Athropharm (Europe) Ltd v The Health Products Regulatory Authority [2019] IEHC 629 (30 August 2019)
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THE HIGH COURT
[2019] IEHC 629
RECORD NO. 2018/1080JR
BETWEEN
ARTHROPHARM (EUROPE) LIMITED
APPLICANT
AND
THE HEALTH PRODUCTS REGULATORY AUTHORITY
RESPONDENT
AND
CHANELLE PHARMACEUTICALS MANUFACTURING LIMITED
NOTICE PARTY
JUDGMENT of Mr. Justice Noonan delivered on the 30th day of August, 2019
Facts
1. This is an application for discovery brought by the applicant (“Arthropharm”) in
these judicial review proceedings against the respondent (“HPRA”) of five categories
of documents.
2. Arthropharm is the manufacturer of a veterinary pharmaceutical product known as
Cartrophen which is used for the treatment of arthritis in dogs. In 1991, Arthropharm
received a licence known as a marketing authorisation (“MA”) for this product from
HPRA. This gave Arthropharm the exclusive right to market and sell this product in
the European Union for a period of 10 years.
3. In 2017, the notice party (“Chanelle”) applied to HPRA for a MA in respect of a
similar product known as Osteopen which is claimed to be a generic of Cartrophen.
In order to make this application, Chanelle availed of what is known as the
decentralised procedure pursuant to the provisions of Directive 2001/82/EC (“the
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Directive”). This enables an applicant for a MA to make an application to the
relevant regulatory body of a Member State (“the Reference Member State”), in this
case HPRA, identifying the Member States in which it is proposed to market the
product. Those other Member States are consulted throughout the process which is
led by the Reference Member State. In this instance, there were 12 such concerned
Member States in addition to Ireland as the Reference Member State.
4. Article 13 (1) provides for an abridged procedure where it can be demonstrated that
the medicinal product in respect of which the MA is sought is a generic of a
reference medicinal product. The advantage of this procedure is that it exempts the
applicant from the necessity to provide the results of safety and residue tests or of
preclinical and clinical trials, the underlying premise being that the generic is
substantially identical to the reference product in respect of which such information
was already provided and which received a MA.
5. Article 13 (2) (b) defines a “generic medicinal product” as:
“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... Bioavailability studies need not be required of the applicant if he can
demonstrate that the generic medicinal product meets the relevant criteria as
defined in the appropriate detailed guidelines.”
6. The reference veterinary medicinal product for Chanelle’s application in respect of
Osteopen was Cartrophen. On 20 July 2018, HPRA granted a MA to Chanelle and on
the same date published a publicly available assessment report (“the PAR”) which
identified Article 13 (1) as the legal basis of the application and Cartrophen as the
reference product. The report records that HPRA accepted the omission of in vivo
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bioequivalence data based upon the essential similarity between the generic and
reference product formulations. The PAR further records that since the application
was a generic application and bioequivalence with the reference product had been
accepted, a range of tests and trials, inter alia, was not required.
7. Arthropharm alleges that it became aware of the grant of the MA on 23 August 2018
and on 10 October 2018, submitted a detailed objection to HPRA. Arthropharm’s
fundamental objection is that Osteopen is not in fact a generic of Cartrophen. The
basis for this assertion lies in the fact that the active ingredient in both products is
Pentosan Polysulfate Sodium (“PPS”) but Arthropharm claims that there are
differences in the manufacturing process of PPS as between different manufacturers
leading to significant differences in the resultant product’s toxicity and potency
levels. Arthropharm further claims that both Cartrophen and Osteopen are biological
veterinary medicinal products and consequently the provisions of article 13 (4) of the
Directive apply which require the applicant to provide the results of appropriate
preclinical tests or clinical trials. Essentially therefore Arthropharm claims that
HPRA ought to have assessed the application under article 13 (4) rather than 13 (1).
8. As noted above, over a month elapsed between the grant of the MA to Chanelle and
Arthropharm becoming aware of it. This is because there is no requirement under the
Directive for the manufacturer of the reference medical product to be put on notice of
an application to licence a generic, presumably on the basis that once the period of
exclusivity expires, the original manufacturer is no longer considered to have an
interest in the matter. When Osteopen went on sale in November, 2018, it obtained a
sample of Osteopen and submitted it for analysis to two companies, respectively
Biopharm, the holder of the MA for Cartrophen in Australia, and Bene pharmaChem,
the manufacturer of the PPS utilised in Cartrophen. The test results from this analysis
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were sent to HPRA on 13 December 2018 in support of Arthropharm’s original
objection.
9. Further reports were subsequently obtained by Arthropharm from four different
academic experts in support of its claim that Osteopen is not a generic of Cartrophen
and both are biological medicinal products. This was to counter any suggestion that
neither Biopharm or Bene pharmaChem could be regarded as independent of
Arthropharm. On the basis of its objection and supporting expert evidence,
Arthropharm invited HPRA to revoke the MA to Chanelle and in a letter of 6 March
2019, HPRA declined to do so. It is of some relevance to note that Arthropharm has
had market exclusivity for its product for some 27 years until the MA was granted to
Chanelle who is now Arthropharm’s only competitor in the market place.
The Statement of Grounds
10. At paragraphs (D) (1) to (7) of the statement of grounds, Arthropharm seeks the
reliefs that continue to be relevant in these proceedings. At (1) to (4) orders of
certiorari of the decision of 20 July 2018 are sought with ancillary declarations that
the decision that Osteopen is a generic of Cartrophen is ultra vires. Paragraph (5)
seeks a declaration that HPRA failed to take relevant considerations into account in
granting the MA and at (7) failed to give adequate reasons for its decision.
Subsequent to the original grant of leave, Arthropharm was permitted to seek relief
(6) being a declaration that HPRA was in error in failing to suspend the MA on 6
March 2019.
11. Paragraph (E) sets out the specific grounds on foot of which each relief is sought. In
brief summary, reliefs (D) (1) – (4) are sought on the grounds that Osteopen is not a
generic of Cartrophen because it does not have the same qualitative and quantitative
composition in active substances as Cartrophen. The manufacturing processes of the
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active ingredient, PPS, are different in each case so that the finished products are not
bioequivalent and have different potency and toxicity. The consequence of this in
legal terms is that the article 13 (1) procedure was not permissible and in utilising if,
HPRA therefore acted ultra vires.
12. The grounds for D (5), (failing to take relevant considerations into account), are that
HPRA failed to have regard to differences in the manufacturing processes of PPS. In
its response, HPRA pleads that, as a matter of law, it had no obligation to take this
into account. The grounds for D (6), (failing to suspend the MA), are that HPRA
ought to have done so when the differences in the manufacturing processes of PPS
were brought to its attention and it failed to engage in any meaningful risk/benefit
analysis in the light of Arthropharm’s submissions and again gave no adequate
reasons for this decision. It is further pleaded that the matters to which HPRA failed
to have regard included the data on the Carthrophen master file. In that latter regard,
the director of HPRA, Dr. J. G. Beechinor, in an affidavit sworn in this discovery
application clarifies that this data was in fact considered by HPRA.
13. Finally, with regard to relief D (7), (failing to give reasons), Arthropharm pleads that
the PAR does not contain sufficient information on the pharmacological qualities of
Osteopen which therefore amounts to inadequate reasons.
Categories Sought
14. In its request for voluntary discovery and in the motion now before the court,
Arthropharm has sought five categories of documents which may be summarised as
follows:
(a) all documents concerning HPRA’s consideration of whether Osteopen is a
generic of Cartrophen including the dossier submitted by Chanelle and any
documents from the Cartrophen file that were considered;
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(b) all documents considered regarding whether Osteopen or Cartrophen are
biological products;
(c) all documents considered in deciding to exempt Chanelle from demonstrating
bioequivalence – these would appear to be included in the documents sought at
category (a);
(d) all documents concerning the specification for the PPS used and comparative
analysis of product composition submitted by Chanelle in respect of Osteopen
and Cartrophen – again this would appear to be covered by (a);
(e) all documents concerning the benefit/risk assessment carried out by HPRA
between 20 July 2018 and 6 March 2019.
Legal Principles
15. The starting point is Order 31 rule 12 which requires the party seeking discovery to
establish that the documents sought are both relevant and necessary for the fair
disposal of the case or for saving costs. The party seeking discovery is required in the
first instance to establish relevance. Once that has been done, prima facie the
documents may be considered to be necessary. Thus, Clark C.J. recently noted in
“7.16 Having regard to the importance which discovery can play in at least some
cases, it should, in my view, remain the case that the default position should be that
a document whose relevance has been established should be considered to be one
whose production is necessary. However, that remains only a default position and
one which is capable of being displaced for a range of other reasons.”
16. While Order 31 rule 12 applies equally to all civil proceedings, including of course
judicial review, it has often been said that the necessity for discovery in judicial
review proceedings is rare and the exception rather than the rule – see for example
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Sheehy v. Ireland (High Court Unreported 30th of July, 2002, Kelly J.). This is for the
reason that in judicial review, decisions of public bodies are challenged on purely
legal grounds and disputes of fact are uncommon. The merits of the decision are
irrelevant to a consideration of whether it has been made lawfully. In Barbara Flynn
v. Charities Regulatory Authority [2018] IEHC 359, Reynolds J. summarised the
principles applicable to discovery in judicial review proceedings, including the
following:
“(e) generally, the only instance in which discovery may be necessary or
appropriate is where the court is required to resolve a conflict on the evidence
is set out on affidavit;
(f) in considering whether such an unavoidable conflict of evidence must be
resolved by way of discovery, such a factual dispute must be based on
substance and on evidence provided by the applicant;”
17. It is important to bear in mind that in judicial review proceedings, as in all other
proceedings, the concept of relevance relates to the issues as defined in the pleadings
rather than being simply relevant to the underlying decision under challenge – see
Clark J. (as he then was) noted in MacAodháin v. Ireland and the Attorney General
[2012] 1 IR 430 at paragraph 14:
“... It seems clear that in judicial review proceedings it is important, when
considering relevance, to identify how the document concerned can be relevant
to the specific types of issues which will arise in the relevant judicial review
application rather than being relevant to the substantive questions which were
before the decision-maker.”
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18. In R v. Secretary of State for Health ex parte Hackney London Borough (Unreported
Court of Appeal 24 July 1994), Sir Thomas Bingham M.R., delivering the judgment
of the Court of Appeal of England and Wales said (at p. 9):
“The basic approach is that discovery and production will be ordered in judicial
review proceedings where they are necessary for disposing fairly of the
application but not otherwise... I think it is probably true to say that discovery
will be regarded as necessary for disposing fairly of the action, or application,
if a party raises a factual issue of sufficient substance to lead the court to
conclude that it may, or will, be unable to try the issue fairly, fairly that is to all
parties, without discovery of documents bearing on the issue one way or the
other... It is not open to a plaintiff in a civil action, or to an applicant for
judicial review, to make a series of bare unsubstantiated assertions and then
call for discovery of documents by the other side in the hope that there may
exist documents which would give colour to the assertions of the applicant, or
the plaintiff, which he is otherwise unable to begin to substantiate.”
19. This judgment was subsequently approved in this jurisdiction in Carlow Kilkenny
Radio Ltd v. Broadcasting Commission of Ireland [2003] IR 528 and Barry v. The
Governor of the Midlands Prison [2018] IEHC 713. Bingham M.R. went on to note
that the courts are averse to granting orders designed to find out whether mere
assertions have any basis in fact. For example, it is not open to an applicant to make
an assertion, unsupported by any evidence, that certain matters were or were not
taken into account by the decision-maker and then seek discovery to find out what
was in fact taken into account.
20. In the course of argument, counsel for Arthropharm relied on the provisions of
Regulation (EC) No. 1049/2001, more commonly known as the Transparency
Regulation, as it applies to the European Medicines Agency (EMA) and a number of
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European decisions considering its application to the EMA. The Transparency
Regulation is most closely analogous in domestic law to the freedom of information
legislation and accordingly the European decisions considering it do not seem to me
to be of great assistance in the context of a discovery application before a national
court. Insofar as the applicant suggests that the Transparency Regulation somehow
modifies the legal principles applicable to a discovery application, I cannot accept
that proposition, being as it is one for which there is no authority.
Discussion
21. The first issue therefore to be considered is whether Arthropharm has established that
the documents sought in each of the categories are relevant to the issues defined by
the pleadings. The fundamental case advanced by Arthropharm is that Osteopen is
not a generic of Cartrophen. If it is right about this, then HPRA concedes that the
application should not have been considered under article 13 (1) but rather 13 (4).
Arthropharm says that its many experts have from their analysis of the actual product
reached the conclusion that Osteopen is not in fact a generic of Cartrophen. This is a
matter of scientific opinion and of law. It is not a dispute of fact. The applicant’s
experts do not require discovery of any documents to reach a conclusion that they
have already arrived at.
22. In reality, it seems to me that there are no facts in dispute in this matter which require
discovery to enable them to be resolved. Certainly Arthropharm has not pointed to
any. Rather it is said that it requires discovery because without it, it cannot determine
the manner in which the decision under challenge was made. As the authorities to
which I have already referred make clear, that is not a permissible use of discovery
but rather is a classic fishing expedition. In any event, this complaint has been
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overtaken by the subsequent affidavit of Dr. Beechinor which makes clear the
matters to which HPRA had regard in arriving at its decision. The complaint about
failing to take relevant matters into account relates to an alleged failure by HPRA to
take differences in the manufacturing processes of PPS by different manufacturers
into account. But HPRA says it had no legal obligation to take that into account and
did not do so. There is thus no dispute of fact arising which requires discovery,
merely an issue of law.
23. In arguing for discovery in this case, Arthropharm contends that the standard of
review to be applied by the court in challenges to decisions of national competent
authorities implementing European directives is that of “manifest error” and that the
court will not be in a position to determine whether such error was made without the
benefit of discovery. Whether that is the relevant standard or not, and in that regard I
do not find it appropriate or necessary in this discovery application to determine that
issue, it is clearly not part of the case pleaded by Arthropharm. As such, it cannot
therefore form a basis for ordering discovery. However, even if manifest error had
been pleaded, I would still reach the same conclusion by analogy with the authorities
on unreasonableness or irrationality. Thus in Carlow Kilkenny Radio Ltd, Geoghegan
J. said (at p. 533):
“Therefore, in so far as any case is being put forward on the basis of
unreasonableness or irrationality, it would be wrong to make an order for
discovery as discovery would be nothing more than a fishing exercise. That has
always been forbidden by the courts irrespective of whether the discovery is
sought in plenary proceedings or in judicial review proceedings. On the other
hand, insofar as procedural misconduct is alleged, that issue can be litigated
without discovery of documents. In the written submissions, counsel for the
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respondent cited in this connection the passage from the judgment of Carswell
J. in Re Glor na Gael’s Application [1991] N.I. 117 which made clear that an
order for discovery of documents concerning the issue of unreasonableness in
relation to the manner in which a decision had been reached would not be made
unless there was material which indicated that the evidence put before the court
was inaccurate or false.”
24. Similarly, in McEvoy v. An Garda Siochana Ombudsman Commission [2015] IEHC
203, McDermott J. expressed the view (at para 25):
“If a decision is challenged as unreasonable or irrational, discovery will not be
necessary because, if the decision is clearly wrong, it is not necessary to
ascertain how it was reached.”
25. It therefore seems to me that Arthropharm has failed to demonstrate the relevance of
the documents sought in any category. In addition to that overarching consideration,
with regard to category 1, Arthropharm advances the reason that discovery of
documents in this category is required because no adequate reasons were given by
HPRA for concluding that Chanelle demonstrated essential similarity as between
Osteopen and Cartrophen. A failure to give reasons is purely a matter of law and
accordingly, discovery cannot be relevant or necessary. As regards category 2,
Arthropharm’s case is that its experts have concluded that both Osteopen and
Cartrophen are biological products and if that is correct, HPRA accepts that the
article 13 (1) procedure is not appropriate. There is thus no necessity for discovery.
26. As I have noted, category 3 is in effect covered by category 1. Here again,
Arthropharm’s experts have concluded that the two products are not bioequivalent
and discovery is therefore not necessary. The same considerations apply to category
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4. The request for category 5 equally fails on relevance grounds but in any event, Dr.
Beechinor has sworn on affidavit that HPRA has no documents in this category.
27. Even if Arthropharm’s discovery application did not fail on grounds of relevance, it
is clear from the voluminous expert evidence adduced by it on the central issues in
the case that the documents sought are not necessary for it to be in a position to fairly
present its case. This is an important point of distinction between this and the public
procurement cases relied upon by Arthropharm. These concerned the circumstances
in which documents which are confidential and commercially sensitive should be the
subject of an order for discovery. In the instant case, this arose in the context of the
argument by HPRA that even if the documents sought were considered to be relevant
and necessary, their disclosure should not be ordered because they contain
confidential and commercially sensitive information concerning not only Osteopen
but also the PPS manufacturer whose identity is protected.
28. In Word Perfect Translation Services Ltd v. the Minister for Public Expenditure and
Reform (No. 2) [2018] IECA 87, the applicant was the unsuccessful tenderer for a
public service contract and sought discovery of the successful tender which was
resisted on the grounds of commercial confidentiality. Hogan J. delivered the
judgment of the Court of Appeal and noted that where documents are relevant,
confidentiality in itself does not preclude discovery. An obvious tension arose
between the need to protect the confidentiality of the commercial tender on the one
hand and the ability of a disappointed tenderer to meaningfully challenge the process
on the other. Hogan J. noted (at p. 9):
“Rather, the critical point is that without access to the tender documentation a
disappointed tenderer might in some instances never be in a position to
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advance a case of manifest error or to contend that there was some other
significant flaw in the assessment process. One might equally say that in such
circumstances the right to challenge the tender award on these grounds – itself
a key aspect of the rule of law and the fair operation of the procurement
process – would remain illusory.
All of this means is that access to a rival’s tender documentation via the
discovery process is not just governed simply by the standard requirements of
relevance and necessity. Rather, the case for discovery of this documentation
must be convincingly established as indispensable for the fair disposal of the
procurement challenge.”
29. These views were echoed by the Supreme Court on appeal (at [2019] IESC 38) at p.
11:
“It is apparent that there are real difficulties here. An unsuccessful party cannot
be permitted to gain access to the full tender of the successful party simply by
alleging that the marks awarded to the latter are too high and constituted a
manifest error. But as long as that is a viable ground for challenge, it is difficult
to see how it can be advanced without sight of the tender, particularly where
the reasons given are limited. It may be that if more detail is given in the
reasons letter, that would mean that discovery would not require to be ordered
unless the challenger could make a convincing case from the reasons that a
manifest error could be in principle identified from the existing material.”
30. This stands very much in contrast to the situation here, where the applicant has had
unfettered access to the product itself which it has subjected to extensive scientific
analysis and assessment and was not, and had no right to be, a participant in the
process that led to the grant of the MA. Both the Court of Appeal and Supreme Court
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identified the requirement for the applicant for discovery to establish a convincing
case for the necessity for discovery of commercially sensitive documents. The
evidence as a whole in this application satisfies me that the documents of which
discovery is sought are commercially sensitive. As such, even if the applicant had
established that they are relevant and necessary, the court would be required to
consider the proportionality of an order for discovery. Thus in Independent
Newspapers (Ireland) limited v. Murphy [2006] 3 IR 566 Clarke J. (as he then was)
observed (at p. 572):
“I am satisfied that the court should only order discovery of confidential
documents (particularly where the documents involve the confidence of a
person or body who is not a party to the proceedings) in circumstances where it
becomes clear that the interests of justice in bringing about a fair result of the
proceedings require such an order to be made…”
31. In my view, apart from any issues of relevance, Arthropharm has not established a
convincing case that the discovery sought is necessary for the fair disposal of the
case.
Conclusion
32. For the reasons I have explained, Arthropharm has not discharged the burden of
establishing either the relevance or necessity of the documents in respect of which
discovery is sought but even if that were not so, the application of the requirement
for proportionality in orders for discovery militates against the making of an order in
this case. I will therefore refuse this application.
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