Hyaltech Limited For Judicial Review Of A Final Determination Of The Secretary Of State For Health
| Jurisdiction | England & Wales |
| Judge | Lord Macphail |
| Neutral Citation | [2007] CSOH 84 |
| Court | Court of Session |
| Docket Number | P818/06 |
| Date | 15 May 2007 |
| Published date | 15 May 2007 |
Opinion of Lord Macphail
In the petition of
Hyaltech Limited, Petitioners
for
Judicial Review of a decision of the Medicine and Health Products Regulatory Agency
15 May 2007 Summary
This application for judicial review concerns a decision of the Medical and Health Products Regulatory Agency ("MHRA"). Hyaltech Limited ("the company") manufactures a product called VisThesia, which they consider to be a medical device. The MHRA, however, determined that it was a medicinal product and required the company to stop selling and supplying it. A Review Panel appointed by the MHRA concurred that VisThesia was a medicinal product.
Lord Macphail decided that the reasons given by the Review Panel were sufficient for their purpose and that the MHRA had not made any error of law in their interpretation of the relevant regulations. The petition was therefore refused.
Hyaltech Limited manufacture in Scotland a product named "VisThesia" which is designed to facilitate intraocular surgery to remove a cataract and implant a prosthetic lens. The product includes a solution called "VisThesia Topical".
The sale and distribution of medical products and medical devices for human use are governed in the United Kingdom by regulations which implement European Community Directives. Manufacturers must obtain the grant of a marketing authorisation from the UK Licensing Authority, the Secretary of State for Health, who acts through the MHRA.
The company considered that VisThesia Topical was a medical device. The MHRA, however, provisionally determined that it was a medicinal product. A Review Panel appointed by the MHRA in accordance with the relevant regulations considered representations from the company and from the MHRA and advised the MHRA that it was a medicinal product. The MHRA then made a final determination that it was a medicinal product and they required the company to stop selling and supplying it. The company applied to the Court of Session for judicial review of that determination, and the MHRA conceded that the determination should be reduced because it had not been supported by proper reasons. Thereafter the MHRA, without obtaining further advice from the Review Panel, issued a second final determination to the same effect as the first, but on this occasion they gave reasons.
The company then applied to the Court of Session for judicial review of the second final determination. They maintained that if they were to be prohibited from selling and supplying VisThesia from the UK, they would only be able to sell and supply it in other member States of the European Union in which VisThesia has been classified by the national licensing authorities as a medical device. They argued, first, that the Review Panel had failed to provide the MHRA with proper and adequate reasons for their advice. Secondly, they argued that in reaching their second final determination the MHRA had made errors of law, had taken into account irrelevant considerations and had failed to take account of relevant considerations.
Summary of Lord Macphail's Opinion in relation to the MHRA's decision:
· Lord Macphail held, first, that although the reasons given by the Review Panel had been briefly expressed, they had been sufficient for the purposes of the MHRA, and the company had been able to understand them.
· Secondly, his Lordship held that the MHRA had not made any error of law in the interpretation of the relevant regulations. He found that they had misunderstood passages in the US patent for the product now called VisThesia, and a sentence in a letter from a medical expert. He concluded, however, that the company had failed to demonstrate that the MHRA had erred in any other respect, and that these errors had not vitiated their determination. Lord Macphail therefore refused the petition.
NOTE
This summary is provided to assist in understanding the Court's decision. It does not form part of the reasons for that decision. The full report of the Court is the only authoritative document.
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| OUTER HOUSE, COURT OF SESSION [2007] CSOH 84 | |
| P818/06 | OPINION OF LORD MACPHAIL in the Petition of HYALTECH LTD Petitioners; for Judicial Review of a Final Determination of the Secretary of State for Health as the UK Licensing Authority established by section 6 of the Medicines Act 1968, acting by The Medicines and Healthcare Products Regulatory Agency Respondents: ________________ |
Petitioners: Cormack, Solicitor Advocate; McGrigors
Respondent: Brodie; Office of the Solicitor to the Advocate General
15 May 2007
Introduction
[1] The petitioners manufacture in Scotland a product named "VisThesia" which is designed to facilitate intraocular surgery for the removal of a cataract and the implantation of a prosthetic lens. The product includes a solution called "VisThesia Topical" which is intended to be applied to the surface of the eye. It contains a viscoelastic product, sodium hyaluronate, and an anaesthetic agent, lidocaine hydrochloride ("lidocaine").
[2] The sale and distribution of medicinal products and medical devices for human use are governed in the United Kingdom by regulations which implement European Community Directives. Manufacturers require to obtain the grant of a marketing authorisation from the European Commission or the UK Licensing Authority. The UK Licensing Authority is the Secretary of State for Health who acts through an executive agency of the Department of Health known as The Medicines and Healthcare Products Regulatory Agency ("the MHRA"). Where a question arises as to whether a particular product should be classified as a medicinal product or a medicinal device, the MHRA may serve on the manufacturer a "provisional determination notice" informing him that they are minded to determine that the product is "a relevant medicinal product". The manufacturer may make oral representations to a Review Panel at a hearing at which the MHRA may also make oral representations. The Review Panel then give advice to the MHRA who, having considered the advice, determine whether or not the product is a relevant medicinal product.
[3] In the present case the MHRA served on the petitioners a provisional determination notice informing them that they were minded to determine that VisThesia Topical was a relevant medicinal product. The petitioners contended that it was a medical device. The matter proceeded to a Review Panel who, after hearing oral representations from the petitioners and the MHRA, advised the MHRA that VisThesia Topical was not a medical device but a relevant medicinal product. The MHRA thereafter served on the petitioners a notice ("the first final determination") that they had determined on behalf of the licensing authority that VisThesia was a relevant medicinal product and that it required the petitioners to cease the sale and supply of VisThesia with immediate effect. They did not state any reasons for their determination. The petitioners applied to this Court for judicial review of that determination. It was conceded that the determination should be reduced. Thereafter the MHRA issued a further notice ("the second final determination") which advised the petitioners that they had made a determination and requirement in the same terms as the first. Unlike the first, the second final determination was accompanied by a statement of reasons.
[4] The petitioners now apply for judicial review of the second final determination. The respondent is the Secretary of State for Health acting by the MHRA. Shortly stated, the petitioners rely on two grounds. The first is that the Review Panel failed to provide the MHRA with proper and adequate reasons for their advice. The second is that alternatively and in any event the second final determination should be reduced because it is ultra vires in respect that the MHRA made material errors of law, took irrelevant matters into account and failed to take relevant matters into account. The petitioners accordingly seek, first, declarator that the respondent made the decision to make the second final determination without having proper advice from the Review Panel, in an unfair manner and in a manner which was contrary to the petitioners' legitimate expectations. They also seek declarator that the second final determination is ultra vires, reduction of that determination, and suspension of the notice given in the notice of final determination.
[5] A common theme in both grounds is the interpretation of the expression "medical device" in the relevant Regulations. It is there defined as including devices which, among other things, incorporate as an integral part a substance which, if used separately, would be a medicinal product and "which is liable to act upon the body with action ancillary to that of the device." The principal issue between the parties in relation to interpretation is whether the lidocaine, the anaesthetic agent in the solution, is liable to act upon the body "with action ancillary to" that of the VisThesia Topical. If it is liable so to act, as the petitioners maintain, VisThesia Topical should be classified as a medical device,. If it is not so liable, as the MHRA maintain, VisThesia should be classified as a relevant medicinal product. The practical significance of the matter for the petitioners is that they claim that if they are to be prohibited from selling and supplying VisThesia from the UK, they will only be able to do so in other Member States of the European Union in which VisThesia has been classified by the national licensing authorities as a medical device.
The regulatory framework
[6] The marketing of medicinal products and the marketing of medical devices are regulated by two separate regimes, each derived from...
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