Canadian animal health industry group warns of risk of counterfeit veterinary drugs

Saturday, February 14, 2015

by SUSAN MANN

Federal veterinary drug importation programs, one of which allows Canadian livestock farmers to directly import some veterinary drugs, could increase the risk of counterfeit drugs making their way into the country, warns an animal health industry association.

Drug counterfeiting, says Jean Szkotnicki, president of the Canadian Animal Health Institute, is “considered to be the deceptive manufacture and sale of a product.”

She estimates in 2013 drugs that are allowed to be imported for own use, or fall under another regulatory category that allows chemicals to be imported in bulk by a health professional such as a veterinarian or pharmacist to create other products (such as feed), were the equivalent to more than one tenth of what CAHI members sold across Canada that year.

The institute’s members’ sales totaled $549.8 million in 2013.

Szkotnicki says own-use importers bring in finished drugs that have not been approved by Health Canada but are registered in other countries and have other countries’ labels.

“The importation and use of (bulk) active pharmaceutical ingredients is being done by both veterinarians and pharmacists who are directing the product into veterinary medicine both at the food and companion animal level,” she says.

The importation of own-use products and bulk active pharmaceutical ingredients are both considered non-approved products, she notes.

Preventing counterfeit drugs from creeping in through these programs is one of the reasons why the institute wants to see greater oversight at the border, “particularly as it relates to antimicrobial products,” she says.

The institute is also concerned that non-approved drugs undermine its members’ market. Szkotnicki says these drugs “are usually being used not because the licensed product is not working, it’s because it’s cheaper.”

Ontario’s chief veterinarian, Greg Douglas, however, says the counterfeit drug problem affects developing countries more than developed ones.

He says the potential of counterfeit drugs brought in through the federal import programs contributing to antimicrobial resistance here in Canada is an unknown.

“We don’t have a very strong handle of what’s coming into the country. I think our guess through the Canadian Integrated Program for Antimicrobial Resistance Surveillance is that 13 per cent of veterinary drugs being used in Canada are coming over the border unregulated. Some of these drugs, I suspect, could be counterfeit but who would really know?”

Health Canada senior media relations adviser Maryse Durette says by email the department collects data on counterfeit veterinary drug incidents but does “not have data related to the use of counterfeit veterinary drugs in Canada.” She says there were no incidents related to counterfeit veterinary drug products in 2014.

Durette also notes Health Canada works with the Canada Border Services Agency to verify imported health products meet the regulatory requirements of the Food and Drugs Act and its regulations.

The Ontario Veterinary Medical Association and the World Organization for Animal Health also drew blanks when it came to estimating counterfeit drug use in livestock agriculture — as did the University of Guelph’s Ontario Veterinary College. A college spokesperson said by email they don’t have enough information on the situation.

Szkotnicki says that stricter border controls are particularly necessary right now because the industry is in the process of removing the growth promotion claims from the labels of licensed antimicrobial products considered to be important in human medicine. The three-year process began last year. It’s part of an effort by government and the agricultural industry to address the overuse of antibiotics in food animal production and the role that has in causing antimicrobial resistance in humans.

She notes that Health Canada is holding consultations March 11 to explore the possibility of having separate veterinary drug regulations that covers “a number of different aspects. An important part of it is controls over the own-use importation and active pharmaceutical ingredient imports.”

She says the institute intends to air its concerns during the consultations.

In a January news release, the World Health Organization for Animal Health (OIE), a Paris-based intergovernmental organization responsible for the global improvement of animal health, stated counterfeit veterinary drugs play “a dangerous role in global antimicrobial resistance.”

The organization estimates that 80 per cent of the veterinary drugs used in some countries are counterfeit.

As well, in 2012, the UN Food and Agriculture Organization and the International Federation for Animal Health spoke out about the use of sub-standard and counterfeit drugs to treat nagana, a disease found in Africa transmitted by the tsetse fly that has proven fatal for cattle, sheep, goats, pigs, camels, horses and donkeys.

“The use of substandard drugs to treat nagana not only leaves farm animals inadequately protected from the disease, but also permits the evolution of tougher, drug-resistant strains when insufficient doses are used," noted FAO chief veterinary officer Juan Lubroth, in a news release at the time.

All three organizations are working towards establishing stricter global controls on veterinary drugs. BF