moved that Bill C-378, An Act to amend the Food and Drugs Act and the Food and Drug Regulations (drug export restrictions), be read the second time and referred to a committee.
Mr. Speaker, I am pleased to have the opportunity this afternoon to discuss with my colleagues from all parties Bill C-378, An Act to amend the Food and Drugs Act and the Food and Drug Regulations (drug export restrictions), although I wish that I did not have to do this bill again. It would have been very simple for the government to deal with this during the prorogation and actually make this bill unnecessary, but it still refused to act.
My bill is aimed at controlling the cross-border trade in prescription drugs and vaccines. The bill would amend the Food and Drugs Act to prohibit the export of drugs set out in schedules D and F to the Food and Drug Regulations, vaccines and prescription drugs, except as permitted under the regulations.
The bill would make it an offence under the Food and Drugs Act to export prescription drugs in prohibited circumstances. By amending the Food and Drugs Act, the legislation will protect Canadians.
My bill is constructed to protect the Canadian pharmaceutical supply from being bulk-exported south of the border. There is such a large price differential between American and Canadian pharmaceutical prices that there is great pressure on the U.S. at this time to import cheaper drugs from Canada.
With over 35 million members, AARP is the leading non-profit, non-partisan membership organization for people aged 50 and over in the United States. It wields an enormous amount of power and is at this time launching a very major communication initiative.
However, during my meeting with the organization in Washington in the spring, it was clear that its real intention was not to import pills from Canada but to import prices from Canada and to make Americans very angry that they were paying too much for brand name prescription drugs.
Let me put it plainly: Canada cannot become America's discount drug store. Canada needs to protect itself from the dramatic expansion of importation by the U.S. of drugs intended for our patients.
The prospect of the U.S. legalizing large-scale purchases from our domestic supply is real. In fact, every Democratic Party presidential candidate is in favour of importation legislation.
The threat to Canada's drug supply increased on January 10 of this year after some U.S. politicians stepped up their efforts to facilitate bulk imports of prescription drugs from Canada with the introduction of the pharmaceutical market access and drug safety act of 2007.
The legislation was introduced by Senators Dorgan and Snowe and Representatives Emanuel and Emerson, who are co-sponsoring the companion house legislation. The legislation, which has the backing of key U.S. Democrats and Republicans, would allow individuals to directly order medications from outside the U.S. It would allow U.S. licensed pharmacists and wholesalers to import FDA-approved medications from a number of countries, including Canada.
In May, senators both approved the measure and then voted to require U.S. health authorities to certify drug imports were safe. Since the U.S. federal drug administration already had made it clear that it would not provide certification, the bill was dead on arrival.
However, on Wednesday, the U.S. Senate adopted U.S. Senator David Vitter's drug reimportation amendment to the U.S. Senate labor, health and human services and education department appropriations bill. In addition to foot traffic, Vitter's amendments would also allow mail order and Internet importation for Canada.
Several steps remain in the U.S. Congress before such a bill is signed into law, but influential lawmakers are on the march on this issue. It is like a voodoo from a video game: it just will not be killed.
In addition, the House budget office has recently completed a budgetary impact analysis demonstrating the savings that would follow the adoption of importation legislation. The announcements will give additional incentives to pass legislation in the context of the budget negotiations.
Any of these measures pose an imminent and serious threat to the security and integrity of Canada's drug supply and a genuine threat to the health of Canadians. It may have been good short term politics, but it is terrible long term policy.
American seniors are rightfully outraged by the high prices of pharmaceuticals in their country, but outsourcing price controls is not a responsible approach. In Canada, we have addressed price control with the Patented Medicine Prices Review Board, which regulates drug prices to ensure that the prices of patent-protected brand name drugs are not excessive.
Canada has regulated drug prices for the past 15 years. The United States does not have a similar control mechanism and the problem is exacerbated by U.S. drug companies spending millions of dollars every year to defend their higher prices.
Every year U.S. drug companies spend hundreds of millions of dollars on political influence, including lobbying, campaign donations, and extensive ad campaigns to defend their high prices and fight against price control. The American drug industry employs over 600 lobbyists in Washington alone, more than one for every member of Congress. This system drives U.S. prices even higher.
Another important difference between the Canadian and American systems is the regulation of advertising.
Prescription drug advertising is one of the most controversial practices in the American pharmaceutical industry. During the first nine months of 2002, American pharmaceutical companies spent over $6 billion promoting their products to physicians and consumers. This kind of advertising drives prices up and is prohibited in nearly all other western countries.
In Canada, the therapeutic products directorate strictly regulates prescription drug advertising.
I would also like to discuss how drug importation legislation represents a threat to American patients by allowing relinquishment of necessary community-based medication monitoring and management at increasing risk for potential counterfeit drugs.
The incidence of counterfeit drugs is small, but is growing in developed nations. The recent tragic death of a British Columbia resident, determined by a coroner to have been caused by counterfeit medicine in her possession, serves as a reminder that North America is not immune from this global phenomenon.
The counterfeiting of medicines is an issue that threatens the quality and integrity of Canada's drug supply, a problem that will be greatly exacerbated if U.S. drug importation legislation is passed into law without a clear and effective Canadian prohibition on bulk drug exportation.
I was pleased to see the public safety committee's report, entitled “Counterfeit Goods in Canada--A Threat to Public Safety”, which included this recommendation:
--that the Government of Canada institute a campaign to raise awareness of counterfeit and pirated goods to make the public aware of the economic and social costs associated with this scourge, and emphasize the public health and safety hazards they represent. The campaign should also raise Canadians' awareness of the involvement of organized crime in the counterfeiting and piracy of goods.
Internationally, the WHO is very concerned about counterfeit drugs. The WHO has struck the international medical products anti-counterfeiting task force, tasked with increasing international collaboration to combat counterfeiting.
I would also like to point out that allowing bulk prescription drug imports would not significantly reduce U.S. prescription prices for very long.
Even a recent University of Texas study concluded, based on the worst case scenario, that Canada's stocks of prescription drugs would amount to about a 38-day supply for the United States, assuming all U.S. medications were Canadian sourced. Once U.S. demand depletes Canadian stocks, prices will almost certainly rise, narrowing or even possibly eliminating the difference between U.S. and Canadian pharmaceutical prices.
Some may argue that Canadians should just increase manufacturing of pharmaceuticals to meet the U.S. demand.
Canada's innovation-focused pharmaceutical industry develops, manufactures and distributes drugs designed to meet the needs of Canadian patients and the Canadian market. It bases its production on the size of the population and the incidence of the illness or condition to be treated.
Manufacturers produce sufficient prescription drugs to meet the expected national demand. Consequently, if one country imports its prescription drugs from another, it diminishes the exporting country's stock of drugs to meet the needs of patients in that country.
Labelling regulations also differ from country to country. As a result, prescription drugs produced for the American or South American markets cannot just be sent to Canada to meet an unexpected need.
Given the complexity of calculating annual estimates of the needs of Canadian patients, not to mention the management by drug companies of their inventory to respond to patients' needs, it is unrealistic to think that products manufactured for Canada could meet American demand.
Cross-border trade is not only detrimental from a public policy perspective, it is almost virtually impossible to do. I would like to underline again that Canada cannot meet the prescription drug needs of approximately 280 million Americans without putting our own supply at risk.
Take, for example, the events during the fall of 2005, when in November Roche Canada took the unprecedented step of suspending sales of Tamiflu to the Canadian market. There were reports that Internet pharmacies were busily filling foreign prescriptions at a significant profit. One B.C. pharmacy alone was reported filling 400 orders a day from the U.S. That is a significant number, when according to the Canadian Pharmacists Association only 4,000 Canadians received that drug that September. Another Internet pharmacy in Montreal issued news releases promoting to U.S. customers its Tamiflu stocks.
The Canadian Pharmacists Association reacted to the Tamiflu incident by saying that the government should have acted to protect the country's supply of the drug. Again, when supply gets siphoned off to the U.S., it is Canadians who come up short.
This situation is a perfect example of the types of scenarios Canadian patients will face if Canadian governments continue to allow drugs to be diverted to the U.S.
This is not an issue unique to North America. In April of this year the European Union passed resolution 31 stating:
Is concerned about the intention of the US Congress to authorise parallel imports of medicines from the EU Member States, that may create obstacles to the EU patients' supply and favour counterfeiting of medicines; asks the EU, therefore, to raise this issue at the forthcoming Summit;
I would also like to take the opportunity to commend my colleague, the member for Vancouver South, who in 2005, when he was health minister, anticipated this problem and put forward legislation, Bill C-28, in order to reach consensus in the House. Unfortunately, an election was called before the bill went forward.
Current Canadian policy is to use only reactive measures and seek to manage shortages once they have already occurred. This is not enough and it may well be too late.
The issue of bulk exports to other countries of medicines and vaccines destined to Canadians should be an issue of concern to all of us. It is of particular interest to the Canadian Pharmacists Association and the Ontario Pharmacists Association.
I believe the passage of Bill C-378 is essential to protect the supply and integrity of prescription drugs here in Canada and will send a strong message to our American colleagues of the futility of their shortsighted legislative initiative.
I urge all colleagues to support my private member's bill, Bill C-378, or to call upon the government to make it unnecessary.