RE: Proposed United States Affordable and Safe Importation of Prescription Drug Act

I write onbehalf of the Newfoundland and Labrador Pharmacy Board (NLPB), the regulatory authority in the Canadian province of Newfoundland and Labrador tasked with regulating and advancing pharmacy care in the public interest.

The NLPB wishes to express our concerns with theproposed United States Affordable and Safe Importation of Prescription Drug Act that would amend the federal Food, Drug, and Cosmetic Act to allow American consumers to buy Health Canada-approved medicines through authorized wholesalers and Canadian online pharmacies.

The NLPB sympathizes with the underlying intent of this legislation, to enable American patients to have access to lower-cost medicines. However, the importation of medicines from Canada is not the solution. The proposed legislation does not include sufficient mechanisms to ensure patient safety, nor does itencourage legal, ethical, and transparent practice by Canadian pharmacists.

The draft legislation proposes to ‘license· pharmacies to participate in this export-import program on the basis of their operating in accordance with provincial standards, rules, and regulations. The standards enforced by the NLPB do not contemplate nor regulate the sale of prescription medications outside of Canada. As such, there is currently no regulatory system in place inour province to ensure public and patient safety if such a program was introduced, nor are there any mechanisms or jurisdictional guidelines in place to address how any concerns, complaints, medication errors, or other patient safety issues arising from the proposed method of sale of medications would be handled.

Further, Canadian pharmacists are prohibited by law from filling prescriptions issued by American health practitioners. Thus, third-party Canadian prescribers would necessarily become part of the process, moving Canadian pharmacists one step further from the direct practitioner-patient relationship and significantly increasing public safety concerns as well as threatening the integrity of ethical pharmacy practice in our province.

The proposed legislation would create a framework with such significant regulatory and operational gaps that it would in essence have the effect of encouraging the lawless sale of prescription medications across borders. This is unacceptable. In order to consider supporting this type of legislation at any point in the future, significant research, consultation, and legislative cooperation would need to take place.

For these reasons, the NLPB opposes policies that authorize American consumers to import prescription drugs from Canada, as it would have the effect of encouraging a practice that is outside the scope of our oversight and regulation and that places the public at risk. We urge policymakers in both jurisdictions to shift their focus to meaningful, long­ term reforms that will deliver affordable and accessible health care and pharmaceuticalproducts to all patients within their respective regulated health care systems.

Sincerely,

Margot Priddle 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

Dr. J. Haggie, Minister of Health, Government of Newfoundland and Labrador

Dr. Linda lnkpen, Registrar, College of Physicians and Surgeons, Newfoundland and Labrador

Ms. Lynn Power, Executive Director, Association of Registered Nurses of Newfoundland and Labrador