A high court judge yesterday said that the Irish Medicines Board (IMB) should contact its counterparts in Northern Ireland and in the UK about a medicinal product, Skin-Cap, which was the subject of a public health warning in the State last month.
Mr Justice Kelly made a number of orders against Mr Patrick Bruen, of Drumshanbo, Co Leitrim, a manufacturing agent trading as Swiss Laboratories, Brentford plc, Skin-Cap Ltd and Skin-Cap (Northern) Ireland Ltd.
Mr Bruen was the subject of a temporary High Court order last month, which restrained him from marketing, importing, selling or distributing an unauthorised and unlicensed medicinal product known as "Skin-Cap".
An earlier court hearing was told by Mr John Lynch, the IMB's director of inspection, that the Department of Health and Children had been notified in June 1997 of a mail order advertisement in a Sunday newspaper, on behalf of Swiss Laboratories, which promoted a spray to treat the medical condition of psoriasis.
Mr Lynch said that that the IMB was notified by a number of countries that the product had been found to contain a potent steroid which was not declared or disclosed. The IMB's senior assessors had informed him that there were risks associated with unsupervised medical use of this steroid. A public health warning had been issued by the authorities.
Yesterday, Mr Eamon Marray, for the IMB, said that the High Court had been told previously that, so far as its investigations showed, the companies did not exist.
In an affidavit, Mr Bruen said that in May 1997 he had been managing director of Brentford plc, a company registered in the UK, which took the agency for Skin-Cap. It had been represented to him by the manufacturers, a Spanish company, that the product was a cosmetic and not a medicine, and that it was a first of its kind in that it treated psoriasis without the use of steroids.
Mr Bruen referred to a letter from the National Psoriasis Foundation, an American organisation, of August last year which, he said, confirmed the false and misleading representations made to him by the manufacturer.
Mr Justice Kelly said the letter stated that the active ingredient in the product had "no history as an effective psoriasis treatment". He added that the letter appeared to be torpedoing Mr Bruen's product.
Mr Bruen said that the first formal notice he received of the existence of a steroid in the product was from the UK Medicine Control Agency last January, when he ceased to market or distribute the product. He had not known that the product required a licence.
The stock was now out of the State and was being stored at Weathern Field, Linton, Swadlin Cote, in the UK. About 300 orders for the product had been received.
He said Brentford had imported 6,000 cans of Skin-Cap spray and 600 tubes of Skin-Cap cream. There were about 3,400 clients and about 1,500 units were at the UK store.
Mr Marray said that the Irish authorities had contacted the UK authorities and were checking out the Swadlin Cote address. So far as the IMB was concerned, Mr Bruen was still in "constructive possession" of the product.
The IMB estimated that 6,700 units of the product had been imported; 5,334 units were accounted for, leaving 1,366 units unaccounted for. Court orders had been made last month restraining Mr Bruen from disposing of the product, but to date he had not disclosed how or when the stock had left the jurisdiction.
Mr Marray said that Mr Bruen had referred to an individual who had taken control of Skin-Cap (Northern) Ireland. This suggested to the IMB that this individual might be selling into this part of Ireland. The board would require the identity of this person.
Mr John McCoy, for Mr Bruen, said he had advised his client to co-operate fully with the court. Of the 6,700 units imported, about 700 had been free samples.
Mr Justice Kelly continued the temporary restraining order for one week and said Mr Bruen should swear an affidavit naming persons in the North engaged in the distribution of the product. He said the IMB should communicate with colleagues in the North because the product should not be available in the North or South or in the UK except under medical supervision.
Mr Bruen should also account for the additional 1,366 units and give the IMB a print-out of all orders received from customers and documentation relating to the removal of the stock to the UK.