The High Court refused Arthropharm (Europe) Limited’s application for discovery of documents from the Health Products Regulatory Authority (HPRA) in its judicial review challenge to the approval of Chanelle Pharmaceuticals Manufacturing Limited’s veterinary medicine, Osteopen.
Mr Justice Noonan delivered the judgment on 30 August 2019. Arthropharm sought five categories of documents concerning HPRA’s assessment of whether Osteopen was a generic of Cartrophen, a product Arthropharm manufactures for treating arthritis in dogs. The company also sought documents about whether the products were biological medicines, the decision to waive bioequivalence evidence, product composition and a benefit-risk assessment.
HPRA granted Chanelle a marketing authorisation for Osteopen on 20 July 2018 under an EU procedure for generic medicines. The authority’s publicly available assessment report identified Cartrophen as the reference product and said in vivo bioequivalence data had been omitted on the basis of essential similarity between the formulations.
Arthropharm alleges that Osteopen is not a generic of Cartrophen. It says differences in how the products’ active ingredient, pentosan polysulfate sodium, is manufactured result in differences in potency and toxicity, and that the products are biological medicines requiring a different assessment. After submitting objections and expert material, Arthropharm asked HPRA to revoke the authorisation. HPRA declined in March 2019. These remain claims in the underlying judicial review; the discovery judgment did not decide whether they are correct.
The judge said the central dispute was one of scientific opinion and law, not a factual conflict requiring documents to resolve it. Arthropharm’s experts had already reached conclusions based on analysis of the products, and the court said discovery could not be used to find out how HPRA made its decision. It also noted that an HPRA director’s affidavit clarified what the authority had considered, and that HPRA said it had no documents in the requested category concerning a benefit-risk assessment.
The court held that Arthropharm had not established the relevance or necessity of the requested documents for the issues pleaded. It also found no convincing case that disclosure of commercially sensitive material was necessary for fair disposal of the proceedings. The court refused the discovery application. The judgment addresses that application only; it does not determine the substantive judicial review challenge to the marketing authorisation.