Dentist and barrister daughter spared jail over unlawful export of 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 today 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.

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All charges against Orna Madden’s sister Emma Madden of the Waterfront, Hanover Quay, Dublin 2 were withdrawn.

Dublin District 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 Madden 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), the agency which regulates medicines in Ireland. It began after the HPRA received a complaint from the Israeli health ministry.

Judge Michael Coghlan heard Jim Madden had wanted to bring down the cost of cancer medication in Ireland and entered into a partnership with Taj Accura Pharmaceutical in India which was run by a local politician and that firm was listed on the Mumbai stock exchange.

His daughter Orna who had worked as a barrister and has also been a vice chair of the Employment Appeals Tribunal 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.

HPRA enforcement manager Hugo Bonar agreed with prosecution counsel Ronan Kennedy (instructed by solicitor Ronan O’Neill) falsified medicines offences related to the identity and history of products.

On February 24, 2016, the HPRA received a complaint from the Israeli health ministry and Taj Accura Pharmaceutical Ltd in Ireland became the focus of the investigation. The firm had premises in Sandyford in Dublin and later at Upper Pembroke Street.

Searches were carried out and computers and documentation including invoices were seized.

A politician and businessman named in court as Mr Singh ran the Indian firm. He was also a member of parliament in India.

He was also listed as a director of the Irish firm and a UK sister company was identified. However, the UK firm was not authorised to manufacture or supply medicinal products.

The court heard that the Madden’s firm had been involved in a total of 14 transactions with Middle East countries including Kuwait and Iran.

The charges related to Fluorouracil 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 Fluorouracil and $85,000 for Melphalan.

When exported, the medication appeared to have been made for the Irish company by their sister firm in England which turned out not to have a pharmaceutical licence.

The defendants had agreed to pay €7,500 in prosecution costs.

The offence, at district court level, can result in fines of up to €4,000 along with possible jail sentences of one year.

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.

Jim Madden had previously been involved the setting up of the Whitfield Clinic in Waterford to help people in the south-east have better access to vital health care. He was no longer involved in that clinic and there has been an IBRC judgement of €37m 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.

However, 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.