**Speaking Notes**

**Lothar Dueck, President, Coaltion for Manitoba Pharmacy**

**FDA Public Meeting on Rx Drug Importation**

-   Good day, and thank you for the opportunity to speak to you today.

-   My name is Lothar Dueck, and I am a community pharmacist in Vita,
    Manitoba, a small, rural town a few miles from the border with North
    Dakota and Minnesota.

-   I am also the President of the Coalition for Manitoba Pharmacy, a
    community pharmacist organization that strongly opposes cross-border
    internet pharmacy and drug re-importation from Canada to the U.S.

-   I am here today to explain that importation of prescription drugs
    into the U.S. is:

a)  Harming Canada's health care system

b)  Extremely risky for Americans

c)  Not a viable policy for the United States

-   Let me begin by saying that I am astonished at the insensitivity of
    American politicians who promote schemes involving diverting
    Canadian drugs south of the border, to meet the needs of Americans.

-   Canadian pharmacists and doctors are extremely sympathetic regarding
    the need to find a way to make Rx drugs more accessible to American
    patients, particularly those without comprehensive drug plans and
    health insurance.

-   But health professionals in Canada are shocked that many U.S.
    politicians, at all levels of government, are telling Americans to
    ignore your own laws and to purchase their medicines in Canada.

-   The United States has the richest, most productive and innovative
    economy in the world. Resolving this issue on your own should not be
    beyond you.

-   Thoughtlessly appropriating Canada's drug supply and pharmacy care
    is not an answer to your problems. Those leaders who cheerfully
    promote re-importation of Canada's medicines should be ashamed of
    themselves.

-   In 2003, Americans bought approximately \$1 billion worth of
    Canadian drugs, through internet pharmacies. That's a drop in the
    bucket in the huge U.S. market, but it is a huge proportion of the
    Canadian drug supply.

-   In fact, last year, more than 40% of the entire drug supply of the
    province of Manitoba was diverted to the U.S.

-   That is causing dangerous shortages. According to a survey
    undertaken by our Coalition, more than 80% of Manitoba community
    pharmacies reported having a harder time finding sufficient
    prescription drugs to treat our Canadian patients.

-   In December, 2003, the largest drug wholesaler in Manitoba literally
    ran out of a number of medicines. Suddenly, it was not possible for
    pharmacies to order supplies of medicines used to treat conditions
    such as depression, influenza and asthma.

-   Shortages of Rx drugs used to be rare occurrences, such as when a
    drug company had a manufacturing problem. We have never seen such a
    severe and broad-based shortage before.

-   In addition, Manitoba is facing a critical shortage of pharmacists
    to care for patients in our province.

-   Because it is so much more profitable to ship drugs to Americans,
    rather than to dispense them to Canadians, now more than 20% of the
    community pharmacists in Manitoba have become involved in internet
    pharmacy, rather than devoting themselves to Manitoba patients. This
    is desperately straining the ability of the remaining community
    pharmacists to offer proper care to their Canadian patients.

-   Cross-border drug sellers buy Rx medicines at Canadian prices, which
    are controlled by the federal Patented Medicine Prices Review Board.
    Internet pharmacies buy up huge quantities of Canadian drugs, at
    controlled Canadian prices, then re-sell them at a large markup to
    Americans.

-   In short, the U.S. demand, with the help of opportunistic
    politicians, has made it more profitable for Canadian pharmacists to
    sell Canadian drugs to Americans, than to care for their own
    patients in the community.

-   Today, thanks to diversion to the U.S., Canada is experiencing
    sudden drug price inflation. Because of the growing cross-border
    diversion, many drug makers have raised their Canadian prices by as
    much as our price-control system will allow. Some of them have
    increased those costs for the first time in a decade of stable drug
    prices.

-   Have any of the American re-importation enthusiasts bothered to ask
    what impact drug diversion is having on Canada? The results have
    been shortages of medicines and pharmacists, and higher drug costs
    for all Canadians. This is not fair and it's not right.

-   American re-importation proponents have also dismissed the concerns
    of the FDA, with respect to the safety of cross-border drugs. They
    do so at the peril of American patients. The safety concerns are
    real, and I will tell you why.

-   Recently, internet pharmacies in British Columbia and Manitoba were
    caught promoting the sale of drugs from foreign countries, to
    Americans. These medicines have been approved by neither the FDA nor
    Health Canada. Neither country has any way of verifying the quality
    of these drugs, or even if they contain any active ingredient at
    all.

-   Reports from Prudential Financial and the FDA have shown a major
    increase in trans-shipments of drugs from countries such as
    Pakistan, India, Bulgaria and Argentina. These drugs may enter
    Canada before being re-shipped to the U.S., but they never enter the
    Canadian drug verification system. Health Canada does not guarantee
    their safety.

-   When I hear U.S. governors saying, "If Canadian drugs are unsafe,
    where are the dead Canadians?", I respond by saying that Canadians
    are safe because they don't take those foreign, unregulated drugs.
    Our government won't permit it. If those drugs are not good enough
    for Canadians, why should you assume that they are good enough for
    Americans?

-   The final point I want to make is that politicians who tell the
    American pubic that they can solve their problem by simply buying up
    Canada's drug supply are misleading you. It may make for a popular
    political sound bite, but it's nothing close to a workable policy.

-   Canada's drug supply system is starting to break down now -- when
    we're supplying less than one-half of one percent of U.S. Rx drug
    demand.

-   Any increase in Canada-U.S. drug diversion, or even continuation at
    the present rate, will result in American patients with chronic
    diseases not receiving their prescriptions from Canada. Then you can
    expect an increase in adverse events for U.S. patients. That's what
    happens when people don't get the medicine they need.

-   Canada's population is one-tenth that of the U.S. Canada is less
    populous than California alone. We simply can't take the strain of
    your buying our medicines.

-   Drug makers ship enough medicines to Canada to meet the needs of our
    population and utilization of different drugs. They do not ship us
    enough to meet U.S. needs, nor will they.

-   Some governors want to sue the drug makers, to force them to keep
    shipping increasing volumes of drugs to Canada, so that the wealthy
    internet drug sellers can continue to re-ship them back to the U.S.
    at much higher prices.

-   This will not happen. Canada's Bureau of Competition Policy, the
    equivalent of the Federal Trade Commission, has ruled that drug
    manufacturers, like any company in any industry, cannot be forced to
    sell their products under conditions they do not agree to.

-   So the drug re-importation supporters are leading Americans down the
    garden path. There is no panacea -- no answer at all -- to be found
    in poaching Canada's drug supply. This is not a workable policy.

-   Let me repeat: Canadians and their health professionals are
    sympathetic to America's challenges regarding Rx drugs. But we can't
    solve your problem for you. Surely America can work this out
    properly itelf.

-   Surely America can solve its own problem, without hurting Canada's
    health care system, without putting American patients at risk from
    unregulated foreign drugs, and without making empty promises
    designed to win votes.

-   Thank you very much, again, for the opportunity to speak to you
    today.