The Supreme Court has upheld a decision requiring PCO Manufacturing Ltd’s dispute with the Irish Medicines Board over alleged delays in approving medicinal products to proceed as a single full High Court hearing.
PCO had complained that the Board was taking too long to determine applications for product authorisations and renewals. In November 1998, it had 52 applications outstanding: 32 for product authorisations and 20 for renewals.
The company obtained permission to bring judicial review proceedings seeking orders directing the Board to determine the outstanding applications and provide an expedited procedure. It also alleged that the Board had breached its duties as the competent medicines authority.
As the case progressed, the outstanding applications were dealt with. PCO then expanded its damages claim, alleging lost profits of £635,523 arising from delays involving 16 products and the initial failure to authorise another four.
PCO asked the High Court to decide the judicial review issues first and leave damages for a later hearing. The Board instead sought a full plenary hearing, meaning a conventional trial with oral evidence and cross-examination. Mr Justice Kelly ordered the entire case to proceed that way and declined to split the issues.
PCO appealed that procedural decision.
Mr Justice Francis D Murphy, delivering the Supreme Court judgment, said the central remaining issue was whether the Board had been guilty of delay and, if so, whether PCO itself contributed to it. Resolving that question would require detailed examination of how individual applications were processed, together with oral evidence, discovery and potentially other pre-trial procedures.
The court found that damages would probably require some of the same witnesses to be recalled. It was therefore not satisfied that separate hearings would produce significant savings in court time or costs.
The Supreme Court also confirmed that the High Court had inherent power to direct judicial review proceedings to continue as a plenary action where the nature of the dispute required it.
The appeal was dismissed and Mr Justice Kelly’s order was affirmed.