Dentist and barrister daughter spared jail for unlawful export of cancer drugs

Jim and Orna Madden fined €1,000 each for relabelling medicines imported from India

Dentist Jim Madden of Upper Pembroke Street, Dublin and his daughter Orna Madden of Hannovver Dock, Hannover Quay, Dublin  who pleaded guilty to breaking medicinal regulation laws. Photograph: Collins Courts
Dentist Jim Madden of Upper Pembroke Street, Dublin and his daughter Orna Madden of Hannovver Dock, Hannover Quay, Dublin who pleaded guilty to breaking medicinal regulation laws. Photograph: Collins Courts

A dentist and his daughter, a qualified barrister and former vice chair of the Employment Appeals Tribunal, have been spared jail sentences for unlawfully exporting unregulated cancer medicine.

Medication was imported from India and relabelled to make it look like it was made in Ireland and the UK before it was exported to countries in the Middle East, Dublin District Court was told.

Taj Accura Pharmaceutical Ltd, incorporated in Ireland in 2011 but no longer trading, and two of its executives, dentist Jim Madden, of Upper Pembroke Street, Dublin 2 and his daughter Orna Madden of Hanover Dock, Hanover Quay, Dublin 2 were each given €1,000 fines on Friday after they pleaded guilty to breaking medicinal regulation laws.

Judge Michael Coghlan said if they had been found guilty following a trial he would have considered imposing jail sentences. He said the offences were complex matters but noted their professions and said there were high standards expected of people in the area of law and dentistry.

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He said it looked like “a bit of a cut of the corner” and “the fact no one has been affected does not mean there was not potential for disaster have to occurred”.

All charges against Orna Madden's sister Emma Madden of the Waterfront, Hanover Quay, Dublin 2, were withdrawn.

The court heard their family business exported controversial Indian-made generic cancer treatment products to Middle East countries. They had been re-branded to appear Ireland and the UK were countries of origin because the EU along with the US had higher quality and testing standards.

Jim and Orna Madden were convicted on charges relating to the sale of suspected falsified products and breaching medicinal product regulations.

They were spared one-year jail sentences after pleading guilty to six counts.

The case follows a one and a half year probe by the Health Products Regulatory Authority (HPRA), which regulates medicines in Ireland. It began after the HPRA received a complaint from the Israeli health ministry.

Judge Michael Coghlan heard Mr Madden had wanted to bring down the cost of cancer medication in Ireland and entered into a partnership with Taj Accura Pharmaceutical in India. His daughter Orna joined him in the business as a director.

The court heard medicine was brought in to Ireland from India via Istanbul, Turkey.

Taj Accura Pharmaceutical Ltd (Ireland) re-branded it to say it was manufactured by a sister company in England, which had a false address in Sussex.

The charges related to Fluourouracil for as well as Afhlan and Melphalan products used in the treatment of colon and breast cancers. The Irish firm was paid €85,000 for Fluourouracil and $85,000 for Melphalan.

Defence counsel Karl Finnegan pleaded with the court to consider leaving his clients without recorded convictions by applying the Probation Act.

The guilty pleas had avoided trial and the need for 20 witnesses, some from overseas, to come to court to give evidence. They had no previous convictions and were unlikely to come before the court again, the barrister said.

Jim Madden, who has been a dentist for decades, set up a family pharmaceutical business. He entered into a partnership with the Indian firm with the aim of bringing down the high price of cancer treatment in Ireland but was unable to do so.

He said Madden believed the Taj Accura operation in India was the largest pharmaceutical firm in India. However, he did not know the Indian supplier had become notorious and was the subject of complaints from Iranian health authorities.

Mr Madden had previously been involved the setting up of the Whitfield Clinic in Waterford. He was no longer involved in that clinic and there has been a IBRC judgement of €37million against him and his wife and “he is left with nothing”, counsel said

Orna Madden had practised as barrister from 2004 until 2013 and she had been a vice chair of the Employment Appeals Tribunal. She left the bar to work with Taj Accura Pharmaceutical Ltd. She was involved in a number of the transactions, the court was told.

The court heard they made no financial gain because the start-up costs were so significant.

Their barrister said they were embarrassed and remorseful and ceased involvement in the business.