Raising awareness of fake medicines.

While there has been an explosion in the amount of counterfeit medications around the world over the last five years, awareness of the problem in New Zealand is limited, according to Eli Lilly's pharmaceutical counterfeit expert for the Asia/Pacific region, Ray Valez. It has been estimated that fake drugs comprise more than ten percent of the global medicine market and reap huge profits for manufacturers and distributors worldwide.

Valez visited New Zealand last month to increase awareness of the extent of the counterfeiting industry--what it is, how it operates and the harm it causes--with groups of doctors, pharmacists, the Ministry of Health agency Medsafe and customs officials. He admits there is as yet no hard evidence to suggest counterfeit medicines have become a problem in New Zealand, but with counterfeit companies and distributors already making inroads into countries like Singapore, Australia and the United States, it could only be a matter of time before similar issues arise here.

According to Valez, who is currently focusing on counterfeit Cialis products, distribution of counterfeit medicines happens in two ways: either through internet pharmacies or through known and legitimate distribution chains direct to pharmacies. "Eli Lilly has already had to recall some Cialis products in the United Kingdom where they had worked their way into legitimate distribution. Some of these counterfeits will use different active ingredients and different doses, and sometimes the active ingredient can be too strong. The fake medications may have some efficacy but the patient is taking a real risk by using counterfeit Cialis pills, whether knowingly or unknowingly."

Many internet pharmacies can look very convincing and often mimic legitimate internet pharmacies, he said. "People can be caught up in the image of the internet site, but the packages being offered are most likely to have been manufactured in countries like India or China with fake ingredients. The site might also be designed and managed by one person sitting in his or living room in some European country. A factory in India or China might be making ecstasy or methamphetamine tablets one day and then receive an order to produce medications like pain killers or anti-malarial drugs the next. The previous products could easily contaminate other products being made."

Valez would like to see much greater public awareness in countries like New Zealand around the use of the internet. Customers, including some GPs, needed to find out where the internet pharmacy was based and where the drugs being offered came from. "If the price of the medications being offered looks too good to be true, then they are probably fake and potentially dangerous. Some government agency should be keeping a watch on these websites and maintain a "hot list" of those sites consumers should avoid. The problem is, of course, that these sites can close and reopen as something else so quickly."

With pharmaceutical drug copying now big business, it is proving equally, if not more profitable, than the manufacture of harder, well-known illegal drugs like heroin. The difference is, however, that the consequences of being caught manufacturing counterfeit medicines are not nearly as severe as those dealt to illegal drug manufacturers and distributors. A fine of a few thousand dollars compares very lightly to a life-long jail sentence.

Eli Lilley, says Valez, is trying to take a responsible attitude to the issue and is keen to work with other pharmaceutical companies to investigate the problem. "Pharmaceutical companies need to take a more co-operative approach to deal with these issues. Our enemy is the counterfeit manufacturer and distributor, not each other. We need to work together and with governments if we are going to control this global epidemic."

Medsafe warns all health care professionals and patients to be vigilant and question anything that does not ring true about a product, eg unusual packaging or unusual action or side effects. It is actively examining internet pharmacy operations to assess whether any are breaching New Zealand's medicines' legislation.