The Queen (on the application of Napp Pharmaceuticals Ltd) v Secretary of State for Health acting as the Licensing Authority Sandoz Ltd (Interested Party)

JurisdictionEngland & Wales
JudgeMrs Justice Whipple
Judgment Date29 July 2016
Neutral Citation[2016] EWHC 1982 (Admin)
CourtQueen's Bench Division (Administrative Court)
Docket NumberCase No: CO/1366/2016
Date29 July 2016

[2016] EWHC 1982 (Admin)

IN THE HIGH COURT OF JUSTICE

QUEEN'S BENCH DIVISION

ADMINISTRATIVE COURT

Royal Courts of Justice

Strand, London, WC2A 2LL

Before:

Mrs Justice Whipple

Case No: CO/1366/2016

Between:
The Queen (on the application of Napp Pharmaceuticals Ltd)
Claimant
and
Secretary of State for Health acting as the Licensing Authority
Defendant

and

Sandoz Ltd
Interested Party

Richard Gordon QC and Marie Demetriou QC (instructed by Bristows LLP) for the Claimant

George Peretz QC (instructed by The Government Legal Department) for the Defendant

Tom de la Mare QC and Ravi Mehta (instructed by Olswang LLP) for the Interested Party

Hearing dates: 6 July 2016

Mrs Justice Whipple

INTRODUCTION

1

This application for judicial review is brought by Napp Pharmaceuticals Ltd ("Napp"). The Defendant is the Licensing Authority established under the Human Medicines Regulations 2012. The powers of that authority are exercised by the Secretary of State for Health through the Medicines and Healthcare Products Regulatory Agency ("MHRA"). Sandoz Ltd is the interested party ("Sandoz"). Napp seeks judicial review of the MHRA's decision to grant marketing authorisations ("MAs") to Sandoz in relation to its product, Reletrans. Reletrans is a generic version of Napp's authorised product, BuTrans. At the heart of Napp's case is the scope and meaning of Article 10(3) of Directive 2001/83/EC on the Community code relating to medicinal products for human use (the "Medicinal Code"). Napp argues that Article 10(3), properly construed, provides protection for the clinical data provided by Napp in support of its application for an MA for BuTrans; alternatively, if the Court is in doubt, a reference to the Court of Justice of the European Union ("CJEU") is required under Article 267 TFEU in order to resolve the uncertainty.

2

Permission to bring this judicial review was granted by Cheema-Grubb J following an oral hearing on 25 May 2016. Permission had initially been refused on the papers by Irwin J (on 12 April 2016).

3

Napp was represented by Richard Gordon QC and Marie Demetriou QC, the MHRA by George Peretz QC, and Sandoz by Tom de la Mare QC and Ravi Mehta. I am grateful to all Counsel for their assistance in this case.

THE MEDICINAL CODE

4

Directive 2001/83/EC was implemented on 6 November 2001. It codified a series of existing directives, the earliest of which was Directive 65/65/EEC of 26 January 1965. The 2001 Directive was amended by Directive 2004/27/EC of 31 March 2004 (the "2004 amending directive"). Member States were required to implement the amendments by 30 October 2005. Article 10(3), on which this case turns, was introduced in its current form by the 2004 amending directive, but it reflected a provision which has formed part of the EU law code for many years, having been contained within the last sub-paragraph of Article 4.8(a) of Directive 65/65/EEC, before becoming part of Article 10(1)(a)(iii) of Directive 2001/83/EC (at those times commonly referred to as the "proviso").

5

The Medicinal Code in its current form is prefaced by a number of recitals. Of particular relevance are the following:

"…

(2) The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.

(3) However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.

(9) Experience has shown that it is advisable to stipulate more precisely the cases in which the results of toxicological and pharmacological tests or clinical trials do not have to be provided with a view to obtaining authorization for a medicinal product which is essentially similar to an authorized product, while ensuring that innovative firms are not placed at a disadvantage.

(10) However, there are reasons of public policy for not conducting repetitive tests on humans or animals without over-riding cause."

The 2004 amending directive included the following relevant recital:

"(14) Since generic medicines account for a major part of the market in medicinal products, their access to the Community market should be facilitated in the light of the experience acquired. Furthermore, the period for protection of data relating to pre-clinical tests and clinical trials should be harmonised."

6

The Medicinal Code is intended to apply to medicinal products for human use intended to be placed on the market in the Member States and either prepared industrially or manufactured by a method involving an industrial process (Article 2).

7

Article 6(1) provides that no medicinal product can be sold without first being authorised by the competent authorities of the Member State by grant of an MA. It is in the following terms:

"1. No Medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (OJ L 378, 27.12. 2006, p.1) and regulation (EC) No 1394/2007.

When a medicinal product has been granted an initial marketing authorisation in accordance with the first subparagraph, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial marketing authorisations. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10(1)."

8

The second paragraph of Article 6(1) was inserted by the 2004 amending directive. It enables additional strengths, pharmaceutical forms, administration routes, presentations, variations and extensions (known as "line extensions") to be authorised under a global marketing authorisation or "GMA". It was common ground that a GMA is available where the line extensions have all been developed by the same company or by connected companies.

9

The procedure for obtaining an MA is outlined in Article 8, which requires an application to be made to the competent authority of the Member State concerned. The MHRA is the competent authority for the United Kingdom. The application is to be accompanied by certain "particulars and documents" which are listed at Article 8(3). Those particulars include:

"(i) results of:

— pharmaceutical (physico-chemical, biological or microbiological) tests,

— pre-clinical (toxicological and pharmacological) tests,

— clinical trials."

10

Articles 10(1) and (2) provide for generic medicinal products to be authorised, subject to specific protections afforded to the innovator of the original (or "reference") medicinal product. Article 10(1), first paragraph, provides as follows:

"By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community."

This is referred to as the "abridged" procedure. The "reference medical product" (or "RMP") is defined at Article 10(2)(a) as follows:

"'reference medicinal product' shall mean a medicinal product authorised under Article 6, in accordance with the provisions of Article 8."

"Generic medicinal product" is defined at Article 10(2)(b) as follows:

"'generic medicinal product' shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies…"

As can be seen, "bioavailability studies", or "bioequivalence data" are required to demonstrate that the particular medicinal product is indeed a "generic" of the RMP.

11

Bioavailability and bioequivalence data are not defined further in the Medicinal Code, but some assistance as to their meaning is provided at Annex 1 to the Code. Under "Introduction and General Principles", paragraphs (1) and (2) of Annex 1 explain that the particulars and documents accompanying an application under Articles 8 and 10(1) shall be presented in accordance with the requirements set out in the Annex and in guidance published by the Commission. The particulars and documents must be presented as five modules, the fifth of which is "clinical study reports". Part 1 of the Annex, headed "Standardised Marketing Authorisation Dossier Requirements", describes the format and presentation of module 5, in the following terms:

"—Clinical study reports

— Reports of Bio-pharmaceutical Studies

— Bio-availability Study Reports

—Comparative Bio-availability and Bio-equivalence Study Reports

—In vitro – In vivo Correlation Study Report

—reports of Bio-analytical and Analytical Methods"

Paragraph 5.2.1 explains these studies further as follows:

"Bio-availability study reports, comparative bio-availability, bio-equivalence study reports, reports on in vitro and in vivo correlation study, and bio-analytical and analytical methods shall be provided."

12

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