As the regulatory authority in the Canadian province of Manitoba tasked with overseeing the public’s access to safe pharmacy practice and prescription medications, we write to express our concerns with proposed United States federal legislation that would amend the US Food, Drug, and Cosmetic Act to allow US consumers to buy Health Canada-approved medicines through authorized wholesalers and Canadian online pharmacies.

Although the College of Pharmacists of Manitoba sympathizes with the underlying intent of this legislation – enabling US patients access to lower-cost medicines – the importation of medicines from Canada is not the solution.

Specifically, we raise the following concerns:

Canadian law prohibits Canadian pharmacists from filling prescriptions issued by US practitioners. US law should not encourage Canadian pharmacists and physicians to violate their professional codes of ethics by cosigning prescriptions and dispensing medicine for patients they have never met and with whom they do not have a practitioner-patient relationship. The international “mail order” of drugs removes the critical patient care role of pharmacists, as neither the local pharmacist nor the “online” pharmacist will have a true patient medication profile. Such practice is contrary to the standards of care in both Canada and the US and puts patient safety at risk. The existing practice that some Canadian online pharmacies have established –  Canadian physicians cosigning a mass of prescriptions for anonymous US patients – is not safe and should be discouraged.

The Canadian medicine supply is not sufficient to support Canada and the US. Canada’s current pharmaceutical supply system, the subject of national price negotiation and regulation, is designed to serve the Canadian population of approximately 36 million. If the US proceeds with its importation plan, Canadian patients’ access to medicine could be endangered. Canada is allotted a certain quantity of pharmaceuticals from manufacturers based on estimated Canadian requirements. If pharmaceuticals meant for Canadians are exported to the US, the Canadian supply will be quickly depleted. Importation is not a sustainable or responsible policy in either jurisdiction as a means to address US prescription drug costs.

There is no way for Canadian or US authorities to be sure the medicines sold to US patients will be safe and effective. There are thousands of websites claiming to be from Canada in order to lure US patients into a false sense of security. These so-called Canadian pharmacy websites sell US patients medicines that have been manufactured in places where one would not even drink the water. Indeed, in 2005 the US Food and Drug Administration (FDA) found that 85% of the medicines coming from sites claiming to be Canadian were actually dispensed from foreign countries. For years, medical practices in the US and individual Americans have ordered prescription drugs from online pharmacies claiming to be from Canada and, instead, have received substandard, contaminated, and counterfeit medicines from other foreign countries that were not approved by Health Canada or FDA.

Moreover, Health Canada does not inspect the packages that Canadian online pharmacies are shipping to Americans. As one Canadian official explained, “Health Canada does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future.”

Sending consumers online to look for Health Canada-approved medicines is reckless, as US patients are likely to receive unapproved, substandard, and counterfeit drugs from unknown foreign sources, posing a serious risk to patient safety. Even if US law required consumers to purchase from only US Department of Health & Human Services-certified Canadian pharmacy or wholesaler websites, the reality is:

• Lists of certified online pharmacies do not work. The National Association of Boards of Pharmacy® (NABP®) has tried for nearly two decades to direct consumers to the NABP Verified Internet Pharmacy Practice Sites® list, with minimal success. Consumers likely do not remember how to find the safe online pharmacy list or do not care to try, preferring to do a quick search instead.
• US patients will do a search for “Canada medicine online” and find tens of thousands of sites that look legitimate but do not actually provide Health Canada-approved medicines to US consumers. The nature of the internet makes this bait-and-switch easy and less visible to regulators and law enforcement.
• Law enforcement cannot protect patients from illegal foreign actors who blatantly disregard Canadian and US laws, operate anonymously, and/or hide offshore. Even with the full force of US law enforcement going after illegal sites that claim to be Canadian, thousands of illegal online pharmacy websites based offshore continue to dupe US patients into believing they are buying from a “real” Canadian online pharmacy.
• Policy that encourages US consumers to find a safe Canadian online pharmacy will lead to a proliferation of fake Canadian online pharmacy websites, exacerbating the patient safety threat and damaging Canada’s reputation. Already there are roughly 35,000 active online drug sellers, 96% of which are operating illegally, and 600 new fake pharmacy sites are launched each month. Fake pharmacy sites are easy to set up and highly profitable, and there is a very low risk of being caught or prosecuted.

For these reasons, the College of Pharmacists opposes policies that authorize US consumers to import prescription drugs from Canada, as it would have the effect of placing US and Canadian patients at risk and negatively impact Canadian drug pricing controls and drug supplies. Rather, we urge policymakers in both jurisdictions to shift their focus to meaningful, long-term reforms that will deliver affordable and accessible health care and pharmaceutical products to all patients within their respective regulated health care systems.

For more information on our views, please contact Registrar Susan Lessard-Friesen (email: slessard­ friesen@cphm.ca or telephone 204.233.1411) directly.

Sincerely,

Jennifer Ludwig President

Susan Lessard/Friesen Registrar

cc:

Canada Minister of Health

Canada Minister of Public Safety and Emergency Preparedness

US House of Representatives

US Senate

US Department of Health & Human Services

Minister of Health Kelvin Goertzen, Province of Manitoba

Deputy Minister of Health Karen Herd, Province of Manitoba

Assistant Deputy Minister of Health Bernadette Preun, Province of Manitoba

Dr. Patricia Caetano, Executive Director, Provincial Drug Program, Province of Manitoba

Dr. Anna Ziomek, Registrar, College of Physicians and Surgeons of Manitoba, and Chair, Federation of Medical Regulatory Authorities of Canada

Robert Cram, Chief Executive Officer, Doctors Manitoba

Katherine Stansfield, Executive Director, College of Registered Nurses of Manitoba