courts and in relation to which Roche will have the opportunity, should any penalty actually be imposed, to raise it in due course before the appropriate EU courts which will be able to give a determinative answer on the issue. There is no good indication that allowing the domestic judicial review proceedings to proceed will provide a better "remedy" via the reference procedure. It may provide no "remedy" at all, as explained above. In my view, although not stated in terms by the judge, this further ground for dismissing the claim in the domestic proceedings and refusing to make a reference is sufficiently covered by the substance of her reasoning at [112], read with [182]-[183].
- As regards the two sentences in the MHRA's letter of 13 December 2013 in which it gave a positive account of co-operation by Roche, Mr Peretz accepted that the statements there would not have been made but for the fact that the MHRA was responding to the EMA's Article 8(3) request of 1 October 2013. In the proceedings Mr Peretz has been prepared to accept that this might mean that the MHRA had no lawful basis for writing these lines, if the EMA had no power under Article 8(3) to make the request it did.
- I question this. The MHRA is in law a manifestation of the Secretary of State, who has the legal capacity of a natural person: R v Secretary of State for Health, ex p. C [2000] HRLR 400. He has capacity and power at common law to write a letter containing information to anyone he wishes, unless such power has been taken away; and I do not see that the EU legislation or the provisions in the 2012 Regulations which we were shown at the hearing have done that. On the contrary, they emphasise the responsibility of the Secretary of State to co-operate as best he can with the EMA and the Commission under the pharmacovigilance regime, and supplying information about the co-operativeness of Roche in the Re-Inspection furthers that objective, not least because it goes to matters of relevance and interest by reason of Article 18(2)(c) of the Penalties Regulation. If the Secretary of State had sent a letter on his own initiative to supply such information it is not obvious to me that that would have been unlawful action by him (though detailed examination of this would also require consideration of other provisions in the 2012 Regulations, in particular regulation 332, which was drawn to our attention after the hearing, which imposes an obligation of non-disclosure other than in performance of the Secretary of State's "functions"). It does not seem to me that the fact that the occasion for writing these sentences in the letter of 13 December 2013 may have been a letter sent unlawfully (if Roche's contention is correct) by the EMA necessarily means that the Secretary of State's own action, by the MHRA, in writing as he did is thereby rendered unlawful. However, since the case was argued below and before us on the footing that an unlawful request by the EMA would have this effect, I address the arguments on that basis.
- At [110] the judge rejected the claim for declaratory relief in so far as it was sought to be based on these two sentences: "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." I agree. Roche has no real interest in trying to establish that this positive report about it by the MHRA was unlawful, other than as a vehicle to obtain indirectly what it cannot obtain directly, namely a determination by the English court (after use of the reference procedure) that the EMA's Article 8(3) request of 1 October 2013 was made unlawfully. Thus the same answers as have been given above are applicable here as well. The claim remains one for an advisory opinion and in relation to which there are adequate alternative remedies, and the judge was right to reject it on ordinary domestic law principles and to reject the request for a reference to the CJEU.
- I turn to consider the additional answer to the appeal under Ground 1 proposed by Mr Peretz in the respondent's notice, namely that it is clear that Article 8(3) provided the EMA with a lawful foundation for writing its letters of 1 and 17 October 2013 requesting the MHRA to provide information. Since the position is clear beyond reasonable argument, Mr Peretz says, Roche's submission regarding the alleged unlawfulness of the action taken by the EMA in sending its requests is "unfounded", in the sense in which that term is used in Case C-344/04 R (International Air Transport Association) v Department for Transport [2006] 2 CMLR 20, at para. [29], in the context of determining in what circumstances the principle in Foto-Frost will not require a national court to make a reference to the CJEU. Putting the point another way, which amounts to the same thing, he submits that it is acte clair according to the principles in Case 283/81 CILFIT [1982] ECR 3415 that the EMA had power under Article 8(3) to send its requests to the MHRA. If this is right, it affords a further reason why no reference should be made under Ground 1.
- The judge was not persuaded by this submission, but I am. In my view, it is clear to the "unfounded" or acte clair standard that the EMA had power under Article 8(3) to make the requests it did. Contrary to Roche's submission, the EMA's power to act under Article 8 is not contained exclusively within Article 8(2):
- This means that in my opinion there is a distinct reason, additional to those given by the judge and above, why the appeal in relation to the Article 8(3) issue should be dismissed.
- If the MHRA has acted unlawfully in breach of its obligation under English public law to act fairly, I think it would be appropriate for declaratory relief to be granted. The domestic courts are in a position to determine the relevant facts and to rule authoritatively upon the legal issue under Ground 2.
- Mr Anderson does not contest the judge's findings regarding the purpose and scope of the Re-Inspection. But he says that fairness required that the MHRA should have told Roche about its engagement with the EMA regarding the interaction between the Re-Inspection and the ongoing infringement procedure, and in particular should have informed Roche that it had received the EMA's Article 8(3) requests in relation to the Re-Inspection. This could have affected the frankness and candour with which Roche would otherwise approach an inspection under the public health track. This ground of challenge turns on the domestic law principle of fairness, as it applies in relation to the conduct of public authorities.
- Mr Anderson relied in particular on observations of Kennedy LJ in R (Kent Pharmaceuticals Ltd) v Director of the Serious Fraud Office [2004] EWCA Civ 1494; [2005] 1 WLR 1302 at [29]. The case concerned documents which the SFO had obtained from the claimant pursuant to search warrants issued for the purpose of a criminal investigation in relation to price fixing in the sale of drugs to the NHS, which the Secretary of State for Health requested the SFO to release to him to enable him to use them in civil proceedings against the claimant and others. The director of the SFO decided to exercise a statutory discretion to release the documents to the Secretary of State. The claimant commenced judicial review proceedings against the director to challenge that decision. The challenge was unsuccessful on the facts, but Kennedy LJ said this at [29]:
- Mr Anderson submits that, in accordance with Kennedy LJ's statement here, the starting point for the MHRA should have been to inform Roche that it had received the Article 8(3) requests in relation to the Re-Inspection and about its engagement with the EMA in that regard, since that was necessary to give Roche a fair opportunity to exercise its rights in relation to the Re-Inspection, including by adopting a less frank and more defensive attitude to the provision of information in the course of the Re-Inspection.
- I do not accept this submission. In my view, the judge was right to find that there had been no unfairness on the part of the MHRA.
- The judge correctly held at [150] that the MHRA did not take unfair advantage of Roche or abuse the inspection process in the way it conducted the Re-Inspection. The need for and the scope of the Re-Inspection were not affected by the Article 8(3) requests sent by the EMA.
- The judge correctly directed herself by reference to the classic statement of principle by Lord Mustill in R v Secretary of State for the Home Department, ex p. Doody [1994] 1 AC 531, 560, as follows:
- The judge correctly distinguished the Kent Pharmaceutical case at [120]-[122]. The demands of fairness are dependent on the context of the decision in question, which as Lord Mustill explained involves having regard to "the shape of the legal and administrative system within which the decision is taken". In Kent Pharmaceutical, although there was a power in the director of the SFO to disclose the documents to the Secretary of State, the claimant had no reason whatever to assume that any such disclosure would happen. By contrast, under the legal and administrative system in place in the present case Roche knew, or could reasonably be expected to know, that the information from the Re-Inspection would be supplied to the EMA and that the EMA could use it for the purposes of the infringement procedure already on foot. Roche thus had a fair opportunity to know what was likely to happen and to decide what stance to take in the course of the Re-Inspection, without anything needing to be said by the MHRA. Accordingly, fairness did not require any warning to be given by the MHRA to alert Roche to that possibility.
- At [138] the judge correctly identified a range of features of the context of the actions by the MHRA which supported her conclusion that there was no breach by the MHRA of its obligation to act fairly, as follows:
- I agree with these points. In the analysis under Ground 2, I consider that the most important matters are the legislative framework and the fact that the Re-Inspection was only directed to what would have been required in any event under the public health track by virtue of Article 111 of the 2001 Directive. As the judge observed, Article 111 makes it clear that information obtained by the MHRA during an inspection or re-inspection will be provided to the EMA. That is especially clear where, as here, as was known to Roche, the CHMP on behalf of the EMA has itself requested the re-inspection. Article 18(2)(c) of the Penalties Regulation makes it clear that information regarding the approach of a MAH to an inspection or re-inspection will be relevant information to which the EMA is highly likely to have regard for the purpose of carrying out its functions under that Regulation. From these features of the pharmacovigilance regime, in particular, Roche was on fair notice of the potential for use of information from the Re-Inspection in the infringement procedure without the MHRA needing to say anything more.
- That there is no additional obligation of fairness resting on the MHRA is further reinforced by the fact that the pharmacovigilance regime provides for extensive procedural protection for a MAH such as Roche before any action is taken to impose a penalty under the Penalties Regulation. Under the scheme of that regime, there is assurance that a MAH will be treated fairly before being made subject to a penalty, and it can complain to the General Court if it is not. It is not necessary to impose additional obligations upon the MHRA to achieve fairness in procedure and fairness in respect of the outcome which might be arrived at under an infringement procedure.
- In my view, the legislative framework is more important than the EMA guidance and Commission guidance, which essentially just summarise the effect of the legislation in this regard. However, the guidance is in each case an official statement which serves to reinforce the basic message to be derived from the legislative framework, and so further undermines Roche's case under Ground 2. In the light of it the MHRA was entitled to expect that Roche understood very well the uses to which the information from the Re-Inspection could be put, including for the purposes of the infringement procedure.
- I also consider that in analysing the position under Ground 2 both the legislative framework and the guidance are more important than what was said by MHRA representatives at the start of the Re-Inspection meetings in the United Kingdom and the USA. That is not a critical point in the case. However, the judge was right to assess that the express references at the meetings to the possibility of use of the information from the Re-Inspection in the infringement procedure is a yet further factor which undermines Roche's case based on a duty of fairness.
- In my judgment, the judge was also right to reject Roche's claim and request for a reference under Ground 3.
- Mr Peretz accepts that, taken as pure legal points, both the MAH responsibility point and the retrospectivity point could be viewed as arguable points of EU law. However, what he emphasises in his submissions is that such statements as were made by the MHRA in the Re-Inspection Report regarding the MAH responsibility point and the retrospectivity point were not made as public statements of the view of the MHRA, nor indeed did they even constitute clear articulations of view by the MHRA on these points. He is correct about this. In substance, all the MHRA did in the Re-Inspection Report was report on what had happened in the course of the Re-Inspection for the benefit of the EMA. Nothing the MHRA says by implication in the report about its view on either the MAH responsibility point or the retrospectivity point will be binding on the EMA or the Commission, which will both obviously have to take their own advice and make their own judgments about those legal issues. They will be obliged under the infringement procedure to give Roche an opportunity to make representations about them and (if the Commission decides to impose a penalty) will have to be prepared to defend their view in proceedings in the General Court.
- In consequence, Mr Peretz says, this is clearly not a case in which an English court would grant declaratory relief. The statements by the MHRA in the Re-Inspection report, such as they are, in relation to the MAH responsibility point and the retrospectivity point are not such as might lead some other public official to act in any particular way in relation to Roche and so in and of themselves will have no practical consequences for Roche. The declaratory relief would again be purely advisory in nature, and the courts will not grant such relief. Accordingly, as with Ground 1, no reference to the CJEU on these points is necessary or appropriate.
- He contrasted this case with the well known case of Gillick v West Norfolk and Wisbech Area Health Authority [1986] AC 112, in which the issue was whether declaratory relief should be granted in respect of the correctness in law of advice issued by central government to local health authorities regarding the provision of contraceptives to minors. At pp. 192-194 Lord Bridge explained that even public advice or guidance given by a public body would be subject to judicial review only in exceptional cases; the case in hand was an exceptional one, because conflicting advice on the issue had been put into the public domain so that "The desirability of an authoritative resolution of this dispute on a pure question of law was obvious in the interests both of the nursing profession and of the public"; but said that the court should exercise its jurisdiction in this area "with the utmost restraint," avoiding "either expressing ex cathedra opinions in areas of social and ethical controversy in which it has no claim to speak with authority or proferring answers to hypothetical questions of law which do not strictly arise for decision." In line with the approach in Gillick, a court will issue declaratory relief regarding guidance or advice issued by a public authority which is likely to lead others into taking action which is unlawful: see e.g. R (Suppiah) v Secretary of State for the Home Department [2011] EWHC 2, [137]; R (S and KF) v Secretary of State for Justice [2012] EWHC 1810 (Admin), [37]-[38]. The present case does not have this feature.
- I accept Mr Peretz's submission that in the present case it is clear that an English court will not issue declaratory relief in relation to the correctness or otherwise of what the MHRA might be taken to have said about the MAH responsibility point and the retrospectivity point in its Re-Inspection Report. The relief sought is purely advisory in a context in which the MHRA's views on these points will not have any effective causative impact on the way in which Roche may be treated in the infringement procedure. The domestic court is being asked to offer answers to hypothetical questions of law which do not require any resolution by it and, moreover, in relation to matters in which it is the EU courts, not the domestic court, which have authority to speak. Further, no reference is required in order to afford the EU courts an opportunity to rule on these issues of EU law, because they will have an opportunity to do so at the proper time, on the basis of actual known facts and in the context of a live dispute between parties who will be directly bound by the result.
- It is not necessary and would be inappropriate to allow the English proceedings to continue as a vehicle to try to obtain a ruling from the CJEU at a time when that would be premature and when the real targets of Roche's complaints – the EMA and the Commission – would not be bound by any ultimate ruling which the English court might give. At most, if a ruling were given by the CJEU on a reference, inferences might possibly be drawn as to how the EMA and the Commission should proceed in the infringement procedure, but there could be no guarantee of such a ruling being definitive and dispositive of the issues between Roche and the EMA and the Commission. The judge was correct to dismiss Roche's application for a reference for the reasons she gave at [182]-[183]. As she said, "It is undesirable to pre-empt the acts of an EU institution and to anticipate the arguments on the substance of the case."
- Upon analysis, therefore, the same answers apply in relation to Ground 3 as apply in relation to Ground 1. For reasons of domestic public law the English court will not grant the declaratory declarations which are sought. The proceedings should also be dismissed because there is an adequate alternative remedy if the EMA and the Commission do take steps against Roche. Since the proceedings must be dismissed by application of principles of domestic public law, the points of EU law are immaterial and no reference is needed.
- For these reasons, I would dismiss Roche's appeal in relation to each of Grounds 1 to 3. The entirety of Roche's claim against the MHRA should be dismissed. No reference to the CJEU should be made.
- I agree.
- Save for para 63 above (which was not argued before us), I agree that the appeal should be dismissed for the reasons so clearly given by Lord Justice Sales.
- During the hearing of this appeal, I expressed concern at the lack of clear procedural guarantees for a MAH in the position of Roche. The EMA (at the request of the Commission) gave notice ("an initiation notice") to Roche that it was initiating an infringement procedure under Article 7 of the Penalties Regulation as long ago as 23 October 2012.
- Procedural guarantees for a MAH are quite separate from the taking of steps to protect public health. Steps to protect public health can and, as we understand it, have been taken in any event. Procedural guarantees do not on the face of it impede the taking of those important steps.
- The starting point in resolving the concern I have raised is that there should in principle be procedural guarantees whenever a person is liable to a penalty. In Entick v Carrington (1765) 19 St Tr 1030; 95 ER 807, an important case in the development of liberty in England, it was held that a secretary of state could not search a person's property and remove his papers without proper statutory authority when that search and removal might lead to a criminal charge being made against that person. Lord Camden LC concluded: English law is "wise and merciful and supposes every man accused to be innocent before he is tried by his peers." What applies to the search of premises and removal of papers in the eighteenth century should go for a regulatory inspection and requests for information in the twenty-first century.
- But there is no "one size fits all" here, and the answer to my concern in this case is, in my judgment, twofold. First, the Penalties Regulation gave Roche a number of guarantees after service of the initiation notice under Article 7. It had the right to submit written observations to the EMA before it adopted its report to the Commission under the infringement procedure (Article 9). It also had the right of access to the documents and other materials compiled by the Agency and the Commission (Article 21) and the right to legal representation (Article 22). In addition, Recital (13) to the Penalties Regulation preserved its right to silence in providing answers. Second, as explained by Sales LJ, the European legislature has in setting up the scheme in the Penalties Regulation afforded the further procedural guarantee of making comments in advance on the grounds on which the Commission bases any fine: see Article 17 of the Penalties Regulation.
- When the framers of the Penalties Regulation formulated the scheme of procedural guarantees as they did, they may well have had in mind a wide range of considerations that are not known to us. Moreover, that point reinforces the conclusion that the question whether the law should imply any procedural guarantees into the Penalties Regulation, in addition to those expressly given, should primarily be a matter for the courts of the European Union. In those circumstances, this Court should not lightly find a breach of the common law duty of fairness (by the failure to give notice before inspecting the premises and records of Roche) which would in effect introduce restrictions on what the EMA or MHRA could do under the Penalties Regulation.
- I would therefore also dismiss the appeal and allow the respondent's notice to the extent indicated by Sales LJ.
Lord Justice Sales:
Introduction
"2. Roche is a wholly owned subsidiary of Roche Holding AG and is the marketing authorisation holder ("MAH") of all centrally-approved medicinal products developed and marketed by the Roche group of companies. The MHRA discharges the Secretary of State's duties and powers as the "licensing authority" for Great Britain under the Human Medicines Regulations 2012 ("the 2012 Regulations") which implement Directive 2001/83/EC of the European Parliament and of the Council ("the 2001 Directive"). The European Medicines Agency ("the EMA") appears as an interested party. The EMA was set up under Regulation (EC) 726/2004 ("the 2004 Regulation") and is responsible for co-ordinating the scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicines authorised centrally. It includes the Committee for Medicinal Products for Human Use ("the CHMP"), which is responsible for preparing the opinion of the EMA on any question relating to the evaluation of medicines, and the Pharmacovigilance Risk Assessment Committee ("PRAC"), which is responsible, amongst other things, for providing recommendations to the CHMP on any question relating to pharmacovigilance activities for human medicines.
…
4. The Re-Inspection related to Roche's pharmacovigilance system and the extent to which Roche had complied with its reporting obligations. Pharmacovigilance is the science and activities relating to the detection, reporting, assessment, understanding and prevention of adverse effects of a medicine or any other medicine-related problem. The obligation on MAHs, such as Roche, to operate a pharmacovigilance system is a critical element of the system of licensing human medicines in the European Union ("EU"). In broad terms, MAHs are obliged to operate a pharmacovigilance system and to audit that system. They are also obliged to monitor suspected adverse reactions to their product and to record and report suspected adverse reactions to their product which are brought to their attention. These are central safeguards for public safety and health purposes. The duty to protect public health exists independently and separately from any disciplinary issues that may arise.
5. Medicines regulators, such as the MHRA, routinely exercise powers under their respective national laws to conduct pharmacovigilance inspections to check compliance with pharmacovigilance obligations. Where deficiencies are identified, the company under inspection proposes and then implements corrective and preventative actions ("CAPAs"). The regulatory body may then re-inspect at a later date to confirm proper implementation. Roche states that it was (and remains) content to comply with such inspections. Additionally, the CHMP routinely requests that national competent authorities conduct inspections in respect of products for which the CHMP is responsible. Roche states that it was (and remains) content to comply with such inspections.
6. The two principal pieces of EU legislation which impose pharmacovigilance obligations on MAHs are the 2004 Regulation and the 2001 Directive. With effect from July 2012 that legislation underwent material amendment, as did the manner in which the EU laws are implemented into UK law. Prior to August 2012 the key national legislation was the Medicines Act 1968 ("the Act") and the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994 ("the 1994 Regulations"). The 2012 Regulations repealed and/or replaced the relevant provisions of the Act and the 1994 Regulations. The pharmacovigilance obligations said by Roche to be relevant to this claim are those pre-dating July 2012, largely to be found in the 2004 Regulation. The Re-Inspection was conducted in late 2013 pursuant to the 2012 Regulations.
7. Roche alleges that, when conducting the Re-Inspection, the MHRA was knowingly gathering evidence in the context and for the purpose of infringement proceedings which have been brought against Roche under the Penalties Regulation (EC) No. 658/2007 ("the Penalties Regulation") ("the infringement proceedings"). These proceedings are of a criminal or quasi-criminal nature and carry a heavy potential financial penalty of up to 5% of Roche's annual EU turnover in the preceding year. It appears that this is the first time that an investigation has been launched under the Penalties Regulation.
8. Article 1 of Chapter 1 of the Penalties Regulation identifies various pharmacovigilance obligations which, if infringed, give rise to a risk of a financial penalty being imposed. Chapter II sets out the "Infringement Procedure" which commences with an "Inquiry" by the EMA which leads to the EMA producing a report which summarises its findings. The "Decision-Making stage" follows next. The European Commission ("the Commission") considers the case and may, having followed the procedure provided for in the Penalties Regulation, adopt a decision imposing a fine. The Penalties Regulation also allows for penalties to be imposed for non-compliance with measures of inquiry. It provides at the outset (by recital 13) that, when carrying out the infringement procedure, the EMA and Commission must ensure the respect of the rights of defence. The MAH must have access to the file of the EMA and the Commission and the right to legal representation. The right to silence must also be respected.
9. The Claimant brings three grounds of challenge:
a) first, that the MHRA provided information to the EMA pursuant to formal requests from the EMA under Article 8(3) of the Penalties Regulation. Article 8(3) did not provide a proper basis for such requests. Accordingly the MHRA's compliance with them was and remains ultra vires;
b) secondly, that the MHRA failed properly to explain to Roche, at the time of the Re-Inspection, that the information was being obtained for use in a criminal or quasi-criminal investigation and that it would be making additional submissions to the EMA for that purpose. Had the MHRA done so, Roche would have been able to consider its position, including by seeking legal advice and representation and by asserting its right to silence and not to incriminate itself. The MHRA's conduct was thus procedurally improper and unlawful. There was no or insufficient procedural protection of Roche's rights in breach of the applicable EU, European Convention of Human Rights ("ECHR") and domestic law standards in the context of 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."
The legislative framework
"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)…"
"…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]."
"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."
323.-(1) The Secretary of State must enforce or secure the enforcement of these Regulations and the relevant EU provisions 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 deficiencies 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."
"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…
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…
Article 14
Requests for information
1. After receipt of a request from the Agency pursuant to Article 10(2) and before adoption of the decision referred to in Article 16, the Commission may at any time request the marketing authorisation holder to provide written or oral explanations, or particulars of documents, relating to the alleged infringement.
Requests shall be addressed in writing to the marketing authorisation holder. The Commission 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)(c) and (d) for failing to comply with the request or for supplying incorrect or misleading information.
2. The Commission may request the Agency, the national competent authorities or any other 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. Where the request is addressed to the Agency or a national competent authority, the time-limit by which the information is to be provided shall be determined by the Commission after consultation of the Agency or the national competent authority to which the request is addressed, having regard to the specific circumstances of the case. Where the request is addressed to other natural or legal persons, it shall fix a time-limit by which the information is to be provided, which shall be at least four weeks.
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 effects of the infringement
…
(c) 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;
…
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.
…
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 29 November 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."
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."
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."
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…"
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."
The judgment
"MHRA inspectors consider that [Roche] co-operated fully with the re-inspection conducted in October and November 2013. The re-inspection was conducted according to the inspection plan and Roche made its documentation and personnel fully available to the inspection team (at both the UK and US site)."
"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."
Discussion
Ground 1: the Article 8(3) point
"The real complaint of DTF is that Milk Marque is abusing its dominant position by its selling system. This complaint, if proved, can be remedied either directly by one of the three alternative routes already mentioned, or indirectly by obtaining relief against the respondents requiring them to take appropriate steps to eliminate the Art. 86 abuse of Milk Marque. DTF has failed to explain why the indirect route [i.e. by judicial review proceedings] is more effective than the direct route. To assert, as DTF does, that its complaint is against the respondents and not against Milk Marque is merely to invite the question, Why?. In determining whether there are alternative adequate remedies, the court must look at the realities of the situation. The reality here is that the complaint is against the system being used by Milk Marque. The issues raised are ones which the European Commission and/or the MMC are well qualified to determine."
i) I agree with Mr Peretz's submission that the obvious and sufficient reason why Article 8(2) refers explicitly to national competent authorities whereas Article 8(3) does not, is that the matters that may be the subject of requests under Article 8(2) are all matters that require the exercise of powers enjoyed by such authorities alone. Accordingly, there is no basis for assuming that the EU legislature intended that requests as to matters falling within Article 8(2) should be the only requests that the EMA could address to such authorities in relation to investigations under the Penalties Regulation;ii) The language of Article 8(3) is clearly apt to cover natural and legal persons of every kind, including national competent authorities. The language used in Article 14(2) of the Penalties Regulation reinforces the point. It shows that the drafter of the Regulation includes national competent authorities within the category of "natural or legal persons", because after listing the EMA and national competent authorities the drafter completes the list with "or any other legal or natural persons";
iii) As is well known, the CJEU applies a strongly purposive approach in matters of construction, so these linguistic points are not decisive in themselves. But consideration of the objectives of the Penalties Regulation points to the same conclusion. To interpret Article 8(3) as covering requests to a national competent authority for information means that the EMA has power to request provision of relevant information already in that authority's possession or which it will acquire otherwise than by an inspection requested under Article 8(2), simply in the course of carrying out its ordinary pharmacovigilance functions. In light of the importance of the objective of protection of public health which the Penalties Regulation is intended to promote and the full procedural protections provided for in relation to the infringement procedure, it would be extraordinary if the EMA was not intended to be clothed with power to ask for such information.
Ground 2: the fairness point
"In some cases it may 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. The documents may be urgently required elsewhere, or it may appear that disclosure would hamper investigations. In such a case the designated member of the SFO would not, in my judgment, be acting unfairly if he decided to go ahead without giving the sort of notice which in other circumstances would be required. But, having disclosed the documents, he would then have to consider whether the owner of the documents should be told what had taken place. 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 insofar as his rights have been curtailed by statute, 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."
"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."
"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)."
Ground 3: the errors of law point
Conclusion
Lord Justice McFarlane:
Lady Justice Arden DBE: