Ireland has been asked by the EU to explain why a synthetic opioid drug said to be 500 times more potent than morphine has not been outlawed, as directed by the bloc two years ago.
Doctors and public health experts have increasingly sounded the alarm in recent years about isotonitazene, an opioid analgesic that is not medically authorised.
The opioid epidemic has become a scourge on American society in recent years, with nearly 100,000 deaths attributed to it in the first 12 months of the Covid-19 pandemic, Centers for Disease Control and Prevention (CDC) data shows.
As of April 4, 2022, national forecasts predict 400–4,300 new #COVID19 hospitalizations will likely be reported on April 29. More: https://t.co/Xys80ZGlxV. pic.twitter.com/V5AFTamRDw— CDC (@CDCgov) April 6, 2022
It has increasingly crept into Western European society, including Ireland, with the European Monitoring Centre for Drugs and Drug Addiction (ECMDDA) saying last year that although its prevalence among European adults is currently low, "in many European countries the use of synthetic opioids has also been growing and, in a few now predominates".
Toxicologists at Imperial College London warned the British Medical Journal late last year that isotonitazene is 500 times more potent than morphine, and has slightly greater potency than fentanyl - the drug that killed legendary musician Prince.
"Its effects are like morphine and fentanyl, causing relaxation, euphoria and respiratory depression. In 2019, the EMCDDA became aware of isotonitazene being available on the drugs market. It is presumed that it is being used by high-risk opioid users," the toxicologists said.
Just published: our initial report on the synthetic opioid analgesic, #isotonitazene. Learn about the potential public health risks of this #NPS, monitored by the EMCDDA through the EU Early Warning System since 2019:https://t.co/YYC8VbaEsz pic.twitter.com/mXEMBWdYXL— EU drugs agency (@EMCDDA) April 28, 2020
Although data is limited, deaths associated with isotonitazene have been observed in Canada, US and Europe, the toxicologists added. The European Commission has this month sent a reasoned opinion to Ireland for failing to notify it of any measures to enact the 2020 directive regarding outlawing isotonitazene into national law.
Member states had until June last year to implement, but Ireland still has not done so. A formal notice is a request for further information on how the problem is to be tackled, and if the answer is unsatisfactory, a formal request to comply with EU law is sent, known as a reasoned opinion.
"Including new psychoactive substances in the definition of 'drug' should lead to measures to reduce their availability, protect public health and deter trafficking of these substances across the EU," the Commission said.
An EU directive, unlike a regulation that becomes law from day one, allows Governments to implement EU legal acts over a certain timeframe. If a country still doesn't comply after the reasoned opinion is sent, the Commission may decide to refer the matter to the European Court of Justice (ECJ).
Most cases are settled before being referred to the court. If the ECJ compels that action be taken, the Government must act or be in breach of EU law. In the event that a country still doesn't rectify the situation, the commission may refer the country back to the court, which can then impose financial penalties.