Arthropharm (Europe) Ltd v The Health Products Regulatory Authority
| Jurisdiction | Ireland |
| Court | High Court |
| Judge | Mr. Justice Noonan |
| Judgment Date | 30 August 2019 |
| Neutral Citation | [2019] IEHC 629 |
| Docket Number | RECORD NO. 2018/1080JR |
| Date | 30 August 2019 |
[2019] IEHC 629
THE HIGH COURT
Noonan
RECORD NO. 2018/1080JR
Discovery – Relevance – Proportionality – Applicant seeking discovery of five categories of documents – Whether the applicant had discharged the burden of establishing either the relevance or necessity of the documents in respect of which discovery was sought
Facts: The applicant, Arthropharm (Europe) Ltd, applied for discovery, in judicial review proceedings against the respondent, the Health Products Regulatory Authority (HPRA), of five categories of documents: (a) all documents concerning HPRA’s consideration of whether the veterinary pharmaceutical product known as Osteopen is a generic of the similar product known as Cartrophen including the dossier submitted by the notice party, Chanelle Pharmaceuticals Manufacturing Ltd, and any documents from the Cartrophen file that were considered; (b) all documents considered regarding whether Osteopen or Cartrophen are biological products; (c) all documents considered in deciding to exempt Chanelle from demonstrating bioequivalence; (d) all documents concerning the specification for the Pentosan Polysulfate Sodium used and comparative analysis of product composition submitted by Chanelle in respect of Osteopen and Cartrophen; and (e) all documents concerning the benefit/risk assessment carried out by HPRA between 20 July 2018 and 6 March 2019.
Held by the High Court (Noonan J) that Arthropharm had not discharged the burden of establishing either the relevance or necessity of the documents in respect of which discovery was sought but even if that were not so, the application of the requirement for proportionality in orders for discovery militated against the making of an order in this case.
Noonan J held that he would refuse the application.
Application refused.
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.
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.
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 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.
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.
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.’
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 vivobioequivalence 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.
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).
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 were sent to HPRA on 13 December 2018 in support of Arthropharm's original objection.
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.
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.
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 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.
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....
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