Canada adopts new regulations ahead of U.S. drug import rule United States



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The Trump administration’s new rule allowing U.S. pharmacists and wholesalers to import prescription drugs in bulk from Canada comes into effect Monday.

The Canadian government announced new measures it says are aimed at preventing drug shortages, just days before a new Trump administration rule allows pharmacists and wholesalers in the United States to import drugs from the Canada.

In a Saturday statement, Canada said that as of Friday, some drugs destined for the Canadian market could no longer be distributed outside the country “if this sale causes or worsens a drug shortage.”

Businesses must also provide the government with information on existing or potential shortages upon request. These requests must be answered within 24 hours in the event of a serious or imminent health risk, the statement said.

“Our health care system is a symbol of our national identity and we are committed to defending it. The actions we take today will help protect Canadians’ access to the drugs they rely on, ”said Canadian Health Minister Patty Hadju.

US President Donald Trump announced late last year his intention to allow US states and Indigenous governments to set up programs to import prescription drugs from Canada as part of an effort to reduce often exorbitant costs for American consumers.

The new regulation, known as the Importation of Prescription Drugs Rule, comes into effect Monday.

Under the new regulations, native governments, pharmacists and wholesalers will be allowed to submit drug import proposals to the United States Food and Drug Administration (FDA).

Importers must demonstrate how these proposals meet U.S. health and safety regulations and help reduce costs, according to the rule.

“The goal… is to achieve a significant reduction in the cost of covered products for the US consumer while posing no additional risk to the health and safety of the public,” according to the new rule.

Ottawa said importing drugs from Canada would not help meet the high costs in the United States, as the Canadian prescription drug market only accounts for 2% of global sales.

The cost of prescription drugs in the United States is often exorbitant [File: George Frey/Reuters]

But several US states, including Florida and Vermont, have expressed interest in importing drugs from Canada, US Department of Health and Human Services (HHS) chief Alex Azar said last year. , Reuters news agency reported.

On November 23, Florida Republican Governor Ron DeSantis announced he had submitted a proposal to HHS to import drugs from Canada.

The state will begin by importing drugs to help people with chronic health conditions, including asthma, diabetes and HIV / AIDS, DeSantis said in a statement.

“For too long, Floridians have paid exorbitant prices for prescription drugs,” he said. “Today, we are taking another step towards lowering these prices.”

US pharmaceutical companies have raised opposition, however, and earlier this week three industry groups filed a lawsuit against the new regulation, alleging it “ignores key protections … designed to keep patients safe. “.

“It is alarming that the administration has chosen to pursue a policy that threatens public health at the same time as we fight a global pandemic,” said James Stansel, executive vice president of pharmaceutical research and US manufacturers, in a communicated.



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