Among the issues on the agenda of an international summit in Dublin tomorrow is ways of cutting the supply of illegal medicines. David Labanyireports
For regulators trying to stem the tide of counterfeit medicines, the big fear is not the odd, embarrassed man who buys fake Viagra on the internet rather than speak to his GP.
No, their concern is that a large quantity of counterfeit medicine will find its way into the supply chain and be dispersed to patients through pharmacies.
This is exactly what happened in Britain during the summer. The Irish Medicines Board (IMB) is particularly concerned about the case because the wholesaler concerned was also licensed to supply medicines into the Republic.
More than 30,000 packets with counterfeit versions of three commonly prescribed drugs - Plavix, Zyprexa and Casodex used for the treatment of blood clots, bipolar disorder and schizophrenia, and prostate cancer respectively - were given to UK patients through their pharmacies. The fakes were identified only after a competitor complained and a product recall was issued.
The case is not the first of fake medicines entering the medicine supply chain in the UK and is a stark warning of the risk of fake medicines, according to IMB chief executive Pat O'Mahony.
"This wholesaler had a licensing operation here for years and was using his office in Ireland to funnel most of the paperwork for the counterfeit medicine.
"As soon as the issue came to light, we started an investigation and suspended his licence. We are satisfied that none of the counterfeit medicine found its way into Ireland."
The wholesaler, who cannot be named for legal reasons, faces prosecution, and had his licence - which included Plavix and Zyprexa - revoked by the IMB last week.
O'Mahony admits this is the nightmare scenario, where a licensed wholesaler with a number of years' exemplary trading suddenly buys a large batch of fake medicine and it reaches patients.
"If the counterfeit was toxic, you could have fatalities. If it was a life-saving medicine but without adequate levels of the active agent, you could also have fatalities. The risks are massive," he says.
The wholesaler is under investigation by Britain's Medicines and Healthcare Regulatory Agency. To date, the agency has had no reports of an adverse reaction from the counterfeit medicine.
Motivating the counterfeiters are potentially huge profits. While many sell their products through the internet, these are small value transactions. Getting large volumes into mainstream pharmacies is the goal.
Cutting this supply of fake medicines is top of the agenda for a Summit of Regulatory Agencies being held tomorrow in Dublin and which is being chaired by the IMB.
As chairman of the European Medicines Agency (EMEA), O'Mahony intends to tell delegates from China and India that counterfeiting medicines is far more serious than copying clothes or software.
"We hope they get the message that this cannot be tolerated. That with medicines, lives are at risk. The Chinese and Indians are fundamental to the supply chain of counterfeit medicines.
"What we are hoping for this week [ is] to develop a dialogue with the heads of medicines agencies from these countries."
Illegal medicines are big business. The World Health Organisation (WHO) estimates that €23 billion ($35 billion) worth of counterfeit medicines was traded worldwide in 2005 and it expects this to double by 2010.
The WHO has also calculated that globally 10 per cent of medicines are fake, rising to over 25 per cent in the developing world. In the European Union, counterfeit medicines are estimated to account for just under 1 per cent of the total.
According to O'Mahony, one reason Ireland has not yet had a breech in its medicine supply is the relatively small size of the market.
"By comparison, the UK market is huge. But I am not so naive or arrogant to think that something could not penetrate our supply chain.
"Where there is money to be made, people will just keep trying," he says.
Asked whether the case exposed a flaw in the Irish and UK regulatory regimes, in particular the fact that it only came to light following a competitor complaint, O'Mahony disagrees.
"With each wholesaler there is a technician checking the quality. You would hope that person identifies any problems. Then it moves to the pharmacists."
In the cases under investigation, the product was issued to patients by pharmacists in part due to the quality of the packaging. "The counterfeit packaging can be superb, with holograms and other security measures," O'Mahony says.
"But if you are suggesting that because this person had been operating for a number of years, was there a lighter regulatory hand? No, that was not the case."
One area the IMB is particularly concerned about is the parallel trade of medicines. This involves a wholesaler taking advantage of a price or currency difference and buying medicines in one country before selling into another for a higher price.
While entirely legal, the medicines are often repackaged to comply with different regulations or translations and this is considered a vulnerability by regulatory agencies and pharmaceutical companies.
A portion of the counterfeit products found in the UK case are understood to have reached patients through this method, known as parallel trade.
"With parallel trade you are introducing another variable," says O'Mahony. Talks have been held at EU level on the issue, although any changes are expected to take time due to EU free trade rules.
Pharmaceutical companies are responding to the loss of earnings through parallel trade and the threat of counterfeiting.
Pfizer last year reduced its 18 approved wholesalers to one after fake versions of its heart drug Lipitor were found in the NHS supply chain. It now just deals with UniChem. Other companies are also stepping up their protections.
Within Ireland, the bulk of the IMB's work against counterfeit medicines involves intercepting prescription products bought online by individuals.
About 100 packages a week are seized by customs and An Post officials every week. The majority are Viagra-type treatments for erectile dysfunction with a significant quality of anabolic steroids also seized.
While importing these products is an offence, O'Mahony admits that, to date, no prosecutions have been taken to date.
"We have not prosecuted any individual for an individual importation. We advise them and try to educate them but maybe prosecutions are something we need to look at again."
The IMB also seeks to close down Irish-registered websites selling prescription-only medicines. Last year it closed about a dozen sites but can only pursue those registered in Ireland.
International co-operation is required to deal with others that are selling products into the State.
Tests on medicines bought over the internet by the IMB show that about half have no active agent and the remainder have a percentage of the active agent contained in the real product.
"People might look at a product on a website and think they are saving money. But the fact is almost every time they are wasting their money and may be putting their health at risk, particularly if they take a prescription medicine without medical advice," O'Mahony says.