We are writing on behalf of the National Association of Pharmacy Regulatory Authorities (NAPRA), Canada’s association of provincial and territorial pharmacy regulatory bodies as well as the Canadian Forces Pharmacy Services. Our members regulate the practice of pharmacy and operation of pharmacies in their respective jurisdictions in Canada and their primary mandate is to protect the public.
NAPRA wishes to express concerns with the proposed US Affordable and Safe Importation of Prescription Drugs Act that would amend the US Food, Drug, and Cosmetic Act to allow American consumers to buy Health Canada-approved medicines through authorized wholesalers and Canadian online pharmacies.
While NAPRA sympathizes with the underlying intent of the legislation – to lower prescription drug costs for US citizens – the importation of medicines from Canada is not the solution. The proposed legislation will not ensure patient safety, and is likely to put patients at risk on both sides of the border.
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 an online pharmacy claims to be from Canada, there is no system currently in place to ensure medicines sold to US patients from foreign sources will be safe and effective. Thousands of websites claim to be from Canada in order to lure US patients into a false sense of security. These rogue websites sell patients medicines that have been manufactured in countries where acceptable drug testing and approval processes are not in place.
Passing a law that encourages US consumers to find a safe Canadian online pharmacy will lead to a proliferation of illegal sites misrepresenting themselves as licensed Canadian pharmacies and exacerbating the patient safety threat on both sides of the border.
The Alliance for Safe Online Pharmacies (ASOP Global) estimates that there are already roughly 35,000 active online drug sellers, 96% of which are operating illegally, and 600 new illegal pharmacy sites are launched each month. Illegal pharmacy sites are easy to set up and highly profitable, and there is a very low risk of being caught or prosecuted.
Law enforcement cannot protect patients from illegal foreign actors who blatantly disregard Canadian and US laws, operate anonymously, 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 would continue to dupe US patients into believing they are buying from a “real” Canadian licensed online pharmacy.
Encouraging consumers to buy medicine from foreign online pharmacies enables prescription drug abuse. NABP estimates that there are more than 3,400 illegal online pharmacies selling controlled substances to US patients, typically without a prescription. Further, foreign online sellers do not connect to state-based prescription drug monitoring programs.
During this time of a national prescription drug abuse epidemic, it is both irresponsible and inconsistent with previous recent Congressional actions to pass laws that bypass existing, effective systems for reducing prescription drug abuse.
Canadian law prohibits the filling of prescriptions issued by US practitioners. This law is circumvented through mass “cosigning” of prescriptions by Canadian practitioners who do not know the patient, do not perform an examination, and do not comply with the standards of care governing practice. US law should not encourage Canadian practitioners to violate their codes of ethics and standards of practice by prescribing or dispensing medications for patients they have never met.
International “mail order” of drugs removes the critical patient care role of pharmacists. Neither the local pharmacist nor the “online” pharmacist will have a complete patient record, which can potentially lead to dangerous drug interactions. In all cases, pharmacists cannot adequately advise patients or manage problems with drug therapy if they do not have an existing practitioner-patient relationship.
The Canadian medicine supply is not sufficient to support both Canadian and US consumers. 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. Based on estimated Canadian requirements, Canada is allotted a certain quantity of pharmaceuticals from manufacturers who have global supply chains. If the US proceeds with its importation plan, the Canadian supply will quickly be depleted and Canadian patients’ access to medication will be endangered.
For these reasons, we support NABP’s opposition to the Affordable and Safe Prescription Drug Importation Act. We urge policy makers in both countries 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.
National Association of Boards of Pharmacy
US House of Representatives
US Department of Health & Human Services Hon. Jane Philpott, Minister of Health
Hon. Ralph Goodale, Minister of Public Safety and Emergency Preparedness Hon. François-Philippe Champagne, Minister of International Trade
Fleur-Ange Fefebvre, Federation of Medical Regulatory Authorities of Canada Beth Ann Kenny, Canadian Council of Registered Nurse Regulators
Tim Smith, Canadian Medical Association Mike Villeneuve, Canadian Nurses Association
Perry Eisenschmid, Canadian Pharmacists Association Registrars, Canadian pharmacy regulatory authorities