An Act to amend the Food and Drugs Act and the Food and Drug Regulations (drug export restrictions)

This bill was last introduced in the 39th Parliament, 2nd Session, which ended in September 2008.

This bill was previously introduced in the 39th Parliament, 1st Session.

Sponsor

Carolyn Bennett  Liberal

Introduced as a private member’s bill. (These don’t often become law.)

Status

Defeated, as of Nov. 28, 2007
(This bill did not become law.)

Summary

This is from the published bill.

This enactment places certain restrictions on the export of drugs described in Schedules D and F of the Food and Drugs Act.

Elsewhere

All sorts of information on this bill is available at LEGISinfo, an excellent resource from the Library of Parliament. You can also read the full text of the bill.

Votes

Nov. 28, 2007 Failed That the Bill be now read a second time and referred to the Standing Committee on Health.

Food and Drugs ActPrivate Members' Business

November 2nd, 2007 / 1:30 p.m.


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Liberal

Carolyn Bennett Liberal St. Paul's, ON

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.

Food and Drugs ActPrivate Members' Business

November 2nd, 2007 / 1:40 p.m.


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Charleswood—St. James—Assiniboia Manitoba

Conservative

Steven Fletcher ConservativeParliamentary Secretary for Health

Mr. Speaker, I listened to the member's comments with interest. I note that her comments began by criticizing the current government. I find this very hypocritical because when the issue of drug exports from Canada to the United States was at its peak, it occurred under the previous Liberal government, a government in which the member was a minister.

The peak was in 2004 and the former minister of public health and the former health minister did nothing at that time. The peak flowed by and they continued to do nothing. The member mentioned that the Liberals brought forward a bill. Not only was it poorly worded and unnecessary, it just again showed how the Liberal Party was all talk and no action.

At the time, in 2004, it should also be noted that the Canadian dollar was in the 70¢ range. Today it closed at over $1.07. So a lot of the economic benefit has been eroded due to the increase in the Canadian dollar.

Moreover, the Internet pharmacy business has collapsed. As far as the U.S. regulations are concerned, the White House opposes the bill, Congress is dividing. It has little chance of passing and even if it does pass there is a poison pill within the bill.

Canadian drugs are not under threat today and it is really a lot less under threat than they were under the Liberal regime when the Liberals did nothing. If this member is so concerned about the issue, why did she not do something in the 13 years that she was in government in 2000 or 2001? Why is she raising it now?

It is just another example of Liberal hypocrisy. That is my question: why now and not then?

Food and Drugs ActPrivate Members' Business

November 2nd, 2007 / 1:45 p.m.


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Liberal

Carolyn Bennett Liberal St. Paul's, ON

Mr. Speaker, I am shocked that the member opposite does not understand the gravity of the situation right now.

The Liberal government did act and the former minister of health did table a bill when it seemed there could be problems, particularly with respect to pandemic preparedness and shortages in flu vaccine like Tamiflu. The bill was tabled and even the Conservative member, who is a former chair of the health committee, actually supported the bill at that time.

It is the ultimate in hypocrisy to say, “How come you did not do then what clearly needs to be done now?”

It has been the political climate in the United States, the pressure from the bills before Congress and, indeed, the endorsement of all presidential candidates now that puts the drugs supplied by Canada under severe risk and Canadians at severe risk from the kind of counterfeit drugs that would come to backfill the shortages.

The price of the Canadian dollar is indeed different, but the idea that we in Canada have for 15 years properly controlled the price of patent medicines in this country is really the risk.

Even today, the costs of patent medicines are very much cheaper in Canada than the United States, and they are still an incentive for Americans to import cheaper drugs from Canada. Why would the Senate and Congress of the United States still be wanting to do this, as the member was suggesting, if indeed the problem was just the price of the Canadian dollar?

This is a huge threat to our country. We need the minister and the government to act. I do not think Canadians are too amused by the hypocrisy of saying that the previous Liberal government did nothing when we actually tabled a bill and the present government is so stubborn that it refuses to bring it forward, even though it knows it is necessary.

Food and Drugs ActPrivate Members' Business

November 2nd, 2007 / 1:45 p.m.


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Charleswood—St. James—Assiniboia Manitoba

Conservative

Steven Fletcher ConservativeParliamentary Secretary for Health

Mr. Speaker, I would like to take this opportunity to outline some of the key factors to consider with respect to cross-border drug sales.

First, let me just touch on some of the comments the member just made. The peak of the cross-border drug sales occurred many years before the bill to which the member referred was tabled. If the previous government had been really serious about dealing with the issue, it would have dealt with it at that time.

The political climate in the United States is actually quite contrary to what the member is suggesting because there is very little likelihood that the bill will actually pass.

Let me go into some other aspects. I hope to usefully inform the hon. members as to the current status of the issue, and how and to what extent this affects the interests of Canadians.

Let me begin by saying that the sale of Canadian prescription drugs to Americans is by no means a new practice. For years a limited number of Americans in border states have crossed into Canada to obtain prescription drugs from Canadian physicians, so that they could fill their prescriptions at lower Canadian prices. This activity is referred to as cross-border foot traffic.

Until recently, the number of individuals purchasing drugs from Canada was limited by the physical distance to the U.S. patient's place of residence and our clinics and pharmacies, not to speak of the need to cross the border. This foot traffic has been relatively stable at about $500 million a year.

In contrast to foot traffic, cross-border Internet pharmacy transactions are a relatively new phenomenon ushered in with the advent of Internet commerce.

The introduction of the use of the Internet to facilitate prescription drug sales significantly lessened the importance of the border as a barrier to sales. Internet pharmacy transactions went through an initial rapid growth and then a dramatic recent decline.

The sales volumes were small in 2001, at about $70 million, but grew tremendously to $840 million per year in 2004, when the Liberals were in power, at a growth rate of over 1,100%. Combined with border foot traffic, total sales to the U.S. amounted to approximately $1.35 billion in 2004.

The majority of the Internet pharmacy industry has been concentrated in the western provinces, particularly in Manitoba. In 2004, Manitoba accounted for nearly $400 million in annual Internet pharmacy sales representing close to half of the industry's business.

Other provinces with a strong industry presence have included Ontario, British Columbia and Alberta. These four provinces have consistently combined to account for more than 95% of the Internet pharmacy activity.

As well, at its peak it has been estimated that the Internet pharmacy industry has been a source of employment for up to 4,500 people.

Internet pharmacy sales peaked in 2004 at a value of $840 million, but annual sales decreased by 25% from 2004 to 2005 and there was a further reduction of about 50% in 2006. Presumably there will be another huge reduction given the rapid appreciation of the Canadian dollar.

The drop in sales volume is due to many factors, including the introduction of a drug benefit for seniors under the U.S. medicare program. The decline in sales has been most pronounced in Manitoba, originally the largest volume Internet pharmacy province.

It is important to note that when the Internet drug sales to the U.S. were at their peak in 2004, there was no evidence of any impact on the Canadian supply.

It is not unreasonable to think that a three-quarter drop in sales would equate to a similar drop in the potential impact on the Canadian supply, but some members are suggesting that the risk to the Canadian supply is rising. This is very difficult to understand.

Cross-border drug sales, including both Internet and foot traffic sales, now amount to about $700 million per year. At the peak of the Internet sales, the total sales volume was $1.3 billion.

In the meantime, proposed U.S. legislation to legalize drug imports, bulk imports in particular, has the potential to impact on the volume of drug exports from Canada to the United States, but for reasons that I will explain in a moment, it is, I believe, highly unlikely that that situation will materialize.

In evaluating the risks for the Canadian supply, it is useful to have a good understanding of the underlying drivers of cross-border drug sales to the United States. The primary motivating factor is drug price differentials between the two countries.

For patented drugs, Canadian prices can range from 35% to 55% below those paid by Americans. This is in large part due to the fact that Canada has legislated the price of patented drugs. The federal Patented Medicines Prices Review Board was created in 1987 under the Brian Mulroney government through the Patent Act with the regulatory mandate of ensuring that patented drug prices in Canada are not excessive.

Combine our lower prices with those Americans who have only partial or no drug insurance and we have a market. There is also interest from smaller drug plans without significant negotiating power with drug manufacturers.

However, overall demand has been reduced dramatically in the last couple of years. This is primarily due to the introduction in the United States of Medicare Part D, which provides drug benefits for seniors and others, such as disabled Americans who previously were under-insured or uninsured.

State governments and many municipalities are also involved. Drug importation is effectively prohibited under U.S. federal law, with the exception of a 90 day personal import provision, but despite the legal considerations, the import option has received significant support from state and municipal governments. A number of states have considered, or in some cases, actually pursued some sort of state facilitated drug import program. That said, such activity seems to have also been moderated by the medicare drug benefit.

In the case of municipalities, the interest has been either on behalf of their own municipal employees or their residents at large. Many of these initiatives have been launched despite warnings from the U.S. Food and Drug Administration of possible contraventions of federal law.

Clearly, this level of interest in drug imports would not exist if Americans were not facing the twin problems of high drug prices and inadequate or non-existent drug coverage. However, I believe that any concern about impacts on the Canadian drug supply needs to be balanced with a calm and considered examination of the situation.

First, the Americans are looking at solving this issue domestically.

Second, a number of factors have combined to dramatically reduce the volume of Internet based cross-border drug sales, including Medicare Part D and the rising Canadian dollar.

Third, imports of prescription drugs via Internet pharmacies are officially not permitted in the United States and we have not seen the floodgates open as a result. In fact, there was a sharp decline in the last quarter of 2006 of 20% of cross-border shipments due to U.S. customs.

Fourth, despite recent changes in the makeup of the U.S. Congress, we are a long a way from a bill legalizing bulk imports being approved by the White House without such a bill including major impediments to actual imports in practice. In other words, the White House does not support the importation of drugs and therefore, the bill would have very little chance of passing.

The Canadian drug supply is safe. There is no danger in the short, medium or long term. This bill is not necessary and therefore, I do not support it.

Food and Drugs ActPrivate Members' Business

November 2nd, 2007 / 1:55 p.m.


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Bloc

Marcel Lussier Bloc Brossard—La Prairie, QC

Mr. Speaker, I would like to thank the member for St. Paul's for her speech. I understand that the purpose of the bill she introduced today is to make it possible to prohibit the export or sale of prescription drugs and medications set out in a schedule to the Food and Drugs Regulations. There are currently no drugs listed in the schedule.

The bill has two specific goals. The first is to establish the principle that exporting any drug listed in the schedule should be prohibited if such activity could compromise the supply of that drug in Canada. The bill's second goal is to make it illegal to export prescription drugs. Bill C-378 is a kind of insurance policy against bulk exportation of prescription drugs in case of shortages in Canada.

To better understand the issue, we need to look at the pricing mechanisms for prescription drugs. In the United States, the power to set prices for prescription drugs is in the hands of pharmaceutical corporations. They can price their products as they see fit. Under pressure from American lobbyists, the Bush administration allows the pharmaceutical industry complete freedom to set its prices.

In Canada, except in Quebec, the Patented Medicine Prices Review Board, the PMPRB, which was established in 1987 in accordance with the Patent Act, sets maximum prices for medicines. The PMPRB is responsible for protecting the interests of Canadian consumers by ensuring that prices charged by manufacturers for patented medicines are not excessive.

Quebec has its own drug review process, the Conseil du médicament. The drug policy includes measures to ensure that Quebec is paying fair and reasonable prices for drugs.

It would be interesting to find out why the price difference is so big that Americans want to buy their medicines in Canada. Because prices in Canada are fixed by independent agencies, prices for identical products are often 30% to 60% lower here than in the United States.

It was pointed out earlier that the price of prescription drugs exported to and paid for by Americans fluctuates according to the value of the Canadian dollar. As the Canadian dollar rises, Canadian drugs become less profitable and attractive to Americans. Today the Canadian dollar was trading at $1.07 U.S., or 7% higher than its U.S. counterpart.

So how can we ensure the security of supply for Canada? Cross-border sales of pharmaceuticals to the United States have become an important source of trade for Canada. Since the Americans can take advantage of lower prices here than at home, they try to stock up in Canada. The potential is considerable, given that 37 million people aged 55 and older want to buy their pharmaceuticals here.

According to the Ordre des pharmaciens du Québec, the on-line pharmaceutical market has reached over $1 billion a year in Canada. Although all Canadian pharmacies must obey Canadian laws, the legislation is not airtight everywhere. While on one hand, the federal government has the authority to legislate exports, on the other hand, the provinces and territories are responsible for regulating medical and pharmaceutical practices through, in Quebec, the Collège des médecins and the Ordre des pharmaciens.

Thus, trade is particularly lucrative in Manitoba, where the laws surrounding the sale of pharmaceuticals are more flexible. According to estimates by a company called Secor, in 2003, nearly 20% of pharmacists in that province worked mainly to sell to Americans. That was the infamous peak year that was mentioned earlier. Also according to the same source, the majority of pharmacists in Canada who sell to the United States happen to be in Manitoba.

The Canadian Pharmacists Association warned of the following:

Canada needs to protect itself from having our drug supply drained, which will occur if the US passes this legislation. The cross border drug trade does not appear to be on the agenda of the current [Conservative] government. We believe that acting only after US bills are passed and Canadians are experiencing drug shortages is not an adequate response on the part of the Canadian government. The government will have to act sooner or later – and sooner is preferred. An important first step would be to pass Bill 378.

In Canada, neither international trade obligations nor domestic law prohibit such exports. However, Quebec and the provinces must follow rules with respect to these export transactions. Someone can speak about Ontario, but I will limit myself to the situation in Quebec.

As in so many other areas, Quebec is way ahead in terms of monitoring sales of prescription drugs and has taken steps to prevent the online sale of prescription drugs to Americans.

Under the Pharmacy Act, a pharmacist can sell drugs only to patients who have prescriptions written by a person authorized under Quebec legislation or the legislation of a Canadian province that authorizes that person to prescribe that drug if that person practises in Quebec.

The Quebec Code of ethics of physicians stipulates that in order to write a prescription for a patient, a doctor must evaluate the patient, establish a diagnosis, formulate a treatment plan, provide information to the patient and obtain consent. Some Quebec doctors have already been struck from the Collège des médecins du Québec for illegally selling drugs on the Internet to Americans they never met. I have with me a newspaper article that mentions the name of four such doctors who were fined between $5,000 and $25,000, in addition to being banned from practising for six months for signing prescriptions for U.S. patients without meeting them. I was quite surprised to see the name of a doctor from my riding on that list of four doctors. They operated on the Internet at myprescription.com, which means that Internet pharmacies are right next door.

Physicians practising in Quebec are not allowed to countersign a prescription from another physician without complying with the requirements that apply to the prescription. A Quebec physician who countersigns a prescription from an American physician therefore risks being sued, not only in Quebec, but also in the United States.

In terms of online business, Quebec already has the necessary tools to protect pharmacies' supply and ensure that patients receive the appropriate medication for their condition and information on how to use it properly.

In conclusion, the Bloc Québécois supports Bill C-378 in principle. The bill answers concerns about the possible reduction in inventories of drugs meant for Canadians. Although there is no shortage at present, we need to look at preventive measures before such a situation occurs. By setting strict criteria to regulate bulk drug exports, Bill C-378 would prevent an unfortunate situation from arising.

The bill should reassure the pharmaceutical industry and prevent it from raising drug prices, as American companies were tempted to do in retaliation.

The bill does not place a total ban on drug exports. It provides for a mechanism based on known criteria that can be produced in evidence.

Food and Drugs ActPrivate Members' Business

November 2nd, 2007 / 2:05 p.m.


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NDP

Peggy Nash NDP Parkdale—High Park, ON

Mr. Speaker, I am pleased to speak to the bill, which is aimed at protecting the Canadian pharmaceutical supply from bulk exports south of the border.

Canadians need to have a secure supply of the pharmaceuticals they need. This is not to say that we do not understand that the health care system south of the border leaves much to be improved. More than 50 million Americans have no health coverage. Many other Americans have substandard coverage in the sense that they think they are covered by health care insurance, but when they become ill, they find out their hospital stay or drug coverage is not there to protect them.

We understand the need. Americans have been facing very high drug prices. That is why Canadian pharmaceutical companies have been appealing to Americans who have been accessing bulk exports of Canadian pharmaceuticals.

We do not want to be locked into a path where the security of supply for export supercedes the security of supply for Canadians. When Canadians need pharmaceutical drugs, whether for catastrophic care, or for an epidemic or pandemic of some kind, we need a policy to ensure we have the security of drugs we need. While we recognize the situation of Americans, the bulk export of Canadian drugs is not the solution.

My colleague, who introduced the bill, has explained that there are many drawbacks to relying on Canadian bulk exports, such as the scarcity of some ingredients that limit the amount of supply needed for some drugs. Many of them are time dated, so they cannot be stockpiled in a warehouse somewhere in case they might be needed by our neighbour south of the border.

We know what happens in a time of scarcity. During the SARS crisis a few years ago in Toronto, there was a great deal of panic about the cause of the epidemic and a great concern about how people could protect themselves from the spread of this disease. In a situation like this there is always the danger of hoarding. People will do what they think is in their best interests to protect themselves and their families. Some people also hoard because they think they can make some business from this situation. If there is a crisis situation, we want to ensure that Canadians will have access to the drug supply they need.

We also know there have been problems with counterfeit medications. Our border inspectors do not inspect every shipment that goes across the border. I have heard that 1% of shipments are physically inspected. This then leaves open the possibility of counterfeiting, which not only endangers the health of Americans, it also diverts production that could be put to beneficial use rather than counterfeit use.

It is important to safeguard the Canadian supply and to avert going down the path where we open ourselves or our neighbours to the south to the risks of bulk drug exports. The Government of Canada must do what is necessary to ensure that Canadians are protected.

I also want to speak about drug coverage in Canada. While Americans may think we have a more desirable situation here, because of lower drug prices, primarily through generic brand pharmaceuticals, we also have a problem with drug prices on this side of the border.

The drug patent laws have been giving brand name pharmaceutical companies more and more patent protection over the years. The Conservative government extended patent protection up to eight years now for brand name drugs. This will see hundreds of millions more dollars of costs added to our pharmaceutical costs in Canada. We also have the problem of evergreening of drugs under patent protection, which has not been addressed.

What it means is higher drug costs for Canadians. They are so costly that in fact many Canadians simply cannot afford to have their prescriptions filled as it stands today. It adds to the financial stress that many Canadian families are under. We can all imagine the situation of people who go to a drug store to fill their prescriptions. They find out the price and they simply cannot afford to have the prescription filled, which would help them regain their health.

It is time Canada had a national universal drug plan to promote better health for Canadians without breaking the bank. We have an opportunity while we have surplus budgets, surplus funds federally, if the government does not give it all away to the banks and the oil companies, to invest in Canadians. We can pool our resources to bulk purchase drugs for Canadians. We could do that through a universal pharmaceutical program.

We have seen with our universal health care program, medicare, that our costs are far below costs south of the border, by pooling our resources and ensuring that everyone is covered, rather than leaving too many people behind.

The government has dropped its promise to deal with wait times when it comes to health care. That has been a shameful oversight. Here is an opportunity for the Conservatives to introduce something positive with respect to health care, and that is a national pharmacare program.

An important step is to secure our supply of drugs for Canadians and to ensure we do not export drugs south of the border that could jeopardize supply in Canada. I believe a more fundamental, an important step and a necessary step for Canadians is to ensure they all have access to the pharmaceutical drugs they need. We have to keep costs down as a country. I believe a national pharmacare program is long overdue. It would make a huge difference for Canadian families.

Food and Drugs ActPrivate Members' Business

November 2nd, 2007 / 2:15 p.m.


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Liberal

Wayne Easter Liberal Malpeque, PE

Mr. Speaker, this bill is about one simple thing. It is about meeting the needs of Canadians who want to feel secure that their prescription drugs and vaccines are there for Canadians. Let me re-emphasize that. This bill talks about security of supply of drugs and vaccines for Canadians.

I will not get into a lot of the technical details of the bill. The member of Parliament for St. Paul's went to great lengths to explain some of the technical details of the bill, but I want to talk about it in layman's terms.

I congratulate the member for St. Paul's for bringing forward this bill. Previously she was a minister of public health and therefore she understands the needs of Canadians on the ground. She is a medical doctor and therefore she knows first hand how important it is that Canadians are able to get not just drugs, but the most recent drugs, the most effective drugs in terms of meeting Canadians' needs. This bill is about meeting Canadians' needs.

Bill C-378 is about Canada not becoming America's drugstore. By amending the Food and Drugs Act, this legislation would protect Canadians.

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 Drugs Act regulations, which are 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. The exporter would be liable, on summary conviction, to a fine of up to $50,000 or imprisonment for a term not exceeding six months, and on conviction by indictment, to a fine of up to $250,000 or imprisonment for a term not exceeding three years.

Simply put, this bill would push the Canadian government to stand up for Canadians. It is something the Conservative government very seldom does.

We heard in the House today that it is not standing up for a Canadian citizen who is facing execution in the United States. The excuse is that a democratic decision was made in the United States. Canadians have always stood up for human rights. That is why we are respected around the world. How can the government go to China and talk about human rights any more when it is allowing a Canadian citizen to be executed in the United States?

That may be a little different story from this particular drug and vaccine issue, but it is all about standing up for Canadians, and the Conservative government is failing to do it. In terms of opposing this bill, it is clearly not standing up for Canadians.

This bill would push the government to stand up for Canadians, rather than just allow the export of drugs that would enhance American health and ignore the need for Canadians to be absolutely sure that the necessary drugs are available for Canadians. The government is opposing that.

I was shocked when I listened to the Parliamentary Secretary for Health. He went on at great length to say that the White House is opposed to the importation of drugs and therefore, we really do not need to deal with it.

I know the Conservatives love George Bush and love to hug him, but if they would just look a little beyond him to the candidates for the next presidency, they would see that most of the candidates support the importation of Canadian drugs into the United States because the drugs are cheaper.

We can understand why those presidential candidates are doing that. It is because the American health care system does not work. Over 40 million people do not have access to health care. It would be a great cover for the Americans to import cheap Canadian drugs, even if it shorted Canadians in terms of their supply, to kind of cover up the failures of their own health care system.

There is no question that the new government would stand by idly and risk the drug supply for Canadians. This bill is basically challenging the government, the companion of George Bush, to actually stand up for Canadians for a change and protect their supply of drugs and vaccines.

I have to ask this question. How often do we need to have Canadians subsidizing the United States?

The United States is our great friend. I spend a fair amount of time down there and the U.S. is our greatest trading partner. However, I think every Canadian is bothered when they learn that we are exporting oil and gas to the United States, a great Canadian resource, and what it is being used for in the United States. It is a cheaper supply. It is subsidizing its industrial plants so they can compete against Canadian industrial plants with cheap Canadian energy.

Why do we always need to be more supportive of the United States economy than our own? Now the government is going to put Canadians at risk by not being proactive and supporting Bill C-378.

Some will argue, as they always do because they like to use the trade agreements as a great crutch, that this will violate the trade rules. I say to the Government of Canada that if the trade rules do not make sense for Canadians then they need to be challenged. If this bill means there needs be a challenge to the trade rules, then let us challenge the trade rules. That would only make sense because then we would be standing up for Canadians.

The parliamentary secretary raised a number of points. He basically said that there was no imminent drug shortage and that the United States Congress has not adopted legislation to legalize the bulk importation of drugs. That is true for the moment but why can we not be proactive?

The fact of the matter is that the government should be proactive by banning bulk exports to the United States rather than waiting until after shortages of prescription drugs and medications occur.

As a coalition of Canadian pharmacists, distributors and patients said in a letter to the health minister on January 12:

We believe it is incumbent on the Government of Canada to respond proactively to this threat, with actions driven by a commitment to prevent harm and protect the public interest.

Why will the Government of Canada not listen to Canadians, to pharmacists, to distributors and to patients and be proactive? These people are concerned. Instead, the parliamentary secretary takes his advice from the White House. That is unacceptable.

He also talked about the Internet pharmacy sales having decreased significantly in the past two years. We really cannot be sure of that. It is difficult to determine the extent of Internet sales to the United States because many of them are being made offshore.

The bottom line is this. This bill is all about protecting the security of the drug and vaccine supply and medications for Canadians. The Canadian government should be proactive in terms of supporting this bill, even if it means it needs to stand up to the United States in terms of its agenda and its wishes. The government should stand up for Canadians, be proactive and support this bill to ensure that protection is there.

Food and Drugs ActPrivate Members' Business

November 2nd, 2007 / 2:25 p.m.


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Conservative

Nina Grewal Conservative Fleetwood—Port Kells, BC

Mr. Speaker, I am pleased to rise today on behalf of the constituents of Fleetwood—Port Kells to participate in the debate on Bill C-378.

The bill has been proposed as a response to developments in the United States. I think it is important that we understand the U.S. situation before deciding how to address it.

This proposed U.S. legislation to legalize drug imports is motivated by shortcomings in the American health care system. These deficiencies have left a sizeable number of Americans exposed to unmanageable prescription drug costs.

As Canadians, we value social supports and health care that seeks to be inclusive of all Canadians. So, while we are not unsympathetic to the issue of Americans without drug insurance, I think we can agree that importation of Canadian sourced drugs is simply not an adequate solution.

I would like to talk about the important role that prescription drugs play in our health care system.

There can be no denying that drugs have brought tremendous health care advances that benefit all Canadians. However, in addition to protecting an adequate supply for Canadians, we must also be vigilant in ensuring that costs remain manageable.

In recent years, drug costs have accounted for an increasingly large portion of expenditures in the Canadian health care system, with expenditures growing faster than any other component of health care. Drugs are now the second largest expenditure in our health care system.

According to the Canadian Institute for Health Information, total expenditures on prescribed and non-prescribed drugs in Canada is estimated to have exceeded $35 billion in 2006. This includes public and private insurance, as well as out of pocket expenditures. Spending on prescribed drugs in 2006 was estimated at more than $21 billion. This represents almost 84% of total drug expenditure and is nearly 20% more than in 1985. Spending on all drugs in 2006 amounted to an estimated 17% of total health expenditures in Canada, outstripping what we spend on doctors.

That said, Canadian patented prescription drug prices are in line with other major industrialized countries, except--

Food and Drugs ActPrivate Members' Business

November 2nd, 2007 / 2:30 p.m.


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The Acting Speaker Royal Galipeau

It is with regret that I interrupt the hon. member but the time provided for the consideration of private members' business has now expired and the order is dropped to the bottom of the order of precedence on the order paper.

When Bill C-378 comes back for study, there will be seven minutes left to the hon. member for Fleetwood—Port Kells.

It being 2:30 p.m., the House stands adjourned until Tuesday, November 13, 2007 at 10 a.m., pursuant to Standing Orders 28(2) and 24(1).

(The House adjourned at 2:30 p.m.)

The House resumed from November 2 consideration of the motion 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.

Food and Drugs ActPrivate Members' Business

November 27th, 2007 / 5:25 p.m.


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The Acting Speaker Andrew Scheer

When the bill was last before the House, the hon. member for Fleetwood—Port Kells had seven minutes remaining, but we will go on to the hon. member for Verchères—Les Patriotes.

Food and Drugs ActPrivate Members' Business

November 27th, 2007 / 5:30 p.m.


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Bloc

Luc Malo Bloc Verchères—Les Patriotes, QC

Mr. Speaker, at the outset, I would like to say that I agree with my colleagues from Québec and Brossard—La Prairie, who spoke earlier about the bill introduced by the member for St. Paul's, An Act to amend the Food and Drugs Act and the Food and Drug Regulations (drug export restrictions).

As my colleagues explained earlier, even though such a threat is not yet a reality, this bill is designed to minimize the possibility of Canada's supply of prescription drugs being exhausted by imposing severe restrictions on exportation. Under the NAFTA framework, partners to the agreement can limit certain exports to avoid a shortage in order to ensure public safety. In other words, the bill before us today would enable us to apply that framework.

The bill would amend the Food and Drugs Act to give the Minister of Health the power to prohibit bulk exports of prescription drugs. Specifically, Bill C-378 would make it possible to ban the export of prescription drugs listed in schedules to the Food and Drug Regulations.

The bill also specifies the kinds of fines offenders would be facing and it provides for a number of exceptions. For example, a drug described in one of the special schedules of the Food and Drug Regulations could still be exported from Canada if, for instance, it was not intended for human consumption or not manufactured or sold for consumption in Canada, under certain conditions of course.

I should point out that this bill targets primarily the western provinces, which have laxer practices. Quebec already has in place mechanisms prohibiting the cross-border trade in prescription drugs, as far as individual prescriptions are concerned. Supply problems and higher prices as a result of laxer practices in some provinces could, however, also affect Quebec.

Nevertheless, I want to make it clear that the role of the federal government in this case should be limited to regulating drug imports and exports. Under no circumstances is the federal government authorized to interfere in doctor-patient, pharmacist-patient or doctor-pharmacist relationships.

If the possibility of a drug shortage is being considered today, it is because of the significant price difference between drugs sold in Canada and those sold in the United States.

It is important to add some qualifications. As the member for Québec commented back in June and the member for Brossard—La Prairie reiterated in early November, the rate of exchange is no longer favouring the Americans, making it less attractive for them to buy on this side of the border. This will be especially true if the dollar remains strong or continues to increase in value, and consequently the threat of a drug shortage should lessen.

Still, even if the rise in value of the Canadian dollar has narrowed the price differential between Canadian and American products, the fact remains that having appropriate checks and balances in place in Quebec and Canada will ensure lower prices on this side of the border. American patients might therefore still be tempted to buy in Canada.

The fact is that, in the United States, pharmaceutical laboratories are allowed to price their products freely, while in Canada, the Patented Medicine Prices Review Board ensures that prices are not excessive.

Similarly, in Quebec, the Conseil du médicament, an organization directly under the Quebec department of health and social services, is tasked with making recommendations on establishing and changing the price of prescription drugs.

Drug manufacturers must submit a request to the board in order to increase the price of a drug. The board will assess the request, which must meet certain criteria. The drug must have been registered on the list of drugs for at least two years and the manufacturer must offer its best price from across Canada. It must also have a distribution agreement with the Quebec department of health and social services. Furthermore, the amount of the increase requested must not exceed a certain maximum rate.

If these conditions are met, the Conseil du médicament recommends that the Quebec department of health and social services accept the price increase.

Thus, as I was saying earlier, the existence in Canada and Quebec of independent methods for price setting is still responsible for a considerable gap between American prices and Canadian prices. This translates into a very large cross-border drug trade between Canada and the United States, a trade that is now facilitated by the Internet.

It is therefore no surprise that, according to the Ordre des pharmaciens du Québec, the on-line pharmaceutical market has reached over $1 billion a year in Canada.

Since Quebec and the provinces are responsible for regulating medical and pharmaceutical practices through their colleges of physicians and societies of pharmacists, the rules that apply to this trade are not the same everywhere.

Online sales of drugs are especially brisk in the western provinces, which have less stringent rules.

In Quebec, the code of ethics of physicians stipulates that in order to write a prescription for a patient, a doctor must evaluate the patient to establish a diagnosis and formulate a treatment plan. The doctor must also provide information to the patient and obtain consent. Under the Pharmacy Act, a pharmacist can sell drugs only to patients who have prescriptions written by an authorized person.

The prescribing and sale of a drug therefore bind both doctor and pharmacist. Both are legally responsible for this professional act, and they risk prosecution if they fail to live up to the standards of their professions.

As my hon. colleague from Brossard—La Prairie pointed out in this speech on November 2, physicians have unfortunately been struck off the roll of the Collège des médecins du Québec in the past for violating the rules of professional conduct to which they are subject by illegally prescribing drugs to Americans via Internet. Needless to say that never having met these patients hardly qualified as complying with the rules set out in their code of professional conduct.

It is important to note that, according to a number of analysts, the expansion of the virtual drug market in the United States will eventually influence drug prices in Canada. These experts say that, to make up for the loss of income from selling at a lower cost to Americans from Canada, the pharmaceutical industry might increase its prices on the Canadian market.

Even if the Conseil du médicament is responsible for administering the price regulation process in Quebec, as I indicated earlier, and the Patented Medicine Prices Review Board plays a similar role in Canada, the pharmaceutical industry's threats are not to be taken lightly.

Companies like Pfizer, Wyeth, AstraZeneca, GlaxoSmithKline and Eli-Lilly have already taken tough action, reducing their exports to Canada, for fear of losing a significant income by allowing their products to cross the border again at a lower price.

I should also mention that increased pharmaceutical sales on the Internet could result in a shortage of pharmacists.

Food and Drugs ActPrivate Members' Business

November 27th, 2007 / 5:40 p.m.


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NDP

Wayne Marston NDP Hamilton East—Stoney Creek, ON

Mr. Speaker, I rise to speak to Bill C-378, An Act to amend the Food and Drugs Act and the Food and Drug Regulations (drug export restrictions).

Canadians are very aware of the quality of our health system as well as our free access to most of its features, and that is in very stark contrast to the market-driven system in the United States.

As we know, there has been a surge of interest from Americans, particularly seniors, who, because of their fixed incomes, find drug pricing in Canada particularly inviting. Bus loads of seniors come to Hamilton to visit and have prescriptions filled.

I am all for being good neighbours and helping our American cousins to the south as much as we can. In fact, in many ways, their needs are much higher than those of most Canadians, particularly when it comes to health care in general and prescription costs in particular.

On the population side, Hamilton, at approximately 500,000, is not huge, but we are friendly, so I want to stress this point. The purpose of the bill is not to shut the border to our American cousins. In fact, American tourists who pick up a prescription or two are not a drain on our druggist's ability to provide prescription services to our hometown clients.

Primarily because of pharmaceutical sales on the Internet and the visits by these bus loads of American tourists picking up prescriptions, combined with the warnings of an anticipated flu pandemic, Canadians are asking about our supply. Where would they stand if a significant part of our drug output was sent south and then there was a shortage in Canada?

We know that earlier this year the United States moved to introduce the pharmaceutical market access and drug safety act. It appears its motivation was the fact that the American government wanted even greater access to the importation of cheaper pharmaceuticals. As I have already related, that door has been open to bulk purchases, and the American act appears to be intended to codify the open door policy by making it official.

This means the door has now been opened further to allow Canadian firms, those that wish to do so, to increase their bulk drug sales to the U.S. On the surface, that may be wise. The increase in employment would be wise in most people's opinion, but is that really a good thing?

On the surface, it appears so, but consider for a moment the impact on Canadians if we were hit by a flu pandemic, by SARS, or another unexpected outbreak and all our stock had been sold to the United States. That goes to the heart of the intent of the bill.

The production of pharmaceuticals is a precise and painstaking process that requires time. It is not as simple as perhaps it might be for one of Hamilton's manufacturing plants to simply add a shift to meet new demand. Pharmaceutical products are often more than not made from scarce biological sources or it cannot be turned out for mass production on a scale to match the needs of 30 million Canadians and 300 million Americans.

One area I have yet to touch on is product safety and border inspections. It is my understanding that of the products crossing our borders now, our security folks are only able to check about 1%. In a time of counterfeit drugs, combined with a freer movement of goods being promoted by both sides of the border, that is a recipe for a very serious concern. We all see the results of ineffective monitoring of the toys imported from China on a near daily basis. Imagine the risks posed here with the transport of pharmaceuticals.

Members may recall the speed with which SARS moved into the Toronto hospital system and elsewhere. We were not only unprepared, but we were shocked by its rapid advance and ravaging effects. It is one thing to struggle against a new and unknown invader like SARS, but it is quite another to allow the much needed protection for Canadians to become a simple commodity to be traded away gratuitously.

In many ways, the pharmaceutical industry survives on its own ability to forecast and predict need. A good example is our yearly flu vaccine. Companies are able to meet the demand because the flu season is a predictable event. Companies for the most part though cannot stockpile medications due to the short life expectancy of many of the ingredients.

In short, we must find and maintain that balance between keeping Canadians protected and having the ability to still export to some degree.

I have spent a large part of my time tonight speaking about the American wants and needs, so I would like to speak briefly to Canadian needs. Just like our American neighbours, many low income or fixed income Canadians are living under a financial strain these days. We refer to the prosperity gap regularly in this House.

Across my riding of Hamilton East—Stoney Creek we hear of far too many people who, when faced with a costly prescription not covered by a plan, simply turn and walk away when they are told the amount by the pharmacist. They just cannot handle it.

In fact, I was in the Rosedale pharmacy in my riding a couple of weeks ago, picking up a prescription of my own. I could not help but overhear a young man talking to the clerk as he dropped off his prescription. He was bent over in pain. He said he was having terrible pain, a problem with his back. It was so bad that he just did not know how to handle it. He had an ear infection as well.

He asked the young woman what the price of the prescribed drugs would be. When he was told it was $28 for the antibiotic and much more for the muscle relaxant and the sleep inducing drugs he needed so badly, even though he was in serious pain he said, “Fill the antibiotic only, that's all the money I got”. Like anybody in the House, I offered to help him that one time, but typical of a hard-working person of Hamilton, he said, “No thanks”, and he shuffled over and sat down while he waited for his antibiotic.

As legislators, it is not only time that we looked at such matters as prescription drug exports, but we must invest in a national universal drug plan to work hand in hand with our health care system to ensure that people like that young man in Hamilton receive the medications they so desperately need. No one should suffer needlessly when the rest of us, through the government, are ready and able to bear part of the load with them.

In closing, I would say that Bill C-378 moves us a long way to finding and maintaining that balance between supply on one side and demand on the other. I want to commend the member for putting forward this important bill. I believe that as responsible legislators we will do the right thing for Canada and will vote to protect the vital supply of pharmaceuticals.

Food and Drugs ActPrivate Members' Business

November 27th, 2007 / 5:45 p.m.


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Conservative

James Bezan Conservative Selkirk—Interlake, MB

Mr. Speaker, I appreciate this opportunity to speak to Bill C-378.

I would like to bring to hon. members' attention the key specific facts to consider with respect to Bill C-378, especially with events that are occurring in the U.S. Congress. In doing so, I wish to draw attention to the U.S. political environment and provide further insight on why U.S. developments are unlikely to affect our drug supply.

I believe that one of the reasons this bill was introduced was to address concerns over potential American legislation to allow the importation of drugs into the U.S.A. from Canada. There are concerns that such legislation would cause drug shortages here in Canada. However, it is premature and overly pessimistic to draw such conclusions at this time. This bill is the wrong response to a problem that does not currently, and may never, exist. I believe that any concern with potential impacts on the Canadian drug supply need to be balanced with a calm assessment of the situation.

I do not have to remind hon. members that 2008 is a major election year in the U.S. While the race for the White House receives the majority of the media attention, most members of Congress are also facing re-election.

As we are all no doubt aware, American legislators sponsor a number of bills in Congress to increase their profile before election time. Understandably, this activity increases closer to the election date. While we can expect to see more U.S. legislative activity in the coming months, this is unlikely to lead to an increased likelihood of bills being passed.

Most bills introduced in Congress do not make it into law. They die at committee level or are amended so many times that they become too unpopular to pass. Even if they are passed by one chamber of Congress, they could be defeated by the other chamber. Also, a bill passed by Congress will not be effective unless the executive branch appropriately directs the U.S. public service on how it should be interpreted.

There is no doubt that high prescription drug prices are a major political issue in the United States. Some proponents of the leading proposal to legalize imports have been open in stating that this is as much a pressure tactic to reduce U.S. domestic drug prices as about importation.

One way they are seeking to reduce domestic drug prices is by pressing for federal negotiation with manufacturers over the prices paid by the federal department of health and human services for those drugs covered by medicare.

Existing U.S. law prohibits medicare price negotiations. But a bill to require the U.S. government to negotiate medicare drug prices was passed in the House of Representatives with significant bipartisan support. While the Senate finance committee voted in favour of this bill, there was not enough support for this version to get passed in the full Senate.

For leading congressional Democrats as well as a number of Republicans, seeking the ability to negotiate prices for medicare drugs is a much higher priority than legalizing drug imports. Democrats and Republicans supporting medicare price negotiations could modify their bill or attach its language to another bill in order to further its progress through Congress.

The leading drug import bill before Congress, the Dorgan-Snowe bill, is stalled at the Senate committee level. The bill's sponsors have tried to go around the Senate committee by proposing amendments that would piggyback their drug importation bill onto another bill meant to overhaul the U.S. Food and Drug Administration. The Food and Drug Administration bill was passed by the Senate with the drug importation provisions. However, the Senate added a poison pill amendment, giving the U.S. administration the power to prevent drug imports until they certify that they are safe, and that such importation could lead to drug savings.

Therefore, it is unknown at this time if the Dorgan-Snowe bill would have any effect even if it became law. We are a long way from a bill legalizing bulk imports being approved by the White House without such a poison pill being included.

Finally, even if the Dorgan-Snowe bill were enacted, and the U.S. administration certified drug safety and cost savings, it would take 12 months before any bulk imports could occur. As such, there would be at least a year for this government to prepare for any concern with the potential impact of bulk exports. But given the current U.S. administration's strong reluctance to take action that would facilitate drug imports from other markets, it is highly unlikely that the Dorgan-Snowe provisions will ever, and I repeat ever, come into effect.

In the unlikely event that those provisions were brought into force, it should be noted that they would provide for imports from a number of countries, not just Canada. As such, the impact of any import legalization would be distributed over many countries. Eligible countries for drug imports would include many of the European Union countries, as well as Australia, Japan, New Zealand and Switzerland.

Again, drug imports from other countries such as Canada are neither a realistic nor a sustainable solution. U.S. federal legislators realize this and are using such legislation for their own political gain.

Regardless of the U.S. situation, Bill C-378 would not prohibit drug exports to the U.S. by foot traffic or Internet pharmacies, nor by drug manufacturers. If the member for St. Paul's is so concerned with the Canadian drug supply, I fail to see why she would want to allow such practices to continue by specifically exempting them from this bill.

As I have indicated, it is important to put the situation south of the border in perspective. That said, it is also appropriate and prudent for the government to continue to monitor the situation with respect to cross-border drug sales and to be prepared to act in a measured fashion if and when such action is indicated. However, we have not arrived at that point, and we are unlikely to get there anytime soon.

Food and Drugs ActPrivate Members' Business

November 27th, 2007 / 5:50 p.m.


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Liberal

Ujjal Dosanjh Liberal Vancouver South, BC

Mr. Speaker, I am delighted to rise in support of Bill C-378, An Act to amend the Food and Drugs Act and the Food and Drug Regulations (drug export restrictions).

This is a very important issue. I wrestled with it in my previous incarnation as the minister of health and introduced similar legislation. However, we did not have time to deal with it successfully.

Canada has a regime that has been developed to protect, at reasonable prices, the supply of drugs for the needs of Canadians. The instrument we have used for that is the Patented Medicine Prices Review Board. I believe the review board has stood us in good stead over the last number of years and has kept the supply of patented drugs available to Canadians at reasonable prices.

Because the prices are reasonable and because the politicians in the U.S. refuse to use similar kinds of devices to control the prices in the U.S., they are busy trying to devise plans in many states and, in fact nationally to try to legalize and legislate the wholesale imports of drugs from Canada. If they are successful in continuing to take bulk exports of drugs from Canada, I am afraid it may endanger the very supply of drugs at reasonable prices for Canadians. In that sense, this legislation is very important for all Canadians.

I want to commend the member, my colleague, for bringing the legislation forward in the House. When we dealt with this last, the sale of drugs at reasonable prices from Canada into the United States had gone into hundreds of millions of dollars and had increased.

I know those sales have gone down as the dollar has gone up. However, Canada faces a very real threat from legislators in the United States. They are attempting, in different ways, to deal with this issue and allow the continued importation of these drugs from Canada into the United States.

There are other aspects to this matter that bear scrutiny. For instance, we have a number of doctors who are engaged in prescribing medication to clients or “patients of their's” without examining the patients, or speaking with them, or physically touching the patients in examining them. That has been held to be unethical for some doctors by doctors' bodies across the country.

It is the same with the pharmacists. Pharmacists then fill those prescriptions, dozens and hundreds every day, knowing that they are signed by the same doctor or same number of doctors across the country. We believe some of those practices are unethical.

Some disciplinary bodies have been crying out for reform by and assistance from the federal government so they do not have to deal with the issues. They do not have the resources to investigate those kinds of unethical practices, and there are many, and then successfully discipline their members who may be involved in these questionable practices.

The way to deal with this issue is for the government to support the legislation so we can then prevent this danger becoming real, if does become real.

Many attempts have been made to make bulk imports into the U.S. legitimate, and we are familiar with those. Many of the U.S. presidential candidates have proposed and dozens of U.S. jurisdictions at state and local levels continue to introduce measures designed to help local citizens, government employees, retirees and others to buy Canadian prescription drugs.

Any of these measures could trigger the unanticipated shortages in Canadian supplies. Some of these programs include: developing websites that recommend Canadian Internet pharmacies for local citizens, employees and retirees and their families to purchase from; certification of Canadian based pharmacies as “qualified” for use by drug benefit program members or by local citizens; and the review of city/state drug benefit programs with a view to hiring Canadian firms to supply those programs with prescription drugs.

On October 31, the U.S. Senate adopted U.S. Senator David Vitter's drug reimportation amendment to the U.S. Senate labour, health and human services and education department appropriations bill. As he stated, “This provision prevents HHS officials from blocking hard working Americans from bringing back prescribed medication from Canada and will help bring more affordable prescription drugs to residents”.

In fact, in the House of Representatives, the agriculture appropriations bill was amended to include language that prevented the FDA from enforcing importation laws on prescription drugs from anywhere, including Canada. This legislation may be stuck in the appropriations process for other reasons and may roll into next year, but the language remains a serious concern as do the consequences that flow from this language.

These bills in the Congress followed legislation passed and signed by the President on October 4, 2006. The bill effectively created an open border for individual Americans to fill their prescription drug needs from Canada's national supply. A key provision of the new legislation prohibits the U.S. customs services from intercepting personal use quantities of prescription drugs at the border through foot traffic.

There are many other examples of what the U.S. governmental bodies, including state legislatures, have been trying to do, and that is to undermine the Canadian supply of drugs available to Canadians at reasonable prices.

It is open to the U.S. legislators and politicians to do exactly what we have done wisely for Canadians. We have protected the supply of drugs for Canadians at reasonable rates by using devices such as the Patented Medicine Prices Review Board. It is open to the U.S. to do the same. Why the Americans are not doing that beats me. I fail to understand why they are not taking the steps within their power to deal with controlling and regulating patented drug prices in their own country.

When I visited the United States of America as minister of health, David Vitter told me that he was interested in dismantling the regime we had in place for controlling and regulating the prices at reasonable rates for drugs for Canadians. That is the real intent behind the fact that they do not want to do anything within the U.S., but they want to undermine our supply and our devices that we use to control our prices at reasonable rates for Canadians.

Therefore, I suggest we support this bill, which would protect the supply of drugs for Canadians at reasonable rates.