Critics oppose proposed drug agreement

by THE CANADIAN PRESS - Ottawa

The federal Health Department is considering an agreement that would allow drugs made in Europe to bypass testing in Canada and that could put the health of Canadians at risk, say critics.

Others charge that the proposed Mutual Recognition Agreement (MRA) with the European Union is another example of how Ottawa is slowly dismantling the Health Protection Branch to save money.

"To have this happen quietly …is yet another signal that the health authorities at Health Canada are simply not respecting the right of the public to determine their own safety standards in their own country," said Dr. Michelle Brill-Edwards.

Brill-Edwards left the Health Department last year saying she was under pressure to quickly approve patent medicines

The huge agreement between Canada and the EU covers several sectors and is intended to harmonize regulations on the importation and sale of foreign drugs with those of the European Union’s.

The deal is supposed to be signed later this spring.

Health Minister Allan Rock did not speak with reporters following question period Monday. A spokesman said the agreement does not pose a safety problem.

"The MRA does not change the drug approval process. The MRA does not lower or change our regulatory standards with respect to safety" said the spokesman.

But Dr. Shiv Chopra, a scientist with the Health Protection Branch, disagreed.

Chopra said if a particular drug is approved in Germany, France or Switzerland, for example, the MRA would mean it wouldn’t have to undergo tests in Canada to make sure the product met Canadian standards, including quality.

"We just take their word for it," said Chopra, who estimates that 90 per cent of all drugs in Canada are imported.

Chopra said he was going public with his concerns because his superiors refuse to listen.

"The Canadian Pharmaceutical Safety Network said there have been many instances where multinational pharmaceutical companies have had to recall their products because drugs were mispackaged or a foreign agent such as glass particles or compressor oil were found in the product.

"With these proposed changes, the government is effectively abrogating all responsibility for the health, safety and efficacy of the drugs and medicines we take," said the network’s Jean Paul Sirois.

The network believes Canada’s testing standards are superior to those in the EU.

As an example, Sirois cites the case of Fenbufen, an anti-inflammatory drug that had to be pulled of f the market after several people died.

The network represents independent drug-testing labs, among others.

Maude Barlow, chairwoman of the citizens advocacy group Council of Canadians, says the agreement is a dangerous one.

"We’re just saying that this government has piece by piece given over power to the transnational corporations through yet another trade agreement that’s putting Canadians health greatly at risk," she said.

Last year Rock put a moratorium on cuts to the Health Protection Branch because of a public outcry over safety. This moratorium came too late to save the bureau of drug safety.

Several regional-labs across the country are responsible for drug testing, but Chopra figures they won’t be needed if the MRA is signed in its present form.

Earlier this year Rock announced that scientist and astronaut Roberts Bondar would head a science advisory board to examine the cuts and health policy in general. The board has yet to report back to the minister.