Irish medicines regulator dragged into row over tackling counterfeit drugs

The Irish medicines regulator has been dragged into an international row over proposals to tackle counterfeit drugs.

Critics of the proposals emanating from a UN agency have dubbed them the "Irish model law" because of the alleged role of an official from the former Irish Medicines Board (IMB) in drafting them.

The board, since renamed the Health Products Regulatory Authority, says it had no role in drawing up the guidance from the UN Office of Drugs and Crime (UNODC). The official was just one of a number of invited external experts who contributed to the process.

Counterfeit drugs are a growing problem internationally and have been blamed for tens of thousands of deaths each year.

While the pharmaceutical industry based in the developed world argues for the need for stronger patent protection for medicines against counterfeiting, countries such as Brazil and India say intellectual property issues should be left out of a criminal law.

Researchers

A recent article in the

Harvard Public Health Review

said the model law “drafted by the Irish Medicines Board” was “dangerously unwise” and was “negligently drafted” as it would expose honest researchers and drug manufacturers to prosecution. Lead author

Amir Attaran

, a Canadian lawyer and scientist, claimed the proposals would criminalise trials where a placebo was used because such products would be regarded as fraudulent if mislabelled.

Dr Attaran was a paid consultant to UNODC until October 2014, but was not consulted on the draft document prepared a month later.

The IMB and UNODC told The Irish Times that Dr Attaran's article was "inaccurate and misleading". It was incorrect to say intellectual property rights were included in the UNODC initiative, and references to the IMB drafting the document were also factually incorrect, according to the board.