Hyaltech Limited for Judicial Review of a Decision of the Medicines and Healthcare Products Regulatory Agency [2008] CSIH 64

Wed, 10 Dec 2008 07:30:00 GMT

Reclaiming Motion:- In 2002, a question arose whether Topical and Intracameral should be classified as medicinal products or as medical devices in terms of United Kingdom regulations implementing European Community Directives. If the correct classification was "medicinal product", Hyaltech would have to cease marketing the product pending clinical tests, investigations, and the grant of the relevant licence. If, however, the correct classification was "medical device", all the regulatory procedures had been complied with and Hyaltech could continue marketing the product without further procedure. The licensing authority in the United Kingdom was the Medicines and Healthcare Products Regulatory Agency. The MHRA accepted that Intracameral was a medical device which did not require a licence. However, they formed the view that Topical was a medicinal product requiring a licence. Hyaltech disagreed and both parties entered into a dispute procedure. The case was considered by a review panel on borderline products who held that Topical was properly classified as a medicinal product and did not include any view on Intracameral, as the panel did not have to consider its classification. The MHRA considered the Advice issued by the review panel, together with other material. They issued a final determination dated 21 December 2004, categorising Topical as a medicinal product, and instructing Hyaltech to cease production until the necessary clinical tests had been carried out and a licence obtained. Hyaltech sought judicial review on inter alia that ground. The determination was reduced by consent. The MHRA then issued a second final determination dated 31 March 2006. Hyaltech sought judicial review and reduction of that second determination, submitting that the review panel had failed to provide proper and adequate reasons in their Advice thus leaving the MHRA without adequate guidance when reaching their determination. Hyaltech further submitted that the determination was ultra vires as the MHRA had made material errors of law, taken irrelevant matters into account, and left relevant matters out of account. A debate took place before Lord Macphail and on 15 May 2007, he refused the petition. Hyaltech reclaimed. It was submitted on behalf of Hyaltech that the Lord Ordinary had erred in failing to hold that the MHRA had acted ultra vires by making material errors of law, in particular errors in construction, and errors by taking irrelevant matters into account and leaving relevant matters out of account. Counsel for the MHRA moved the court to refuse the reclaiming motion and to adhere to the interlocutor of the Lord Ordinary.

Regulation

Hyaltech Limited for Judicial Review of a Decision of the Medicines and Healthcare Products Regulatory Agency [2008] CSIH 64