Hygeia Chemicals Ltd v Irish Medicines Board

• Jurisdiction: Ireland
• Judge: Finnegan P
• Judgment Date: 04 May 2005
• Neutral Citation: [2005] IEHC 226
• Court: High Court
• Docket Number: NO. 32 J.R./2003
• Date: 04 May 2005

HYGEIA CHEMICALS LTD v IRISH MEDICINES BOARD

HYGEIA CHEMICALS LIMITED

APPLICANT

AND

IRISH MEDICINES BOARD

RESPONDENT

[2005] IEHC 226

NO. 32 J.R./2003

THE HIGH COURT

LICENSING

Revocation of licence

Natural justice - Administrative body - Fair procedures - Licensing authority for veterinary products - Suspension of product authorisation - Bias - Prejudgment -Estoppel - Whether procedures complied with natural justice - Whether requirements of natural justice varied for administrative body - Whether applicant estopped from raising objections to procedures - Whether decision vitiated by bias - Whether decision to suspend authorisation proportionate -Corrigan v Irish Land Commission [1977] IR317; Frenchurch Properties Ltd v Wexford County Council [1992] 2 IR 268; O'Donoghue v Veterinary Council [1975] IR398 and O'Neill v Irish Hereford Breeds Society Ltd [1992] 1 IR 431 considered -Radio Limerick One Ltd v Independent Radio and Television Commission [1997] 2 IR 291applied - Irish Medicines Board Act 1995 (No29 ), s 8 (8) - Animal Remedies Regulations1996 (SI 179/1996), reg 19 - Council Directive 2001/82/EC - Judicial review refused (2003/32JR - Finnegan P - 4/5/2005)[2005] IEHC 226

Hygeia Chemicals Ltd v Irish MedicinesBoard

Facts: the applicant's product was determined by the respondent not to comply with certain specifications which would allow it be marketed in the State. The applicant was informed that it could appeal that decision to an appeal committee of the respondent which included amongst its members, a person who had taken part in the initial decision. The applicant also complained that it had not been afforded the opportunity of examining reports and other material relied on by the respondent in coming to its decision, to prepare its appeal and that there were no written procedures for the appeal and was carried on in ad hoc manner. The applicant also complained that the respondent took ultra vires matters into consideration. The respondent raised as a preliminary issue that the applicant was estopped from raising its objections due to acquiescence in the procedures complained of.

Held by Finnegan P in refusing the relief sought but holding the applicant was not estopped from raising objections to the procedures adopted by the respondent that the time constraints with which the applicant was faced in relation to the appeal were relevant to determining the objection on grounds of estoppel. There was no acquiescence on the part of the applicant in the stipulated procedures.

That the fact that there were no standing orders or other written appeal procedures did not represent a defect provided the procedures actually adopted were fair and notified.

That the appeal was not an inter partes process and there was a significant difference between a complainant and an expert statutorily authorised to advise and that in the circumstances, the expert's involvement in the administrative process would not disqualify him from partaking in the ultimate decision. In all the circumstances, the procedures adopted were sufficient and appropriate.

That the evaluation of risks associated with the applicant's product was a matter for the respondent and the court, on a judicial review, would not act as a forum for an appeal and, provided there was evidence which if accepted would justify the decision of the respondent, would not interfere.

Reporter: P.C.

REPORT OF THE COMMITTEE ON TOXICITY OF CHEMICALS IN FOOD COMSUMER PRODUCTS & THE ENVIRONMENT 1999

ANIMAL REMEDIES REGS 1996

SI 179/1996 REG 19EC DIR 2001/82I

RISH MEDICINES BOARD ACT 1995 S4

EEC DIR 65/65

HEALTH ACT 1947

EEC DIR 2309/93

EEC DIR 81/851

IRISH MEDICINES BOARD ACT 1995 S9(8)

IRISH MEDICINES BOARD ACT 1995 S9(5)

EC DIR 2001/82 ART 94

ANIMAL REMEDIES REGS 1996 SI 179/1996 REG 5

CORRIGAN v IRISH LAND COMMISSION 1977 IR 317

IRISH MEDICINES BOARD ACT 1995 S8(8)

IRISH MEDICINES BOARD ACT 1995 S9(2)

FREN CHURCH PROPERTIES LTD v WEXFORD CO COUNCIL 1992 2 IR 268 1991 ILRM 769

EC DIR 2001/82 ART 83.1(a)

EC DIR 2001/82 ART 1.6

EC DIR 2001/82 RECITAL 2

EC DIR 2001/82 ART 83 SCHEDULE PART III ART 6.4

REPORT OF THE VETERINARY PRODUCTS COMMITTEE (UK) ON OP SHEEP DIPS 1999

RADIO LIMERICK ONE LTD v INDEPENDENT RADIO & TELEVISION COMMISSION (IRTC) 1997 2 IR 291 1997 2 ILRM 1

O'DONOGHUE v VETERINARY COUNCIL 1975 IR 398

O'NEILL & BOVA GENETICS LTD v IRISH HEREFORD BREED SOCIETY LTD 1992 1 IR 431 1991 ILRM 612

SIAC CONSTRUCTION LTD v MAYO CO COUNCIL 2002 3 IR 148 2002 2 ILRM 401

UPJOHN LTD v LICENSING AUTHORITY 1999 1 WLR 927 1999 1 CMLR 825

MATRA v COMMISSION OF THE EUROPEAN COMMUNITIES 1993 ECR 1 3203

R v MEDICINES CONTROL AGENCY EX PARTE PHARMA NORD (UK) TLR 10/6/1998

1 Judgment of Finnegan P. delivered on the 4th day of May 2005

Facts

2 The Applicant is the producer of chemical products. In respect of two sheep dip products Hygeia Winter Dip and Hygeia Summer Dip it holds Veterinary Product Authorisations granted for a period of five years from 1st October 1999 the Schedule to the Authorisations having been varied on the 14th March 2001. The products are liquid organophosphate - based (hereafter OP) sheep dips. The products contain 10% diazinon and are sold in plastic containers. To use the products the container is unscrewed and the product poured into the sheep dip bath.

3 For some time there has been a concern that exposure to OP can result in neurological, psychological and psychiatric health effects in humans. It is fair to say that the reports referred to in the course of this hearing are not fully conclusive as to the effects of OP. However the Report of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment of November 1999 ("The COT Report") justifies the concern in relation to acute poisoning and to a much lesser extent in relation to prolonged low level exposure.

4 The Respondent (hereafter "IMB") requested the Liaison Committee on Organophosphate Veterinary Concentrates to the Veterinary Advisory Committee of the Irish Medicines Board to review the COT Report and other relevant Reports and scientific articles in relation to OP concentrated solutions intended for veterinary use, to evaluate what changes if any were necessary to OP concentrates intended for veterinary use, their containers, labelling and health and safety literature based on the scientific findings and the control mechanisms for the supply of OP concentrated solutions intended for veterinary use. The Liaison Committee reported on the 21st March 2000 and dealt with containers for OP product as follows -

"The Committee noted that current containers meet the current requirements under the Carriage of Dangerous Goods by Road (Regulations) 1999 as drafted for transport of dangerous liquids. The Committee noted that considerable variation existed in the type and size of containers marketed in Ireland. However no uniform standard for design specifications of OP concentrate containers for veterinary use appear to be available. The reported practice among some farmers to transfer concentrate to other smaller receptacles, thereby increasing the risk of exposure, appears to have diminished through the provision of small volume containers. The Committee felt that more specialised expertise was necessary to define any new standard for these containers. These specifications would in any event take time to elaborate and products would have to demonstrate stability in any new container."

5 The following attributes would be desirable for such containers -

6 Durable to survive handling, storage and transport from the manufacturer through to farmer.

7 Capable of being opened while wearing the recommended gloves.

8 Where a handle is provided it should be offset from the spout, to minimise operator contact. It was suggested that a handle would be necessary for handling products greater than one litre.

9 Have a wide spout opening to avoid glugging.

10 Have a spout which would extend and not allow the fluid to dribble and to pool on the top surface.

11 A closed system of delivery was considered by the Committee as an alternative, but it was acknowledged that there were many practical problems associated with this option. It was noted that there is no generically available system. Many of the simpler closed systems would lead to exposure to the operator at the point of setting up or dismantling or would not give the necessary control for the performance needed or would have a potential for misuse.

12 Attempts to improve existing containers through the provision of a screw top tap for insertion on to the product containers had proved unsuccessful due to cross threading and tap leakage. Other possibilities for ensuring the integrity of the concentrate such as the use of alginates were rejected on the basis of design failures and the need to have a product capable of use at different concentrations to fulfil the requirements for differing initial and replenishment loads which are needed to meet the so called stripping characteristics of the product".

13 The Committee among its recommendations made the following -

"That the containers in which OP concentrates are supplied for veterinary use be kept under review by the Irish Medicines Board in the light of national and international developments and that all authorised products should comply with any new standards".

14 The Advisory Committee on Veterinary Medicine of the I.M.B. endorsed the Report of the Liaison Committee on the 15th March 2001. On the 19th November 2001 the I.M.B. wrote to the Applicant and having referred to the recommendation of the Liaison Committee said -

"The I.M.B. is aware that new standards in delivery systems have been developed or are currently under development by a...