Canada enacts new rules earlier than US drug import rule | United States

The new Trump administrative rule that allows U.S. pharmacists and wholesalers to import prescription drugs from Canada in bulk goes into effect Monday.

The Canadian government announced new measures aimed at preventing drug shortages just days before a new Trump administrative rule would allow pharmacists and wholesalers in the US to import drugs from Canada.

In a statement on Saturday, Canada said that as of Friday, certain drugs destined for the Canadian market will no longer be allowed outside the country “if that sale would cause or worsen a drug shortage.”

Companies are also required to provide the government with information about existing or potential bottlenecks upon request. These requests must be answered within 24 hours if there is a serious or imminent health risk, the statement said.

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

US President Donald Trump announced plans late last year to enable US states and indigenous governments to set up programs to import prescription drugs from Canada to cut costs, which are often exorbitant for American consumers.

This new regulation, known as the Prescription Drug Import Regulation, goes into effect Monday.

The new regulations allow indigenous governments, pharmacists and wholesalers to submit proposals to the US Food and Drug Administration (FDA) for importing drugs.

Importers must demonstrate how these proposals comply with U.S. health and safety regulations and help reduce costs, it is usually said.

“The purpose … is to significantly reduce the cost of insured products for the American consumer while not presenting an additional risk to the health and safety of the public,” says the new rule.

Ottawa said importing drugs from Canada would not help cover high costs in the United States, given that Canada’s prescription drug market accounts for just two percent of global sales.

The cost of prescription drugs in the US is often exorbitant [File: George Frey/Reuters]But several US states, including Florida and Vermont, have expressed an interest in importing drugs from Canada, US Department of Health (HHS) chief Alex Azar said last year, Reuters reported.

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

The state will initially import medicines to help people with chronic conditions like asthma, diabetes and HIV / AIDS, DeSantis said in a statement.

For too long, Floridians have paid high prices for prescription drugs. Yesterday we took another step towards lowering those prices by telling @HHSGov a proposal for a first Canadian prescription drug import program. Info – https://t.co/Wnutjc1KM8

– Ron DeSantis (@GovRonDeSantis) November 24, 2020

“For far too long, the Floridians have been paying exorbitant prices for prescription drugs,” he said. “Today we’re taking another step towards lowering these prices.”

US drug companies have appealed, however, and earlier this week three industry groups filed a lawsuit against the new regulation claiming they were “disregarding important safeguards … designed to ensure patient safety.”

“It is alarming that the government has adopted policies that threaten public health while we fight a global pandemic,” said James Stansel, executive vice president of Pharmaceutical Research and Manufacturers in America, in a statement.

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